U.S. patent application number 15/320284 was filed with the patent office on 2017-07-13 for devices, systems and methods for using and monitoring spinal implants.
This patent application is currently assigned to CANARY MEDICAL INC.. The applicant listed for this patent is CANARY MEDICAL INC.. Invention is credited to William L. Hunter.
Application Number | 20170196508 15/320284 |
Document ID | / |
Family ID | 54938945 |
Filed Date | 2017-07-13 |
United States Patent
Application |
20170196508 |
Kind Code |
A1 |
Hunter; William L. |
July 13, 2017 |
DEVICES, SYSTEMS AND METHODS FOR USING AND MONITORING SPINAL
IMPLANTS
Abstract
Spinal device/implants are provided, comprising a spinal
device/implant and a sensor.
Inventors: |
Hunter; William L.;
(Vancouver, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CANARY MEDICAL INC. |
Vancouver |
|
CA |
|
|
Assignee: |
CANARY MEDICAL INC.
Vancouver
BC
|
Family ID: |
54938945 |
Appl. No.: |
15/320284 |
Filed: |
June 25, 2015 |
PCT Filed: |
June 25, 2015 |
PCT NO: |
PCT/US15/37825 |
371 Date: |
December 19, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62017106 |
Jun 25, 2014 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/7074 20130101;
G16H 20/40 20180101; A61B 17/7037 20130101; A61B 90/06 20160201;
A61B 17/8855 20130101; A61B 2560/0219 20130101; A61B 5/4566
20130101; A61B 17/80 20130101; A61B 2505/05 20130101; A61B 17/8822
20130101; A61B 2090/065 20160201; A61F 2/4611 20130101; A61F 2/442
20130101; A61B 2017/00221 20130101; A61F 2/44 20130101; A61B
2090/064 20160201; A61B 17/7035 20130101; A61B 5/686 20130101; A61B
17/70 20130101; A61B 17/7049 20130101; A61F 2002/30985 20130101;
G06F 19/3481 20130101; A61B 5/0031 20130101; A61B 17/7032 20130101;
A61B 5/4851 20130101; A61B 17/00 20130101; G16H 40/67 20180101;
A61B 5/6853 20130101; A61F 2/4455 20130101; A61B 17/7059 20130101;
A61B 5/036 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61F 2/46 20060101 A61F002/46; A61F 2/44 20060101
A61F002/44; A61B 17/70 20060101 A61B017/70; A61B 90/00 20060101
A61B090/00 |
Claims
1. An implantable medical device, comprising a pedicle screw, and a
sensor.
2. An implantable medical device, comprising a spinal wire, and a
sensor.
3. An implantable medical device, comprising a spinal rod, and a
sensor.
4. An implantable medical device, comprising a spinal plate, and a
sensor.
5. An implantable medical device, comprising a spinal cage, and a
sensor.
6. An implantable medical device, comprising an artificial disc,
and a sensor.
7. An implantable medical device kit, comprising a pedicle screw, a
spinal rod and a sensor.
8. An implantable medical device kit, comprising a pedicle screw, a
spinal plate and a sensor.
9. An implantable medical device, comprising a polymer and a
sensor.
10. The medical device according to claim 9 wherein said polymer is
selected from the group consisting of a polymethylmethacrylate, a
methylmethacrylate-styrene copolymer, fibrin, polyethylene glycol,
carboxymethylcellulose, and polyvinylalcohol.
11. An implantable medical device, comprising a kyphoplasty
balloon, and a sensor.
12. The medical device according to any one of claims 1 to 11
wherein said sensor is located within said implant.
13. The medical device according to any one of claims 1 to 11
wherein said sensor is located on said implant.
14. The medical device according to any one of claims 1 to 13
wherein said device is sterile.
15. The medical device according to any one of claims 1 to 14
wherein said sensor is a contact sensor.
16. The medical device according to any one of claims 1 to 14
wherein said sensor is a pressure sensor.
17. The medical device according to any one of claims 1 to 14
wherein said sensor is an accelerometer sensor.
18. The medical device according to claim 17 wherein said
accelerometer detects acceleration, tilt, vibration, shock and or
rotation.
19. The medical device according to any one of claims 1 to 14
wherein said sensor is a temperature sensor.
20. The medical device according to any one of claims 1 to 14
wherein said sensor is a mechanical stress sensor.
21. The medical device according to any one of claims 1 to 14
wherein said sensor is selected from the group consisting of
position sensors, chemical microsensors, and tissue metabolic
sensors.
22. The medical device according to any one of claims 1 to 22
further comprising: an electronic processor positioned upon and/or
inside the spinal device/implant or medical device that is
electrically coupled to sensors.
23. The medical device according to claim 22 wherein the electric
coupling is a wireless coupling.
24. The medical device according to claim 22 further including: a
memory coupled to the electronic processor and positioned upon
and/or inside the spinal device/implant or medical device.
25. The medical device according to any one of claims 1 to 24
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.
26. The medical device according to any one of claims 1 to 24
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.
27. A method comprising: obtaining data from sensors positioned at
a plurality of locations between on and/or within the medical
device according to any one of claims 1 to 26 of a patient; storing
the data in a memory device located on or within the medical
device; and transferring the data from the memory to a location
outside the medical device.
28. The method according to claim 27 further comprising the step of
analyzing said data.
29. A method for detecting and/or recording an event in a subject
with the medical device according to any one of claims 1 to 26,
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.
30. The method according to claim 29 wherein the step of
interrogating is performed by a subject which has said medical
device.
31. The method according to claim 29 or 30 wherein said recording
is performed on a wearable device.
32. The method according to any one of claim 29, 30 or 31, wherein
said recording, or a portion thereof, is provided to a health care
provider.
33. A method for imaging the medical device in the spine,
comprising the steps of (a) detecting the location of one or more
sensors in the medical device according to any one of claims 1 to
26; and (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 spine is created.
34. The method according to claim 33 wherein the step of detecting
occurs over time.
35. The method according to claim 33 or 34, 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.
36. The method according to any one of claims 33 to 35 wherein said
visual display is a three-dimensional image of said medical device
in the spine.
37. A method for inserting the spinal device/implant according to
any one of claims 1 to 26, comprising the steps of (a) inserting an
implantable medical device according to any one of claims 1 to 26
into a subject; and (b) imaging the placement of said medical
device according to the method of an one of claims 33 to 36.
38. A method for examining the spinal device/implant according to
any one of claims 1 to 26 which has been previously inserted into a
patient, comprising the step of imaging the spinal device/implant
according to the method of any one of claims 33 to 36.
39. A method of monitoring a spinal device/implant within a
subject, comprising: (a) transmitting a wireless electrical signal
from a location outside the body to a location inside the subject's
body; (b) receiving the signal at a sensor positioned on a spinal
device/implant according to any one of claims 1 to 26 located
inside the body; (c) powering the sensor using the received signal;
(d) sensing data at the sensor; and (e) outputting the sensed data
from the sensor to a receiving unit located outside of the
body.
40. The method according to claim 39 wherein said receiving unit is
a watch, wrist band, cell phone or glasses.
41. The method according to claim 39 or 40 wherein said receiving
unit is located within a subject's residence or office.
42. The method according to claims any one of claims 39 to 41
wherein said sensed data is provided to a health care provider.
43. The method according to any one of claims 39 to 42 wherein said
sensed data is posted to one or more websites.
44. A non-transitory computer-readable storage medium whose stored
contents configure a computing system to perform a method, the
method comprising: (a) identifying a subject, the identified
subject having at least one wireless spinal device/implant
according to any one of claims 1 to 26, each wireless spinal
device/implant having one or more wireless sensors; (b) directing a
wireless interrogation unit to collect sensor data from at least
one of the respective one or more wireless sensors; and (c)
receiving the collected sensor data.
45. The non-transitory computer-readable storage medium of claim 44
whose stored contents configure a computing system to perform a
method, the method further comprising: (a) identifying a plurality
of subjects, each identified subject having at least one wireless
spinal device/implant, each wireless spinal device/implant having
one or more wireless sensors; (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; (c) receiving the collected sensor data; and (d)
aggregating the collected sensor data.
46. The non-transitory computer-readable storage medium of claim 44
whose stored contents configure a computing system to perform a
method, the method further comprising: (a) removing sensitive
subject data from the collected sensor data; and (b) parsing the
aggregated data according to a type of sensor.
47. The non-transitory computer-readable storage medium of claim 44
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.
48. The non-transitory computer readable storage medium according
to any one of claims 44 to 47, wherein said spinal device/implant
is according to any one of claims 1 to 26.
49. The storage medium according to any one of claims 44 to 48
wherein said collected sensor data is received on a watch, wrist
band, cell phone or glasses.
50. The storage medium according to any one of claims 44 to 49
wherein said collected sensor data is received within a subject's
residence or office.
