U.S. patent application number 15/640314 was filed with the patent office on 2017-10-19 for devices for intraluminal sensing.
The applicant listed for this patent is Endophys Holdings, LLC. Invention is credited to Steven J. Ferry, Phillip D. Purdy.
Application Number | 20170296780 15/640314 |
Document ID | / |
Family ID | 43857396 |
Filed Date | 2017-10-19 |
United States Patent
Application |
20170296780 |
Kind Code |
A1 |
Purdy; Phillip D. ; et
al. |
October 19, 2017 |
DEVICES FOR INTRALUMINAL SENSING
Abstract
Medical devices, perfusion systems, and methods for detecting a
pressure within a space in a subject and for perfusion of fluid
into a space in a subject. The space may be a fluid-filled space,
or a space that is depleted of fluid due to an obstruction to fluid
flow into the space. Methods for forming the medical devices.
Inventors: |
Purdy; Phillip D.;
(Maypearl, TX) ; Ferry; Steven J.; (Maple Grove,
MN) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Endophys Holdings, LLC |
Dallas |
TX |
US |
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|
Family ID: |
43857396 |
Appl. No.: |
15/640314 |
Filed: |
June 30, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14687761 |
Apr 15, 2015 |
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15640314 |
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12900360 |
Oct 7, 2010 |
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14687761 |
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61249573 |
Oct 7, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/0261 20130101;
A61B 5/02007 20130101; A61B 5/026 20130101; A61M 2025/0001
20130101; A61M 25/005 20130101; A61M 2205/3303 20130101; A61B
5/0215 20130101; A61M 25/0012 20130101; A61B 5/02154 20130101; A61M
2025/0002 20130101; A61M 2205/3368 20130101; A61B 5/6852 20130101;
A61M 2205/3334 20130101; A61B 2562/12 20130101; Y10T 29/49002
20150115; A61M 2025/0003 20130101; A61B 2017/00084 20130101; A61B
2090/064 20160201; A61M 25/0097 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 25/00 20060101 A61M025/00; A61B 5/0215 20060101
A61B005/0215; A61B 5/026 20060101 A61B005/026; A61B 5/00 20060101
A61B005/00 |
Claims
1. A method comprising: forming an elongated body having a wall
that defines a first lumen, a stiffener embedded in the wall, and a
sensor lumen positioned in the wall, where the sensor lumen is not
in direct fluid communication with the first lumen and does not
impinge on the first lumen, the elongated body has a first end and
a second end, and the first lumen extends from the first end to the
second end such that both the first and second ends are open; and
positioning a sensor at least partially in the sensor lumen.
2. The method of claim 1, where the sensor lumen is bounded, at
least in part, by a liner.
3. The method of claim 2, where the liner includes a polymer.
4. The method of claim 2, where the liner includes a metal.
5. The method of claim 1, where the forming included heating a
polymer that forms the wall.
6. The method of claim 1, where the first lumen is shaped using a
mandrel, and where the sensor lumen is shaped using another
mandrel.
7. The method of claim 1, where the sensor is connected to a
transmission line, and the positioning the sensor at least
partially in the sensor lumen comprises positioning the sensor at
least partially in the sensor lumen and positioning a portion of
the transmission line in the sensor lumen.
8. The method of claim 1, further comprising: securing the sensor
to the elongated body using an embedding medium.
9. The method of claim 8, where the forming includes forming the
elongated body to have an opening in the wall that is in
communication with the sensor lumen, and the securing includes
inserting the embedding medium into the sensor lumen through the
opening.
10. The method of claim 1, the method further comprising: securing
the sensor to the elongated body such that the sensor can detect a
parameter through an opening at the first end of the elongated
body.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/687,761, filed Apr. 15, 2015, which is a
continuation of U.S. patent application Ser. No. 12/900,360, filed
Oct. 7, 2010, which claims priority to U.S. Provisional Application
No. 61/249,573 filed Oct. 7, 2009, the entireties of all of which
are incorporated by reference without disclaimer.
BACKGROUND
Field
[0002] The invention relates generally to medical devices,
perfusion systems, and combinations of medical devices and
perfusion systems configured to detect fluid pressure in a
fluid-filled space or space normally occupied by fluid and/or to
transfer fluid to or from a space in a subject. The invention also
relates to perfusion systems configured to be used to perfuse a
fluid into a site in a subject, such as a site downstream to an
arterial or venous occlusion in a subject. The invention further
relates to methods of perfusing a fluid into a subject that has an
obstruction to fluid flow by employing a medical device, perfusion
system, or combination of medical device and perfusion system to
perfuse fluid downstream to a site of obstruction to fluid flow.
The obstruction to fluid flow may be, for example, an obstruction
to blood flow in a blood vessel, such as a cerebral artery. The
invention also relates to methods of manufacturing the present
medical devices.
Description of the Related Art
[0003] Examples of medical devices that include pressure sensors
and reperfusion devices include those disclosed in U.S. Pat. Nos.
5,701,905, 5,800,374, 6,042,559, 6,044,845, 6,295,990, 6,435,139,
and 7,520,858, and U.S. Patent Application Pub. Nos. 2008/0142783,
2008/0161794, 2008/0228167, 2009/0125007, 2010/0114063.
SUMMARY
[0004] Methods for incorporating one or more sensors (e.g.,
pressure sensors) into conduits like catheters, sheaths, and hubs
for either are disclosed. Some embodiments of the methods include
creating passageways for the transmission lines for the
sensors.
[0005] Some embodiments of the present methods include forming an
elongated body having a wall that defines a first lumen, a
stiffener embedded in the wall, and a sensor lumen positioned in
the wall, where the sensor lumen is not in direct fluid
communication with the first lumen and does not impinge on the
first lumen, the elongated body has a first end and a second end,
and the first lumen extends from the first end to the second end
such that both the first and second ends are open; and positioning
a sensor at least partially in the sensor lumen. In some
embodiments, the method also includes connecting a hub to the
elongated body, the hub containing a first lumen in communication
with the first lumen of the elongated body, a valve configured to
seal the first lumen of the hub, and a second lumen in
communication with the sensor lumen of the elongated body. The hub
may have multiple pieces. The hub lumens may be positioned in
separate pieces or the same piece.
[0006] Some embodiments of the present methods include positioning
one or more of: a first lumen mandrel; a stiffener; a second lumen
mandrel; a first lumen tube; a second lumen tube; and a shrink wrap
material such that the stiffener is outside of the first lumen
mandrel, the first lumen tube is outside of the stiffener, the
shrink wrap material is outside of the first lumen tube, and both
the second lumen mandrel and the second lumen tube are inside of
the shrink wrap material, thereby forming a combination; heating
the combination such that a melting temperature of the first lumen
tube is reached and such that an activation temperature of the
shrink wrap material is reached, the heating being sufficient to
form an elongated body having a wall defining a first lumen, the
elongated body also having a second lumen positioned in the wall;
after the heating, removing the second lumen mandrel leaving the
second lumen formed at least in part by the second lumen tube; and
positioning a sensor at least partially in the second lumen; where
the elongated body has a first end and a second end, and the first
lumen extends from the first end to the second end such that both
the first and second ends are open. The heating may be accomplished
through an infrared heater.
[0007] Medical devices made using the present methods are also
disclosed. Some embodiments of the present medical devices include
an elongated body having a wall that defines a first lumen, a
stiffener embedded in the wall, and a sensor lumen positioned in
the wall; and a sensor positioned at least partially in the sensor
lumen; where the sensor lumen is separate from the first lumen so
as not to be in direct fluid communication with the first lumen and
does not impinge on the first lumen, the elongated body has a first
end and a second end, and the first lumen extends from the first
end to the second end such that both the first and second ends are
open.
[0008] Some embodiments of the present medical devices include a
body configured as a hub for connection to an elongated tube, the
body including a primary lumen, a side arm that includes a flushing
lumen that is in direct fluid communication with the primary lumen,
and an embedded transmission line that is not in direct fluid
communication with the flushing lumen or the primary lumen within
the body; and a valve configured to seal the primary lumen.
[0009] Some embodiments of the present medical devices and
perfusion systems can be used to detect fluid pressure in a space
and to transmit fluid to or from a space in a subject. The medical
devices and perfusion systems have a wide application in the
treatment of subjects with an obstruction to fluid flow, such as an
obstruction to blood flow in a blood vessel or an obstruction of a
visceral organ.
[0010] The present medical devices may have an elongated body
having a passageway, a downstream end, and a proximal end; and a
pressure sensor attached to the elongated body, the pressure sensor
having a length along any axis that is not greater than 2 mm, the
pressure sensor being configured to detect a fluid pressure and
output one or more signals representative of the detected fluid
pressure. Whether an end is "proximal" or "distal" is determined
relative to the position of a user. For example, if an elongated
body is inserted by a user into a subject, the "distal end" is the
end that is farthest away from the user and the "proximal end" is
the end that is closest to the user. Some embodiments are further
defined as having a device length extending from the distal end of
the elongated body to the proximal-most exposed portion of the
proximal end of the elongated body, where the device length is
between 10 cm and 160 cm. In some embodiments, the device length is
between 60 cm and 140 cm. At least a portion of the elongated body
of the medical device has an outer diameter of 3 French (1.0 mm) to
10 French (3.3 mm). The French size will in part depend on the
application. For example, for applications that involve infusion of
fluid into a cerebral artery, the outer diameter of the medical
devices will range from 3 French to 4 French. Larger diameters may
be used for infusion of fluid into larger vessels (such as a
femoral artery, carotid artery) or a hollow visceral organ (such as
urethra, ureter, or bladder) or when used as an introducer
sheath.
[0011] In some embodiments, the pressure sensor is configured to
have a thickness of between 1 micron and 500 microns. The pressure
sensor may have a thickness of between 1 micron and 100 microns.
The pressure sensor may be configured to communicate a signal
corresponding to fluid pressure via radiofrequency signals or other
forms of wireless communication. In some embodiments, the pressure
sensor has a width of 10 microns to 2.0 mm, a length of 10 microns
to 2.0 mm, and a thickness of 10 microns to 1.0 mm.
[0012] The present medical devices may further include a hub
coupled to or integral with the proximal end of the elongated body.
The hub can be configured in any manner known to those of ordinary
skill in the art. For example, the hub may be configured to
interlock with a second medical device such as a tubular medical
device for transfer of a fluid from one site (such as the
passageway of the medical device) to a second site.
[0013] The present medical devices may optionally include a side
arm having a side arm passageway in communication with the
passageway of the elongated body, where the pressure sensor is not
exposed to the passageway of the elongated body. In some
embodiments, the medical device further includes a stopcock coupled
to or integral with the side arm. The side arm may have a proximal
end coupled to or integral with a hub.
[0014] In some embodiments, the medical device includes an
introducer slidably positioned in the passageway of the elongated
body, the introducer having a tapered distal tip. The introducer is
configured to facilitate insertion of the medical device into a
fluid-filled site in a subject, such as a blood vessel. The
introducer may be positioned in the passageway of the elongated
body such that the distal tapered tip protrudes from the distal end
of the elongated body. The proximal end of the introducer may be
configured to contact or interlock with the proximal end of the
elongated body such that the position of the introducer is secured
with the distal tapered tip protruding from the distal end of the
elongated body. Such stabilization facilitates the use of the
introducer to insert the medical device into a fluid-filled space
in a subject.
