U.S. patent application number 15/511598 was filed with the patent office on 2018-05-10 for devices, systems and methods for using and monitoring medical devices.
This patent application is currently assigned to CANARY MEDICAL INC.. The applicant listed for this patent is CANARY MEDICAL INC.. Invention is credited to Douglas R. Holberg, William L. Hunter.
Application Number | 20180125365 15/511598 |
Document ID | / |
Family ID | 55533873 |
Filed Date | 2018-05-10 |
United States Patent
Application |
20180125365 |
Kind Code |
A1 |
Hunter; William L. ; et
al. |
May 10, 2018 |
DEVICES, SYSTEMS AND METHODS FOR USING AND MONITORING MEDICAL
DEVICES
Abstract
Medical devices are provided, comprising a medical device and a
sensor.
Inventors: |
Hunter; William L.;
(Vancouver, CA) ; Holberg; Douglas R.; (Wimberley,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CANARY MEDICAL INC. |
Vancouver |
|
CA |
|
|
Assignee: |
CANARY MEDICAL INC.
Vancouver
BC
|
Family ID: |
55533873 |
Appl. No.: |
15/511598 |
Filed: |
September 17, 2015 |
PCT Filed: |
September 17, 2015 |
PCT NO: |
PCT/US15/50789 |
371 Date: |
March 15, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62051855 |
Sep 17, 2014 |
|
|
|
62184820 |
Jun 25, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/00 20130101; A61B
2562/043 20130101; A61B 5/6862 20130101; A61N 1/3702 20130101; A61F
2/32 20130101; A61B 5/02108 20130101; A61B 5/4851 20130101; A61F
2/0059 20130101; A61F 2/3859 20130101; A61F 2/389 20130101; A61B
5/021 20130101; A61B 17/74 20130101; A61F 5/0123 20130101; A61B
5/036 20130101; A61B 5/7275 20130101; A61B 2562/0219 20130101; A61F
2/07 20130101; A61C 8/00 20130101; A61F 2/3877 20130101; A61B
2562/0247 20130101; A61F 2/16 20130101; A61B 2562/063 20130101;
A61B 5/02014 20130101; A61B 2560/0219 20130101; A61B 5/686
20130101; A61B 5/029 20130101; G16H 40/63 20180101; A61N 1/3956
20130101; A61F 2/2412 20130101; A61B 5/026 20130101; A61B 5/6853
20130101; A61B 5/01 20130101; G16H 40/60 20180101; A61B 5/6812
20130101; A61F 5/055 20130101; A61B 5/0024 20130101; A61B 5/0031
20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; G16H 40/60 20060101 G16H040/60; A61N 1/37 20060101
A61N001/37 |
Claims
1. A sensor module, comprising: a sensor channel; and a
communication interface coupled to the sensor channel.
2-12. (canceled)
13. A medical device, comprising a medical device and a sensor
module according to claim 1.
14-23. (canceled)
24. A method, comprising: sensing a physical quantity using the
sensor module of claim 1; and generating a representation of the
sensed quantity.
25-79. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C. .sctn.
119(e) of U.S. Provisional Patent Application No. 62/051,855 filed
Sep. 17, 2014, and U.S. Provisional Patent Application No.
62/184,820 filed Jun. 25, 2015, which applications are incorporated
herein by reference in their entireties.
FIELD OF THE INVENTION
Technical Field
[0002] The present invention relates generally to medical devices,
and more specifically, to devices and methods for monitoring the
placement, efficacy, durability and performance of a wide variety
of temporary and/or permanently implantable medical devices.
BACKGROUND
Description of the Related Art
[0003] Medical devices and implants have become common-place in
modem medicine. Typically, medical devices and implants are
manufactured to replace, support, or enhance an anatomical or
biological structure. Examples of medical devices include
cardiovascular implants such as implantable cardioverter
defibrillators, pacemakers, stents, stent grafts, bypass grafts,
catheters and heart valves; orthopedic implants such as hip and
knee prosthesis; spinal implants and hardware (spinal cages,
screws, plates, pins, rods and artificial discs); intrauterine
devices; orthopedic hardware used to repair fractures and soft
tissue injuries (casts, braces, tensor bandages, plates, screws,
pins and plates); cochlear implants; aesthetic implants (breast
implants, fillers); dental implants: medical polymers; and
artificial intraocular eye lenses.
[0004] Unfortunately, various complications may arise during
insertion of the medical device or implant (whether it is an open
surgical procedure or a minimally invasive procedure). For example,
a surgeon may wish to confirm correct anatomical alignment and
placement of the implant within surrounding tissues and structures.
This can however be difficult to do during the procedure itself,
making corrective adjustments difficult.
[0005] In addition, a patient may experience a number of
complications post-procedure. Such complications include
neurological symptoms, pain, malfunction (blockage, loosening,
etc.) and/or wear of the implant, movement or breakage of the
implant, inflammation and/or infection. While some of these
problems can be addressed with pharmaceutical products and/or
further surgery, they are difficult to predict and prevent; often
early identification of complications and side effects is difficult
or impossible.
[0006] The present invention discloses novel medical devices and
implants which can overcome many of the difficulties and
limitations found with previous medical devices and implants,
methods for constructing and monitoring these novel medical devices
and implants, and further provides other related advantages.
[0007] All of the subject matter discussed in the Background
section is not necessarily prior art and should not be assumed to
be prior art merely as a result of its discussion in the Background
section. Along these lines, any recognition of problems in the
prior art discussed in the Background section or associated with
such subject matter should not be treated as prior art unless
expressly stated to be prior art. Instead, the discussion of any
subject matter in the Background section should be treated as part
of the inventor's approach to the particular problem, which in and
of itself may also be inventive.
SUMMARY
[0008] Briefly stated, medical devices and implants (also referred
to as `medical devices`) are provided comprising a medical device
along with one or more ISMs ("Implantable Sensor Modules") which
can be utilized to monitor the integrity and efficaciousness of the
medical device.
[0009] Representative examples of medical devices and implants
include, for example, cardiovascular devices and implants such as
implantable cardioverter defibrillators, pacemakers, stents, stent
grafts, bypass grafts, catheters and heart valves; orthopedic
implants such as hip and knee prosthesis; spinal implants and
hardware (spinal cages, screws, plates, pins, rods and artificial
discs); a wide variety of medical tubes, cosmetic and/or aesthetic
implants (e.g., breast implants, fillers); a wide variety of
polymers; intrauterine devices; orthopedic hardware (e.g., casts,
braces, tensor bandages, external fixation devices, tensors, slings
and supports) and internal hardware (e.g., K-wires, pins, screws,
plates, and intramedullary devices (e.g., rods and nails));
cochlear implants; dental implants; medical polymers, a wide
variety of neurological devices; and artificial intraocular eye
lenses.
[0010] The ISMs may be positioned on the inside of the medical
device, within the body of the medical device, or on the
outer/inner surface (or surfaces) of the medical device, and/or
between the medical device and any device that might be utilized to
deliver the implant, as well as cements, sutures and glues that may
also be utilized within a surgical procedure. Within certain
embodiments, the sensors are of the type that are passive and thus
do not require their own power supply.
[0011] Within one embodiment of the invention, the ISM is a
self-contained module having one or more sensors as described
herein, a sensor interface, a processor interface, battery
management, and a wireless interface. Within preferred embodiments
of the invention the ISM will be less than 5, 4, 3, 2, or 1 cubic
centimeter in size, and more preferably, less than 5.0, 4.5, 4.0,
3.5, 3.0, 2.5, 2.0, 1.5, 1.0, 0.9, 0.8. 0.7, 0.6, 0.5, 0.4, 0.3,
0.2, or 0.1 cubic centimeters in size. Within various embodiments
the ISM can be comprised of a solid outer core, or composed of
flexible materials (e.g., a degradable or non-degradable outer
polymeric surface). Within certain embodiments the ISM may be
relatively square and solid, and yet with in other embodiments very
thin, malleable and lengthy (as compared to its width and/or
height). It can be constructed for a number of different
applications (e.g., for insertion or implantation into any of the
medical devise or implants provided herein).
[0012] ISMs can also be utilized in delivery devices which are
associated with, or used along with the medical device and implant.
Representative examples include drills, drill guides, mallets,
guidewires, catheters, balloons, trocars, endoscopes, bone
tunneling catheters, microsurgical tools and general surgical
tools.
[0013] In addition, further components or compositions may be
delivered along with the medical device and implant which also can
have or contain an ISM, including for example, fillers such as
sutures, glues, collagen, fibrin, growth factors, barriers,
hemostats, bone cement and polymers such as PMMA.
[0014] Within preferred embodiments of the above, the ISM, medical
device, medical delivery device and filler are all provided in a
sterile form (e.g., ETO sterilized), non-pyrogenic, suitable for
use in humans and in a kit containing components suitable for a
particular surgery. Within further embodiments one or more of the
components may be provided together as a kit.
[0015] Representative examples of sensors which may be contained
within an ISM and which are suitable for use within the present
invention include accelerometers (acceleration, tilt, vibration,
shock and rotation sensors), pressure sensors, contact sensors,
position sensors, chemical sensors, tissue metabolic sensors,
mechanical stress sensors, auditory sensors and temperature
sensors. Within particularly preferred embodiments the sensor is a
wireless sensor, or a sensor connected to a wireless
microprocessor. Within further embodiments the medical device,
delivery device or surgical tool can have more than one type of the
above-noted sensors.
[0016] According to various embodiments, sensors can be placed into
an ISM at different locations in order to monitor the operation,
movement, anatomical location, medical imaging (both of the medical
device and the surrounding tissues), function, physical integrity,
wear, performance, potential side effects, medical status of the
patient and the medical status of the medical device and its
interface with the live tissue of the patient. Live, continuous or
intermittent, in situ, monitoring of patient activity, patient
function, medical device activity, medical device function, medical
device performance, medical device placement, medical device forces
and mechanical stresses, medical device and surrounding tissue
anatomy (imaging), mechanical, functional and physical integrity of
the medical device, and potential local and systemic side effects
is provided. In addition, information is available on many aspects
of the medical device and its interaction with the patient's own
body tissues, including clinically important measurements not
currently available through physical examination, medical imaging
and diagnostic medical studies.
[0017] According to one embodiment, the ISM has one or more sensors
to provide evaluation data of any motion or movement of the medical
device. Motion sensors and accelerometers can be used to accurately
determine the movement of the medical device and to determine if
there is movement between the device and surrounding tissue (e.g.,
bone, blood vessels, soft tissues, organs). Such evaluation can be
utilized to help reduce the incidence of improper placement,
alignment and deployment during surgical placement,
migration/breakage/wear during medical and physical examination
post-operatively, and malfunction or side effects during normal
daily activities after the patient returns home.
[0018] According to another embodiment, ISMs having contact sensors
are provided between the medical device and implant and the
surrounding tissue and/or between articulated components of the
device/implant itself (e.g., in the case of orthopedic devices or
implants, stent grafts, overlapping stents, heart valves, etc.). In
other embodiments, vibration sensors are provided to detect the
vibration between the medical device and/or the surrounding tissue.
In other embodiments, ISMs having strain gauges are provided to
detect the strain between the medical device and the surrounding
tissue and/or between articulated components of the device/implant
itself (e.g., in the case or orthopedic devices, stent grafts,
multiple stents, heart valves, etc.). Sudden increases in strain
may indicate that too much stress is being placed on the medical
device, which may increase damage to the body and/or breakage,
cracking and/or damage to the device.
[0019] According to other embodiments, accelerometers are provided
in the ISM which detect vibration, shock, tilt and rotation of the
device/implant and by extension the surrounding tissue itself.
According to other embodiments, sensors are provided in the ISM for
measuring surface wear, such as contact or pressure sensors, which
may be embedded at different depths within the medical device in
order to monitor contact of the medical device with surrounding
tissues, or degradation of the medical device over time (e.g., in
the context of a biodegradable or bioerodible implants and devices,
or surfaces subject to repeated rubbing or wear such as joint
surfaces or heart valve leaflets). In other embodiments, ISMs are
provided with position sensors, as well as other types of sensors,
which indicate potential problems such as movement, migration,
pressure on surrounding anatomical structures, alignment, breakage,
cracking and/or bending of the medical device in actual use over a
period of time.
[0020] Within further embodiments, the medical device can contain
one or more ISMs with sensors at specified densities in specific
locations. For example, the medical device can have a density of
sensors of greater than one, two, three, four, five, six, seven,
eight, nine, or ten sensors [e.g., accelerometers (acceleration,
tilt, vibration, shock and rotation sensors), pressure sensors,
contact sensors, position sensors, chemical sensors, tissue
metabolic sensors, mechanical stress sensors and temperature
sensors, or any combination of these] per square centimeter of the
device/implant. Within other embodiments, the medical device can
have a density of sensors of greater than one, two, three, four,
five, six, seven, eight, nine, or ten sensors [e.g., accelerometers
(acceleration, tilt, vibration, shock and rotation sensors),
pressure sensors, contact sensors, position sensors, chemical
sensors, tissue metabolic sensors, mechanical stress sensors and
temperature sensors, or any combination of these] per cubic
centimeter of the device.
[0021] Within certain embodiments of the invention, the medical
device is provided with a specific unique identifying number, and
within further embodiments, each of the ISMs and/or each of the
sensors on, in or around the medical device each have either a
specific unique identification number, or a group identification
number [e.g., an identification number that identifies the sensor
as accelerometers (acceleration, tilt, vibration, shock and
rotation sensors), pressure sensors, contact sensors, position
sensors, chemical sensors, tissue metabolic sensors, mechanical
stress sensors and temperature sensors]. Within yet further
embodiments, the specific unique identification number or group
identification number is specifically associated with a position
on, in or around the medical device.
[0022] Within other aspects of the invention methods are provided
for monitoring an anatomically-implanted medical device comprising
the steps of transmitting a wireless electrical signal from a
location outside the body to a location inside the body; receiving
the signal at a sensor positioned on, in or around a medical device
located inside the body; powering the sensor using the received
signal; sensing data at the sensor; and outputting the sensed data
from the sensor to a receiving unit located outside of the
body.
[0023] Within another aspect of the invention methods are provided
for monitoring an anatomically-implanted medical device comprising
the steps of transmitting a wireless electrical signal from a
location outside the body to a location inside the body; receiving
the signal at ISM implanted on or within a medical device located
inside the body; sensing data at the sensor; and outputting the
sensed data to a location outside of the body. Within one
embodiment, the sensed data may be output to a location outside of
the body by a further implantable module that does not contain
sensors, or which is designed to coordinate and distribute sensed
data between one or more ISMs.
[0024] Within related aspects of the invention, a subject may have
more than one implanted ISM. Furthermore, multiple ISMs may be
`connected`, in that, they can be designed to communicate with each
other, and can perform different functions. For example, within one
aspect of the invention methods are provided for monitoring two or
more anatomically-implanted medical devices comprising the steps of
transmitting a wireless electrical signal from a location outside
the body to a location inside the body; receiving the signal at one
of a plurality of ISMs implanted on or within a medical device
located inside the body; receiving said signal at ISM implanted on
or within a medical device located inside the body; processing said
signal and transmitting to one or more other ISMs implanted on or
within a medical device located inside the body; sensing data at a
sensor in one or more of the other ISMs; and outputting the sensed
data from one or more of the other ISMs to the one of a plurality
of ISMs; processing the data received from the one or more of the
other ISMs; and outputting processed data to a receiving unit
located outside of the body. Within various embodiments, one of the
plurality of ISMs receiving said signal from outside the body may
not necessarily contain sensors, or be utilized to provide sensor
data, but rather, for example, for signal processing. Within yet
other embodiments an implantable module can be utilized solely to
receive, send and/or store signals. Such implantable modules may be
utilized to coordinate and transmit signals within a subject, to
locations outside of the subject.
[0025] Within other aspects of the invention methods are provided
for imaging a medical device as provided herein, comprising the
steps of (a) detecting the location of one or more ISMs having
sensors in or on the medical device, any associated anatomical or
radiological "landmarks", and/or associated medical delivery device
or surgical tool; and (b) visually displaying the relative
anatomical location of said one or more ISMs having one or more
sensors, such that an image of the medical device is created.
Within various embodiments, the step of detecting may be done over
time, and the visual display may thus show positional movement over
time. Within certain preferred embodiments the image which is
displayed is a three-dimensional image.
[0026] The imaging techniques provided herein may be utilized for a
wide variety of purposes. For example, within one aspect, the
imaging techniques may be utilized during a surgical procedure in
order to ensure proper anatomical placement, alignment, deployment
and functioning of the medical device. Particularly in orthopedic
reconstructive surgery (joint replacement) proper alignment and
motion is critical, while in trauma surgery and fracture reduction,
proper alignment and immobilization of the bone fragments is
critical to obtaining a good outcome; therefore, allowing the
surgeon to be able to see the implant's position in "real time"
(particularly in procedures where direct vision is not possible)
would be beneficial for achieving proper anatomical placement,
alignment and immobilization. Within other embodiments, the imaging
techniques may be utilized post-operatively in order to examine the
medical device, examine the interface with surrounding tissues,
and/or to compare operation, integrity, alignment and/or movement
of the device/implant over time.
[0027] The integrity of the medical device can be wirelessly
interrogated and the results reported on a regular basis. This
permits the health and status of the patient to be checked on a
regular basis or at any time as desired by the patient and/or
physician. Furthermore, the medical device can be wirelessly
interrogated when signaled by the patient to do so (via an external
signaling/triggering device) as part of "event recording"--i.e.
when the patient experiences a particular event (e.g. pain, injury,
instability, etc.) she/he signals/triggers the device/implant to
obtain a simultaneous reading in order to allow the comparison of
subjective/symptomatic data to objective/sensor data. Matching
event recording data with sensor data can be used as part of an
effort to better understand the underlying cause or specific
triggers of a patient's particular symptoms. Hence, within various
embodiments of the invention, methods are provided for detecting
and/or recording an event in a subject with one of the medical
devices provided herein, comprising interrogating one of the ISMs
on the medical device as provided herein at a desired point in
time. Within one aspect of the invention, methods are provided for
detecting and/or recording an event in a subject with the medical
device as provided herein, comprising the step of interrogating at
a desired point in time the activity of one or more of the ISMs
having sensors within the medical device, and recording said
activity. Within various embodiments, interrogation may be
accomplished by the subject and/or by a health care professional.
Within related embodiments, the step of recording may be performed
with one or more wired devices, or, wireless devices that can be
carried, or worn (e.g., a cellphone, watch or wristband, shoe,
and/or glasses).
[0028] Within yet other aspects of the invention methods, devices
are provided suitable for transmitting a wireless electrical signal
from a location outside the body to a location inside the body;
receiving the signal at one of the aforementioned sensors
positioned on, in or around the medical device located inside the
body; powering the sensor using the received signal; sensing data
at the sensor; and outputting the sensed data from the sensor to a
receiving unit located outside of the body. Within certain
embodiments the receiving unit can provide an analysis of the
signal provided by the sensor.
[0029] The data collected by the sensors can be stored in a memory
located within the ISM, or on the medical device, or on an
associated device (e.g., an associated medical device, or an
external device such as a cellphone, watch, wristband, and/or
glasses). During a visit to the physician, the data can be
downloaded via a wireless sensor, and the doctor is able to obtain
data representative of real-time performance of the medical
implant, and any associated medical device.
[0030] The advantages obtained include more accurate monitoring of
the medical device and permitting medical reporting of accurate, in
situ, data that will contribute to the health of the patient. The
details of one or more embodiments are set forth in the description
below. Other features, objects and advantages will be apparent from
the description, the drawings, and the claims. In addition, the
disclosures of all patents and patent applications referenced
herein are incorporated by reference in their entirety.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] FIG. 1 is a diagram of a sensor module, according to an
embodiment.
[0032] FIG. 2 is a diagram of a sensor module that includes
multiple sensing channels, according to an embodiment.
[0033] FIG. 3 is a diagram of a sensor-module power system,
according to an embodiment.
[0034] FIG. 4 is a diagram of a sensor-module data system,
according to an embodiment.
[0035] FIG. 5 is a diagram of a sensor-module data system,
according to another embodiment.
[0036] FIG. 6 is a diagram of a sensor-module network, according to
an embodiment.
[0037] FIG. 7 is a schematic illustration of an ISM positioned on a
stent graft within a patient which is being probed for data and
outputting data, according to one embodiment of the invention.
[0038] FIG. 8 illustrates the development of an endoleak from the
beginning of the leak (8A) to substantial formation of the leak
(8B). FIGS. 8C and 8D are a blown up images of 8A and 8B,
respectively, which depicts the movement of the ISM sensors during
development of the endoleak.
[0039] FIG. 9 is a schematic of various types of stent placement,
and contact sensors which can aid in this placement. FIG. 9A
illustrates a site of bifurcation with stenosis occurring at
multiple points in the vessel. FIG. 9B illustrates a stent with
PTCA. FIG. 9C illustrates a stent plus stent deployment (also
referred to as a "reverse-T"). FIG. 9D illustrates a stent plus
stent deployment (referred to as "T stenting"). FIG. 9E illustrates
a stent plus stent deployment referred to as a "Crush". FIG. 9F
illustrates a stent plus stent deployment referred to as a "Y" or
"V". FIG. 9G illustrates a stent plus stent deployment referred to
as "Kissing". FIG. 9H illustrates a stent plus stent deployment
referred to as a "Culotte".
[0040] FIG. 10 is a schematic illustration of an ISM having contact
sensors that can be utilized to aid and or assist the placement of
overlapping stents.
[0041] FIG. 11 illustrates the medical imaging of vasculature by an
ISM having sensors which can detect positional movement due to
vascular pathology (e.g., restenosis or thrombus formation).
[0042] FIG. 12 is a representative example of an implantable hip
prosthesis.
[0043] FIG. 13 is an illustration of an implanted hip prosthesis
having several ISMs.
[0044] FIG. 14 is an isometric view of a total knee
replacement.
[0045] FIG. 15A is an exploded view of the total knee replacement
of FIG. 14. FIG. 15B depicts a tibial plate with attached tibial
extension. FIG. 15C depicts a tibial extension separated from a
tibial plate. FIG. 15D depicts a tibial extension.
[0046] FIG. 16 shows the total knee replacement within a
patient.
[0047] FIG. 17 is a side view of a total assembled knee with
examples of different sensor locations.
[0048] FIG. 18 illustrates one embodiment wherein an ISM having
sensors of various types are deployed throughout a balloon
catheter.
[0049] FIG. 19 illustrates one embodiment wherein sensors of
various types are deployed by an ISM on the surface of an aesthetic
(breast) implant.
[0050] FIG. 20 illustrates one embodiment called vertebroplasty
wherein an ISM is placed into the body of the body of a vertebrae,
followed by injection of bone cement (without the use of a
balloon). These Figures illustrate one embodiment wherein, a hole
is created in the vertebral body (FIG. 20A) through a bone
tunneling catheter; introduction of an ISM (FIG. 20B); and
introduction of a delivery device (FIG. 20C) which allows injection
of the bone cement directly into the collapsed bone. The
compression fracture is corrected and supported through the
injection of bone cement into the vertebral body (as shown in FIGS.
20D and 20E) to restore the normal height of the vertebra.
[0051] FIG. 21 illustrates one embodiment wherein one or more ISMs
are placed on and/or within a kyphoplasty balloon.
[0052] FIG. 22 illustrates a variety of spinal fusion implants,
including pedicle screws affixed to rods (FIG. 22A), and a spinal
plate retained by screws (FIG. 22B).
[0053] FIG. 23 illustrate a spinal (interbody) cage having an
ISM.
[0054] FIG. 24 illustrate an artificial intervertebral disc having
an ISM.
[0055] FIG. 25 illustrates the use and placement of an external
fixation device (including the use of screws, pins and clamps) on a
bone (FIG. 25A), and an external fixation device having several
ISMs placed on it (FIG. 25B) implanted on the arm (FIG. 25C).
[0056] FIG. 26 illustrates a variety of braces and slings. FIG. 26A
illustrates a knee brace having ISMs; FIG. 26B a neck brace.
[0057] FIG. 27 illustrates one embodiment wherein an ISM is placed
on or within several pins (Steinmann pins) inserted to reduce a
humeral fracture.
[0058] FIG. 28 illustrates one embodiment wherein an ISM is placed
on and/or within several K-wires (Kirschner wires) inserted to
reduce a radial fracture.
[0059] FIGS. 29A and 29B illustrate representative dynamic hip
screws having ISMs, including cortical screws inserted into the
sideplate (FIG. 29A), and an illustration of the device inserted
into a subject (FIG. 29B). FIG. 29C illustrates an embodiment
wherein ISMs are placed on a representative fixation plate.
[0060] FIG. 30 illustrates representative intramedullary rods or
nails, including an intramedullary nail (FIG. 30A) having ISMs, and
placement of an intramedullary nail having ISMs in the tibia (FIG.
30B).
[0061] FIG. 31A illustrates a representative bileaflet mechanical
valve with an ISM. FIG. 31B illustrates a tilting disc mechanical
valve with an ISM.
[0062] FIG. 32A illustrates a representative porcine valve with an
ISM. FIG. 32B illustrates a representative bovine valve with an
ISM.
[0063] FIG. 33A illustrates an ISM on an expanded (stent) scaffold,
and FIG. 33B illustrates a representative percutaneous heart valve
with an ISM and a representative delivery system with an ISM.
[0064] FIG. 34A illustrates an ISM on a balloon delivery device for
a balloon-expandable percutaneous heart valve, as well as an ISM on
the balloon itself. FIG. 34B illustrates an ISM on a
balloon-expandable percutaneous heart valve.
[0065] FIG. 35 is a schematic illustration of an ISM on a medical
device as described herein within a subject which is being probed
for data and outputting data, according to one embodiment of the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0066] Briefly stated the present invention provides a variety of
medical devices and implants that can be utilized to monitor the
placement, location, anatomy, alignment, immobilization,
performance, healing, integrity, wear, side effects, and/or
efficaciousness of the medical device, and any associated medical
devices and or device delivery instruments. Prior to setting forth
the invention however, it may be helpful to an understanding
thereof to first set forth definitions of certain terms that are
used hereinafter.
[0067] "Medical device" refers to an instrument, apparatus,
constructed element or composition, machine, implement, or similar
or related article that can be utilized to diagnose, prevent, treat
or manage a disease or other condition(s). The medical devices
provided herein may, depending on the device and the embodiment, be
implanted within a subject, utilized to deliver a device to a
subject, or, utilized externally on a subject. In many embodiments
the medical devices provided herein are sterile, and subject to
regulatory requirements relating to their sale and use.
Representative examples of medical devices and implants include,
for example, cardiovascular devices and implants such as
implantable cardioverter defibrillators, pacemakers, stents, stent
grafts, bypass grafts, catheters and heart valves; orthopedic
implants (e.g., total or partial arthroplastic joints such as hip
and knee prosthesis); spinal implants and hardware (spinal cages,
screws, plates, pins, rods and artificial discs); a wide variety of
medical tubes, cosmetic and/or aesthetic implants (e.g., breast
implants, fillers); a wide variety of polymers, bone cements, bone
fillers, scaffolds, and naturally occurring materials (e.g., heart
valves, and grafts from other naturally occurring sources);
intrauterine devices; orthopedic hardware (e.g., casts, braces,
tensor bandages, external fixation devices, tensors, slings and
supports) and internal hardware (e.g., K-wires, pins, screws,
plates, and intramedullary devices (e.g., rods and nails));
cochlear implants; dental implants; medical polymers, a wide
variety of neurological devices; and artificial intraocular eye
lenses.
[0068] "Sensor" refers to a device that can be utilized to measure
one or more different aspects of a body tissue (anatomy,
physiology, metabolism, and/or function) and/or one or more aspects
of the medical device. Representative examples of sensors suitable
for use within the present invention include, for example, fluid
pressure sensors, fluid volume sensors, contact sensors, position
sensors, pulse pressure sensors, blood volume sensors, blood flow
sensors, chemistry sensors (e.g., for blood and/or other fluids),
metabolic sensors (e.g., for blood and/or other fluids),
accelerometers, mechanical stress sensors and temperature sensors.
Within certain embodiments the sensor can be a wireless sensor, or,
within other embodiments, a sensor connected to a wireless
microprocessor. Within further embodiments one or more (including
all) of the sensors can have a Unique Sensor Identification number
("USI") which specifically identifies the sensor and/or a Unique
Device Identification number ("UDI") with which the sensors can
provide unique information of the associated Medical device for
tracking purposes of the Medical Device manufacturer, the health
care system, and regulatory requirements.
[0069] A wide variety of sensors (also referred to as
Microelectromechanical Systems or "MEMS", or Nanoelectromechanical
Systems or "NEMS", and BioMEMS or BioNEMS, see generally
https://en.wikipedia.org/wiki/MEMS) can be utilized within the
present invention. Representative patents and patent applications
include U.S. Pat. Nos. 7,383,071, 7,450,332; 7,463,997, 7,924,267
and 8,634,928, and U.S. Publication Nos. 2010/0285082, and
2013/0215979. Representative publications include "Introduction to
BioMEMS" by Albert Foch, CRC Press, 2013; "From MEMS to Bio-MEMS
and Bio-NEMS: Manufacturing Techniques and Applications by Marc J.
Madou, CRC Press 2011; "Bio-MEMS: Science and Engineering
Perspectives, by Simona Badilescu, CRC Press 2011; "Fundamentals of
BioMEMS and Medical Microdevices" by Steven S. Saliterman, SPIE-The
International Society of Optical Engineering, 2006; "Bio-MEMS:
Technologies and Applications", edited by Wanjun Wang and Steven A.
Soper, CRC Press, 2012; and "Inertial MEMS: Principles and
Practice" by Volker Kempe, Cambridge University Press, 2011; Polla,
D. L., et al., "Microdevices in Medicine," Ann. Rev. Biomed. Eng.
2000, 02:551-576; Yun, K. S., et al., "A Surface-Tension Driven
Micropump for Low-voltage and Low-Power Operations," J.
Microelectromechanical Sys., 11:5, October 2002, 454-461; Yeh, R.,
et al., "Single Mask, Large Force, and Large Displacement
Electrostatic Linear Inchworm Motors," J. Microelectromechanical
Sys., 11:4, August 2002, 330-336; and Loh, N. C., et al., "Sub-10
cm.sup.3 Interferometric Accelerometer with Nano-g Resolution," J.
Microelectromechanical Sys., 11:3, June 2002, 182-187; all of the
above of which are incorporated by reference in their entirety.
[0070] Within various embodiments of the invention the sensors
described herein may be placed at a variety of locations and in a
variety of configurations, on the inside of a medical device,
within the body of the medical device, on the outer surfaces (or
inner surfaces) of the medical device, between the medical device
and other medical devices or implants, and/or between the medical
device and any device that might carry or deliver it (e.g., a
delivery device, injection device, or surgical instrument). When
the phrase "placed in a medical device" or "placed in a medical
implant" is utilized, it should be understood to refer to any of
the above embodiments (or any combination thereof) unless the
context of the usage implies otherwise.
[0071] The sensors may be placed in the medical device alone, or
along with an associated medical device which might be utilized in
a desired surgical procedure. For example, within certain
embodiments, the medical device and/or medical device kit comprises
sensors at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
or greater than 10 sensors per square centimeter. Within other
aspects, the medical device and/or medical device kit comprises
sensors at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
or greater than 10 sensors per cubic centimeter. Within either of
these embodiments, there can be less than 50, 75, 100, or 100
sensors per square centimeter, or per cubic centimeter. Within
various embodiments, at least one or more of the sensors may be
placed randomly, or at one or more specific locations within the
medical device, medical device, or kit as described herein.
[0072] In various embodiments, the sensors may be placed within
specific locations and/or randomly throughout the medical device
and/or associated devices. In addition, the sensors may be placed
in specific patterns (e.g., they may be arranged in the pattern of
an X, as oval or concentric rings around the orthopedic implant
and/or associated devices).
[0073] "Implantable Sensor Module" or "ISM" is a sensing device
which is configured to be implanted in, or otherwise attachable to,
a living subject, such as a human subject, and is configured to
sense one or more physical quantities, to generate a signal that
represents the sensed quantity, and to transmit the signal to a
remote receiver. The ISM may have one or more sensors as provided
above. The ISM may be implanted into a subject directly, or, within
one or more medical devices which are implanted within a subject.
Within an embodiment, the signal may contain information encoded to
represent one or more of a magnitude, phase, and type of the sensed
physical quantity.
[0074] Within one embodiment of the invention, the ISM is a
self-contained module having one or more sensors as described
herein, a sensor interface, a processor interface, battery
management, and a wireless interface. Within preferred embodiments
of the invention the ISM will be less than 5, 4, 3, 2, or 1 cubic
centimeter in size, and more preferably, less than 5.0, 4.5, 4.0,
3.5, 3.0, 2.5, 2.0, 1.5, 1.0, 0.9, 0.8. 0.7, 0.6, 0.5, 0.4, 0.3,
0.2, or 0.1 cubic centimeters in size. Within various embodiments
the ISM can be comprised of a solid outer core, or composed of
flexible materials (e.g., flexible/malleable alloys, a degradable
or non-degradable outer polymeric surface). Within related
embodiments, the ISM can be comprised of flexible circuitry
(including for example, single and double-sided flexible circuits.
Within certain embodiments the ISM may be relatively square and
solid, and yet with in other embodiments very thin, pliable and
lengthy (as compared to its width and/or height). It can be
constructed for a number of different applications (e.g., for
insertion, attachment or implantation into any of the medical
devices or implants provided herein).
Representative Embodiments of Medical Devices and Medical Uses of
Sensor-Containing Medical Devices
[0075] In order to further understand the various aspects of the
invention provided herein, the following sections are provided
below: [0076] A. Implantable Sensor Modules; [0077] B. Implantable
Medical Devices (including B1--Stent Grafts; B2--Stents; B3--Hips;
B4--Knees; B5--Tubes; B6--Implants; B7--Spinal Implants;
B8--Orthopedic Hardware; B9--Polymers; B10--Heart Valves; and B11
Methods of Manufacture); [0078] C. Use of Medical Devices Having
ISMs to Deliver Therapeutic Agent(s); [0079] D. Methods for
Monitoring Infection in Medical devices; [0080] E. Further Uses of
ISM-containing Medical Devices or Implants in Healthcare; [0081] F.
Generation of Power from Medical Devices or Implants; [0082] G.
Medical Imaging and Self-Diagnosis of Assemblies Comprising Medical
Devices or Implants, Predictive Analysis and Predictive
Maintenance; [0083] H. Methods of Monitoring Assemblies Comprising
Medical Devices or Implants; and [0084] I. Collection,
Transmission, Analysis, and Distribution of Data from Assemblies
Comprising Medical Devices or Implants.
A. Implantable Sensor Modules
[0085] As noted above, the present invention provides ISM's
suitable for implantation in, or otherwise being attached
(internally or externally) to a living subject [e.g., by
implantation into a medical device and/or attachment to a medical
device which is then surgically placed internally (hip and knee
replacements, stents, heart valves, etc.) or applied to the outside
of the body (casts, braces, tensors, external fixation devices,
etc.)]. FIG. 1 is a diagram of a sensor module 10, according to one
embodiment of the invention. The sensor module 10 is configured to
be implantable in, or otherwise attachable to, a living subject,
such as a human subject, and is configured to sense a physical
quantity, to generate a signal that represents the sensed quantity,
and to transmit the signal to a remote receiver (not shown in FIG.
1) for processing. The ISM may be implanted into a subject
directly, within one or more medical devices which are implanted
within a subject, or, within (or attached to) a medical device that
is affixed to the outside of the body. Within an embodiment, the
signal may contain information encoded to represent one or more of
a magnitude, phase, and type of the sensed physical quantity.
[0086] The sensor module 10 may be suitable for applications that
call for the sensing of one or more biological quantities
(biological quantities are physical quantities) of the subject in
which the module is implanted or to which the module is attached.
For example, the sensor module 10 may sense one or more of the
electrical signals generated by the subject's heart, and may
generate a signal that represent an electrocardiogram of the heart;
the device that receives the signal may then generate a visual
representation of the electrocardiogram in response to the signal.
Other applications include, but are not limited to, sensing one or
more parameters (e.g., contact, pressure, position, movement, wear,
stability, level of bone attachment) related to an artificial
joint, brain activity, organ function, blood flow, digestion,
and/or drug effectiveness.
[0087] The sensor module 10 includes a power supply 12, one or more
sensors 14, a sensor interface 16, a sensor-module controller 18, a
wireless interface 20, and an antenna 22. The supply 12, sensor(s)
14, channel 16, controller 18, interface 20, and antenna 22 may be
disposed on one or more integrated-circuit dies that are
respectively disposed in one or more integrated-packages to form
one or more integrated circuits (ICs); and these one or more ICs
may be disposed in (not shown in FIG. 1), is implantable in, or
otherwise attachable too, a subject. Or, the sensor(s) 14 and the
antenna 20, or any other of the afore-mentioned components, may be
not be disposed on an IC die, but may be discrete components.
[0088] The power supply 12 is configured to generate a regulated
supply signal (e.g., a regulated supply voltage V.sub.o) to power
the other components of the sensor module 10, and includes an
energy harvester 24, a battery charger 26, a power coil 28, a
protector 30, and a battery receptacle 32 for receiving a battery
34, according to an embodiment.
[0089] The regulated supply voltage V.sub.o may be in, for example,
an approximate range of 1-24 Volts (V), according to an embodiment.
Furthermore, although not shown in FIG. 1, the power supply 12 may
generate more than one regulated supply signal.
[0090] The energy harvester 24 is configured to convert an
environmental stimulus into an electrical current or voltage for
charging the battery 34, according to an embodiment. For example,
the harvester 24 may convert, into a battery-charging electrical
current or voltage, one or more of body heat from the subject in
which the sensor module 10 is implanted or otherwise attached,
kinetic energy generated by the subject's movement, changes in
pressure (e.g., barometric pressure or pressure within the subject,
such as the subject's blood pressure), energy generated by an
electrochemical reaction within the subject's body, radio-frequency
(RF) energy (e.g., ambient RF transmissions), and light.
[0091] The battery charger 26 includes the power coil 28, which is
configured to generate a voltage and current in response to a near
magnetic field generated by a power unit (not shown in FIG. 1),
according to an embodiment; such near-magnetic-field charging may
be similar to a technique for powering a smart card. For example,
the battery charger 26 and coil 28 may be used to charge the
battery 34 while the energy harvester 24 is unable to generate
enough energy to charge the battery to a voltage level sufficient
for proper operation of the sensing module 10.
[0092] The protector 30 protects the battery 34 from overcharging
or other conditions that may damage the battery, and also protects
the power supply 12 in case a load current drawn from the regulated
voltage V.sub.o (or from another regulated supply signal that the
power supply generates) exceeds a predetermined safe threshold. The
protector 30 may also monitor temperature of battery 34 and make
appropriate adjustments of safe thresholds. For example, the
protector 30 may disable the energy harvester 24 and the battery
charger 26 if the voltage across the battery 34 exceeds a
predetermined safe threshold, and may also generate some type of
alarm to indicate a malfunction. And, the protector 30 may limit
the load current drawn from V.sub.o (or from another regulated
supply signal) to a safe limit, or may otherwise disable the power
supply 12 if the load current exceeds a predetermined safe
threshold; for example, the protector may implement such a limit or
disabling if the node carrying V.sub.o is short-circuited to
ground.
[0093] And the battery 34 may be any type of rechargeable battery,
such as a lithium-ion battery, that is suitable for use in an
electronic device that is implantable in, or otherwise attachable
to, a biological subject.
[0094] Still referring to FIG. 1, the one or more sensors 14 are
each configured to sense a respective physical quantity within, or
otherwise influenced by, the body of the subject in which the
module 10 is implanted or to which the module is attached, and are
each configured to generate a respective sensor signal that
represents one or more of a magnitude, phase (if applicable), and
type of the respective sensed quantity. Examples of such a physical
quantity include, but are not limited to, a relative or absolute
position of the sensor module 10, a movement (e.g., acceleration,
velocity, rotation) of the sensor module, and the following
quantities in the vicinity of the sensor module: an electric field,
voltage, or current, a magnetic field, a temperature, a pressure
(e.g., blood pressure), radiation, electrical conductivity, an
optical intensity, a spatial or temporal differential in the
physical quantity (e.g., a temperature differential, a pressure
differential, or a voltage differential), a biological marker
(e.g., a tumor marker, bacterial marker or DNA fragment), a
chemical composition of a substance, and a chemical reaction or a
byproduct thereof. Examples of the one or more sensors 14 include,
but are not limited to, the following types of sensors:
global-positioning-system (GPS), accelerometer, Hall-effect,
electrical (e.g., current, voltage, and conductivity), magnetic,
thermal, pressure, radiation, optical, quantity-differential,
capacitive, inductive, and microelectromechanical (MEMS). And
examples of the sensor signal include an analog or digital voltage
or current.
[0095] The sensor interface 16, which, together with the sensor(s)
14, forms a sensor channel 36, includes a power-management circuit
38, an oscillator 40, an amplifier 42, a signal conditioner 44, an
optional analog-to-digital converter (ADC) 46, and a control
circuit 50, according to an embodiment.
[0096] The power-management circuit 38 is configured to convert
V.sub.o from the power supply 12 into one or more other supply
voltages or supply currents for the sensor 14 and the circuits of
the sensor interface 16. The power manager 38 may provide power to
the sensor using a conductor or by induction using a coil. Sensor
14 may provide a signal to sensor interface 16 using one or more
conductors or by induction using a coil. The coil used to provide
power to sensor 14 may be the same coil that receives the signal
from sensor 14. Alternatively, the coil used to provide power to
sensor 14 may be separate from the coil that receives a signal from
sensor 14.
[0097] The oscillator 40 generates one or more clock signals for
the digital and mixed-signal circuits of the sensor interface 16,
and, depending on the types of the one or more sensors 14, may
generate an analog reference signal for the sensor(s) 14. For
example, a sensor 14 may generate a sensor signal by modifying one
or more of the frequency, amplitude, and phase of such an analog
reference signal in response to a respective physical quantity.
Examples of the oscillator 40 include a ring oscillator, an
operational-amplifier-based oscillator, or other digital or analog
oscillator.
[0098] The amplifier 42 is configured to amplify the sensor signal
generated by a sensor 14, according to an embodiment. Although
shown as a having a single-ended input and a single-ended output,
the amplifier 42 may have one or both of a differential input and a
differential output. Examples of the amplifier 42 include an
operational amplifier (e.g., having a feedback configuration), a
transconductance (g.sub.m) amplifier (e.g., having an open-loop
configuration), and a low-noise amplifier (LNA). If there are more
than one sensor 14, then the sensor interface 16 may include a
respective amplifier 42 for each sensor, or a mux that selects
which sensor output is input to amplifier 42. The gain of amplifier
42 may be controlled by one or more of the signal conditioner 44,
the ADC 46.
[0099] The signal conditioner 44 is configured to condition the
amplified sensor signal from the amplifier 42 for reception by the
ADC 46 if present, or for reception by the sensor-module controller
18 if the ADC is not present. For example, the conditioner 44 may
be configured to adjust the amplitude and the DC offset of the
amplified sensor signal so that it is compatible with the dynamic
input range of the ADC 46, to remove noise from, or to otherwise
filter, the amplified sensor signal, or to equalize the amplified
sensor signal. In addition, the signal conditioner 44 may be
configured to add error-correction coding (ECC) to the amplifier
sensor signal.
[0100] If present, the ADC 46 is configured to convert the
conditioned sensor signal from the analog domain to the digital
domain; but if the sensor 14 is configured to generate the sensor
signal in the digital domain, then the amplifier 42 and the signal
conditioner 44 may be digital circuits, and the ADC 46 may be
omitted as described above.
[0101] And the control circuit 50 is configured to control the
operations of one or more of the power manager 38, oscillator 40,
amplifier 42, signal conditioner 44, and ADC 46, and may be
configured to control the operations of one or more other
components of the sensor interface 16. For example, the control
circuit 50 may include, or be coupled to, a memory (not shown in
FIG. 1) that stores configuration data or programming instructions
for the sensor(s) 14 or for the sensor interface 16, and may
configure the sensor(s) 14 or the interface 16 in response to this
data or these instructions upon power up of the sensor module 10.
Furthermore, the control circuit 50 may be configured to control
communications between the interface 16 and the sensor-module
controller 18.
[0102] Still referring to FIG. 1, the sensor-module controller 18
is configured to control the operations of the power supply 12, the
sensor channel 36, the wireless interface 20, and other components
of the sensor module 10, according to an embodiment, and includes a
microcontroller or microprocessor 52, a memory 54, and a
co-controller or co-processor, such as a digital-signal processor
(DSP) 56, according to an embodiment. For clarity, hereinafter the
microcontroller/microprocessor 52 is referred to as a
microcontroller, it being understood that the microcontroller may
instead be a microprocessor.
[0103] The microcontroller 52, in cooperation with the DSP 56, is
configured to process the signal from the sensor channel 36, to
generate data from the processed signal, and to condition the
signal for transmission by the wireless interface 20. For example,
if the sensor 14 measures temperature, then the microcontroller 52
may convert the signal from the sensor interface 16 into a
temperature value in units of Fahrenheit or Celsius; or, if the
sensor measures pressure, then the microcontroller may convert the
signal from the sensor interface into a pressure value in units of
Pascal.
[0104] The memory 54 may include volatile memory and non-volatile
memory, according to an embodiment. For example, the volatile
memory may be configured to store the operating system and one or
more applications executed by the microcontroller 52, and the
non-volatile memory may be programmed to store configuration
information for the sensor module 10, such configuration
information including, but not limited to, the type of the sensor
14, the frequency signal generated by the oscillator, the gains of
the amplifier 42 and the signal conditioner 44, and the level of
the voltage V.sub.o generated by the power supply 12.
[0105] And the wireless interface 20 is configured to receive the
data from the sensor-module controller 18, to modulate one or more
carrier signals with the data, and to transmit, via the antenna 22,
the modulated carrier signal(s) to a remote device (not shown in
FIG. 1) for use by, e.g., the subject in which the sensor module 10
is implanted or attached, or to his/her physician. For example, the
wireless interface 20 may be configured to operate according to a
specification such as, but not limited to, one of the following
specifications: Bluetooth.RTM., near-field communication (NFC),
ZigBee (IEEE 802.15), WiFi, wireless local area network (WLAN, IEEE
802.11).
[0106] Furthermore, the wireless interface 20 may be configured to
receive a signal from a remote device (not shown in FIG. 1) via the
antenna 22, and to provide this signal to the supply-module
controller 18. For example, such a signal may include sensor-module
configuration data or program instructions, or may include a
request that the sensor-module 10 transmit specified data to the
remote device. Examples of the remote device include, but are not
limited to, a smart phone or tablet computer (FIG. 4), a computer
system (FIG. 5), or another sensor module 10 (FIG. 6).
[0107] Still referring to FIG. 1, the operation of the sensing
module 10 during a sensing mode is described, according to an
embodiment.
[0108] The power supply 12 generates the regulated supply voltage
V.sub.o (and perhaps one or more other regulated supply signals)
from the voltage V.sub.BATT across the battery 34. For example, if
the battery voltage V.sub.BATT>V.sub.o, then the power supply 12
steps down V.sub.BATT to V.sub.o; the power supply may include a
buck converter to perform such a voltage step down. Alternatively,
if V.sub.BATT<V.sub.o, then the power supply 12 steps up
V.sub.BATT to V.sub.o; the power supply may include a boost
converter to perform such a voltage step up.
[0109] The sensor 14 senses a physical quantity that the sensor is
configured to sense, and provides to the sensor interface 16 a
sensor signal that represents the sensed quantity.
[0110] The sensor interface 16 amplifies, conditions, and, if the
sensor signal is an analog signal, converts the conditioned sensor
signal to the digital domain via the amplifier 42, signal
conditioner 44, and ADC 46, respectively.
[0111] The sensor-module controller 18 processes the conditioned
(and possibly ADC converted) sensor signal from the interface 16,
and generates data representing the sensed quantity. The controller
18 may store the generated data in the memory 54 for later
retrieval, or may provide the data to the wireless interface
20.
[0112] And if the sensor-module controller 18 provides the data to
the wireless interface 20, then the wireless interface modulates
one or more carriers signals with the data from the sensor-module
controller 18, generates a transmission signal from the one or more
carriers signals, and transmits the transmission signal to a remote
device (not shown in FIG. 1) via the antenna 22.
[0113] Still referring to FIG. 1, the operation of the sensing
module 10 during a data-receiving mode is described, according to
an embodiment.
[0114] The power supply 12 generates the regulated supply voltage
V.sub.o (and perhaps one or more other regulated supply signals)
from the voltage V .sub.BATT across the battery 34 as it does
during the above-described sensing mode.
[0115] The wireless interface 20 senses a signal being received by
the antenna 22 and notifies the sensor-module controller 18.
[0116] In response to the wireless interface 20 sensing the
received signal, the sensor-module controller 18 instructs the
wireless interface to demodulate, and, if necessary, decode, the
received signal, recover the data from the signal, and provide the
data to the sensor-module controller.
[0117] The sensor-module controller 18 analyzes the recovered data,
and takes appropriate action. For example, if the data is
configuration data, then the sensor-module controller 18 may load
this data into a non-volatile portion of the memory 54, and
initiate a configuration cycle so as to configure, or reconfigure,
one or more portions of the sensing module 10 in response to the
configuration data. Or, if this data is a command, then the
sensor-module controller 18 may execute the command. For example,
if the command is a request for the sensor module 10 to send
specified other data to a remote device (not shown in FIG. 1), then
the controller 18 sends the requested data via the wireless
interface 20, which modulates one or more carrier signals with the
requested data, generates a transmission signal from the one or
more carriers signals, and transmits the transmission signal to a
remote device via the antenna 22 as described above in conjunction
with the sensing mode.
[0118] Still referring to FIG. 1, alternate embodiments of the
sensor module 10 are contemplated. For example, any of the
functions performed by the sensor module 10 may be performed either
by dedicated hardware, configurable hardware [e.g., a
field-programmable gate array (FPGA)], a microprocessor or
microcontroller executing program instructions, or a combination or
sub-combination of dedicated hardware, configurable hardware, and a
microprocessor or microcontroller executing program instructions.