51. The storage medium according to any one of claims 44 to 50
wherein said collected sensed data is provided to a health care
provider.
52. The storage medium according to any one of claims 44 to 51
wherein said sensed data is posted to one or more websites.
53. The method according to any one of claims 39 to 43, or storage
medium according to any one of claims 44 to 52, wherein said data
is analyzed.
54. The method or storage medium according to claim 53 wherein said
data is plotted to enable visualization of change over time.
55. The method or storage medium according to claim 53 or 54
wherein said data is plotted to provide a three-dimensional
image.
55. A method for determining degradation of a spinal
device/implant, comprising the steps of a) providing to a subject a
spinal device/implant according to any one of claims 1 to 26, and
b) detecting a change in a sensor, and thus determining degradation
of the spinal device/implant.
56. The method according to claim 55 wherein said sensor is capable
of detecting one or more physiological and/or locational
parameters.
57. The method according to claim 55 or 56 wherein said sensor
detects a location within the subject.
58. The method according to any one of claims 55 to 58 wherein said
sensor moves from its original location, thereby indicating
degradation of the spinal device/implant.
59. The method according to any one of claims 55 to 59 wherein the
step of detecting is a series of detections over time.
60. A method for determining an infection associated with a spinal
device/implant, comprising the steps of a) providing to a subject a
spinal device/implant according to any one of claims 1 to 26,
wherein said spinal device/implant 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.
61. The method according to claim 60 wherein the step of detecting
is a series of detections over time.
62. The method according to claim 60 or 61 wherein said change is
greater than a 1% change over the period of one hour.
63. The method according to any one of claims 60 to 62 wherein said
change is a continually increasing temperature and/or metabolic
activity over the course of 4 hours.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit under 35 U.S.C.
.sctn.119(e) of U.S. Provisional Patent Application No. 62/017,106,
filed Jun. 25, 2014, which application is incorporated herein by
reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to spinal implants,
and more specifically, to devices and methods for monitoring the
placement, efficacy, and performance of a wide variety of spinal
implants, including for example, in instruments that are utilized
to operate on the spine, such as rods, vertebroplasty balloons,
bone fillers and cements, screws (e.g., pedicle screws), spinal
fusion devices (e.g., plates), spinal cages, and artificial
discs.
BACKGROUND
[0003] The vertebral column, also known as the backbone or spine,
has many functions, including for example, to provide support for
the body, to provide protection for the spinal cord and associated
nerves, to allow a body to be flexible, and to act as a shock
absorber for bearing loads. For example, as shown in FIG. 1A, the
spine consists of bony vertebrae 2, (see also FIG. 1C), and the
intervertebral disc 4. The disc (FIG. 1B) has a strong, thick outer
part (Annulus 5) and a gelatinous internal component (Nucleus
Pulposis 3). Associated spinal nerve roots 6 can be seen exiting
the spine between the bony vertebrae.
[0004] However, conditions affecting vertebrae and/or the vertebral
discs can result in injury to the spinal cord and/or the spinal
nerves (e.g., trauma, diseases of the vertebral body or
intervetebral disc), resulting in serious complications such as
severe pain, nerve damage, lower limb weakness, bowel and bladder
dysfunction, paralysis and even death. Common conditions affecting
the vertebral column include degenerative disc disease (herniated
discs), osteoporosis (resulting in vertebral compression
fractures), traumatic fracture, and various forms of spinal
instability or deformation (e.g., scoliosis).
[0005] In order to lessen the effects of injury or disease, a wide
variety of spinal implants, and instruments suitable for operating
on the spine and/or delivering or implanting a spinal implant have
been developed. Representative examples of spinal implants include
rods, screws (e.g., pedicle screws), spinal fusion devices (e.g.,
plates), spinal cages, and artificial discs (see e.g.,: 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. 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), and 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)).
[0006] Unfortunately, when spinal surgery is performed or when a
spinal implant is inserted, various complications may arise during
the procedure (whether it is an open surgical procedure such as the
placement of spinal fusion devices, cages or artificial discs, or
minimally invasive procedures such as vertebroplasty, kyphoplasty
or microdiscectomy). For example, during a procedure, the surgeon
may wish to confirm correct anatomical alignment of the spinal
column and/or implant and/or detect any abnormal motion between the
spinal implant and the surrounding tissue so that corrective
adjustments can be made during the procedure itself. In addition,
to the extent the spinal device or implant is utilized in a
surgical procedure, a physician may wish to confirm the correct
placement of the device (such as a spinal fusion device, a spinal
cage, an artificial discs) or implant (such as bone cement,
synthetic polymers, bone tissue, bone matrix, bone growth factors),
and confirm the delivery of it to its final, desired anatomical
location. Post-procedure, the patient may experience neurological
symptoms and pain if there is abnormal movement, migration of the
device, breakage of the device, or in more serious cases infection,
inflammation and/or pressure on the spinal cord and spinal nerves
resulting from complications associated with the spinal
implant.
[0007] The present invention discloses novel spinal implants which
overcome many of the difficulties and limitations found with
previous spinal devices and implants, methods for constructing and
monitoring these novel spinal devices and implants, and further
provides other related advantages.
SUMMARY
[0008] Briefly stated, spinal devices and implants (also referred
to as `medical devices`) are provided comprising a spinal device or
implant along with one or more sensors to monitor the integrity,
function, location and efficaciousness of the spinal device or
implant. The sensors may be positioned on the inside of the spinal
device/implant, within the body of the spinal device/implant, or on
the outer surface (or surfaces) of the spinal device/implant,
and/or between the spinal device/implant and any device that might
be utilized to deliver or secure the implant (e.g., a cement,
adhesive, catheter, balloon catheter, or other medical device).
Within certain embodiments, the sensors are of the type that are
passive and thus do not require their own power supply.
[0009] According to various embodiments of the invention, the
medical device comprises a spinal implant, along with one or more
sensors. Examples of spinal devices and implants include pedicle
screws, spinal rods, spinal wires, spinal plates, spinal cages,
artificial discs, bone cement, growth factors (Bone Morphogenic
Protein--BMP) as well as combinations of these (e.g., one or more
pedicle screws and spinal rods, one or more pedicle screws and a
spinal plate). In addition medical delivery devices for the
placement of spinal devices and implants, along with one or more
sensors, are also provided. Examples of medical delivery devices
for spinal implants include kyphoplasty balloons, catheters
(including thermal catheters and bone tunnel catheters), bone
cement injection devices, microdscectomy tools and other surgical
tools. In addition, further components or compositions may be
delivered along with the spinal implant and/or by the medical
delivery device itself, and include fillers such as bone cement
(PMMA), growth factors (such as BMP) and/or other polymers combined
with one or more sensors. Within preferred embodiments of the
above, the medical device, spinal implant, medical delivery device
and filler are all provided in a sterile form (e.g., ETO
sterilized), and in a kit containing components suitable for a
particular spinal surgery.
[0010] Representative examples of sensors 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 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 spinal device, implant, delivery device or surgical
tool can have more than one type of the above-noted sensors.
[0011] According to various embodiments, sensors are placed at
different locations in the spinal device/implant in order to
monitor the operation, movement, location, medical imaging (both of
the spinal device/implant and the surrounding tissues), function,
wear, performance, potential side effects, medical status of the
patient and the medical status of the spinal device/implant and its
interface with the live tissue of the patient. Live, continuous, in
situ, monitoring of patient activity, patient function, spinal
device/implant activity, spinal device/implant function, spinal
device/implant performance, spinal device/implant placement, spinal
device/implant forces and mechanical stresses, spinal
device/implant and surrounding tissue anatomy (imaging), mechanical
and physical integrity of the spinal device/implant, and potential
local and systemic side effects is provided. In addition,
information is available on many aspects of the spinal
device/implant 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.
[0012] According to one embodiment, the sensors provide evaluation
data of any motion or movement of the spinal device/implant. Motion
sensors and accelerometers can be used to accurately determine the
movement of the spinal implant during surgical placement, during
medical and physical examination post-operatively and during normal
daily activities after the patient returns home.
[0013] According to another embodiment, contact sensors are
provided between the spinal implant and the surrounding tissue
and/or between articulated components of the device/implant itself.
In other embodiments, vibration sensors are provided to detect the
vibration between the spinal implant and the surrounding tissue
and/or articulated components of the device/implant itself.
Increases in vibration may indicate that the spinal implant is
loosening from the surrounding tissue (or articulated device
segments), which may result in damage to the body and/or lead to
breakage or failure of the device. In other embodiments, strain
gauges are provided to detect the strain between the spinal implant
and the surrounding tissue and/or between articulated components of
the device/implant itself. Sudden increases in strain may indicate
that too much stress is being placed on the spinal implant, which
may increase damage to the body and/or breakage and damage to the
device.