[0015] Some embodiments of the present medical devices include: (1)
sheath that includes a sheath elongated body having a passageway, a
distal end, and a proximal end; a side arm having a side arm
passageway in communication with the passageway of the sheath
elongated body; and a sheath pressure sensor attached to the sheath
elongated body, the sheath pressure sensor being configured to
detect a fluid pressure and output one or more signals
representative of the detected fluid pressure; (2) an introducer
that includes an introducer elongated body having a proximal end
and a distal end that includes a tapered tip, the introducer being
configured to be slidably positioned within the passageway of the
sheath elongated body; and (3) a catheter that includes a catheter
elongated body having a catheter passageway, a distal end, and a
proximal end coupled to or integral with a hub; and a catheter
pressure sensor attached to the catheter elongated body, the
catheter pressure sensor being configured to detect a fluid
pressure and output one or more signals representative of the
detected fluid pressure; where the catheter is configured to be
slidably positioned within the passageway of the sheath elongated
body when that passageway is not occupied by the introducer.
[0016] The sheath may have a sheath length extending from the
distal end of the sheath elongated body to the proximal-most
exposed portion of the proximal end of the sheath elongated body,
the sheath length being between 10 cm and 150 cm. In some
embodiments, the sheath length is between 60 cm and 90 cm. At least
a portion of the sheath elongated body may have an outer diameter
of 5 French (1.67 mm) to 10 French (3.3 mm).
[0017] The catheter may have a catheter length extending from the
distal end of the catheter elongated body to the proximal-most
exposed portion of the proximal end of the catheter elongated body,
the catheter length being between 70 cm and 160 cm. In further
embodiments, such as embodiments utilized for insertion into the
cerebral vasculature of a subject, the catheter length is between
120 cm and 140 cm. At least a portion of the catheter elongated
body has an outer diameter of 3 French (1 mm) to 7 French (2.3
mm).
[0018] In some embodiments, the passageway of the sheath elongated
body has a diameter that is 0.5 to 2 mm larger than the outer
diameter of the catheter that is slidably configured to be
positioned within the passageway of the sheath elongated body. In
other embodiments, the passageway of the sheath elongated body is
0.5 to 1 mm larger than the outer diameter of the catheter that is
slidably configured to be positioned within the passageway of the
sheath elongated body.
[0019] The introducer may include an introducer passageway
configured to receive a guidewire. In some embodiments, the medical
device further includes a guidewire slidably positioned in the
introducer passageway. The guidewire may be any guidewire known to
those of ordinary skill in the art. The guidewire typically
includes a proximal end and a distal end. The length of the
guidewire, which is the distance between the proximal end and the
distal end, is typically greater than the length of the
introducer.
[0020] In some embodiments of the present medical devices that
include a sheath, and the passageway of the sheath is thermally
insulted. Thermal insulation of the passageway of the sheath may be
performed using any method known to those of ordinary skill in the
art, including any of the methods described below for thermally
insulating a passageway of a catheter.
[0021] The catheter elongated body may optionally include a region
that thermally insulates the catheter passageway. For example, a
fluid that is cooled below the body temperature of a subject may be
infused into a space in a subject using the catheter. Thermal
insulation of the catheter passageway facilitates retention of
temperature of the infused fluid. A separate pump may be used to
pump a coolant through the catheter wall (or the sheath wall in
instances where the catheter is slidably positioned within the
sheath) in a closed loop system. Any method known to those of
ordinary skill in the art may be used to insulate the catheter
passageway.
[0022] In some embodiments, the medical device includes: (1) a
first sheath comprising a first sheath elongated body having a
first sheath passageway, a distal end, and a proximal end coupled
to a valve, the first sheath having a length extending from the
distal end of the first sheath elongated body to the proximal-most
exposed portion of the first sheath elongated body; (2) a second
sheath that includes a second sheath elongated body having a second
sheath passageway, a distal end, and a proximal end coupled to or
integral with a hub, the second sheath having a length extending
from the distal end of the second elongated body to the
proximal-most exposed portion of the second elongated body, the
length of the first sheath being greater than the length of the
second sheath, the second sheath being couplable to the first
sheath so that, in use during a procedure, the distal end of the
second sheath elongated body will be proximal of the distal end of
the first sheath elongated body; (3) a catheter including a
catheter elongated body configured to be positionable in the first
sheath passageway, the catheter having a distal end and a proximal
end coupled to or integral with a hub; (4) a first pressure sensor
attached to the first sheath or the second sheath, the first
pressure sensor being configured to detect a fluid pressure and
output one or more signals representative of the detected fluid
pressure; (5) a second pressure sensor attached to the catheter,
the second pressure sensor being configured to detect a fluid
pressure and output one or more signals representative of the
detected fluid pressure; (6) a first introducer positionable in the
first sheath passageway, the first introducer having a tapered
distal tip; and (7) a second introducer positionable in the second
sheath passageway.
[0023] The first introducer may include an introducer passageway
configured to receive a guidewire, and the medical device further
includes a guidewire positionable in the introducer passageway. In
some embodiments, the distal tip of the second introducer is
configured to align with the distal end of the second sheath
elongated body to form a substantially flush end surface.
[0024] Further embodiments include perfusion systems that include:
(1) a sheath including a sheath elongated body having a passageway,
a distal end, and a proximal end; a side arm having a side arm
passageway in communication with the passageway of the sheath
elongated body; a sheath pressure sensor attached to the sheath
elongated body, the sheath pressure sensor being configured to
detect a fluid pressure and output one or more signals
representative of the detected fluid pressure; (2) a catheter
including a catheter elongated body having a catheter passageway, a
distal end, and a proximal end coupled to or integral with a hub;
and a catheter pressure sensor attached to the catheter elongated
body, the catheter pressure sensor being configured to detect a
fluid pressure and output one or more signals representative of the
detected fluid pressure; where the catheter is configured to be
slidably positioned within the passageway of the sheath elongated
body; and (3) a device including a detector system configured to
receive one or more signals from the sheath pressure sensor and/or
the catheter pressure sensor to determine and/or display a value
corresponding to each detected fluid pressure; and a pump coupled
to the side arm and to the catheter, the pump configured to
facilitate the transfer of fluid from the side arm to the
catheter.
[0025] The pump may be configured to facilitate the transfer of
fluid from the side arm to the catheter using any method known to
those of ordinary skill in the art. For example, the pump may
utilize a roller on a piece of tubing to facilitate pumping of
fluids. In other embodiments, a chamber with a compressor
facilitates transfer of fluids. A power syringe may be employed
such as a power injector pump used for angiographic procedures.
Other examples of pumps contemplated include diaphragm-type
mechanisms to fill a chamber and then empty it, with valves to
control the directionality of flow.
[0026] The device may further be configured to reduce temperature
of the fluid that is being transferred from the side arm to the
catheter. Any method known to those of ordinary skill in the art
may be used to reduce temperature of the transferred. For example,
the device may include a thermoregulator that functions to reduce
temperature of the fluid that is being pumped from the side arm to
the catheter.
[0027] The perfusion system may include any of the medical devices
as set forth in this disclosure. In some embodiments, the perfusion
system further includes a thermoregulator. The thermoregulator is
configured to cool blood that has passed from the side arm to the
catheter. The thermoregulator may be separate or integral to the
detector system. The thermoregulator may further include a monitor
that displays temperature of the fluid that has passed from the
side arm to the catheter. In some embodiments, an ice bath is
configured to be a thermoregulator.
[0028] Some embodiments of the present perfusion systems include:
(1) a first sheath including a first sheath elongated body having a
first sheath passageway, a distal end, and a proximal end coupled
to a valve, the first sheath having a length extending from the
distal end of the first sheath elongated body to the proximal-most
exposed portion of the first sheath elongated body; (2) a second
sheath including a second sheath elongated body having a second
sheath passageway, a distal end, and a proximal end coupled to or
integral with a hub, the second sheath having a length extending
from the distal end of the second sheath elongated body to the
proximal-most exposed portion of the second sheath elongated body,
the length of the first sheath being greater than the length of the
second sheath, the second sheath being couplable to the first
sheath so that, in use during a procedure, the distal end of the
second sheath elongated body will be proximal of the distal end of
the first sheath elongated body; (3) a catheter comprising a
catheter elongated body configured to be positionable in the first
sheath passageway, the catheter having a distal end and a proximal
end coupled to or integral with a hub; (4) a first pressure sensor
attached to the first sheath or the second sheath, the first
pressure sensor being configured to detect a fluid pressure and
output one or more signals representative of the detected fluid
pressure; (5) a second pressure sensor attached to the catheter,
the second pressure sensor being configured to detect a fluid
pressure and output one or more signals representative of the
detected fluid pressure; (6) a first introducer positionable in the
first sheath passageway, the first introducer having a tapered
distal tip; a second introducer positionable in the second sheath
passageway; and (7) a device having a detector system configured to
receive one or more signals from the first pressure sensor and/or
the second pressure sensor to determine and/or display a value
corresponding to each detected fluid pressure; and a pump coupled
to the side arm and to the catheter, the pump configured to
facilitate the transfer of fluid from the second sheath passageway
to the catheter.
[0029] The device components may be incorporated into a single
unit, or may be in multiple units. In some embodiments, a control
system facilitates coordinating of the separate components of the
device.
[0030] Also disclosed are methods of perfusing a fluid in a subject
that has an obstruction to fluid flow, including: inserting a first
elongated body having a passageway into the subject; inserting a
catheter through the passageway and advancing the catheter in a
downstream (distal) direction through the obstruction; detecting a
fluid pressure downstream of the obstruction with a pressure
detector attached to the catheter; detecting a fluid pressure
upstream of the obstruction with a pressure detector attached to
the first elongated body; withdrawing blood from the subject; and
perfusing the blood through the catheter and to a location
downstream of the obstruction if a fluid pressure detected
downstream of the obstruction satisfies a safety check. In some
embodiments, the blood withdrawn from the subject is withdrawn out
of a side port of the first elongated body. In further embodiments,
the blood withdrawn from the subject is withdrawn out of a second
elongated body coupled to the first elongated body.
[0031] The subject may be a patient with an obstruction to blood
flow. For example, the patient may have a plaque in an artery or a
thrombus in a vein. In particular embodiments, the patient has an
obstruction to flow in a cerebral artery, resulting in a stroke.
The stroke may be a non-hemorrhagic stroke. One embodiment may be a
method of treating a patient with a stroke that involves
reperfusion of blood beyond a site of arterial occlusion in a
cerebral artery. Blood obtained from the hub of the second catheter
may be perfused through the passageway of the catheter. Restoration
of perfusion to levels that will sustain tissue without infarction
is one purpose of the present methods.
[0032] In some embodiments, the fluid that is perfused into the
subject is cooled fluid. For example, in methods that concern the
treatment of a patient with a stroke, reperfusion of cooled blood
provides for preservation of brain tissue to slow cerebral
metabolism sufficiently that metabolic demands of the brain are
decreased. Lowered tissue temperature lowers the requirements of
oxygen and glucose to maintain tissue viability, thus reducing the
likelihood of infarction and permanent damage. Other means to slow
cerebral metabolism that are contemplated for inclusion in the
present methods include infusion of barbiturates through the
catheter to induce a "barbiturate coma" in portions of the brain
that are undergoing reperfusion. Other means to slow tissue
metabolism are contemplated for optional inclusion in the present
methods.
[0033] In some embodiments, a catheter pressure sensor monitors
fluid pressure downstream (distal) to a site of obstruction to
blood flow. Infusion of fluid through the catheter will be
controlled such that the intravascular pressure encountered by the
catheter pressure sensor will not exceed the fluid pressure as
detected by the sheath pressure sensor. Such monitoring of pressure
provides for a safety mechanism to limit the prospect that pressure
will rise unexpectedly to levels that will result in vascular
compromise, such as arterial rupture. Hence, the monitoring of
fluid pressure proximal and distal to a site of vascular occlusion
is integral to the safe function of the reperfusion system.