Furthermore, although the sensor module 10 is described as
including components disposed in a single housing, the sensor
module may include multiple housings/pieces linked together
wirelessly and/or operating independently. Moreover, although
described as being implantable or otherwise attachable to a
subject, the sensor module 10 may be configured to be disposed
remotely from a subject, or to be ingested or inhaled by a
subject.
[0119] FIG. 2 is a diagram of a sensor module 60, according to an
embodiment. The sensor module 60 is similar to the sensor module 10
of FIG. 1, except that the sensor module 60 includes multiple
sensor channels 36.sub.1-36.sub.n, each of which may have one or
more sensors 14.
[0120] FIG. 3 is a diagram of a sensor-module power-transfer system
70, according to an embodiment.
[0121] The system 70 includes the sensor module 10 of FIG. 1, and
includes a sensor power unit 72 having a power coil 74. The sensor
power unit 72 is configured to provide energy to the sensor module
10 in a manner similar to the manner in which a smart-card reader
may power a smart card.
[0122] In operation during a power-transfer mode of the sensor
module 10, one first positions the power coil 74 in near-field
proximity (e.g., in an approximate range of 0-4 inches) to the
power coil 28 of the sensor module.
[0123] Next, one activates the power unit 72, which generates,
across the coil 74, an alternating (AC) voltage, which causes an
alternating (AC) current to flow through the coil.
[0124] Because the power coil 74 is in near-field proximity to the
power coil 28, the coils are magnetically (i.e., inductively)
coupled such that each coil acts as a respective winding of a
transformer. This coupling occurs even though the coil 28 may be
implanted in a subject such that items like air, clothing, and
biological materials (e.g., skin or other tissue, and blood)
separate the coils 28 and 74.
[0125] Due to the inductive coupling between the coils 28 and 74,
the magnetic flux generated by the AC current flowing through the
coil 74 magnetically induces an AC current through, and an AC
voltage across, the coil 28.
[0126] Consequently, the charger 26 of the power supply 12 (FIG. 1)
is configured to use the induced AC current through, and the
induced AC voltage across, the coil 28 to charge the battery 34
(FIG. 1), or the power supply 12 may include circuitry that is
configured to directly power the sensor module 10 from the induced
AC current and voltage.
[0127] After the power-transfer mode is complete, one deactivates
the sensor power unit 72 and removes the coil 74 from near-field
proximity with the coil 28.
[0128] Still referring to FIG. 3, alternate embodiments of the
sensor-module power system 70 are contemplated. For example, the
system 70 may include the sensor module 60 of FIG. 2 instead of the
sensor module 10 of FIG. 1. Or the system 70 may include more than
one sensor module (e.g., one or more of one or both sensor modules
10 and 60) or more than one power unit 72. Furthermore, as
described above in conjunction with FIG. 1, while the coil 74 is
not in near-field proximity with the sensor module 10, or while the
power unit 72 is inactive, the power supply 12 of FIG. 1 may
convert other sources of energy (e.g., kinetic energy,
temperature-induced energy, pressure-induced energy) into a voltage
and current suitable to charge the battery 34 (FIG. 1) or to power
the sensor module 10.
[0129] FIG. 4 is a diagram of a sensor data system 80, according to
an embodiment.
[0130] The sensor data system 80 includes the sensor module 10 of
FIG. 1 and a remote data-receiving device 82.
[0131] The remote data-receiving device 82 may be, or include, a
smart phone or tablet computer having circuitry sufficient to
receive, demodulate, and recover sensor data from the wireless
signal that the sensor module 10 transmits via the antenna 22. And
the device 82 may also be configured to analyze, or otherwise
process, the recovered sensor data. For example, the device 82 may
be configured to display the recovered sensor data (e.g., an
electrocardiogram), to make a recommendation or warning (e.g.,
"blood sugar level low") in response to the sensor data, or to
store the sensor data for later processing by the device 82 or by
another device or for later review by a medical professional.
[0132] Still referring to FIG. 4, the operation of the sensor data
system 80 is described, according to an embodiment.
[0133] First, the device 82 notifies the sensor module 10 that the
device would like to receive sensor data, or the sensor module
notifies the device that the sensor module would like to send
sensor data to the device.
[0134] Next, the sensor module 10 and the device 82 establish
communications using, e.g., a handshake technique.
[0135] Then, the sensor module 10 transmits a signal including the
sensor data according to a communications protocol such as
Bluetooth.RTM. or NFC.
[0136] Next, the device 82 receives the transmitted signal and
recovers the data therefrom.
[0137] Then, the sensor module 10 notifies the device 82 when all
of the data has been transmitted.
[0138] Next, the device 82 notifies the sensor module 10 that it
has received all of the data, or that it needs the sensor module to
resend some or all of the data (e.g., due to a communications
error).
[0139] Then, the sensor module 10 notifies the device 82 if it has
more data to send, or the device requests additional data from the
sensor module. If the sensor module 10 sends additional data, then
it does so according to the same procedure described above.
[0140] After the sensor module 10 is finished transmitting all
available or requested data, it notifies the device 82, which
acknowledges this notification to the sensor module.
[0141] Next, the sensor module 10 and the device 82 cease
communicating with one another.
[0142] Then, the device 82 may display a representation of the
recovered data, may make a recommendation or warning based on the
recovered data, may transmit the data to another device, such as to
a computer system at a doctor's office, via, e.g., a phone system,
or may store the data for later access.
[0143] Still referring to FIG. 4, alternate embodiments of the
sensor data system 80 are contemplated. For example, the system 80
may include the sensor module 60 of FIG. 2 instead of the sensor
module 10 of FIG. 1. Or the system 80 may include more than one
sensor module (e.g., one or more of one or both sensor modules 10
and 60) or more than one device 82. Furthermore, the data that the
sensor module 10 sends to the remote device may be
sensor-module-status data instead of, or in addition to, sensor
data. Moreover, the remote device 82 may send data, such as
configuration data or command data, to the sensor module 10.
[0144] FIG. 5 is a diagram of a sensor data system 90, according to
an embodiment.
[0145] The sensor data system 90 can be similar to the sensor data
system 80 of FIG. 4, except that instead of the device 82, the
system 90 includes a computer system 92 having a communication
interface (e.g., a Bluetooth.RTM. interface) 94. The computer
system 92 and the interface 94 can be configured to perform,
together or separately, the operations that the device 82 of FIG. 4
is described as performing.
[0146] Still referring to FIG. 5, alternate embodiments of the
sensor data system 90 are contemplated. For example, the system 90
may include the sensor module 60 of FIG. 2 instead of the sensor
module 10 of FIG. 1. Or the system 90 may include more than one
sensor module (e.g., one or more of one or both sensor modules 10
and 60) or more than one computer system 92. Furthermore, the data
that the sensor module 10 sends to the computer system 92 may be
sensor-module-status data instead of, or in addition to, sensor
data. Moreover, the computer system 92 may send data, such as
configuration data or command data, to the sensor module 10.
[0147] FIG. 6 is a diagram of a sensor-module network 100,
according to an embodiment.
[0148] The network 100 includes multiple sensor modules 10 (FIG.
1), which are configured to communicate with one another using,
e.g., ZigBee or another multi-node wireless-network protocol. For
example, the sensor modules 10 may be implanted in, or otherwise
attached to, a same subject, or in or to two or more different
subjects.
[0149] Still referring to FIG. 6, the operation of the
sensor-module network 100 is described, according to an
embodiment.
[0150] First, when an initiating one of the modules 10 in the
network 100 is ready to communicate with a responding one of the
modules, the initiating module first determines if the
communication channel is clear, i.e., that there are no other
sensor modules currently using the channel for inter-module
communications.
[0151] If the initiating module 10 determines that the
communication channel is clear, then it notifies the responding
sensor module that the initiating sensor module would like to
receive sensor data or other data from the responding sensor
module, or the initiating sensor module notifies the responding
sensor module that the initiating sensor module would like to send
sensor data or other data to the responding sensor module.
[0152] Next, the initiating and responding sensor modules 10
establish communications using, e.g., a handshake technique, and
also inform the remaining sensor modules that the communication
channel is being used.
[0153] Then, the initiating sensor module 10 transmits a signal
including the sensor data; or, if the initiating sensor module is
requesting data, then the responding sensor module transmits a
signal to the initiating sensor module.
[0154] Next, the one of the initiating and responding sensor module
10 that is to receive the data receives the transmitted signal and
recovers the data therefrom.
[0155] Then, the transmitting one of the initiating and responding
sensor modules 10 notifies the receiving one of the initiating and
responding sensor modules when all of the data has been
transmitted.
[0156] Next, the receiving one of the initiating and responding
sensor modules 10 notifies the transmitting one of the initiating
and responding sensor modules that it has received all of the data,
or that if needs the transmitting one of the initiating and
responding sensor modules to resend some or all of the data (e.g.,
due to a communications error).
[0157] Then, the transmitting one of the initiating and responding
sensor modules 10 notifies the receiving one of the initiating and
responding sensor modules if it has more data to send, or the
receiving one of the initiating and responding sensor modules
requests additional data from the transmitting one of the
initiating and responding sensor modules. If the transmitting one
of the initiating and responding sensor modules 10 sends additional
data, then it does so according to the same procedure.
[0158] After the transmitting one of the initiating and responding
sensor modules 10 is finished transmitting all available or
requested data, it notifies the receiving one of the initiating and
responding sensor modules, which acknowledges this notification to
the transmitting one of the initiating and responding sensor
modules.
[0159] Next, the initiating and responding sensor modules 10 cease
communicating with one another.
[0160] Then, the receiving one of the initiating and responding
sensor modules 10 may use the recovered data for any suitable
purpose.
[0161] Still referring to FIG. 6, alternate embodiments of the
sensor-module network 100 are contemplated. For example, the
network 100 may include sensor modules 60 of FIG. 2 instead of
sensor modules 10 of FIG. 1. Or the network 100 may include one or
more of one or both sensor modules 10 and 60.
[0162] Still referring to FIG. 6, alternate embodiments of the
sensor-module network 100 are contemplated. For example, the
network 100 may employ a master-slave protocol where only one of
the sensor modules serves as master, sending and receiving data to
a plurality of sensors simultaneously or one at a time, and
receiving data from sensor modules one at a time; whereas the
master sensor module, in the alternative, may not contain any
sensors. The master sensor module sends and receives data from a
transceiver outside the body.
B. Temporary and Permanent Implantable Medical Devices and their
Use
[0163] B.1. Stent Grafts 0.401
[0164] Within one embodiment of the invention, stent grafts are
provided having one or more ISMs as described herein. Briefly,
"stent graft", as utilized herein, refers to a device comprising a
graft or covering (composed of a textile, polymer, or other
suitable material such as biological tissue) which maintains the
flow of fluids (e.g., blood) from one portion of a vessel to
another, and an endovascular scaffolding or stent (including
expandable and balloon-inflatable stent structures) that holds open
a body passageway and/or supports the graft or covering.
Endovascular stent grafts may be used to treat a variety of
vascular conditions, including treating abdominal aortic aneurysms
and thoracic aortic aneurysms (referred to as "EVAR"--endovascular
aortic aneurysm repair), atherosclerosis, peripheral vascular
disease or other vascular diseases. Endovascular stent grafts are
also used in dialysis grafts and dialysis fistulas to treat
obstructions or aneurysms that occur at the site of vascular access
in hemodialysis patients. Non-vascular stent grafts can be used in
a variety of other body passageways such as the esophagus, colon,
bile duct, urethra and ureter to name a few examples. Within
certain embodiments, the stent graft has at least two openings (and
within further embodiments, three or more openings), an outer
(adluminal) surface, and an inner (luminal) surface. Within certain
embodiments the stent graft is an "articulated" or "segmented"
stent graft; these multi-component stent grafts are inserted as
separate segments which are then assembled inside the body (artery
or other body passageway) into their final configuration. Within
other embodiments, the stent graft is fenestrated (e.g.
FEVAR--fenestrated endovascular aortic aneurysm repair) with holes
in the graft body material that maintain the patency of important
blood vessels (or side branches). With certain embodiments, the
stent graft has a Unique Device Identification ("UDI") number.
[0165] Within embodiments of the invention one or more ISMs, and/or
sensors may be placed on (the luminal side or abluminal side),
and/or within a stent grafts (e.g., within the metallic struts of
the stent graft or embroidered into the fabric of the stent graft).
Representative examples of sensors placed on a stent graft are
provided in PCT Publication No. WO2014/100795, which is hereby
incorporate by reference in its entirety.
[0166] B.1.A. Stent Grafts and Endoleaks
[0167] As noted above, stent grafts are typically utilized in a
wide variety of medical procedures to open up and/or maintain the
lumen of a body passageway (e.g. artery, gastrointestinal tract,
urinary tract). They are most commonly used however for vascular
procedures, e.g., in the treatment of aortic aneurysm disease. An
aortic aneurysm (AA) is a dilatation of the aorta that usually
results from underlying disease (typically atherosclerosis) causing
weakness in the vessel wall. As the aneurysm progressively grows
(dilates) in size over time, the risk of it bursting or rupturing
rapidly increases; a condition which if not promptly treated, leads
to massive hemorrhage and death. Stent grafts are inserted into an
aneurysm, not only to simply hold open the diseased vessel, but
also to bridge across the dilated vascular segment from healthy
vessel to healthy vessel.
[0168] Briefly, a stent graft is inserted over a guide wire, from
the femoral or iliac artery and deployed within the aneurysm,
resulting in maintenance of blood flow from an aorta of acceptable
(usually normal) caliber above the aneurysm to a portion of aorta
or iliac artery(s) of acceptable (usually normal) caliber below the
aneurysm. The aneurysm sac is thus excluded from the circulation.
Blood within the excluded aneurysm sac thromboses and thus has no
flow within it, presumably reducing the pressure and thus its
tendency to burst.
[0169] Presently available stent grafts, however, have a number of
limitations such as endoleaks, migration, detachment, wear and
durability issues, rupture, stenosis, kinking and malpositioning.
For example, current stent grafts are prone to persistent leakage
of blood around the area of the stent graft and into the aneurysm
sac (a condition known as an "endoleak"). Hence, pressure within
the aneurysm sac is not reduced, stays at or near arterial
pressure, and the aneurysm remains at risk for rupture. Endoleaks
are among the most common and the most clinically dangerous
complications of stent graft placement and the early detection and
treatment of endoleaks remains a significant medical problem. Stent
grafts of the present invention have, within certain embodiments,
pressure detecting sensors that are able to detect elevated
pressure within the aneurysm sac and warn the patient and/or the
attending physician that there may be a potential endoleak.
Pressure sensors contained within an ISM that is itself contained
within a stent graft (e.g., within the metallic struts of the stent
graft or embroidered into the fabric of the stent graft) or
attached to a stent graft can recognize adluminal (the outer
surface of the graft in contact with the blood vessel wall)
pressure rising; this is suggestive that pressure within the
aneurysm sac is becoming elevated and that the aneurysm is no
longer excluded from the circulation. Since most endoleaks are
asymptomatic to the patient (rupture is often the first symptom), a
gradual or rapid increase in stent graft adluminal pressure (or
aneurysm wall pressure) is an important early indicator that
medical care should be sought and that investigation into its
underlying cause is warranted. Currently, there is no such
continuous monitoring and early detection system available to
recognize endoleaks and embodiments of the present invention will
greatly facilitate the identification and early treatment of this
potentially fatal complication of stent graft treatment.
[0170] There are 5 common types of perigraft leakage (endoleak),
and corrective measures can vary depending upon the underlying
cause. Stent grafts of the present invention contain, within
certain embodiments, ISMs comprising one or more sensors of various
types including but not limited to fluid pressure sensors, contact
sensors, position sensors, pulse pressure sensors, blood volume
sensors, blood flow sensors, chemistry sensors (e.g., for blood
and/or other fluids), metabolic sensors (e.g., for blood and/or
other fluids), accelerometers, mechanical stress sensors,
temperature sensors, and the like, which are capable of providing
information useful to the physician for determining which type of
endoleak might be present.
[0171] The first type of endoleak (Type I Endoleak) occurs when
there is direct leakage of blood around the stent graft (either
proximally or distally) and into the aneurysm sac. This type of
endoleak can be persistent from the time of insertion because of
poor sealing between the stent graft and vessel wall, or can
develop later because the seal is lost. In addition, this problem
can develop due to changes in the position or orientation of the
stent graft in relation to the aneurysm as the aneurysm grows,
shrinks, elongates or shortens with time after treatment. Type I
endoleaks also commonly occur if the stent graft "migrates
downstream" from its initial point of placement as a result of
being shifted distally by the flow of blood and arterial
pulsations. Representative stent grafts can have an ISM with
contact and/or position sensors implanted/affixed to the proximal
end of the stent graft to detect loss of contact with the vessel
wall which could be indicative of a potential Type I endoleak. IMRs
could also be located at the distal ends of the stent graft (as
well as within the body of the stent graft) to assist in the
identification of a Type I endoleak. Stent grafts equipped with an
ISM (or ISMs) having pressure and contact sensing devices can
indicate the suspected presence of an endoleak through the
detection of elevated adluminal pressure; furthermore loss of
contact with the vessel wall (as detected by the contact sensors)
at the proximal and/or distal ends of the graft would suggest the
presence of a Type I endoleak, while loss of contact of the body of
the stent graft with the vessel wall would suggest the location,
size and extent of the endoleak present in the aneurysm sac.
Lastly, ISMs having position sensors and/or accelerometers
concentrated at the proximal and/or distal ends of the stent graft
(as well as in the body of the stent graft) can detect movement
(migration) of the stent graft from its original point of placement
(a common cause of Type I Endoleaks) and also aid in determining
the size and location of the endoleak (by detecting deformations of
the stent graft wall).
[0172] As noted above, within certain embodiments of the invention
specific sensors can be identified by their USI, as well as by
their positional location within the stent graft. Hence, a more
comprehensive image or analysis of the overall function of the
stent graft (and of the patient's response to the stent graft) can
be ascertained based upon knowledge of the location and activities
of a group of sensors collectively. For example, a collection of
sensors, when analyzed as a group could be utilized to ascertain
the specific type of endoleak, the degree and the location of the
endoleak. In addition, the collection of sensors could be utilized
to assess a variety of other conditions, including for example,
kinking or deformation of the stent graft, and stenosis of the
stent graft.
[0173] The second type of perigraft leak (Type II Endoleak) can
occur because there are side arteries extending out the treated
segment of blood vessel (typically the lumbar arteries, testicular
arteries and/or the inferior mesenteric artery). Once the aneurysm
is excluded by the stent graft, flow can reverse within these blood
vessels and continue to fill the aneurysm sac around the stent
graft. Representative stent grafts can have ISMs with contact
and/or position sensors (ideally an ISM would be incorporated to
the proximal and distal ends of the stent graft, as well as well
potentially as within the body of the stent graft) to assist in the
identification of a Type II endoleak. Stent grafts equipped with
ISMs having pressure and contact sensing devices can indicate the
suspected presence of an endoleak through the detection of elevated
adluminal pressure; furthermore continued contact with the vessel
wall (as detected by the contact sensors) at the proximal and/or
distal ends of the graft would suggest the endoleak could be a Type
II, while loss of contact of the body of the stent graft with the
vessel wall would suggest the location, size and extent of the
endoleak present in the aneurysm sac. Lastly, ISMs having position
sensors and/or accelerometers concentrated at the proximal and
distal ends of the stent graft would confirm that the stent graft
had not migrated from its original point of placement, while those
in the body of the stent graft would aid in determining the size
and anatomical location of the endoleak (by detecting deformations
of the stent graft wall) which could suggest the blood vessel
responsible for the Type II endoleak.
[0174] The third type of endoleak (Type III Endoleak) can occur
because of disarticulation of the device (in the case of modular or
segmented devices). Due to the complicated vascular anatomy, the
diversity of aneurysm shapes and the need to custom fit the stent
graft to a particular patient, many stent grafts are composed of
several segments that are inserted separately and constructed
within aorta into their final configuration. Disarticulation of the
device at the junction points can develop due to improper placement
or deployment, or due to changes in shape of the aneurysm as it
grows, shrinks, elongates or shortens with time after treatment.
Representative segmented stent grafts can have ISMs having contact
and/or position sensors implanted/affixed to the stent graft at the
articulation points to assist in assessing the integrity of the
seal between stent graft segments. During placement of the stent
graft, ISMs having complimentary (paired/matched) contact sensors
on the respective articulated segments can confirm that a precise
and accurate connection has been achieved during construction of
the device. Should a Type III endoleak develop,
gaps/discontinuities between contact sensors on complimentary
segments can be detected to ascertain both the location and extent
of the endoleak present.
[0175] A fourth type of endoleak (Type IV Endoleak) occurs due to
the development of holes within the graft material through which
blood can leak into the aneurysm sac. Continuous pulsation of the
vessel causes the graft material to rub against the metallic stent
tynes eventually leading to fabric wear and graft failure.
Representative stent grafts have ISMs with fluid pressure sensors,
contact sensors, position sensors, pulse pressure sensors, blood
volume sensors, blood flow sensors, chemistry sensors (e.g., for
blood and/or other fluids), metabolic sensors (e.g., for blood
and/or other fluids), accelerometers, mechanical stress sensors,
temperature sensors, and the like that are incorporated within the
body of the stent graft (e.g., within the metallic struts of the
stent graft or embroidered into the fabric of the stent graft) to
assist in the identification of a Type IV endoleak. Should a defect
develop in the graft material, the embedded ISM sensors will aid in
determining the size and location of the endoleak by detecting
deformations and defects of the stent graft wall. In extreme cases,
stent graft wall defects can lead to rupture of the stent graft; a
condition that can be detected early as a result of embodiments of
this invention.
[0176] The final type of endoleak (Type V Endoleak) is a leak of
unknown origin. Representative stent grafts equipped with ISMs
having fluid pressure sensors, contact sensors, position sensors,
pulse pressure sensors, blood volume sensors, blood flow sensors,
chemistry sensors (e.g., for blood and/or other fluids), metabolic
sensors (e.g., for blood and/or other fluids), accelerometers,
mechanical stress sensors, temperature sensors, and the like can
indicate the suspected presence of an endoleak through the
detection of elevated adluminal pressure. Furthermore, loss of
contact with the vessel wall detected by contact sensors, changes
in position sensors and/or movements detected by accelerometers can
detect changes in the stent graft and assist in determining the
size and location of the endoleak (by detecting deformations of the
stent graft wall).
[0177] The integration of data from the fluid pressure sensors,
contact sensors, position sensors, pulse pressure sensors, blood
volume sensors, blood flow sensors, chemistry sensors (e.g., for
blood and/or other fluids), metabolic sensors (e.g., for blood
and/or other fluids), accelerometers, mechanical stress sensors,
temperature sensors, and the can produce a computer reconstruction
of the stent graft wall that can serve a function similar to
medical "imaging" of the device (see e.g., FIGS. 9 and 10). Stent
grafts of the present invention containing ISMs, within certain
embodiments, can provide sensing information to serve a variety of
important clinical functions.
[0178] For example, this information is useful to the clinician
during initial placement of the stent graft to determine if it is
correctly placed anatomically, if there is leakage around the
graft, if stent graft segments are correctly assembled, to detect
kinking or deformation of the graft, to ascertain if there is
uniform blood flow through the device--to name but a few important
functions. Malpositioning of the stent graft, either at the time of
placement or due to subsequent movement/migration, is a common
complication of stent graft therapy. ISM-containing stent grafts of
the present embodiment can be used to confirm proper initial
placement, assembly and deployment and any ensuing disarticulation
or migration. Detachment of the graft as a whole (from the artery),
or detachment of individual graft segments from each other is
another problematic complication of stent graft insertion and
ongoing therapy. Stent grafts of the present invention have the
ability to detect movement/detachment of the entire stent graft, as
well as movement and/or detachment of individual segments,
providing the clinician and patient with valuable diagnostic
information. Kinking of the stent graft during deployment and/or as
the result of subsequent movement after placement is also a
significant clinical problem if it develops. Stent grafts of the
present invention have ISMs with position sensors and
accelerometers distributed throughout the stent graft capable of
detecting deformation and kinking of the stent graft.
[0179] In some cases, the lumen of the stent graft can become
narrowed and restrict blood flow through the graft due to external
compression (such as an endoleak), stenosis (the growth of
thickened vascular tissue called neointimal hyperplasia on the
inner surface of the stent graft), or the formation of a blot clot.
Stent grafts of the present invention have a variety of ISM
containing sensors capable of detecting and differentiating types
of stenosis. Blood flow, fluid pressure and blood volume sensors
located on the luminal surface are able to detect the presence and
location of a stenosis due to the increased blood flow speed and
increased blood (and pulse) pressure at the site of a stenosis
(relative to normal segments of the graft). Stenosis due to
external compression (such as the presence of an endoleak as
discussed above) will be experienced as such (increased blood flow
speed and increased pressure). Stenosis due to neointimal
hyperplasia or luminal clot formation will be detected as "dead
spots" and/or altered readings on the luminal surface as ISMs
having blood flow sensors, blood metabolic and/or chemistry sensors
(e.g., for blood and/or other fluids) will become covered by
vascular tissue or clot and will cease to register; while ISM
adluminal pressure sensors and accelerometers will not show changes
in adluminal pressure or stent graft wall deformation (as would
occur with an endoleak). ISMs having metabolic sensors and
chemistry sensors are capable of determining the difference between
stenosis (normal pH and physiologic readings) and clot (lowered pH
and altered physiologic readings).
[0180] As mentioned, stent grafts are often placed in arteries
(typically the aorta) in anatomic locations where important
arterial side branches originate. Of greatest importance are the
renal arteries, but the lumbar, testicular, inferior mesenteric and
internal iliac arteries can be affected by an aortic aneurysm. To
maintain patency of these arteries (and prevent them from being
obstructed by the placement of the stent graft), stent grafts with
holes (or fenestrations) have been developed that allow blood flow
through the graft and into the arteries that branch out from the
aorta. FEVAR (fenestrated endovascular aortic aneurysm repair) is a
form stent graft design and treatment that maintains the patency of
important blood vessels that originate from the aorta. Stent grafts
of the present invention have ISMs possessing blood flow sensors,
fluid pressure sensors, pulse pressure sensors, blood volume
sensors and/or blood chemistry and metabolic sensors at the
fenestration sites to monitor blood flow through the side branches.
Stent grafts of the present invention may also have ISMs having
position sensors, contact sensors and/or accelerometers at the
fenestration sites to monitor patency of the side branches (due to
stenosis and/or kinking, migration and obstruction of the arterial
branches by the stent graft itself).
[0181] In addition, patients requiring stent grafts often have
extensive cardiovascular disease resulting in impaired cardiac and
circulatory function. For example, patients receiving stent grafts
are at an increased risk for myocardial infarction (heart attack),
congestive heart failure, renal failure and arrhythmias. The aorta
is the largest blood vessel to originate from the heart; therefore,
monitoring certain hemodynamic and metabolic parameters within the
aorta can provide the clinician with very important information
regarding the patient's cardiac, renal and circulatory function.
Stent grafts of the present invention contain ISMs having fluid
pressure sensors, contact sensors, position sensors, pulse pressure
sensors, blood volume sensors, blood flow sensors, chemistry
sensors (e.g., for blood and/or other fluids), metabolic sensors
(e.g., for blood and/or other fluids), accelerometers, mechanical
stress sensors, temperature sensors, and the like, suitable for
such purposes. Representative stent grafts of the present invention
can have ISMs with pressure sensors, pulse pressure sensors, pulse
contour sensors, blood volume sensors, blood flow sensors on and/or
within the stent graft which can be used by one of ordinary skill
in the art to calculate and monitor important physiologic
parameters such as cardiac output (CO), stroke volume (SV),
ejection fraction (EV), systolic blood pressure (sBP), diastolic
blood pressure (dBP), mean arterial pressure (mAP), systemic
vascular resistance (SVR), total peripheral resistance (TPV) and
pulse pressure (PP). For example, the FloTrac/Vigileo (Edwards Life
Sciences, Irvine, Calif.) uses pulse contour analysis to calculate
stroke volume (SV) and systemic vascular resistance (SVR); the
pressure recording analytical method (PRAM) is used by Most Care
(Vytech, Padora, Italy) to estimate cardiac output (CO) from
analysis of the arterial pressure wave profile. Changes in cardiac
output (CO), stroke volume (SV) and ejection fraction (EF) and
cardiac index (CI) can be an important in detecting complications
such myocardial ischemia and infarction; they can also assist the
clinician in implementation and adjusting cardiac medications and
dosages. ISMs having pulse pressure sensors, pulse contour sensors
and heart rate sensors contained on and within stent grafts of the
present invention can assist in the detection and monitoring of
cardiac arrhythmias and heart rate abnormalities; they can also be
used to monitor the patient's response to cardiac medications that
effect heart rate and rhythm. Systolic blood pressure (sBP),
diastolic blood pressure (dBP), mean arterial pressure (mAP),
systemic vascular resistance (SVR) and total peripheral resistance
(TPV) readings can be used by the clinician to monitor the dosage
and effect of blood pressure lowering medications and pressor
(blood pressure increasing) agents.
[0182] As described above, patients requiring stent grafts often
have concurrent medical problems related to cardiovascular disease
such as renal impairment or renal failure. The renal arteries
originate from the aorta, often in close approximation to the
typical location of stent graft placement; therefore, monitoring
certain hemodynamic and metabolic parameters within the aorta can
provide the physician and patient with very important "real time"
information regarding ongoing renal function. Stent grafts of the
present invention can contain ISMs having circulatory sensors (as
described herein) as well as chemistry sensors (e.g., for blood
and/or other fluids) and metabolic sensors (e.g., for blood and/or
other fluids) suitable for monitoring kidney function. Examples of
blood chemistry and metabolic sensors of utility for this
embodiment include, but are not limited to, Blood Urea Nitrogen
(BUN), Creatinine (Cr) and Electrolytes (Calcium, Potassium,
Phosphate, Sodium, etc.). Furthermore, combining metabolic data
with hemodynamic data and urinalysis can allow the clinician to
calculate the Glomerular Filtration Rate (GFR) which is a very
useful measure of kidney function. This information would be of
particular utility in the management of dialysis patients to
monitor the timing, effectiveness, and frequency of dialysis
therapy.
[0183] Finally, due to the numerous complications described above,
there is long term uncertainty about the utility of stent graft
technology as a treatment for aortic aneurysm. Although much more
invasive and traumatic, standard open surgical aneurysm repair is
extremely durable and effective. Uncertainties about endovascular
stent grafts include whether they will lower the aneurysm rupture
rate, rate of perigraft leak (endoleak), device migration, ability
to effectively exclude aneurysms over a long term, and device
rupture or disarticulation. Stent grafts containing ISMs of the
present invention, with their ability to detect and monitor many
(if not all) of the aforementioned complications, are an important
advancement of stent graft therapy as a whole.
[0184] Representative examples of sensors placed on a stent graft
are provided in PCT Publication No. WO2014/100795, which is hereby
incorporate by reference in its entirety).
[0185] B.1.B. Representative Embodiments of Stent Grafts and
Endoleaks
[0186] Representative examples of stent grafts having ISMs are
shown in FIGS. 7 and 8. Briefly, FIG. 7 illustrates an abdominal
aortic aneurism of the type which may occur in patients. A stent
graft has been positioned inside the aneurism to form a stent graft
which is in physical contact with a blood vessel wall proximally
and distally (and "seals" or excludes the aneurysm from the
circulation). While such stent grafts are beneficial to reduce
pressure in the aneurism sac and significantly increase the health
of the patient, sometimes difficulties occur in which blood gets
around or through the stent graft leading to various types of
endoleaks. In order to monitor the health of the patient, it is
desirable to identify any one of the five types of endoleaks
(discussed above) which may occur in a stent graft. In addition, it
is desirable to monitor cardiac output, blood flow, blood volume,
and various characteristics of the blood internal to the stent
graft.
[0187] FIG. 7 also illustrates that one or more ISMs can be
positioned in, on, or within the wall of the stent graft (e.g.,
within the metallic struts of the stent graft or embroidered into
the fabric of the stent graft) in order to sense various conditions
of the stent graft relative to the blood vessel, the circulation,
and the status of the aneurism. Although the ISM (or ISMs) can be
located wherever is practical (e.g., multiple ISMs can be located
in bands, proximally, distally, and/or circumferentially throughout
the stent), particularly important locations include the proximal
end (and to a lesser extent the distal ends) of the stent graft and
the section of the graft adjacent to the aneurysm sac. For example,
one or more ISMs containing one or more pressure sensors can be
located at the proximal and distal ends of the stent graft, as well
as within the aneurism sac in order to sense the fluid pressure at
various locations along the outer wall of the stent graft and
within the aneurism sac. Additionally, the ISMs may include one or
more contact sensors and be located at the distal end of the stent
graft, the proximal end of the stent graft, and various locations
along the stent graft in contact with the aneurysm wall in order to
determine whether the stent is in physical contact with the blood
vessel wall. The ISM contact sensors may be of a type of physical
pressure sensors, whereas the ISM pressure sensors are fluid
pressure sensors. In addition, one or more position markers can be
placed in the ISM and located to determine whether or not the ISM
(and hence the stent graft) has moved relative to the blood vessel
wall, since movement of the stent graft is one of the conditions
which causes endoleak and failure.
[0188] Within various embodiments the ISMs may be powered by one or
more batteries that is located on the outside of the stent graft
(e.g. positioned such that it would be located within a site of an
aneurysm. Similarly, other components of an ISM may likewise be
located on a stent graft such that, once deployed, they would be
located within the site of an aneurysm.
[0189] An ISM with sensors which are in contact with the inner
(luminal) wall of the stent graft can both monitor the integrity of
the stent graft and also the properties of the blood flowing
through the stent graft. Accordingly, the ISM sensors on the
luminal surface of the stent graft may include a pulse analyzer to
determine the pulse properties of the patient. It may also include
a plurality of blood pressure sensors to sense the blood pressure
of the patient. It may include both blood flow and blood volume
detectors to calculate the cardiac output of the patient. In
addition, the stent graft provides an excellent location in order
to determine various blood properties, such as the pH, the glucose
level, the oxygen content, the cholesterol level, and other
properties of the arterial blood as it flows by. Thus, a variety of
different luminal sensors in an ISM can be utilized to sense for
both the integrity of the stent graft as well as the properties of
the blood flowing through the stent graft.
[0190] The ISM sensors used can also include accelerometers and
motion sensors to detect movement of the stent graft due to heart
beats, migration or other physical changes. Changes in the position
of the accelerometers and/or motion sensors over time can be used
as a measurement of changes in the position of the stent graft
and/or vascular wall over time. Such positional changes can be used
as a surrogate marker of vascular and stent graft anatomy--i.e.
they can form an "image` of the stent graft and/or vascular wall to
provide information on the size, shape and location of endoleaks,
kinking of the stent graft, disarticulation of a segmented stent
graft, stenosis with the stent graft, clot formation, and/or stent
graft movement/migration.
[0191] For example, as shown in FIG. 8 is an enlargement of the
proximal end of the stent graft showing the location of an ISM
containing various sensors which can perform sensing functions for
both for the integrity of the stent graft and the blood properties
of the patient. More specifically, FIG. 8A shows development of an
endoleak, which eventually becomes more complete (FIG. 8B). As
shown in the blown-up images (FIGS. 8C and 8D), an ISM located in
the stent graft wall adjacent to the aneurysm sac will possess
sensors that will be moved from their typical (original) specified
position, to a different position, as a result of the endoleak. The
movement, rate of movement, pressure, and other metrics of
measurement (depending upon the type of sensors contained in the
ISM) can be interrogated at a single time point, as well as over a
time course to follow the progression of the endoleak (and the
success/failure of treatment attempts to correct it). Moreover, the
three-dimensional spacial deformation of the stent graft (and
four-dimensional if time is also considered), may be determined
based upon the movement, pressure, and other metrics of the ISM
sensors and used to provide sizing and anatomical location of the
endoleak.
[0192] The, collection of data from the ISM sensors can also be
utilized to ensure proper placement of the stent graft (e.g., that
no leaks are present at the time of placement), complete
articulation of the stent graft, full deployment (expansion) of the
stent graft, and that the stent graft is appropriately positioned
(e.g., relative to the aneurysm and arterial branches of the
aorta).
[0193] B.2. Stents
[0194] Within one embodiment of the invention, stents are provided
having one or more ISMs as described herein. Briefly, "stent"
refers to a medical device that can be utilized to hold open body
structures and/or passageways, and can be utilized to treat and/or
prevent a wide variety of diseases and/or conditions resulting from
lumen narrowing or obstruction; whether due to an injury or
external compression of the vessel wall (a benign or malignant
tumor, abscess, cyst), a disease process occurring within the
vessel wall (e.g., cancer, atherosclerosis, inflammation, scarring
or stenosis), a disease processes occurring on the surface (or in
the lumen) of the vessel wall (thrombus, atherosclerosis,
restenosis, tumor growth, inflammation and scarring, biliary and
urinary "stones", mucous impaction, etc.), and/or an operation or
other medical intervention causing damage to the vessel.
[0195] Stents can be used in a wide variety of variety of tubular
body passageways to preserve the normal movement of luminal
materials (blood, digestive contents, digestive enzymes and bile,
air, urine, reproductive materials) through them, including for
example, vascular structures (e.g., coronary, carotid, cerebral,
vertebral, iliac, femoral, popliteal, tibial, mesenteric,
pulmonary, and other branches of these arteries; large veins such
as the superior and inferior vena cava and veins of the neck, upper
and lower extremities), gastrointestinal structures (e.g.,
esophagus, duodenum, small intestine, colon, biliary tract and
pancreatic ducts), pulmonary structures (e.g., to hold open the
trachea, bronchi, or bronchioles), urinary system structures
(collecting system, ureters, urethra), female and male reproductive
system structures (e.g., to maintain patency of the fallopian
tubes, prostatic urethra), sinus structures in the head and skull
(maxillary sinus, frontal sinus, lacrimal duct), and inner ear
structures (tympanostomy tubes).
[0196] Typically, stents are composed of metallic or polymeric
components, and have a unitary structure, or multiple components
(e.g., a bifurcated stent system). Stents may be non-degradable,
partially degradable, or fully degradable. In addition, stents may
be coated with one or more different compositions, including both
polymers and drugs (including biologics and stem cells).
Representative examples of stents include those disclosed in U.S.
Pat. Nos. 6,852,153, 7,942,923, 7,753,947, 7,879,082, and
8,287,588, as well as various publications (see, e.g., "Open Stent
Design: Design and analysis of self expanding cardiovascular
stents", by Craig S. Bonsignore, CreateSpace Independent Publishing
Platform, November 2012, and "Coronary Stents" by Sigwart and Frank
(eds.), Springer, 2012)
[0197] Within preferred embodiments the stents of the present
invention have a Unique Device Identification ("UDI") number, and
each of the sensors of the ISM located within the stent have a
Unique Sensor Identification ("USI").
[0198] In addition, within various embodiments of the invention one
or more ISMs, and/or sensors may be placed on (the luminal side or
abluminal side), and/or within a stent (e.g., within the metallic
struts of the stent or embroidered into the fabric of a "covered"
stent). Representative examples of sensors placed on a stent are
provided in PCT Application No. PCT/US2014/028323, which is hereby
incorporate by reference in its entirety).
[0199] B.2.A. Stents and their Use
[0200] As noted above, stents are used to open up and maintain the
lumen of a diseased body passageway (e.g. artery, gastrointestinal
tract, urinary tract), but have found their greatest utility in the
management of vascular disease. Briefly, a stent is inserted into
body a lumen to physically hold open structures and/or passageways
(typically tubular organ structures such as blood vessels, the
gastrointestinal tract, the urinary tract, the sinuses of the
skull, the respiratory tract, or the male and female reproductive
tracts) which have become blocked or partially obstructed thereby
reducing or eliminating the movement of materials (typically
fluids, solids or air) through them. The stent is usually placed
percutaneously (e.g. vascular stents are often inserted into the
vasculature via the femoral artery in the groin or the radial
artery in the arm and then maneuvered through the blood stream
under radiological guidance until they reach the diseased blood
vessel) or via insertion through a natural orifice (e.g. the mouth,
nose, anus, urethra) and placed under direct vision (endoscopy)
into the affected organ (lungs, GI tract, urinary tract). Most
often the stent is delivered to the deployment site in a compressed
form and then expanded into place (often by inflating a balloon
with the stent or through the use of "self-expanding" stents) to
open the organ lumen back up to its original size and shape. The
symptoms of blockage or obstruction (e.g. chest pain, claudication,
neurological deficit, dysphagia, bowel obstruction, jaundice,
difficulty breathing, infertility, urinary obstruction, sinus pain)
depend upon the organ affected and restoration of normal anatomy
and lumen function is the goal of stent treatment. Stent failure
can be due to a multitude of causes but includes things such
improper placement, improper sizing, incomplete opening or
deployment of the stent, tissue ingrowth into the stent lumen
(restenosis, tumor cell growth, inflammation), luminal obstruction
(clot, biliary stone, kidney stone), stent fracture, stent kinking
and stent migration. Stents containing ISM sensors able to assist
the physician in their proper placement and deployment, and stents
capable of ongoing monitoring to detect evidence of partial and/or
complete obstruction, would have significant benefits over existing
devices.
[0201] Within various embodiments an ISM containing sensors can be
positioned on/in the stent in a location where the sensors are
exposed to the blood flowing through the stent (on the luminal
surface of the stent). A wide variety of sensors can be placed in
an ISM on the luminal wall of the stent, within the stent, and/or,
on the outer (adluminal) wall of the stent (for example, part of
the stent strut itself can be composed of an ISM such that the
sensors are in contact with all aspects--luminal, internal,
adluminal--of the stent). Representative sensors that can be
utilized within one or more ISMs on/in a stent include fluid
pressure sensors, contact sensors, position sensors, pulse pressure
sensors, blood volume sensors, blood flow sensors, blood chemistry
sensors, blood (and tissue) metabolic sensors, accelerometers,
mechanical stress sensors, vibration sensors and temperature
sensors.
[0202] Within various embodiments, vascular stents (coronary,
peripheral and cerebral) of the present invention can have one or
more ISMs with variety of sensors capable of detecting and
differentiating types of normal vascular healing versus stenosis,
restenosis, and/or thrombosis. For example, as generally shown in
FIG. 11, an ISM can be contained within or on the strut or tynes of
a vascular stent and contain sensors that detect blood flow, fluid
pressure and blood volume on the luminal surface such that they are
able to detect the presence and location of a stenosis due to the
increased blood flow speed and increased blood (and pulse) pressure
at the site of a stenosis (relative to normal pressures). Stenosis
due to neointimal hyperplasia or clot formation can be detected as
"dead spots" and/or altered readings on the luminal surface as an
ISM having blood flow sensors, blood metabolic and/or blood
chemistry sensors that become covered by vascular tissue or clot
will no longer obtain readings; however, "upstream" sensors will
show increased pressure and decreased flow rates, while sensors
"downstream" from the obstruction will show decreased pressure and
increased flow rates (a "jet" effect). An ISM having metabolic
sensors and chemistry sensors are capable of determining the
difference between stenosis (normal pH and physiologic readings)
and clot (lowered pH and altered physiologic readings). Lastly,
complete coverage of the luminal surface of the stent in the
absence of altered pressure, blood flow rates, stent deformation
and metabolic/chemistry readings is suggestive of normal healing;
that the stent has become endothelialized (covered with the cells
that line the body's blood vessels). This indicator of healthy and
complete incorporation of the stent within the blood vessel wall
(i.e. the stent is no longer exposed to the elements of the
bloodstream) has an important clinical consequence--it alerts the
clinician that it may be possible to discontinue the patient's
(costly and dangerous) anticoagulant therapy since the risk of
subacute and delayed thrombosis is now markedly reduced. In the
case of biodegradable stents, complete coverage of the luminal
surface of the stent and incorporation of it into the vessel wall
means that dissolution of the stent is now safe (i.e. stent
fragments will not be released into the blood stream).
[0203] In addition, subjects requiring stents often have extensive
cardiovascular disease resulting in impaired cardiac and systemic
circulatory function. For example, subjects receiving stents are at
an increased risk for myocardial infarction (heart attack),
cerebral vascular accidents (stroke), congestive heart failure,
renal failure and arrhythmias. The coronary arteries are critical
to the functioning of the heart, and hence, monitoring certain
hemodynamic and metabolic parameters within these arteries can
provide the clinician with very important information regarding the
subject's cardiac, renal and circulatory function. Coronary stents
of the present invention can contain one or more ISMs with fluid
pressure sensors, contact sensors, position sensors, pulse pressure
sensors, blood volume sensors, blood flow sensors, blood chemistry
sensors, blood metabolic sensors, accelerometers, mechanical stress
sensors, temperature sensors, and the like, suitable for such
purposes. Representative stents of the present invention can be
utilized by one of ordinary skill in the art to calculate and
monitor important physiologic parameters such as cardiac output
(CO), stroke volume (SV), ejection fraction (EV), systolic blood
pressure (sBP), diastolic blood pressure (dBP), mean arterial
pressure (mAP), systemic vascular resistance (SVR), total
peripheral resistance (TPV) and pulse pressure (PP). For example,
the FloTrac/Vigileo (Edwards Life Sciences, Irvine, Calif.) uses
pulse contour analysis to calculate stroke volume (SV) and systemic
vascular resistance (SVR); the pressure recording analytical method
(PRAM) is used by Most Care (Vytech, Padora, Italy) to estimate
cardiac output (CO) from analysis of the arterial pressure wave
profile. Changes in cardiac output (CO), stroke volume (SV) and
ejection fraction (EF) and cardiac index (CI) can be an important
in detecting complications such myocardial ischemia and infarction;
they can also assist the clinician in implementation and adjusting
cardiac medications and dosages. ISMs with pulse pressure sensors,
pulse contour sensors and heart rate sensors contained on and
within stents of the present invention can assist in the detection
and monitoring of cardiac arrhythmias and heart rate abnormalities;
they too can be used to monitor the subject's response to cardiac
medications that effect heart rate and rhythm. Systolic blood
pressure (sBP), diastolic blood pressure (dBP), mean arterial
pressure (mAP), systemic vascular resistance (SVR) and total
peripheral resistance (TPV) readings can be used by the clinician
to monitor the dosage and effect of blood pressure lowering
medications and pressor (blood pressure increasing) agents. It is
obvious that peripheral and cerebral vascular stents implanted in
other arteries (renal, iliac, femoral, carotid, etc.) are capable
of monitoring virtually all of the above cardiac/vascular
parameters as well.
[0204] Vascular stents of the present invention can contain ISMs
with circulatory sensors (as described herein) as well as blood
chemistry sensors and blood metabolic sensors suitable for
monitoring kidney function. Examples of blood chemistry and
metabolic sensors of utility for this embodiment include, but are
not limited to, Blood Urea Nitrogen (BUN), Creatinine (Cr) and
Electrolytes (Calcium, Potassium, Phosphate, Sodium, etc.).
Furthermore, combining metabolic data with hemodynamic data and
urinalysis can allow the clinician to calculate the Glomerular
Filtration Rate (GFR) which is a very useful measure of kidney
function. This information would be of particular utility in the
management of dialysis subjects to monitor the timing,
effectiveness, and frequency of dialysis therapy.
[0205] Within one embodiment of the invention the stent may also
comprise an ISM with one or more temperature sensors. These sensors
may be utilized to track both the discrete temperature of the
blood, vessel wall and surrounding environment, but the change of
temperature overtime. Such change in temperature may be utilize to
diagnose a possible developing infection (or other disease or
condition), and allow a physician or care-giver to treat the
infection (or other disease or condition) prior to a full onset
[0206] B.2.B. Stents with Sensors Located within the Stent
[0207] As noted above, within various aspects of the invention ISMs
with sensors as described herein can be contained within the stent,
including for example, within the tines of a stent, or within holes
in the struts of the stent, or within the struts themselves. As
utilized herein, "holes" should be understood to include openings
that run entirely through a stent, as well as cavities,
depressions, wells, or other openings or partial openings which
permit insertion of a sensor within the stent. Representative
examples of stents include those described within U.S. Pat. Nos.
7,208,010, and 7,179,289.
[0208] Within yet other embodiments, an ISM is designed to be
placed, in, within, or on a stent, and one or more individual
sensors which communicate with the ISM placed in, within, or on the
stent.
[0209] B.2.C. Stent Placement, Deployment and Connections
[0210] Stents of the present invention, within certain embodiments,
can provide sensing information to serve a variety of important
clinical functions. It is widely accepted that the greater the
amount of trauma experienced by the vessel wall during stent
placement and deployment, the higher the probability that the stent
will ultimately become obstructed (often due to restenosis). Causes
of vessel trauma during placement include inaccurate sizing (stents
too large for the vessel), difficult placement and deployment
(requiring extensive manipulation to place the stent), long
lesions, overlapping stents, over-inflation of the balloon or
over-expansion of the stent, complicated lesions (including
stenting at branch points) and placing stents in tortuous vessels.
Accurate placement, sizing, deployment, and full expansion of
stents continues to be a challenge, particularly in the
vasculature, where primarily indirect visualization techniques,
such as angiography, are used for stent positioning; angiography
(radio-opaque dye running through the bloodstream) shows only the
vascular luminal anatomy and gives no information about the vessel
wall anatomy (which is often the critical diseased segment being
treated) and only limited information about the stent itself. "Real
Time" sensing information from the stent containing an ISM is
useful to the clinician during placement of the stent to determine:
if it is correctly implanted anatomically, if the stent is
appropriately sized for the vessel in which it is placed, if it is
completely opened (deployed) during balloon expansion (or during
self-expansion), if it exerts too much (or too little) pressure
against the vessel wall, if stent segments are correctly assembled,
if there is an optimal amount of overlap between adjacent stents,
if there is kinking or deformation of the stent, if there is
cracking or fracturing of the stent, and if there is uniform flow
through the device--to name but a few important functions. Stents
of the present invention can allow the operating physician to
monitor many valuable parameters that can lead to better and less
traumatic stent placement and deployment.
[0211] Improper sizing of the stent relative to the vessel wall in
which it is placed can significantly increase the risk of failure
(particularly due to restenosis); stents with ISM sensors able to
detect the amount, presence and/or absence of pressure and contact
with the vessel wall can assist in matching the stent size and
degree of expansion (deployment) to that of the vessel wall.