[0014] According to other embodiments, accelerometers are provided
which detect vibration, shock, tilt and rotation of the
device/implant and by extension the surrounding tissue itself.
According to other embodiments, sensors for measuring surface wear,
such as contact or pressure sensors, may be embedded at different
depths within the spinal device/implant in order to monitor contact
of the spinal device/implant with surrounding tissues, or
degradation of the spinal device/implant over time (e.g., in the
context of a biodegradable or bioerodible implants and devices). In
other embodiments, position sensors, as well as other types of
sensors, are provided which indicate potential problems such as
movement, migration, pressure on surrounding anatomical structures,
alignment, breakage, cracking and/or bending of the spinal
device/implant in actual use over a period of time.
[0015] Within further embodiments, the spinal device/implant can
contain sensors at specified densities in specific locations. For
example, the spinal device/implant 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 spinal device/implant 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.
[0016] Within certain embodiments of the invention, the spinal
device/implant is provided with a specific unique identifying
number, and within further embodiments, each of the sensors on, in
or around the spinal device/implant 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 spinal device/implant.
[0017] Within other aspects of the invention methods are provided
for monitoring an anatomically-implanted spinal device/implant
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
spinal device/implant 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.
[0018] Within other aspects of the invention methods are provided
for imaging a spinal device/implant as provided herein, comprising
the steps of (a) detecting the location of one or more sensors in
the spinal device/implant and any associated anatomical or
radiological "ladmarks" and/or associated medical delivery device
or surgical tool; and (b) visually displaying the relative
anatomical location of said one or more sensors, such that an image
of the spinal implant 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.
[0019] 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 and functioning of the
spinal device/implant. Particularly in spinal surgery, proper
alignment and kyphosis (spinal curvature) are 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. Within other embodiments,
the imaging techniques may be utilized post-operatively in order to
examine the spinal device/implant, and/or to compare operation,
integrity and/or movement of the device/implant over time.
[0020] The integrity of the spinal device/implant 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 spinal implant 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,
numbness, tingling, weakness, 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 spinal device/implants provided herein,
comprising the device/implant interrogation 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 spinal
device/implant as provided herein, comprising the step of
interrogating at a desired point in time the activity of one or
more sensors within the spinal device/implant, 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, and/or
glasses).
[0021] Within further embodiments, each of the sensors contains a
signal-receiving circuit and a signal output circuit. The
signal-receiving circuit receives an interrogation signal that
includes both power and data collection request components. Using
the power from the interrogation signal, the sensor powers up the
parts of the circuitry needed to conduct the sensing, carries out
the sensing, and then outputs the data to the interrogation module.
The interrogation module acts under control of a control unit which
contains the appropriate I/O circuitry, memory, a controller in the
form of a microprocessor, and other circuitry in order to drive the
interrogation module. Within yet other embodiments the 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] are constructed such that
they may readily be incorporated into, or otherwise mechanically
attached to, the spinal device/implant (e.g., by way of a an
opening or other appendage that provides permanent attachment of
the sensor to the spinal device/implant) and/or readily
incorporated into body of the spinal device/implant.
[0022] 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 spinal device/implant 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.
[0023] The data collected by the sensors can be stored in a memory
located within the spinal device/implant, 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 spinal implant, and any associated
medical device.
[0024] The advantages obtained include more accurate monitoring of
the spinal device/implant 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
[0025] FIG. 1A illustrates various portions of the spinal column,
including a portion of a spine (FIG. 1A), an intervetebral disc
(FIG. 1B), and a bony vertebrae (FIG. 1C).
[0026] FIG. 2 illustrates the repair of a compression fracture in a
vertebral body (typically due to osteoporosis) through a form of
vertebroplasty known as kyphoplasty (FIGS. 2A,B,C,D). A balloon 200
is first inserted into the collapsed vertebral body (FIG. 2B) via a
bone tunneling catheter and then inflated (FIG. 2C) in order to
create a void in the cancellous bone and restore normal vertebral
height and shape (kyphosis). PMMA (polymethylmethacrylate or bone
cement--201) is then injected into the void, and allowed to harden
in order to form a permanent support structure in the vertebrae
(see FIG. 2D).
[0027] FIG. 3 illustrates one embodiment called vertebroplasty
wherein bone cement is injected directly within the body of the
vertebrae (without the use of a balloon). These Figures illustrate
one embodiment wherein, a hole is created in the vertebral body
(FIG. 3A) through a bone tunneling catheter, followed by
introduction of a delivery device (FIG. 3B) 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.
3C and 3D) to restore the normal height of the vertebra.
[0028] FIG. 4 illustrates a variety of medical instruments that can
be utilized to assist in the preparation for vertebroplasty and
kyphoplasty, including guidewires, trochars, bone tunnel catheters,
kyphoplasty balloons, and an injector for the bone cement.
[0029] FIG. 5 illustrates one embodiment wherein a variety of
sensors are placed on and/or within a kyphoplasty balloon.
[0030] FIG. 6 illustrates one embodiment wherein the filler
(typically bone cement) administered into the vertebral compression
fracture contains a variety of sensors.
[0031] FIG. 7 illustrates a normal intervertebral disc, as well as
various degenerative disc disease-related conditions.
[0032] FIG. 8 illustrates spinal fusion surgery (spondylodesis or
spondylosyndesis) demonstrating two embodiments wherein a pedicle
screw (and supporting rod) are placed into the spine, as well as an
interbody fusion cage.
[0033] FIGS. 9A and 9B illustrate the use of bone tissue (with or
without bone morphogenic protein) to fuse vertebrae. FIG. 9A is a
posterolateral fusion (the bone graft is placed between the
transverse processes of adjacent vertebrae) and FIG. 9B is an
interbody fusion (the bone graft occurs between the bodies of the
vertebrae in the space usually occupied by the intervetebral disc).
Typically supporting devices (rods, screws, plates) are used as
well (see FIG. 10).
[0034] FIG. 10 illustrates a variety of spinal fusion implants,
including pedicle screws affixed to rods (FIGS. 10A and 10B), and a
spinal plate retained by screws (FIG. 10C).
[0035] FIGS. 11A-11D illustrate a variety of sensors on and/or
within a spinal fusion implant (on or within pedicle screws and a
rod).
[0036] FIGS. 12A-12C illustrate a variety of spinal (interbody)
cages some of which are hollow to allow the incorporation of bone
graft material.
[0037] FIGS. 13A-13D illustrate spinal (interbody) cages having a
variety of sensors and associated bone graft material having a
variety sensors.
[0038] FIGS. 14A-14D illustrate a surgical procedure wherein a
diseased intervertebral disc is removed and an artificial disc is
inserted into a subject.
[0039] FIG. 15 illustrates a variety of artificial intervertebral
discs.
[0040] FIGS. 16A-16D illustrate a variety of sensors on and in an
artificial intervertebral disc.
[0041] FIGS. 17A and FIG. 17B illustrate two different views of a
vertebral column with a herniated intervertebral disc applying
pressure to the spinal cord and/or the spinal nerves.
[0042] FIG. 18 illustrates a common surgical procedure
(microdiscectomy) wherein a portion of a herniated disc is removed
endoscopically.
[0043] FIG. 19A illustrates insertion of an electrothermal catheter
(IDET--intradiscal electrothermal annuloplasty) into the diseased
intervertebral disc, followed by heating of the tip of the thermal
catheter as shown in FIG. 19B to repair the weakened part of the
annulus.
[0044] FIG. 20 illustrates an information and communication
technology system embodiment arranged to process sensor data.
[0045] FIG. 21 is a block diagram of a sensor, interrogation
module, and a control unit according to one embodiment of the
invention.
[0046] FIG. 22 is a schematic illustration of one or more sensors
positioned on the spinal implant within a subject which is being
probed for data and outputting data, according to one embodiment of
the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0047] Briefly stated, the present invention provides a variety of
spinal devices and implants that can be utilized to monitor the
placement, location, anatomy, performance, integrity and/or
efficaciousness of the spinal device/implant, 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.
[0048] "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
vertebroplasy/kyphoplasty balloons and bone cement (see e.g., US
2007/0100449, US 2009/0299373); all of which are incorporated by
reference in their entirety.
[0049] 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); and non-polymeric
materials such as silicon nitride.
[0050] "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.
[0051] 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.
[0052] "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), one or more aspects of
the spinal device/implant, and one or more aspects of an associated
medical device (e.g., screws, rods, hooks and wires) inserted
within a body. Representative examples of sensors suitable for use
within the present invention include, for example, fluid pressure
sensors, contact sensors, position sensors, pulse pressure sensors,
blood or fluid volume sensors, blood or fluid flow sensors,
chemistry sensors (e.g., for cerebrospinal fluid--CSF, interstitial
fluid, blood and/or other fluids), metabolic sensors (e.g., for
cerebrospinal fluid--CSF, interstitial fluid, 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.