[0034] If fluid pressure as measured by the catheter pressure
sensor equals pressure as measured by the catheter sheath, a safety
mechanism may be incorporated into the device such that pumping of
fluid from the second sheath (or side arm) is halted or slowed.
[0035] The present methods may further include, while at least a
portion of the first elongated body is surrounding at least a
portion of the catheter, directing a cooled solution through the
first elongated body for a period of time while perfusing the blood
through the catheter. In some embodiments, the perfusing is
controlled based on one or more of the fluid pressure detected
downstream of the obstruction and the fluid pressure detected
upstream of the obstruction.
[0036] Some embodiments of the present methods that include the
dual sheath system further include flushing a cooled solution such
as heparinzed saline along the catheter between the catheter and
the sheath when the catheter is slidably positioned within the
sheath and blood is flowing through catheter to a location
downstream of the obstruction. This flushing with cooled fluid may
be particularly useful if the blood traveling through the catheter
is cooled in that it will help to maintain that cooled state. The
flushing may be accomplished in any suitable manner (e.g., with a
compressible bulb, a plungable syringe, a pump separate from the
pump that advances the blood, etc.). The flushing may also help to
prevent thrombus formation along the course of the catheter passing
through the sheath.
[0037] Some embodiments of the present methods anticipate
administering one or more additional therapies directed at the
treatment of a subject with an obstruction to flow of a fluid. For
example, a subject with an obstruction to blood flow may receive a
pharmacological agent such as an agent that facilitates clot
dissolution. Other therapeutic agents contemplated for
administration include anticoagulants, medications to prevent
seizure occurrence, and antibiotics. Also, devices which remove a
clot ("Merci") or aspirate a clot ("Penumbra") exist currently for
stroke therapy and may be used in conjunction with the present
method. In some embodiments, the additional treatment includes
stent placement or angioplasty.
[0038] Some aspects of the present kits include any of the present
medical devices or perfusion systems in suitable packaging. For
example, the kit may include a present medical device in a
hermetically sealed package and instructions for use. Further
embodiments of the kits include a present perfusion system in
suitable packaging, with instructions for use. Medical device and
perfusion system components, such as catheters, sheaths,
introducers, and guidewires, may be packaged separately in the kit
in hermetically sealed containers or may be packaged in the same
hermetically sealed container.
[0039] Some embodiments of the present kits include a pump for
administration of a hypothermic flushing solution into a passageway
of a lumen of a catheter, sheath, or side arm of the present
medical devices.
[0040] Any embodiment of any of the present medical devices,
perfusion systems, methods and kits may consist of or consist
essentially of--rather than comprise/include/contain/have--the
described features and/or steps. Thus, in any of the claims, the
term "consisting of" or "consisting essentially of" may be
substituted for any of the open-ended linking verbs recited above,
in order to change the scope of a given claim from what it would
otherwise be using the open-ended linking verb.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] The following drawings illustrate by way of example and not
limitation. Identical reference numbers do not necessarily indicate
an identical structure. Rather, the same reference number may be
used to indicate a similar feature or a feature with similar
functionality, as may non-identical reference numbers. Every
feature of each embodiment is not always labeled in every figure in
which that embodiment appears, in order to keep the figures
clear.
[0042] FIG. 1A is a side view of an embodiment of the present
medical devices.
[0043] FIG. 1B is a side view of another embodiment of the present
medical devices.
[0044] FIG. 1C is a cross-sectional view of the device depicted in
FIG. 1A through the pressure sensor.
[0045] FIG. 1D is a cross-sectional view of the device depicted in
FIG. 1B through the pressure sensor.
[0046] FIG. 1E is a side view of the proximal end of an embodiment
of the present medical devices that includes a hub at the proximal
end of the medical device.
[0047] FIG. 2 is a side view of an embodiment of the present
medical devices showing a proximal end that includes a side arm
with a stopcock.
[0048] FIG. 3 is a side view of an embodiment of the present
medical devices depicting a sheath with an introducer slidably
positioned in the sheath passageway and a guidewire slidably
positioned within the introducer passageway.
[0049] FIG. 4 is a cross-sectional view of one embodiment of the
present medical devices depicting a plurality of spaces within the
wall of the elongated body that provide for thermoregulation of
fluid within the passageway of the elongated body.
[0050] FIG. 5A is a side view of an embodiment of the present
medical devices having a first sheath and a second sheath, with a
catheter slidably positioned within the passageway of the first
sheath.
[0051] FIG. 5B is a side view of an embodiment of the present
medical devices having a first sheath and a second sheath as in
FIG. 5A, with a first introducer slidably positioned within the
first sheath passageway and a second introducer slidably positioned
within the second sheath passageway.
[0052] FIG. 5C is a cross-sectional view of the medical device
shown in FIG. 5B, depicting a first introducer within the first
sheath passageway and a second introducer within the second sheath
passageway.
[0053] FIG. 6 is a side view of an embodiment of the present
perfusion systems, depicting a sheath with a sheath pressure
sensor, a catheter (having a catheter pressure sensor) positioned
within the sheath passageway, and schematically-depicted leads
extending from the pressure sensors to a device that includes a
detector system for receiving one or more signals from each of the
sensors.
[0054] FIG. 7 is a side view of one embodiment of a device of one
of the present perfusion systems, which includes a detector system,
a pump, a power source, a cooling system, and a control system. The
depicted embodiment shows connected tubing for transporting cooling
fluid to and from the device, connected tubing for transporting
blood to and from a sheath and catheter, and leads attached to the
device that are configured to receive signals from the pressure
sensors of one of the present medical devices.
[0055] FIG. 8 is a diagram that depicts one embodiment of the
present kits that includes sealed packaging containing one of the
present medical devices and instructions for use.
[0056] FIG. 9 is a diagram depicting the use of an embodiment of
the present perfusion systems to deliver blood to a site located
downstream of an obstruction in a carotid artery of a subject.
[0057] FIG. 10 depicts a side view of the distal end of one
embodiment of the present medical devices that has been positioned
for reperfusion of blood across a site of obstruction in a blood
vessel.
[0058] FIG. 11 is a diagram depicting positioning of an embodiment
of the present medical devices in a subject with an obstruction of
the left middle cerebral artery.
[0059] FIG. 12A is a cross-sectional view of one embodiment of a
combinations of the constituent parts of one of the present sheaths
before heat is applied.
[0060] FIG. 12B is a cross-sectional view of another embodiment of
a combinations of the constituent parts of one of the present
sheaths before heat is applied.
[0061] FIG. 13 is a cross-sectional view of one embodiment of a
combinations of the constituent parts of one of the present sheaths
after heat is applied.
[0062] FIG. 14 is a cross-sectional view of one embodiment of one
of the present sheaths that is configured to receive a sensor.
[0063] FIG. 15 is a side cross-sectional view of the sheath
depicted in FIG. 14.
[0064] FIG. 16 is a cross-sectional view of the sheath in FIG. 14
in combination with a sensor.
[0065] FIG. 17A is a side cross-sectional view of a portion of the
sheath depicted in FIG. 16.
[0066] FIG. 17B is a side cross-sectional view of another portion
of the sheath depicted in FIG. 16.
[0067] FIG. 18 is a side cross-sectional view of one embodiment of
one of the present catheters in combination with a sensor.
[0068] FIG. 19 is a side cross-sectional view of one embodiment of
a hub in combination with a transmission line configured to be
coupled to a sensor.
[0069] FIG. 20 is a perspective view of a portion of one of the
present medical devices that includes one of the present hubs.
[0070] FIG. 21 depicts in cut-away form portions of the structures
shown in FIG. 20.
[0071] FIG. 22 is a perspective view of a portion of one of the
present medical devices that includes another of the present
hubs.
[0072] FIG. 23 is a perspective view of a portion of one of the
present medical devices that includes yet another of the present
hubs.
[0073] FIG. 24 is a perspective view of a portion of one of the
present medical devices that includes still another of the present
hubs.
DETAILED DESCRIPTION
[0074] The terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has" and "having"), "contain" (and any form of contain, such as
"contains" and "containing"), and "include" (and any form of
include, such as "includes" and "including") are open-ended linking
verbs. As a result, a medical device, a perfusion system, a kit, or
a method that "comprises," "has," "contains," or "includes" one or
more recited elements or steps possesses those recited elements or
steps, but is not limited to possessing only those elements or
steps; it may possess elements or steps that are not recited.
Likewise, an element of a medical device, a perfusion system, a
kit, or a method that "comprises," "has," "contains," or "includes"
one or more recited features possesses those features, but is not
limited to possessing only those features; it may possess features
that are not recited. Furthermore, a medical device, perfusion
system, or a structure of one or both of these that is configured
in a certain way must be configured in at least that way, but also
may be configured in a way or ways that are not specified.
[0075] The terms "a" and "an" are defined as one or more than one
unless this disclosure explicitly requires otherwise. The terms
"substantially" is defined as at least close to (and includes) a
given value or state. The term "coupled" is defined as connected,
although not necessarily directly, and not necessarily
mechanically; two items that are "coupled" may be integral with
each other.
[0076] In some embodiments, the present medical devices may be used
to detect a fluid pressure in a space within a subject, to
continually monitor fluid pressure in such a space, and/or to
deliver a fluid to a space in a subject to which fluid flow has
been reduced or eliminated due to the presence of an obstruction,
such as a patient whose blood flow is obstructed due to a thrombus,
plaque, or embolus. Embodiments of the present medical devices and
perfusion systems may be used to concurrently monitor fluid
pressure downstream or distal to a site of obstruction to fluid
flow and upstream of the obstruction site (or otherwise in a
location where the fluid is flowing normally) and to provide for
controlled infusion of blood and/or other fluid distal to a site of
obstruction. For example, a user can position an embodiment of the
present medical devices in a blood vessel of a subject, position
the medical device in a manner such that a first pressure sensor is
distal to a site of obstruction in a blood vessel and a second
pressure sensor is proximal to the site of obstruction. Based on
information concerning fluid pressure that is detected from one or
both pressure sensors, fluid such as blood can be delivered in a
controlled manner distal to the site of obstruction to fluid flow
to provide for controlled reperfusion. Embodiments of the present
medical devices and perfusion systems therefore allow for
restoration of perfusion of fluid or blood downstream to a site of
obstruction in a blood vessel or other space through which fluid
flows in a subject. Restoration of blood flow distal to a site of
obstruction in a blood vessel, such as a cerebral blood vessel,
enables both the reperfusion of ischemic tissue and the metabolic
protection of the brain tissue in the distribution of the occluded
vessel.
Medical Devices
[0077] FIG. 1A shows one embodiment of the present medical devices,
which takes the form of a catheter. Medical device 10 comprises an
elongated body 15 having a passageway 12, a distal end 14, and a
proximal end 16, and a pressure sensor 30 attached to the elongated
body 15. The pressure sensor 30 has a length along any axis that is
not greater than 2 mm (meaning that a straight line that intersects
the outer boundary at any two points will not have a length greater
than 2 mm between those two points), and is configured to detect a
fluid pressure and output one or more signals representative of the
detected fluid pressure.
[0078] Any pressure sensor known to those of ordinary skill in the
art that has the capability to generate a signal or signals
representative of a detected fluid pressure is contemplated as a
pressure sensor for use with at least some embodiments of the
present medical devices and present perfusion systems. Non-limiting
examples of pressure sensors that may be included in the present
medical devices and perfusion systems include those set forth in
U.S. Patent Appl. Pub. No. 2008/0228167, which is specifically
incorporated by reference in its entirety. For example, some
particular information concerning pressure sensors can be found in
paragraphs [0010]-[0016], [0024]-[0027], [0030], and FIGS. 1-5 of
U.S. Patent Appl. Pub. No. 2008/00228167. Other examples of
pressure sensors include those set forth in U.S. Patent Appl. Pub.