Incomplete opening of all, or parts of the stent (known as
"incomplete malaposition"--areas where the stent is not in full
contact with the vessel wall and it projects into the arterial
lumen), increases the risk of subsequent clotting (thrombosis) and
stent failure. ISM position sensors, contact sensors and
accelerometers contained within the stent can be used to identify
and correct areas of incomplete opening (deployment) during stent
insertion and furthermore can confirm that the stent has "locked"
into the fully opened position. Improper positioning
(malapositioning) of the stent, either at the time of placement or
due to subsequent movement/migration, is also a common complication
of stent therapy. ISM sensor-containing stents of the present
invention can be used to confirm proper initial placement and any
ensuing migration or relocation within the vessel. Movement of the
stent as a whole, or detachment of individual stent segments from
each other is another problematic complication of stent insertion
and ongoing therapy. Stents of the present invention have the
ability to detect movement/detachment of the entire stent, as well
as movement and/or detachment of individual segments (or
fragments), providing the clinician and patient with valuable
diagnostic information. Kinking of the stent during deployment
and/or as the result of subsequent movement after placement is also
a significant clinical problem if it develops. Stents of the
present invention have ISM components containing position sensors
and accelerometers distributed capable of detecting deformation and
kinking of the stent. Stent cracking and fracture can be a problem
with all stents, but particularly in peripheral stents of the lower
limb (due to movement of the limb or bending of the stent across
the knee joint), as well as in polymeric degradable stents
(coronary, peripheral and non-vascular) that can become fragile
during the polymeric degradation process. ISMs having vibration
sensors, position sensors, location sensors and accelerometers
located within the stent device could alert the clinician and the
patient to the development of this complication prior to it
developing into an acute emergency.
[0212] Within various aspects of the invention assemblies are
provided wherein a stent may be composed of a unitary component
which is combined with another stent, or of multiple components
which need to be placed in the appropriate configuration to ensure
proper utility. When the patient has arterial disease and vessel
narrowing at branching points in the vascular tree, it is often
necessary to use stents (or stent components) than can be placed
together in situ to match the anatomy of the obstructed segment.
For example, FIG. 9 is a schematic illustration of various types of
multiple stent placements, wherein ISMs with contact sensors can be
utilized to ensure proper placement, configuration, and attachment
(overlap) of the various stent segments. FIG. 9A illustrates a site
of bifurcation with stenosis occurring at multiple points in the
vessel. FIG. 9B illustrates a stent with PTCA (along with ISMs and
representative sensors). FIG. 9C illustrates a stent plus stent
deployment (also referred to as a "reverse-T"). FIG. 9D illustrates
a stent plus stent deployment (referred to as "T stenting"). FIG.
9E illustrates a stent plus stent deployment referred to as a
"Crush" (along with ISMs and representative sensors). FIG. 9F
illustrates a stent plus stent deployment referred to as a "Y" or
"V" (along with ISMs and representative sensors). FIG. 9G
illustrates a stent plus stent deployment referred to as "Kissing".
FIG. 9H illustrates a stent plus stent deployment referred to as a
"Culotte" (along with ISMs and representative sensors). In each
case, stents containing an ISM with multiple sensors (the "stars"
in FIG. 9), such as contact sensors (potentially "matched" or
complimentary for adjacent or overlapping stents) used to confirm
accurate positioning and assembly; accelerometers used to
corroborate anatomical location and conformation; position sensors
used to monitor movement; flow sensors used to validate vascular
patency; and pressure/vessel wall sensors used to verify full
deployment and accurate vessel sizing. Taken collectively, this
sensing information can create a 3-dimensional image of the
vascular and stent anatomy and greatly improve the data available
from angiography alone. This dramatically increases the chances of
accurate, safe and effective deployment of multiple stents in
complicated vascular lesions.
[0213] FIG. 10 is a schematic illustration of ISM sensors (the
"stars" in FIG. 10) that can be utilized to aid and or assist the
placement of overlapping stents. Overlapping stents are used in the
treatment of long lesions or tortuous lesions where a single stent
is insufficient to span the entire length of the diseased segments.
While often effective, overlapping stents are more prone to failure
and the rate of failure is directly proportional to the degree of
overlap between adjacent stents; too much overlap increases failure
risk, while too little--particularly if there is a gap between the
two stents--is equally problematic. Stents containing ISMs with
contact sensors can be used to confirm both the presence and the
extent of overlap between adjoining stents. In a preferred
embodiment the ISM contact sensors between stents are "matched," or
complementary, confirming when the ideal amount of overlap has been
achieved between neighboring stents. Furthermore, ISM pressure
sensors, position sensors and accelerometers can be used to confirm
that the overlapping segments are equally deployed to ensure that
there is not a "mismatch" in lumen size in the two stents where
they overlap.
[0214] B.2.D. Partially or Fully Biodegradable Stents
[0215] As noted above, stents of the present invention (including
for example, vascular (e.g., coronary, carotid, cerebral,
vertebral, iliac, femoral and arteries of the lower extremities),
gastrointestinal (e.g., esophageal, duodenal, colonic, biliary and
pancreatic), pulmonary (e.g., to hold open the trachea, bronchus,
or bronchi), head and neck (sinus, lacrimal, tympanostomy), and
genitourinary (e.g., ureteral and urethral, prostate, fallopian
tube) may be comprised of one or more biodegradable polymers. Such
stents may be fully, or partially biodegradable and or resorbable.
Representative examples of such stents include for example U.S.
Patent App. Nos. 2009/0192588, 2007/0270940, and 2003/0104030, and
U.S. Pat. Nos. 6,387,124, 6,869,443 and 7,044,981.
[0216] Placement of ISMs having sensors as described herein on or
within a biodegradable or partially biodegradable stent (at varying
depths within the polymer) allows a determination of degradation of
the stent, as well as, optionally, the rate of biodegradation or
resorption of the stent. Hence, within one aspect of the invention
methods are provided for determining degradation of a stent are
provided, comprising the steps of a) providing to a body passageway
of a subject an assembly comprising a stent and one or more ISMs
having sensors, and b) detecting a change in a sensor, and thus
determining degradation of the stent. Within various embodiments
the ISM has sensors capable of detecting one or more physiological
(e.g., contact, fluid flow, pressure and/or temperature) and/or
locational (e.g., location within the subject) parameters. Within
further embodiments the step of detecting is a series of detections
over time, and optionally, the method may further comprise the step
of determining the rate of degradation of the stent, and/or
estimating the time for complete degradation of the stent. Within
still further embodiments, the stent can determine luminal coverage
of the device by healing tissue and therefore confirm that the
stent is embedded within the vessel wall (reducing or eliminating
the possibility that stent fragments are released into the luminal
fluids).
[0217] Within one embodiment the biodegradable stent is an
esophageal, ureteral, urethral, sinus, vascular, or prostatic stent
and degradation of the stent can be monitored by detecting the loss
or movement of ISM sensors over a period of time.
[0218] B.2.E. Stent Coatings
[0219] Within certain embodiments of the invention the stents
provided herein can have one or more coatings on one or more
surfaces of the stent. Coatings can be provided on stents for a
variety of purposes. Coatings may be biodegradable, or
non-biodegradable, or a combination of these. Typically, many
coatings are polymer-based (e.g., polymers comprised of
polyurethane, polyester, polylactic acid, polyamino acid,
polytetrafluroethylene, tephlon, Gortex.RTM.), although non-polymer
coatings may also be utilized.
[0220] Representative examples of suitable coatings include those
described in, for example, U.S. Pat. Nos. 8,123,799, 8,080,051,
8,001,925, 7,553,923, and 5,779,729, all of which are incorporated
by reference in their entirety.
[0221] B.3. Prosthetic Hip Joints
[0222] Within one embodiment of the invention, prosthetic hip
joints are provided having one or more ISMs as described herein.
Briefly, "hip replacement" as that term is utilized herein, may
take a variety of different forms and may involve replacement of
all or portions of the patient's hip joint with synthetic
materials. In total hip replacement (THR), both the femoral head
and the acetabulum are replaced. In a hemi (partial) hip
arthroplasty, only the femoral head is replaced while the patient's
own acetabulum is retained. The femoral component of a hip
replacement may be a single piece with the head and stem as an
integral, complete unit, or it may be constructed in several
pieces, such as a femoral stem which is then coupled to a separate
femoral head piece and neck section (which is often done to provide
the patient with custom fitting for length and/or femoral head
size). The femoral component can be cemented in place with PMMA
bone cement (cemented hip) or it can be fitted precisely within the
medullary canal of the femur and held in place without cement
(AML--anatomic medullary locking--stem design). Similarly, the
acetabular component of a THR can also be a single piece coupled to
the hip socket to receive the femoral head, or be a two-piece
component with a shell coupled to the pelvic bone and an inner
liner attached to the shell. The acetabular component of a THR can
be held in place with screws and/or cement or it can be affixed
without cement.
[0223] Currently, the various components may be made of the same
material, for example, all portions can be made of metal, or
individual components can be made from a variety of different
materials. For example, it is common for the acetabular component
to have a metal shell with an outer surface coating to facilitate
bone attachment and ingrowth, and an inner lining made from
polyethylene, ultrahigh molecular weight polyethylene, ceramic, or
surgical-grade stainless steel. Similarly, there may be several
different combinations of materials used in the construction of the
femoral head. For example, the femoral head can be composed of
metal, usually cobalt chromium (but also stainless steel or
titanium), or a ceramic material, while the femoral stem is
typically metal (stainless steel, titanium, or cobalt chromium) and
often possesses a surface coating to encourage incorporation of the
implant within the femur.
[0224] As utilized herein the terms "hip implant" "prosthetic hip"
or "hip replacement" or "hip replacement or portion thereof" or
"medical device" should be understood, unless the specific context
requires otherwise, to refer to any or all of the various
components that go into making a total hip prosthesis, including
for example, the femoral stem, femoral head, and acetabular
assembly, as well as their various sub-components. "Hip replacement
prosthesis" should be understood to refer to either a partial or
total hip replacement prosthesis.
[0225] Within various embodiments of the invention one or more
ISMs, and/or sensors may be placed on or within a hip replacement.
Representative examples of sensors placed on a hip replacement are
provided in PCT Application No. PCT/US2014/028323, which is hereby
incorporate by reference in its entirety).
[0226] B.3.A. Medical Uses of Hip Replacements
[0227] Hip replacement is carried out when the patient loses
sufficient use of the hip so as to result in disability, loss of
movement and function, impaired ambulation, and/or continuous joint
pain and discomfort. Common causes of impaired hip function leading
to total or partial hip replacement include trauma (typically a hip
fracture; often at the femoral neck), avascular necrosis of the
hip, or various types of arthritis (such as rheumatoid arthritis or
osteoarthritis). In most patients, the operation is successful in
improving ambulation, restoring function and reducing pain; as a
result, it is one of the most common orthopedic procedures in the
Western World.
[0228] B.3.B. Representative Embodiments of Hip Implants
[0229] Hip replacement prostheses are described in more detail in
PCT Application No. PCT/US2014/028381, which is hereby incorporated
by reference in its entirety. Briefly, the prosthesis typically, is
comprised of an acetabular shell in which an acetabular liner is
placed. It also includes a femoral assembly which includes two
components, a femoral head and a femoral implant or femoral stem
(also having a femoral neck) (see generally, FIG. 12).
[0230] One or more ISMs having sensors can be positioned within the
prosthesis in order to monitor, in situ, the real-time operation of
the patient activity and the prosthesis performance. In one
embodiment, an ISM having contact sensors can be placed within the
acetabular shell. These sensors detect and record contact between
adjacent parts, such as the between the acetabular shell and the
pelvis and/or between the acetabular shell and the bone cement (if
present) and/or between the bone cement (if present) and the
pelvis, and can detect loosening of the prosthesis and its
connection to the surrounding cement (if present) and/or pelvic
bone. Loosening of the acetabulum is a common complication that
occurs (typically over 8-12 years) when bone loss takes place in
the pelvic bones surrounding the acetabulum (e.g., due to a process
known as osteolysis). Erosion of the bone around the implant may be
caused by material debris (metal, ceramic, and/or polyurethane
fragments) generated by friction between the femoral head and
acetabular cup entering the pelvic tissues surrounding the
acetabulum and causing inflammation and bone loss. Other potential
causes of inflammation and osteolysis are implant vibration and
motion, mechanical wear and tear, lack of biocompatibility between
the implant materials and the surrounding bone, metal allergy, and
lack of biocompatibility between the bone cement and the
surrounding bone. In addition, an ISM having contact sensors may
indicate that the acetabular shell is positioned further from the
pelvic bone than desired as a result of material debris being built
up over time and/or the presence of inflammation between the shell
and the pelvic bone. An ISM having contact sensors can also be
placed within the bone cement (if present) so as to collect data on
the physical contact between the bone cement and the acetabular
prosthesis and/or between the bone cement and the pelvic bone.
[0231] Within various embodiments, an ISM having contact sensors
may also be positioned at various locations on the two surfaces of
the acetabular liner. The contact sensors can therefore sense the
contact (and/or movement) between the acetabular liner and the
acetabular shell (these sensors could be "paired" so as to detect
shifting between the acetabular liner and shell), as well as
contact between the femoral head and the acetabular liner.
Similarly the ISM having contact sensors can be positioned at
various locations on the femoral head to detect contact between the
femoral head and the acetabular liner. Thus, in the embodiment, an
ISM having a variety of contact sensors are provided in order to
monitor contact between the bone and the acetabular component, and
between the femoral head and the acetabular liner. Dislocation of
the femoral head from the natural or synthetic acetabulum of a
prosthetic hip is a common complication of hip replacement
occurring shortly after surgery (particularly while the surrounding
supportive tissues are healing from surgery); ISM sensors on the
femoral head and/or acetabulum can alert the patient and the
healthcare provider if joint dislocation has occurred. Partial or
incomplete dislocation (subluxation) of the hip joint can also
occur and may not be readily evident to the patient or the
physician; contact sensors on the femoral head and/or acetabulum
can determine of the joint is functioning (tracking) correctly and
if subluxation (even if subclinical or asymptomatic) is
occurring.
[0232] Additional (or alternative) ISMs having contact sensors can
be positioned on or within the femoral stem as well, to monitor
contact between the femoral stem and the femur and/or contact
between the femoral stem and the surrounding bone cement (if
present). An ISM having contact sensors on and/or within the
femoral shaft can detect loosening of the prosthesis and its
connection to the surrounding cement (if present) and/or the femur.
Loosening of the femoral shaft is a common complication that occurs
when (typically over 8-12 years), bone loss occurs in the femoral
canal surrounding the femoral shaft due to osteolysis. As described
above, erosion of the bone around the implant may be caused by
material debris (metal, ceramic, and/or polyurethane fragments)
generated by friction between the femoral head and acetabular cup
entering the femoral tissues surrounding the femoral prosthesis and
causing inflammation and bone loss. Other potential causes of
inflammation and osteolysis are implant vibration and motion,
mechanical wear and tear, lack of biocompatibility between the
implant materials and the surrounding bone, metal allergy, and lack
of biocompatibility between the bone cement and the surrounding
bone. In addition, ISMs containing contact sensors can also be used
to detect and record contact between connecting parts in a modular
femoral prosthesis, such as the between the femoral head, femoral
neck and/or the femoral stem. These ISMs, can be used to insure
that the connecting elements of a modular femoral prosthesis are
properly aligned and fitted.
[0233] Within other embodiments, ISMs having strain gauges can be
positioned a various places on or within a prostheses particularly
the femoral stem, but also the femoral neck and the femoral head,
in order to detect strain encountered between the prosthesis and
the surrounding bone. A decrease in strain may indicate that there
is bone resorbtion (loss), which could lead to loosening of the
prosthesis, or fractures. The strain sensors provide a different
data point than the contact sensors, which merely specify whether
there is current contact between adjacent structures and thus
provide a good indication of whether there is abutting contact
between two surfaces. However, they do not provide an indication of
the strain that is present in either of the surfaces, on the other
hand, the strain sensors output data indicative of the mechanical
strain forces being applied across the implant which, if not
corrected, can be a harbinger of future loosening and prosthesis
failure. In addition, an ISM having strain gauges may be of the
type which indicates the strain which is being exhibited between
two surfaces, such as between the acetabular liner and the pelvic
bone or between the acetabular shell and the acetabular liner.
[0234] Within other embodiments an ISM is provided with
accelerometers that can be positioned at various locations in and
on the femoral shaft, femoral neck and femoral head. Accelerometers
provide the benefit of being able to detect acceleration,
vibration, shock, tilt, and rotation of various components. They
permit the ability to measure performance of the prosthesis under
various conditions and over long periods of time.
[0235] Shortly after the hip has been replaced, the leg will be
mobilized, at first passively, then actively; shortly thereafter,
the patient will begin gradual weight bearing on the joint. The ISM
accelerometers will measure the movement of the hip socket during
movement, including during ambulation as the leg swings forward,
hits the ground, plants, is lifted off the ground, and the body is
propelled forward. In addition, the accelerometers will measure the
impact of the foot hitting the ground and the effect of the force
being transferred through the femur to the pelvic bones and any
vibration, shock or rotation which may occur at different locations
in the prosthesis. As the patient continues to improve their range
of motion postoperatively, the acceleration experienced at
different locations in the prosthetic hip joint, can be monitored.
It will be expected that as the patient heals from the surgery,
activity levels will progressively increase, ambulation will
improve, steps will be more rapid (and fluid) and, in addition,
greater stride length will be achieved with each step. This may
result in greater impact every time the foot hits the ground, which
can be measured over time (and compared to previous values) by the
various accelerometers positioned on the femoral head, in the
femoral stem, and/or in other locations on the prosthesis.
Postoperative progress can be monitored (readings compared from
day-to-day, week-to-week, etc.) and the information compiled and
relayed to both the patient and the attending physician allowing
rehabilitation to be followed sequentially and compared to expected
(typical population) norms. Within certain embodiments, a wearable
device interrogates the sensors on a selected or randomized basis,
and captures and/or stores the collected sensor data. This data may
then be downloaded to another system or device (as described in
further detail below).
[0236] Within certain embodiments of the invention, the ISM is a
unitary implantable device such as is shown in FIG. 13. For an ISM
collecting mechanical data (position, motion, vibration, rotation,
shock, tilt, steps), the implanted ISM sensors (accelerometers,
position sensors, pedometers) have the advantage of not requiring
either direct physical contact with the surface of the device or
with patient tissues; only a secure and immobile attachment within
the prosthetic joint is needed. In a particularly preferred
embodiment, the ISM containing multiple mechanical sensors (as
described above) is placed within the internal canal of the femoral
stem; a location that provides more than enough space to insert and
seal an ISM with multiple sensor functions and battery capability.
Furthermore, the motion of the stem of a total hip joint that
occurs during normal activities (such as walking) can provide
opportunities to power the ISM.
[0237] The sensors used in the ISM for contact, strain and
accelerometers can be an acceptable type of those generally
available and as described herein.
[0238] Integrating the data collected by the sensors described
herein (e.g., contact sensors, position sensors, strain gauges
and/or accelerometers) with simple, widely available, commercial
analytical technologies such as pedometers and global positioning
satellite (GPS) capability, allows further clinically important
data to be collected such as, but not restricted to: extent of
patient ambulation (time, distance, steps, speed, cadence), patient
activity levels (frequency of activity, duration, intensity),
exercise tolerance (work, calories, power, training effect), range
of motion (discussed later) and prosthesis performance under
various "real world" conditions. It is difficult to overstate the
value of this information in enabling better management of the
patient's recovery. An attending physician (or physiotherapist,
rehabilitation specialist) only observes the patient episodically
during scheduled visits; the degree of patient function at the
exact moment of examination can be impacted by a multitude of
disparate factors such as: the presence or absence of pain, the
presence or absence of inflammation, stiffness, time of day,
compliance and timing of medication use (pain medications,
anti-inflammatories), recent activity and exercise levels, patient
strength, mental status, language barriers, the nature of their
doctor-patient relationship, or even the patient's ability to
accurately articulate their symptoms--to name just a few.
Continuous monitoring or at repeated periodic intervals as a means
to manage battery life and data collection can allow the patient
and the physician to monitor progress objectively by supplying
information about patient function under numerous conditions and
circumstances, to evaluate how performance has been affected by
various interventions (pain control, exercise, physiotherapy,
anti-inflammatory medication, rest, etc.), and to compare
rehabilitation progress versus previous function and future
expected function. Better therapeutic decisions and better patient
compliance can be expected when both the doctor and the patient
have the benefit of observing the impact of various treatment
modalities on patient rehabilitation, activity, function and
overall performance.
[0239] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can comprise a
variety of different sensors within different locations of the ISM
on and/or within the prosthetic hip. In addition, within various
embodiments of the invention one or more sensors may be placed
separate from the ISM (but still be, optionally, able to
communicate with, and be controlled, by the ISM). Representative
examples of sensors placed on a hip prosthesis are provided in PCT
Application No. PCT/US2014/028381, which is hereby incorporated by
reference in its entirety.
[0240] B.3.C. Coatings on Hip Implants
[0241] Within certain embodiments of the invention the hip implants
are provided that can have one or more coatings on one or more
surfaces of the prosthesis. Coatings can be provided on hip implant
for a variety of purposes. Coatings may be biodegradable, or
non-biodegradable, or a combination of these. Representative
examples of coatings are polymer-based (e.g., polymers comprised of
polyurethane, polyester, polylactic acid, polyamino acid,
polytetrafluroethylene, tephlon, Gortex.RTM.), although non-polymer
coatings may also be utilized. Within certain embodiments of the
invention, one or more ISMs containing sensors, as described
herein, may be disbursed throughout the coating (e.g., even in a
random manner).
[0242] B.4. Prosthetic Knee Joints
[0243] Within one embodiment of the invention, knee replacements
are provided having one or more ISMs as described herein. Briefly,
"knee replacement" or "knee prosthesis" as that term is utilized
herein, may take a variety of different forms and may involve
replacement of all (total knee replacement) or portions (partial
knee replacement) of the patient's knee joint with synthetic
materials. In total knee replacement (TKR), both the femoral side
and the tibial side are replaced. In a partial, or
unicompartmental, knee replacement, only one or two portions
(surfaces--tibial or femoral; or compartments--medial, lateral or
patellar) of the knee are replaced.
[0244] The various components of a TKR can typically include a
femoral implant, a patellar implant, and a tibial implant (which
can be composed of a tibial plate--with or without a stem--and a
tibial liner). Currently, the various components can be made from a
variety of different materials, including for example,
polyethylene, ultrahigh molecular weight polyethylene, ceramic,
surgical-grade stainless steel, cobalt chromium, titanium, and
various ceramic materials. Within certain devices, the femoral
implant (typically made of a metal such as stainless steel,
titanium, or cobalt chromium) can be designed with a bone surface
coating to encourage incorporation of the implant within the femur
and the tibial plate (and stem) can also have a surface coating to
encourage incorporation into the tibia. Representative examples of
the various components of a knee replacement are described in U.S.
Pat. Nos. 5,413,604, 5,906,643, 6,019,794 and 7,922,771.
[0245] "Bone Cement" refers to a material that can be administered
between the prosthetic hardware and the surrounding bone and
hardens in place when cooled (or otherwise activated); it is an
agent used to secure one or more of the components (the prosthetic
femur surface, the tibial plate/stem, the patellar "button") of the
prosthesis to the appropriate bony tissue (femur, tibia, tibial
medulla, patella). Bone cement is often composed of PMMA
(polymethylmethacrylate) or PMMA and MMA copolymer blends. It
should be noted that bone screws and/or other metallic (or
polymeric) securing devices can also be used to assist in anchoring
the prosthetic components to the surrounding bony tissues.
[0246] The present invention provides knee prosthesis (which may
include a full or a partial implant), medical devices (e.g., a
portion of a knee implant, and/or components or materials which are
useful in the process of implanting the device), and kits (e.g., a
knee prosthesis, medical device, and additional necessary materials
such as bone cement and any associated delivery devices), all of
which can have one or more of the ISMs provided herein. The knee
prosthesis, medical devices and kits as provided herein (including
related materials such as bone cement) are preferably sterile,
non-pyrogenic, and/or suitable for use and/or implantation into
humans. However, within certain embodiments of the invention the
knee prostheses, medical devices and/or kits can be made in a
non-sterilized environment (or even customized to an individual
subject), and sterilized at a later point in time.
[0247] B.4.A. Knee Prosthesis, Medical Devices and Kits and their
Use
[0248] Knee replacement is carried out when the patient loses
sufficient use of the knee so as to result in disability, loss of
movement and function, impaired ambulation, and/or continuous joint
pain and discomfort. Common causes of impaired knee function
leading to total or partial knee replacement include various types
of arthritis (such as rheumatoid arthritis or osteoarthritis, and
trauma (for example, previous knee ligament injuries or
cartilage/meniscus tears). In most patients, the operation is
successful in improving ambulation, restoring normal daily function
and reducing pain; as a result, it is a very common orthopedic
procedure in the Western World.
[0249] FIG. 14 shows a total knee joint of a type known in the art,
as well as a unicompartmental (medial compartment) knee
replacement. FIG. 15 illustrates the components and materials of a
typical artificial joint (K10), including a metallic tibial plate
(K5) and tibial stem (K2) (present in this Figure, although some
tibial plate components do not have stems), a polyethylene
articulating surface (K7), cement used to hold the various
components in place (K4), patellar "button" prosthesis (K8), and
the femoral knee component (K9).
[0250] Within one embodiment of the invention an ISM may be placed
within a tibial extension. For example, a portion of an artificial
joint as shown in FIG. 15B may be composed of a tibial plate (FIG.
15C T1) and a tibial extension (FIG. 15C T2). The tibial extension
(FIG. 15D) may be comprised of various aspects, including a screw
engagement (T3), a first portion (T4) and a second portion (T5),
which optionally may be ribbed to assist with bone engagement. It
is also understood that the screw engagement (T3) may be configured
alternatively as a press-fit cylinder, a threaded cylinder, or
other means that can be accepted into a mating unit on a tibial
plate to effect fixation. Within certain embodiments of the
invention an ISM as described herein may be placed within a tibial
extension (e.g., within portion T4). Within certain embodiments the
extension is formed into two pieces with a joint located at the
maximum outer dimension of T5. The tibial extension containing an
ISM (e.g., T4a) can be sealed at a joint using glue, threads,
ultrasonic weld, or any combination of the foregoing. Within
further embodiments, a battery (e.g., T5a) which powers the ISM may
also be placed within the body of the tibial extension (e.g. within
portion T5). Although a standard battery is provided in FIG. 15D
T5a merely for purposes of illustration, the battery may also be
designed to have a shape which conforms to the ribbed segment in
order to maximize the battery volume and hence its power capacity.
Such shape also provides the additional benefit of inhibiting
rotation of the battery within the tibial extension when the joint
is in motion. It is also understood that the tibial extension
containing the ISM can be configured as an extension for any total
arthroplasty joint where the extension is placed into the medullary
canal of bone used to seat the arthroplasty device in the patient.
Particularly preferred ISMs for use in this aspect of the invention
can be made with flexible circuitry (e.g, as shown in FIG. 15D
T4a), and have an accelerometer, and gyroscope for measurement of
the movement of the artificial joint. Additionally, ISMs suitable
for use herein may include one or more of: a temperature sensor, a
magnetometer, a radio transceiver, an energy harvester, a signal
processor, a microcontroller, and piezoelectric sensor.
[0251] FIG. 16 depicts another typical TKR, with a femoral
component, a tibial plate, a tibial lining and a patellar button
which may be attached with screws and/or cement to the underlying
bone (in FIG. 16 the tibial plate is attached to the tibia by
screws and/or cement as opposed to a stemmed tibial plate as
depicted in FIG. 15).
[0252] FIG. 17 illustrates a representative prosthesis having one
or more ISMs (10) positioned in or on the prosthesis in order to
monitor, in situ, the real-time operation of the prosthesis, levels
of patient function and activity, and the prosthesis performance
acutely and over time. Note that in a knee prosthesis containing a
tibial stem (as in FIG. 15), the inner canal of the tibial stem is
a preferred location for the placement of an ISM.
[0253] As an example, one or more ISMs having contact sensors can
be provided for placement or attachment on or within the tibial
component (the liner, plate or stem), femoral component, and/or
patellar components ("button") of a knee prosthesis. The ISM can
also be contained within the bone cement (if present).
[0254] Within other aspects of the invention methods are provided
for imaging a knee replacement or medical device containing one or
more ISMs as provided herein, comprising the steps of (a) detecting
the location of one or more sensors within an ISM in a knee
replacement or medical device; and (b) visually displaying the
location of said one or more sensors, such that an image of the
knee replacement or medical device is created. Within various
embodiments, the step of detecting may be done over time, and the
visual display may thus show positional movement over time. Within
certain preferred embodiments the image which is displayed is a
three-dimensional image.
[0255] The imaging techniques provided herein may be utilized for a
wide variety of purposes. For example, within one aspect, the
imaging techniques may be utilized during a surgical procedure in
order to ensure proper placement, alignment and working of the knee
replacement or medical device. Within other embodiment, the imaging
techniques may be utilized post-operatively in order to examine the
knee replacement or medical device, and/or to compare operation
and/or movement of the device over time.
[0256] Within one embodiment, a prosthetic knee containing one or
more ISMs equipped with contact or pressure sensors can be used to
detect loosening of the prosthesis and its connection to the
surrounding cement (if present) and/or bone. For example, an ISM
having contact or pressure sensors located on/in the tibial
component (and/or on/in the bone cement around the tibial
component), can detect loosening of the tibial component within the
tibia; this can be detected acutely during surgery and alert the
surgeon that some intra-operative adjustment is required.
Progressive loosening of the tibial component within the tibia over
time (as compared to post-operative levels) is a common
complication that occurs when bone loss takes place (e.g., due to a
process known as osteolysis); this too can be detected by the ISM
contact or pressure sensors on/in the tibial component (and/or
on/in the surrounding bone cement). Furthermore, ISM contact or
pressure sensors located between segments of the tibial component
(e.g. between the tibial plate and the tibial liner) can detect
abnormal movement, loosening, or wear between component segments;
these sensors can be "matching" (i.e. "paired" between adjacent
components) so as to also allow accurate fitting during (and after)
surgical placement.
[0257] Hence, in one embodiment ISMs having contact or pressure
sensors are provided in order to monitor contact between the tibia
and the tibial component, between the femur and the femoral
component, between the patella and the patellar component, between
the complimentary segments of the individual prosthetic components,
and between the various articular surfaces present (medial and
lateral tibial-femoral joint; the patellar-femoral joint) of a
multi-compartmental or uni-compartmental prosthetic knee joint.
Specifically, full or partial dislocation (subluxation) of the
femoral prosthetic joint surface from the natural or synthetic
tibial joint surface (medial, lateral or both) of a prosthetic knee
is a common complication of knee replacement, often occurring
shortly after surgery (particularly during the post-operative
recovery period when the surrounding muscles and ligaments are
still healing from surgery). ISM contact sensors on the femoral
component articular surface and/or tibial component articular
surface can alert the patient and the healthcare provider if joint
dislocation or subluxation has occurred. This is of particular
value in the detection of subclinical partial or incomplete
dislocation (subluxation) of the knee joint which may not be
readily evident to the patient or the physician; this is of
greatest concern during early mobilization and post-operative
rehabilitation efforts. Additionally, an ISM having contact or
pressure sensors on the various knee components can determine of
the joint is functioning and aligning (tracking) correctly during
movement and activity. This is particularly true with respect to
the movement of the knee cap, as accurate patellar tracking can be
difficult to accurately measure clinically; accurate measurement of
patellar tracking, both intra-operatively and post-operatively,
would be beneficial.
[0258] In other embodiment ISMs having one or more strain gauges
(or sensors) are provided, including for example, on and/or within
the femoral condyle prosthesis-bone interface, on and or within the
tibial bone--metal plate (and stem if present) interface, and on or
within the patellar prosthesis (patellar "button")--patellar bone
interface. In some embodiments (and to the extent space permits),
the ISM having strain gauges can be contained on/within the bone
cement (if present) used to secure the prosthesis to the
surrounding bone, and in still other embodiments the strain gauges
are contained on/within both the prosthetic components and the bone
cement (PMMA).
[0259] Within various embodiments ISMs having strain gauges can be
positioned at various locations on the tibial component to detect
strain encountered between the tibial prosthesis and the
surrounding tibial bone (and/or bone cement if present). Many
tibial prostheses contain a stem that extends into the medullary
canal of the tibia to enhance anchoring and stability. A decrease
in strain in the tibial prosthesis and/or tibial bone cement may
indicate that conditions are present that could potentially lead to
bone resorbtion (loss) in all, or parts, of the tibial canal; bone
resorbtion can lead to loosening of the prosthesis, or to tibial
fracture (conversely, increased strain would favour bone growth in
the region). Therefore, ISMs having strain sensors can provide an
indication of the strain that is present in the tibial shaft and
measure the most important mechanical strain forces being applied
across the implant which, if mal-aligned or not corrected, have a
high probability of resulting in loosening and prosthesis failure.
An increase of strain may also indicate bone hypertrophy (growth),
which can be a source of pain. The same dynamic exists in the
interface between the femoral and patellar prosthetic components
(and/or bone cement) and the femur and patellar; ISMs having strain
gauges of the present invention can be used to monitor for these
purposes as well. "Real life" strain information would not just be
beneficial to the doctor and patient, who could use the data to
determine the (positive and negative) effects of various activities
on prosthetic-bone health, but also to manufacturers who could use
it to design better prostheses.
[0260] Similarly, in other embodiments ISMs are provided having one
or more accelerometers that can be located throughout the implant,
including ISMs having accelerometers distributed on and within the
femoral condyle prosthesis, on and within the tibial plate (and
stem if present) and tibial liner, and on or within the patellar
prosthesis (patellar "button"). In some embodiments, the ISM having
accelerometers are on/within the prosthetic components themselves
(tibial, femur and patellar segments), while in others the ISM
having accelerometers are contained on/within the bone cement (if
present) used to secure the prosthesis to the surrounding bone, and
in still other embodiments the accelerometers are contained
on/within both the prosthetic components and the bone cement
(PMMA).
[0261] ISMs having accelerometers provide the benefit of being able
to detect acceleration, vibration, shock, tilt, and rotation of
various components. They permit the ability to measure performance
of the prosthesis (K10) under various conditions and over long
periods of time.
[0262] During knee replacement surgery, the prosthetic joint will
be moved through a full range of motion and stability testing to
assess prosthetic function and mobility prior to surgical closure.
The ISMs having accelerometers can provide the surgeon with
accurate, numeric, quantitative range of motion data at that time;
this data can be compared to expected values to assess efficacy of
the implantation surgery and can serve as a baseline value for
comparison to functional values obtained post-operatively. Any
abnormalities in vibration (indicative of an inadequate anchoring
of the prosthesis in the surrounding bone), tilt (indicative of
improper tracking and/or alignment of the tibial-femoral joint and
the patellar-femoral joint), rotation (indicative of dislocation or
subluxation), and/or range of motion can be addressed at this time
and allow the surgeon to make adjustments intra-operatively.
Shortly after the knee has been replaced, the leg will be mobilized
post-operatively, at first passively, then actively; shortly after
recovering from the procedure, the patient will begin gradual
weight bearing on the joint. The ISM accelerometers can measure the
movement and tracking of the knee joint during movement, including
during ambulation as the leg swings forward, hits the ground,
plants, is lifted off the ground, and the body is propelled
forward. In addition, the accelerometers can measure the impact of
the foot hitting the ground and the effect of the force being
transferred through the tibia to the knee joint and any vibration,
shock or rotation which may occur at different locations in the
prosthesis. As the patient continues to improve their range of
motion postoperatively, the acceleration experienced at different
locations in the prosthetic knee joint, can be monitored. It will
be expected that as the patient heals from the surgery, activity
levels will progressively increase, ambulation will improve and
increase, steps will be more rapid (and fluid) and, in addition,
greater stride length will be achieved with each step. The effects
of exercise and various activities can be monitored by the various
accelerometers and can be compared to patient's subjective
experiences to determine which life activities are improving (or
inhibiting) post-operative recovery and rehabilitation.
[0263] In another embodiment, one or more ISMs containing position
sensors are provided for inclusion or attachment throughout the
implant, including ISM containing position sensors distributed on
and within the femoral condyle prosthesis, distributed on and
within the tibial plate (and stem if present) and tibial liner, and
distributed on within the patellar prosthesis (patellar "button").
In some embodiments, the ISM containing position sensors are
on/within the prosthetic components themselves (tibial, femur and
patellar segments), while in others the position sensors are
contained on/within the bone cement (if present) used to secure the
prosthesis to the surrounding bone, and in still other embodiments
the position sensors are contained on/within both the prosthetic
components and the bone cement (PMMA).
[0264] ISMs having positional sensors as described herein can be
utilized to provide accurate positional data (intra-operatively and
post-operatively) for the prosthetic knee joint, including the
measurement of flexion and extension, to enhance the accuracy of a
physical exam by providing 3 dimensional data of the implant, to
detect full and partial dislocation (subluxation) of the
tibial-femoral (knee) joint and/or the patella-femoral joint, and
to determine proper tracking and alignment of the knee joint and
the patella.
[0265] Within another embodiment ISMs can be placed in any of the
polymer components of the medical device. Representative polymers
that can, within certain embodiments, be utilized, include
polyethylene, highly crosslinked polyethylene, ultra-high molecular
weight polyethylene, polyether ether ketone ("PEEK"), carbon fiber
reinforced PEEK, and/or vitamin E stabilized highly crosslinked
polyethylene (HXLPE) (as described in greater detail below under
the section entitled "Medical Polymers".
[0266] For an ISM collecting mechanical data (position, motion,
vibration, rotation, shock, tilt, steps), the implanted ISM sensors
(accelerometers, position sensors, pedometers) have the advantage
of not requiring either direct physical contact with the surface of
the device or with patient tissues; only a secure and immobile
attachment within the prosthetic joint is needed. In a particularly
preferred embodiment, an ISM with multiple mechanical sensors (as
described above) is placed within the internal canal of the tibial
stem; a location that provides more than enough space to insert and
seal an ISM with multiple sensor functions and battery capability.
Furthermore, the motion of the stem of a total knee joint that
occurs during normal activities (such as walking) can provide
opportunities to power the ISM.
[0267] Integrating the data collected by the sensors described
herein (e.g., contact sensors, position sensors, strain gauges
and/or accelerometers) with simple, widely available, commercial
analytical technologies such as pedometers and global positioning
satellite (GPS) capability, allows further clinically important
data to be collected such as, but not restricted to: extent of
patient ambulation (time, distance, steps, speed, cadence), patient
activity levels (frequency of activity, duration, intensity),
exercise tolerance (work, calories, power, training effect), range
of motion and prosthesis performance under various "real world"
conditions. Continuous monitoring or at repeated periodic intervals
as a means to manage battery life and data collection can allow the
patient and the physician to monitor progress objectively by
supplying information about patient function under numerous
conditions and circumstances, to evaluate how performance has been
affected by various interventions (pain control, exercise,
physiotherapy, anti-inflammatory medication, rest, etc.), and to
compare rehabilitation progress versus previous function and future
expected function.
[0268] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can comprise a
variety of different sensors within different locations of the ISM.
In addition, within various embodiments of the invention one or
more sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with, and be controlled by, the
ISM). Representative examples of sensors placed on a knee
prosthesis are provided in PCT Application No. PCT/US2014/043736,
which is hereby incorporated by reference in its entirety).
[0269] B.4.B. Use of a Knee Prosthesis, Medical Device or Kit
having Sensors to Measure Degradation or Wearing of an Implant
[0270] As noted above, within various aspects of the present
invention knee prosthesis, medical devices and kits are provided
which can detect and monitor the degradation of an implant. For
example, within one embodiment of the invention, a method is
provided for degradation of a knee replacement, medical device or
kit, comprising the steps of a) providing to a subject a knee
replacement, medical device or kit having one or more ISMs
containing sensors as described herein, and b) detecting a change
in an ISM sensor, and thus determining degradation of the knee
replacement, medical device or kit. Within various embodiments the
ISM sensor(s) can detect one or more physiological and/or
locational parameters. Within another embodiment, the ISM sensor(s)
can detect contact, fluid flow, pressure and/or temperature. Within
yet another embodiment the ISM sensors can detect a location within
the subject.
[0271] When a knee prosthesis degrades or is damaged, ISM sensors
can detect a change so that a determination of damage and/or
degradation can be made. For example, a sensor that was previously
embedded within a polymer portion of a device, upon degradation may
be exposed to fluid forces, and pressures where none existed
before. Hence, within preferred embodiments of the invention
degradation can be detected over a period of time.
[0272] B.5. Medical Tubes
[0273] Within yet another embodiment of the invention medical tubes
are provided having one or more ISMs as described herein. Briefly,
a "medical tube" refers to a generally cylindrical, closed,
water-tight body, and as utilized herein, can be used in a wide
variety of medical procedures (e.g., the tubes are generally
sterile, non-pyrogenic, and/or suitable for use and/or implantation
into humans). For example, tubes can be utilized to: 1) bypass an
obstruction (e.g., in the case of Coronary Artery Bypass Grafts, or
"CABG" and peripheral bypass grafts) or open up an obstruction
(balloon dilation catheters, angioplasty balloons); 2) to relieve
pressure (e.g., shunts, drainage tubes and drainage catheters,
urinary catheters); 3) to restore or support anatomical structures
(e.g., endotracheal tubes, tracheostomy tubes, and feeding tubes);
and 4) for access (e.g., CVC catheters, peritoneal and hemodialysis
catheters). Representative examples of tubes include catheters (as
discussed in more detail below), auditory or Eustachian tubes,
drainage tubes, tracheotomy tubes (e.g., Durham's tube),
endobronchial tubes, endotracheal tubes, esophageal tubes, feeding
tubes (e.g., nasogastric or NG tubes), stomach tubes, rectal tubes,
colostomy tubes, and a wide variety of vascular grafts (e.g.,
bypass grafts).
[0274] Tubes may be composed of synthetic materials (e.g.,
silicone, polyurethane and rubber), composed of non-synthetic
components (e.g., harvested vein and artery grafts for bypass), or
some combination of these [e.g., artificial blood vessels having a
synthetic polymer scaffold, and naturally occurring cells (e.g.,
fibroblasts) which produce matrix materials for the vessel (e.g.,
collagen)].
[0275] "Catheter" as that term is utilized herein, refers to a thin
tube that is commonly used for a wide variety of medical
conditions, and in a wide variety of medical procedures. Typically,
they are inserted into a body cavity, lumen, duct, or vessel.
Catheters are often inserted into the body by first advancing a
flexible, metallic guidewire to the desired anatomical location;
the catheter is then placed over the guidewire and maneuvered into
position and the guidewire is then removed. In this manner they
can, depending on the indication or procedure, allow for drainage,
administration of fluids (e.g., saline solutions, drugs, etc.),
provide access for various medical or surgical instruments, and/or
of themselves be utilized to perform a wide variety of surgical
procedures (such as balloon catheters used to dilate an obstructed
body passageway). Catheters may be used either temporarily, or for
extended periods of time (even permanently), and may have one, two,
three, or more lumens or channels.
[0276] Catheters may be composed of a wide variety of materials
(including for example metals such as nitinol), although most are
made from polymers. Catheters may be made of either biodegradable
or non-biodegradable polymers (or combinations of these). Typical
polymers that are used in the construction of catheters include
silicone, nylon, polyurethane, and polyethylene terephthalate. As
will be readily evident given the disclosure provided herein, the
catheter can be designed suitable to the intended use, and may be
designed in a wide variety of forms and shapes (see e.g., FIG. 18
for an example of a balloon-based catheter having an ISM with
various sensors).
[0277] Catheters can be utilized for a wide variety of clinical
indications and procedures, including for example, for 1) draining
fluids or eliminating obstructions through the placement of
catheters via natural body orifices, such as: draining the urinary
tract (e.g., the bladder or kidney) via the urethra with Foley
catheters, intermittent (Robinson) catheters and ureteric
catheters; accessing the GI tract through anal catheters, and
suction catheters; reaching the respiratory system through the nose
and mouth with pulmonary catheters; entering the reproductive
system via the vagina (female) or urethra (male); 2) draining
bodily fluids or relieving an obstruction through a surgically
created access into an anatomical space or cavity; e.g., peritoneal
catheters (placed in the abdominal cavity for ascites, dialysis),
chest tubes (placed in the pleural space for pneumothorax, pleural
effusion, chylothorax, infection), pericardial drainage tubes (in
the heart), CNS drainage catheters or shunts (placed in the
cerebrospinal fluid for hydrocephalus, infection, inflammation,
obstruction); 3) drainage catheters which are surgically placed
percutaneously or intraoperatively to drain collections of sterile
fluid or abscesses elsewhere [can be placed virtually anywhere,
including the thorax (heart, lungs), abdomen (liver, biliary
drainage catheters), knees, hips, urinary tract (ureters, kidneys,
prostate, bladder), reproductive tract (uterus, fallopian tubes),
GI tract (anal fistulas, other fistulas, abcesses, stomas,
colostomies), soft tissues (abscesses, seromas, compartment
syndromes) to name a few]; 4) intervenous catheters [e.g.
peripheral i.v.'s, central venous catheters (CVCs),
peripherally-inserted central venous catheters (PICCs), arterial
(e.g. hemodialysis access grafts and catheters, arterial
catheters), and peritoneal (e.g. peritoneal dialysis catheters,
peritoneal catheters) catheters that are placed for the
administration of fluids (e.g., intravenous administration of
fluids, medication, direct administration of a desired substance
(e.g., a drug) to a desired location), access, dialysis or
nutrition (nasogastric tubes, feeding tubes, total parental
nutrition tubes, gastric tubes); 5) catheters placed for the
implementation of a medical or surgical procedure or device [e.g.,
coronary angioplasty, peripheral angioplasty, angiography, dilation
of an artery and/or placement of a stent, balloon septostomy,
balloon sinuplasty, catheter-based ablation, balloon dilation
catheters (esophageal, biliary, tracheal, bronchial, urethral,
etc.)]; and 6) catheters placed for the direct measurement of a
biological function or value (e.g., arterial or venous blood
pressure, cardiac function, and intracranial pressure).
[0278] Commonly available catheters include Foley-catheters for the
drainage of urine, ureteral catheters, central venous catheters
(CVCs, PICCs, ports) for the administration of drugs and fluids,
and Swan-Ganz catheters utilized principally for diagnostic
purposes in the pulmonary artery. Representative examples of
catheters are described in U.S. Pat. Nos. 8,491,569, 8,469,989,
8,460,333, 8,359,082, 8,246,568, 8,285,362, 8,257,420, 8,317,713,
8,328,829, 8,262,653, 6,966,914, 5,989,213, 5,509,897, 4,772,268,
and U.S. Publication Nos. 2012/0310158, 2012/0283641, 2012/0239032,
2012/0253276, all of which are incorporated by reference in their
entirety. Within one limited embodiment of the invention a balloon
catheter which is utilized to deploy a stent or at stent graft can
be optionally excluded, to the extent said exclusion is
specifically stated or claimed.
[0279] Representative examples of intravascular catheters and
balloon dilation catheters (including drug delivery catheters and
balloon catheters are described in U.S. Pat. Nos. 5,180,366;
5,171,217; 5,049,132; 5,021,044; 6,592,568; 5,304,121; 5,295,962;
5,286,254; 5,254,089; 5,112,305, 5,318,531, 5,336,178, 5,279,565,
5,364,356, 5,772,629, 5,810,767, 5,941,868, 5,362,309, 5,318,014,
5,315,998, 5,304,120, 5,282,785, 5,267,985, 5,087,244, 5,860,954,
5,843,033, 5,254,089, 5,681,281, 5,746,716, 6,544,221, 6,527,739,
6,605,056, 6,190,356, 5,279,546, 5236424, 5,226,888; 5,181,911,
4,824,436, 4,636,195, 5,087,244, 6,623,452, 5,397,307, 4,636,195,
4,994,033, 5,362,309 and 6,623,444; U.S. patent application
Publication Nos. 2002/0138036, 2002/0068869, 2005/0186243; and PCT
Publication Nos. WO 01/15771; WO 93/08866, WO 92/11890, WO
92/11895, WO 94/05361; WO 96/04955 and WO 96/22111, all of which
are incorporated by reference in their entirety.
[0280] "Guidewire" refers to a medical device which is utilized to
position another medical device (e.g., an intravenous catheter,
endotracheal tube, central venous line, balloon catheter, or
gastric feeding tube), or to localize a tumor (e.g., during a
breast biopsy). Representative examples of guidewires are described
in U.S. Pat. Nos. 4,787,884, 5,911,734, 5,910,154, 6,676,682,
6,936,065, 6,964,673, and 7,691,123 and U.S. Publication Nos.
2006/0100694, and 2007/0027522, all of which are incorporated by
reference in their entirety.
[0281] B.5.A. Catheters, Tubes and their Use
[0282] B.5.A.1. Balloon Catheters and their Use
[0283] As noted above, within various embodiments of the invention,
balloon catheters (and their associated medical devices, e.g.,
stents and/or guidewires), are provided with one or more ISMs
having one or more of the sensors described herein. For example,
FIG. 18 illustrates a balloon catheter having one or more ISMs
containing a variety of sensors positioned in or on the balloon
catheter (and/or potentially the guidewire) in order to monitor, in
situ, the real-time operation of the catheter, the inflation and
deflation of the balloon, the forces exerted by the balloon against
adjacent tissues or devices (e.g. stents), flow levels through and
around the balloon, and the catheter performance acutely and over
time. The ISM containing sensors may be positioned inside the
balloon catheter, within the walls of the balloon catheter, or on
the outer surface of the balloon catheter. While in certain
embodiments, ISMs containing contact sensors, pressure sensors, and
positions sensors can be utilized as shown in FIG. 18, a wide
variety of other sensors can also be used within the ISM that is
placed in, on, or within the balloon catheter, including for
example, fluid pressure sensors, accelerometers, vibration sensors,
pulse sensors, liquid (e.g., blood) volume sensors, liquid (e.g.,
blood) flow sensors, liquid (e.g., blood) chemistry sensors, liquid
(e.g., blood) metabolic sensors, mechanical stress sensors, and
temperature sensors.