[0053] 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.
[0054] 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 the spinal
device/implant, within the body of the spinal/device implant, on
the outer surface (or surfaces) of the spinal device/implant,
between the spinal implant and any device that might carry or
deliver it (e.g., a delivery device, injection device, or surgical
instrument) or be associated with it (e.g., screws, rods, hooks and
wires). When the phrase "placed in the spinal 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.
[0055] The sensors may be placed in the spinal device/implant
alone, or in the context of associated medical devices (e.g.,
screws, rods, hooks and wires), or in the context of a kit (e.g., a
kit containing a delivery device, spinal device/implant, and/or
associated devices suitable for a desired surgical procedure.). For
example, within certain embodiments, the spinal device/implant,
medical device or 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 spinal device/implant,
medical device or 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 spinal device/implant, medical device, or kit
as described herein.
[0056] In various embodiments, the sensors may be placed within
specific locations and/or randomly throughout the spinal
device/implant 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 spinal
implant and/or associated devices.
Representative Embodiments of Spinal Device/Implants and Medical
Uses of Sensor-Containing Spinal Device/Implants
[0057] In order to further understand the various aspects of the
invention provided herein, the following sections are provided
below: A. Spinal device/implants and their Use; B. Use of Spinal
device/implants to Deliver Therapeutic Agent(s); C. Methods for
Monitoring Infection in Spinal device/implants; D. Further Uses of
Sensor-containing Spinal device/implants in Healthcare; E.
Generation of Power from Spinal device/implants; F. Medical Imaging
and Self-Diagnosis of Assemblies Comprising Spinal device/implants,
Predictive Analysis and Predictive Maintenance; G. Methods of
Monitoring Assemblies Comprising Spinal device/implants; and H.
Collection, Transmission, Analysis, and Distribution of Data from
Assemblies Comprising Spinal device/implants.
A. Spinal Device/Implants and Their Use
[0058] A1. Vertebroplasty and Kyphoplasty Procedures
[0059] As noted above, within various aspects of the invention
spinal device/implants and associated medical devices are provided
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).
[0060] For vertebroplasty procedures, bone cement (e.g.,
polymethylmethacrylate or "PMMA") is injected percutaneously into
the fractured vertebral body (see e.g., FIGS. 3C and 3D) in order
restore normal vertebral height and anatomy so as to relieve the
pain and symptoms associated with compression. Using a percutaneous
approach or a small surgical incision, a hole is created in the
wall of the vertebral body (FIG. 3A) by a specialized bone
tunneling catheter, a delivery catheter is advanced into the
vertebral body at the site of the fracture (FIG. 3B), and bone
cement is injected (as shown in FIGS. 3C and 3D) into the
cancellous bone within the vertebral body. The cement is allowed to
infiltrate the cancellous bone of the collapsed vertebral body
(FIG. 3C) until sufficient PMMA material has been injected to
restore the vertebra to its normal height (FIG. 3D) and anatomy
(the cement hardens and supports the fractured bone).
[0061] Kyphoplasty is a specialized form of vertebroplasty. In
kyphoplasty procedures, a balloon is first inserted (FIG. 2B) into
the cancellous bone of the vertebral compression fracture and then
inflated (FIG. 2C) 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 in
the vertebrae (see FIG. 2D).
[0062] As shown in FIG. 4, 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.
[0063] Within various embodiments of the invention, sensors may be
placed in some or all of the spinal implants and associated devices
used for vertebroplasty and kyphoplasty. For example, as shown in
FIG. 5, a variety of sensors can be placed on, or within the
kyphoplasty balloon. For example, pressure sensors (designated by
an open triangle) may be distributed throughout the balloon 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).
Contact sensors (designated as an open rectangle) may also be
distributed throughout the balloon in order to monitor contact
between the balloon and the cancellous bone of the vertebral body.
Position sensors/location markers (designated as a solid circle)
may be distributed throughout the balloon (as well as on placement
devices such as the introducers or bone tunnel catheters) 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 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. Chemical sensors (indicated by
the star) may also be utilized, along with temperature sensors (not
shown).
[0064] The 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.
[0065] Similarly, as shown in FIG. 6, one or more sensors may be
placed within the bone cement (and hence injected into the
vertebral body). For example, contact sensors (shown as the open
rectangle) may be distributed throughout the bone cement in order
to monitor contact with the vertebral body, and to detect any
loosening that might occur between the bone cement and the
surrounding bone (particularly after hardening and during
post-operative follow-up). Pressure sensors (shown as open
triangles) may be distributed throughout the bone cement to detect
any areas of excessive pressure, either due to improper injection
at the time of placement, or due to shifting or further bone
collapse in the post-operative follow-up. One or more position
sensors and/or location sensors (shown as the solid circles) may be
included within the bone cement in order to assist in accurate
placement of the cement, to provide for correct filling (but not
overfilling), to avoid or detect possible leaks into the spinal
canal or adjacent spinal nerves, and to maintain the correct
vertebral height and spinal kyphosis. Post-operatively, the sensors
can be utilized to assess maintenance of vertebral anatomy, to
monitor and image the placement, size and volume of the cement over
time, and to determine the exact cement location (including any
possible migration, dissolution, resorption, leakage, impingement
against the spinal cord or spinal nerves, and/or embolization; such
as to the lungs or elsewhere).
[0066] As is also shown in FIG. 6, chemical sensors 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 (not shown), 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.
[0067] Accelerometers (not shown in FIG. 6) may also be distributed
through 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 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.
[0068] In vertebroplasty, the bone cement is injected directly into
the fracture without the creation of a void (See FIG. 3C, 3D).
Because of this, the use of sensors within the injected bone cement
(as described above and demonstrated in FIG. 6) to monitor
pressure, location, position, contact and other measures
(temperature, pH, etc.) during both placement and in subsequent
follow-up is as, or more, important than as described for
kyphoplasty. Once implanted the monitoring of sensor-containing
bone cement is identical regardless of whether it is administered
as part of vertebroplasty or kyphoplasty.
[0069] The above 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 implants are exposed
to in the real world.
[0070] A2. Intervertebral Disc Disease/Spinal Fusion
[0071] 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 are shown in FIG. 7,
which depicts a normal disc, degenerated disc, bulging disc,
herniated disc, thinning disc, and disc degeneration with
osteophyte formation.
[0072] 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 (as shown in FIGS. 9A and 9B).
FIG. 9A illustrates a Posterolateral spinal fusion (bony fusion
occurs between the transverse processes of the vertebrae) while
FIG. 9B depicts an interbody spinal fusion (the bone graft is
created between the bodies of the vertebrae in the area usually
occupied by the intervertebral disc; 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 as shown in FIG. 8), rods or
plates to connect the screws, and fusion cages (including bone
graft material which is placed inside a cage--an interbody fusion
cage--see also FIG. 8 and FIG. 9B). FIG. 10 depicts a variety of
spinal fusion devices, including pedicle screws affixed to rods
(FIGS. 10A and 10B), as well as plates which can be utilized to
fuse to vertebrae together (FIG. 10C).
[0073] 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).
[0074] Within various embodiments of the invention, sensors are
described herein that can be placed on the spinal fusion devices,
and/or instruments, in order to ensure that the devices are placed
properly during surgery, and to monitor and assess their
performance (or lack thereof) subsequent to surgery.
[0075] For example, as shown in FIG. 11A, position sensors (shown
as solid circles) can be provided on and/or within the pedicle
screws, rods, wires and/or plates of a spinal fusion device. The
position sensors 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.
[0076] As shown in FIG. 11B, contact sensors (shown as rectangles)
can also be placed on and/or within the pedicle screws, rods, wires
and/or plates of a spinal fusion device. The contact sensors 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.
[0077] FIG. 11C depicts a variety of accelerometers and/or strain
gauges (shown as triangles) which can be placed on and/or within
the pedicle screws, rods, wires and/or plates of a spinal fusion
device. The sensors 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.
[0078] As shown in FIG. 11D, a wide variety of sensors may be
placed on the spinal fusion devices (e.g., on or within the pedicle
screws, wires, rods and/or plates), 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. Sensors can be
placed on any or all of the spinal fusion devices (e.g., on or
within the pedicle screws, wires, rods and/or plates) 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 sensors are
placed on the spinal fusion devices (e.g., on or within the pedicle
screws, wires, rods and/or plates) 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.
[0079] A3. Degenerative Disc Disease (DDD)/Interbody Fusion/Spinal
Cages
[0080] 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, Number 3 in FIG. 1B) can bulge or
herniate (protrude, shown in FIGS. 17A&B) through weakened
areas of the annulus fibrosis (the outer, stronger part of the
disc, Number 5 in FIG. 1B) 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 (as shown in FIG. 17B) or the
spinal nerves (as shown in FIG. 17A) that leads to the pain and
neurological symptoms described previously.