Nos. 20070135718, 20090024015, 20050187487, and 20030018273, each
of which is specifically incorporated by reference in its
entirety.
[0079] Elongated body 15 has length L that extends from the most
distal portion of distal end 14 and the proximal-most exposed
portion (e.g., not covered by a hub, valve, or the like) of
proximal end 16 that ranges from 10 cm to 160 cm. In other
embodiments, length L ranges from 60 cm to 140 cm. In further
embodiments, length L ranges from 80 cm to 140 cm. In other
embodiments, length L ranges from 100 cm to 140 cm. Length L may be
10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55
cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm, 95 cm, 100 cm,
105 cm, 110 cm, 115 cm, 120 cm, 125 cm, 130 cm, 135 cm, 140 cm, 145
cm, 150 cm, 155 cm, 160 cm, or any range derivable within any of
the aforementioned lengths.
[0080] Embodiments of the present medical devices can be fabricated
to be a variety of lengths. Length L may be selected by one of
ordinary skill in the art depending upon the application of the
medical device and/or the size of the subject. For example, a
medical device with length L of 15 cm may be chosen for treatment
of an obstruction in a femoral artery. Longer lengths, such as 125
cm to 135 cm, may be selected for treatment of an obstruction to
cerebral blood flow in a subject. For treatment of a carotid artery
obstruction in a patient, length L of 60 cm to 90 cm may be
selected. The foregoing are examples, and are not intended to limit
the application of the present medical devices.
[0081] Passageway 12 may have a uniform diameter, or a diameter
that varies along the length of the passageway. For example, in
some embodiments, the passageway diameter decreases near the distal
end of the elongated body. In some embodiments, the passageway
diameter varies from 0.25 mm to 1 cm. In other embodiments, the
passageway diameter ranges from 0.5 mm to 5 mm. In further
embodiments, the passageway diameter ranges from 0.5 mm to 2
mm.
[0082] In some embodiments, elongated body 15 may have a uniform
outer diameter along length L of the medical device, and in other
embodiments may have an outer diameter that varies. The outer
diameter D of elongated body 15 may range from 3 French (1.0 mm) to
10 French (3.3 mm). In some embodiments, the outer diameter D of
elongated body 15 ranges from 3 French to 7 French. In some
embodiments, outer diameter D of medical device 10 ranges from 3
French to 6 French. Outer diameter of medical device 10 may be 1
French, 2 French, 3 French, 4 French, 5 French, 6 French, 7 French,
8 French, 9 French, 10 French, 11 French, 12 French, or any range
of outer diameters derivable within these specific outer diameters.
The outer diameter will largely depend on the application. For
example, it is contemplated that for treatment of occlusion of a
cerebral artery in a human subject, that outer diameter of medical
device 10 will not be larger than 4 French.
[0083] Proximal end 14 of the elongated body may have a rounded
edge or may have a blunt edge.
[0084] Pressure sensor 30 is depicted near distal end 14 of medical
device 10. The diameter of the pressure sensor along any axis of
pressure sensor is not greater than 2 mm. For example, the diameter
of pressure sensor may range from 0.5 mm to 2.0 mm. In other
embodiments, the diameter of the pressure sensor ranges from 1.0 mm
to 2.0 mm.
[0085] Pressure sensor 30 is configured to detect a fluid pressure
and output one or more signals representative of the detected fluid
pressure. In some embodiments, the pressure sensor detects fluid
pressure continually (real-time), and provides a continual output
of signals that are representative of the detected fluid pressure.
In other embodiments, the pressure sensor detects fluid pressure
intermittently, such as once a minute, twice a minute, three times
a minute, four times a minute, or five or more times a minute.
Pressure sensor 30 is configured to output a signal corresponding
to fluid pressure using any method known to those of ordinary skill
in the art. For example, the pressure sensor may detect fluid
pressure in response to a signal it receives from a remote
controller, or it may be internally programmed to detect fluid
pressure at a given rate. The rate at which fluid pressure is
detected and/or the rate at which a signal or signals
representative of the detected fluid pressure are outputted from
the sensor may range, for example, from 5 hertz to 200 hertz, 20
hertz to 100 hertz, or 40 hertz to 80 hertz. In some embodiments,
the rate for detection and/or for outputting signal(s) is 60 hertz.
In other embodiments, the rate for detection and/or for outputting
signal(s) may be 250 hertz or higher.
[0086] The one or more signals are transmitted to at least a
detector. The transmission of signals from the pressure sensor to
the detector may be accomplished in any suitable manner known to
those of ordinary skill in the art, including in "wired" or
"wireless" fashion. Embodiments of the present pressure sensors may
also be configured to receive power in any suitable manner known to
those of ordinary skill in the art, including in wired or wireless
fashion.
[0087] Medical device 10 includes pressure sensor 30 that has an
outer surface 31 that is not flush with elongated body 15 of
medical device 10. In other embodiments, the outer surface of the
pressure sensor 31 may be flush with the outer surface of the
elongated body, as shown in FIG. 1B, which depicts medical device
20. The pressure sensor may be attached to the elongated body of
the medical device using any method known to those of ordinary
skill in the art. FIG. 1C depicts a cross-section of medical device
10 depicting pressure sensor 30 attached to the elongated body of
medical device 10. In this embodiment, pressure sensor 30 is not
exposed to the passageway of elongated body 15 of medical device
10. As a result, it is not capable of detecting the pressure of
fluid that is flowing through the passageway while the fluid is
flowing through the passageway. FIG. 1D depicts a cross-section of
medical device 20, and shows pressure sensor 40 embedded into the
wall of elongated body 25. In this embodiment, pressure sensor 40
is not in contact with the passageway of medical device 20.
[0088] Medical device 10 may include a hub 27. FIG. 1E depicts an
embodiment of the present medical devices with hub 27 attached to
the distal end of the elongated body, illustrating that, in some
embodiments, a hub is separately coupled to the distal end of the
elongated body of the medical device and secured in position using
any method known to those of ordinary skill in the art. In further
embodiments, the hub is integrally fabricated with the elongated
body of medical device 10. Hub 27 is represented generically, and
can have any suitable configuration known to those of ordinary
skill in the art, such as a luer lock configuration that is
configured for coupling to a second medical device. The second
medical device may be, for example, tubing configured for
transferring blood or fluid from the lumen of the tubing through
the hub of the medical device and into the passageway of the
medical device. In some embodiments, device 10 includes a valve at
proximal end 16 of elongated body 15. The valve may be attached to
the elongated body using any technique known to those of ordinary
skill in the art.
[0089] FIG. 2 depicts medical device 40, another embodiment of the
present medical devices, which takes the form of a sheath. Medical
device 40 includes side arm 42 having a side arm passageway 46 in
communication with the passageway of elongated body 41 of medical
device 40. Medical device 40 also includes pressure sensor 48.
Pressure sensor 48 is not in contact with passageway 43 of medical
device 40. In medical device 40, side arm 42 forms an angle A with
elongated body 41 of medical device 40. The angle A is less than 90
degrees in medical device 40. The angle A may be more or less than
90 degrees. In some embodiments, angle A ranges from 30 degrees to
150 degrees. In some other embodiments, angle A ranges from 45
degrees to 135 degrees. Angle A may be 30, 35, 40, 45, 50, 55, 60,
65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135,
140, 145, or 150 degrees, or any range of angles derivable within
these recited angles. Any side arm known to those of ordinary skill
in the art may be used, including the most frequent embodiment in
which the side arm is constructed of flexible tubing and angle A is
therefore variable, and the side arm may be provided at its
proximal end with a hub, valve, stopcock, any suitable combination
of these, or any other fitting suited to accomplishing the
reperfusion described in this disclosure. Furthermore, the proximal
end (not labeled) of elongated body 41 may be provided with a valve
for regulating fluid entering the proximal end of the sheath and
around any device positioned in its passageway, such as one of the
present catheters (which may take the form of microcatheters).
[0090] The side arm passageway has an outer diameter ranging from 2
mm to 5 mm. Side arm 42 has length L, which may range from 1 cm to
30 cm.
[0091] Side arm 42 of medical device 40 depicts stopcock 44.
Stopcock 44 is configured to regulate the passage of fluid from
passageway 43 of elongated body 41 of medical device 40 through
passageway 46 of side arm 42 and out of proximal end 45 of side arm
42. When the stopcock is in the open position, proximal end 45 of
side arm 42 is in communication with passageway 46 of side arm 42
and passageway 43 of elongated body 41 of medical device 40.
[0092] Some embodiments of the present medical devices include an
introducer. FIG. 3 depicts an embodiment 50 of the present medical
devices that includes introducer 60, a sheath 51, and a guidewire
64. Introducer 60 is slidably positioned in the passageway of
elongated body 54 of sheath 51. Introducer 60 includes a tapered
distal tip 57 that is configured to facilitate the introduction of
medical device 50 into a space in a subject, such as a blood
vessel, by facilitating blunt dilation of tissue including a skin
surface and a wall of a blood vessel, after a first small incision
has been made. A needle is first introduced into the space, a
guidewire is introduced via the needle, and the introducer/sheath
combination is passed over the guidewire into the space. The
introducer gently dilates the channel in advance of the sheath.
Introducer 60 includes passageway 62 that extends from the proximal
end of introducer 59 to the distal end of introducer 57. Passageway
42 of the introducer has a diameter ranging from 0.5 mm to 5.0
mm.
[0093] Introducer 60 is configured to be removable from sheath 51
following introduction of medical device 50 into a target location
in a subject.
[0094] Introducer length L is the length of the distance between
the most distal portion of distal tapered tip 57 and the most
proximal portion of proximal end 59. In some embodiments, length L
ranges from 10 cm to 140 cm.
[0095] In other embodiments, length L ranges from 50 cm to 140 cm.
Length L may be any length suitable for the application, including
10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55
cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm, 95 cm, 100 cm,
105 cm, 110 cm, 115 cm, 120 cm, 125 cm, 130 cm, 135 cm, 140 cm, 145
cm, 150 cm, 155 cm, 160 cm, or any range derivable within any of
the aforementioned lengths.
[0096] Sheath length l is the distance between the distal end of
sheath 51 and proximal end 61 of sheath 51. A valve, shown
schematically as an enlarged portion, may be coupled to the
elongated body of the sheath and define the sheath's proximal end.
Sheath length l may range from 10 cm to 160 cm. In some
embodiments, sheath length l ranges from 60 cm to 140 cm. In
further embodiments, sheath length l ranges from 80 cm to 140 cm.
In other embodiments, sheath length l ranges from 100 cm to 140 cm.
Sheath length l may be any length suitable for the application,
including 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm,
50 cm, 55 cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm, 95
cm, 100 cm, 105 cm, 110 cm, 115 cm, 120 cm, 125 cm, 130 cm, 135 cm,
140 cm, 145 cm, 150 cm, 155 cm, 160 cm, or any range derivable
within any of the aforementioned lengths.
[0097] In some embodiments, sheath elongated body 54 may have a
uniform outer diameter along the region between its distal end 52
and the junction point of the sheath elongated body with the distal
portion of the hub 53, and in other embodiments it may have an
outer diameter that varies along this region. The outer diameter of
the sheath may range from 4 French (1.3 mm) to 12 French (4 mm). In
some embodiments, the outer diameter of the sheath ranges from 4
French to 7 French. In some embodiments, the outer diameter of the
sheath ranges from 4 French to 6 French. The outer diameter of the
sheath may have any diameter suitable for the application,
including 4 French, 5 French, 6 French, 7 French, 8 French, 9
French, 10 French, 11 French, 12 French, or any range of outer
diameters derivable within these specific outer diameters.