[0284] For example, balloon catheters containing an ISM can be
inserted via a guidewire into a stenosed artery (such as a coronary
artery or peripheral artery). ISMs having contact sensors able to
monitor the surface of the balloon can be utilized to measure
contact with the vessel wall during inflation, deployment and
deflation. Specifically, the balloon is expanded, thereby expanding
the artery (coronary artery or peripheral artery); ISMs having
pressure sensors can monitor pressure in the balloon, and the
pressure which is exerted against the vascular wall. Within
preferred embodiments the pressure is monitored and, if needed,
adjusted in order to prevent injury to the vascular wall due to
excessive pressure. The drop in pressure during deflation of the
balloon can also be monitored to confirm that it is safe to
withdraw the balloon catheter from the treated vascular lesion.
Similarly, ISMs containing contact sensors can be used to monitor
contact of the balloon with the vessel wall during balloon
deflation to confirm that it is safe to withdraw the balloon
catheter from the treated vascular lesion. ISMs containing position
sensors can be utilized in balloon catheters and guidewires, in
order to assist in placement of the balloon catheter, (and
placement of a stent, if desired), and for medical imaging. The ISM
position sensors contained in or on the balloon can be utilized to
provide an image of vascular anatomy, pre- and post-inflation
anatomy, confirmation of full balloon inflation and deflation,
confirmation of stent placement and confirmation of full stent
expansion and deployment (if present).
[0285] In other embodiments, balloons containing ISMs with sensors
can be utilized to assist the placement of a balloon-expandable
stent. For example, FIG. 9A illustrates a site of bifurcation with
stenosis occurring at multiple points in the vessel. FIG. 9B
illustrates a stent with PTCA to open up a side branch. In this
case, (potentially "matched" or complimentary) contact sensors on
an ISM in the stent and the balloon can be used to confirm accurate
assembly; ISM accelerometers on the stent and the balloon can be
used to confirm anatomical location and conformation; ISM position
sensors on the stent and the balloon can monitor movement; ISM flow
sensors on the stent and the balloon can confirm vascular patency;
and ISM pressure/vessel wall sensors on the stent and the balloon
can confirm full deployment and accurate vessel sizing. Taken
collectively, this sensing information can create a 3-dimensional
image of the vascular and stent anatomy and physiology and greatly
improve the data available from angiography alone. This
dramatically increases the chances of accurate, safe and effective
deployment of multiple stents in complicated vascular lesions.
[0286] It should be readily evident given the disclosure provided
herein that the above ISM-containing balloon catheters and
associated medical devices containing ISM sensors can be utilized
in the management of non-vascular disease. Balloon catheters are
used to open up obstructed body passageways and lumens in many
other tissues, such as, but not restricted to, the sinuses,
respiratory tract, gastrointestinal tract, biliary tract, urinary
tract and reproductive tract. While the size, shape and purpose of
the balloon catheter (and associated devices) may vary, the type,
placement and role of various ISM sensors is analogous to that
described above for the vascular system. In summary, a wide variety
of ISMs having multiple sensor types may be placed on and/or within
balloon catheters and associated devices (such as guidewires)
described herein, in order to provide "real time" information and
feedback to a health care provider. Such ISM-containing balloons
can be used by a surgeon during a surgical procedure safely and
effectively open up an obstructed body passageway, to confirm
proper placement, verify anatomy, ensure effective dilation (and
elimination of the obstruction), monitor forces exerted on
surrounding tissues, follow full balloon inflation and deflation,
and to detect the strain/forces encountered in a balloon
procedure.
[0287] In this embodiment, the balloon catheters and associated
devices (such as guidewires) provided herein can contain one or
more ISMs having one or more contact sensors, strain gauge sensors,
pressure sensors, fluid pressure sensors, position sensors,
accelerometers, shock sensors, rotation sensors, vibration sensors,
tilt sensors, pressure sensors, tissue chemistry sensors, tissue
metabolic sensors, mechanical stress sensors and temperature
sensors. The above ISMs may be continuously monitored in order to
provide a `real-time` data, imaging, and changes in function over
the course of the procedure, and to better understand the
conditions which balloon catheters are exposed to in clinical
practice.
[0288] B.5.A.2. Central Venous Catheters and their Use
[0289] Within other embodiments of the invention central venous
catheters are provided having at least one ISM having one or more
sensors placed thereon. Briefly, central venous catheters (also
referred to as "central lines", "CVC"s) are catheters that are most
typically placed into the great veins of the body [usually the
superior vena cava (SVC), or the inferior vena cava (IVC)] via
access through the large vein of the neck [e.g., the internal
jugular vein), the chest (e.g., the subclavian vein or axillary
vein), or the groin (e.g., the femoral vein)] when reliable, longer
term vascular access is required. However, CVCs can also be
inserted peripherally (e.g., placed into the peripheral vasculature
system such as the veins of the arm and then advanced through the
venous system until the tip reaches the SVC), and in this instance
are commonly referred to as "Peripherally Inserted Central
Catheters" or "PICC"s. CVCs are utilized to deliver medication
and/or fluids to a subject, to obtain blood for testing, and for
measuring pressure (typically at the distal tip of the
catheter).
[0290] CVCs can be `non-tunneled` (i.e., fixed at the site of
insertion), and `tunneled` (i.e., passed under the skin from the
insertion site, to a separate exit site). One type of catheter
similar to a `tunneled` catheter is a "port", which although
similar, differs in that it is left entirely under the skin. In
this case, medications and fluids can be injected directly through
the skin into the port, or, for some types of ports, into a
reservoir contained in the port. The term "Central Venous Catheter"
or "CVC" used herein should be interpreted to include PICCs, Ports,
Tunneled CVCs and Non-tunneled CVCs.
[0291] Common complications of central lines include pneumothorax,
central line associated bloodstream infections (CRBSI), thrombosis,
hemorrhage, and the formation of hematomas or seromas at the
insertion site.
[0292] Hence, central venous catheters of the present invention can
be utilized which have one or more ISMs having at least one of the
sensors described herein. For example, within one embodiment,
central venous catheters of the present invention can have an ISM
with one or more fluid flow sensors. Such ISMs can, within various
embodiments be located on the inner (luminal) surfaces of the
catheter the outer (adluminal or blood contacting) surfaces of the
catheter, throughout the catheter, and/or (in a preferred
embodiment) located at tip of the catheter. The ISMs with flow
sensors can be utilized to measure fluid flow through the catheter
lumen. If at least one ISM with a flow sensor is located proximally
and at least one ISM with a flow sensor is located at the tip, it
is possible to determine if and where a blockage has occurred; for
example from the formation of a fibrin sheath, catheter stenosis,
catheter thrombosis, or catheter kinking (e.g., there would be
decreased luminal fluid flow rate prior to a narrowing and
increased luminal fluid flow rate following an narrowing; there
would be no fluid flow before or after a complete obstruction). The
ability to monitor flow rates would be valuable in normal operation
and during/after procedural attempts to "reopen" obstructed
catheters.
[0293] Within other embodiments, ISMs having pressure sensors can
be incorporated into a central venous catheter on the inner
(luminal) wall, outer (abluminal) wall, and/or within the body of
the catheter itself. Such ISMs are able to measure pressure within
or exerted against the catheter wall. Increased pressures can be
suggestive of stenosis, thrombosis or kinking upstream from a
narrowing or obstructing event, whereas decreased pressures would
be seen downstream from a narrowing and (little or) no pressure
would be seen downstream from an obstruction. Having the ability to
measure pressure (proximally and distally) throughout the catheter
allows for functional monitoring of the central venous catheter (in
normal operation and during/after attempts to "reopen" obstructed
catheters), and the capability to detect events prior to a
complication developing.
[0294] Within yet other embodiments, ISMs are provided having
contact sensors which can be incorporated into a central venous
catheter on the inner (luminal) wall, outer (abluminal) wall,
and/or within the body of the catheter itself to measure contact
between the luminal and adluminal surfaces and the surrounding
environment. Sustained foreign body contact on either surface could
be indicative of the formation of a fibrin sheath, thrombosis,
biofilm formation or infection; sustained contact at the tip could
indicate that the catheter has become pushed up against the
vascular wall and needs to be repositioned. In yet another
embodiment, an ISM containing chemical sensors can be placed
primarily on the adluminal (blood contacting) surface in order to
measure a wide variety of metabolic parameters, including for
example: Blood Oxygen content; Blood CO.sub.2 content; Blood pH;
Blood cholesterol; Blood lipids (HDL, LDL); Blood Glucose; Cardiac
enzymes; Hepatic Enzymes; and Kidney Function (BUN, Creatinine,
etc.).
[0295] Within other embodiments, an ISM having position sensors can
be placed in, on or within the catheter in order to allow imaging
of the catheter, and detection of changes and/or movement over
time. Position sensors on an ISM within a CVC catheter are useful
during placement of the catheter to ensure advancement into the
SVC, but not the right atria of the heart; post-placement, they can
be used to determine if the catheter has migrated proximally or
distally (into the right atrium) with time.
[0296] Within yet other embodiments, an ISM having chemical and/or
temperature sensors can be incorporated into a CVC such that it is
blood contacting (on the adluminal surface) and can be utilized to
monitor changes in temperature, which could suggest the presence of
an infection or a developing infection.
[0297] In a particularly preferred embodiment, an ISM containing
multiple sensors (flow sensor, position sensor, accelerometer,
pressure sensor, contact sensors, chemical sensors, temperature
sensors) is located at the tip of the catheter such that it has
both luminal and adluminal surface exposure.
[0298] In summary, one or more ISMs containing a wide variety of
sensors may be placed on and/or within the central venous catheters
described herein, in order to provide "real time" information and
feedback to a health care provider (during placement, repositioning
or "reopening" procedures), to detect proper anatomical placement,
vascular anatomy, alignment, forces exerted on surrounding tissues,
and to detect changes encountered during placement and subsequent
manipulation or repositioning procedures. For example, the central
venous catheters (CVCs, PICCs, Ports) provided herein can have one
or more ISMs having one or more contact sensors, strain gauge
sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, blood chemistry sensors,
blood metabolic sensors, mechanical stress sensors and temperature
sensors.
[0299] B.5.A.3. Dialysis Catheters and their Use
[0300] Within other embodiments, specialized central venous
catheters can be utilized in hemodialysis procedures (typically
when dialysis is only needed for a short period of time or as a
bridge to permanent dialysis procedures--see later). Briefly, a
hemodialysis catheter (or alternatively--"acute dialysis catheter")
is a specialized CVC placed into the central circulation that is
used for exchanging blood to and from a hemodialysis machine.
Typically, the catheter has two lumens, one for venous flow and the
other for arterial flow. The arterial lumen withdraws blood from
the patient and carries it to the hemodialysis machine, and the
venous lumen returns blood to the patient (after the blood has been
treated by the dialysis machine). Typically, flow rates of dialysis
catheters range from between 200 and 500 milliliters per minute. If
the patient requires long term dialysis therapy, a `chronic`
dialysis catheter can be utilized, which typically includes a cuff
that is buried beneath the skin (and which is believed to aid as a
barrier to infection). Common complications of hemodialysis
catheters include fibrin sheath formation, clotting, biofilm
formation, infection and kinking. Hence, hemodialysis catheters of
the present invention can be utilized which have one or more of the
ISMs described herein. For example, within one embodiment
hemodialysis catheters of the present invention can have one or
more ISMs having a blood flow sensor. Such ISMs can, within various
embodiments be located on the inner (luminal) surfaces of the
catheter, the outer (adluminal) surface of the catheter, and within
the walls of the catheter; in a preferred embodiment, the ISM
containing a blood flow sensor is located at the tip of the
catheter such that it can measure flow in both the arterial and the
venous lumen. They can be utilized to measure fluid flow through
the catheter. By comparing the readings of ISM flow sensors at
different locations in the hemodialysis catheter (i.e. the
difference between proximal and distal readings), a determination
of blockage (and the extent of a blockage; for example from the
formation of a fibrin sheath, catheter stenosis, catheter
thrombosis, or catheter kinking) can be determined (e.g., there
would be decreased fluid/blood flow prior to a narrowing and
increased fluid/blood flow following an narrowing; there would be
no fluid/blood flow before or after a complete obstruction). The
ability to monitor flow rates would be valuable in normal operation
and during/after procedural attempts to "reopen" obstructed
catheters. Within other embodiments, ISMs having pressure sensors
can be incorporated into a hemodialysis catheter on the inner
(luminal) wall, outer (adluminal) wall, and/or within the body of
the catheter itself. Such sensors are able to measure pressure
within or exerted against the catheter wall. Increased pressures
can be suggestive of stenosis, thrombosis or kinking upstream from
a narrowing or obstructing event, whereas decreased pressures would
be seen downstream from a narrowing and (little or) no pressure
would be seen downstream from an obstruction. Having the ability to
measure pressure at different points in the catheter allows for
functional monitoring of the hemodialysis catheter (in normal
operation and during/after attempts to "reopen" obstructed
catheters), and the capability of detecting events prior to a
complication developing.
[0301] Within yet other embodiments, ISMs having contact sensors
can be placed on the luminal and adluminal surfaces of the
hemodialysis catheter in order to measure contact between the
luminal and adluminal surfaces and the surrounding environment.
Sustained foreign body contact on either surface could be
indicative of the formation of a fibrin sheath, thrombosis, biofilm
formation or infection; sustained contact at the tip could indicate
that the catheter has become pushed up against the vascular wall
and needs to be repositioned.
[0302] In yet another embodiment, ISMs having chemical sensors can
be placed primarily on the adluminal (blood contacting) surface in
order to measure a wide variety of metabolic parameters, including
for example: Blood Oxygen content; Blood CO.sub.2 content; Blood
pH; Blood cholesterol; Blood lipids (HDL, LDL); Blood Glucose;
Cardiac enzymes; Hepatic Enzymes; and Kidney Function (BUN,
Creatinine, etc.). Many of these parameters are important in the
monitoring the need, effectiveness, timing and frequency of
dialysis treatments and would be a great assistance to the
clinician managing a renal patient; similarly comparing values in
the arterial arm of the catheter, the venous arm of the catheter
and the systemic circulation would also provide useful clinical
data.
[0303] Within other embodiments, ISMs having position sensors can
be placed on or within the hemodialysis catheter (e.g., on both the
luminal and adluminal surfaces, and within the catheter material
itself) in order to allow imaging of the catheter, and detection of
changes and/or movement over time. Position sensors are useful
during placement of the catheter to ensure advancement into the
proper anatomical location; post-placement, they can be used to
determine if the catheter has migrated proximally or distally with
time.
[0304] Within yet other embodiments ISMs having chemical and
temperature sensors can be utilized to monitor changes in
temperature which could be suggestive of the presence of an
existing infection, biofilm formation or a developing
infection.
[0305] In a particularly preferred embodiment, an ISM containing
multiple sensors (flow sensor, position sensor, accelerometer,
pressure sensor, contact sensors, chemical sensors, temperature
sensors) is located at the tip of the catheter such that it has
both luminal and adluminal surface exposure to both the arterial
and venous lumens of the dialysis catheter.
[0306] In summary, one or more ISMs with a wide variety of sensors
may be placed on and/or within the hemodialysis catheters described
herein, in order to provide "real time" information and feedback to
a health care provider (or during placement or subsequent
manipulation or "reopening" procedures), to detect proper
placement, vascular anatomy, alignment, forces exerted on
surrounding tissues, and to detect changes encountered during
placement and subsequent manipulation or repositioning procedures.
For example, the hemodialysis catheters (acute and chronic)
provided herein can have one or more ISMs having contact sensors,
strain gauge sensors, pressure sensors, fluid pressure sensors,
position sensors, accelerometers, shock sensors, rotation sensors,
vibration sensors, tilt sensors, pressure sensors, blood chemistry
sensors, blood metabolic sensors, mechanical stress sensors and
temperature sensors. The above sensors may be continuously
monitored in order to provide a `real-world` activity, patency, and
changes in function over time, to evaluate patient physiology, and
to better manage the dialysis patient.
[0307] B.5.A.4. Drainage Catheters and their Use
[0308] Within other embodiments of the invention, drainage
catheters are provided having one or more ISMs placed thereon.
Briefly, drainage catheters are typically placed in order to drain
fluid (e.g., surgical fluids, blood, peritoneal fluids, CSF,
biliary fluids, joint fluids, intestinal fluids, pus, an abscess,
pleural fluids, or urine to name a few) from a body structure. In
the context of urinary drainage, Foley catheters, which are
designed to drain urine from the bladder, and ureteral catheters
which are designed to allow flow of urine from the kidneys, are
commonly utilized in a wide variety of medical procedures. Drainage
catheters are typically made of polymers such as silicon or rubber,
but other materials (including biodegradable polymers) can also be
utilized. In the case of a Foley catheter, the catheter typically
has two separated lumens, one of which allows urine to drain
(typically to a collection bag), and the other has a valve which
allows inflation of a balloon at the distal end of the catheter
which is inflated within the bladder after insertion in order to
ensure that the catheter doesn't inadvertently fall out.
[0309] Common complications of drainage catheters include
infections, kinking of the catheter, biofilm build-up (resulting in
potential obstruction and infection), breaking of the balloon (as
well as overinflating or failing to inflate the balloon) and the
accumulation of obstructing foreign bodies (urinary stones, biliary
stones, blood/clot, inflammatory tissue, fibrotic tissue,
infectious tissue) on the luminal surface.
[0310] Hence, drainage catheters of the present invention can be
utilized which have one or more of the ISMs described herein. For
example, within one embodiment, drainage catheters of the present
invention can have one or more ISMs having flow sensors. Such
sensors can, within various embodiments be located on the inner
(luminal) surfaces, adluminal surfaces of the catheter, throughout
the catheter, and/or concentrated at the ends of the catheter. They
can be utilized to measure fluid flow through the catheter. By
comparing the readings of ISMs containing flow sensors at different
points in the drainage catheter, a determination of blockage (and
the extent of a blockage; for example from the formation of a clot,
stone, or catheter kinking) can be determined (e.g., there would be
decreased fluid flow prior to a narrowing and increased fluid flow
following an narrowing; there would be no fluid flow before or
after a complete obstruction). The ability to monitor flow rates
would be valuable in normal operation and during/after procedural
attempts to "reopen" obstructed drainage catheters.
[0311] Within other embodiments, ISMs having pressure sensors can
be incorporated into a drainage catheter on the inner (luminal)
wall, outer (adluminal) wall, and/or within the body of the
catheter itself. Such sensors are able to measure pressure within,
or exerted against, the catheter wall. Increased pressures can be
suggestive of narrowing, thrombosis, foreign body obstruction, or
kinking upstream from a narrowing or obstructing event, whereas
decreased pressures would be seen downstream from a narrowing and
(little or) no pressure would be seen downstream from an
obstruction. Having the ability to measure pressure within the
drainage catheter allows for functional monitoring of the catheter
(in normal operation and during/after attempts to "reopen"
obstructed catheters), and the capability of detecting events prior
to a complication developing.
[0312] Within yet other embodiments, ISMS having contact sensors
can be placed on and throughout the drainage catheter in order to
measure contact between the luminal and adluminal surfaces and the
surrounding environment. Sustained foreign body contact on either
surface could be indicative of the formation of a fibrin sheath,
thrombosis, stone formation, biofilm formation or infection;
sustained contact at the tip could indicate that the catheter has
become pushed up against the luminal wall (or an adjacent tissue)
and needs to be repositioned.
[0313] Within other embodiments, ISMs having chemical sensors can
be utilized to measure a wide variety of physiological parameters,
including for example: 1) urinary function (e.g., measurement of
nitrate, sodium, potassium, calcium and phosphate); 2) presence of
cells (e.g., white cells which may suggest an infection, and/or red
cells which may indicate trauma, stones, infections, and/or a
malignancy); 3) protein/proteinuria (indicative of diabetes, kidney
or liver disease, hyperthyroidism, etc.); 4) glucose (to measure
diabetes); and various other chemicals (e.g., ketones, bilirubin,
urobilinogen, hemoglobin, creatinine, catecholamines, dopamine,
cortisol, phenylalanine) and characteristics of the urine (e.g.,
specific gravity, osmolality, pH, presence of bacteria, and hcG);
5) the presence of bacteria (in all cases suggestive of
infection).
[0314] Within other embodiments, ISMs having position sensors can
be placed throughout the drainage catheter (e.g., on both the
luminal and adluminal surfaces, and within the catheter material
itself) in order to allow imaging of the catheter, and detection of
changes and/or movement over time. Position sensors are useful
during placement of the catheter to ensure advancement into the
proper anatomical location (prior to balloon inflation, if present,
such as in Foley catheters); post-placement, they can be used to
determine if the catheter has migrated proximally or distally with
time.
[0315] Within yet other embodiments ISMs having chemical and/or
temperature sensors can be utilized to monitor changes in
temperature, which could suggest the presence of an infection,
biofilm formation, or a developing infection.
[0316] In a particularly preferred embodiment, an ISM containing
multiple sensors (flow sensor, position sensor, accelerometer,
pressure sensor, contact sensors, chemical sensors, temperature
sensors) is located at the tip of the drainage catheter such that
it has both luminal and adluminal surface exposure.
[0317] Taken collectively, ISMs having one or more of a wide
variety of sensors as described herein can be utilized to detect,
measure and assess a number of factors relevant to the function of
the kidneys (and/or bladder) and any other organ in which the
drainage catheter is placed (liver, pleural space, CSF, joint,
etc.). Such drainage catheters can provide "real time" information
and feedback to a health care provider (or during placement or
subsequent manipulation or "reopening" procedures), to detect
proper placement, anatomy, alignment, forces exerted on surrounding
tissues, and to detect changes encountered during placement and
subsequent manipulation or repositioning procedures. For example,
the drainage catheters provided herein can one or more ISMs with
one or more contact sensors, strain gauge sensors, pressure
sensors, fluid pressure sensors, position sensors, accelerometers,
shock sensors, rotation sensors, vibration sensors, tilt sensors,
pressure sensors, chemistry sensors, metabolic sensors, mechanical
stress sensors and temperature sensors. The above sensors may be
continuously monitored in order to provide a `real-world` activity,
patency, and changes in function over time, to evaluate patient
physiology, and to better manage the drainage catheter patient.
[0318] B.5.A.6. Vascular Grafts and their Use
[0319] Within other embodiments of the invention, ISMs can be
placed on a variety of vascular grafts. Briefly, medical grafts are
hollow tubes or cylinders that are utilized to allow fluids
(typically blood) to flow from one place to another. Medical grafts
may be obtained from natural materials (e.g., saphenous vein or
mammary artery grafts), constructed from natural and/or artificial
materials (e.g., bioengineered grafts or blood vessels), or
constructed from entirely synthetic materials (e.g., vascular
grafts comprised of polymers such as polytetrafluoroethylene or
"PTFE" or dacron). Representative examples of medical grafts are
disclosed in U.S. Pat. Nos. 5,556,426, 5,628,786, 5,641,373,
6,863,686, and 8,062,354.
[0320] Within one embodiment of the invention, one or more ISMs
containing multiple sensors (flow sensor, position sensor,
accelerometer, pressure sensor, contact sensors, chemical sensors,
temperature sensors) is located at the distal end of the bypass
graft (made from natural materials) such that it has luminal
surface exposure. For example, during Coronary Artery Bypass
Grafting (or "CABG" procedures), arteries or veins from elsewhere
in the body can be grafted onto the coronary arteries to bypass
atherosclerotic narrowings and improve blood supply to the
myocardium (e.g., wherein saphenous veins are utilized for coronary
artery bypass, and a mammary artery is used for a coronary artery
bypass).
[0321] Within other embodiments of the invention, synthetic
vascular grafts can be utilized to bypass an obstruction (e.g.,
synthetic vascular bypass grafts can be utilized to bypass an
obstruction in the lower limb). Hence, grafts which have ISMs of
the present invention have a wide variety of utilities. For
example, within one embodiment, grafts of the present invention can
have ISMs with one or more blood flow sensors. Such ISMs containing
blood flow sensors can, within various embodiments be located on
the inner (luminal) surfaces of the graft, on the outer (adluminal)
surfaces of the graft, throughout the graft (e.g., woven into the
fabric of a synthetic graft, or incorporated into the metal of a
"supported" graft), and/or concentrated at the ends of the graft
(i.e. the proximal and distal vascular anastomoses). They can be
utilized to measure blood flow through the graft. By comparing the
readings of sensors from one part of the graft to another part of
the graft, a determination of partial narrowing (and the extent of
narrowing) can be determined (e.g., there would be an decreased
blood flow prior to a narrowing or stenosis, and increased blood
flow following a narrowing). If the vascular graft was completely
obstructed, there would be no flow through the graft (before or
after the obstruction). The ability to monitor flow rates would be
valuable in normal operation and during/after procedural attempts
to "reopen" obstructed catheters.
[0322] Within other embodiments, ISMs having pressure sensors can
be incorporated into a graft [e.g., on the outer (adluminal) walls,
the inner (luminal) walls and/or within the body of the graft
itself (as described above for flow sensors)]. Such sensors are
able to measure pressure in or against the vessel wall. Increased
pressures can be suggestive of stenosis, thrombosis or kinking
upstream from an obstructing event, whereas decreased pressures
would be seen downstream from a narrowing and (little or) no
pressure would be seen downstream from an obstruction. Having the
ability to measure pressure throughout the vascular allows for
functional monitoring of the graft (in normal operation and
during/after attempts to "reopen" obstructed grafts), and the
capability of detecting events prior to a complication
developing.
[0323] Within yet other embodiments ISMs having contact sensors can
be placed on and throughout the graft in order to measure contact
(integrity of the seal) between the bypass graft and the vessel to
which it is attached (the anastomosis) in order to identify leaks
or anastomotic failure (during and after surgical placement).
Contact sensors on the luminal surface of the graft could also
detect the presence of unwanted accumulated luminal surface
materials such as restenosis tissue, fibrin or biofilm and alert
the clinician to potential problems.
[0324] Within further embodiments ISMs having chemical sensors can
also be placed on and throughout the graft in order to measure a
wide variety of important metabolic paramaters, including for
example: Blood Oxygen content; Blood CO.sub.2 content; Blood pH;
Blood cholesterol; Blood lipids (HDL, LDL); Blood Glucose; Cardiac
enzymes; Hepatic Enzymes; and Kidney Function (BUN, Creatinine,
etc.).
[0325] Within other embodiments ISMs can be provided with
sufficient number of position sensors (e.g., on both the luminal
and adluminal surfaces, and within the graft material itself) in
order to allow imaging of the graft, and detection of changes (such
as bending or kinking) and/or movement over time.
[0326] In a particularly preferred embodiment, an ISM containing
multiple sensors (flow sensor, position sensor, accelerometer,
pressure sensor, contact sensors, chemical sensors, temperature
sensors) is located at both anastomoses of a bypass graft, such
that it has luminal surface exposure.
[0327] Taken collectively, ISMs within vascular grafts can be
utilized to detect, measure and assess a number of factors relevant
to cardiac function. For example, blood flow rate detectors, blood
pressure detectors, and blood volume detectors (e.g., to measure
blood volume over a unit of time) can be placed within (on the
luminal side), and on other parts of the vascular graft in order to
measure systolic and diastolic pressure, cardiac output, ejection
fraction, cardiac index and systemic vascular resistance.
[0328] Within other embodiments of the invention, vascular grafts
(synthetic grafts and native grafts such as arterio-venous
fistulas) can be utilized in a hemodialysis procedure. Briefly, a
hemodialysis access graft is a vascular graft that is implanted by
a vascular surgeon as an artificial, high-flow, interposition graft
(or direct anastomosis) between an artery and a vein (typically in
the forearm or the thigh) to provide permanent access for
hemodialysis (native arteries and veins tend to collapse and close
after being repeatedly instrumented numerous times). Once mature
and suitable for use, the hemodialysis access graft (or AV fistula)
is used as a permanent site into which to insert another catheter
that is used for exchanging blood to and from a hemodialysis
machine. Typically, that catheter has two lumens, one for venous
flow and the other for arterial flow (as described in a previous
section above). Common complications of hemodialysis access grafts
include clotting, stenosis (narrowing of the graft most often
occurring at the graft-venous anastomosis, but also occasionally at
the arterial-graft anastomosis), infection and kinking. Hence,
hemodialysis access grafts of the present invention can be utilized
which have one or more ISMs having one or more sensors described
herein. For example, within one embodiment, hemodialysis access
grafts of the present invention can have an ISM with one or more
blood flow sensors. Such ISMs with blood flow sensors can, within
various embodiments be located on the inner (luminal) surfaces of
the access graft, within the walls of the access graft (e.g., woven
into the fabric of a synthetic graft, or incorporated into the
metal of a "supported" graft), and/or concentrated at the various
locations (e.g., the ends--the anastomoses--of the access graft).
The ISMs with blood flow sensors can be utilized to measure blood
flow through the hemodialysis access graft. By comparing the
readings of ISM flow sensors at various locations in the grafts
(for example the arterial and venous anastomses), a determination
of partial narrowing (and the extent of narrowing) can be
determined (e.g., there would be a decreased blood flow prior to a
narrowing or stenosis, and increased blood flow following a
narrowing). If the access graft was completely obstructed, there
would be no flow through the graft (before or after the
obstruction). The ability to monitor flow rates would be valuable
in normal operation and during/after procedural attempts to
"reopen" obstructed dialysis catheters (a common interventional
procedure).
[0329] Within other embodiments, ISMs which have pressure sensors
can be incorporated into a dialysis access graft [e.g., on the
outer (adluminal) walls, on the inner (luminal) walls, or within
the body of the access graft itself as described above]. Such
sensors are able to measure pressure in or against the access graft
wall. Increased pressures within the graft can be suggestive of
stenosis (typically at the graft-vein anastomsis, but occasionally
at the artery-graft anastomosis), thrombosis or kinking upstream
from an obstructing event, whereas decreased pressures would be
seen downstream from a narrowing and (little or) no pressure would
be seen downstream from an obstruction. Having the ability to
measure pressure throughout the vascular allows for functional
monitoring of the graft (in normal operation and during/after
attempts to "reopen" obstructed grafts), as well as the capability
of detecting events prior to a clinical complication
developing.
[0330] Within yet other embodiments, ISMs having contact sensors
can be placed on at the ends of the hemodialysis access graft in
order to measure contact (integrity of the seal) between the access
graft and the vessel to which it is attached (i.e. the arterial and
venous anastomosis) in order to identify leaks or anastomotic
failure (during and after surgical placement). Contact sensors in
ISMs on the luminal surface of the graft could also detect the
presence of surface materials such as restenosis tissue, fibrin
(clot) or biofilm and alert the clinician to potential problems. In
yet another example, ISMs having chemical sensors can also be
placed on and/or within the access graft such that the sensors have
luminal exposure in order to measure a wide variety of metabolic
paramaters, including for example: Blood Oxygen content; Blood
CO.sub.2 content; Blood pH; Blood cholesterol; Blood lipids (HDL,
LDL); Blood Glucose; Cardiac enzymes; Hepatic Enzymes; and Kidney
Function (BUN, Creatinine, etc.); parameters which are very
important in the clinical management of a patient with late-stage
renal disease.
[0331] Within other embodiments ISMs having position sensors can be
placed throughout the hemodialysis access graft (e.g., on both the
luminal and adluminal surfaces, and within the access graft
material itself) in order to allow imaging of the access graft, and
detection of changes (bending, kinking) and/or movement over
time.
[0332] Taken collectively, one or more ISMs having wide variety of
sensors as described herein can also be utilized to detect, measure
and assess a number of factors relevant to cardiac function. For
example, blood flow rate detectors, blood pressure detectors, and
blood volume detectors (e.g., to measure blood volume over a unit
of time) can be placed within (on the luminal side), and on other
parts of the access graft in order to measure systolic and
diastolic pressure, and estimate systemic vascular resistance.
Within particularly preferred embodiments ISMs having one or more
blood flow rate detectors, blood pressure detectors, and blood
volume detectors can also be utilized to calculate cardiac output,
ejection fraction and cardiac index (which are key clinical
measurements that are valuable in monitoring cardiac-compromised
patients, which many renal patients are). For example, an ISM
containing high-fidelity pressure transducers can be located on,
in, or within a hemodialysis access graft in order to measure the
timing and pressure of pulsations. Such measurements can be
utilized to assess stroke volume and systemic vascular resistance,
and also provide continuous cardiac output monitoring and heart
rate monitoring. Within yet other embodiments chemical and
temperature sensors can be utilized to monitor changes in
temperature, and/or the presence of an infection or a developing
infection. With repeated instrumentation of the access graft, the
incidence of infection is quite high and monitoring for its
presence prior to the onset of clinical symptoms is of great value
to the management of the patient.
[0333] In a particularly preferred embodiment, an ISM containing
multiple sensors (flow sensor, position sensor, accelerometer,
pressure sensor, contact sensors, chemical sensors, temperature
sensors) is located at one or both ends of the hemodialysis access
catheter (i.e. at the arterial and venous anastomoses) such that it
has luminal surface exposure.
[0334] In summary, ISMs with a wide variety of sensors may be
placed on and/or within hemodialysis access grafts described
herein, in order to provide "real time" information and feedback to
a health care provider (or a surgeon during a surgical procedure to
implant a hemodialysis access graft, or an interventionalist
performing a procedure to open up an obstructed hemodialysis access
graft), to detect proper placement, vascular anatomy, alignment,
cardiac output, renal function, infection, and to detect any
changes encountered before, during or after an interventional
procedure. For example, the hemodialysis access grafts provided
herein can have one or more ISMs with one or more contact sensors,
strain gauge sensors, pressure sensors, fluid pressure sensors,
position sensors, accelerometers, shock sensors, rotation sensors,
vibration sensors, tilt sensors, pressure sensors, tissue chemistry
sensors, tissue metabolic sensors, mechanical stress sensors and
temperature sensors. The above sensors may be continuously
monitored in order to provide a `real-world` activity, healing, and
changes in function over time, to evaluate patient activity, and to
better understand the conditions which hemodialysis access grafts
are exposed to in the real world.
[0335] B.5.A.7. Other Medical Tubes and their Use
[0336] Within other embodiments a wide variety of medical tubes are
provided which may have ISMs with one or more sensors.
Representative examples of medical tubes include tympanostomy
tubes, endotracheal tubes, tracheostomy tubes, nasogastric tubes,
gastric tubes, feeding tubes, colostomy tubes, rectal tubes, and
chest tubes.
[0337] For example within one embodiment one or more ISMS having
one or more sensors can be placed on an endotracheal tube. Briefly,
an endotracheal tube is a type of catheter that is inserted into
the trachea for the primary purpose of establishing and maintaining
a patent airway. The tube may be orotracheal (inserted into the
mouth, nasotracheal (inserted into the nose), or via a tracheostomy
(e.g., inserted via a hole or incision in the trachea).
[0338] Within other embodiments the tube having one or more ISMs
having one or more sensors can be a drainage tube such as a chest
tube. Briefly, chest tubes (also referred to as `chest drains`,
thoracic catheters, tube thoracostomy and intercostal drains) are
flexible tubes that can be inserted through the chest wall and into
the pleural space or mediastinum. Such tubes can be utilized to
remove air (e.g., pneumothorax), fluid (e.g., pleural effusion,
blood, chyle), and infectious material (e.g., empyema, pus)
[0339] Chest tubes come in a range of sizes (e.g., 6 Fr to 40 Fr),
can have multiple drainage fenestrations, and optionally, be marked
for distance (or length) of the tube, as well as contain radiopaque
markers. They are available in a wide variety of configurations
(e.g., right angle, trocar, flared, and tapered), and may be coated
in an effort to prevent thrombus formation or clogging. Such tubes
can be made from a wide variety of materials, including polyvinyl
chloride ("PVC"), silicone, latex, and polyurethane.
[0340] Tubes (e.g., tympanostomy tubes, endotracheal tubes,
tracheostomy tubes, nasogastric tubes, gastric tubes, feeding
tubes, colostomy tubes, rectal tubes, and chest tubes) can suffer
from a variety of complications, such as improper placement, damage
to (or penetration into) surrounding tissues, narrowing,
obstruction, movement/migration and infection, For example,
endotracheal tubes have been found to cause a number problems,
including aspiration, improper placement, airway obstruction,
perforation of the esophagus or trachea, development of a sore
throat, pneumonia, narrowing, as well as arrhythmia, hypertension,
increased intracranial pressure, increased intraocular pressure,
bronchospasms, laryngospasms, vocal cord damage, retropharyngeal
abcesses, nerve injury, and fistulas.
[0341] Hence, tubes of the present invention can be utilized which
have one or more ISMs having a flow sensor as described herein. For
example, within one embodiment chest tubes and endotracheal tubes
of the present invention are provided with ISMs which have one or
more flow sensors. Such sensors can, within various embodiments be
located on the inner (luminal) surfaces of the tube, the outer
(adluminal) surface of the tube, within the tube, and/or
concentrated at the ends of the tube. They can be utilized to
measure fluid flow through the tube, such as air flow (endotracheal
tubes, chest tubes in pneumothorax; note other tubes as described
above may have other body fluids passing through them). By
comparing the readings of sensors throughout the tube, a
determination of partial narrowing (and the extent of narrowing)
can be determined (e.g., there would be decreased air flow prior to
a narrowing or stenosis, and increased air flow following a
narrowing). If the tube was completely obstructed, there would be
no flow through the tube lumen (before or after the obstruction).
The ability to monitor flow rates would be valuable in normal
operation and during/after procedural attempts to "reopen"
obstructed tubes.
[0342] Within other embodiments, ISMs containing pressure sensors
can be incorporated into a tube [e.g., on the outer (adluminal)
walls, the inner (luminal) walls and/or within the body of the tube
itself]. Such sensors are able to measure pressure in or against
the tube wall. Increased pressures (e.g. ventilation pressures in
endotracheal tubes) can be suggestive of stenosis (narrowing),
obstruction or kinking upstream from an obstructing event, whereas
decreased pressures would be seen downstream from a narrowing and
(little or) no pressure would be seen downstream from an
obstruction. Monitoring pressure in the inflation cuff of an
endotracheal tube can ensure that proper inflation is present; not
too much pressure so as to lead to mucosal damage to the
surrounding trachea, but not too little so as to allow fluids to
pass by the cuff and aspiration to occur. Having the ability to
measure pressure at different locations within the tube allows for
functional monitoring of the tube (in normal operation and
during/after attempts to "reopen" obstructed tubes), as well as the
capability of detecting events prior to a clinical complication
developing.
[0343] Within yet other embodiments, ISMs containing contact
sensors are placed on or within the tube in order to measure
contact (integrity of the seal) between the tube and the tissue in
which it is placed in order to identify leaks, cracks, or migration
of the tube (during and after surgical placement). ISM contact
sensors with access to the luminal surface of the tube could detect
the presence of fibrous/inflammatory tissue or biofilm formation
and alert the clinician to potential problems. Monitoring contact
on the surface of the inflation cuff of an endotracheal tube can
ensure that proper inflation is present; creating a sufficient seal
between the cuff and the tracheal mucosa such that fluids are
unable to pass by the cuff and allow aspiration to occur.
[0344] Within other embodiments, ISMs having chemical sensors are
located on or within medical tubes for the purpose of measuring a
wide variety of physiological parameters, including for example: 1)
tissue chemistry (e.g., measurement of nitrate, sodium, potassium,
calcium and phosphate); 2) the presence of cells (e.g., white cells
which may suggest an infection, and/or red cells which may indicate
trauma, erosions/ulcers, penetration of the device into a blood
vessel); 3) protein, serous fluid); 4) glucose ketones, bilirubin,
urobilinogen, hemoglobin, osmolality, pH, presence of bacteria,
tumor markers.
[0345] Within other embodiments ISMs containing position sensors
are located on or within a medical tube (e.g., on both the luminal
and adluminal surfaces, and within the tube material itself) in
order to allow imaging of the tube, and detection of changes and/or
movement of the tube over time. For example, improper placement of
endotracheal tubes (usually inadvertent placement in the esophagus)
is a very dangerous complication; 50% of misplacements in the
Emergency Room result in death. Position sensors able to better
define the anatomical position and placement of the medical tube
(in "real time") would be of great utility. Many other tubes (e.g.
proper chest tube placement in the area of pleura requiring
decompression/drainage and not in adjacent tissues--lung, heart,
pericardium) would similarly benefit. Post-insertion, many tubes
can move from their initial site of placement (e.g., tympanostomy
tubes often fall out, endotracheal tubes can migrate into one of
the bronchi to produce uneven ventilation, chest tubes can move
from the required drainage area) and would benefit from the ability
to monitor their movement and current location.
[0346] Within yet other embodiments ISMs are provided with chemical
and/or temperature sensors which can be utilized to monitor changes
in temperature, and/or the presence of an infection or a developing
infection.
[0347] Taken collectively, a wide variety of tubes are provided
with ISMs having one or more sensors as described herein, which can
be utilized to detect, measure and assess a number of factors
relevant to the function numerous implanted tubes. In a
particularly preferred embodiment, an ISM containing multiple
sensors (flow sensor, position sensor, accelerometer, pressure
sensor, contact sensors, chemical sensors, temperature sensors) is
located at the distal end of the medical tube (i.e. at the tissue
contacting end) such that it has luminal surface exposure.
[0348] In summary, one or more ISMs containing a wide variety of
sensors may be placed on and/or within the medical tubes described
herein, in order to provide "real time" information and feedback to
a health care provider (or a physician during an insertion or
follow-up procedure), to detect proper placement, anatomy,
alignment, forces exerted on surrounding tissues (and entry into,
damage to, non-target tissues), integrity, flow, surface
conditions, patency and movement/migration of the implanted tube
and to detect and monitor the properties of the fluids flowing
through them. For example, the tubes (e.g., tympanostomy tubes,
endotracheal tubes, tracheostomy tubes, nasogastric tubes, gastric
tubes, feeding tubes, colostomy tubes, rectal tubes, and chest
tubes) provided herein can have one or more ISMs with one or more
contact sensors, strain gauge sensors, pressure sensors, fluid
pressure sensors, position sensors, accelerometers, shock sensors,
rotation sensors, vibration sensors, tilt sensors, pressure
sensors, chemistry sensors, metabolic sensors, mechanical stress
sensors and temperature sensors.
[0349] The above sensors may be continuously or intermittently
monitored in order to provide a `real-world` function, healing, and
changes in function over time, to evaluate patient responses, and
to better understand the conditions which tubes are exposed to in
the real world.
[0350] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can comprise a
variety of different sensors within different locations of the ISM.
In addition, within various embodiments of the invention one or
more sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with and be controlled by the ISM).
Representative examples of sensors placed on a medical tube are
provided in U.S. Provisional No. 62/017,086, which is hereby
incorporated by reference in its entirety).
[0351] B.6. Implants
[0352] Within one embodiment of the invention implants are provided
having one or more ISMs as described herein. Briefly, "implant" as
that term is utilized herein, refers to an artificial or synthetic
prosthesis that has, or can be, implanted into a body. Implants are
typically utilized to augment or replace a structure within the
body, and have been utilized in a wide variety of aesthetic
applications, including for example, for facial (e.g., lips, chin,
nasal, nasal/labial fold and malar implants), penile, and body
contouring (e.g., breast, pectoral, calf, buttocks, abdomen and
biceps/triceps) implants.
[0353] "Surrounding Implant" as that term is utilized herein,
refers to an artificial or synthetic implant or implanted material
that is placed into the implant pocket where the aesthetic implant
will ultimately be inserted. When an aesthetic implant is inserted
into the body, a "pocket," or surgically created anatomical space,
is first dissected into the tissue which will receive the aesthetic
implant. A "surrounding implant" is typically a gel, adhesion
barrier, hemostat, glue, and/or adhesive that is placed into the
implant pocket such that it lies between the aesthetic implant and
the host tissue (bags or other devices can placed around the
aesthetic implant for the same purpose). Generally, the role of the
"surrounding implant" is to prevent or minimize (at least
initially) the contact between the aesthetic implant and the host
tissue in an attempt to reduce scarring and capsular
contraction.
[0354] Implants can be composed of a wide variety of materials, but
utilizing breast implants as an example, they are typically
comprised of an elastomeric outer surface or `shell`, and an
interior `filling`. With respect to the shell, silicone is the most
commonly used elastomer, which may be either smooth, or textured.
With respect to the filling, most implants are filled with either
silicone, or saline (although other compositions have been
suggested, including for example, peanut oil, sunflower oil, soy
oil and polypropylene string).
[0355] Within various embodiments, the implants may contain more
than one internal filling (e.g., in different compartments), and
may be coated (polymers, gels, drugs) and/or textured on the outer
shell or provided with a bag in order to reduce the incidence of
capsular contractions. In addition, implants can be provided in
different sizes, and different shapes, and even customized to
specific anatomical requirements. Within yet other embodiments one
implant can be delivered to one location in the breast (e.g.,
subfascially), and another implant delivered to a different
location (e.g., subglandularly).
[0356] Representative examples of implants are described in U.S.
Pat. Nos. 4,995882, 6,251,137, 6,464,726, 8,420,077 and U.S.
Publication Nos. 2006/0136056, 2009/0099656, 2011/0184277,
2014/0088700. Representative examples of implant delivery devices
include U.S. Pat. No. 8,550,090 and U.S. Publication Nos.
2014/0074235, and 2014/0074236.
[0357] The implants and medical devices provided herein are
preferably sterile, non-pyrogenic, and/or suitable for use and/or
implantation into humans. However, within certain embodiments of
the invention the medical devices and/or kits may be made in a
non-sterilized environment (or even customized or "printed" for an
individual subject), and sterilized at a later point in time.
[0358] Within one embodiment of the invention, implants are
provided with an ISM having one or more sensors as shown in FIG.
19. For example, the ISM having one or more position sensors and/or
accelerometers can be placed within the `filling` of the implant,
or on or within the `shell` of an implant. Such sensors are capable
of providing: a) an image of the implant (or `real-time` imaging of
the implant); b) assistance during placement of the implant, and
confirmation subsequent to implant of the correct anatomical
location (e.g., by way of the aforementioned imaging, or by
comparison with external markers); and c) confirmation of full
inflation (i.e. not folded or wrinkled in situ). In addition, such
sensors are useful in confirming that the implant is operating as
expected [e.g., a) confirming that it has not moved or migrated; b)
confirming that scarring or capsular contraction has not begun; c)
confirming that the integrity of the implant is sound (i.e., that
there are no leaks), or by determination of a leak from the surface
of the implant; and d) confirming that the implant is not wrinkled
or folded]. Sensors can also be utilized to ensure that acute
complications are not developing (e.g., the development of a
hematoma, seroma, granuloma, abscess, or other mass in the tissues
surrounding the implant that applies external pressure to the
implant itself).
[0359] Within other embodiments, implants are provided with one or
more ISMs possessing contact sensors and/or pressure sensors. As
noted above, the contact and/or pressure sensors can be placed
within the `filling` of the implant, or, on or within the `shell`
of the implant. Such sensors are capable of providing: a) an image
of the implant (or `real-time` imaging of the implant); b)
assistance during placement of the implant, and confirmation
subsequent to implant of the correct anatomical location (e.g., by
way of the aforementioned imaging, or by comparison with external
markers); and c) confirmation of full inflation (i.e. not folded or
wrinkled in situ). In addition, such sensors are useful in
confirming that the implant is operating as expected [e.g., a)
confirming that it has not moved or migrated; b) confirming that
scarring or capsular contraction has not begun; and c) confirming
that the integrity of the implant is sound (i.e., that there are no
leaks), or by determination of a leak from the surface of the
implant; and d) confirming that the implant is not wrinkled or
folded]. Sensors can also be utilized to ensure that acute
complications are not developing (e.g., the development of a
hematoma, seroma, granuloma, abscess, or other mass in the tissues
surrounding the implant that applies external pressure to the
implant itself).
[0360] Within yet other embodiments implants are provided with one
or more ISMs possessing one or more accelerometers. Such
accelerometers can be utilized to a) determine the durability of
the implant based upon `real-world` conditions; b) determine if
different implants are better in certain patients (based upon
activity levels, impact, forces, weight, etc.); and c) assist
manufacturers in the design of new implants, product improvements,
and collection of clinical data. Moreover, it would allow the
evaluation of performance of different devices under similar
conditions, and the ability of the patient to monitor their
progress at home.
[0361] Within other embodiments implants are provided with one or
more ISMs possessing one or more temperature sensors and/or
chemical or metabolic sensors. Such sensors can be utilized to
detect the presence of infection, seroma, hematoma and inflammation
and allow for rapid or preemptive intervention (e.g.,
administration of antibiotics before a full-blown infection has
developed, drainage of a subclinical hematoma or seroma, or
undertake measures to reduce inflammation in an effort to lower the
chance of a capsular contracture developing).
[0362] It should be obvious to one of skill in the art that ISMs
containing the same sensors can be incorporated into a surrounding
implant for the same purposes as described above.
[0363] As will be evident given the disclosure provided herein, a
wide variety of other sensors may also be utilized within the ISM,
including for example, pulse pressure sensors, heart rate sensors,
glucose sensors, or sensors to detect tumor (particularly breast
cancer) markers.
[0364] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can contain a variety
of different sensors within different locations of the ISM. In
addition, within various embodiments of the invention one or more
sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with and be controlled by the ISM).
Representative examples of sensors placed on an implant are
provided in U.S. Provisional No. 62/017,099, which is hereby
incorporated by reference in its entirety).
[0365] B.7. Spinal Implants
[0366] Within one embodiment of the invention, spinal implants are
provided having one or more ISMs as described herein. Briefly,
"spinal device and or spinal implant" as those terms are utilized
herein, refers to a wide variety of devices (typically hardware)
and implants (typically biomaterials like bone cement and bone
grafts) that can be implanted into, around, or in place of part of
a subject's spine (typically in an interventional or surgical
procedure), and which can be utilized to facilitate vertebral body
fracture repair, fusion of vertebrae, correct degenerative disc
disease (DDD), to stabilize the spinal column, and to correct
deformities due to disease and/or injury. Spinal devices/implants
are typically permanent, but in some cases may be temporary.
Representative examples of spinal devices and implants include, for
example: spinal cages (e.g., U.S. Pat. Nos. 5,425,772, 6,247,847,
6,428,575, 6,746,484, 7,722,674, 7,744,599, 7,988,713, 8,172,905,
and U.S. Patent App. Nos. 2004/0082953, 2011/0015742, 2012/0046750,
2013/0053894, and 2013/0158669): pedicle screws and associated
devices (e.g., U.S. Pat. Nos. 7,678,137, 8,361,121 and U.S. Patent
App. Nos. 2005/0187548, 2006/0195086, 2008/0154309 and
2009/0287255); artificial discs and associated assemblies (e.g.,
U.S. Pat. Nos. 5,676,701, 8,226,723, and U.S. Patent App. Nos.