[0081] 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)
[0082] As shown in FIG. 12A, 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 particular orientation. For
example, as shown in FIGS. 12B and 12C, spinal cages may have 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.
[0083] Within various embodiments of the invention position sensors
can be placed on and/or within a spinal cage. For example, as
illustrated in FIG. 13A, position sensors (shown as solid circles)
can be placed on and/or within the bone graft material, and/or on
and/or within the spinal cage. 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 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
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. 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.
[0084] Similarly, as illustrated in FIG. 13B contact and pressure
sensors (shown as rectangles) can be placed on and/or within the
bone graft material and/or within the spinal cage. Within certain
embodiments of the invention two cages are provided with "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.
[0085] FIG. 13C depicts a variety of accelerometers and/or strain
gauges (shown as triangles) which can be placed on and/or within
the bone graft material and/or on and/or within the spinal cage.
The sensors 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 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.
[0086] As shown in FIG. 13D, a wide variety of sensors may be
placed on and/or within the bone graft material and/or on/within
the spinal cage, 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. Sensors can be placed on any or
all of the spinal fusion devices (e.g., on or within the spinal
cages, the bone graft material and any other hardware utilized to
complete the fixation such as pedicle screws, wires, rods and/or
plates) 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 sensors are placed on and/or within the bone graft material
and/or on/within the spinal cage (and any other hardware utilized
in the fusion such as pedicle screws, wires, rods and/or plates) 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.
[0087] A4. Artificial Discs
[0088] 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 are shown in FIG. 15, and
include the Charite Lumbar Disc (DePuy), Prodisc Lumbar Disc
(Synthes), ProDisc Cervical Disc (Synthes) and the Maverick Lumbar
Dis (Medtronic).
[0089] Typically, the intervertebral disc (FIG. 14A) is completely
excised (FIG. 14B) by the surgeon via an anterior (abdominal)
approach, and plates (usually composed of titanium or titanium
alloys--FIG. 14C) 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 (also FIG. 14C). The completed artificial disc is shown in
FIG. 14D.
[0090] Within various embodiments of the invention, position
sensors can be placed on and/or within an artificial disc. For
example, as illustrated in FIG. 16A, position sensors can be placed
on and/or within the artificial disc (i.e., on or within the
metallic plates as shown by the black arrows, and/or on/within the
articular core piece between the plates as shown by the lined
arrows; for cemented prostheses, the position sensors can also be
contained within the bone cement). Intraoperatively, the position
sensors can be utilized by the surgeon to determine accurate
placement, alignment and spinal anatomy (medical imaging).
Postoperatively, the 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 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.
[0091] Similarly, as illustrated in FIG. 16B contact sensors can be
placed on and/or within the artificial disc (i.e., on or within the
metallic plates as shown by solid black arrows, and/or on/within
the articular core piece between the plates as shown by the lined
arrows; for cemented prostheses, the sensors can be contained
within the bone cement). Intraoperatively, the 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,
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. As demonstrated by FIG. 16D, contact
sensors can also be contained at various depths within the
polymeric articular core (as shown by the lined arrows) and within
the metallic endplates (as shown by the solid arrows) to provide
ongoing assessment of the amount of surface wear of the synthetic
articular components. 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.
[0092] FIG. 16C depicts a variety of accelerometers and/or strain
gauges which can also be placed on and/or within the artificial
disc (e.g., on or within the metallic plates as shown by the solid
black arrows, and/or on/within the articular core piece between the
plates as shown by the lined arrows; for cemented prostheses, the
sensors can be contained within the bone cement). The sensors 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
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 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 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.
[0093] As shown in FIG. 16D, a wide variety of sensors may be
placed on and/or within the artificial disc in order to detect and
monitor articular surface wear in the metal plates and/or polymer
components (if present). Within various embodiments contact and/or
pressure sensors may be layered at various depths within the
metallic plate (the solid black arrows in FIG. 16D) or within the
polymeric articular surface (the lined arrows in FIG. 16D). The
sensors may then be uncovered (and activated) as the surface above
them is worn away or damaged, indicating the extent and depth of
surface loss, and providing a diagnostic to determine the relevant
remaining effective lifespan of the implant.
[0094] In summary, a wide variety of 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 sensors can also be contained
within the bone cement) in order to provide an evaluation of
performance in the clinic as well as `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 artificial disc can have 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 on any or
all of the artificial disc devices (e.g., on or within the metallic
plates, and/or on/within the articular core piece between the
plates; for cemented prostheses, the sensors can be contained
within the bone cement) 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 sensors are placed 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 sensors can be contained within the bone cement) 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.
[0095] A5. Microdiscetomy
[0096] Within various aspects of the present invention, devices and
methods are provided for treating herniated discs. Briefly, unlike
a typical vertebrae (FIG. 17A), 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 (see, e.g., FIG. 17A, wherein the disc is
herniated, resulting in compression of the nerve roots and FIG. 17B
where the disc is herniated resulted in compression of the spinal
cord) and neurological symptoms (numbness, weakness, tingling,
paralysis, bowel or bladder dysfunction) are present.
[0097] 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 (see FIG. 18).
[0098] Within various embodiments, microdiscectomy tools containing
sensors, as described herein, are provided. For example, within one
embodiment microdiscectomy tools containing 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 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 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 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.
[0099] Within other aspects of the invention Intradiscal
Electrothermal Annuloplasty can be utilized to treat, for example,
Degenerative Disc Disease. For example, as shown in FIG. 19A, an
electrothermal catheter can be inserted along the back inner wall
of the disc. The catheter is then heated as shown in FIG. 19B,
thereby thickening collagen fibers which make up the disc wall (and
sealing any ruptures in the disc wall), and cauterizing sensitive
nerve endings.
[0100] Within various embodiments of the invention electrothermal
catheters are provided comprising one or more sensors that can be
utilized in the process of Intradiscal Eletrothermal Annuloplasty.
For example, contact sensors can be utilized to monitor contact
between the electrothermal catheter and the inner wall of the
annulus. 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.
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, 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).
[0101] In summary, a wide variety of 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 strain encountered in an interventional procedure.
For example, the microdissectomy and electrothermal tools can have
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.
[0102] A6. Bone Cement and Other Implantable Materials
[0103] As described herein bone cement is utilized in a large
number of spinal procedures. Most typically, methylmethacrylates
are utilized (e.g., polymethylmethacrylate, or
amethylmethacrylate-styrene copolymer), although other materials
can also be utilized.
[0104] 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).
[0105] 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.
[0106] The bone cement and other implantable materials described
herein may contain one or more sensors, including for example,
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 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
[0107] A7. Manufacturing Methods
[0108] Within various embodiments of the invention, methods are
also provided for manufacturing a spinal implant or device, medical
delivery device for a spinal implant or device, or further
compositions (e.g., fillers) having one of the sensors provided
herein. For example, within one embodiment of the invention sensors
can be placed directly into, onto or within: 1) spinal devices or
implants (e.g., pedicle screws, spinal rods, spinal wires, spinal
plates, spinal cages, artificial discs, bone cement, growth factors
(Bone Morphogenic Protein--BMP) as well as combinations of these
(e.g., one or more pedicle screws and spinal rods, one or more
pedicle screws and a spinal plate); and/or 2) medical delivery
devices for the placement of spinal devices and implants (e.g.,
kyphoplasty balloons, catheters (including thermal catheters and
bone tunnel catheters), bone cement injection devices,
microdiscectomy tools and other surgical tools; and/or 3) further
components or compositions (e.g., fillers such as bone cement
(PMMA), growth factors (such as BMP) and/or other polymers) at the
time of manufacture, and subsequently sterilized in a manner
suitable for use in subjects.
[0109] Within further embodiments, the present disclosure provides
a method of making a spinal implant or device, medical delivery
device for a spinal implant or device, or further compositions
(e.g., fillers) by 3D printing, additive manufacturing, or a
similar process whereby the spinal implant or device, medical
delivery device for a spinal implant or device, or further
compositions (e.g., fillers) is formed from powder or filament that
is converted to a fluid form that 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 provide a method of making a spinal implant or device,
medical delivery device for a spinal implant or device, or further
compositions (e.g., fillers) by a printing process, where that
spinal implant or device, medical delivery device for a spinal
implant or device, or further compositions (e.g., fillers) includes
a sensor, circuit or other feature as disclosed herein
(collectively sensor or sensors). The sensor may be separately
produced and then incorporated into the spinal implant or device,
medical delivery device for a spinal implant or device, or further
compositions (e.g., fillers) during the printing process. For
example, a sensor may be placed into a desired position and the
printing process is carried out around the sensor so that the
sensor becomes embedded in the printed spinal implant or device,
medical delivery device for a spinal implant or device, or further
compositions (e.g., fillers). Alternatively, the printing process
may be started and then at appropriate times, the process is paused
to allow a sensor to be placed adjacent to the partially completed
spinal implant or device, medical delivery device for a spinal
implant or device, or further compositions (e.g., fillers). The
printing process is then re-started and construction of the spinal
implant or device, medical delivery device for a spinal implant or
device, or further compositions (e.g., fillers) is completed. The
software that directs the printing process may be programmed to
pause at appropriate predetermined times to allow a sensor to be
added to the partially printed spinal implant or device, medical
delivery device for a spinal implant or device, or further
compositions (e.g., fillers).