[0098] Sheath 51 includes a sheath passageway sized to accommodate
introducer 60 and, subsequently, a catheter configured to advance
through an obstruction. Sheath 51 also includes a pressure sensor
56. Pressure sensor 56 is not in contact with the passageway of the
sheath. Pressure sensor 56 is configured to detect a fluid pressure
and output one or more signals representative of the detected fluid
pressure in the manner previously discussed.
[0099] The present medical devices optionally include a guidewire.
Medical device 50 includes guidewire 64 that is shown slidably
positioned within passageway 62 of introducer 60. The length of
guidewire 64 will depend on the length of medical device 50 and the
application for which the medical device is intended. In some
embodiments guidewire 64 has a length that ranges from 25 cm to 150
cm.
[0100] The proximal end of introducer 60 is configured to include
portion 58 that provides for positioning and stabilization of the
introducer within elongated body 54 such that tapered distal tip 57
of introducer 60 extends to a fixed position distal to distal end
52 of elongated body 54. Alternatively, portion 58 may not be used
and the sheath may have a locking mechanism capable of clamping the
introducer such that it cannot move relative to the sheath.
[0101] Any suitable guidewire known to those of ordinary skill in
the art may be used for guidewire 64. Non-limiting examples of
materials that may be included in the guidewire include stainless
steel, nitinol, tantalum, platinum, cobalt alloy, titanium, gold, a
biocompatible metal alloy, iridium, silver, tungsten, and
combinations of these materials.
[0102] In some embodiments of the present medical devices that
include a sheath and an introducer, the medical device further
includes a catheter. For example, the catheter may be a device as
depicted as in FIG. 1A or FIG. 1B, and, depending on its size, may
be characterized as a microcatheter.
[0103] In some embodiments, the catheter is configured to insulate
whatever occupies its passageway, so as to minimize heat transfer
to, e.g., fluid flowing through the catheter's passageway. Any
catheter known to those of ordinary skill in the art that is
configured to thermally insulate the contents of its passageway may
be used in this regard. For example, the catheter may include one
or more coatings of material on a region of the elongated body of
the catheter or on a region of the inner wall defining the
passageway of the catheter. In some embodiments, the catheter
includes a region that includes a plurality of spaces that are
configured to thermally insulate the catheter passageway. One such
embodiment is depicted in FIG. 4, which shows a cross-section of
one catheter 80 that includes a plurality of spaces 82 within the
catheter wall. In some embodiments, the catheter is configured to
provide for infusion of a cooling solution within the wall of the
catheter, thus providing for maintenance of a relatively cool
temperature within the passageway of the catheter. In this manner,
the infusion of cooled blood or fluid through the passageway of the
catheter may be facilitated.
[0104] A further embodiment of the present medical devices is
depicted in FIGS. 5A and 5B. FIG. 5A depicts medical device 100,
which includes first sheath 101 that includes first sheath
elongated body 108 having a first sheath elongated passageway,
distal end 109, and proximal end 111 coupled to valve 105. Medical
device further includes a second sheath 102 that includes a second
sheath elongated body 112 having a second sheath passageway, a
distal end 103, and a proximal end 113. Proximal end 113 is coupled
to a hub 104. In other embodiments, hub 104 is integral to proximal
end. The first sheath and the second sheath each have a length
extending from the distal end of the respective elongated body to
the proximal-most exposed portion of the respective elongated body.
The length of first sheath 101 is greater than the length of second
sheath 102. In embodiment 100, second sheath 102 is coupleable to
first sheath 101 so that, in use during a procedure, the distal end
of the second sheath will be proximal to the distal end of the
first sheath. Any suitable means may be used to couple the two
sheaths, including co-extrusion or attachment of separate sheaths
using any suitable compound or structure, such as a clip, band,
glue, or the like.
[0105] Medical device 100 also includes catheter 110, which is
configured to be positionable in the passageway of first sheath
101. Catheter 110 includes distal end 115 and proximal end 116.
Catheter 110 also includes a hub 114 coupled to proximal end 116.
In other embodiments, the hub is integral with the catheter.
Catheter 110 includes pressure sensor 107, and second sheath 102
includes pressure sensor 106. These pressure sensors may be
configured to detect fluid pressure as discussed above.
[0106] FIG. 5B depicts device 110 showing the introducers in
position in first sheath 101 and second sheath 102. First
introducer 120 is depicted slidably positioned in the first sheath
passageway. Those of ordinary skill in the art will understand that
the recitation of a first device being positionable (e.g., slidably
positionable) or positioned (e.g., slidably positioned) in a second
device (e.g., in the passageway of a second device) does not
require that the entire first device be bounded by the second
device (or more specifically, by the passageway of the second
device); rather, only a portion of the first device need be
surrounded by the second device (or, more specifically, the
passageway of the second device) for the first device to be
positioned in the second device (or, more specifically, in the
passageway of the second device) within the meaning of this
disclosure. First introducer 120 has tapered distal tip 121, and
includes a passageway 122 configured to receive a guidewire. Second
introducer 130 is slidably positioned within the second sheath
passageway. Introducers 120 and 130 are configured to be removable
from the first and second sheaths. The distal tips of second
introducer 130 and second sheath 102 are oriented at an oblique
angle to the axis of the passageway of the second sheath in order
to ease introduction of the second sheath. Furthermore, as FIG. 5B
shows, the two distal tips are configured to align with each other
to form a substantially flush end surface.
[0107] FIG. 5C depicts a cross-section of medical device 100 with
introducers in position within the first and second sheath
passageways, respectively. Pressure sensor 106 is depicted attached
to second sheath 102. First introducer 120 positioned within the
passageway of first sheath 108, and second introducer 130 is
positioned within the passageway of second sheath 102.
[0108] Embodiments of the present medical devices, sheaths,
catheters, and introducers may be fabricated of any substance or
mixture of substances known to those of ordinary skill in the art.
In some embodiments, the present medical devices, sheaths,
catheters, and introducers are at least in part made of a polymeric
material. Non-limiting examples of materials include polyether
block amides, polyethylene, polyamide, polytetrafluorethylene,
silicone, polyvinylchloride, polyurethane,
polyethyleneterephthalate, polypropylene, or copolymers,
polyacrylonitrile, polyvinylacetates, polylacticacids, starch,
cellulose, polyhydroxyalkanoates, polyesters, polycaprolactone,
polyvinylalcohol, polystyrene, polyethers, polycarbonates,
polyamides, poly(acrylic acid), Carboxy Methyl Cellulose (CMC),
protein based polymers, gelatine, biodegradable polymers, cotton,
latex, silicone, polytetrafluoroethene, polyvinylchloride,
polycarbonate, Acrylonitrile Butadiene Styrene (ABS), polyacrylate,
polyolefins, polystyrene, rubbers, carbon, carbon fiber, cellulose
acetate, cellulose nitrate, silicone, polyethylene teraphthalate,
polyorthoester, polyanhydride, polyether sulfone, polycarbonate,
polypropylene, polytetrafluoroethylene, polylactic acid,
polyglycolic acid, a polyanhydride, polycaprolactone,
polyhydroxybutyrate, and combinations or mixtures thereof. Some
embodiments of the present medical devices include a metal
component. Non-limiting examples of such metals include stainless
steel, nitinol, tantalum, platinum, cobalt alloy, titanium, gold, a
biocompatible metal alloy, iridium, silver, tungsten, and
combinations thereof.
[0109] The medical devices, sheaths, and catheters set forth herein
may be inflexible or flexible, as best suited to the
application.
Perfusion Systems
[0110] The present perfusion systems may be used in perfusing fluid
into a space in a subject. The space may be a space that that
includes fluid, or a space that is normally occupied by fluid but
is depleted of fluid due to an obstruction to fluid flow into the
space. For example, the space may be a blood vessel. Fluid may be
perfused, for example, downstream of a site of obstruction to fluid
flow in a space in a subject.
[0111] FIG. 6 depicts one embodiment of the present perfusion
systems. Perfusion system 70 includes one of the present medical
devices, which includes sheath 83 having an elongated body with
distal end 86. Sheath 83 includes sheath pressure sensor 75
attached to the elongated body of the sheath near distal end 84 of
sheath 83. Perfusion system 70 further includes catheter 73 that is
configured to be slidably positioned within the passageway of
sheath 83. Catheter 73 includes catheter pressure sensor 74
attached to the elongated body of the catheter near the distal end
of catheter 72. The proximal end of the elongated body of catheter
73 includes a hub portion 76. Hub portion may be attached
separately to the elongated body of catheter 73 or it may be
integral with the elongated body of catheter 73. Sheath length L
and catheter length l are depicted.
[0112] In the embodiment depicted in FIG. 6, lead 87 is attached to
catheter pressure sensor 74 and device 71, and lead 88 is attached
to sheath pressure sensor 75 and device 71. The pressure sensors
are each configured to detect a fluid pressure, and to provide a
signal or signals that is representative of the detected fluid
pressure. as discussed above. Leads 87 and 88 (as well as the leads
depicted in FIG. 7) are graphic/schematic representations of an
embodiment of the present medical devices in which power and
signals representative of detected fluid pressures are transmitted
to and from the sensors in a wired manner.
[0113] Device 71 includes a power source 77 that transmits power
through leads 87 and 88 to catheter pressure sensor and sheath
pressure sensor, respectively. For a sensor that is fiber optic,
that "power" may be a transmitted light signal. A signal (or
signals) representative of the detected fluid pressure in the
sheath pressure sensor and/or the catheter pressure sensor is
generated by the respective pressure sensor and transmitted through
lead 87 and/or lead 88 to a detector 78 that is configured to
receive a signal from one or both pressure sensors and convert
(and/or display) the signal(s) to a fluid pressure or a difference
in fluid pressure between the detected fluid pressures. For a
sensor that is fiber optic, that signal may take the form of light,
such as light that is reflected from the sensor (e.g., from the
sensor diaphragm). Display 79 receives input from detector 78, and
displays the value corresponding to the detected fluid pressure or
difference in fluid pressures. Controller 89 transmits the signal
to a pump 82. Controller 89 is configured such that when a
predetermined pressure from the catheter pressure sensor or a
predetermined pressure differential between the catheter pressure
sensor and the sheath pressure sensor is detected, the controller
activates pump 82. Pump 82 is configured to facilitate the transfer
of fluid from side arm 85 of sheath to catheter 73. The controller
may also be configured to shut off the pump, not send a signal to
the pump, and/or reverse the direction of flow controlled by the
pump if the pressure from the catheter pressure sensor is too high
(e.g., if it meets or exceeds the pressure detected by the sheath
pressure sensor). The controller may be programmed in any suitable
manner, including using hardware, firmware, software, or any
suitable combination of these. The controller may be configured to
be programmed with pump flow rates, cut-off pressures, and the like
by the user.
[0114] Pump 82 can be configured to transmit fluid from side arm 85
of sheath 83 to catheter 73, or from sheath 112 to catheter 110
(see FIG. 5A), using any method known to those of ordinary skill in
the art. For example, pump 82 may be configured to include a roller
that becomes activated to transfer fluid through a compressible
tubing. Some embodiments include a compressor system for transfer
of fluid from a chamber. The end result is transmission of fluid
from the relevant sheath (e.g., sheath 83 via side arm 85 or sheath
112) to the relevant catheter (e.g., catheter 72 or catheter
110).