2006/0293753, 2007/0088439, 2007/0179611, 2008/0133014,
2011/0054617, and 2012/0232662); spinal rods and associated
assemblies (e.g. U.S. Patent App. Nos. 2003/0050640, 2004/0015166,
2007/0118122, 2008/0306528, 2009/0177232, 2011/0245875,
2013/0211455, and 2013/0231703), spinal plates and their assemblies
(e.g., U.S. Pat. Nos. 8,246,664, 8,262,594, 8,343,223, and U.S.
Patent App. Nos. 2009/0210008, 2010/0069968, and 2013/0006367); and
vertebroplasty/kyphoplasty balloons and bone cement (see e.g., US
2007/0100449, US 2009/0299373); all of which are incorporated by
reference in their entirety.
[0367] Spinal device/implants may be composed of a wide variety of
materials (including for example metals such as titanium, titanium
alloys, and/or stainless steel), although other materials can also
be utilized, including polymers (e.g., polymethylmethacrylate or
"PMMA", poly-ether-ether-ketone or "PEEK" for cervical cages and
anterior thoracolumbar implants, and bone graft material that can
be allographic, xenographic or synthetic); growth factors (e.g.,
bone morphogenic protein); and non-polymeric materials such as
silicon nitride.
[0368] "Spinal Implant Surgical Device" or "Spinal Implant Delivery
Device" refers to devices that can be utilized to introduce a
spinal implant into a patient, and/or to surgical tools and devices
that can be utilized to operate on the spine. Representative
examples include guidewires, trocars, bone tunnel catheters,
electrothermal catheters, endoscopes, microsurgical instruments,
surgical instruments, kyphoplasty balloons, and bone cement
injection devices to name a few.
[0369] The medical devices, implants and kits provided herein are
preferably sterile, non-pyrogenic, and/or suitable for use and/or
implantation into humans. However, within certain embodiments of
the invention the medical devices and/or kits may be made in a
non-sterilized environment (or even customized or "printed" for an
individual subject), and sterilized at a later point in time.
[0370] B.7.A. Vertebroplasty and Kyphoplasty Procedures
[0371] Within various aspects of the invention spinal
device/implants and associated medical devices are provided with
ISMs suitable for use in a wide variety of vertebroplasty and
kyphoplasty procedures. Briefly, vertebral compression fractures
can result from the sudden collapse of the vertebral body, and
result in the rapid onset of back pain, numbness, tingling,
weakness, spinal cord compression, and cauda equine syndrome (e.g.,
extremity weakness, paraplegia, urinary retention, urinary/fecal
incontinence, sexual dysfunction, sciatica, decreased ankle reflex,
and saddle anesthesia). It is typically found in patients with
osteoporosis, but can occur due to other causes (e.g., trauma,
lytic lesions from metastatic or primary tumors, infections, and
osteogenesis imperfecta).
[0372] For vertebroplasty procedures, bone cement (e.g.,
polymethylmethacrylate or "PMMA") is injected percutaneously into
the fractured vertebral body in order restore normal vertebral
height and anatomy so as to relieve the pain and symptoms
associated with compression fractures. Using a percutaneous
approach or a small surgical incision, a hole is created in the
wall of the vertebral body by a specialized bone tunneling
catheter, followed by introduction of a delivery catheter into the
vertebral body at the site of the fracture. Bone cement is then
injected into the cancellous bone of the collapsed vertebral body
until sufficient PMMA material has been injected to restore the
vertebra to its normal height and anatomy (the cement hardens and
supports the fractured bone).
[0373] Kyphoplasty is a specialized form of vertebroplasty. In
kyphoplasty procedures, a balloon is first inserted into the
cancellous bone of the vertebral compression fracture and then
inflated in order to restore normal vertebral height and spinal
shape (kyphosis) and to create a void. The balloon is then removed
and PMMA is injected into the void created by the balloon and
allowed to harden in place to form a solid support structure within
the fractured vertebrae. A number of medical instruments can be
utilized to complete a kyphoplasty, including, an introducing
needle, an injector for the bone cement, bone needles, guidewires,
bone tunnel catheters, balloon introducing catheters and a
kyphoplasty balloon catheter.
[0374] Within various embodiments of the invention, ISMs containing
sensors may be placed in some or all of the spinal implants and
associated devices used for vertebroplasty and/or kyphoplasty.
[0375] For example, as shown in FIG. 20, a hole is created in the
vertebral body (FIG. 20A) through a bone tunneling catheter; an ISM
is introduced (FIG. 20B); followed by a delivery device (FIG. 20C)
which allows injection of the bone cement directly into the
collapsed bone. The compression fracture is corrected and supported
through the injection of bone cement into the vertebral body (as
shown in FIGS. 20D and 20E) to restore the normal height of the
vertebra.
[0376] Similarly, as shown in FIG. 21, one or more ISMs can be
placed on, or within the kyphoplasty balloon. The ISM can have
pressure sensors in order to monitor pressure exerted on the
cancellous bone by the kyphoplasty balloon (particularly during
inflation) and to optimize the inflation pressure (preventing
over-inflation leading to potential tissue damage) and deflation
pressure (ensuring the balloon is fully deflated before attempting
to remove the device). ISMs containing contact sensors can also be
placed on or within the kyphoplasty balloon in order to monitor
contact between the balloon and the cancellous bone of the
vertebral body. Similarly, ISMs containing position
sensors/location markers can be placed on or within the kyphoplasty
balloon in order to assist in accurate placement of the insertion
device, the balloon, and bone cement into the compression fracture.
Position sensors and location markers are also useful to monitor
the expansion of the vertebral body (by, for example monitoring the
position of the balloon walls as the balloon is progressively
inflated) to achieve a more precise expansion; one that can be more
accurately matched to the anatomical deficit present.
"Visualization" via the ISM sensors present on the balloon assist
with accurate placement, optimum expansion, more precise
measurement of deficit correction and safe deflation and
extraction; all completed in "real time" during the procedure. In a
preferred embodiment, one or more ISMs contained on or within the
kyphoplasty balloon contain several sensors including position
sensors, location markers, accelerometers, pressure sensors, and
contact sensors.
[0377] ISMs having sensors may have a variety of additional uses,
including to assist in identifying vertebral anatomy (e.g., to
measure the exact vertebral height restored and proper kyphosis
during kyphoplasty), to prevent accidental placement of the
kyphoplasty instruments into surrounding tissues (the spinal cord,
spinal nerves, etc.), to confirm full (or optimal) balloon
inflation and deflation, to confirm restoration of vertebral height
and kyphosis after kyphoplasty, and to image the void where bone
cement will be injected, to more precisely match the volume to be
injected, and to prevent overfilling and/leakage of the bone
cement. Within various embodiments of the invention ISMs, or
passive sensors along with the ISMs can be added to the bone
cement, and utilized to interrogate various aspects of the
procedure (as noted above), as well as ultimate success and
maintenance of the procedure (See FIGS. 20 and 21). An ISM
containing accelerometers can be placed within the bone cement in
order to detect acceleration, vibration, shock, tilt and rotation
of the cement within the vertebral body. Such sensors may be
utilized to create 2D and 3D imaging data which show the size and
shape of the filled void, movement and/or dissolution of the bone
cement, and potentially complications such as leakage or
impingement of the cement into the spinal cord and/or around the
spinal nerves. Within preferred embodiments the image data can be
collected over time, in order to visually show changes (e.g., a
"movie" or `moving images") detected by the sensors.
[0378] In a preferred embodiment, one or more ISMs contained within
the bone cement contain several sensors including position sensors,
location markers, accelerometers, pressure sensors, and contact
sensors in order to monitor spinal anatomy, function and the
development of side effects.
[0379] Optionally, ISMs containing chemical sensors and placed
within the bone cement can be utilized to monitor pH, calcium
content, and other parameters (e.g., in order to predict and/or
monitor the progression of osteoporosis, tumor growth and/or bone
metabolism). Similarly, temperature sensors, can be utilized to
monitor the temperature of the cement (the cement is above body
temperature when initially inserted before hardening), as well as
indicate any possible early signs of inflammation or infection.
[0380] The above described ISMs within bone cement can be utilized
to monitor pressure, location, position, contact and other measures
(temperature, pH, etc.) during both placement and in subsequent
follow-up. Once implanted, the ISM contained within the bone cement
is identical, regardless of whether it is administered as part of
vertebroplasty (FIG. 20) or kyphoplasty (FIG. 21).
[0381] The above ISM containing sensors may be continuously
monitored in order to provide a `real-world` range of motion for
the spine, to assist in detecting any decrease in spinal health, to
collect and compare procedure performance data over time, to
evaluate patient function, and to better understand the conditions
which spinal implants are exposed to in the real world.
[0382] B.7.B. Intervertebral Disc Disease/Spinal Fusion
[0383] Injury and/or disease of the intervertebral disc can result
in substantive, chronic neck and/or back pain and/or neurological
symptoms. Examples of chronic disc problems include degenerated
discs, bulging discs, herniated discs, thinning discs, and disc
degeneration with osteophyte formation.
[0384] In order to address problems associated with intervertebral
disc injuries or disease, spinal fusion surgery is often indicated.
In this surgery, two or more adjacent vertebrae (vertebral bodies)
are fused together by creating a `bony bridge` across the
damaged/diseased intervertebral disc, for example, by using
autologous or allograph bone tissue. For posterolateral spinal
fusion a bony fusion is created between the transverse processes of
the vertebrae, while in an interbody spinal fusion the bone graft
is created between the bodies of the vertebrae in the area usually
occupied by the intervertebral disc. In the latter case the disc is
often removed entirely and is typically replaced by a plastic or
titanium cage to maintain alignment and height and promote bone
growth. Fusion may also be augmented by fixation devices, including
metal screws (including pedicle screws and a rod), rods or plates
to connect the screws, and wires.
[0385] Spinal fusion devices, and spinal fusion surgery in general
can be associated with many complications, both during the surgery,
as well as post-surgically. Typical complications include vertebral
subluxation (abnormal movement between the vertebra), collapse of
structural elements and loss of support, tissue-reaction against
the device, infection, pseudo-arthritis, failure to heal properly
(i.e., delayed union or non-union of the vertebrae) and problems
with the implanted devices themselves such as: hardware fracture,
loosening and/or migration; pedicle screw breakage, loosening or
movement: and transitional syndrome (i.e., stress placed on nearby
vertebrae due to the fusion).
[0386] Within various embodiments of the invention ISMs having one
or more sensors can be placed on the instruments and fixation
devices described herein in order to assist placement of the
medical device and/or implant, and to monitor for efficacy
subsequent to surgery. For example, ISMs can be placed on rods
which are affixed by pedicle screws (FIG. 22A), as well as on
plates which can be utilized to fuse to vertebrae together (FIG.
22B). It should be evident given the disclosure provided herein
that the ISMs can also be placed on or within the pedicle screws,
wires and/or other hardware used in spinal fusion.
[0387] For example, the ISMs shown in FIGS. 22A and 22B can have
position sensors that can be utilized to assess the range of motion
of the spinal segment (flexion and extension of the spinal segment,
adduction and rotation of the spinal segment), to enhance the
accuracy of physical exam (from 3D data which may be utilized to
produce an image, and to assess position and movement of the spine
and the device, to assess if there is subluxation between the
segments), to monitor spinal and device anatomy (alignment,
kyphosis), to assess the contact and interaction between adjacent
device components (e.g., between screws, plates rods and/or wires),
and to monitor for breakage, bending, loosening and/or movement of
any of the implant parts. Collection of data from position sensors
will also allow for both short-term and long-term assessment of
product performance, as well as assessment of healing and patient
recovery.
[0388] The ISMs shown in FIGS. 22A and 22B can also have contact
sensors that can be utilized to detect the space, movement and
integrity of the bond between the hardware and the surrounding
tissues, and the integrity of the connections between the various
different pieces of hardware (disconnection of the hardware
components), bending or breakage of the hardware pieces, and to
detect loosening and/or osteolysis associated with the hardware
(bone loss in the tissues surrounding the implanted devices;
particularly for screws). Collection of data from contact sensors
will also allow for both short-term and long-term assessment of
product performance, as well as assessment of healing and patient
recovery.
[0389] The ISMs shown in FIGS. 22A and 22B can also have
accelerometers and/or strain gauges that can be utilized to
indicate strains (and/or repetitive strains over time) that can
result in destructive bone remodeling. In addition, the sensors can
detect and record the magnitude, direction of acceleration,
orientation, vibration and shock of a given strain. Hence,
loosening of screw in bone, movement between components, vertebral
subluxation (spondylolisthesis), breakage and/or failure of
components, and the collapse of structural elements (including
damage to the surrounding bone) can also be monitored and recorded.
The data can also be integrated and utilized to create a 2D and/or
3D image of the hardware and spinal anatomy, both at a single point
as well as over time based upon real-world stresses. Such sensors
also allows for the continuous monitoring of the device in order to
assess both short-term and long-term assessment of product
performance, as well as assessment of healing and patient
recovery.
[0390] A wide variety of other sensors (alone or in combination)
can also be contained within the ISMs shown in FIGS. 22A and 22B,
including for example, one or more contact sensors, strain gauge
sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, tissue chemistry sensors,
tissue metabolic sensors, mechanical stress sensors and temperature
sensors.
[0391] B.7.C. Degenerative Disc Disease (DDD)/Interbody
Fusion/Spinal Cages
[0392] Degenerative Disc Disease, also known as spondylosis, is
typically a disease associated with aging (although it can also be
caused by injury or trauma), and can be associated with chronic
neck and/or back pain and peripheral nervous symptoms (numbness,
tingling, weakness, bowel and bladder problems). Fibrocartilage
typically develops in the intervertebral disc as a result of aging
or repeated injury. Contents of the nucleus pulposis (the inner,
gelatinous part of the disc) can bulge or herniate through weakened
areas of the annulus fibrosis and come into contact with the spinal
cord or the spinal nerves. It is the pressure from the bulging or
herniated disc on the spinal cord or the spinal nerves that leads
to the pain and neurological symptoms described previously.
[0393] Spinal cages have been developed in order to assist with
interbody fusion, and can be utilized to treat Degenerative Disc
Disease, herniated discs, and low grade spondylolisthesis. They are
typically small, hollow cylindrical devices composed of titanium,
titanium alloys, stainless steel, or polymers. They can be filled
with bone graft material (allograft or autograft) and/or growth
factors (e.g. bone morphogenic protein, BMP)
[0394] A wide variety of spinal cages are presently available
commercially from a number of manufacturers (e.g., BAK from Sulzer
Spine Tech, Ray TFC from Stryker, Contact Fusion Cage from Synthes,
and Interfix Cage and LT Cage from Medtronic). Spinal cages can be
manufactured to be placed between the vertebral bodies of the spine
in a specific orientation (e.g., a vertebral body side and a
vertical side). Furthermore, the vertical sides can be flattened to
allow the placement of two cages side-by-side in the intervertebral
space. The spinal cage can be packed during surgery with autologous
or allogeneic bone graft material, with or without other factors
such as bone morphogenic proteins ("BMPs"), in order to assist in
bone growth through the perforated walls of the cage, and the
formation of a bony fusion between the vertebrae.
[0395] Within various embodiments of the invention, ISMs having
sensors can be placed on and/or within a spinal cage (e.g., as
shown in FIG. 23). For example, an ISM having position sensors can
be placed on and/or within a spinal cage and/or within the bone
graft material. The sensors can be utilized to detect and monitor
location and fixation of the affected spinal cage, movement of the
cage within the intervertebral space, to monitor breakage and/or
wear of the spinal cage, and to monitor the anatomy, contact and
interaction between adjacent components (particularly when more
than one cage is used),. For example, during placement, the ISM
position sensors can be utilized to determine if the cages are
correctly placed, if spinal alignment is correct, and if
intervertebral spacing is optimal; following placement, the ISM
position sensors can monitor any movement, migration, or breakage
of the spinal cage; furthermore, they can be used to follow the
progress of bony fusion as spinal cage movement should become
progressively less as new bone growth successfully fuses the two
segments together (and "locks" the cages within the bone mass);
conversely, ongoing positional movement or increasing positional
movement would be cause for concern that fusion is not progressing
as expected. ISM positional sensors therefore allow for the
continuous monitoring of the device, spinal anatomy (alignment,
spacing, etc.) and bony fusion in order to assess both short-term
and long-term product performance, as well as assessment of healing
and patient recovery.
[0396] Within other embodiments, ISMs containing contact and/or
pressure sensors can be placed on or within the spinal cage (as
shown in FIG. 23) and/or within the bone graft material. Within
certain embodiments of the invention two cages are provided with
ISMs which allow "matching" sensor placement, in order to allow an
analysis of movement and/or migration between the different
(paired) pieces of spinal cage hardware. Contact sensors can also
be utilized to detect space, movement, and the integrity of bond
between the hardware and the developing bony tissue. For example,
increasing contact and/or decreasing pressure between the hardware
and the surrounding tissue is suggestive of ongoing fusion (i.e.
the new bone growth is assuming the compressive forces and
decreasing the dependence on the cage), while eventual
contact/pressure stabilization suggests healing is almost complete;
such measurements can guide rehabilitation and physiotherapy
decisions. On the other hand, lessening of contact between the bone
tissue and the cage might suggest inadequate bone growth, failure
of fusion, or failure of the device; increasing pressure on the
cage in this context would suggest that the device (and not the new
bone growth) is taking a disproportionate amount of the compressive
forces between the intervertebral bodies. The sensors also allow
for the continuous monitoring of the device in order to assess both
short-term and long-term product performance, as well as assessment
of healing and patient recovery and can help guide activity and
recovery regiments.
[0397] Within yet other embodiments, ISMs containing accelerometers
and/or strain gauges can be placed on or within the spinal cages
(as shown in FIG. 23) and/or within the bone graft material. The
ISM accelerometers can be utilized to detect and record the
magnitude, direction of acceleration, orientation, vibration and
shock of a given strain. Hence, detection of vibration/movement may
indicate loosening within the fused disc, movement between paired
spinal cage components (if more than one cage is used),
breakage/failure of the spinal cage, migration of the cage(s),
vertebral subluxation (spondylolisthesis), collapse of structural
elements and loss of support, as well as damage to surrounding new
bone. Data which is generated from the sensors can also be
integrated and utilized to create a 2D and/or 3D image of the
hardware and spinal anatomy, both at a single time point, as well
as over time, based upon real-world stresses. Accelerometers can
provide the clinician with an understanding of the overall movement
and stability of the affected spinal segment--the flexion,
extension and rotation of the spinal segment (which if bony fusion
is successful, should all decrease with time). Such sensors also
allow for the continuous monitoring of the implanted device in
order to monitor both short-term and long-term product performance,
as well as assessment of healing and patient recovery. This data is
helpful in monitoring patient progress and the effects of specific
rehabilitation efforts as well as identifying potential
activities/actions that are detrimental to recovery.
[0398] As will be evident given the disclosure provided herein, in
addition to the above noted sensors, the ISM on the spinal cage of
FIG. 23 (or in the bone graft material) may also have a variety of
sensors, including for example, one or more contact sensors, strain
gauge sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, tissue chemistry sensors,
tissue metabolic sensors, mechanical stress sensors and temperature
sensors.
[0399] B.7.D. Artificial Discs
[0400] Within various aspects of the present invention,
intervertebral disc damage (e.g., injury or disease such as
Degenerative Disc Disease) may also be treated utilizing artificial
discs (i.e., by complete replacement of the damaged disc with a
prosthetic replacement). The intent of an artificial disc is,
unlike a spinal fusion, to preserve motion between the vertebrae,
e.g., to provide for more natural spinal flexion, extension and
rotation. Representative artificial discs include the Charite
Lumbar Disc (DePuy), Prodisc Lumbar Disc (Synthes), ProDisc
Cervical Disc (Synthes) and the Maverick Lumbar Dis (Medtronic).
Typically, the intervertebral disc is completely excised by the
surgeon via an anterior (abdominal) approach, and plates (usually
composed of titanium or titanium alloys) are placed over the
vertebral bodies. A core piece (usually comprised of a polymer such
as polyethylene) is sized to provide the correct height and
positioned between the plates in order to complete the artificial
disc.
[0401] Within an embodiment of the invention, artificial discs are
provided with one or more ISMs (see, e.g., FIG. 24). For example,
within one embodiment, artificial discs are provided with an ISM
having one or more positions sensors placed on and/or within the
artificial disc (i.e., on or within the metallic plates, and/or
on/within the articular core piece between the plates). For
artificial discs that a cemented in place, the one or more ISMs can
also be contained within the bone cement. Intraoperatively, the ISM
position sensors can be utilized by the surgeon to determine
accurate placement, alignment and spinal anatomy (medical imaging).
Postoperatively, the ISM Position sensors can be utilized to detect
and accurately monitor flexion, extension and rotation of the
artificial disc (precise, numeric measurements of all motion), and
to assess, measure and evaluate the range of motion of the spinal
segment. The ISM position sensors can also be utilized to determine
and monitor the location and fixation of the artificial disc,
movement of the artificial disc, to monitor the anatomy, contact
and interaction between adjacent components (detect normal
component movement and abnormal component movement such as
artificial joint dislocation or subluxation), and to monitor
migration, breakage and/or wear of the artificial disc. It also
allows for the continuous monitoring of the device in order to
assess both short-term and long-term product performance, as well
as assessment of healing and patient recovery.
[0402] Within other embodiments, the ISM of FIG. 23 can have one or
more contact sensors, and be placed on and/or within the artificial
disc (i.e., on or within the metallic plates, and/or on/within the
articular core piece between the plates); for cemented prostheses,
the ISM can be contained within the bone cement. Intraoperatively,
the ISM contact sensors can be utilized by the surgeon to determine
accurate placement, alignment and contact between the metallic
plates and the surrounding tissues and between the components of
the artificial disc (the metallic plates and the articular core).
Postoperatively, the ISM contact sensors can also be utilized to
detect space, movement, and the integrity of bond between the disc
hardware (the metallic plates) and bone, and to detect increasing
movement (which could be suggestive of osteolysis); to monitor
articular surface contact (to identify artificial joint dislocation
or subluxation); and to detect and/or monitor wear, erosion,
migration and/or failure or breakage of the device. An ISMs can
also be placed at critical depth within the polymeric articular
core to notify the patient and physician when the amount of surface
wear of the synthetic articular component has become concerning.
The sensors also allow for the continuous monitoring of the device
in order to assess both short-term and long-term product
performance, as well as assessment of healing and patient
recovery.
[0403] Within other embodiments, the ISMs of FIG. 23 can have one
or more accelerometers and/or strain gauges and can be located on
and/or within the artificial disc (e.g., on or within the metallic
plates, and/or on/within the articular core piece between the
plates); for cemented prostheses, the ISM can be contained within
the bone cement). The ISM accelerometers can be utilized to detect
and record the magnitude, direction of acceleration, orientation,
vibration and shock of a given strain. Hence, detection of
vibration/movement may indicate loosening of the prosthetic disc
from the surrounding bone (improper fixation or osteolysis); or
within the artificial disc, vibration/movement may be an indicator
of migration/breakage/failure of the artificial disc, vertebral
artificial joint subluxation or dislocation, collapse of the
structural elements and loss of support, as well as damage to
surrounding new bone. Data which is generated from the ISM
accelerometers can also be integrated and utilized to create a 2D
and/or 3D image of the hardware and spinal anatomy, both at a
single point as well as over time based upon real-world stresses.
ISM accelerometers can provide the clinician with an understanding
of the overall movement and stability of the affected spinal
segment--the flexion, extension and rotation of the spinal segment
containing the artificial disc. Such sensors also allow for the
continuous monitoring of the device under "real world" conditions
in order to assess both short-term and long-term performance, as
well as assessment of healing and patient recovery. This data is
helpful in monitoring patient progress and the effects of specific
rehabilitation efforts as well as identifying potential
activities/actions that are detrimental to recovery.
[0404] In summary, a wide variety of ISMs having sensors may be
placed on and/or within the artificial disc (i.e., on or within the
metallic plates, and/or on/within the articular core piece between
the plates; for cemented prostheses, the ISMs can also be contained
within the bone cement) in order to provide an evaluation of
performance in the clinic as well as in `real-world` settings, to
detect loosening between the prosthesis and the surrounding bone,
to detect joint subluxation or dislocation, to monitor spinal
anatomy and alignment, to detect infection and/or inflammation, to
detect the strain encountered in the prosthesis, to detect
acceleration and impact events, and to detect articular surface
wear in the metal plates and/or polymer components (if present).
For example, the ISM contained on or within an artificial disc can
have a combination of one or more contact sensors, strain gauge
sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, tissue chemistry sensors,
tissue metabolic sensors, mechanical stress sensors and temperature
sensors.
[0405] B.7.E. Microdiscetomy
[0406] Within various aspects of the present invention, devices and
methods are provided for treating herniated discs. Briefly, unlike
a typical vertebrae, a tear in the Annulus Fibrosis of the disc
allows the soft, central Nucleus Pulposis to herniate out through
the Annulus. This may occur for a variety of reasons, e.g., trauma,
lifting, repeated injury, or may be idiopathic in nature. Such
herniated discs may be initially treated conservatively with rest,
anti-inflammatory medication, and physiotherapy, but in certain
cases, surgery may be required if the nerve roots or spinal cord
are involved and neurological symptoms (numbness, weakness,
tingling, paralysis, bowel or bladder dysfunction) are present.
[0407] In a typical surgical procedure, a patient is anesthetized,
and a small incision is made in the back. The spinal muscles and
ligaments are separated, and a small amount of the facet joint may
be removed. The herniated disc material is then removed
endoscopically.
[0408] Within various embodiments, microdiscectomy tools containing
ISMs with sensors, as described herein, are provided. For example,
within one embodiment microdiscectomy tools containing ISMs with
contact sensors are provided which can be utilized to monitor
contact between the rongeur and nerve root, spinal cord and/or
surrounding nerve tissue. Microdiscectomy tools containing ISMs
with pressure sensors may be utilized to monitor pressure exerted
on the nerve tissue during dissection, and to prevent tissue damage
and nerve injury from excessive pressure. Microdiscectomy tools
containing ISMs with position sensors and accelerometers can be
utilized to assist in resection of herniated disc tissue, and used
for medical imaging (e.g., to provide an image of spinal and disc
anatomy, the herniated segment, and disc wall) pre and
post-resection. Within certain embodiments of the invention, a
naturally occurring or synthetic nucleus-like material may be
reinjected back into the disc (see generally, Eur Spine J. 2009
November; 18(11): 1706-1712. Published online 2009 Aug. 18). Within
preferred embodiments, the naturally occurring or synthetic
nucleus-like material may contain one or more ISMs having sensors
to monitor pressure, position, contact and/or movement within the
nucleus, as well as leaks or ruptures of the disc and inflammation
and/or infection of the disc.
[0409] Within other aspects of the invention, Intradiscal
Electrothermal Annuloplasty can be utilized to treat, for example,
Degenerative Disc Disease. For example, an electrothermal catheter
can be inserted along the back inner wall of the disc. The catheter
can then be heated, thereby thickening collagen fibers which make
up the disc wall (and sealing any ruptures in the disc wall), and
cauterizing sensitive nerve endings.
[0410] Within various embodiments of the invention electrothermal
catheters are provided comprising one or more ISMs having sensors
that can be utilized in the process of Intradiscal Eletrothermal
Annuloplasty. For example, ISMs having contact sensors can be
utilized to monitor contact between the electrothermal catheter and
the inner wall of the annulus. ISMs having pressure sensors can be
utilized to monitor the pressure in the annulus, to aid in avoiding
perforation through the annulus, and to confirm the
integrity/sealing of the annulus post-procedure. ISMs having
position sensors and accelerometers can be utilized to assist in
catheter placement, and used for medical imaging (e.g., to confirm
correct catheter placement and to image spinal anatomy and disc
anatomy, both pre and post-treatment). In addition, ISMs having
temperature sensors can be utilized to control the heat of the
catheter, in order to ascertain and maintain the correct operating
temperature (and prevent thermal injury to non-target tissues).
[0411] In summary, one or more ISMs having one or more sensors may
be placed on and/or within microdiscectomy and electrothermal
catheter tools in order to provide "real time" information and
feedback to the surgeon during the procedure, to detect instrument
placement, spinal and disc anatomy, forces exerted on surrounding
tissues, and to detect the physiologic conditions encountered in an
interventional procedure. For example, the microdissectomy and
electrothermal tools can have one or more ISMs having one or more
contact sensors, strain gauge sensors, pressure sensors, fluid
pressure sensors, position sensors, accelerometers, shock sensors,
rotation sensors, vibration sensors, tilt sensors, pressure
sensors, tissue chemistry sensors, tissue metabolic sensors,
mechanical stress sensors and temperature sensors.
[0412] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can contain a variety
of different sensors within different locations of the ISM. In
addition, within various embodiments of the invention one or more
sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with and be controlled by the ISM).
Representative examples of sensors placed on a spinal implant or
spinal device, or spinal implant surgical delivery device are
provided in U.S. Provisional No. 62/017,106, which is hereby
incorporated by reference in its entirety).
[0413] B.8. Orthopedic Hardware
[0414] Within one embodiment of the invention, ISMs are provided in
orthopedic hardware and/or orthopedic implants. "Orthopedic device
and/or orthopedic implant" as those terms are utilized herein,
refers to a wide variety of devices (typically hardware) and
implants (typically biomaterials like bone cement, glues,
adhesives, hemostats and bone grafts) that can be implanted into,
around, or in place of part of a subject's musculoskeletal system
(e.g., bone), in order to facilitate treatment of the disease,
injury or disorder. Representative conditions that may be treated
include musculoskeletal trauma (e.g., falls, trauma, motor vehicle
accidents, projectile injuries), sports injuries, degenerative
diseases (such as osteoarthritis and other forms of arthritis,
osteoporosis), infections (osteomyelitis), tumors (primary and
metastatic bone tumors), and congenital disorders (deformities,
osteogenesis imperfect).
[0415] Orthopedic devices and implants can be utilized both
externally and internally to correct musculoskeletal injuries and
deformities. Representative examples of external orthopedic devices
and implants include, for example: casts (e.g., made of plaster of
paris, polyurenthane, fiberglass, or thermoplastics; see, e.g.,
U.S. Pat. Nos. 4,308,862, 4,817,590, 6,053,882), braces (see e.g.,
U.S. Pat. Nos. 4,862,878 and 5,437,617), tensor bandages (e.g.,
elastic bandages which are stretchable and can create localized
pressure; e.g., Kendall Tensor Elastic Bandages), slings, supports
and braces (e.g., ACE Adjusted Padded Sling, and Flexibrace.RTM.),
(see generally "Orthopedic Taping, Wrapping, Bracing &
Padding", Joel W. Beam, F. A. David Company, 2006).
[0416] Representative examples of internal hardware and implants
include K-wires (Kirschner wires), pins (Steinmann pins), screws,
plates, and intramedullary devices (e.g., rods and nails) and
associated devices. Briefly, intramedullary rods or nails
(including for example interlocking nails, Kuntscher nails, Ender's
nail, Grosse-Kempf (GK) nails, Gamma nails, and Rush nails) are
long metal rods which are implanted into the medullary cavity of a
long bone (e.g., a femur, humerus, or tibia), thereby providing
greater stability and support to the bone during healing. Kirschner
wires (or "K-wires") are sharpened, smooth pins which are utilized
to hold bone fragments together, or to serve as an anchor for
skeletal traction. K-wires come in a variety of sizes and shapes,
and within certain embodiments may be threaded. Orthopedic screws,
pins and plates are utilized in a wide variety of orthopedic
procedures to secure, stabilize, mend, fix, replace, or immobilize
bone (or bone fragments). Representative orthopedic implants
include Smith Peterson nails for fracture of the neck of the femur,
McLaughin's plate (which along with Smith Peterson nails are used
for inter-trochanteric factures), Buttress plates for condylar
fractures of the tibia, the Condylar blade plate for condylar
fractures of the femur, Dynamic compression plates, Steinmann pins
for skeletal traction, Talwalkar nails for fractures of the radius
and ulna, and Moore's pin for fractures of the head of the femur.
Representative examples of the above devices, implants and devices
are described in Oxford Textbook of Orthopedics and Trauma, Oxford
University Press, 2002; (see also U.S. Pat. Nos. 6,565,573,
7,044,951, 7,686,808, 7,811,311, 7,905,924, 8,048,134, and
8,361,131) all of the above of which are incorporated by reference
in their entirety.
[0417] Orthopedic devices or implants may be composed of a wide
variety of materials (including for example metals such as
titanium, titanium alloys, and/or stainless steel), although other
materials can also be utilized, including polymers (e.g.,
polymethylmethacrylate or "PMMA", poly-ether-ether-ketone or
"PEEK", and bone graft material that can be allographic,
xenographic or synthetic); and non-polymeric materials such as
silicon nitride.
[0418] Within certain embodiments of the invention, ISMs can be
placed into orthopedic devices which are traditionally made of
metallic materials (e.g., plates) by a variety of different means.
For example, within one embodiment small holes, cavities, or
openings can be placed into a device (e.g., through use of a
laser), and one or more sensor inserted into the opening. Within
other embodiments, a surface of a metallic device can be coated
with one or more polymers which contain or comprise one or more
ISMs having one or more sensors. Within other embodiments, the ISM
can be inserted into the "shaft" of the device (intermedullary
rods, pins or nails; dynamic hip screws) or attached to the device
surface.
[0419] "Orthopedic implant surgical device" or "orthopedic implant
delivery device" refers to devices that can be utilized to
introduce an orthopedic implant into a patient, and/or to surgical
devices that can be utilized to operate on the bone. Representative
examples include power drills, power screw devices, and power saw
devices, mallets, hammers, and chisels all of which are composed of
selected sterilizable components. Other examples include glue,
hemostat, and bone cement injection devices.
[0420] The medical devices (e.g., orthopedic devices and implants,
orthopedic delivery devices, etc.) and kits provided herein are
preferably sterile, non-pyrogenic, and/or suitable for use and/or
implantation into humans. However, within certain embodiments of
the invention the medical devices and/or kits may be made in a
non-sterilized environment (or even customized or "printed" for an
individual subject), and sterilized at a later point in time.
[0421] B.8.A. External Orthopedic Devices: Casts, Splints, Braces,
Tensors, Slings and Supports
[0422] As noted above, within various aspects of the invention,
external orthopedic devices or implants and associated medical
devices are provided for use in a wide variety of orthopedic
procedures.
[0423] For example, within one embodiment of the invention ISMs can
be placed onto, within, and/or under casting material (e.g.,
typically plaster of paris on a mesh, fiberglass mesh, or a
polymer--based composition such as polyurethane or a thermoplastic
polymer), in order to form a cast. Within other embodiments one or
more ISMs can be placed on the surface of, within, and/or under the
3-D printed cast.
[0424] Such ISMs can be utilized for a variety of purposes. For
example, one of the complications associated with casts is the
development of points of pressure between the cast and the skin,
which can result in tissue sores, pain, and even tissue necrosis.
ISMs having pressure sensors can be utilized to detect pressures
during placement of the cast, as well as over the period that the
cast is in place. The pressure sensors can be utilized to monitor
inappropriate or dangerous increases in pressure (which can occur,
for example, with inflammation occurring in the days following
injury or after ambulation), and to serve as a basis to alert a
patient, health care provider, or other entity or object as
discussed in more detail below.
[0425] ISMs having accelerometers and/or position sensors can be
utilized in casts in order to monitor joint movement and
immobilization, and to ensure that too much stress is not placed on
the casted body part. Proper fracture healing often requires not
only immobilization of the bone fragments, but also the
immobilization of the joints above and below the fracture.
Accelerometers and/or position sensors can help to ensure that the
underlying structure (e.g., bone) maintains proper alignment and
that the related joints are adequately immobilized. In addition,
the ISM accelerometers and position sensors can be utilized to
monitor twisting, torque, flexion, extension and bending, all of
which may lead to complications such as inadequate or improper
healing.
[0426] Within certain embodiments, ISMs having external
accelerometers and/or position sensors may be correlated with
sensors which have been placed within the body (e.g., implanted by
injection or surgically, or associated with an internal orthopedic
implant as described in more detail below).
[0427] For example, as shown in FIG. 25, ISMs (e.g. ISMs having one
or more of accelerometers, position sensors, pressure sensors,
etc.) can be placed on an external support structure (e.g. see FIG.
25A). ISMs (e.g. ISMs having one or more of accelerometers,
position sensors, pressure sensors, etc.) can be placed on various
aspects of the support structure (including for example on external
screws, pins, clamps or other supporting structures), as well as on
various aspects of the orthopedic devices or implants inserted on
or into a bone (e.g., the radius as shown in FIG. 25B implanted on
the arm (FIG. 25C). Movement between the internal (implanted)
sensors and external sensors can be utilized to assess whether
anatomical segments have become misaligned, and whether such
misalignment might need to be adjusted or corrected in a further
procedure.
[0428] Within yet other embodiments ISMs having chemical and
temperature sensors can be utilized to monitor skin temperature,
skin integrity, and/or the presence of an infection or a developing
infection. ISM sensors positioned on casts and splints in contact
with the skin are ideally located to serve this function.
[0429] Within other embodiments of the invention, ISMs can be
placed on a variety of supports, braces, slings, splints, and
tensors. For example, as shown in FIG. 26, one or more ISMs can be
placed on knee braces (FIG. 26A), head and neck braces (FIG. 26B),
tensor bandages (not shown), arm slings (not shown) and back braces
(not shown).
[0430] Within other embodiments of the invention, ISMs can be
placed at a variety of locations within a sports helmet designed to
protect the sporting participant such as but not limited to
football, ice hockey, and lacross helmets. ISMs with accelerometers
and gyroscopes can measure impact G-force sustained during play and
monitor acute and cumulative concussive effects for real time
assessment of potential brain injury.
[0431] Within various embodiments, ISMs having one or more pressure
sensors can be placed in any of the braces, tensors, slings or
supports provided herein. ISMs with pressure sensors can be
utilized to measure compression, rotation and axial loading, and
the amount of support. Detection of increased pressure can indicate
the possibility of, or potential for, skin and or tissue damage.
Detection of decreased pressure can indicate that the device might
be ineffective and/or need reapplication or replacement. A rapid
increase or decrease in pressure can indicate a traumatic event.
For example, detection of a rapid increase in pressure could
indicate swelling, inappropriate motion, and/or a risk of breakage
or injury, or even the development of a compartment syndrome. A
rapid decrease in pressure could indicate a total failure of the
device.
[0432] Within other embodiments of the invention, ISMs having
accelerometers (and strain gauges) can be placed in any of the
braces, tensors, slings, splints or supports provided herein. ISMs
containing accelerometers can be utilized to monitor alignment,
stability and healing. They can also be utilized to monitor and
assess patient activity levels (e.g., daily function, range of
motion, physiotherapy, rehab and exercise), and to monitor for
rotation, bending, breakage, movement and/or slippage of the
device.
[0433] Within other embodiments of the invention, ISMs having
position sensors (and locations markers such as GPS) can be placed
in any of the braces, tensors, slings, splints or supports provided
herein. ISMs containing position sensors (and location markers) can
be utilized to monitor for example, any changes in anatomy,
alignment, or mobility. In addition, through the use of location
sensors, patient activity, compliance, mobility/immobility, the
effect of rehab, and falls, breakage or emergencies can all be
monitored.
[0434] Within yet other embodiments ISMs having chemical and
temperature sensors can be utilized to monitor skin temperature,
skin integrity, and/or the presence of an infection or a developing
infection.
[0435] In summary, ISMs having a wide variety of sensors may be
placed on and/or within the external orthopedic hardware described
herein, in order to provide "real time" information and feedback to
a health care provider (or a surgeon during a surgical procedure),
to detect proper placement, anatomy, alignment, mobility/immobility
(of injured tissues and related joints), forces exerted on
surrounding tissues, and to detect the strain encountered in an
surgical procedure. For example, the external orthopedic hardware
provided herein (e.g., casts, splints, braces, tensors, slings and
supports) can have one or more ISMs which contain a combination of
contact sensors, strain gauge sensors, pressure sensors, fluid
pressure sensors, position sensors, accelerometers, shock sensors,
rotation sensors, vibration sensors, tilt sensors, pressure
sensors, tissue chemistry sensors, tissue metabolic sensors,
mechanical stress sensors and temperature sensors. ISMs can be
placed at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
or greater than 10 sensors per square centimeter or at a density of
greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or greater than 10
sensors per cubic centimeter. Within either of these embodiments
there can be less than 50, 75, 100, or 100 sensors per square
centimeter, or per cubic centimeter.
[0436] The above described ISMs may be continuously or
intermittently monitored in order to provide `real-world` activity
(of affected limbs. joints etc.), fixation, mobility/immobility,
healing, progressive rehabilitation and function and to collect and
compare procedure performance data over time, to evaluate patient
activity, and to better understand the conditions which implants
are exposed to in the real world.
[0437] B.8.B. Internal Orthopedic Hardware: K-Wires, Pins, Screws,
Plates, and Intramedullary Devices
[0438] Within other aspects of the invention, ISMs are provided for
incorporation into a wide variety of internal orthopedic devices.
For example, Kirschner-wires or "K-wires", pins, screws, plates,
and intramedullary devices (e.g., rods and nails) used to repair
fractured, dislocated and injured musculoskeletal tissues.
[0439] B.8.B.1. Pins
[0440] Pins are a common orthopedic device, and are typically
utilized as a way to stabilize bone fractures. One of the most
common pins is the Steinmann Pin (also sometimes referred to as
Intramedullary Pins or IM Pins), which is driven through the skin
and into the bone in order to provide an anchor or support for the
patient's fracture. Most commonly, pins have either a two-sided
(chisel) or a three-sided trocar tip (which is better suited to
penetrating cortical bone). FIG. 27 illustrates one embodiment
wherein an ISM is placed on or within several pins.
[0441] Within one embodiment of the invention, Pins are provided
with an ISM having one or more pressure sensors. The pressure
sensors can be distributed on, or within, the Pin at specific or
randomized locations. Within certain embodiments the ISM may be
concentrated on the cutting end of the Pin. The ISM pressure
sensors can be useful during placement and removal (if necessary)
of the Pin, during movement through different tissues [e.g., in
order to determine soft tissue (low pressure), cortical bone (high
pressure), cancellous bone (moderate pressure), marrow (low
pressure), fracture planes (little to no pressure)--in order to
assist in detection, placement and anatomical location].
[0442] ISM pressure sensors can also be useful after placement of a
Pin. For example, detection of increased pressure on the Pin, or
across the fracture plane, can indicate the potential for stress
shielding (e.g., a reduction of bone density due to too much stress
being borne by the implanted Pin and not enough being borne by the
bone tissue) and/or increased potential for the Pin to bend, crack
or break. Detection of increased pressure on the Pin in soft
tissues can indicate the potential for the development of
compartment syndrome. Detection of reduced pressure on the Pin, or
across the fracture plane, can indicate the potential for non-union
of the fracture (early in the healing process) or the successful
completion of healing (later in the healing process when the bone
has assumed normal support functions). Unequal and/or unbalanced
pressures on the Pin, or across the fracture plane, can be a sign
of poor alignment, shifting, and/or the application of torque on
the healing bone. In all cases, identifying the presence of
improper pressure forces across the fracture plane can allow for
preemptive intervention to better stabilize the injury and prevent
further damage to the bone.
[0443] Within other embodiments Pins are provided with an ISM
having accelerometers (and strain gauges). ISMs having
accelerometers (and strain gauges) can be distributed on, or within
the Pin at specific or randomized locations. However, within
certain embodiments the ISM may be concentrated on the cutting end
of the Pin. The ISM accelerometer sensors can be useful during
placement and removal (if necessary) of the Pin by being able to
detect movement through different tissues; they can also assist
with achieving correct anatomical placement, alignment and imaging
intraoperatively.
[0444] ISM accelerometers and strain gauges can also be useful
after insertion of a Pin. For example, they can be utilized
post-operatively to monitor alignment, stability, fragment
mobility/immobility, healing, patient activities, stresses across
the fracture, and related joint immobilization (or lack
thereof).
[0445] Within another embodiment of the invention, Pins are
provided with one or more ISMs having one or more position
sensors/location marker sensors. The ISM containing position
sensors/location marker sensors can be distributed on, or within
the Pin at specific or randomized locations. Within certain
embodiments the ISM may be concentrated on the cutting end of the
Pin. The position sensors/location marker sensors can be useful
during placement and removal (if necessary) of the Pin, during
movement through different tissues (e.g., in order to determine
soft tissue, cortical bone, cancellous bone, marrow, fracture
planes--to assist in detection and determination of anatomical
location, fracture anatomy, and correct post-surgical alignment),
as well as in imaging and functional monitoring after
placement.
[0446] ISM position sensors/location marker sensors can also be
useful after placement of a Pin. For example, they can be utilized
to monitor healing anatomy, and compare changes in location over
time (e.g., post-surgery). They can also be utilized to monitor
alignment, shifting and migration, to confirm joint immobilization,
and to detect wire bending and/or breakage.
[0447] Within yet other embodiments of the invention, Pins are
provided with ISMs having temperature sensors and or chemical
sensors. Briefly, temperature and/or chemical sensors can be
utilized to monitor skin and tissue temperature, skin and tissue
integrity, and/or the presence of an infection or a developing
infection [e.g., bone infections (Osteomyelitis), and/or tissue
necrosis].
[0448] As should be readily evident given the disclosure provided
herein, the Pins of the present invention can have one or more ISMs
having a combination of one or more contact sensors, strain gauge
sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, tissue chemistry sensors,
tissue metabolic sensors, mechanical stress sensors and temperature
sensors. Sensors can be placed at a density of greater than 1, 2,
3, 4, 5, 6, 7, 8, 9, 10 or greater than 10 sensors per square
centimeter or at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8,
9, 10 or greater than 10 sensors per cubic centimeter. Within
either of these embodiments there can be less than 50, 75, 100, or
100 sensors per square centimeter, or per cubic centimeter.
[0449] The above ISMs containing sensors may be continuously or
intermittently monitored in order to provide a `real-world`
assessment of alignment of the bone, to assist in detecting
mobility/immobility of the fracture (and associated joints), to
monitor healing and the development of complications, to collect
and compare procedure performance data over time, to evaluate
patient function, and to better understand the conditions which
implants are exposed to in the real world.
[0450] B.8.B.2. Kirschner Wires
[0451] Kirschner wires (or K-wires) are sharpened, sterilized steel
wires that were originally developed by Martin Kirschner in 1909.
K-wires came along after Steinmann Pins, when Dr. Kirschner
recognized that larger pins caused more bone damage, as well as
infection. Dr. Kirschner created his own device made of chrome
piano wire to provide better tension when aligning fractured
fragments of bone into place. Hence, the principle difference
between wires and pins is one of size. Smaller diameters are
referred to as wires and larger diameters are referred to as pins.
Although there is no standardized definition of diameter cut off,
typically pins are between 1.5 mm and 6.5 mm in diameter, wherein
K-wires are 0.9 to 1.5 mm in diameter.
[0452] K-wires are typically made of metal (e.g., stainless steel
or nitinol), and come in a variety of sizes, diameters and lengths.
They are commonly utilized to hold together bone fragments, to
provide an anchor for skeletal fixation, or as a guide for screw
placement, and are often driven into bone using a power or hand
drill. FIG. 28 illustrates one embodiment wherein an ISM is placed
on and/or within several K-wires.
[0453] Within one embodiment of the invention K-wires are provided
with an ISM having one or more pressure sensors. The ISM can have
pressure sensors can be distributed on, or within the K-wire at
specific or randomized locations. Within certain embodiments the
ISM may be concentrated on the cutting end of the K-wire. The ISM
pressure sensors can be useful during placement and removal (if
necessary) of the K-wire, during movement through different tissues
[e.g., in order to determine soft tissue (low pressure), cortical
bone (high pressure), cancellous bone (moderate pressure), marrow
(low pressure), fracture planes (little to no pressure)--in order
to assist in detection, placement and anatomical location].
[0454] ISM pressure sensors can also be useful after placement of a
K-wire. For example, detection of increased pressure on the K-wire,
or across the fracture plane, can indicate the potential for stress
shielding and/or increased potential for the Pin to bend, crack or
break. Detection of increased pressure on the K-wire in soft
tissues can indicate the potential for the development of
compartment syndrome. Detection of reduced pressure on the K-wire,
or across the fracture plane, can indicate the potential for
non-union of the fracture (early in the healing process) or the
successful completion of healing (later in the healing process when
the bone has assumed normal support functions). Unequal and/or
unbalanced pressures on the K-wire, or across the fracture plane,
can be a sign of poor alignment, shifting, and/or the application
of torque on the healing bone. In all cases, identifying the
presence of improper pressure forces across the fracture plane can
allow for preemptive intervention to better stabilize the injury
and prevent further damage to the bone.
[0455] Within other embodiments K-wires are provided with an ISM
having accelerometers (and strain gauges). Similar to ISMs having
pressure sensors, ISMs having accelerometers (and strain gauges)
can be distributed on, or within the K-wire at specific or
randomized locations. However, within certain embodiments the ISM
may be concentrated on the cutting end of the K-wire. The ISM
accelerometer sensors can be useful during placement and removal
(if necessary) of the K-wire by being able to detect movement
through different tissues; they can also assist with achieving
correct anatomical placement, alignment and imaging
intraoperatively.
[0456] ISM accelerometers and strain gauges can also be useful
after insertion of a K-wire. For example, they can be utilized
post-operatively to monitor alignment, stability, fragment
mobility/immobility, healing, patient activities, stresses across
the fracture, and related joint immobilization (or lack
thereof).
[0457] Within another embodiment of the invention, K-wires are
provided with one or more ISMs having one or more position
sensors/location marker sensors. The ISMs having position
sensors/location marker sensors can be distributed on, or within
the K-wire at specific or randomized locations. Within certain
embodiments the ISM may be concentrated on the cutting end of the
K-wire. The position sensors/location marker sensors can be useful
during placement and removal (if necessary) of the K-wire, during
movement through different tissues (e.g., in order to determine
soft tissue, cortical bone, cancellous bone, marrow, fracture
planes--to assist in detection and determination of anatomical
location, fracture anatomy, and correct post-surgical alignment),
as well as in imaging and functional monitoring after
placement.