[0110] In addition, or alternatively, the sensor itself, or a
portion thereof may be printed by the 3D printing process.
Likewise, electronic connectively to, or from, or between, sensors
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 sensors of a spinal
implant or device, medical delivery device for a spinal implant or
device, or further compositions (e.g., fillers). 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 spinal implant or device, medical delivery device for a
spinal implant or device, or further compositions (e.g., fillers)s
wherein the sensor is printed onto a substrate, or a substrate is
printed and a sensor is embedded or otherwise incorporated into or
onto the substrate, or both the substrate and the sensor are
printed by a 3D printing technique.
[0111] 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.
[0112] When the spinal implant or device, medical delivery device
for a spinal implant or device, or further compositions (e.g.,
fillers) 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 spinal implant or device,
medical delivery device for a spinal implant or device, or further
compositions (e.g., fillers)s has been finally printed. In this
way, significant hollow spaces may be incorporated into the spinal
implant or device, medical delivery device for a spinal implant or
device, or further compositions (e.g., fillers).
[0113] 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 may be embedded into the
alloy powder bed, and the laser melts the powder around the sensor
so as to incorporate the sensor 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.
[0114] Accordingly, in one embodiment the present disclosure
provides a method of fabricating sensor-containing spinal implant
or device, medical delivery device for a spinal implant or device,
or further compositions (e.g., fillers)s, the method comprising
forming at least one of a sensor and a support for the sensor 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 spinal implant or device, medical
delivery device for a spinal implant or device, or further
compositions (e.g., fillers) that is produced by a process
comprising a 3D printing process, such as an additive manufacturing
process, where the spinal implant or device, medical delivery
device for a spinal implant or device, or further compositions
(e.g., fillers)s includes a sensor.
[0115] Within yet further embodiments of the invention, the spinal
implant or device, medical delivery device for a spinal implant or
device, or further compositions (e.g., fillers)s provided herein
can be sterilized suitable for use in a subject.
[0116] 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.
B. Use of Spinal Implants to Deliver Therapeutic Agent(s)
[0117] As noted above, the present invention also provides
drug-eluting spinal implants and drug-coated spinal implants which
comprise one or more sensors, 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 the intervertebral disc, the
vertebral body, the spinal nerves or the spinal cord). Within
related embodiments, a drug-eluting delivery device may be included
within the spinal implant 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 Spine", which is incorporated by reference
in its entirety).
[0118] For example, within certain embodiments of the invention,
biological agents can be administered along with or released from a
spinal implant in order to increase bone growth, fibrosis or
scarring within the implant (e.g., within or along with bone
fragments in spinal cage, or along with naturally occurring or
synthetic components which can be injected into the Nucleus
Propulsis). 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 spinal
implant include components of extracellular matrix, fibronectin,
polylysine, ethylenevinylacetate, and inflammatory cytokines such
as TGF.beta., PDGF, bFGF, TNF.alpha., NGF, GM-CSF, IGF-.alpha.,
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).
[0119] 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 a spinal implant in order to prevent scarring of the
implant inappropriately, e.g., to prevent scaring or fibrosis in or
around the spinal nerves or spinal cord (see, e.g., U.S. Pat. Nos.
7,491,188, U.S. Patent Application Nos. 2005/0152945, 2005/0187639,
2006/0079836, US 2009/0254063, US 2010/0023108, and US
2010/0042121).
[0120] 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, 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.
[0121] Within other embodiments a wide variety of additional
therapeutic agents may be delivered (e.g., to prevent or treat an
infection or to treat another disease state), 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.
[0122] Within preferred embodiments one or more sensors (e.g.,
pressure sensors, contact sensors, and/or position sensors) can be
utilized to determine appropriate placement of the desired drug, as
well as the quantity and release kinetics of drug (e.g. flow
sensors, fluid volume sensors and accelerometers) to be released at
a desired site.
C. Methods for Monitoring Infection
[0123] Within other embodiments spinal device/implants are provided
comprising one or more temperature sensors. Such spinal
devices/implants can be utilized to measure the temperature of the
spinal device/implant, and in the local tissue adjacent to the
spinal device/implant. Methods are also provided for monitoring
changes in temperature over time, in order to determine and/or
provide notice (e.g., to a patient and/or a healthcare provider)
that an infection may be imminent. For example, temperature sensors
may be included within one or more components of the spinal
device/implant in order to allow early detection of infection that
could allow preemptive treatment with antibiotics or surgical
drainage and eliminate the need to surgically remove the spinal
device/implant.
[0124] In certain embodiments of the present invention, metabolic
and physical sensors can also be placed on or within the various
components of a spinal device/implant in order to monitor for rare,
but potentially life-threatening complications of spinal
device/implants. In some patients, the spinal device/implant 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). 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 spinal
device/implant.
[0125] Hence, within one embodiment of the invention methods are
provided for determining an infection associated with a spinal
implant, comprising the steps of a) providing a spinal device
and/or implant to a subject a monitored spinal device and/or
implant as described herein, wherein the spinal implant and/or
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. 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).
[0126] 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 B
(the "Therapeutic Agents")
D. Further Uses of Sensor-Containing Spinal Device/Implants in
Healthcare
[0127] Sensors on spinal device/implants, and any associated
medical devices 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 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).
[0128] 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 spinal device/implant 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;
also, since a significant amount of back pain can have a
psychosocial origin, data such as this can help better distinguish
somatic from psychosomatic symptoms. 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.
E. Generation of Power
[0129] Within certain aspects of the invention, a small electrical
generation unit can be positioned along an outer, or alternatively
an inner, surface of the spinal device/implant, 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.
[0130] 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 the sensor is physically coupled to the
spinal device/implant, 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.
F. Medical Imaging and Self-Diagnosis of Assemblies Comprising
Spinal Device/Implants; Predictive Analysis and Predictive
Maintenance
[0131] Within other aspects of the invention methods are provided
for imaging the spinal device/implant as provided herein,
comprising the steps of (a) detecting the location of one or more
sensors in the spinal device/implant, and/or associated medical
device; and (b) visually displaying the location of said one or
more sensors, such that an image of the spinal device/implant
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, such as during placement
(intra-operatively) or during the post-operative (rehabilitative)
period. Within certain preferred embodiments the image which is
displayed is a three-dimensional image. Within preferred
embodiments the various images may be collected and displayed in a
time-sequence (e.g., as a 2D or 3D moving image or `movie-like`
image). Within other embodiment, the imaging techniques may be
utilized post-operatively in order to examine the spinal
device/implant, and/or to compare operation and/or movement of the
device over time.
[0132] The present invention provides spinal device/implants and
associated medical devices which are capable of imaging through the
use of sensors over a wide variety of conditions. For example,
within various aspects of the invention methods are provided for
imaging the spinal device/implant (or portion thereof) or an
assembly comprising the spinal device/implant, medical device or
kit (as described herein) with sensors, comprising the steps of
detecting the changes in sensors in, on, and or within the spinal
device/implant, medical device or kit over time, and wherein the
spinal device/implant, medical device or 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
spinal device/implant medical device or 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 the at least one or more of the sensors may be placed
randomly, or at one or more specific locations within the spinal
device/implant, 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.
[0133] For example, the spinal device/implant, 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 spinal device/implant 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 spinal device/implant over time.
Such positional changes can be used as a surrogate marker of spinal
device/implant anatomy--i.e. they can form an "image` of the spinal
device/implant to provide information on the size, shape,
integrity, alignment and location of changes to the spinal
device/implant, and/or spinal device/implant 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).
[0134] 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 spinal device/implant 10 having
sensor 22 as shown in FIG. 20. The sensors as described herein are
collecting data on a constant basis, during normal daily activities
and even during the night if desired. For example, the contact
sensors can obtain and report data once every 10 seconds, once a
minute, or once a day. Other sensors will 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.
[0135] In certain instances the spinal device/implant is of
sufficient size and has more than sufficient space in order to
house one or more processor circuits, CPUs, memory chips and other
electrical circuits as well as antennas for sending and receiving
the data. Within other embodiments, the associated medical device
may be able to house the one or more processor circuits, CPUs,
memory chips and other electrical circuits as well as antennas for
sending and receiving the data. Processors can be programmed to
collect data from the various sensors on any desired schedule as
set by the medical professional. All activity can be continuously
monitored post operation or post-procedure and the data collected
and stored in the memory located inside the spinal
device/implant.