[0115] FIG. 7 depicts a part of perfusion system 150, another
embodiment of the present perfusion systems. Device 151 is shown
schematically as including controller 160, power source 157,
detector system 158, display 159, pump 156, and thermoregulator
161. Power source 157 is configured to transfer power through
schematically-represented lead 154 and lead 155. The power that is
transmitted is sufficient to permit detection of a signal
corresponding to fluid pressure from the sheath pressure sensor and
the catheter pressure sensor. The signals that are generated from
the pressure sensors are transferred through lead 154 and lead 155
to detector system 158. Detector system 158, which may include on
or more detectors, such that each pressure sensor sends signals to
a separate detector, is configured to receive the signals and to
convert the signals to a fluid pressure. The detector system (or,
more specifically in some embodiments, the individual detectors)
transmits this information to display 159, which then displays the
fluid pressure to a user. The detector system can also send
information to controller 160, which can be configured to activate
pump 162 upon detection of a particular magnitude of fluid
pressure. Input tube 153 transmits blood from one structure of the
present medical devices (e.g., the side arm of a medical device as
set forth in FIG. 6 or one of the two sheaths of the medical device
shown in FIG. 7) into a chamber in device 151. Thermoregulator 161
provides for a cooling system which cools blood or fluid in the
chamber to a specified level. Input tube 151 provides for input of
cooled solution or refrigerant into device 151, and output tube 152
provides for output of solution or refrigerant from device 141.
Thermoregulator is configured to provide for adjustment of
temperature within the chamber by a user. Cooled fluid within the
thermoregulator is transmitted from the chamber through a catheter
(such as the catheter depicted in FIG. 6 or in FIG. 7) when the
pump is activated.
[0116] Any thermoregulator, pump, detector system, display and
power source known to those of ordinary skill in the art are
contemplated for inclusion in the present devices for use with the
present perfusion systems.
Kits
[0117] Some aspects of the invention concern kits that include any
of the present medical devices in suitable packaging. One
embodiment of a kit is kit 200, depicted in FIG. 8. Kit 200
includes package 230 that includes sealed container 210 containing
medical device 10 set forth in FIG. 1A. Packaging 230 is
hermetically sealed.
[0118] In some embodiments of the present kits, components of the
medical devices or perfusion systems are packaged into separate
containers. For example, some embodiments include a kit that
includes the medical device, such as device 50 in FIG. 3. For
example, introducer 60, sheath 51, and guidewire 64 may be packaged
in a first sealed container, a second sealed container, and a third
sealed container, respectively. Each of the sealed containers may
be included in a single large container or packaged in separate
containers. Kit 200 further includes instructions for use 220, that
explains how to use the medical device, such as how to use in a
procedure for reperfusing blood to an obstructed region of a blood
vessel.
Methods
[0119] The present methods include any procedure that involves
inserting a present medical device and/or perfusion system
component into a subject, where a pressure from a pressure sensor
of the medical device and/or perfusion system component is
detected. Other embodiments of the present methods include
inserting one of the present medical devices and/or perfusion
system components into a subject, detecting a fluid pressure from
the subject from the pressure sensor of the medical device and/or
perfusion system component, and inserting a fluid into the subject
through a medical device, sheath or catheter of the medical device
and/or perfusion system. The present methods further include any
procedure that involves using an embodiment of the present
perfusion systems to infuse a fluid into a subject.
[0120] The subject may be any subject, such as a mammal. In some
embodiments, the subject is a human. The subject may be known or
suspected to have an obstruction to fluid flow into a space that is
normally filled with fluid. For example, the obstruction to fluid
flow may be an obstruction to blood flow in an artery or a vein.
The obstruction to blood flow may be, for example, a plaque, an
embolus, or clot in an artery or vein. The artery or vein may be
any artery or vein in a human subject. Nonlimiting examples of
arteries include a cerebral artery, a carotid artery, a vertebral
artery, a femoral artery, brachial artery, renal artery, coronary
artery, or a subclavian artery. In this disclosure, the aorta is an
artery.
[0121] The present medical devices and/or perfusion system
components may be introduced into a subject via any method known to
those of ordinary skill in the art, such as percutaneously. In
particular embodiments, an introducer is employed to introduce a
sheath of the present medical devices or perfusion systems into a
blood vessel of a subject. FIG. 9 depicts an example of a subject
410 with an obstruction to blood flow 380 in the left carotid
artery. Medical device 300 includes a first sheath 360 and a second
sheath 350. A first introducer and a second introducer may be used
to insert first sheath 360 and second sheath 350 into the subject.
A guidewire (not shown) may then be inserted into the first
introducer and advanced through a passageway of the introducer. The
introducer may then be removed. Under fluoroscopic guidance, the
guidewire may be advanced into subject 410, and then catheter 370
may be advanced over the guidewire and positioned such that the
pressure sensor 390 attached to the catheter body is positioned
downstream of obstruction 380. Second sheath pressure sensor 430
may be positioned upstream of the obstruction as shown in FIG. 9,
or otherwise in a position in which the relevant fluid (blood, in
this case) is flowing normally and under normal pressure. A
connection between the pressure sensors and device 300 is
established through schematically-represented leads 450. Device 300
includes power source 310 for supplying power to the pressure
sensors through the leads 450, detector system 320 for detecting
signals from the pressure sensors and converting detected signals
to fluid pressures, and display 330, which is configured to display
the fluid pressures based on data received from the detector system
320. Hub 440 of second sheath 350 is connected to pump 340 of
device 300 such that blood from the passageway of second sheath 350
can pass into device 300. The proximal end of the elongated body of
catheter 370 is connected to pump 340 of device 300 such that blood
that has passed into the device from second sheath 350 can pass
into catheter 370 and subsequently downstream of the site of
obstruction 380.
[0122] In some embodiments, no pump is incorporated into device
300, and blood flow from the sheath to the catheter occurs due to
natural pressure differences. In some embodiments, a valve is
present that is configured to open upon detection by the detector
system of a predetermined fluid pressure from the pressure sensor
of the catheter. Opening the valve results in the transmission of
blood from the second sheath through the catheter and downstream to
the site of the obstruction, as a result of the natural pressure
difference between the two locations. In some embodiments, the
valve may be manually operated.
[0123] FIG. 10 depicts one embodiment of one of the present medical
devices that is configured for reperfusion of blood downstream of
an obstruction in a blood vessel. The medical device depicted
includes second sheath 500, with pressure sensor 510 attached to
the elongated body of sheath 500. First sheath 520 is shown with
catheter 530 slideably positioned through the passageway of first
sheath 520. Pressure sensor 540 of catheter 530 is positioned
downstream (distal, in this embodiment) to the site of the
obstruction 550 to blood flow. The pressure sensors transmit
signals that are representative of the detected fluid pressures.
Depending upon the pressures detected, blood can be transmitted
from second sheath 500 to the passageway of catheter 530 and out
the distal end of catheter 530, resulting in reperfusion of blood
flow downstream of obstruction 550. In some embodiments, the method
further includes transmitting cooled blood or fluid through the
passageway of the catheter, wherein the temperature of the cooled
blood or fluid is below the body temperature of the subject.
[0124] The catheter elongated body and/or sheath elongated body may
optionally include a region that provides for thermal insulation of
the catheter passageway. For example, a fluid that is cooled below
the body temperature of a subject may be infused into a space in a
subject using the catheter. Thermal insulation of the catheter
passageway may facilitate retention of the temperature of the
infused fluid. Any method known to those of ordinary skill in the
art may be used to insulate the catheter passageway. For example,
the catheter elongated body and/or sheath elongated body may
include a plurality of spaces that are configured to provide
thermal insulation. In some embodiments, the catheter wall (and/or
sheath wall) includes channels configured to transfer a coolant
through the wall of the catheter (and/or sheath). The medical
device may optionally include a pump configured to transfer coolant
through the channels in the wall of the catheter and/or sheath. The
coolant fluid may be infused through the channels as a closed loop
system, thus adding a cooling layer into the wall of the catheter
and/or the wall of the sheath. The coolant may be super-cooled even
below a freezing temperature, and thus act not only as an
insulation but as an actual cooling mechanism.
[0125] Additional information concerning cooling systems that can
be applied to cool fluids or tissues in the context of the present
invention include those disclosed in U.S. Pat. Nos. 7,494,504,
7,485,109, 6,656,209, 6,635,076, U.S. Patent Appl. Pub Nos.
20070043409, 20060089689, 20060052854, 20040147987, 20040068311,
20020007202, and 20010001832, each of which is specifically
incorporated by reference.
[0126] FIG. 11 depicts positioning of an embodiment of the present
medical devices in a subject with an obstruction of the left middle
cerebral artery. In FIG. 11, sheath 400 has been placed in left
internal carotid 410 in the neck of a subject, near the base of the
skull. Catheter 420 is passing from the tip of the sheath into the
head into the internal carotid, through a thrombus 430 at the
bifurcation of the internal carotid into anterior cerebral artery
440 and middle cerebral artery 450. Tip 460 of catheter 420 is in
left middle cerebral artery 450, positioned such that tip 460 of
catheter and pressure detector 470 on wall of catheter 420 near tip
460 are both downstream to thrombus 430. In this situation,
thrombus 430 has blocked flow from left internal carotid 410 into
both the left anterior and left middle cerebral artery. However,
flow into distal anterior cerebral artery 470 on the left comes
from right internal carotid 480 through right anterior cerebral
artery 490 and further through anterior communicating artery 590, a
normal collateral channel between the two sides of the brain.
Therefore, left middle cerebral artery 450 is the target vessel for
reperfusion. Any of the foregoing vessels, and any other cerebral
vessel not explicitly set forth, are also target vessels for
reperfusion within the brain.
Methods for Incorporating One or More Sensors into a Side Wall
[0127] In some embodiments, it is desirable to incorporate one or
more sensors into the side wall (also characterizable as simply the
wall) of a given one of the present medical devices, such as the
present sheaths, catheters, introducers and other tubular
structures conforming to the present disclosure. The following
FIGS. 12A-16B illustrate devices and methods of manufacturing a
medical device (e.g., a sheath or a catheter) with one or more
sensors (e.g., pressure or temperature sensors) incorporated into
its side wall; one of skill in the art will understand that such
medical devices include but are not limited to introducer sheaths,
diagnostic catheters, multi-lumen catheters, balloon catheters
(including those specifically designed for angioplasty),
ventriculostomy catheters, and central venous pressure
catheters.
[0128] FIGS. 12A-14 are illustrative of methods of manufacturing a
medical device (which can take the form of a sheath, labeled as
sheath 700 in, for example, FIG. 14) with a sensor incorporated
into its side wall. FIGS. 12A-12B show cross-section views of two
combinations 600 of the constituent parts of sheath 700. The
arrangements, or combination, depicted in both of these figures
include a first lumen tube 606 that is positioned outside of a
first mandrel 603, with a stiffener 608 disposed within first lumen
tube 606 and outside first lumen mandrel 603, such that the
stiffener is between the first lumen tube and the first lumen
mandrel. First lumen tube 606 and stiffener 608 are disposed within
a shrink wrap material 604. In some embodiments, as shown in FIG.
12A, a sensor lumen tube 602 is placed between the first lumen tube
606 and the shrink wrap material 604. In other embodiments, as
shown in FIG. 12B, sensor lumen tube 602 is disposed between
stiffener 608 and first lumen tube 606.