[0458] ISM position sensors/location marker sensors can also be
useful after placement of a K-wire. For example, they can be
utilized to monitor healing anatomy, and compare changes in
location over time (e.g., post-surgery). They can also be utilized
to monitor alignment, shifting and migration, to confirm joint
immobilization, and to detect wire bending and/or breakage.
[0459] Within yet other embodiments of the invention, K-wires are
provided with ISMs having temperature sensors and or chemical
sensors. Briefly, temperature and/or chemical sensors can be
utilized to monitor skin and tissue temperature, skin and tissue
integrity, and/or the presence of an infection or a developing
infection [e.g., bone infections (Osteomyelitis), and/or tissue
necrosis].
[0460] As should be readily evident given the disclosure provided
herein, the K-wires of the present invention can have one or more
ISMs having a combination of one or more contact sensors, strain
gauge sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, tissue chemistry sensors,
tissue metabolic sensors, mechanical stress sensors and temperature
sensors. Sensors can be placed at a density of greater than 1, 2,
3, 4, 5, 6, 7, 8, 9, 10 or greater than 10 sensors per square
centimeter or at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8,
9, 10 or greater than 10 sensors per cubic centimeter. Within
either of these embodiments there can be less than 50, 75, 100, or
100 sensors per square centimeter, or per cubic centimeter.
[0461] The above ISMs can be continuously monitored in order to
provide a `real-world` assessment of alignment of the bone, to
assist in detecting mobility/immobility of the fracture (and
associated joints), to monitor healing and the development of
complications, to collect and compare procedure performance data
over time, to evaluate patient function, and to better understand
the conditions which implants are exposed to in the real world.
[0462] B.8.B.3. Screws
[0463] Bone screws are one of the most common devices used in
orthopedic surgery. In 1850 two French surgeons (Cucel and Rigaud)
are credited with performing the first internal fixation procedure
with 2 transcutaneous screws fastened by string. Subsequently, in
1866 German surgeon Carl Hansmann performed an internal plate
fixation using a removable steel plate and nickel-plated screws. It
wasn't until the 1940s however that surgeons began to advocate for
screws that were specifically designed for human bone. For example,
Belgian surgeon Robert Danis proposed three key design features for
bone screws: 1) a ratio of exterior diameter to core diameter of
3:2, not 4:3 as was typical to common metal screws; 2) a reduction
of thread surface area to one-sixth that of metal screws (because
bone is not as strong as metal); and 3) a buttress thread design to
replace standard V-shaped threads, hence enhancing holding
power.
[0464] Bone screws now come in a variety of sizes and shapes. They
may be composed of a wide variety of polymers, metals and metal
alloys, and a variety of shapes, configurations and sizes (e.g.,
polyaxial screws, monoaxial screws, locking screws, self-drilling
screws, self-locking screws, self-tapping screws, cannulated
screws, screws with a low-profile, hex heads, etc.).
[0465] In addition, screws may be designed for a particular
purpose. For example, cortical screws (for use in cortical bone)
are typically fully threaded and require a tap to cut threads prior
to insertion.
[0466] Cancellous screws (which are designed for cancellous bone)
are typically self-tapping screws with a relatively thin core and
wide deep threads. They may be fully threaded (e.g., ideally for
use in fastening devices such as plates into the metaphyseal or
epiphyseal areas of bone), or partially threaded (they may be
utilized for an area far from the cortex, but do not, however, have
as much holding power).
[0467] In addition to more common screw types (such as the
cancellous and cortical screws), there are a large number of
specialty bone screws. For example, dynamic hip screws ("DHS") are
a type of orthopedic implant composed of a plate, along with
different types of bone screws that are specifically designed for
certain types of hip fractures (typically intertrochanteric
fractures). More specifically, a DHS side plate is aligned to a
joint (e.g., a broken femoral head), and a hole is prepared
utilizing a reamer. The sideplate, lag screw and cortical screws
are attached to the bone. The idea of this implant is to cause
dynamic compression of the femur and the femoral head, causing them
to move along one plane (thereby hopefully allowing the native
femur to undergo remodeling and proper fracture healing).
[0468] Other specialty bone screws include the Herbert screws and
Acutrak screws which are cannulated and threaded at both ends, and
typically utilized in fractures of small articular bones (e.g.,
carpal and scaphoid fractures). Interference screws can be
specifically designed for certain procedures (e.g., soft tissue and
bone-tendon-bone grafts), and are commonly comprised of polymers
(e.g., PLDLA) and other components (e.g., Tri-Calcium Phosphate),
(see, e.g., U.S. Patent Pub. No. 2009/0198288).
[0469] Within one embodiment of the invention ISMs having pressure
sensors are provided on or within a bone screw (e.g., cancellous or
cortical screw, interference screw, or dynamic hip screw). The ISM
can be positioned within specific locations (e.g., at the point
and/or head), or distributed throughout the screw. They can be
utilized to assist in implanting the screw by detecting various
tissue types (e.g., cancellous/cortical bone and bone marrow),
detecting fracture planes, and assisting in the determination of
anatomy and location. They can also be utilized to prevent
accidental placement (e.g., into the articular cartilage; i.e. the
pressure would drop from higher to lower when the screw moved from
cortical bone into the articular cartilage). For example, detection
of increased pressure on the screw, or across the fracture plane,
can indicate the potential for stress shielding and/or increased
potential for the screw to bend, crack or break. Detection of two
much pressure on a DHS can be an indicator of impaction (with the
risk of bone shortening). Detection of reduced pressure on the
screw, or across the fracture plane, can indicate the potential for
non-union of the fracture (early in the healing process) or the
successful completion of healing (later in the healing process when
the bone has assumed normal support functions; monitoring this can
be helpful in determining the timing of ambulation). Unequal and/or
unbalanced pressures on the screw, or across the fracture plane,
can be a sign of poor alignment, shifting, and/or the application
of torque on the healing bone. In all cases, identifying the
presence of improper pressure forces across the fracture plane can
allow for preemptive intervention to better stabilize the injury
and prevent further damage to the bone.
[0470] Within another embodiment bone screws are provided with ISMs
having accelerometers (and strain gauges). Similar to ISMs having
pressure sensors, ISMs having accelerometers (and strain gauges)
can be distributed on, or within the bone screw at specific or
randomized locations. However, within certain embodiments the ISM
may be concentrated on the point or head of the screw. The ISM
accelerometer sensors can be useful during placement and removal
(if necessary) of the screw by being able to detect movement
through different tissues; they can also assist with achieving
correct anatomical placement, alignment and imaging
intraoperatively.
[0471] ISM accelerometers and strain gauges can also be useful
after insertion of a screw. For example, they can be utilized
post-operatively to monitor alignment, stability, fragment
mobility/immobility, healing, patient activities, stresses across
the fracture, and related joint immobilization (or lack
thereof).
[0472] Within another embodiment of the invention, screws are
provided with one or more ISMs having position sensors/location
marker sensors. The ISMs having position sensors/location marker
sensors can be distributed on, or within the screw at specific or
randomized locations. Within certain embodiments the ISM may be
concentrated on the cutting end of the screw. The ISM position
sensors/location marker sensors can be useful during placement and
removal (if necessary) of the screw, during movement through
different tissues (e.g., in order to determine soft tissue,
cortical bone, cancellous bone, marrow, fracture planes--to assist
in detection and determination of anatomical location, fracture
anatomy, and correct post-surgical alignment), as well as in
imaging and functional monitoring after placement.
[0473] ISM position sensors/location marker sensors can also be
useful after placement of a bone screw. For example, they can be
utilized to monitor healing anatomy, and compare changes in
location over time (e.g., post-surgery). They can also be utilized
to monitor alignment, shifting and migration, to confirm joint
immobilization, and to detect screw bending and/or breakage.
Importantly, bone screws with position sensors/location markers can
be utilized to detect movement (e.g., `backing out`) of the screw
before serious complications arise. In DHS, lack of movement of the
screw in the tunnel is a sign of non-union or of advancement of the
screw into the articular cartilage, while excessive movement of the
screw in the tunnel is inactive of shortening (and impaction).
Similarly, for screws that are utilized with plates, a bone screw
with ISMs containing sensors can be utilized to detect plate
movement, and allow intervention prior to serious
complications.
[0474] Within yet other embodiments of the invention bone screws
are provided with one or more ISMs having temperature sensors and
or chemical sensors. Briefly, temperature and/or chemical sensors
can be utilized to monitor mineralization, tissue health, bleeding,
tissue temperature, tissue health (such as avascular necrosis of
the hip), and/or the presence of an infection or a developing
infection [e.g., bone infections (Osteomyelitis), and/or tissue
necrosis].
[0475] In a particularly preferred embodiment, a dynamic hip screw
is provided with an ISM containing multiple sensors located in the
"shaft" of the screw (see FIGS. 29A and 29B). For an ISM collecting
mechanical data (position, motion, vibration, rotation, shock,
tilt, steps), the implanted ISM sensors (accelerometers, position
sensors, pedometers) have the advantage of not requiring either
direct physical contact with the surface of the device or with
patient tissues; only a secure and immobile attachment within the
dynamic hip screw is needed. In this preferred embodiment, the ISM
containing multiple mechanical sensors (as described above) is
placed within the internal canal of the dynamic hip screw; a
location that provides more than enough space to insert and seal an
ISM with multiple sensor functions and battery capability.
Furthermore, the motion of the screw as the hip joint goes through
its range of motion during normal activities (such as walking) can
provide opportunities to power the ISM.
[0476] As should be readily evident given the disclosure provided
herein, the bone screws of the present invention can have one or
more ISMs having a combination of one or more contact sensors,
strain gauge sensors, pressure sensors, fluid pressure sensors,
position sensors, accelerometers, shock sensors, rotation sensors,
vibration sensors, tilt sensors, pressure sensors, tissue chemistry
sensors, tissue metabolic sensors, mechanical stress sensors and
temperature sensors. Sensors can be placed at a density of greater
than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or greater than 10 sensors per
square centimeter or at a density of greater than 1, 2, 3, 4, 5, 6,
7, 8, 9, 10 or greater than 10 sensors per cubic centimeter. Within
either of these embodiments there can be less than 50, 75, 100, or
100 sensors per square centimeter, or per cubic centimeter.
[0477] The above ISM sensors may be continuously monitored in order
to provide a `real-world` assessment of the alignment of the bone,
to assist in detecting mobility/immobility of the fracture (and
associated joints), to monitor healing and the development of
complications, to collect and compare procedure performance data
over time, to evaluate patient function, and to better understand
the conditions which implants are exposed to in the real world.
[0478] B.8.B.4. Plates
[0479] Orthopedic plates (also referred to as `fixation plates` and
`trauma plates`) have been utilized to fix fractures for over a
hundred years. The first metal plate was introduced by Dr. Lane in
1895 for the internal fixation of fractures.
[0480] Fixation plates now come in a wide variety of shapes and
sizes, for a variety of specific indications. Representative
examples include: 1) the DHS sideplate shown in FIG. 29A for the
fixation of fractures at or near the femoral head; 2) DC plates
(typically used for the ulna and radius repairs); 3) Buttress
plates (e.g., for the repair of comminuted tibial fractures);
L-Buttress plates (for complicated surgeries); 4) Clavicle Hook
plates; 5) Clover Leaf plates; 6) Condylus Humerus Bone plates; and
7) Humerus and Tibial Compression plates (too name a few).
Typically plates are comprised of metals such as stainless steel or
titanium. FIG. 29 illustrates an embodiment wherein an ISM is
placed on or within a representative fixation plate.
[0481] Within one embodiment of the invention an ISM having
pressure sensors are provided on or within a plate. The ISM having
pressure sensors can be positioned within specific locations (e.g.,
on the bone or tissue surface, around screw holes), or distributed
throughout the plate. They can be utilized to assist in implanting
the plate by detecting adherence to or contact with bone (e.g., for
malleable plates like reconstruction plates), and or movement
through tissue or bone during placement (e.g. on the chisel of
blade plates). They can also be useful after placement. For
example, detection of increased pressure can indicate the potential
for stress shielding or the potential for bending cracking or
fracture of the plate. Detection of increased pressure on the
tissue surface could be an indicator of compartment syndrome.
Detection of a rapid change in pressure can indicate plate
breakage. Detecting a slow decrease in pressure can indicate that
healing is occurring and can assist in decisions on weight bearing
and rehabilitation. Monitoring the pressure around the screw holes
can assist with appropriate tightening during placement; later it
can be used to detect "backing out" of the screws or other
complications such as breakage.
[0482] Within another embodiment plates are provided with one or
more ISMs having accelerometers (and strain gauges). Such ISMs can
be distributed on, or within the plate at specific or randomized
locations. Within certain embodiments they may be concentrated on
specific locations (e.g., on both the bone and tissue surface, at
the ends, and/or around screw holes). The ISM accelerometers can be
useful during placement and removal (if necessary) of the plate,
for proper alignment, fit, contour, blade placement and
imaging.
[0483] ISM accelerometers and strain gauges can also be useful
after placement of a plate. For example, they can be utilized
post-operatively to monitor alignment, stability, healing, patient
activities, stresses across the fracture, rotation, bending,
breakage, plate movement/slippage, and joint immobilization (or
lack thereof).
[0484] Within another embodiment of the invention, plates are
provided with one or more ISMs having position sensors/location
marker sensors. Such ISMs can be distributed on, or within the
plate at specific or randomized locations. Within certain
embodiments they may be concentrated on specific locations (e.g.,
on both the bone and tissue surface, plate ends, and/or around
screw holes). The ISM position sensors/location marker sensors can
be useful during placement and removal (if necessary) of the plate,
during movement through different tissues (for blade plates), to
monitor alignment and molding to the bone surface, and in an
imaging function after placement.
[0485] ISM position sensors/location marker sensors can also be
useful after placement of a plate. For example, they can be
utilized to monitor healing anatomy, and compare changes in
location over time (e.g., post-surgery). They can also be utilized
to monitor alignment, shifting and migration, to confirm joint
immobilization, and to detect plate bending and/or breakage.
Importantly, plates with position sensors/location markers can be
utilized to detect movement (e.g., `backing out`) of the screw
before serious complications arise.
[0486] Within yet other embodiments of the invention plates are
provided with an ISM having temperature sensors and or chemical
sensors. Briefly, temperature and/or chemical sensors can be
utilized to monitor mineralization, galvanic corrosion, tissue
health, bleeding, tissue temperature, tissue integrity, and/or the
presence of an infection or a developing infection [e.g., bone
infections (Osteomyelitis), and/or tissue necrosis].
[0487] As should be readily evident given the disclosure provided
herein, the plates of the present invention can have one or more
ISMs having a combination of one or more contact sensors, strain
gauge sensors, pressure sensors, fluid pressure sensors, position
sensors, accelerometers, shock sensors, rotation sensors, vibration
sensors, tilt sensors, pressure sensors, tissue chemistry sensors,
tissue metabolic sensors, mechanical stress sensors and temperature
sensors. Sensors can be placed at a density of greater than 1, 2,
3, 4, 5, 6, 7, 8, 9, 10 or greater than 10 sensors per square
centimeter or at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8,
9, 10 or greater than 10 sensors per cubic centimeter. Within
either of these embodiments there can be less than 50, 75, 100, or
100 sensors per square centimeter, or per cubic centimeter.
[0488] The above ISMs may be continuously monitored in order to
provide a `real-world` assessment of alignment of the bone, to
assist in detecting mobility/immobility of the fracture (and
associated joints), to monitor healing and the development of
complications, to collect and compare procedure performance data
over time, to evaluate patient function, and to better understand
the conditions which implants are exposed to in the real world.
[0489] B.8.B.5. Intramedullary Fixation: Rods and Nails
[0490] Intramedullary rods and nails are long metal rods which are
implanted into the medullary cavity of a fractured long bone (e.g.,
a femur, humerus, or tibia), thereby providing greater stability
and support to the bone during healing.
[0491] Intramedullary fixation of long bone fractures has been
around for centuries. The earliest recorded evidence is that of an
anthropologist who in the 16.sup.th century travelled to Mexico and
witnessed Aztec physicians placing wooden sticks into the medullary
canals of patients with long bone non-unions. Ivory and metal was
also utilized in early treatments, although the rate of infection
and complications was very high. During the 1900s, Gerhard
Kuntscher believed that the same science behind the Smith-Petersen
nails might work for diaphyseal fractures, and thus he developed
his `marrow nail`.
[0492] Since that time the science of intramedullary devices (e.g.,
rods and nails) has expanded greatly. Today there are a wide
variety of intramedullary rods or nails which are designed for
specific applications, including for example, interlocking nails,
Kuntscher nails, Ender's nail, Grosse-Kempf (GK) nails, Gamma
nails, and Rush nails.
[0493] As noted above, the present invention provides
intramedullary rods and nails (also referred to as "intramedullary
devices") which have ISMs containing a variety of sensors. FIG. 30A
illustrates a representative flexible nail or rod having an ISM for
intramedullary fixation. FIG. 30B illustrates the rod or nail
within the humerus.
[0494] Within one embodiment of the invention ISMs having pressure
sensors are provided on or within an intramedullary rod or nail
device. The ISMs can be positioned within specific locations (e.g.,
at the ends, on or around screw holes in interlocking nails, or
contained within the shaft of the rod or nail), or distributed
throughout the intramedullary device. They can be utilized to
assist in implanting the intramedullary nail or rod device by
detecting soft tissues, bone and marrow, and or movement through
tissue or bone during placement. They can also be useful after
placement. For example, detection of increased pressure can
indicate the potential for stress shielding or the potential for
bending cracking or fracture of the rod or nail. Detection of a
rapid change in pressure can indicate rod or nail breakage.
Detecting a slow decrease in pressure can indicate that healing is
occurring and can assist in decisions on weight bearing and
rehabilitation. Monitoring the pressure around the screw holes can
assist with appropriate tightening during placement; later it can
be used to detect "backing out" of the screws or other
complications such as breakage.
[0495] Within another embodiment intramedullary devices are
provided with ISMs having accelerometers (and strain gauges). Such
ISMs can be distributed on, or within the intramedullary device at
specific or randomized locations. Within certain embodiments they
may be concentrated on specific locations (e.g., on both ends,
and/or around screw holes, or contained within the shaft of the rod
or nail). The accelerometers can be useful during placement and
removal (if necessary) of the intramedullary device, during
movement through different tissues, and for proper placement, fit,
alignment, movement and imaging.
[0496] ISM accelerometers and strain gauges can also be useful
after placement of an intramedullary device. For example, they can
be utilized post-operatively to monitor alignment, stability,
healing, patient activities, stresses across the fracture, axial
loading, and rod/nail rotation, bending, breakage or slippage.
[0497] Within another embodiment of the invention intramedullary
devices are provided with one or more ISMs having one or more
position sensors/location marker sensors. The ISMs can be
distributed on, or within, the intramedullary device at specific or
randomized locations. Within certain embodiments they may be
concentrated on specific locations (e.g., at the ends, and/or
around screw holes, or contained within the shaft of the rod or
nail). The ISM position sensors/location marker sensors can be
useful during placement and removal (if necessary) of the
intramedullary device, during movement through different tissues
(soft tissue, cortical bone cancellous bone, marrow, through the
fracture plane), to monitor alignment, and in an imaging function
after placement.
[0498] ISM position sensors/location marker sensors can also be
useful after placement of an intramedullary device. For example,
they can be utilized to monitor healing anatomy, and compare
changes in location over time (e.g., post-surgery). They can also
be utilized to monitor alignment, shifting and migration, to
confirm fracture immobilization, and to detect rod/nail bending
and/or breakage. Importantly, intramedullary devices with position
sensors/location markers can be utilized to detect movement,
slippage and alignment changes before serious complications
arise.
[0499] Within yet other embodiments of the invention intramedullary
devices are provided with and ISM having temperature sensors and or
chemical sensors. Briefly, temperature and/or chemical sensors can
be utilized to monitor mineralization, tissue health, bleeding,
tissue temperature, tissue integrity, and/or the presence of an
infection or a developing infection [e.g., bone infections
(Osteomyelitis), and/or tissue necrosis].
[0500] In a particularly preferred embodiment, an intramedullary
rod or nail is provided with an ISM containing multiple sensors
located in the "shaft" of the shaft of the rod or nail. For an ISM
collecting mechanical data (position, motion, vibration, rotation,
shock, tilt, steps), the implanted ISM sensors (accelerometers,
position sensors, pedometers) have the advantage of not requiring
either direct physical contact with the surface of the device or
with patient tissues; only a secure and immobile attachment within
the intramedullary rod or nail is needed. In this preferred
embodiment, the ISM containing multiple mechanical sensors (as
described above) is placed within the internal canal of the
intramedullary rod or nail; a location that provides more than
enough space to insert and seal an ISM with multiple sensor
functions and battery capability. Furthermore, the motion of the
intramedullary rod or nail as the lower limb goes through its range
of motion during normal activities (such as walking) can provide
opportunities to power the ISM.
[0501] As should be readily evident given the disclosure provided
herein, the intramedullary devices of the present invention can
have one or more ISMs having a combination of one or more contact
sensors, strain gauge sensors, pressure sensors, fluid pressure
sensors, position sensors, accelerometers, shock sensors, rotation
sensors, vibration sensors, tilt sensors, pressure sensors, tissue
chemistry sensors, tissue metabolic sensors, mechanical stress
sensors and temperature sensors. Sensors can be placed at a density
of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or greater than 10
sensors per square centimeter or at a density of greater than 1, 2,
3, 4, 5, 6, 7, 8, 9, 10 or greater than 10 sensors per cubic
centimeter. Within either of these embodiments there can be less
than 50, 75, 100, or 100 sensors per square centimeter, or per
cubic centimeter.
[0502] The above sensors may be continuously monitored in order to
provide a `real-world` assessment of the alignment of the bone, to
assist in detecting mobility/immobility of the fracture (and
associated joints), to monitor healing and the development of
complications, to collect and compare procedure performance data
over time, to evaluate patient function, and to better understand
the conditions which implants are exposed to in the real world.
[0503] B.8.B.6. General Considerations
[0504] In summary, one or more ISMs having a combination of one or
more sensors may be placed on and/or within internal orthopedic
hardware in order to provide "real time" information and feedback
to the surgeon during and after the procedure, to detect proper
device placement, to achieve proper fracture reduction and
alignment during and after surgery, and to detect and monitor the
forces the implant will be subjected to in the activities of daily
life.
[0505] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can comprise a
variety of different sensors within different locations of the ISM.
In addition, within various embodiments of the invention one or
more sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with and be controlled by the ISM).
Representative examples of sensors placed on an orthopedic hardware
device, or an orthopedic hardware surgical delivery device are
provided in U.S. Provisional No. 62/017,106, which is hereby
incorporated by reference in its entirety.
[0506] B.9. Medical Polymers
[0507] Within another aspect of the invention, ISMs as described
herein are provided for use in one or more polymers. "Polymer"
refers to a macromolecule, typically in excess of 1,000 g/mol, or
in excess of 5,000 g/mol molecular weight, or in excess of 10,000
g/mol, which comprises a plurality of repeating units that are
present as part of the backbone of the polymer, the plurality
typically in excess of 10, or in excess of 20, or in excess of
50.
[0508] Polymers may be composed of synthetic materials (e.g.,
silicone, polyurethane and rubber), composed of non-synthetic
components (e.g., collagen, fibrin, hyaluronic acid, chitosan, and
harvested grafts for bypass), or some combination of these (e.g.,
artificial blood vessels having a synthetic polymer scaffold, and
naturally occurring cells (e.g., fibroblasts) which produce matrix
materials for the vessel (e.g., collagen). Representative examples
of polymers include polyester, polyurethanes, silicones, epoxy
resin, melamine formaldehyde resin, acetal, polyethyelene
terephthalate, polysulphone, polystyrene, polyvinyl chloride,
polyamide, polyolefins, polycarbonate, polyethylene, polyamides,
polimides, polypropylene, polytetrafluoroethylene, ethylene
propylene diene rubber, styrenes (e.g., styrene butadiene rubber),
nitriles (e.g., nitrile rubber), hypalon, polysulphide, butyl
rubber, silicone rubber, cellulose, chitosan, fibrinogen, collagen,
hyaluronic acid, PEEK, PTFE, PLA, PLGA, PCL and PMMA.
[0509] The polymer containing sensors of the present invention are
preferably suitable for medical applications (e.g., medical devices
and/or implants as described herein), and hence are preferably
sterile, non-pyrogenic, and/or suitable for use and/or implantation
into humans. However, within certain embodiments of the invention
the polymer can be made in a non-sterilized environment (or even
customized or "printed" for an individual subject), and sterilized
at a later point in time.
[0510] B.9.A. Polymers
[0511] A wide variety of polymers can be utilized with the ISMs
described herein. Examples include polyester, polyurethane,
silicone, epoxy resin, melamine formaldehyde resin, acetal,
polyethyelene terephthalate, polysulphone, polystyrene, polyvinyl
chloride, polyamide, polycarbonate, polyethylene, polypropylene,
polytetrafluoroethylene, ethylene propylene diene rubber,
polyurethane rubber, styrene butadiene rubber, nitrile rubber,
hypalon, polysulphide, butyl rubber, and silicone rubber. The
polymer may be classified by whether it is synthetic or
non-synthetic. In addition, or alternatively, it may be classified
as being biodegradable or non-biodegradable. In one embodiment, the
polymer is a synthetic biodegradable polymer, for example, a
co-polymer of lactide and glycolide. In another embodiment, the
polymer is a synthetic non-biodegradable polymer, such as polyvinyl
chloride. In another embodiment, the polymer is a non-synthetic,
i.e., a natural occurring polymer that is biodegradable, such as
collagen, fibrinogen, and/or hyaluronic acid. In another aspect,
the polymer is a non-synthetic polymer that is non-biodegradable,
e.g., cellulose and chitin. Some of these, as well as additional
examples, are discussed further below.
[0512] In one embodiment ISMs may be contained in a polymer such as
a polyester. Polyesters contain repeating ester groups separated by
aliphatic or aromatic groups. Polyesters may be formed by reaction
between a di-acid (e.g., adipic acid, phthalic acid) and a
di-alcohol (e.g., ethylene glycol, butylene glycol), or reactive
equivalents thereof. The polyester may be biodegradable, such as
polylactic acid (PLA), poly (lactic-co-glycolic) acid (PLGA), and
polycaprolactone (PCL).
[0513] In another embodiment ISMs may be contained in a polymer
such as a polyether, optionally including other repeating units.
For example, the polymer may be a polyetherimide, having both
repeating ether and imide groups. As another example, the polymer
may be a polyethersulfone, with repeating ether and sulfone
groups.
[0514] The polymer may be characterized in terms of its thermal
properties. For example, in one embodiment the polymer is a
thermoplastic. A thermoplastic becomes plastic (i.e., fluid) upon
heating and hardens upon cooling and is able to repeat this phase
change multiple times in response to changes in temperature.
Examples of thermoplastics include PET, polysulphone, polystyrene,
UPVC, polyamides, polycarbonates, polyethylene, polypropylene and
PTFE. In another embodiment the polymer is a thermoset. A thermoset
is does not become fluid upon heating, but instead retains it
hardened form even at elevated temperature. Examples of thermosets
include epoxy and phenolics.
[0515] In another embodiment ISMs may be contained in a polymer
such as a phenolic. Many phenolic polymers are thermoset. Phenolic
resins are typically formed between a phenol and formaldehyde, and
is sometimes referred to a phenol formaldehyde resin. Novolacs are
phenolics made with a formaldehyde to phenol molar ratio of less
than one, while resoles are phenolics made with a formaldehyde to
phenol ratio of greater than one (usually around 1.5).
[0516] The polymer may be an epoxy. Many epoxy polymers are
thermoset. Hardened epoxy resins are formed between a polyepoxide
compound (often a di-epoxide) and a curing agent such as a
poly-hydroxyl or poly-amine. A common epoxy resin is the reaction
product between epichlorohydrin and bisphenol A to form diglycidyl
ethers of bisphenol A. A common curing agent is
triethylenetetramine. Epoxy resins may also be thermally cured.
Epoxy resins are tough and resistant to many environments, making
them useful components of many medical polymers.
[0517] ISMs may also be incorporated in to a polymer such as a
polyolefin. Many polyolefin polymers are thermoplastic. Exemplary
polyolefins are polyethylene (PE) and polypropylene (PP).
Polyolefins are commercially available in a wide range of molecular
weights, and different molecular weights have different properties
and different applications. For example, ultra-high molecular
weight PE can be used to prepare load bearing materials in total
joint replacements.
[0518] In one aspect, the invention utilizes ISMs in polyethylene,
for example crosslinked polyethylene (XLPE) and ultra high
molecular weight polyethylene (UHMWPE) which may be crosslinked.
The crosslinked polyethylene may be so-called highly-crosslinked
polyethylene. (See, e.g., Lachiewicz et al. "The use of highly
cross-linked polyethylene in total knee arthroplasty" J Am Acad
Orthop Surg. 2011 March; 19(3):143-51, and Journal of the AAOS
(Vol. 16, Supplement 1, 2008), providing the proceedings of a
symposium titled 2007 AAOS/NIH Osteolysis and Implant Wear:
Biological, Biomedical Engineering, and Surgical Principles, and
Glyn-Jones et al. "The creep and wear of highly cross-linked
polyethylene: a three-year randomized controlled trial using
radiostereometric analysis" J Bone Joint Surg Br. 2008 May;
90(5):556-61, and Hodrick et al. "Highly crosslinked polyethyelene
is safe for use in total knee arthroplasty" Clin Orthop Relat Res.
November 2008; 466(11): 2806-2812. See also PCT Publication
WO2013/124577 and U.S. Pat. Nos. 8,728,379; 8,663,335; 8,653,154;
7,431,874; 7,182,784; and 6,726,727, all of the above of which are
incorporated by reference in their entirety.
[0519] In another embodiment ISMs may be contained in a polymer
such as an acrylonitrile butadiene styrene (ABS), which is
typically a thermoplastic. As its name suggests, ABS is formed by
copolymerization of the monomers acrylonitrile, butadiene and
styrene. ABS may be viewed as a styrene-acrylonitrile copolymer
modified by butadiene rubber. ABS combines the resilience of
polybutadiene with the hardness and rigidity of polyacrylonitrile
and polystyrene. The properties of the ABS polymer depend to a
large extent on the relative amount of each of the monomers used in
its preparation. Acrylonitrile tends to impart chemical resistance,
heat stability, increased tensile strength, and aging resistance.
Styrene tends to impart gloss and rigidity, and also help aid is
processing the plastic. Butadiene imparts toughness, impact
strength, good low temperature properties.
[0520] In another embodiment ISMs may be contained in a polymer
such as an ethylene vinyl alcohol (EVA, or EVAL or EVOH) copolymer
which is formed by copolymerization of ethylene and vinyl acetate,
whereupon the acetate groups are hydrolyzed to hydroxyl (alcohol)
groups. EVOH is biocompatible and biodegradable. EVOH is recognized
as having excellent bather properties to oxygen, and accordingly is
often used as a coating to provide this desirable function.
[0521] In another embodiment ISMs may be contained in a polymer
such as a fluoroplastic. As used herein, a fluoroplastic refers to
a polymer that is a thermoplastic and which contains
carbon-fluorine bonds. Examples are poly(tetrafluoroethylene), also
known as PTFE.
[0522] The polymer may be polyvinyl chloride (PVC). PVC comes in
two basic grades: flexible and rigid. The flexible form is
typically prepared by incorporation of various additives into the
PVC, where exemplary additives are plasticizers (e.g., phthalates)
and stabilizers. Flexible PVC is used in many medical applications
due to its biocompatibility, transparency, softness, light weight,
high tear strength, kink resistance, and suitability for
sterilization. PVC may be chlorinated to increase its chlorine
content, thereby creating CPVC.
[0523] In another embodiment ISMs may be contained in a polymer
such as a polysulfone (PS). For example, the polymer may be a
polyphenylsulfone. Westlake Plastics (Lenni, Pa.) markets medical
grade Radel R5500 polyphenylsulfone resin. This polymer provides
hydrolytic stability, toughness, and good impact strength over a
wide temperature range. Recommended sterilization techniques for
Radel R5500 include EtO gas, radiation, steam autoclaving, dry heat
and cold sterilization.
[0524] In another embodiment ISMs may be contained in a polymer
such as a polyether ether ketone (PEEK). An exemplary PEEK polymer
is formed by reaction of 4,4'-difluorobenzophenone with the
disodium salt of hydroquinone. PEEK is a semicrystalline,
high-temperature (up to 500.degree. F.) engineering thermoplastic
that is useful in applications where thermal, chemical, and
combustion properties are important to performance. PEEK also
resists radiation and a wide range of solvents including water.
With its resistance to hydrolysis, PEEK can withstand boiling water
and superheated steam used with autoclave and sterilization
equipment at temperatures higher than 482.degree. F., thus making
it useful in the manufacture of many medical parts.
[0525] In another embodiment ISMs may be contained in a polymer
such as a polycarbonate (PC). For example, Westlake Plastics
(Lenni, Pa.) markets medical grade Zelux GS polycarbonate which may
be sterilized by EtO gas and limited autoclaving sterilization.
[0526] In another embodiment ISMs may be contained in a polymer
such as a polyimide, such as a polyetherimide. For example,
Westlake Plastics (Lenni, Pa.) markets medical grade Tempalux
polyetherimide. This polymer maintains its size and shape over a
broad temperature range as well as tolerates a high amount of
stress over extended periods of time. Recommended sterilization
techniques for Tempalux include EtO gas, radiation, steam
autoclaving, dry heat and cold sterilization.
[0527] In another embodiment ISMs may be contained in a polymer
such as a one with repeating oxymethylene units. For example, the
polymer may be a homopolymer of oxymethylene units, which is known
polyoxymethylene (POM) or acetal or polyacetal. The term POM will
be used to refer to homopolymers prepared from formaldehyde or
equivalent, which may have various endgroups to enhance the
stability of the homopolymer. When a high molecular weight version
of the homopolymer is reacted with acetic anhydride, the resulting
product is hard, rigid and has high strength. A version is sold by
du Pont (Wilmington Del.) as their Delrin polymer and advertised
for use in medical products. The polymer may be a copolymer
including repeating oxymethylene units. For example, formaldehyde
may be converted to 1,3,5-trioxane, which in turn is reacted with a
suitable co-monomer such as ethylene oxide or dioxolane. Hostaform
from Ticona (now Celanese, Irving, Tex.) and Ultraform from BASF
(Florham Park, N.J.) are two examples of commercially available
oxymethylene copolymers. Polyplastics (Taipei, Taiwan) manufactures
DURACON POM, which may be used in medical products. TECAFORM MT is
a POM manufactured by Ensinger Inc. (Washington, Pennsylvania)
which is particularly suited for use as sizing trials in knee, hip
and shoulder replacement procedures.
[0528] The polymer may be characterized in terms of its
viscoelastic properties. For example, in one embodiment the polymer
is elastic, in which case the polymer may be referred to as an
elastomer. At ambient temperatures, elastomers are relatively soft
and deformable, i.e., they may be stretched and will return back to
its original shape after the stretching force is removed. One type
of elastomer is a rubber, where a rubber is typically formed by a
process that includes vulcanization. Alternatively, the polymer may
be rigid and non-deformable.
[0529] In another embodiment ISMs may be contained in a polymer
such as a polyurethane. Polyurethanes are formed when a polyol
(i.e., a polyhydroxylated compound) reacts with a diisocyanate or a
polymeric isocyanate when there are suitable catalysts and
additives present. The polyurethane may be a thermoset,
particularly when crosslinking reactants are used in its
preparation. Alternatively, the polyurethane polymer may be an
elastomer. For example, Bayer (Leverkusen, Germany) markets
Vulkollan.RTM. polymer which is produced by reacting
polyesterpolyols, Desmodur.RTM. 15 (one or both of MDI
(diphenylmethane diisocyanate) and TDI (toluylene diisocyanate) and
glycols at temperatures exceeding 100.degree. C. in a multistage
process. Vulkollan.RTM. polymer may be formed into parts and is
particularly well-suited when high mechanical load bearing and high
dynamic load bearing capacity is needed. Another suitable
polyurethane elastomer, also from Bayer, is Baytec.RTM. Spray, a
material consisting of two liquid, polyurethane-based components.
Baytec.RTM. Spray can be used to provide an elastomeric coating on
the surface of a polymer.
[0530] In another embodiment ISMs may be contained in a polymer
such as a may be a natural polymer or a synthetic polymer. A
natural polymer is found in nature, where rubber is an example of a
natural polymer. A synthetic polymer is not found in nature but is
instead made through human-controlled chemical reactions.
Polyurethanes are exemplary synthetic polymers. Carbohydrates
(e.g., cellulose, hyaluronic acid) and poly(amino acid) (e.g.,
protein, collagen) are examples of natural polymers. Cellulose
finds use in, e.g., the manufacture of dialysis membranes. Chitin
is a natural polymer, however the synthetic deacylation of chitin
produces the synthetic polymer chitosan. Hyaluronic acid is a
natural polymer that finds use in the treatment of osteoarthritis
and other joint disorders.
[0531] In another embodiment ISMs may be contained in a polymer
such as a synthetic elastomer, also known as a synthetic rubber.
There are several well-known synthetic elastomers, which are named
from the monomer(s) from which they are produced. Those elastomers
include cis-polybutadiene (butadiene rubber, BR), styrene-butadiene
rubber (SBR), ethylene-propylene monomer (EPM),
acrylonitrile-butadiene copolymer (nitrile rubber),
isobutylene-isoprene copolymer (butyl rubber),
ethylene-propylene-diene monomer (EPDM, where the diene may be,
e.g., butadiene), and polychloroprene (neoprene). In large part
these synthetic rubbers consist of two or more different monomer
units, e.g., styrene and butadiene, arranged randomly along the
molecular chain. EPM and nitrile rubber also consist of a random
arrangement of two monomers-in this case, ethylene and propylene
(which form EPM) and butadiene and acrylonitrile (which form
nitrile rubber). Another suitable rubber is silicon rubber, which
finds widespread use in catheters and other types of medical
tubing. Silicon rubber may be prepared by curing a liquid
precursor, e.g., with a platinum catalyst, usually at elevated
temperature. The glass transition temperatures of all these
polymers are quite low, well below room temperature, so that all of
them are soft, highly flexible, and elastic. The present disclosure
provides that any one or more of the named synthetic rubbers may be
used in the compositions and methods as identified herein.
[0532] Instead of an organic polymer, the polymer or coating may be
formed in whole or in part from a ceramic biomaterial, sometimes
referred to as a bioceramic. An example of a ceramic biomaterial is
hydroxyapatite, which may be combined with a binder to create a
solid mass or a coating. Suitable binders include collagen,
gelatin, and polyvinylalcohol. A sol-gel process may be used to
prepare the final product. Other examples of bioceramics include
alumina (Al.sub.2O.sub.3) and zirconia (ZrO.sub.2), tricalcium
phosphate (Ca.sub.3(PO.sub.4).sub.2), and bioglass
(Na.sub.2OCaOP.sub.2O.sub.3--SiO). The bioceramic may be
biodegradable (e.g., tricalcium phosphate) or biostable (e.g.,
alumina). The bioceramics alumina and zirconia are used in
orthopedics to produce, for example, femoral heads, artificial
knees, bone screws and bone plates, and in dental applications are
used to produce crowns and bridges.
[0533] The medical polymer may be multi-component. For example, it
may be a blend of two or more polymers. As another example, it may
be a composite of organic and inorganic materials. For example, the
medical polymer may be a blend of polyester and a mineral
component, or a blend of silicone and a mineral component.
[0534] B.9.B. Bone Cement and other Implantable Materials
[0535] As described herein bone cement and other implantable
materials can be utilized in a large number of orthopedic
procedures (including for example, hip and knee procedures, spinal
procedures and orthopedic procedures as described herein. Most
typically, methylmethacrylates are utilized (e.g.,
polymethylmethacrylate, or amethylmethacrylate--styrene copolymer),
although other materials can also be utilized.
[0536] However, a wide variety of implantable materials can also be
utilized (see generally US 2007/0100449). For example, suitable
materials include both biocompatible polymers, therapeutic agents,
and naturally occurring materials. Biocompatible polymers may be
both bioabsorbable and/or nonbioabsorbable. Typically, the polymers
will be synthetics (e.g., aliphatic polyesters, poly(amino acids),
copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine
derived polycarbonates, poly(iminocarbonates), polyorthoesters,
polyoxaesters, polyamidoesters, polyoxaesters containing amine
groups, poly(anhydrides), polyphosphazenes, poly(propylene
fumarate), polyurethane, poly(ester urethane), poly(ether
urethane), copolymers of lactide (e.g., D,L lactide), glycolides,
caprolactones and blends and copolymers thereof. However, in
certain embodiments natural polymers can also be utilized (e.g.,
fibrin-based materials, collagen-based materials, hyaluronic
acid-based materials, glycoprotein-based materials, cellulose-based
materials, silks and combinations thereof).
[0537] Within certain embodiments of the invention the bone cement
or implantable material may contain a desired agent, compound, or
matrix, such as, for example, bone morphogenic protein or "BMP",
bone graft material, and calcium phosphate.
[0538] The bone cement and other implantable materials described
herein may contain one or more ISMs having one or more sensors,
including for example, fluid pressure sensors, contact sensors,
position sensors, pulse pressure sensors, fluid (e.g., blood,
urine, bile) volume sensors, fluid (e.g. blood, urine, bile) flow
sensors, air flow sensors, chemistry sensors (e.g., for blood,
urine, bile and/or other fluids), metabolic sensors (e.g., for
blood, urine, bile and/or other fluids), accelerometers, mechanical
stress sensors and temperature sensors. Within certain embodiments
the bone cement or implantable material will sensors at a density
of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per
square centimeter; and or sensors a density of greater than 1, 2,
3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.
[0539] B.9.C. Manufacture of Medical Polymers
[0540] A polymer may be fabricated into a desired shape for a
medical polymer by various methods including extrusion, molding
(e.g., injection molding, compression molding) thermoforming,
electrospinning, and cutting (e.g., stamping, die cutting). During
the fabrication process, a sensor may be incorporated into the
polymer.
[0541] For example, the polymer may be fabricated by a
thermoforming technique, including vacuum, pressure and mechanical
types of thermoforming. In general, thermoforming refers to a
process of converting an initially flat thermoplastic sheet into a
desired three-dimensional shape, where the process includes at
least two stages: softening the sheet by heating, followed by
forming it in a mold cavity. In vacuum thermoforming, the heated
thermoplastic sheet is held in the cavity by means of vacuum
produced between the sheet and the surface of the mold cavity
space. In pressure thermoforming, gas pressure is applied against
the heated sheet in the direction of the mold cavity, thereby
forcing the sheet against the contours of the cavity. In mechanical
thermoforming, a solid object is pushed against the sheet so that
the sheet is forced against the contour of the mold. Upon cooling,
the thermoplastic sheet adopts the shape of the mold. A sensor may
be placed in the heated sheet before or during the forming process,
so that upon cooling, the sheet adopts a desired shape and the
sensor is embedded in whole or part in the thermoplastic sheet.
[0542] As another example, the polymer may be fabricated by a
molding process, whereby solid or molten polymer or pre-polymer is
placed within a mold. Upon cooling, the polymer will adopt the
configuration of the mold. Various types of molding process that
may be used. For example, compression molding squeezes a
pre-polymer into a pre-heated mold and then applies heat and
pressure to the pre-polymer, causing the pre-polymer to cure into
the shape of the mold. This process may be used for both
thermoplastic and thermosetting polymer. In blow molding, a heated
hollow thermoplastic tube is inflated within a closed mold until it
adopts the shape of the mold. Upon cooling, the newly shaped tube
will retain the shape of the mold.
[0543] Electrospinning is particularly suited for preparing
polymeric fibers, and represents another example of fabricating a
polymer. For example, it can be used to form nanofibers from
various organic polymers. See, e.g., Doshi, J. and Reneker, D. H.,
Journal of Electrostatics 35(2-3):151-160, 1995. Fibers formed from
electrospinning may be made into various shapes, including matrices
formed from woven and non-woven fibers. Sensors may be embedded
within the matrix formed from the electrospun fibers.
[0544] As yet another example, the medical article may be formed by
any of weaving, plying, braiding, knitting, and stitching of
polymeric fibers. These processes may be used to form various
shapes, including a sheet (as found, e.g., in a mesh), filament (as
found, e.g., in a suture), and a tube (as found, e.g., in a graft).
See, e.g., U.S. Pat. No. 5,378,469 directed to high strength
collagen threads, which are optionally crosslinked, where the
threads may be used to form braided constructs, plied into yarn,
and knitted to provide an implant. A sensor as described herein can
be incorporated in, or associated with, the braided, knitted, or
woven materials.
[0545] The medical polymer may be sterilized by techniques known in
the art. For example, the medical polymer may be exposed to
ionizing radiation, such as gamma radiation and electron beam
radiation. While ionizing radiation may sterilize the medical
polymer, it can also cause some breakdown of the polymer's basic
structure. To combat this problem, stabilizers may be added to the
polymer, where examples include antioxidants such as phenolics that
react with free radicals, and organo-phosphorous compounds which
react with peroxide and hydroperoxides generated by the reaction of
oxygen with reactive sites generated by the ionizing radiation.
Another sterilization technique is to expose the medical polymer to
ethyelene oxide. An advantage of ethylene oxide sterilization is
that it is not harmful to the structure of the polymer, and
accordingly is a suitable sterilization technique when a medical
polymer must be repeated sterilized. Another sterilization
technique is to expose the medical polymer to high temperature,
optionally in the presence of steam, e.g., in an autoclave.
[0546] B.9.D. Use of Medical Polymers in Medical Polymers and
Implants
[0547] Polymers containing ISMs can be utilized in a wide variety
of medical devices and implants, including for example, hip and
knee prosthesis, tubes (e.g., grafts and catheters), implants
(e.g., breast implants), spinal implants, orthopedic and general
surgery implants, and cardiovascular implants (e.g., stents, stent
grafts, and heart valves). Representative examples of such implants
are discussed in more detail in International Patent Application
No. PCT/US2013/077356; International Patent Application No.
PCT/US2014/028323; International Patent Application No.
PCT/US2014/028381; International Patent Application No.
PCT/US2014/043736; U.S. Provisional Patent Application Entitled
`Devices, Systems and Methods for Using and Monitoring Catheters`,
filed Jun. 25, 2014, Attorney Docket No. CANA.405P1; U.S. Patent
Provisional Application Entitled `Devices, Systems and Methods for
Using and Monitoring Implants, filed Jun. 25, 2014, Attorney Docket
No. CANA.406P1; U.S. Patent Provisional Application Entitled
`Devices, Systems and Methods for Using and Monitoring Spinal
Implants`, filed Jun. 25, 2014, Attorney Docket No. CANA.407P1;
U.S. Patent Provisional Application Entitled `Devices, Systems and
Methods for Using and Monitoring Orthopedic Hardware`, filed Jun.
25, 2014, Attorney Docket No. CANA.408P1; U.S. Patent Provisional
Application Entitled `Devices, Systems and Methods for Monitoring
Heart Valves`, filed Jun. 25, 2014, Attorney Docket No. CANA.410P1;
all of the aforementioned patent applications incorporated herein
by reference in their entireties for all purposes.
[0548] Some additional discussion of medical polymers and devices
that can be used in the present invention is as follows:
[0549] B 9.D.1. Glues, Adhesives and Cements
[0550] The medical polymer may be useful to hold tissue together,
or to hold tissue together with a medical implant, such as a glue
or adhesive, where the tissue includes soft tissue or bone. When
used in bone, the medical polymer is frequently referred to as a
bone cement, where bone cement is also used to fill in cavities of
bone. For example, the polymer may be the reaction product of two
synthetic polyethylene glycols which have reactive endgroups such
that upon forming a mixture of the two components, the two
materials react with one another and form a crosslinked film. A
version of this material is commercially available as COSEAL
(Baxter Healthcare, Fremont, Calif., USA). See, e.g., Cannata, A.,
et al., Ann. Thorac. Surg. 2013, 95:1818-1826. COSEAL may be spayed
over a large area, and to varying depths, to provide a glue or
adhesive layer on living tissue. A modified chitosan-dextran gel as
prepared by the process described in Liu G., et al. Macromolecular
Symposia 2009 279:151. See, e.g., Lauder, C. I. W., et al. Journal
of Surgical Research 2012 176:448-454. This material may be applied
to soft tissue and will function to hold the tissue together. A
sprayable material that functions primarily as a barrier but also
has some adhesive properties is marketed by Covidien and known as
SprayShield. SprayShield is a synthetic two-component product that
forms a gel when applied to an organ.
[0551] As an example, a syringe containing a product such as COSEAL
can be delivered along with, or admixed with an ISM as provided
herein. Within various embodiments one or more ISMs having sensors
(e.g., fluid pressure sensors, contact sensors, position sensors,
pulse pressure sensors, liquid (e.g., blood) volume sensors, liquid
(e.g., blood) flow sensors, chemistry sensors (e.g., for blood
and/or other fluids), metabolic sensors (e.g., for blood and/or
other fluids), accelerometers, mechanical stress sensors and
temperature sensors) can be incorporated into one or more
polymers.
[0552] B.9.D.2. Medical Polymers--Meshes and Films
[0553] Various medical polymers are used to form implantable films
of meshes. For example, the biodegradable copolymer of
hydroxybutyrate and hydroxyvalerate known as (PHBV) is available
from Metabolix, Inc. (Cambridge, N.J., USA) and can function as a
barrier film. Oxidized regenerated cellulose is commercially
available as Interceed (Johnson & Johnson, Canada), which is a
knitted fabric that converts to a gel within 8 hours and is
completely cleared from the body within 28 days. See, e.g., Larsson
B., J. Reprod. Med. 1996, 41:27-34 and ten Broek R. P. G., et al.,
The Lancet 2014 383:48-59. Collagen foil in combination with
polypropylene mesh is commercially available as TissueFoil E from
Baxter (Germany). See, e.g., Schonleben, F., Int. J. Colorectal
Dis. 2006, 21(8):840-6. INTERCOAT, also known as OXIPLEX AP, made
by Johnson & Johnson and licensed from Fziomed, may be used as
an implantable film. PREVADH, made by Sofradim-Covidien in France
is a collagen film and fleece composite that may be used as an
implantable filem. W.L. Gore manufactures and sells non-absorbable
adhesion barrier films using expanded polytetrafluoroethylene film,
sometimes referred to as GoreTex Surgical Membrane or as Preclude.