[0136] A patient with a spinal device/implant 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 spinal device/implant 10, in this
example the spinal device/implant, in order to transfer the data
from the internal circuit inside the spinal device/implant 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 spinal
device/implant 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 spinal device/implant. 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 spinal
device/implant 10, including the accelerations and strains during
the event itself. The doctor can then look at the health of the
spinal device/implant 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 spinal device/implant to forces beyond the
manufacturer's performance specifications for that particular
spinal device/implant. Data can be collected and compared with
respect to the ongoing and long term performance of the spinal
device/implant from the strain gauges, the contact sensors, the
surface wear sensors, the accelerometer, the position 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").
[0137] In one alternative, the patient may also have such a reading
device in their home which collates the data from the spinal
device/implant 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." 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. 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
spinal device/implants 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 spinal
device/implant 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.
G. Methods of Monitoring Assemblies Comprising Spinal
Device/Implants
[0138] As noted above, the present invention also provides methods
for monitoring one or more of the spinal device/implants provided
herein. For example, FIG. 21 illustrates a monitoring system usable
with the spinal device/implant 10 as of the type shown in any one
of the Figures described above. The monitoring system includes one
or more sensors 22 an interrogation module 124, and a control unit
126. The sensor 22 can be passive, wireless type which can operate
on power received from a wireless source. Such sensors of this type
are well known in the art and widely available. A pressure sensor
of this type might be a MEMS pressure sensor, for example, Part No.
LPS331AP, sold on the open market by STMicroelectronics. MEMS
pressure sensors are well known to operate on very low power and
suitable to remain unpowered and idle for long periods of time.
They can be provided power wirelessly on an RF signal and, based on
the power received wirelessly on the RF signal, perform the
pressure sensing and then output the sensed data.
[0139] In one embodiment, an electrical generation system (as
described above) is provided that can be utilized to power the
sensors described herein. During operation, as shown in FIG. 20, an
interrogation module 124 outputs a signal 128. The signal 128 is a
wireless signal, usually in the RF band, that contains power for
the sensors 22 as well as an interrogation request that the sensors
perform a sensing. Upon being interrogated with the signal 128, the
sensors 22 powers up and stores power in onboard capacitors
sufficient to maintain operation during the sensing and data
reporting. Such power receiving circuits and storing on onboard
capacitors are well known in the art and therefore need not be
shown in detail. The appropriate sensing is carried out by the
sensors 22 and then the data is output from the sensor back to the
interrogation module 124 on a signal 130, where it is received at
an input port of the integration module.
[0140] According to one embodiment, sufficient signal strength is
provided in the initial signal 128 to provide power for the sensor
and to carry out the sensing operation and output the signal back
to the interrogation module 124. In other embodiments, two or more
signals 128 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
130 back to the interrogation module 124. For example, the signal
128 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 124 that data is coming
and the signal 128 can be turned off to avoid interference.
Alternatively, the integration signal 128 can be at a first
frequency and the output signal 130 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 128 and send
signal 130.
[0141] The interrogation signal 128 may contain data to select
specific sensors on the spinal device/implant. For example, the
signal 128 may power up all sensors on the spinal device/implant at
the same time and then send requests for data from each at
different selected times so that with one interrogation signal 128
provided for a set time, such as 1-2 seconds, results in each of
the sensors on the spinal device/implant collecting data during
this time period and then, at the end of the period, reporting the
data out on respective signals 130 at different times over the next
0.5 to 2 seconds so that with one interrogation signal 128, the
data from all sensors 22 is collected.
[0142] The interrogation module 124 is operating under control of
the control unit 126 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.
[0143] FIG. 21 illustrates the operation according to a one
embodiment within a subject. The subject has an outer skin 132. As
illustrated in FIG. 21, the interrogation module 124 and control
unit 126 are positioned outside the skin 132 of the subject. The
interrogation signal 128 passes through the skin of the subject
with a wireless RF signal, and the data is received on a wireless
RF signal 130 from the sensors within the spinal device/implant 10
back to the interrogation module 124. While the wireless signal can
be in any frequency range, 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.
H. Collection, Transmission, Analysis, and Distribution of Data
from Assemblies Comprising Spinal Device/Implants
[0144] FIG. 22 illustrates one embodiment of an information and
communication technology (ICT) system 800 arranged to process
sensor data (e.g., data from the sensors 22). In FIG. 22, 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. 22
include computing servers 802, control units 126, interrogation
units 124, and other devices that are not shown for simplicity.
[0145] In FIG. 22, one or more sensors 22 communicate with an
interrogation module 124. The interrogation module 124 of FIG. 22
is directed by a control unit 126, but in other cases,
interrogation modules 124 operates autonomously and passes
information to and from sensors 22. One or both of the
interrogation module 124 and control unit 126 can communicate with
the computing server 802.
[0146] Within certain embodiments, the interrogation module and/or
the control unit may be a wearable device on the subject. The
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 sensors over a set (or random) period of time, collect the
data, and forward the data on to one or more networks (804).
Furthermore, the wearable device 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 wearable 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.
[0147] The information that is communicated between an
interrogation module 124 and the sensors 22, 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 sensor data from 22 may be collected
and aggregated with other data collected from a wearable device
(e.g., a device that may, in certain embodiments, include GPS data
and the like).
[0148] FIG. 22 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.
[0149] 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.
[0150] An interrogation module 124 and a control unit 126 are
optionally illustrated as communicating with a computing server
802. Via the interrogation module 124 or control unit 126, sensor
data is transferred to (and in addition or alternatively from) a
computing server 802 through network 804.
[0151] 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.
[0152] 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, control unit 126, interrogation
unit 124, 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.
[0153] Storage module 814 may include one or more types of storage
media. For example, storage module 814 of FIG. 22 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.
[0154] 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., spinal device/implant sensors). The sensor data
application typically executes a set of instructions stored on
computer-readable media.
[0155] 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.
[0156] 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.
[0157] 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.
[0158] In FIG. 22, sensor data from, e.g., sensors 22 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 sensors 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.
[0159] 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 (HIPPA).
[0160] 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.
[0161] 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.
[0162] 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.
[0163] In one embodiment, the operation of the information and
communication technology (ICT) system 800 of FIG. 22 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 spinal device/implant sensors spinal
device/implanted 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.
[0164] In one embodiment, a computer program to direct the
collection and use of spinal device/implant 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 spinal device/implant inserted in his or her body. The
wireless spinal device/implant may include one or more wireless
sensors.
[0165] 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 wireless spinal device/implants,
and each wireless spinal device/implant may have one or more
wireless sensors of the type described herein.
[0166] The computer program is arranged to direct the collection of
sensor data from the wireless spinal device/implant devices. The
sensor data is generally collected with a wireless interrogation
unit 124. In some cases, the program communicates with the wireless
interrogation unit 124. In other cases, the program communicates
with a control unit 126, which in turn directs a wireless
interrogation unit 124. In still other cases, some other mechanism
is used direct the collection of the sensor data.
[0167] 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.
[0168] 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. 22:
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
[0169] 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.
[0170] 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).
[0171] 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.
[0172] In conclusion, spinal device/implants utilizing a variety of
sensors can be utilized to serve a variety of critical clinical
functions, such as safe, accurate and less traumatic placement and
deployment of the spinal device/implant, procedural and
post-operative "real time" imaging of the spinal device/implant and
the surrounding anatomy, the early identification of the
development of spinal device/implant 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 spinal device/implant 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" spinal
device/implant performance, particularly as they relate to patient
activity levels, exercise tolerance, and the effectiveness of
rehabilitation efforts and medications.
[0173] At present, neither the physician nor the patient has access
to the type of "real time," continuous, objective, spinal
device/implant performance measurements that they might otherwise
like to have. Being able to monitor in situ spinal device/implant
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.
[0174] In one alternative, the patient may have a reading device in
their home which collates the data from the spinal device/implant
on a periodic basis, such as once per day or once per week. 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 spinal device/implants
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 spinal device/implants and assist physicians in the
selection of the right spinal device/implant 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
[0175] 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.
[0176] 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".
[0177] 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.
[0178] 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.
[0179] 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.
[0180] The following are some specific numbered embodiments of the
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.
[0181] 1) An implantable medical device, comprising a pedicle
screw, and a sensor.
[0182] 2) An implantable medical device, comprising a spinal wire,
and a sensor.
[0183] 3) An implantable medical device, comprising a spinal rod,
and a sensor.
[0184] 4) An implantable medical device, comprising a spinal plate,
and a sensor.
[0185] 5) An implantable medical device, comprising a spinal cage,
and a sensor.
[0186] 6) An implantable medical device, comprising an artificial
disc, and a sensor.