[0129] First lumen tube 606 may be comprise any plastic material
having a known melting point, including polyether block amides,
polyethylene, polyamide, polytetrafluorethylene, silicone,
polyvinylchloride, polyurethane, polyethyleneterephthalate,
polypropylene, or copolymers, polyacrylonitrile, polyvinylacetates,
polylacticacids, starch, cellulose, polyhydroxyalkanoates,
polyesters, polycaprolactone, polyvinylalcohol, polystyrene,
polyethers, polycarbonates, polyamides, poly(acrylic acid), Carboxy
Methyl Cellulose (CMC), protein based polymers, gelatine,
biodegradable polymers, cotton, latex, silicone,
polytetrafluoroethene, polyvinylchloride, polycarbonate,
Acrylonitrile Butadiene Styrene (ABS), polyacrylate, polyolefins,
polystyrene, rubbers, carbon, carbon fiber, cellulose acetate,
cellulose nitrate, silicone, polyethylene teraphthalate,
polyorthoester, polyanhydride, polyether sulfone, polycarbonate,
polypropylene, polytetrafluoroethylene, polylactic acid,
polyglycolic acid, a polyanhydride, polycaprolactone,
polyhydroxybutyrate, and combinations or mixtures thereof. Certain
specific embodiments of first lumen tube 606 may comprise
PEBAX.RTM.. First lumen tube 606 may comprise multiple a single
section having a single hardness (e.g., Shore 75D), or multiple
sections, such as sections have different (e.g., graduated)
hardness values. For example, one embodiment of first lumen tube
606 may a proximal section (such as one that will be approximately
2/3 of the length of sheath 700) that has a hardness of Shore 75D,
another section (which can over- or underlap the proximal section)
that has a hardness of Shore 45D-55D, and a distal section (which
can over- or underlap the 45D-55D section) that has a hardness of
Shore 25D-35D. In other embodiments, any desired number of sections
may be used to achieve any desired configuration for first lumen
tube 606, such as one that has a graduated flexibility from its
proximal end to its distal end (e.g., that increases from its
proximal end to its distal end). In some embodiments, first lumen
tube 606 may include a radiopacifier in any desired amount, such as
45% by weight of barium sulfate.
[0130] Stiffener 608 acts to provide structural support to sheath
700. Stiffener 608 may comprise wire or a plurality of wires having
a spiral, helical, net, grid, or chicken-wire shape, or such other
suitable shape as may provide support to sheath 700 while
maintaining the flexibility of sheath 700. For example, in an
embodiment suited for producing a 6.0 French version of sheath 700,
stiffener 608 may comprise a round, 0.001-inch or 0.0015-inch braid
made from 303 stainless steel or 3043/4 hard stainless steel
containing 130 pics per inch. In other embodiments in which
stiffener 608 comprises a coil, the coil may be made from a
nickel-titanium alloy (e.g., nitinol) flat wire that is 0.0007
inches by 0.003 inches, or from 0.002-inch round stainless steel
3/4 hard wire (e.g., 3043/4 hard stainless steel wire). Either of
these wire embodiments may have any suitable pitch, such as 0.002
inches. Stiffener 608 may comprise metals, non-limiting examples of
which include stainless steel, nitinol, tantalum, platinum, cobalt
alloy, titanium, gold, a biocompatible metal alloy, iridium,
silver, tungsten, and combinations thereof. Stiffener 608 may also
include other rigid non-metals, including certain
polymer-containing materials, such as a para-aramid synthetic fiber
(e.g., KEVLAR.RTM.). In certain embodiments of sheath 700,
stiffener 608 is not necessary for structural support, and
therefore may not be used.
[0131] Sensor lumen tube 602 may comprise any material capable of
containing a pressure sensor. Specific embodiments of sensor lumen
tube 602 comprise polytetrafluoroethylene, known under the brand
name TEFLON.RTM.. Sensor lumen tube 602 may be positioned as in
FIGS. 12A-12B using a second mandrel 601 sized to equal or
approximately equal to the internal diameter of sensor lumen tube
602. The internal diameter of sensor lumen tube 602 and second
mandrel 601 may be less than or equal to 350 microns. Although not
shown, an inner first lumen tube, which can comprise the same
material as sensor lumen tube 602, may be placed between first
mandrel 603 and first lumen tube 606. Sensor lumen tube 602 and
such an inner first lumen tube may both be characterized as lumen
liners.
[0132] The melting point of the material used for sensor lumen tube
602 will be higher, in some embodiments, than the melting point of
the material used for first lumen tube 606. The activation point of
shrink wrap material 604 is approximately equal to the melting
point of the material used for first lumen tube 606. That is, at a
given melting temperature, first lumen tube 606 begins to melt,
while simultaneously or nearly simultaneously the shrink function
of shrink wrap material 604 is activated. For example, in
embodiments where first lumen tube 606 comprises PEBAX.RTM. and
sensor lumen tube 602 comprises TEFLON.RTM., the activation point
of shrink wrap material 604 and the melting point of PEBAX.RTM.
will be around 135.degree. C., while the melting point of
TEFLON.RTM. will be around 327.degree. C. Shrink wrap material 604
may be FEP (fluorinated ethylene propylene) heat shrink tubing,
which, for producing a 6.0 French version of sheath 700, may have
an inner diameter of 6 French and an outer diameter of 7.8 French
(ID=0.081 inches.+-0.0.0005 inches and OD=0.101 inches.+-0.0.0005
inches).
[0133] First and second mandrels 603 and 601, respectively, may
comprise any suitable material, such as silver-plated copper or
reusable stainless steel. In an embodiment for producing a 6.0
French version of sheath 700, first mandrel 603 may have an outer
diameter of 0.135 inches.
[0134] In certain embodiments, combination 600 of first lumen tube
606, stiffener 608, shrink wrap material 604, and sensor lumen tube
602 may be positioned as shown in FIGS. 12A-12B. In other
embodiments, mandrels 601, 603 may not be necessary to combination
600, and are not used. In still other embodiments, only one of
mandrels 601, 603 may be used in combination 600. Once combination
600 is positioned, combination 600 is heated past the melting point
of the material used for first lumen tube 606. For example, where
first lumen tube 606 comprises PEBAX.RTM., the melting point will
be approximately 135.degree. C. Once the assembly has been brought
to or past the appropriate temperature, first lumen tube 606 melts
and shrink wrap material 604 shrinks Sensor lumen tube 602 and
stiffener 608 are incorporated into the side wall of first lumen
tube 606, as shown in FIG. 13. The heating may be accomplished
using any suitable technique known to those of ordinary skill in
the art, such as through an infrared (IR) heater or heat
source.
[0135] The assembly is then allowed to cool. Once cool, shrink wrap
material 604 is then removed, yielding sheath 700, as shown in
FIGS. 14-15. In certain embodiments, mandrels 601, 603 may remain
disposed within lumen tubes 602, 606 during the heating and cooling
of sheath 700. Mandrels 601, 603 may be removed from lumen tubes
602, 606 once sheath 700 has cooled, or during the cooling period
before sheath 700 has completely cooled.
[0136] In other embodiments, sheath 700 comprising first lumen 610
and sensor lumen 612 may be formed using extrusion techniques. For
example, the lumens may be formed using mandrels, or may be formed
using high-pressure air flows.
[0137] As a result of these formation steps, sheath 700 comprises a
wall 614, a first lumen 610 and a sensor lumen 612. Sensor lumen
612 is independent from first lumen 610, and is further separated
from and prevented from impinging into or invaginating first lumen
610 by sensor lumen tube 602. As those of ordinary skill in the art
having the benefit of this disclosure will appreciate, multiple
side wall lumens may be formed in a given medical device using the
techniques described above (including 2, 3, 4, 5, 6 or more), and
the passageways forming those lumens may extend the length of the
device in question (so as to be exposed or open at both ends) or
terminate at any suitable point along the length of the relevant
wall.
[0138] For an embodiment of sheath 700 that has a length of 5.625
inches, a tapered introducer (such as introducer 60) may be coupled
to it for use in a medical procedure that has an introducer length
L of 7.5 inches, where the proximal 6.312 inches of the introducer
has an outer diameter of 0.079 inches and the distal 1.187 inches
tapers from an outer diameter of 0.079 inches to an outer diameter
of 0.050 inches at the distal tip of the introducer, and the inner
diameter of the introducer is 0.036 inches. Such an introducer may
be made from any suitable material, including any of those from
which the first lumen tube are made, such as Shore 72D PEBAX.RTM.,
or GRILAMID.RTM..
[0139] As seen in FIG. 15, wall 614 of sheath 700 has a wall
thickness T. In certain embodiments, wall thickness T is less than
400 microns, though wall thickness T may, in various embodiments,
be less than 350 microns, 300 microns, 250 microns, 200 microns, or
150 microns. First lumen 610 has a diameter D. In certain
embodiments, diameter D may, in various embodiments, be less than
600 microns, 550 microns, 500 microns, 450 microns, 400 microns,
350 microns, 300 microns, 250 microns, or 200 microns. Sensor lumen
612 has a diameter d. In certain embodiments, diameter d is less
than 350 microns, though diameter d may, in various embodiments, be
less than 325 microns, 300 microns, 275 microns, 250 microns, 200
microns, 175 microns, 150 microns, 125 microns, or 100 microns.
[0140] As shown in FIG. 16, a sensor 620 may be inserted into
sensor lumen 612 of sheath 700. In certain specific embodiments,
sensor 620 comprises a fiber optic Fabry-Perot pressure sensor
having a diameter of, or about, 260 microns. Other embodiments of
sensor 620 may, in various embodiments, have a diameter of less
than 350 microns, 325 microns, 300 microns, 275 microns, 250
microns, or 200 microns. Other suitable sensors or sensor/fiber
combinations may be used, such as those described above.
[0141] Side views of embodiments of sheath 700 are shown in FIGS.
17A-17B, which show portions of a wall of the sheath. For clarity,
certain features, such as first lumen 610 and stiffener 608, are
not shown. Sheath 700 has a proximal end 702, and a distal end 704.
Sensor 620 is coupled to a transmission line 622. At least a
portion of sensor 620 and transmission line 622 are secured to
sheath 700 or disposed within sensor lumen 612. In some
embodiments, as shown in FIG. 17A, sensor 620 may be positioned
within sensor lumen 612 at or adjacent to distal end 704 of sheath,
such that it can detect a parameter through the opening to the
sensor lumen at the distal end of the sheath. In other embodiments,
as shown in FIG. 17B, sensor 620 may be positioned within sensor
lumen 612 at, near, within, or adjacent to an opening 616 in wall
614 of sheath 700 that is proximal to distal end 704. After the
sensor and, if used, the transmission line have been inserted into
the sensor lumen, an embedding medium (for example, an epoxy,
methacrylate, a curable adhesive (such as one curable with
ultraviolet light), or any other suitable medium known to one of
ordinary skill in the art) may be inserted into the sensor lumen to
secure the sensor and, if used, the transmission line, to the
sheath (or relevant medical device). The embedding medium may be
used to fix the sensor into a particular position, such as at the
distal end of the medical device. The embedding medium may be
inserted through any suitable opening that is in communication with
the sensor lumen, such as one at the proximal end of the medical
device or through an opening formed at any suitable location along
the length of the medical device that is in communication with the
sensor lumen.
[0142] In certain embodiments, sheath 700 may comprise more than
one sensor lumen 612, including for example, two, three, or more
sensor lumens 612. These additional sensor lumens 612 are
positioned in wall 614 of sheath 700 such that sensor lumens 612
are independent from first lumen 610, and are further separated
from and prevented from impinging into or invaginating first lumen
610; this prevention is generally a function of the stiffener, but
may also or alternatively be a function of the use of sensor lumen
tubes 602. Further, sensor lumens 612 may be configured to receive
at least a portion of a sensor 620 and at least a portion of a
transmission line 622. In various embodiments, the types of sensors
620 and transmission lines 622 used in each sensor lumen 612 may be
the same, or may be different from one another.
[0143] In certain embodiments, wall thickness T, diameter D,
diameter d, or any combination of these dimensions may vary along
the length of sheath 700. For example, in some embodiments, T at
proximal end 702 of sheath 700 may be greater than T at distal end
704 of sheath 700. As another example, T may vary near the location
of a given sensor, such as being slightly thicker adjacent the
sensor than at other areas (including those that are
circumferentially aligned with the sensor).