Each of these films may be used as a medical polymer according to
the present invention.
[0554] Meshes are available from various vendors. For example,
Ethicon markets a synthetic mesh, PROLENE mesh, made from
polypropylene. Biological meshes are also known and may be used in
the present invention. Examples are meshes formed from human or
animal dermis or porcine small intestinal submucosa. See, e.g.,
Nguyen et al., JAMA Surg., epub Feb. 19, 2014 and Carbonell et al.,
J. Am. Coll. Surg., 217(6):991-998, 2013.
[0555] Within one embodiment of the invention one or more ISMs can
be incorporated into a mesh (e.g., by interweaving, attaching,
interlayering, or otherwise securing the ISM to the mesh).
Representative examples of ISMs have one or more sensors such as
fluid pressure sensors, contact sensors, position sensors, pulse
pressure sensors, liquid (e.g., blood) volume sensors, liquid
(e.g., blood) flow sensors, chemistry sensors (e.g., for blood
and/or other fluids), metabolic sensors (e.g., for blood and/or
other fluids), accelerometers, mechanical stress sensors and
temperature sensors. Sensors within a mesh or film can be utilized
to determine contact between various organs or anatomical
structures (e.g. utilizing contact sensors and/or pressure
sensors); the presence of or development of an infection (e.g.,
utilizing temperature and/or metabolic sensors), to determine
degradation, wear, movement and/or fracture (e.g., utilizing
contact sensors, pressure sensors, and/or location sensors).
[0556] B.9.D.3. Medical Polymers--Suture and Staples
[0557] The medical polymer may be formed into a device for securing
or fastening tissue, such as a staple or a suture. See, e.g., U.S.
Pat. Nos. 8,506,591 and 8,721,681 as well as U.S. Publication Nos.
2001/0027322, 2006/0253131, 2011/0093010, 2013/0165971, and
2014/0130326 for exemplary suitable staples and discussion of
insertion devices. The medical polymer may be formed into a suture,
e.g., PROLENE polypropylene suture by Ethicon (New Jersey), or
DEKLENE polypropylene suture sold by Teleflex Medical (North
Carolina). See also, e.g., U.S. Pat. Nos. 6,908,466; 4,750,492;
4,662,068 for medical fasteners prepared in whole or part from
polymer.
[0558] Within one embodiment of the invention one or more ISMs can
be incorporated into, or otherwise attached or secured to a
fixation device such as a suture or staple. The Isms can have one
or more sensors such as fluid pressure sensors, contact sensors,
position sensors, pulse pressure sensors, liquid (e.g., blood)
volume sensors, liquid (e.g., blood) flow sensors, chemistry
sensors (e.g., for blood and/or other fluids), metabolic sensors
(e.g., for blood and/or other fluids), accelerometers, mechanical
stress sensors and temperature sensors. Sensors within a suture or
staple can be utilized to determine contact with various organs or
anatomical structures (e.g. utilizing contact sensors and/or
pressure sensors); the presence of or development of an infection
(e.g., utilizing temperature and/or metabolic sensors), to
determine degradation, wear, movement and/or fracture (e.g.,
utilizing contact sensors, pressure sensors, and/or location
sensors).
[0559] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can comprise a
variety of different sensors within different locations of the ISM.
In addition, within various embodiments of the invention one or
more sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with and be controlled by the ISM).
Representative examples of polymers for use with ISMs are provided
in U.S. Provisional No. 62/017159, which is hereby incorporated by
reference in its entirety).
[0560] B.10. Heart Valves
[0561] Within another aspect of the invention, ISMs as described
herein are provided for use in one or more types of heart valves.
As utilized herein "heart valve" refers to a device which can be
implanted into the heart of a patient with valvular disease. There
are three principle types of heart valves: mechanical, biological,
and tissue-engineered (although, for purposes of this disclosure
tissue-engineered valves will be considered along with other
biological valves). Mechanical and biological valves typically fall
into two categories: 1) heart valves for surgical procedures
utilizing a sternotomy or "open heart" procedure (e.g., `caged
ball`, `tilting disc`, bileaflet and trileaflet biologic designs
with sewing rings for attachment in the valvular annulus); and 2)
heart valves which are percutaneously implanted [e.g., either a
stent framed (self-expanding stent or balloon-expandable stent) or
non-stent framed design] that can often contain valve cusps which
are fabricated from biological sources (bovine or porcine
pericardium). Tissue-based or `biological` valves are typically
made from either porcine or bovine sources, and are usually
prepared either from the valve of the animal (e.g., a porcine
valve), or from tissue of the pericardial sac (e.g., a bovine
pericardial valve or a porcine pericardial valve).
Tissue-engineered valves are valves that have been artificially
created on a scaffold (e.g., through the growth of suitable cells
on a tissue scaffold). Tissue-engineered valves have not yet been
commercially adopted.
[0562] In addition to heart valves, delivery devices are also
provided. In the context of percutaneous heart valve delivery,
particularly preferred delivery devices comprise a guidewire,
delivery catheter, catheters with a "sheath" that deploy
self-expanding devices, catheters with an expandable balloon, and
anchoring suture devices. By utilizing such devices and methods
heart valves can be replaced without the need for open heart
surgery.
[0563] Representative examples of heart valves and associated
delivery devices are described in U.S. Pat. Nos. 6,564,805,
6,730,122, 7,033,090, 7,578,842, 8,142,497, 8,287,591, and
8,568,474; U.S. Publication Nos. 2010/0076548, 2010/0161046,
2010/117471, 2011/0009818, 2011/0190897, 2012/0179243,
2013/0096671, 2013/0166023, 2013/0268066; and PCT Publication Nos.
WO 2012/011108, and WO 2013/021374; all of the above of which are
incorporated by reference in their entirety.
[0564] The present invention provides heart valves and related
delivery devices, all of which have sensors as described in further
detail below. The heart valve and related delivery devices are
preferably sterile, non-pyrogenic, and/or suitable for use and/or
implantation into humans. However, within certain embodiments of
the invention the heart valve and/or delivery device can be made in
a non-sterilized environment (or even customized or "printed" for
an individual subject), and sterilized at a later point in
time.
[0565] B.10.A. Heart Valves and their Use
[0566] B.10.A.1. Mechanical Heart Valves and their Use
[0567] B.10.A.1.1. `Open Heart` Surgery Heart Valves: "Caged Ball",
"Tilting Disc", and Bi and Tri-Leaflet Designs
[0568] As noted above, within various embodiments of the invention,
mechanical heart valves are provided with one or more ISMs as
described herein. Representative examples include: 1) heart valves
based upon a "caged ball" design [e.g., these devices have a
restraining cage (typically made of metal), an occluder ball
(typically made from a silicone elastomer), and a suture ring) such
as the Starr-Edwards valve and the Smeloff-Cutter valve]; 2) heart
valves based upon a "tilting disc" design [typically including an
occluder disc that rotates on a flange and 2 metal struts (an inlet
and an outlet strut) which stop the occluder disc in either the
open or the closed position; additionally, there is a metal ring
covered by ePTFE that is used as a suture ring to anchor the valve
in place]; and 3) bileaflet and trileaflet valves (with two or
three hinged leaflets and a anchoring suture ring).
[0569] Mechanical valves have improved greatly since their
introduction, yet they still suffer from numerous complications.
For example, the caged-ball design can last for a long time, but
require a lifetime of anticoagulation for the patient. Red blood
cells and platelets get damaged flowing through the mechanical
valves which can lead to a hypercoagulative state that can result
in thrombus and embolis formation (necessitating blood thinner
therapy) and can even result in anemia. The leaflet (bileaflet and
trileaflet) mechanical valves cause less damage to blood cells (and
are less thrombogenic and require lower levels of anticoagulation
therapy), but they are vulnerable to backflow. Mechanical valves
are also subject to impact wear (occurs in the hinges of bileaflet
valves, between the occluder and ring in tilting disc valves, and
between the ball and cage in ball-cage valves) and frictional wear
(occurs between the occluder and the struts in tilting disc valves
and between the leaflet pivots and hinge cavities in bileaflet
valves), and can cause `cavitation` (i.e., the formation of
microbubbles, which can erode the valve surface, increase blood
cell damage and increase the incidence of thromboembolic
events).
[0570] Hence, the present invention provides mechanical heart
valves which have one or more ISMs having one or more sensors,
including for example, fluid pressure sensors, contact sensors,
accelerometers, vibration sensors, pulse sensors, liquid (e.g.,
blood) volume sensors, liquid (e.g., blood) flow sensors, liquid
(e.g., blood) chemistry sensors, liquid (e.g., blood) metabolic
sensors, mechanical stress sensors, and temperature sensors. Such
sensors can be placed on, in, or within the various components of
the heart valve, and can be utilized to monitor, amongst other
things, thrombogenesis, wear, blockage, sticking (impaired movement
of the `valve`), trans-valvular pressure gradients (an indicator of
the potential for cavitation), cardiac function, leakage (backflow
or regurgitation), detachment of the suture ring (from, for
example, suture breakage), assembly of the device (where possible),
correct anatomical placement of the device, failure, and safety.
Within preferred embodiments of the invention ISMs can be provided
on the sewing ring or other sites that are utilized to attach the
valve to the heart.
[0571] For example, as shown in FIGS. 31A and 31B, mechanical
valves are illustrated with an ISM incorporated. Within one
embodiment, an ISM containing blood flow (motion) sensors are
provided on a mechanical heart valve (e.g., `caged-ball`, `tilting
disc`, bi or tri-leaflet valves).
[0572] ISMs having blood flow sensors can be utilized to measure
fluid flow through the mechanical valve, and to detect
abnormalities that occur acutely, or gradually over time. The ISMs
can be provided in a variety of locations, but are preferred within
the suture ring (`10` as shown in FIGS. 31A and 31B); other
preferred location include incorporation into the leaflets, the
occluder disc/ring, the cage/ball, and the struts. For example, a
decrease in forward flow may suggest the development of a stenosis
[from thrombus formation, infection (biofilm or vegetations)],
sticking of moving components (the ball, disc, or leaflets), or
failure of the device. Increases in backwards flow can be
suggestive of regurgitation, due to sticking, thrombus, infection
or failure of the moving components. ISM blood flow sensors can
show real-time movement of blood through the valve, and permit
hemodynamic monitoring and determination of cardiac output (similar
to an echocardiogram), ejection fraction and cardiac index (key
clinical measurements that are valuable in monitoring
cardiac-compromised patients, which many valvular patients
are).
[0573] Within other embodiments, ISMs are provided having one or
more pressure sensors which can be utilized to measure pressure on
both sides of the valve, and to detect abnormalities that occur
acutely, or gradually over time. The ISMs containing pressure
sensors can be provided in a variety of locations (particularly
such that sensors are located on both the atrial and ventricular
side of the valve), but are preferred within the suture ring (`10`
as shown in FIGS. 31A and 31B); other preferred location include
incorporation into the leaflets, the occluder disc/ring, the
cage/ball, and the struts. For example, an increased pressure
gradient across the valve can indicate occlusion due to thrombus,
panus, or in the case of biologic valves restrictive leaflet
immobility due to calcification. Excessive regurgitation can be an
indication of the prosthetic valve leaflet's inability to seat on
the housing (mechanical valves) or coapt (biological valves)
properly due to thrombus, panus, and/or calcification. Valvular
regurgitation can also occur due to perivalvular leakage at the
interface of the valve's suture ring with the host annulus. ISM
pressure sensors on the ventricular side of a valve can measure
systolic and diastolic pressure, and estimate systemic vascular
resistance and pulmonary vascular resistance (depending upon the
valve). These sensor readings can also be utilized to calculate
cardiac output, ejection fraction and cardiac index and permit in
situ hemodynamic monitoring.
[0574] Within further embodiments ISMs are provided having one or
more blood volume sensors which can be utilized to measure fluid
flow through the valve, and to detect abnormalities that occur
acutely, or gradually over time. The ISMs containing blood volume
sensors can be provided in a variety of locations (particularly
such that sensors are located on both the atrial and ventricular
side of the valve), but are preferred within the suture ring (`10`
as shown in FIGS. 31A and 31B); other preferred location include
incorporation into the leaflets, the occluder disc/ring, the
cage/ball, and the struts. For example, a decrease in forward blood
volume may suggest the development of a stenosis [from thrombus
formation, infection (biofilm or vegetations)], sticking of moving
components (the ball, disc, or leaflets), or failure of the device.
Increases in backwards blood volume (>5 ml) can be suggestive of
regurgitation, due to sticking, thrombus, infection or failure of
the moving components. ISM blood volume sensors (e.g., to measure
blood volume over a unit of time) can show real-time movement of
blood through the valve, and permit hemodynamic monitoring and
determination of cardiac output (similar to an echocardiogram),
ejection fraction and cardiac index and permit in situ hemodynamic
monitoring.
[0575] Within yet other embodiments ISMs are provided having
metabolic (or chemical) sensors on mechanical valves which can be
utilized to measure metabolic parameters important in vascular
function. The ISMs containing metabolic can be provided in a
variety of locations, but are preferred within the suture ring
(`10` as shown in FIGS. 31A and 31B); other preferred location
include incorporation into the leaflets, the occluder disc/ring,
the cage/ball, and the struts; they must be blood contacting.
Representative examples include coagulation/clotting parameters
such as PT, PTT, clotting time and INR; Blood Oxygen content; Blood
CO.sub.2 content; Blood pH; Blood cholesterol; Blood lipids (HDL,
LDL); Blood Glucose; Cardiac enzymes; Hepatic Enzymes;
Electrolytes; Blood Cell Counts; and Kidney Function parameters
(BUN, Creatinine, etc.).
[0576] Within other embodiments, ISMs are provided with position
sensors that can be utilized to measure the location of fixed and
moving components of the mechanical valve. The ISMs can be provided
in a variety of locations, but are preferred within the suture ring
(`10` as shown in FIGS. 31A and 31B); other preferred location
include incorporation into the leaflets, the occluder disc/ring,
the cage/ball, and the struts. For example, gaps in the leaflets,
occluder disc/ring and cage/ball are suggestive of leakage and
regurgitation. ISM position sensors can also be utilized to `image`
valvular motion (opening, closing, and integrity of the seal).
Changes in ISM position sensors on the suture ring can show
slippage, migration, failure, and suture breakage. Dilation of the
ring can indicate possible dilative cardiomyopathy, whereas
narrowing of the ring can indicate myocardial hypertrophy.
[0577] Within further embodiments ISMs are provided with contact
sensors that can be utilized to measure the contact between fixed
and moving components of a mechanical valve. For example,
incomplete contact between the leaflets, between the occluder disc
and the ring, and between the ball and cage are suggestive of
leakage and regurgitation. The ISMs containing contact sensors can
be provided in a variety of locations, but are preferred within the
suture ring (`10` as shown in FIGS. 31A and 31B); other preferred
locations include incorporation into the leaflets, the occluder
disc/ring, the cage/ball, and the struts. Contact sensors can also
be utilized to `image` valvular motion (opening, closing, and
integrity of the seal). Changes in contact sensors on the suture
ring can show slippage, migration, failure, and suture breakage.
ISM contact sensors can also be utilized to monitor the surface of
the valve (e.g., to detect the presence of surface anomalies such
as the formation of clot or thombi, biofilm or vegetations on the
valve surface), and to monitor for friction wear, impact wear, and
breakage (e.g., contact sensors can be placed at various depths of
any of the various components (e.g., occluder disc, strut, occluder
ring, leaflets, leaflet pivots, hinges, ball and/or cage).
[0578] Within yet other embodiments ISMs are provided with
accelerometers which can be utilized to measure the location and
movement of fixed and moving components of a mechanical valve. The
ISMs containing accelerometers can be provided in a variety of
locations, but are preferred within the suture ring (`10` as shown
in FIGS. 31A and 31B); other preferred locations include
incorporation into the leaflets, the occluder disc/ring, the
cage/ball, and the struts. For example, gaps in the leaflets,
occluder disc and ring, and ball and cage are suggestive of leakage
and regurgitation. Accelerometers can also be utilized to `image`
real time valvular motion (opening, closing, and integrity of the
seal), and to image changes that might occur in the mechanical
valve over time. Changes in accelerometers on the suture ring can
show slippage, migration, failure, and suture breakage.
[0579] B.10.A.1.2. Biological (Tissue-Based) Heart Valves and their
Use
[0580] As noted above, within various embodiments of the invention
biological (tissue-based) heart valves are provided with one or
more ISMs as described herein. Briefly, biological valves are heart
valves that are typically designed from xenographic (i.e., from a
different species) tissue. Most typically, biological heart valves
are constructed from porcine or bovine (usually either valvular or
pericardial) tissue, although other animal tissues (e.g., equine)
have also been utilized.
[0581] For purposes of this disclosure, tissue-engineered valves
can also be considered to be a biological valve. Briefly,
tissue-engineered valves generally comprise a layer of cells (e.g.,
fibroblasts, stem cells, or some combination of cells), that are
grown over a tissue scaffold (typically a synthetic polymer-based
scaffold, see generally Lichtenberg et al., `Biological scaffolds
for heart valve tissue engineering", Methods Mol. Med. 2007;
140:309-17; see also U.S. Pub. No. 2010/117471).
[0582] Biological valves have a number of advantages in that they
do not damage red blood cells or platelets (and therefore do not
require anticoagulation therapy) after the healing of the suture
ring and they do not cause cavitation like mechanical valves.
However, they still suffer from several complications, including
for example: 1) they have a more limited lifespan than mechanical
valves; 2) they can cause an immune reaction; 3) they can clot and
form emboli (causing strokes or myocardial infarction); 4) they can
also become infected and form septic emboli; 5) they can become
covered with fibrous tissue; and 6) they can become calcified.
Common biological valves are currently made by Edwards
Lifesciences, Medtronic, St. Jude, Sorin, 3F Therapeutics, CryoLife
and LifeNet Health.
[0583] Hence, the present invention provides biological heart
valves which have one or more ISMs having one or more sensors,
including for example, fluid pressure sensors, contact sensors,
accelerometers, vibration sensors, pulse sensors, liquid (e.g.,
blood) volume sensors, liquid (e.g., blood) flow sensors, liquid
(e.g., blood) chemistry sensors, liquid (e.g., blood) metabolic
sensors, biological stress sensors, and temperature sensors. Such
ISMs can be placed on, in, or within the various components of the
heart valve, and can be utilized to monitor, amongst other things,
thrombogenesis, infection (vegetations), wear, blockage, sticking
(impaired movement of the valve leaflets), trans-valvular pressure
gradients, leakage (backflow or regurgitation), detachment of the
suture ring (from, for example, suture breakage), correct
anatomical placement of the device, failure, and safety.
[0584] FIGS. 32A and 32B schematically illustrate biological valves
with representative ISMs. Within one embodiment ISMs are provided
with blood flow (motion) sensors on a biological heart valve. The
ISMs containing blood flow sensors can be provided in a variety of
locations (particularly such that sensors are located on both the
atrial and ventricular side of the valve), but are preferred within
the suture ring (`10` as shown in FIG. 32A) and the leaflet
supports (`10" in FIG. 32B); another preferred location includes
incorporation into the leaflets (for pericardial valves). ISM blood
flow sensors can be utilized to measure fluid flow through the
valve, and to detect abnormalities that occur acutely, or gradually
over time. For example, a decrease in forward flow may suggest the
development of a stenosis [from thrombus formation, infection
(biofilm or vegetations), fibrosis, or calcification], sticking of
the leaflets, or failure of the device. Increases in backwards flow
can be suggestive of regurgitation, due to sticking, thrombus,
infection, fibrosis, calcification or failure of the moving
components. ISM blood flow sensors can show real-time movement of
blood through the valve, and permit hemodynamic monitoring and
determination of cardiac output (similar to an echocardiogram),
ejection fraction and cardiac index (key clinical measurements that
are valuable in monitoring cardiac-compromised patients, which many
valvular patients are).
[0585] Within other embodiments, ISMs are provided with pressure
sensors which can measure pressure on both sides of the valve, and
to detect abnormalities that occur acutely, or gradually over time.
The ISMs containing pressure sensors can be provided in a variety
of locations (particularly such that sensors are located on both
the atrial and ventricular side of the valve), but are preferred
within the suture ring (`10` as shown in FIG. 32A) and the leaflet
supports (`10" in FIG. 32B); another preferred location includes
incorporation into the leaflets (for pericardial valves). Excessive
regurgitation can be an indication of the prosthetic valve
leaflet's inability to coapt properly due to thrombus, panus,
and/or calcification. Valvular regurgitation can also occur due to
perivalvular leakage at the interface of the valve's suture ring
with the host annulus. ISM pressure sensors on the ventricular side
of a biological valve can measure systolic and diastolic pressure,
and estimate systemic vascular resistance and pulmonary vascular
resistance (depending upon the valve). These sensor readings can
also be utilized to calculate cardiac output, ejection fraction and
cardiac index and permit in situ hemodynamic monitoring.
[0586] Within further embodiments ISMs are provided with blood
volume sensors which can be utilized to measure fluid volume
through the valve, and to detect abnormalities that occur acutely,
or gradually over time. The ISMs containing blood volume sensors
can be provided in a variety of locations (particularly such that
sensors are located on both the atrial and ventricular side of the
valve), but are preferred within the suture ring (`10` as shown in
FIG. 32A) and the leaflet supports (`10" in FIG. 32B); another
preferred location includes incorporation into the leaflets (for
pericardial valves). For example, a decrease in forward blood
volume may suggest the development of a stenosis [from thrombus
formation, infection (biofilm or vegetations), fibrosis,
calcification], sticking of the leaflets, or failure of the device.
Increases in backwards blood volume (>5 ml) can be suggestive of
regurgitation, due to sticking, thrombus, infection, fibrosis,
calcification, or failure of the moving components. ISM blood
volume sensors (e.g., to measure blood volume over a unit of time)
can show real-time movement of blood through the valve, and permit
hemodynamic monitoring and determination of cardiac output (similar
to an echocardiogram), ejection fraction and cardiac index and
permit in situ hemodynamic monitoring.
[0587] Within yet other embodiments ISMs are provided with
metabolic (or chemical) sensors can be utilized to measure
metabolic parameters important in vascular function. Representative
examples include: Coagulation/Clotting parameters such as PT, PTT,
clotting time and INR; Blood Oxygen content; Blood CO.sub.2
content; Blood pH; Blood cholesterol; Blood lipids (HDL, LDL);
Blood Glucose; Cardiac enzymes; Hepatic Enzymes; Electrolytes;
Blood Cell Counts; and Kidney Function parameters (BUN, Creatinine,
etc.).
[0588] Within other embodiments ISMs are provided with position
sensors that can be utilized to measure location of fixed and
moving components of a biological valve. The ISMs containing
position sensors can be provided in a variety of locations
(particularly such that sensors are located on both the atrial and
ventricular side of the valve), but are preferred within the suture
ring (`10` as shown in FIG. 32A) and the leaflet supports (`10" in
FIG. 32B); another preferred location includes incorporation into
the leaflets (for pericardial valves). For example, gaps in the
leaflets (upon closing of the valve) are suggestive of leakage and
regurgitation. ISM position sensors can also be utilized to `image`
valvular motion (opening, closing, and integrity of the seal).
Changes in position sensors on the suture ring can show slippage,
migration, failure, and suture breakage. Dilation of the ring can
indicate possible cardiomyopathy, whereas narrowing of the ring can
indicate myocardial hypertrophy.
[0589] Within further embodiments ISMs are provided with contact
sensors that can be utilized to measure location of fixed and
moving components. The ISMs containing contact sensors can be
provided in a variety of locations (particularly such that sensors
are located on both the atrial and ventricular side of the valve),
but are preferred within the suture ring (`10` as shown in FIG.
32A) and the leaflet supports (`10" in FIG. 32B); another preferred
location includes incorporation into the leaflets (for pericardial
valves). For example, gaps in the leaflets (upon closing of the
valve) are suggestive of leakage and regurgitation. ISM contact
sensors can also be utilized to `image` valvular motion (opening,
closing, and integrity of the valvular seal). Changes in contact
sensors on the suture ring can show slippage, migration, failure,
and suture breakage. ISM contact sensors can also be utilized to
monitor the surface of the valve (e.g., to detect the presence of
surface anomalies such as the formation of clot or thombi, biofilm
or vegetations, fibrosis or calcification on the valve surface),
and to monitor for friction wear, impact wear, tears and breakage
of the leaflets.
[0590] Within yet other embodiments ISMs are provided with
accelerometers which can be utilized to measure the location and
movement of fixed and moving components of a biological valve. The
ISMs containing accelerometers can be provided in a variety of
locations (particularly such that sensors are located on both the
atrial and ventricular side of the valve), but are preferred within
the suture ring (`10` as shown in FIG. 32A) and the leaflet
supports (`10" in FIG. 32B); another preferred location includes
incorporation into the leaflets (for pericardial valves). For
example, gaps in the leaflets during valve closure are suggestive
of leakage and regurgitation and integrity of the seal), and to
image changes that might occur over time. Changes in accelerometers
on the suture ring can show slippage, migration, failure, and
suture breakage.
[0591] Within yet other embodiments of the invention any of the
ISMs described herein can be placed in mitral or tri-cuspid
annuloplasty rings (e.g., 2-D Carpentier Edwards rings and 3-D MDT
Colvin-Gallaway or Duran rings).
[0592] B.10.A.1.3. Percutaneous Heart Valves and their Use
[0593] Within other aspects of the invention percutaneous heart
valves (and their associated delivery devices) are provided with a
variety of sensors described herein. Briefly, percutaneous aortic
valve replacement (PAVR) or transcatheter aortic valve replacement
(TAVR) is the replacement of the aortic valve through blood vessels
or other minimally invasive techniques (thus eliminating a need for
`open-heart` surgery). Typically, the heart is accessed through the
femoral artery in the leg, apically (through the apex of the
heart), through the subclavian arteries, or via the aorta. Two
companies have currently approved devices for aortic valve
replacement: 1) COREVALVE (Medtronic); and 2) SAPIEN (Edwards
Lifesciences). Other percutaneous aortic valves, percutaneous
mitral valves and other percutaneous heart valves are under
development.
[0594] The COREVALVE (Medtronic) is schematically illustrated in
FIGS. 33A and 33B. Briefly, it is composed of a self-expanding
nitinol support frame (stent) with cells in a diamond design (see
FIG. 33A). It is fitted with bovine or procine pericardium shaped
into valve leaflets, and provided along with a 18F delivery
catheter. The SAPIEN (Edwards Lifesciences) is a trileaflet heart
valve constructed of bovine pericardium which is mounted on a
balloon-expandable stainless steel stent (see FIGS. 34A and
34B).
[0595] Percutaneous heart valve delivery has a number distinct
advantages, including the fact that they do not require open heart
surgery for placement, and hence can be utilized in high-risk
patients that might not live through such a surgery. However, they
still suffer from complications, including for example: 1)
cardiogenic shock, stroke and/or death; 2) perforation of the
myocardium; 3) cardiac tamponade; 4) ascending aorta trauma; 5)
embolism; 6) thrombosis; 7) valve migration; 8) valve
regurgitation; and 9) a variety of other valve dysfunctions [e.g.,
breaking or fracturing of the valve frame, incomplete expansion,
bending, build-up of minerals (calcification) or clots
(thrombosis), wear and tear, pannus (fibrous tissue) formation that
might block the valve, and failures during the surgical procedure
(e.g., failure to properly size and/or place the valve)].
[0596] Hence, the present invention provides percutaneous heart
valves and/or their associated delivery devices (guidewires,
catheters, balloon catheters, anchoring devices) which have one or
more ISMs having one or more sensors, including for example, fluid
pressure sensors, contact sensors, position sensors,
accelerometers, vibration sensors, pulse sensors, liquid (e.g.,
blood) volume sensors, liquid (e.g., blood) flow sensors, liquid
(e.g., blood) chemistry sensors, liquid (e.g., blood) metabolic
sensors, stress sensors, and temperature sensors. Such sensors can
be place on, in, or within the various components of the heart
valve, and can be utilized to monitor, amongst other things, proper
placement of the valve, anatomical location of the valve, pressure
exerted on surrounding tissues, balloon inflation/deflation, stent
scaffold expansion, deployment of the valve, migration,
thrombogenesis, infection (vegetations), calcification, fibrous
tissue accumulation, wear, blockage, sticking (impaired movement of
the `valve`), trans-valvular pressure gradients, leakage (backflow
or regurgitation), detachment, leaflet damage, assembly of the
device (where possible), failure, and safety.
[0597] FIGS. 33A, 33B, 34A and 34B schematically illustrate
percutaneous valves and their associated delivery devices
(guidewires, catheters, balloon catheters, anchoring devices) with
a variety of ISM sensors. Within one embodiment ISMs are provided
with one or more blood flow (motion) sensors are provided on a
percutaneous heart valve and/or delivery device. The ISMs
containing blood flow sensors can be provided in a variety of
locations on the percutaneous valve (particularly such that sensors
are located on both the atrial and ventricular side of the valve),
but are preferred within the stent support, stent covering,
anchoring ring and leaflet supports. ISMs with blood flow sensors
can also be provided on a variety of locations on the delivery
devices such as on/in the guidewires, catheters, balloon catheters,
anchoring devices. ISM blood flow sensors can be utilized to
measure fluid flow through the valve and/or delivery device, and to
detect abnormalities that occur acutely, or gradually over time.
During percuatenous placement of the valve, ISM blood flow sensors
on the valve and/or delivery devices can be used to ensure that
adequate blood circulation is being maintained and that the device
assembly is not critically obstructing cardiac outflow and output.
After deployment, changes in flow through the implanted valve can
provide valuable clinical information. For example, a decrease in
forward flow through the valve leaflets may suggest the development
of a stenosis [from thrombus formation, infection (biofilm or
vegetations), fibrosis, or calcification], sticking of the
leaflets, or failure of the device. Increases in backwards flow can
be suggestive of regurgitation, due to sticking, thrombus,
infection, fibrosis, calcification or failure of the moving
components. Blood flow sensors can also detect leakage through or
around the valve frame. ISM blood flow sensors can show real-time
movement of blood through the valve, and permit hemodynamic
monitoring and determination of cardiac output (similar to an
echocardiogram), ejection fraction and cardiac index (key clinical
measurements that are valuable in monitoring cardiac-compromised
patients, which many valvular patients are).
[0598] Within other embodiments, ISMs are provided with one or more
pressure sensors which can be utilized to measure pressure on both
sides of the valve and/or delivery device, and to detect
abnormalities that occur acutely, or gradually over time. The ISMs
containing pressure sensors can be provided in a variety of
locations on the percutaneous valve (particularly such that sensors
are located on both the atrial and ventricular side of the valve),
but are preferred within the stent support, stent covering,
anchoring ring and leaflet supports. ISMs with pressure sensors can
also be provided on a variety of locations on the delivery devices
such as on/in the guidewires, catheters, balloon catheters,
anchoring devices. During percuatenous placement of the valve, ISM
pressure sensors on the valve (particularly the metallic stent
scaffold) and/or delivery devices (particularly the delivery
balloon) can be used to monitor the pressure being applied to
surrounding tissues. This can help prevent procedural complications
such as damage to the wall of the aorta or myocardium and/or
perforation of these tissues. After deployment, changes in
pressures across the implanted valve can provide valuable clinical
information. For example, an increased pressure gradient across the
valve can indicate stenosis. A low, or decreasing, pressure
gradient can indicate regurgitation and/or possible valve failure.
ISM pressure sensors on the ventricular and aortic side of a
percutaneous valve can measure systolic and diastolic pressure, and
estimate systemic vascular resistance. These sensor readings can
also be utilized to calculate cardiac output, ejection fraction and
cardiac index and permit in situ hemodynamic monitoring.
[0599] Within further embodiments ISMs are provided with blood
volume sensors which can be utilized to measure fluid flow through
the percutaneous valve and/or associated delivery devices, and to
detect abnormalities that occur acutely, or gradually over time.
The ISMs containing blood volume sensors can be provided in a
variety of locations on the percutaneous valve (particularly such
that sensors are located on both the atrial and ventricular side of
the valve), but are preferred within the stent support, stent
covering, anchoring ring and leaflet supports. ISMs with blood
volume sensors can also be provided on a variety of locations on
the delivery devices such as on/in the guidewires, catheters,
balloon catheters, anchoring devices. During percuatenous placement
of the valve, ISM blood volume sensors on the valve and/or delivery
devices can be used to ensure that adequate systemic blood volume
is being maintained and that the device assembly is not critically
obstructing cardiac outflow and output. After deployment, changes
in blood volume through the implanted valve can provide valuable
clinical information. For example, a decrease in forward blood
volume may suggest the development of a stenosis [from thrombus
formation, infection (biofilm or vegetations), fibrosis,
calcification], sticking of the leaflets, or failure of the device.
Increases in backwards blood volume (>5 ml) can be suggestive of
regurgitation, due to sticking, thrombus, infection, fibrosis,
calcification, or failure of the moving components. ISM blood
volume sensors (e.g., to measure blood volume over a unit of time)
can show real-time movement of blood through the valve, and permit
hemodynamic monitoring and determination of cardiac output (similar
to an echocardiogram), ejection fraction and cardiac index and
permit in situ hemodynamic monitoring.
[0600] Within yet other embodiments ISMs are provided with
metabolic (or chemical) sensors which can be utilized on the valve
and/or delivery devices to measure metabolic parameters important
in vascular function. Representative examples include
Coagulation/Clotting parameters such as PT, PTT, clotting time and
INR; Blood Oxygen content; Blood CO.sub.2 content; Blood pH; Blood
cholesterol; Blood lipids (HDL, LDL); Blood Glucose; Cardiac
enzymes; Hepatic Enzymes; Electrolytes; Blood Cell Counts; and
Kidney Function parameters (BUN, Creatinine, etc.).
[0601] Within other embodiments ISMs are provided with position
sensors that can be utilized on the percutaneous valve and/or
associated delivery devices to measure the location of fixed and
moving components. The ISMs with position sensors can be provided
in a variety of locations on the percutaneous valve (particularly
such that sensors are located on both the atrial and ventricular
side of the valve), but are preferred within the stent support,
stent covering, anchoring ring and leaflet supports. ISMs
containing position sensors can also be provided on a variety of
locations on the delivery devices such as on/in the guidewires,
catheters, balloon catheters, anchoring devices. During
percuatenous placement of the valve, ISM position sensors on the
valve and/or delivery devices are invaluable in assisting in
correct anatomical placement of the artificial valve across the
native valve. Monitoring position changes of the device in "real
time" during deployment can help the clinician place and secure the
device correctly. After deployment, changes in position of the
implanted valve can indicate migration of the device away (upstream
or downstream) from its original placement site. ISM position
sensors can also be utilized to monitor valve function after
implantation. For example, gaps in the leaflets upon closing of the
valve are suggestive of leakage and regurgitation. ISM position
sensors can also be utilized to `image` valvular leaflet motion
(opening, closing, and integrity of the seal). Changes in ISM
position sensors located on the stent scaffold can show slippage,
migration, failure, and anchoring suture breakage. Dilation of the
scaffold can indicate possible overexpansion, breakage or failure;
whereas narrowing of the scaffold can indicate possible
underexpansion, collapse, breakage, or failure.
[0602] Within further embodiments ISMs are provided with contact
sensors that can be utilized on the percutaneous valve and/or
associated delivery devices to measure the contact between the
device and the surrounding tissues, the contact between related
device components/moving pieces, and the status of blood-contacting
surface of the device. The ISMs containing contact sensors can be
provided in a variety of locations on the percutaneous valve
(particularly such that sensors are located on both the atrial and
ventricular side of the valve), but are preferred within the stent
support, stent covering, anchoring ring and leaflet supports. ISMs
with contact sensors can also be provided on a variety of locations
on the delivery devices such as on/in the guidewires, catheters,
balloon catheters, anchoring devices. During percuatenous placement
of the valve, ISM contact sensors on the valve and/or delivery
devices are invaluable in assisting in correct anatomical placement
of the artificial valve across the native valve. Monitoring contact
changes of the device in "real time" during deployment can help the
clinician place, size, and secure the device correctly. In
addition, ISM contact sensors on the valve (particularly the
metallic stent scaffold) and/or delivery devices (particularly the
delivery balloon) can be used to monitor the amount and extent of
contact with surrounding tissues. This can help prevent procedural
complications such as damage to the wall of the aorta or myocardium
(and/or perforation of these tissues), monitor for correct
inflation and full deflation of the balloon catheter (if present),
and full deployment of the stent scaffold across the native valve.
After deployment, changes in contact between the implanted valve
and surrounding tissues can indicate migration of the device away
(upstream or downstream) from its original placement site. ISM
contact sensors can also be utilized to monitor valve function
after implantation. For example, gaps in the valve leaflets (upon
closing) are suggestive of leakage and regurgitation. ISM contact
sensors can also be utilized to `image` valvular motion (opening,
closing, and integrity of the seal) in real time. Increased contact
between the stent scaffold and the vascular wall can indicate
possible overexpansion, breakage or failure; whereas decreased
contact between the stent scaffold and the vascular wall can
indicate possible under-expansion, collapse, breakage, or failure.
ISM contact sensors can also be utilized to monitor the
blood-contacting surface of the valve (e.g., to detect the presence
of surface anomalies such as the formation of clot or thombi,
biofilm or vegetations, fibrosis or calcification on the valve
surface), and to monitor for friction wear, impact wear, tears and
breakage of the leaflets.
[0603] Within yet other embodiments ISMs are provided with
accelerometers which can be utilized to measure the location and
movement of fixed and moving components on the valve and/or
delivery devices. The ISMs containing accelerometers can be
provided in a variety of locations on the percutaneous valve
(particularly such that sensors are located on both the atrial and
ventricular side of the valve), but are preferred within the stent
support, stent covering, anchoring ring and leaflet supports. ISMs
with accelerometers can also be provided on a variety of locations
on the delivery devices such as on/in the guidewires, catheters,
balloon catheters, anchoring devices. During percuatenous placement
of the valve, accelerometers on the valve and/or delivery devices
are invaluable in assisting in correct anatomical placement of the
artificial valve across the native valve. Monitoring movement of
the device in "real time" during deployment can help the clinician
place, size, and secure the device correctly. In addition,
accelerometers on the valve (particularly the metallic stent
scaffold) and/or delivery devices (particularly the delivery
balloon) can be used to monitor the interaction between the
device(s) and surrounding tissues. This can help prevent procedural
complications such as damage to the wall of the aorta or myocardium
(and/or perforation of these tissues), monitor for correct
inflation and full deflation of the balloon catheter (if present),
and full deployment of the stent scaffold across the native valve.
After deployment, movement of the implanted valve can indicate
migration of the device away (upstream or downstream) from its
original placement site. ISM accelerometers can also be utilized to
monitor valve function after implantation. For example, gaps in the
valve leaflets (when in the closed position) are suggestive of
leakage and regurgitation. ISM accelerometers can also be utilized
to `image` valvular motion (opening, closing, and integrity of the
seal), and to image changes that might occur over time. ISM
accelerometers can detect changes in the stent scaffold: increases
in diameter are indicative of possible overexpansion, breakage or
failure; whereas decreases in the diameter can indicate possible
underexpansion, collapse, breakage, or failure.
[0604] Within further embodiments of the invention ISMs are
provided with sensors that can be utilized on the heart valve and
delivery devices in tandem in order to ensure proper placement and
deployment of the heart valve (see FIGS. 33B and 34B). Utilizing
for example, ISMs having one or more position sensors,
accelerometers, and/or contact sensors, a physician can help to
ensure: 1) accurate placement across the native valve; 2) imaging
during placement; 3) full balloon deployment and deflation; 4) full
stent (heart valve) deployment and expansion; and 5) movement or
migration during or subsequent to the procedure.
[0605] B.10.A.1.4. General Consideration Regarding Heart Valves
[0606] As briefly noted above, heart valves (e.g., mechanical,
biological or percutaneous heart valves) and their associated
delivery devices (guidewires, catheters, balloon catheters, and
anchoring devices if present) of the present invention can have one
or more ISMs having one or more of the sensors provided herein. The
ISMs can be incorporated on the surface of (in or on), or within
the heart valve or delivery devices. Representative examples of
sensors include contact sensors, strain gauge sensors, pressure
sensors, fluid pressure sensors, position sensors, accelerometers,
shock sensors, rotation sensors, vibration sensors, tilt sensors,
pressure sensors, blood chemistry sensors, blood metabolic sensors,
mechanical stress sensors and temperature sensors. Sensors can be
placed at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
or greater than 10 sensors per square centimeter or at a density of
greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or greater than 10
sensors per cubic centimeter. Within either of these embodiments
there can be less than 50, 75, 100, or 100 sensors per square
centimeter, or per cubic centimeter.
[0607] ISMs having one or more of the sensors described herein can
be continuously or intermittently monitored in order to provide
analysis of `real-world` activity, healing, and changes in function
over time, to evaluate patient activity, patient cardiac function,
and to better understand the conditions under which artificial
heart valves are exposed to in the real world. They can be utilized
to detect, monitor and report, a wide variety of metabolic
parameters, including for example: Coagulation/Clotting parameters
such as PT, PTT, clotting time and INR; Blood Oxygen content; Blood
CO.sub.2 content; Blood pH; Blood cholesterol; Blood lipids (HDL,
LDL); Blood Glucose; Cardiac enzymes; Hepatic Enzymes;
Electrolytes; Blood Cell Counts; and Kidney Function parameters
(BUN, Creatinine, etc.). They can also be utilized to detect,
monitor and report measurements of cardiac output, ejection
fraction and cardiac index; permit in situ hemodynamic monitoring
of parameters such as systolic and diastolic pressure,
transvalvular pressure and regurgitation; and estimate parameters
such systemic (or pulmonary) vascular resistance.
[0608] As will be readily evident given the disclosure provided
herein, the ISMs described and claimed herein can comprise a
variety of different sensors within different locations of the ISM.
In addition, within various embodiments of the invention one or
more sensors may be placed separate from the ISM (but still be,
optionally, able to communicate with and be controlled by the ISM).
Representative examples of ISMs for use with heart valves are
provided in U.S. Provisional No. 62/017,161, which is hereby
incorporated by reference in its entirety).
[0609] B.11. Methods of Manufacture
[0610] Within various embodiments of the invention, methods are
also provided for manufacturing a medical device having one of the
sensor or ISMs provided herein. For example, within one embodiment
of the invention a medical device is constructed such that one or
more sensor or ISMs provided herein are placed directly into, onto,
or within the medical device at the time of manufacture, and
subsequently sterilized in a manner suitable for use in
subjects.
[0611] Within other embodiments, scaffolds can be prepared for
medical devices (see, e.g., U.S. Pat. No. 8,562,671, and WO
2013/142879 which are incorporated by reference in their entirety).
Briefly, scaffolds composed of one or more polymers can be prepared
in order to mimic the shape of a biological structure (e.g.,
vessel), or a portion thereof. Sensors or ISMs can be placed into
the structure before, during, or subsequent to manufacture of the
valve (e.g., in the case or electro-spinning or molding of polymer
fibers, or in the case of 3D printing as described in more detail
below). Within certain preferred embodiments the scaffold can be
seeded with stem cells suitable for growth of tissue on the
artificial medical device (see, e.g., WO 1999/003973 and U.S. Pat.
No. 8,852,571, which are incorporated by reference in their
entirety).
[0612] Within further embodiments, the present disclosure provides
a method of making a medical device by 3D printing, additive
manufacturing, or a similar process whereby the medical device is
formed from powder or filament that is converted to a fluid form
such subsequently solidifies as the desired shape. For convenience,
such processes will be referred to herein as printing processes or
3D printing processes. The present disclosure provides a method of
making a medical device by a printing process, where that medical
device includes a sensor or ISM. The sensor or ISM may be
separately produced and then incorporated into the medical device
during the printing process. For example, a sensor or ISM may be
placed into a desired position and the printing process is carried
out around the sensor or ISM so that the sensor or ISM becomes
embedded in the printed medical device. Alternatively, the printing
process may be started and then at appropriate times, the process
is paused to allow a sensor or ISM to be placed adjacent to the
partially completed medical device. The printing process is then
re-started and construction of the medical device is completed. The
software that directs the printing process may be programmed to
pause at appropriate predetermined times to allow a sensor or ISM
to be added to the partially printed medical device.
[0613] In addition, or alternatively, the sensor or ISM itself, or
a portion thereof may be printed by the 3D printing process.
Likewise, electronic connectively to, or from, or between, sensor
or ISMs may be printed by the 3D printing process. For example,
conductive silver inks may be deposited during the printing process
to thereby allow conductivity to, or from, or between sensor or
ISMs of a medical device. See, e.g., PCT publication nos. WO
2014/085170; WO 2013/096664; WO 2011/126706; and WO 2010/0040034
and US publication nos. US 2011/0059234; and US 2010/0037731. Thus,
in various embodiments, the present disclosure provides medical
devices wherein the sensor or ISM is printed onto a substrate, or a
substrate is printed and a sensor or ISM is embedded or otherwise
incorporated into or onto the substrate, or both the substrate and
the sensor or ISM are printed by a 3D printing technique.
[0614] 3D printing may be performed using various printing
materials, typically delivered to the 3D printer in the form of a
filament. Two common printing materials are polylactic acid (PLA)
and acrylonitrile-butadiene-styrene (ABS), each being an example of
a thermoplastic polymer. When strength and/or temperature
resistance is particularly desirable, then polycarbonate (PC) may
be used as the printing material. Other polymers may also be used.
See, e.g., PCT publication nos. WO 2014/081594 for a disclosure of
polyamide printing material. When metal parts are desired, a
filament may be prepared from metal or metal alloy, along with a
carrier material which ultimately will be washed or burned or
otherwise removed from the part after the metal or metal alloy has
been delivered.
[0615] When the medical device is of a particularly intricate
shape, it may be printed with two materials. The first material is
cured (using, e.g., actinic radiation) as it is deposited, while
the second material is uncured and can be washed away after the
medical device has been finally printed. In this way, significant
hollow spaces may be incorporated into the medical device.
[0616] Additive manufacturing is a term sometimes used to encompass
printing techniques wherein metal or metal allow is the material
from which the desired part is made. Such additive manufacturing
processes utilizes lasers and build an object by adding ultrathin
layers of materials one by one. For example, a computer-controlled
laser may be used to direct pinpoint beams of energy onto a bed of
cobalt-chromium alloy powder, thereby melting the alloy in the
desired area and creating a 10-30-micron thick layer. Adjacent
layers are sequentially and repetitively produced to create the
desired sized item. As needed, a sensor or ISM may be embedded into
the alloy powder bed, and the laser melts the powder around the
sensor or ISM so as to incorporate the sensor or ISM into the final
product. Other alloys, including titanium, aluminum, and
nickel-chromium alloys, may also be used in the additive
manufacturing process. See, e.g., PCT publication nos. WO
2014/083277; WO 2014/074947; WO 2014/071968; and WO 2014/071135; as
well as US publication nos. US 2014/077421; and US 2014/053956.
[0617] Accordingly, in one embodiment the present disclosure
provides a method of fabricating a sensor or ISM-containing medical
device, the method comprising forming at least one of a sensor or
ISM and a support for the sensor or ISM using a 3D printing
technique. Optionally, the 3D printing technique may be an additive
manufacturing technique. In a related embodiment, the present
disclosure provides a medical device that is produced by a process
comprising a 3D printing process, such as an additive manufacturing
process, where the medical device includes a sensor or ISM.
[0618] Disclosure of 3D printing processes and/or additive
manufacturing is found in, for example PCT publication nos. WO
2014/020085; WO 2014/018100; WO 2013/179017; WO 2013/163585; WO
2013/155500; WO 2013/152805; WO 2013/152751; WO 2013/140147 and US
publication nos. 2014/048970; 2014/034626; US 2013/337256;
2013/329258; US 2013/270750.
[0619] Within yet other embodiments of the invention methods of
fabricating a medical device having a sensor or one or more ISMs
are provided comprising the steps of forming an implantable medical
device (e.g., as described herein), and implanting a sensor into
the device during the fabrication process. Within further
embodiments, such methods further comprise the steps of determining
a medical device shape that is suitable for a particular subject,
or a particular group of subjects (e.g., by imaging a subject, and
utilizing CAD programs or other 3-D design programs to design a
suitable medical device for a particular subject, or, for a group
of subjects. Within yet further embodiments, one or more ISMs can
be implanted onto a medical device in a particular location for a
particular subject. For example, based upon imaging (e.g., CT, MRI,
ultrasound, or other forms of analysis), stent grafts can be
designed so that one or more ISMs, or components thereof (e.g.,
communication modules and/or batteries) can be placed on a stent
graft so that, once implanted, they would fall within an aneurysm
sac of a subject.
C. Use of Medical Devices or Implants having ISMs to Deliver
Therapeutic Agent(s)
[0620] As noted above, the present invention also provides
drug-eluting medical devices or implants which comprise one or more
ISMs, and which can be utilized to release a therapeutic agent
(e.g., a drug) to a desired location within the body (e.g., a body
tissue such as bone marrow, or sites of possible or typical
infection or inflammation). Within related embodiments, a
drug-eluting delivery device may be included within the medical
device in order to release a desired drug upon demand (e.g., upon
remote activation/demand, or based upon a timed schedule), or upon
detection of an activating event (e.g., detection of an
accelerometer of a significant impact event, or detection of
loosening by a contact sensor) (see generally U.S. Patent App. No.
2011/0092948 entitled "Remotely Activated Piezoelectric Pump For
Delivery of Biological Agents to the Intervertebral Disc and Bone",
which is incorporated by reference in its entirety).
[0621] For example, within certain embodiments of the invention,
biological agents can be administered along with or released from
an orthopedic implant in order to increase bone growth, fibrosis or
scarring within the implant. Representative examples of suitable
agents include, for example, irritants, silk, wool, talcum powder,
metallic beryllium, and silica. Other agents which may be released
by the orthopedic implant include components of extracellular
matrix, fibronectin, polylysine, ethylenevinylacetate, and
inflammatory cytokines such as TGF.beta., PDGF, VEGF, bFGF,
TNF.alpha., NGF, GM-CSF, IGF-a, IL-1, IL-8, IL-6, BMP and growth
hormone, and adhesives such as cyanoacrylate (see U.S. Patent App.