[0187] 7) An implantable medical device kit, comprising a pedicle
screw, a spinal rod and a sensor.
[0188] 8) An implantable medical device kit, comprising a pedicle
screw, a spinal plate and a sensor.
[0189] 9) An implantable medical device, comprising a polymer and a
sensor.
[0190] 10) The medical device according to embodiment 9 wherein
said polymer is selected from the group consisting of a
polymethylmethacrylate, a methylmethacrylate-styrene copolymer,
fibrin, polyethylene glycol, carboxymethylcellulose, and
polyvinylalcohol.
[0191] 11) An implantable medical device, comprising a kyphoplasty
balloon, and a sensor.
[0192] 12) The medical device according to any one of embodiments 1
to 11 wherein said sensor is located within said implant.
[0193] 13) The medical device according to any one of embodiments 1
to 11 wherein said sensor is located on said implant.
[0194] 14) The medical device according to any one of embodiments 1
to 13 wherein said device is sterile.
[0195] 15) The medical device according to any one of embodiments 1
to 14 wherein said sensor is a contact sensor.
[0196] 16) The medical device according to any one of embodiments 1
to 14 wherein said sensor is a pressure sensor.
[0197] 17) The medical device according to any one of embodiments 1
to 14 wherein said sensor is an accelerometer sensor.
[0198] 18) The medical device according to embodiment 17 wherein
said accelerometer detects acceleration, tilt, vibration, shock and
or rotation.
[0199] 19) The medical device according to any one of embodiments 1
to 14 wherein said sensor is a temperature sensor.
[0200] 20) The medical device according to any one of embodiments 1
to 14 wherein said sensor is a mechanical stress sensor.
[0201] 21) The medical device according to any one of embodiments 1
to 14 wherein said sensor is selected from the group consisting of
position sensors, chemical microsensors, and tissue metabolic
sensors.
[0202] 22) The medical device according to any one of embodiments 1
to 22 further comprising:
[0203] an electronic processor positioned upon and/or inside the
spinal device/implant or medical device that is electrically
coupled to sensors.
[0204] 23) The medical device according to embodiment 22 wherein
the electric coupling is a wireless coupling.
[0205] 24) The medical device according to embodiment 22 further
including: a memory coupled to the electronic processor and
positioned upon and/or inside the spinal device/implant or medical
device.
[0206] 25) The medical device according to any one of embodiments 1
to 24 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.
[0207] 26) The medical device according to any one of embodiments 1
to 24 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.
[0208] 27) A method comprising:
[0209] obtaining data from sensors positioned at a plurality of
locations between on and/or within the medical device according to
any one of embodiments 1 to 26 of a patient;
[0210] storing the data in a memory device located on or within the
medical device; and transferring the data from the memory to a
location outside the medical device.
[0211] 28) The method according to embodiment 27 further comprising
the step of analyzing said data.
[0212] 29) A method for detecting and/or recording an event in a
subject with the medical device according to any one of embodiments
1 to 26, 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.
[0213] 30) The method according to embodiment 29 wherein the step
of interrogating is performed by a subject which has said medical
device.
[0214] 31) The method according to embodiment 29 or 30 wherein said
recording is performed on a wearable device.
[0215] 32) The method according to any one of embodiments 29, 30 or
31, wherein said recording, or a portion thereof, is provided to a
health care provider.
[0216] 33) A method for imaging the medical device in the spine,
comprising the steps of
[0217] (a) detecting the location of one or more sensors in the
medical device accordi to any one of embodiments 1 to 26; and
[0218] (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 spine is created.
[0219] 34) The method according to embodiment 33 wherein the step
of detecting occurs over time.
[0220] 35) The method according to embodiment 33 or 34, 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.
[0221] 36) The method according to any one of embodiments 33 to 35
wherein said visual display is a three-dimensional image of said
medical device in the spine.
[0222] 37) A method for inserting the spinal device/implant
according to any one of embodiments 1 to 26, comprising the steps
of
[0223] (a) inserting an implantable medical device according to any
one of embodiments 1 to 26 into a subject; and
[0224] (b) imaging the placement of said medical device according
to the method of an one of embodiments 33 to 36.
[0225] 38) A method for examining the spinal device/implant
according to any one of embodiments 1 to 26 which has been
previously inserted into a patient, comprising the step of imaging
the spinal device/implant according to the method of any one of
embodiments 33 to 36.
[0226] 39) A method of monitoring a spinal device/implant within a
subject, comprising:
[0227] transmitting a wireless electrical signal from a location
outside the body to a location inside the subject's body;
[0228] receiving the signal at a sensor positioned on a spinal
device/implant according to any one of embodiments 1 to 26 located
inside the body;
[0229] powering the sensor using the received signal;
[0230] sensing data at the sensor; and
[0231] outputting the sensed data from the sensor to a receiving
unit located outside of the body.
[0232] 40) The method according to embodiment 39 wherein said
receiving unit is a watch, wrist band, cell phone or glasses.
[0233] 41) The method according to embodiments 39 or 40 wherein
said receiving unit is located within a subject's residence or
office.
[0234] 42) The method according to embodiments any one of
embodiments 39 to 41 wherein said sensed data is provided to a
health care provider.
[0235] 43) The method according to any one of embodiments 39 to 42
wherein said sensed data is posted to one or more websites.
[0236] 44) A non-transitory computer-readable storage medium whose
stored contents configure a computing system to perform a method,
the method comprising:
[0237] identifying a subject, the identified subject having at
least one wireless spinal device/implant according to any one of
embodiments 1 to 26, each wireless spinal device/implant having one
or more wireless sensors;
[0238] directing a wireless interrogation unit to collect sensor
data from at least one of the respective one or more wireless
sensors; and
[0239] receiving the collected sensor data.
[0240] 45) The non-transitory computer-readable storage medium of
embodiment 44 whose stored contents configure a computing system to
perform a method, the method further comprising:
[0241] identifying a plurality of subjects, each identified subject
having at least one wireless spinal device/implant, each wireless
spinal device/implant having one or more wireless sensors;
[0242] 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;
[0243] receiving the collected sensor data; and
[0244] aggregating the collected sensor data. 46) The
non-transitory computer-readable storage medium of embodiment 44
whose stored contents configure a computing system to perform a
method, the method further comprising:
[0245] removing sensitive subject data from the collected sensor
data; and parsing the aggregated data according to a type of
sensor.
[0246] 47) The non-transitory computer-readable storage medium of
embodiment 44 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.
[0247] 48) The non-transitory computer readable storage medium
according to any one of embodiments 44 to 47, wherein said spinal
device/implant is according to any one of embodiments 1 to 26.
[0248] 49) The storage medium according to any one of embodiments
44 to 48 wherein said collected sensor data is received on a watch,
wrist band, cell phone or glasses.
[0249] 50) The storage medium according to any one of embodiments
44 to 49 wherein said collected sensor data is received within a
subject's residence or office.
[0250] 51) The storage medium according to any one of embodiments
44 to 50 wherein said collected sensed data is provided to a health
care provider.
[0251] 52) The storage medium according to any one of embodiments
44 to 51 wherein said sensed data is posted to one or more
websites.
[0252] 53) The method according to any one of embodiments 39 to 43,
or storage medium according to any one of embodiments 44 to 52,
wherein said data is analyzed.
[0253] 54) The method or storage medium according to embodiment 53
wherein said data is plotted to enable visualization of change over
time.
[0254] 55) The method or storage medium according to embodiments 53
or 54 wherein said data is plotted to provide a three-dimensional
image.
[0255] 56) A method for determining degradation of a spinal
device/implant, comprising the steps of a) providing to a subject a
spinal device/implant according to any one of embodiments 1 to 26,
and b) detecting a change in a sensor, and thus determining
degradation of the spinal device/implant.
[0256] 57) The method according to embodiment 55 wherein said
sensor is capable of detecting one or more physiological and/or
locational parameters.
[0257] 58) The method according to embodiments 55 or 56 wherein
said sensor detects a location within the subject.
[0258] 59) The method according to any one of embodiments 55 to 58
wherein said sensor moves from its original location, thereby
indicating degradation of the spinal device/implant.
[0259] 60) The method according to any one of embodiments 55 to 59
wherein the step of detecting is a series of detections over
time.
[0260] 61) A method for determining an infection associated with a
spinal device/implant, comprising the steps of a) providing to a
subject a spinal device/implant according to any one of embodiments
1 to 26, wherein said spinal device/implant 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.
[0261] 62) The method according to embodiment 60 wherein the step
of detecting is a series of detections over time.
[0262] 63) The method according to embodiments 60 or 61 wherein
said change is greater than a 1% change over the period of one
hour.
[0263] 64) The method according to any one of embodiments 60 to 62
wherein said change is a continually increasing temperature and/or
metabolic activity over the course of 4 hours.
[0264] 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.
[0265] 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