[0144] Certain embodiments comprise a method for making a catheter,
such as the balloon catheter 800 shown in side section view in
FIGS. 18A-18B. Balloon catheter 800 may be made in substantially
the same way as sheath 700 is made, as described above in relation
to FIGS. 12A-17B.
[0145] Balloon catheter 800 has a proximal end 802, a distal end
804, a primary lumen 810, and a wall 814. In some embodiments, such
as the embodiment illustrated in FIG. 18, balloon catheter 800
further comprises sensor lumen 812 embedded in wall 814. Balloon
catheter 800 is configured to be placed in an environment 1000
(e.g., within a blood vessel, within an artery, or within a
urethra).
[0146] In addition, balloon catheter 800 may comprise one or more
balloon membranes 840 forming envelopes 850 between balloon
membrane 840 and wall 814. Balloon catheter 800 may have a length L
between 3 centimeters and 175 centimeters. In certain embodiments,
balloon membrane 840 may terminate at a distance 1 from distal end
804 of balloon catheter 800. In certain embodiments, 1 may be
between 2 millimeters and 5 centimeters.
[0147] Balloon catheter 800 further comprises an inflation lumen
815 in communication with envelope 850. Inflation lumen 815 is
separate from primary lumen 810 and is configured to provide fluid
(e.g., air or liquid) to envelope 850. Balloon membrane 840 is
configured to expand when fluid is introduced into envelope 850.
For example, balloon catheter 800 may be a catheter used to drain
urine, such as a Foley catheter. When balloon membrane 840 is
inflated, balloon catheter 800 may be held in place in a patient
(e.g., the patient's urethra).
[0148] Balloon catheter 800 may comprise one or more sensors 620
and transmission lines 622. In the embodiment illustrated, sensor
620 is coupled to transmission line 622. In other embodiments,
including those relevant to the present sheaths, sensor 620 may be
configured to transmit signals wirelessly, and in such embodiments,
transmission line 622 may be unnecessary. Sensor 620 is shown
coupled to transmission line 622 and may be disposed at least
partially within sensor lumen 812 and positioned proximal to
opening 616 in communication with envelope 850. In other
embodiments, sensor 622 may be positioned at distal end 804 and in
communication with environment 1000. In still other embodiments,
sensor 622 may be positioned on the proximal side of balloon
membrane 840.
[0149] In certain embodiments, sheath 700 and catheter 800 may be
configured to be coupled to one another, such as through a hub. An
example of such a hub 900 is shown in cross-section in FIG. 19.
Though the following discussion concerns an embodiment where sheath
700 is configured to be coupled to hub 900, and catheter 800 is
configured to be coupled to sheath 700 through a valve of the hub,
one skilled in the art will understand that other embodiments may
include other tubular members configured for insertion into a
patient that may be coupled to hub 900.
[0150] Hub 900 may comprise a first lumen 910 configured to be in
communication with first lumen 610 of sheath 700, and a sensor
lumen 912 configured to be in communication with sensor lumen 612
of sheath 700. Hub 900 may further comprise a valve 902 in some
embodiments, where valve 902 is configured to seal first lumen 910,
including where catheter 700 is inserted into the lumen of the
sheath. Valve 902 is depicted as a graphic symbol positioned
outside of hub 900, it should be understood that valve 902 may take
the form of a structure that is bound partly or completely by hub
900, such as a valve in the form of a septum (a pierceable,
self-sealing member) extending across the proximal entrance to
first lumen 910. The valve may be a hemostasis valve. In some
embodiments, hub 900 may be characterized as a housing.
[0151] Hub 900 may comprise one or more side arms, each side arm
having one or more ports. The embodiment depicted in FIG. 19
comprises a side arm 924 comprising a first port 926 and a second
port 928. First port 926 comprises a flushing lumen 914 in direct
fluid communication with first lumen 910. A stop cock (not shown)
may be coupled (e.g., through a flexible conduit) to first port 926
for controlling the flow of fluid through flushing lumen 914.
[0152] In the illustrated embodiment, second port 928 comprises
sensor lumen 912 in which a portion of transmission line 622 is
contained. In some embodiments, transmission line 622 is embedded
within hub 900. In certain embodiments, hub 900 or side arm 924 may
comprise more than one sensor lumen 912, including for example,
two, three, or more sensor lumens 912. These additional sensor
lumens 912 are positioned such that sensor lumens 912 are
independent from first lumen 910.
[0153] In some embodiments, a portion of transmission line 622 is
contained or embedded in a second side arm separate from the first
side arm. In other embodiments, second side arm 922 comprises a
portion of sensor lumen 912, and a portion of transmission line 622
may be contained within sensor lumen 912. The sensor lumens of a
given one of the present hubs may be formed according to the
methods described above for forming, for example, the present
sheaths and catheters, and an embedding medium may be used to
secure the respective sensor(s) in place, as described above.
[0154] The present hubs may comprise multiple pieces coupled
together. FIG. 20 shows hub 950, another embodiment of the present
hubs that was formed to include a sensor lumen. Hub 950 includes a
first (e.g., distal) element 960 that includes a central (e.g.,
main) segment 951 that is aligned with the medical device (sheath
700, in this embodiment) to which the element is coupled, and first
element side arm 962 extending in a proximal direction and that
includes a suture opening tab 964, which in the depicted embodiment
is located near the distal end of the first element. Angled side
arm 962 is oriented at an oblique angle to main segment 951; in the
depicted embodiment, the angle between the side arm and the main
segment is acute.
[0155] First element 960 is coupled to sheath 700 (only a portion
of which is shown) and to a second element 970 of hub 950 through a
threaded connection. Second element 970 of hub 950 includes a
second element side arm 972 that is oriented at a right angle to
central (e.g., main) segment 971 of second element 970. Second
element 970 also includes valve 974 at its proximal end (the
proximal end thus be characterizable as a valved end), which is
similar to valve 902 and may take the form of, e.g., a septum. In
the depicted embodiment, first element side arm 962 and second
element side arm 972 are rotationally offset from each, such as
from 5 to 10 degrees. Some embodiments of the present medical
devices that include hub 950 may also include a stabilizing element
(not shown) that is clipped to the hub and is configured to keep
first and second side arms 962 and 972 from rotationally moving
with respect to each other. In other embodiments, the two side arms
may be aligned (see FIG. 23, described in greater detail below), or
offset to a greater extent, such as from 10 to 180 degrees, and any
increment in between. Embodiments of the present medical devices
that include hub 950 may also include a sensor support conduit 980
that is coupled to first element side arm 962 and that includes a
lumen in which a sensor transmission line (e.g., line 622) is
embedded (e.g., with an embedding medium). Such embodiments may
also include a flush conduit 985 that is coupled to second element
side arm 972, a stop cock 987 that is coupled to flush conduit 985
and is configured to control the flow of fluid through the flush
conduit and into the main lumen of the hub, and a connector 989
(such as a male luer connector) configured to facilitate the
connection of the flush conduit to a fluid source or the like.
[0156] FIG. 21 depicts in cut-away form portions of the structures
shown in FIG. 20. FIG. 21 also shows the proximal portion of sheath
700 coupled to first element 960 of hub 950 by being positioned in
the lumen of central segment 961. This figure also shows line 622
extending from the sensor lumen of sheath 970 out a side port
(unlabeled) and into a sensor lumen formed in first element side
arm 962, where it then extends into the lumen of sensor support
conduit 980 which is coupled to first element side arm 962 in the
same way sheath 970 is coupled to first element 960. The
connections between the sensor support conduit and the first
element and between sheath 970 and the first element of hub 950 may
be reinforced in any way known to those of ordinary skill in the
art, including through an adhesive, a weld (e.g., one or more sonic
welds), heat, and the like. The lumen of first element side arm 962
may vary in size; for example, it may be larger near the proximal
end of the side arm to accommodate the insertion of the sensor
support conduit, and it may then transition to a lumen that is only
as large as or slightly larger than the outside of the sensor
transmission line. Flush conduit 985 may be coupled to second
element side arm 972 in any suitable way known to those of ordinary
skill in the art, including through a friction fit, and may be
reinforced as described above. Flush conduit 985 may be oriented as
a straight conduit, as shown in FIGS. 20 and 21, or it may be
oriented with a bend in it (e.g., a 90 degree bend) as shown via
conduit 985' in FIG. 22. Nut 975, which is shown in FIGS. 20 and
21, may be integral with second element 970 when the first and
second elements are in a separated state (as shown in FIG. 21) or
it may be coupled to either the first or second element when the
two elements are in a separated state. Nut 975' may not include
exterior ridges, as shown in FIG. 22, in contrast to nut 975.
[0157] Other embodiments of the present hubs include multi-piece
hubs that include spaced-apart first and second element side arms
that are not rotationally-offset from each, as shown in FIG. 23,
which depicts a version of hub 950 that is identical to hub 950
depicted in FIGS. 20 and 21 except that the side arms are aligned
and nut 975', and that also includes a bent sensor support conduit
980'.
[0158] Another embodiment of the present hubs that includes side
arms configured for a sensor transmission line and a flush line
that are aligned and that share the same angle relative to main
segment of the hub is shown in FIG. 24, which depicts hub 1050 that
includes a first element 1060 that includes a first side arm 1062
extending at an oblique (acute, in this embodiment) angle from
central segment 1061, a suture opening tab 1064 extending from the
proximal end of the first element, and a second side arm 1065
positioned proximal to first side arm 1062 and also extending at an
oblique (acute, in this embodiment) angle from central segment
1061. Hub 1050 includes a second element 1070 that is coupled to
first element 1060 with screw 1075 and that includes a valved
proximal end 1074 (the valve, not shown, may for example be a
septum) that is configured, like the proximal ends of the hubs
depicted in the remaining figures, to be sealingly coupled to
another tubular structure, like a catheter. Embodiments of the
present medical devices that include hub 1050 may also include a
sensor support conduit 1080 that is coupled to first side arm 1062
and that includes a lumen in which a sensor transmission line
(e.g., line 622) is embedded (e.g., with an embedding medium). Such
embodiments may also include a flush conduit 1085 that is coupled
to second side arm 1064, a stop cock 1087 that is coupled to flush
conduit 1085 and is configured to control the flow of fluid through
the flush conduit and into the main lumen of the hub, and a
connector 1089 (such as a male luer connector) configured to
facilitate the connection of the flush conduit to a fluid source or
the like. Sensor support conduit 1080 and flush line 1085 are
coupled to first and second side arms 1062 and 1072, respectively,
in the manner described above with respect to the sensor support
conduits and flush lines depicted in the other figures, and they
serve the respective functions described above with respect to the
sensor support conduits and flush lines depicted in the other
figures.
[0159] The present medical devices, perfusion systems, kits and
methods are not intended to be limited to the particular forms
disclosed. Rather, they are to cover all modifications,
equivalents, and alternatives falling within the scope of the
claims. For example, the medical device set forth in FIG. 1A may
further include one or more additional pressure sensors. As a
further example, the perfusion system set forth in FIG. 6 may
further include an introducer for the depicted sheath. Furthermore,
in some embodiments it may be advantageous to coat certain surfaces
of the medical devices. Any suitable coating could be used, such as
one that tends to thwart infection or otherwise make the medical
device more acceptable to a living being. The coating may
optionally include a therapeutic agent, such as an antibiotic or
anticoagulant.
[0160] The claims are not to be interpreted as including
means-plus- or step-plus-function limitations, unless such a
limitation is explicitly recited in a given claim using the
phrase(s) "means for" or "step for," respectively.
* * * * *