Nos. 2005/0149173 and 2005/0021126, both of which are incorporated
by reference in their entirety).
[0622] Within other embodiments of the invention anti-scarring
biological agents (e.g., drugs such as paclitaxel, sirolimus, or an
analog or derivative of these), can be administered along with or
released from an orthopedic implant or a vascular implant in order
to prevent scarring of the implant inappropriately (see, e.g., U.S.
Pat. No. 7,491,188, U.S. Patent Application Nos. 2005/0152945,
2005/0187639, 2006/0079836, US 2009/0254063, US 2010/0023108, and
US 2010/0042121).
[0623] Within other embodiments of the invention, anti-inflammatory
agents, local anesthetics and pain-relief medications (e.g., drugs
such as cortisone, dexamethasone, nonsteroidal anti-inflammatories,
lidocaine, bupivacaine, marcaine, morphine, codeine, narcotic pain
relievers and analogs or derivatives of these) can be utilized to
reduce post-operative pain and swelling and reduce the need for
systemic pain relief therapy.
[0624] Within other embodiments a wide variety of additional
therapeutic agents may be delivered (e.g., to prevent or treat an
infection such as osteomyelitis, myocarditis, biofilm formation, or
to treat another disease state such as a primary or secondary bone
tumor), including for example: Anthracyclines (e.g., gentamycin,
tobramycin, doxorubicin and mitoxantrone); Fluoropyrimidines (e.g.,
5-FU); Folic acid antagonists (e.g., methotrexate); Podophylotoxins
(e.g., etoposide); Camptothecins; Hydroxyureas, and Platinum
complexes (e.g., cisplatin) (see e.g., U.S. Pat. No. 8,372,420
which is incorporated by reference in its entirety. Other
therapeutic agents include beta-lactam antibiotics (e.g., the
penicillins, cephalosporins, carbacephems and carbapenems);
aminoglycosides (e.g., sulfonamides, quinolones and the
oxazolidinones); glycopeptides (e.g., vancomycin); lincosamides
(e.g., clindamycin); lipopeptides; macrolides (e.g., azithromycin);
monobactams; nitrofurans; polypeptides (e.g., bacitracin); and
tetracyclines.
[0625] Within preferred embodiments one or more ISMs can be
utilized to determine appropriate placement of the desired drug, as
well as the quantity and release kinetics of drug to be released at
a desired site.
D. Methods for Monitoring Infection in Medical Devices or
Implants
[0626] Within other embodiments medical devices or implants are
provided comprising an ISM having one or more temperature sensors.
Such medical devices or implants can be utilized to measure the
temperature of the medical device, and in the local tissue adjacent
to the medical device. Methods are also provided for monitoring
changes in temperature over time, in order to determine and/or
provide notice (e.g., to a patient or a healthcare provider) that
an infection may be imminent. For example, an ISM having
temperature sensors can be included within one or more components
of the medical device in order to allow early detection of
infection could allow preemptive treatment with antibiotics or
surgical drainage and eliminate the need to surgically remove the
medical device.
[0627] In certain embodiments of the present invention, ISMs having
metabolic and physical sensors can also be placed on or within the
various components of a device or implant in order to monitor for
rare, but potentially life-threatening complications of medical
devices. In some patients, the medical device and surrounding
tissues can become infected; typically from bacteria colonizing the
patient's own skin that contaminate the surgical field or the
device surface (often Staphylococcus aureus or Staphylococcus
epidermidis). ISMs having sensors such as temperature sensors
(detecting temperature increases), pH sensors (detecting pH
decreases), and other metabolic sensors (e.g. oxygen content,
CO.sub.2 content, bacterial DNA detection assays) can be used to
suggest the presence of infection on or around the medical
device.
[0628] Hence, within one embodiment of the invention methods are
provided for determining an infection associated with a medical
device, comprising the steps of a) providing to a patient an
medical device as described herein, wherein the medical device
comprises an ISM having at least one temperature sensor and/or
metabolic sensor, and b) detecting a change in said temperature
sensor and/or metabolic sensor, and thus determining the presence
of an infection. Within various embodiments of the invention the
step of detecting may be a series of detections over time, and a
change in the sensor is utilized to assess the presence or
development of an infection. Within further embodiments a change of
0.5%, 1.0%, or 1.5% elevation of temperature or a metabolic factor
over time (e.g., 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4 hours, 12
hours, 1 day, or 2 days) can be indicative of the presence of an
infection (or a developing infection).
[0629] Within various embodiments of the invention an antibiotic
may be delivered in order to prevent, inhibit or treat an infection
subsequent to its detection. Representative examples of suitable
antibiotics are well known, and are described above under Section C
(the "Therapeutic Agents")
E. Further Uses of ISM-Containing Medical devices in Healthcare
[0630] ISM having sensors on medical devices, and any associated
medical device have a variety of benefits in the healthcare
setting, and in non-healthcare settings (e.g., at home or work).
For example, postoperative progress can be monitored (readings
compared from day-to-day, week-to-week, etc.) and the information
compiled and relayed to both the patient and the attending
physician allowing rehabilitation to be followed sequentially and
compared to expected (typical population) norms. Within certain
embodiments, a wearable device interrogates the ISM sensors on a
selected or randomized basis, and captures and/or stores the
collected sensor data. This data may then be downloaded to another
system or device (as described in further detail below).
[0631] Integrating the data collected by the ISM sensors described
herein (e.g., contact sensors, position sensors, strain gauges
and/or accelerometers) with simple, widely available, commercial
analytical technologies such as pedometers and global positioning
satellite (GPS) capability, allows further clinically important
data to be collected such as, but not restricted to: extent of
patient ambulation (time, distance, steps, speed, cadence), patient
activity levels (frequency of activity, duration, intensity),
exercise tolerance (work, calories, power, training effect), range
of motion and medical device performance under various "real world"
conditions. It is difficult to overstate the value of this
information in enabling better management of the patient's
recovery. An attending physician (or physiotherapist,
rehabilitation specialist) only observes the patient episodically
during scheduled visits; the degree of patient function at the
exact moment of examination can be impacted by a multitude of
disparate factors such as: the presence or absence of pain, the
presence or absence of inflammation, time of day, compliance and
timing of medication use (pain medications, anti-inflammatories),
recent activity, patient strength, mental status, language
barriers, the nature of their doctor-patient relationship, or even
the patient's ability to accurately articulate their symptoms--to
name just a few. Continuous monitoring and data collection can
allow the patient and the physician to monitor progress objectively
by supplying objective information about patient function under
numerous conditions and circumstances, to evaluate how performance
has been affected by various interventions (pain control,
anti-inflammatory medication, rest, etc.), and to compare patient
progress versus previous function and future expected function.
Better therapeutic decisions and better patient compliance can be
expected when both the doctor and the patient have the benefit of
observing the impact of various treatment modalities on patient
rehabilitation, activity, function and overall performance.
F. Generation of Power from Medical Devices or Implants
[0632] Within certain aspects of the invention, a small electrical
generation unit can be positioned along an outer, or alternatively
an inner, surface of the medical device, or associated medical
device. Briefly, a variety of techniques have been described for
scavenging power from small mechanical movements or mechanical
vibration. See, for example, the article entitled "Piezoelectric
Power Scavenging of Mechanical Vibration Energy," by U.K. Singh et
al., as published in the Australian Mining Technology Conference,
Oct. 2-4, 2007, pp. 111-118, and the article entitled "Next
Generation Micro-power Systems by Chandrakasan et al., as published
in the 2008 Symposium on VLSI Circuits Digest of Technical Papers,
pp. 1-5. See also U.S. Pat. No. 8,283,793 entitled "Device for
Energy Harvesting within a Vessel," and U.S. Pat. No. 8,311,632
entitled "Devices, Methods and Systems for Harvesting Energy in the
Body," all of the above of which are incorporated by reference in
their entirety. These references provide examples of different
types of power scavengers which can produce electricity from very
small motion and store the electricity for later use. The above
references also describes embodiments in which pressure is applied
and released from the particular structure in order to produce
electricity without the need for motion, but rather as a result of
the application of high pressure. In addition, these references
describe embodiments wherein electricity can be produced from
pulsatile forces within the body and movements within the body.
[0633] After the electricity is generated by one or more
generators, the electricity can be transmitted to any one of the
variety of sensors which is described herein. For example, it can
be transmitted to any of the sensors shown in Figures. It may also
be transmitted to the other sensors described herein. The
transmission of the power can be carried out by any acceptable
technique. For example, if a ISM sensor is physically coupled to
the medical device, electric wires may run from the generator to
the particular sensor. Alternatively, the electricity can be
transmitted wirelessly in the same way that wireless smartcards
receive power from closely adjacent power sources using the
appropriate send and receive antennas. Such send and receive
techniques of electric power are also described in the publication
and the patent applications and issued U.S. patent previously
described, all of which are incorporated herein by reference.
G. Medical Imaging and Self-Diagnosis of Assemblies Comprising
Medical Devices or Implants; Predictive Analysis and Predictive
Maintenance
[0634] Within other aspects of the invention methods are provided
for imaging the medical device as provided herein, comprising the
steps of (a) detecting the location of one or more ISM sensors in
the medical device, and/or associated medical device; and (b)
visually displaying the location of said one or more ISM sensors,
such that an image of the medical device and/or medical device is
created. Within various embodiments, the step of detecting may be
done over time, and the visual display may thus show positional
movement over time. Within certain preferred embodiments the image
which is displayed is a three-dimensional image. Within preferred
embodiments the various images (e.g., 2D or 3D) may be collected
and displayed in a time-sequence (e.g., as a moving image or
`movie-like` image). Within other embodiment, the imaging
techniques may be utilized post-operatively in order to examine the
medical device, and/or to compare operation and/or movement of the
device over time such as during placement (intra-operatively) or
during the post-operative (rehabilitative) period.
[0635] The present invention provides medical devices and
associated medical devices which are capable of imaging through the
use of ISM having sensors over a wide variety of conditions. For
example, within various aspects of the invention methods are
provided for imaging the medical device (or portion thereof) having
an ISM (and/or delivery device, comprising the steps of detecting
the changes in the ISM in, on, and or within the medical device,
medical device or kit over time, and wherein the medical device,
medical device or kit comprises one or more ISM having sensors at a
density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or greater
than 10 sensors per square centimeter. Within other aspects the
medical device medical device or kit comprises an ISM having
sensors at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
or greater than 10 sensors per cubic centimeter. Within either of
these embodiments there can be less than 50, 75, 100, or 100
sensors per square centimeter, or per cubic centimeter. Within
various embodiments the at least one or more of the sensors may be
placed randomly, or at one or more specific locations within the
medical device, medical device, or kit as described herein. As
noted above, a wide variety of sensors can be utilized therein,
including for example, contact sensors, strain gauge sensors,
pressure sensors, fluid pressure sensors, position sensors, tissue
chemistry sensors, tissue metabolic sensors, mechanical stress
sensors, and temperature sensors.
[0636] For example, the medical device, medical device, or kit
comprising sensors as described herein can be utilized to image
anatomy through sensors which can detect positional movement. The
sensors used can also include accelerometers and motion sensors to
detect movement of the medical device due to a variety of physical
changes. Changes in the position of the accelerometers and/or
motion sensors over time can be used as a measurement of changes in
the position of the medical device over time. Such positional
changes can be used as a surrogate marker of medical device
anatomy--i.e. they can form an "image` of the medical device to
provide information on the size, shape, integrity, alignment and
location of changes to the medical device, and/or medical device
movement/migration. In particular, as noted above the image data
can be collected over time, in order to visually show changes
(e.g., a "movie" or `moving images", which may be in 2D or 3D).
[0637] Certain exemplary embodiments will now be explained in more
detail. One particular benefit is the live and in-situ monitoring
of the patient's recovery with a medical device having an ISM as
described herein. The ISM can, optionally, collect data on a
constant basis, during normal daily activities and even during the
night if desired. For example, contact sensors within an ISM can
obtain and report data once every 10 seconds, once a minute, or
once a day. Other sensors can collect data more frequently, such as
several times a second. For example, it would be expected that the
temperature, contact, and/or position data could be collected and
stored several times a second. Other types of data might only need
to be collected by the minute or by the hour. Still other sensors
may collect data only when signaled by the patient to do so (via an
external signaling/triggering device) as part of "event
recording"--i.e. when the patient experiences a particular event
(e.g. pain, injury, instability, etc.)--and signals the device to
obtain a reading at that time in order to allow the comparison of
subjective/symptomatic data to objective/sensor data in an effort
to better understand the underlying cause or triggers of the
patient's symptoms. All activity can be continuously monitored post
operation or post-procedure and the data collected and stored in
the memory located inside the medical device.
[0638] A patient with a medical device will generally have regular
medical checkups. When the patient goes to the doctor's office for
a medical checkup, the doctor will bring a reading device closely
adjacent to the medical device or ISM 10, in this example the
medical device, in order to transfer the data from the internal
circuit inside the medical device to the database in the
physician's office. The use of wireless transmission using
smartcards or other techniques is very well known in the art and
need not be described in detail. Examples of such wireless
transmission of data are provided in the published patent
applications and patents which have been described herein. The data
which has been collected (e.g., over a short period of time, over
several weeks or even several months) is transferred in a few
moments from the memory which is positioned in the medical device
to the doctor's computer or wireless device. The computer therefore
analyzes the data for anomalies, unexpected changes over time,
positive or negative trends, and other signs which may be
indicative of the health of the patient and the operability of the
medical device. For example, if the patient has decided to go
skiing or jogging, the doctor will be able to monitor the effect of
such activity on the medical device having an ISM, including the
accelerations and strains during the event itself. The doctor can
then look at the health of the medical device in the hours and days
after the event and compare it to data prior to the event to
determine if any particular event caused long term damage, or if
the activities subjected the medical device to forces beyond the
manufacturer's performance specifications for that particular
medical device. Data can be collected and compared with respect to
the ongoing and long term performance of the medical device from
the strain gauges, the contact sensors, the surface wear sensors,
or other sensors which may be present. Hence, within preferred
embodiments the data can be collected over time, in order to
visually show changes (e.g., a 2D or 3D "movie" or `moving
images").
[0639] In one alternative, the patient may also have such a reading
device in their home which collates the data from the medical
device on a periodic basis, such as once per day or once per week.
As described above, the patient may also be able to "trigger" a
device reading (via an external signaling/triggering device) as
part of "event recording." Empowering the patient to follow their
own rehabilitation--and enabling them to see the positive (and
negative) effects of various lifestyle choices on their health and
rehabilitation--can be expected to improve compliance and improve
patient outcomes. Furthermore, their experience can be shared via
the web with other patients to compare their progress versus
expected "norms" for function and rehabilitation and alert them to
signs and symptoms that should be brought to their doctor's
attention. The performance of different medical devices can be
compared in different patients (different sexes, weights, activity
levels, etc.) to help manufacturers design better devices and
assist surgeons and other healthcare providers in the selection of
the right medical device for specific patient types. Payers,
patients, manufacturers and physicians could all benefit from the
collection of this comparative information. Lastly, data
accumulated at home can be collected and transmitted via the
Internet to the physician's office for analysis--potentially
eliminating unnecessary visits in some cases and encouraging
immediate medical follow-up in others.
H. Methods of Monitoring Assemblies Comprising Medical Devices with
ISMs
[0640] As noted above, the present invention also provides methods
for monitoring one or more of the medical devices or implants with
ISMs provided herein. For example, FIG. 35 illustrates a monitoring
system usable with the medical device or ISM 10 as of the type
shown in any one of the Figures described herein.
[0641] Within other embodiments, the monitoring system however may
be composed of passive sensors, which respond to an external
signal. For example, according to one embodiment, sufficient signal
strength is provided in the initial signal to provide power for the
sensor and to carry out the sensing operation and output the signal
back to an interrogation module. In other embodiments, two or more
signals are sent, each signal providing additional power to the
sensor to permit it to complete the sensing operation and then
provide sufficient power to transfer the data via the signal path
back to the interrogation module. For example, the signal can be
sent continuously, with a sensing request component at the first
part of the signal and then continued providing, either as a steady
signal or pulses to provide power to operate the sensor. When the
sensor is ready to output the data, it sends a signal alerting the
interrogation module that data is coming and the signal can be
turned off to avoid interference. Alternatively, the integration
signal can be at a first frequency and the output signal at a
second frequency separated sufficiently that they do not interfere
with each other. In a preferred embodiment, they are both the same
frequency so that the same antenna on the sensor can receive the
signal and send signal.
[0642] The interrogation signal may contain data to select specific
sensors on the medical device. For example, the signal may power up
all sensors on the medical device at the same time and then send
requests for data from each at different selected times so that
with one interrogation signal provided for a set time, such as 1-2
seconds, results in each of the sensors on the medical device
collecting data during this time period and then, at the end of the
period, reporting the data out on respective signals at different
times over the next 0.5 to 2 seconds so that with one interrogation
signal, the data from all sensors is collected.
[0643] While the wireless signal can be in any frequency range,
within certain embodiments an RF range is preferred. A frequency in
the VLF to LF ranges of between 3-1300 kHz is preferred to permit
the signal to be carried to sufficient depth inside the body with
low power, but frequencies below 3 kHz and above 1300 kHz can also
be used. The sensing does not require a transfer of large amounts
of data and low power is preferred; therefore, a low frequency RF
signal is acceptable. This also avoids competition from and
inadvertent activation by other wireless signal generators, such as
blue tooth, cell phones and the like.
[0644] The interrogation module is operating under control of the
control unit which has a microprocessor for the controller, a
memory, an I/O circuit to interface with the interrogation module
and a power supply. The control unit may output data to a computer
or other device for display and use by the physician to treat the
subject.
I. Collection, Transmission, Analysis, and Distribution of Data
from Assemblies Comprising Medical Devices or Implants
[0645] FIG. 35 illustrates one embodiment of an information and
communication technology (ICT) system 800 arranged to process
sensor data (e.g., data from the ISM 10). In FIG. 35, the ICT
system 800 is illustrated to include computing devices that
communicate via a network 804, however in other embodiments, the
computing devices can communicate directly with each other or
through other intervening devices, and in some cases, the computing
devices do not communicate at all. The computing devices of FIG. 35
include computing servers 802, and other devices that are not shown
for simplicity.
[0646] In FIG. 35, one or more ISMs 10 communicate with a remote
data receiving device 82. The remote data receiving device can be a
wearable device (e.g., a watch-like device, a wrist-band, or other
device that may be carried or worn by the subject) can interrogate
the ISMs over a set (or random) period of time, collect the data,
and forward the data on to one or more networks (804).
Alternatively, the remote data receiving device 82 can be a
stationary device in a hospital, home, or office. The remote data
receiving device 82 may collect data of its own accord which can
also be transmitted to the network. Representative examples of data
that may be collected include location (e.g., a GPS), body or skin
temperature, and other physiologic data (e.g., pulse). Within yet
other embodiments, the remote data receiving device may notify the
subject directly of any of a number of prescribed conditions,
including but not limited to possible or actual failure of the
device.
[0647] The information that is communicated between the ISM 10 and
the data receiving device 82 may be useful for many purposes as
described herein. In some cases, for example, sensor data
information is collected and analyzed expressly for the health of
an individual subject. In other cases, sensor data is collected and
transmitted to another computing device to be aggregated with other
data (for example, the ISM data may be collected and aggregated
with other data collected from an additional data receiving device
(e.g., a device that may, in certain embodiments, include GPS data
and the like).
[0648] FIG. 35 illustrates aspects of a computing server 802 as a
cooperative bank of servers further including computing servers
802a, 802b, and one or more other servers 802n. It is understood
that computing server 802 may include any number of computing
servers that operate individually or collectively to the benefit of
users of the computing servers.
[0649] In some embodiments, the computing servers 802 are arranged
as cloud computing devices created in one or more geographic
locations, such as the United States and Canada. The cloud
computing devices may be created as MICROSOFT AZURE cloud computing
devices or as some other virtually accessible remote computing
service.
[0650] The network 804 includes some or all of cellular
communication networks, conventional cable networks, satellite
networks, fiber-optic networks, and the like configured as one or
more local area networks, wide area networks, personal area
networks, and any other type of computing network. In a preferred
embodiment, the network 804 includes any communication hardware and
software that cooperatively works to permit users of computing
devices to view and interact with other computing devices.
[0651] Computing server 802 includes a central processing unit
(CPU) digital signal processing unit (DSP) 808, communication
modules 810, Input/Output (I/O) modules 812, and storage module
814. The components of computing server 802 are cooperatively
coupled by one or more buses 816 that facilitate transmission and
control of information in and through computing server 802.
Communication modules 810 are configurable to pass information
between the computer server 802 and other computing devices (e.g.,
computing servers 802a, 802b, 802n, and the like). I/O modules 812
are configurable to accept input from devices such as keyboards,
computer mice, trackballs, and the like. I/O modules 812 are
configurable to provide output to devices such as displays,
recorders, LEDs, audio devices, and the like.
[0652] Storage module 814 may include one or more types of storage
media. For example, storage module 814 of FIG. 35 includes random
access memory (RAM) 818, read only memory (ROM) 810, disk based
memory 822, optical based memory 8124, and other types of memory
storage media 8126. In some embodiments one or more memory devices
of the storage module 814 has configured thereon one or more
database structures. The database structures may be used to store
data collected from sensors 22.
[0653] In some embodiments, the storage module 814 may further
include one or more portions of memory organized a non-transitory
computer-readable media (CRM). The CRM is configured to store
computing instructions executable by a CPU 808. The computing
instructions may be stored as one or more files, and each file may
include one or more computer programs. A computer program can be
standalone program or part of a larger computer program.
Alternatively or in addition, each file may include data or other
computational support material for an application that directs the
collection, analysis, processing, and/or distribution of data from
sensors (e.g., medical device sensors). The sensor data application
typically executes a set of instructions stored on
computer-readable media.
[0654] It will be appreciated that the computing servers shown in
the figures and described herein are merely illustrative and are
not intended to limit the scope of the present invention. Computing
server 802 may be connected to other devices that are not
illustrated, including through one or more networks such as the
Internet or via the Web that are incorporated into network 804.
More generally, a computing system or device (e.g., a "client" or
"server") or any part thereof may comprise any combination of
hardware that can interact and perform the described types of
functionality, optionally when programmed or otherwise configured
with software, including without limitation desktop or other
computers, database servers, network storage devices and other
network devices, PDAs, cell phones, glasses, wrist bands, wireless
phones, pagers, electronic organizers, Internet appliances,
television-based systems (e.g., using set-top boxes and/or
personal/digital video recorders), and various other products that
include appropriate inter-communication capabilities. In addition,
the functionality provided by the illustrated system modules may in
some embodiments be combined in fewer modules or distributed in
additional modules. Similarly, in some embodiments the
functionality of some of the illustrated modules may not be
provided and/or other additional functionality may be
available.
[0655] In addition, while various items are illustrated as being
stored in memory or on storage while being used, these items or
portions of them can be transferred between memory and other
storage devices for purposes of memory management and/or data
integrity. In at least some embodiments, the illustrated modules
and/or systems are software modules/systems that include software
instructions which, when executed by the CPU/DSP 808 or other
processor, will program the processor to automatically perform the
described operations for a module/system. Alternatively, in other
embodiments, some or all of the software modules and/or systems may
execute in memory on another device and communicate with the
illustrated computing system/device via inter-computer
communication.
[0656] Furthermore, in some embodiments, some or all of the modules
and/or systems may be implemented or provided in other manners,
such as at least partially in firmware and/or hardware means,
including, but not limited to, one or more application-specific
integrated circuits (ASICs), standard integrated circuits,
controllers (e.g., by executing appropriate instructions, and
including microcontrollers and/or embedded controllers),
field-programmable gate arrays (FPGAs), complex programmable logic
devices (CPLDs), and the like. Some or all of the systems, modules,
or data structures may also be stored (e.g., as software
instructions or structured data) on a transitory or non-transitory
computer-readable storage medium 814, such as a hard disk 822 or
flash drive or other non-volatile storage device 8126, volatile 818
or non-volatile memory 810, a network storage device, or a portable
media article (e.g., a DVD disk, a CD disk, an optical disk, a
flash memory device, etc.) to be read by an appropriate input or
output system or via an appropriate connection. The systems,
modules, and data structures may also in some embodiments be
transmitted as generated data signals (e.g., as part of a carrier
wave or other analog or digital propagated signal) on a variety of
computer readable transmission mediums, including wireless-based
and wired/cable-based mediums. The data signals can take a variety
of forms such as part of a single or multiplexed analog signal, as
multiple discrete digital packets or frames, as a discrete or
streaming set of digital bits, or in some other form. Such computer
program products may also take other forms in other embodiments.
Accordingly, the present invention may be practiced with other
computer system configurations.
[0657] In FIG. 35, sensor data from, e.g., ISM 10 is provided to
computing server 802. Generally speaking, the sensor data,
represents data retrieved from a known subject and from a known
sensor. The sensor data may possess include or be further
associated with additional information such as the USI, UDI, a time
stamp, a location (e.g., GPS) stamp, a date stamp, and other
information. The differences between various ISMs is that some may
include more or fewer data bits that associate the data with a
particular source, collection device, transmission characteristic,
or the like.
[0658] In some embodiments, the sensor data may comprise sensitive
information such as private health information associated with a
specific subject. Sensitive information, for example sensor data
from sensors e.g., 22, may include any information that an
associated party desires to keep from wide or easy dissemination.
Sensitive information can stand alone or be combined with other
non-sensitive information. For example, a subject's medical
information is typically sensitive information. In some cases, the
storage and transmission of a subject's medical information is
protected by a government directive (e.g., law, regulation, etc.)
such as the U.S. Health Insurance Portability and Accountability
Act (HIPAA).
[0659] As discussed herein, a reference to "sensitive" information
includes information that is entirely sensitive and information
that is some combination of sensitive and non-sensitive
information. The sensitive information may be represented in a data
file or in some other format. As used herein, a data file that
includes a subject's medical information may be referred to as
"sensitive information." Other information, such as employment
information, financial information, identity information, and many
other types of information may also be considered sensitive
information.
[0660] A computing system can represent sensitive information with
an encoding algorithm (e.g., ASCII), a well-recognized file format
(e.g., PDF), or by some other format. In a computing system,
sensitive information can be protected from wide or easy
dissemination with an encryption algorithm.
[0661] Generally speaking, sensitive information can be stored by a
computing system as a discrete set of data bits. The set of data
bits may be called "plaintext." Furthermore, a computing system can
use an encryption process to transform plaintext using an
encryption algorithm (i.e., a cipher) into a set of data bits
having a highly unreadable state (i.e., cipher text). A computing
system having knowledge of the encryption key used to create the
cipher text can restore the information to a plaintext readable
state. Accordingly, in some cases, sensitive data (e.g., sensor
data 806a, 806b) is optionally encrypted before being communicated
to a computing device.
[0662] In one embodiment, the operation of the information and
communication technology (ICT) system 800 of FIG. 35 includes one
or more sensor data computer programs stored on a computer-readable
medium. The computer program may optionally direct and/or receive
data from one or more medical device sensors medical devices in one
or more subjects. A sensor data computer program may be executed in
a computing server 802. Alternatively, or in addition, a sensor
data computer program may be executed in a control unit 126, an
interrogation unit 124.
[0663] In one embodiment, a computer program to direct the
collection and use of medical device sensor data is stored on a
non-transitory computer-readable medium in storage module 814. The
computer program is configured to identify a subject who has a
wireless medical device inserted in his or her body. The wireless
medical device may include one or more wireless sensors.
[0664] In some cases, the computer program identifies one subject,
and in other cases, two or more subjects are identified. The
subjects may each have one or more medical devices or implants, and
each medical device may have one or more ISMs of the type described
herein.
[0665] The computer program is arranged to direct the collection of
sensor data from the ISM containing medical device. Once the sensor
data is collected, the data may be further processed. For example,
in some cases, the sensor data includes sensitive subject data,
which can be removed or disassociated with the data. The sensor
data can be individually stored (e.g., by unique sensor
identification number, device number, etc.) or aggregated together
with other sensor data by sensor type, time stamp, location stamp,
date stamp, subject type, other subject characteristics, or by some
other means.
[0666] The following pseudo-code description is used to generally
illustrate one exemplary algorithm executed by a computing server
802 and generally described herein with respect to FIG. 35:
TABLE-US-00001 Start Open a secure socket layer (SSL) Identify a
subject Communicate with a predetermined control unit Request
sensor data from the subject via the control unit Receive sensor
data If the sensor data is encrypted THEN decrypt the sensor data
Store encrypted data in the selected storage locations Aggregate
the sensor data with other sensor data Store encrypted data in the
selected storage locations Maintain a record of the storage
transaction Perform post storage actions End
[0667] Those skilled in the art will recognize that it is common
within the art to implement devices and/or processes and/or
systems, and thereafter use engineering and/or other practices to
integrate such implemented devices and/or processes and/or systems
into more comprehensive devices and/or processes and/or systems.
That is, at least a portion of the devices and/or processes and/or
systems described herein can be integrated into other devices
and/or processes and/or systems via a reasonable amount of
experimentation. Those having skill in the art will recognize that
examples of such other devices and/or processes and/or systems
might include--as appropriate to context and application--all or
part of devices and/or processes and/or systems of (a) an air
conveyance (e.g., an airplane, rocket, helicopter, etc.), (b) a
ground conveyance (e.g., a car, ambulance, truck, locomotive, tank,
armored personnel carrier, etc.), (c) a building (e.g., a home,
hospital, warehouse, office, etc.), (d) an appliance (e.g., a
refrigerator, a washing machine, a dryer, etc.), (e) a
communications system (e.g., a networked system, a telephone
system, a Voice over IP system, etc.), (f) a business entity (e.g.,
an Internet Service Provider (ISP) entity such as Comcast Cable,
Qwest, Southwestern Bell, etc.), or (g) a wired/wireless services
entity (e.g., AT&T, T-Mobile, Verizon.), etc.
[0668] In certain cases, use of a system or method may occur in a
territory even if components are located outside the territory. For
example, in a distributed computing context, use of a distributed
computing system may occur in a territory even though parts of the
system may be located outside of the territory (e.g., relay,
server, processor, signal-bearing medium, transmitting computer,
receiving computer, etc. located outside the territory).
[0669] A sale of a system or method may likewise occur in a
territory even if components of the system or method are located
and/or used outside the territory. Further, implementation of at
least part of a system for performing a method in one territory
does not preclude use of the system in another territory.
[0670] In conclusion, medical devices utilizing a variety of ISMs
can be utilized to serve a variety of critical clinical functions,
such as safe, accurate and less traumatic placement and deployment
of the medical device, procedural and post-operative "real time"
imaging of the medical device and the surrounding anatomy, the
early identification of the development of medical device
complications (often prior to becoming evident by other medical
diagnostic procedures), and the patient's overall health status and
response to treatment. Currently, post-operative (both in hospital
and out-patient) evaluation of medical device patients is through
patient history, physical examination and medical monitoring that
is supplemented with diagnostic imaging studies as required.
However, most of the patient's recuperative period occurs between
hospital and office visits and the majority of data on daily
function goes uncaptured; furthermore, monitoring patient progress
through the use of some diagnostic imaging technology can be
expensive, invasive and carry its own health risks (the use of
nuclear isotopes or certain dyes, radiation exposure). It can,
therefore, be very difficult to accurately measure and follow the
development or worsening of symptoms and evaluate "real life"
medical device performance, particularly as they relate to patient
activity levels, exercise tolerance, and the effectiveness of
rehabilitation efforts and medications.
[0671] At present, neither the physician nor the patient has access
to the type of "real time," continuous, objective, medical device
performance measurements that they might otherwise like to have.
Being able to monitor in situ medical device function, integrity,
anatomy and physiology can provide the physician with valuable
objective information during office visits; furthermore, the
patient can take additional readings at home at various times (e.g.
when experiencing pain, during exercise, after taking medications,
etc.) to provide important complementary clinical information to
the doctor (which can be sent to the healthcare provider
electronically even from remote locations). From the perspective of
the patient, being able to monitor many of these same parameters at
home allows them to take a more proactive role in their care and
recovery and provide him or her with either an early warning
indicator to seek medical assistance or with reassurance.
[0672] In one alternative, the patient may have a reading device in
their home which collates the data from the medical device on a
periodic basis, such as once per day or once per week. For example,
within certain embodiments the devices and systems provided herein
can instruct or otherwise notify the patient, or a permitted
third-party as to deviations (e.g., greater than 10%, 20%, 25%,
50%, 70%, and or 100%) from normal, and/or, set parameters. In
addition to empowering the patient to follow their own
rehabilitation--and enabling them to see the positive (and
negative) effects of various lifestyle choices on their health and
rehabilitation--such information access can be expected to improve
compliance and improve patient outcomes. Furthermore, their
recovery experience can be shared via the web with other patients
to compare their progress versus expected "norms" for function and
rehabilitation and alert them to signs and symptoms that should be
brought to their doctor's attention. From a public health
perspective, the performance of different medical devices can be
compared in different patients (different sexes, disease severity,
activity levels, concurrent diseases such as hypertension and
diabetes, smoking status, obesity, etc.) to help manufacturers
design better medical devices and assist physicians in the
selection of the right medical device for a specific patient types.
Payers, patients, manufacturers and physicians could all benefit
from the collection of this comparative information. Poor and
dangerous products could be identified and removed from the market
and objective long-term effectiveness data collected and analyzed.
Lastly, data accumulated at home can be collected and transmitted
via the Internet to the physician's office for
analysis--potentially eliminating unnecessary visits in some cases
and encouraging immediate medical follow-up in others.
Conventions
[0673] In general, and unless otherwise specified, all technical
and scientific terms used herein shall have the same meaning as
those commonly understood by one of ordinary skill in the art to
which the embodiment pertains. For convenience, the meanings of
selected terms are provided below, where these meanings are
provided in order to aid in describing embodiments identified
herein. Unless stated otherwise, or unless implicit from the
context in which the term is used, the meanings provided below are
the meanings intended for the referenced term.
[0674] Embodiment examples or feature examples specifically
provided are intended to be exemplary only, that is, those examples
are non-limiting on an embodiment. The term "e.g." (latin, exempli
gratia) is used herein to refer to a non-limiting example, and
effectively means "for example". In addition, the Figures, while
being understood to generally show the subject matter being
described, should not be seen as limiting. For example, while ISMs
can be shown as a block, linear, or rectangular symbolically, they
can in practice look quite differently, and be attached differently
than shown. For example, where ISMs are shown diagrammatically on
stents as relatively linear objects, they can follow the struts or
tynes of a stent and in practice be non-linear on the stent.
[0675] "Subjects" or "Patients" refers to an organism for which the
medical device can be utilized. Representative organisms include
horses, cows, sheep, pigs, dogs, cats, rats and mice. Within one
embodiment a particularly preferred organisms are humans.
[0676] Singular terms shall include pluralities and plural terms
shall include the singular, unless otherwise specified or required
by context. For example, the singular terms "a", "an" and "the"
include plural referents unless the context clearly indicates
otherwise. Similarly, the term "or" is intended to include "and"
unless the context clearly indicates otherwise.
[0677] Except in specific examples provided herein, or where
otherwise indicated, all numbers expressing quantities of a
component should be understood as modified in all instances by the
term "about", where "about" means .+-.5% of the stated value, e.g.,
100 refers to any value within the range of 95-105.
[0678] The terms comprise, comprising and comprises are used to
identify essential features of an embodiment, where the embodiment
may be, for example, a composition, device, method or kit. The
embodiment may optionally contain one or more additional
unspecified features, and so the term comprises may be understood
to mean includes.
[0679] The following are some specific numbered embodiments of the
devices, methods, systems and processes disclosed herein. These
embodiments are exemplary only. It will be understood that the
invention is not limited to the embodiments set forth herein for
illustration, but embraces all such forms thereof as come within
the scope of the above disclosure.
[0680] 1. A sensor module, comprising: a sensor channel; and a
communication interface coupled to the sensor channel.
[0681] 2. The sensor module of embodiment 1 wherein the sensor
channel includes a sensor and a sensor channel coupled to the
sensor and to the communication interface.
[0682] 3. The sensor module of embodiments 1 or 2 wherein the
sensor includes one or more of the following sensors: a
global-positioning-system (GPS), accelerometer, Hall-effect,
electrical, magnetic, thermal, pressure, radiation, optical,
quantity-differential, capacitive, inductive, and time.
[0683] 4. The sensor module of any one of embodiments 1 to 3
wherein the sensor is a microelectromechanical sensor. (MEMS).
[0684] 5. The sensor module of any one of embodiments 1 to 4
wherein said sensor module includes one or more of the following
sensors: fluid pressure sensors, fluid volume sensors, contact
sensors, position sensors, pulse pressure sensors, blood volume
sensors, blood flow sensors, chemistry sensors, metabolic sensors,
accelerometers, mechanical stress sensors and temperature sensors.
Within preferred embodiments the sensor module includes an
accelerometer, gyroscope, and optionally, a temperature sensor.
[0685] 6. The sensor module of any one of embodiments 1 to 5
wherein the communication interface includes a wireless
interface.
[0686] 7. The sensor module of any one of embodiments 1 to 6
wherein the communication interface is configured to communicate
with another sensor module.
[0687] 8. The sensor module of any one of embodiments 1 to 7,
further comprising a power supply coupled to the sensor channel and
the communication interface.
[0688] 9. The sensor module of any one of embodiments 1 to 8,
further comprising a power supply coupled to the sensor and the
communication interface and configured to harvest energy from an
organism in which the sensor module is implanted. Within further
embodiments the power supply is a battery, which optionally, can
power the sensor module continuously or intermittently. Within yet
other embodiments the battery can power the sensor module in
response to a signal.
[0689] 10. The sensor module of any one of embodiments 1 to 9,
further comprising a power supply coupled to the sensor channel and
to the communication interface and configured to receive energy
wirelessly.
[0690] 11. The sensor module of any one of embodiments 1 to 10,
further comprising a controller coupled to the sensor channel and
the communication interface.
[0691] 12. The sensor module of any one of embodiments 1 to 11,
further comprising: an implantable housing; and wherein the sensor
channel and the communication interface are disposed within the
housing. Within certain embodiments of the invention, the sensor
module is less than less than 5.0, 4.5, 4.0, 3.5, 3.0, 2.5, 2.0,
1.5, 1.0, 0.9, 0.8. 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, or 0.1 cubic
centimeters in size.
[0692] 13. A medical device, comprising a medical device and a
sensor module according to any one of embodiments 1 to 12.
[0693] 14. The medical device according to embodiment 13, wherein
said medical device is a cardiovascular device, orthopedic device,
spinal device, intrauterine device, cochlear implant, aesthetic
implant, dental implant, medical polymer or artificial eye
lense.
[0694] 15. The medical device according to embodiment 14 wherein
said cardiovascular device is an implantable cardioverter
defibrillator, pacemaker, stent, stent graft, bypass graft,
catheter, or heart valve
[0695] 16. The medical device according to embodiment 14, wherein
said orthopedic device is a cast, brace, tensor bandage, support,
sling, tensor bandage, hip or knee prosthesis, orthopedic plate,
bone screw, spinal cage, artificial disc, orthopedic pin,
intramedullary device, K-wire, or orthopedic plate. Within one
embodiment the medical device is a tibial extension on a total
arthroplastic joint (e.g, total hip or knee joint).
[0696] 17. The medical device according to embodiment 14, wherein
said medical polymer is a biodegradable polymer.
[0697] 18. The medical device according to embodiment 14, wherein
said medical polymer is a non-biodegradable polymer.
[0698] 19. The medical device according to embodiment 14, wherein
said medical polymer is a polymethylmethacrylate, a
methylmethacrylate--styrene copolymer, fibrin, polyethylene glycol,
carboxymethylcellulose, and polyvinylalcohol.
[0699] 20. The medical device according to any one of embodiments
13 to 19 wherein said sensor module is located within said
implant.
[0700] 21. The medical device according to any one of embodiments
13 to 20 wherein said medical device is sterile.
[0701] 22. The medical device according to any one of embodiments
13 to 21, further comprising one or more passive sensors.
[0702] 23. The medical device according to embodiment 22 wherein
said passive sensors are selected from the group consisting of
fluid pressure sensors, fluid volume sensors, contact sensors,
position sensors, pulse pressure sensors, blood volume sensors,
blood flow sensors, chemistry sensors, metabolic sensors,
accelerometers, mechanical stress sensors and temperature
sensors.
[0703] 24. A method, comprising: sensing a physical quantity; and
generating a representation of the sensed quantity.
[0704] 25. The method of embodiment 24 wherein the physical
quantity relates to an organism.
[0705] 26. The method of embodiment 24 wherein sensing the physical
quantity includes sensing the physical quantity from inside of an
organism.
[0706] 27. The method of embodiment 24, further comprising storing
the representation of the sensed quantity.
[0707] 28. The method of embodiment 24, further comprising
transmitting wirelessly the representation of the sensed quantity
to a device.
[0708] 29. The method of embodiment 24, further comprising
receiving wirelessly data from a device.
[0709] 30. The method of embodiment 24, further comprising: wherein
the sensing and generating are performed by a first sensor module;
and transmitting wirelessly the representation of the sensed
quantity to a second sensor module that is remote from the first
sensor module.
[0710] 31. The method of embodiment 24, further comprising: wherein
the sensing and generating are performed by a first sensor module;
and receiving with the first sensor module data from a second
sensor module that is remote from the first sensor module.
[0711] 32. The method according to embodiment 30 or embodiment 31
wherein said first sensor module is a sensor module according to
any one of embodiments 1 to 12.
[0712] 33. A system, comprising: a sensor module including a
battery; and a battery charger configured to charge the battery
wirelessly.
[0713] 34. The system according to embodiment 33 wherein said
sensor module is a sensor module according to any one of
embodiments 1 to 12.
[0714] 35. A system, comprising: a first sensor module; and a
second sensor module configured to communicate with the first
sensor module.
[0715] 36. The system according to embodiment 35 wherein said
sensor module is a sensor module according to any one of
embodiments 1 to 12.
[0716] 37. The system of embodiment 35 wherein at least one of the
first and second sensor modules is configured to be attached to an
organism.
[0717] 38. The system of embodiment 35 wherein at least one of the
first and second sensor modules is configured to be implanted in an
organism.
[0718] 39. The system of embodiment 35 wherein one of the first and
second sensor modules is configured to power the other of the first
and second sensor modules.
[0719] 40. The medical device according to any one of embodiments
13 to 23 wherein said sensor is a plurality of sensors which are
positioned on or within said medical device at a density of greater
than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square
centimeter.
[0720] 41. The medical device according to any one of embodiments
13 to 23 wherein said sensor is a plurality of sensors which are
positioned on or within said medical device at a density of greater
than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic
centimeter.
[0721] 42. A method comprising:
[0722] obtaining data from sensors positioned at a plurality of
locations between, on, and/or within the medical device according
to any one of embodiments 13 to 23 of a subject;
[0723] storing the data in a memory device located on or within the
medical device; and
[0724] transferring the data from the memory to a location outside
the medical device.
[0725] 43. The method according to embodiment 42 further comprising
the step of analyzing said data.
[0726] 44. A method for detecting and/or recording an event in a
subject with the medical device according to any one of embodiments
13 to 23, comprising the step of interrogating at a desired point
in time the activity of one or more sensors within the medical
device, and recording said activity.
[0727] 45. The method according to embodiment 44 wherein the step
of interrogating is performed by a subject which has said medical
device.
[0728] 46. The method according to embodiment 44 or 45 wherein said
recording is performed on a wearable device.
[0729] 47. The method according to any one of embodiments 43 to 45
wherein said recording, or a portion thereof, is provided to a
health care provider.
[0730] 48. A method for imaging the medical device in the bone,
comprising the steps of [0731] (a) detecting the location of one or
more sensors in the medical device according to any one of
embodiments 13 to 23; and [0732] (b) visually displaying the
location of said one or more sensors, such that an image of the
medical device, or a portion thereof, in the bone is created.
[0733] 49. The method according to embodiment 48 wherein the step
of detecting occurs over time.
[0734] 50. The method according to embodiment 47 or 48 wherein said
visual display shows changes in the positions of said sensors over
time, and/or changes in temperature of the sensors or surrounding
tissue over time.
[0735] 51. The method according to any one of embodiments 47 to 50
wherein said visual display is a three-dimensional image of said
medical device in the bone.
[0736] 52. A method for inserting the medical device according to
any one of embodiments 13 to 23, comprising the steps of (a)
inserting a medical device according to any one of embodiments 13
to 23 into a subject; and (b) imaging the placement of said medical
device according to the method of an one of embodiments 47 to
50.
[0737] 53. A method for examining the medical device according to
any one of embodiments 13 to 23 which has been previously inserted
into a patient, comprising the step of imaging the medical device
according to the method of any one of embodiments 47 to 50.
[0738] 54. A method of monitoring a medical device within a
subject, comprising:
[0739] (a) transmitting a wireless electrical signal from a
location outside the body to a location inside the subject's
body;
[0740] (b) receiving the signal at a sensor positioned on a medical
device according to any one of embodiments 13 to 23 located inside
the body;
[0741] (c) powering the sensor using the received signal;
[0742] (d) sensing data at the sensor; and
[0743] (e) outputting the sensed data from the sensor to a
receiving unit located outside of the body.
[0744] 55. The method according to embodiment 54 wherein said
receiving unit is a watch, wrist band, cell phone or glasses.
[0745] 56. The method according to embodiments 54 or 55 wherein
said receiving unit is located within a subject's residence or
office.
[0746] 57. The method according to embodiments any one of
embodiments 54 to 56 wherein said sensed data is provided to a
health care provider.
[0747] 58. The method according to any one of embodiments 54 to 57
wherein said sensed data is posted to one or more websites.
[0748] 59. A non-transitory computer-readable storage medium whose
stored contents configure a computing system to perform a method,
the method comprising: [0749] (a) identifying a subject, the
identified subject having at least one wireless medical device
according to any one of embodiments 13 to 23, each wireless medical
device having one or more wireless sensors; [0750] (b) directing a
wireless interrogation unit to collect sensor data from at least
one of the respective one or more wireless sensors; and [0751] (c)
receiving the collected sensor data.
[0752] 60. The non-transitory computer-readable storage medium of
embodiment 59 whose stored contents configure a computing system to
perform a method, the method further comprising: [0753] (a)
identifying a plurality of subjects, each identified subject having
at least one medical device, each medical device having one or more
wireless sensors; [0754] (b) directing a wireless interrogation
unit associated with each identified subject to collect sensor data
from at least one of the respective one or more wireless sensors;
[0755] (c) receiving the collected sensor data; and [0756] (d)
aggregating the collected sensor data.
[0757] 61. The non-transitory computer-readable storage medium of
embodiment 60 whose stored contents configure a computing system to
perform a method, the method further comprising: [0758] (a)
removing sensitive subject data from the collected sensor data; and
[0759] (b) parsing the aggregated data according to a type of
sensor.
[0760] 62. The non-transitory computer-readable storage medium of
embodiment 60 whose stored contents configure a computing system to
perform a method, wherein directing the wireless interrogation unit
includes directing a control unit associated with the wireless
interrogation unit.
[0761] 63. The non-transitory computer readable storage medium
according to any one of embodiments 60 to 62, wherein said medical
device is according to any one of embodiments 13 to 23.
[0762] 64. The storage medium according to any one of embodiments
60 to 63 wherein said collected sensor data is received on a watch,
wrist band, cell phone or glasses.
[0763] 65. The storage medium according to any one of embodiments
60 to 64 wherein said collected sensor data is received within a
subject's residence or office.
[0764] 66. The storage medium according to any one of embodiments
60 to 65 wherein said collected sensed data is provided to a health
care provider.
[0765] 67. The storage medium according to any one of embodiments
60 to 66 wherein said sensed data is posted to one or more
websites.
[0766] 68. The method according to any one of embodiments 54 to 58,
or storage medium according to any one of embodiments 60 to 67,
wherein said data is analyzed.
[0767] 69. The method or storage medium according to embodiment 68
wherein said data is plotted to enable visualization of change over
time.
[0768] 70. The method or storage medium according to embodiments 68
or 69 wherein said data is plotted to provide a three-dimensional
image.
[0769] 71. A method for determining degradation of a medical
device, comprising the steps of a) providing to a subject a medical
device according to any one of embodiments 13 to 23, and b)
detecting a change in a sensor, and thus determining degradation of
the medical device.
[0770] 72. The method according to embodiment 71 wherein said
sensor is capable of detecting one or more physiological and/or
locational parameters.
[0771] 73. The method according to embodiments 71 or 72 wherein
said sensor detects a location within the subject.
[0772] 74. The method according to any one of embodiments 71 to 73
wherein said sensor moves from its original location, thereby
indicating degradation of the medical device.
[0773] 75. The method according to any one of embodiments 71 to 74
wherein the step of detecting is a series of detections over
time.
[0774] 76. A method for determining an infection associated with a
medical device, comprising the steps of a) providing to a subject a
medical device according to any one of embodiments 13 to 23,
wherein said medical device comprises at least one temperature
sensor and/or metabolic sensor, and b) detecting a change in said
temperature sensor and/or metabolic sensor, and thus determining
the presence of an infection.
[0775] 77. The method according to embodiment 76 wherein the step
of detecting is a series of detections over time.
[0776] 78. The method according to embodiments 76 or 77 wherein
said change is greater than a 1% change over the period of one
hour.
[0777] 79. The method according to any one of embodiments 76 to 78
wherein said change is a continually increasing temperature and/or
metabolic activity over the course of 4 hours.
[0778] The various embodiments described above can be combined to
provide further embodiments. All of the U.S. patents, U.S. patent
application publications, U.S. patent applications, foreign
patents, foreign patent applications and non-patent publications
referred to in this specification are incorporated herein by
reference, in their entirety. Aspects of the embodiments can be
modified, if necessary to employ concepts of the various patents,
applications and publications to provide yet further
embodiments.
[0779] In general, in the following claims, the terms used should
not be construed to limit the claims to the specific embodiments
disclosed in the specification and the claims, but should be
construed to include all possible embodiments along with the full
scope of equivalents to which such claims are entitled.
Accordingly, the claims are not limited by the disclosure.
* * * * *
References