U.S. patent application number 17/207194 was filed with the patent office on 2021-07-29 for combined stent reperfusion system.
This patent application is currently assigned to CorFlow Therapeutics AG. The applicant listed for this patent is CorFlow Therapeutics AG. Invention is credited to Jon H. HOEM, Martin T. ROTHMAN, Robert S. SCHWARTZ.
Application Number | 20210228387 17/207194 |
Document ID | / |
Family ID | 1000005507874 |
Filed Date | 2021-07-29 |
United States Patent
Application |
20210228387 |
Kind Code |
A1 |
HOEM; Jon H. ; et
al. |
July 29, 2021 |
COMBINED STENT REPERFUSION SYSTEM
Abstract
Devices and methods for preventing reperfusion injuries when an
occlusion balloon is deflated. A catheter having an infusion lumen
exiting the catheter distal of a stent balloon and/or occlusion
balloon allows a therapeutic agent to be introduced to a target
location to establish desired temperatures and pressures prior to
deflation of the balloon such that negative effects of reperfusion
are minimized.
Inventors: |
HOEM; Jon H.; (Baar, CH)
; SCHWARTZ; Robert S.; (Inver Grover Heights, MN)
; ROTHMAN; Martin T.; (Santa Rosa, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CorFlow Therapeutics AG |
Baar |
|
CH |
|
|
Assignee: |
CorFlow Therapeutics AG
Baar
CH
|
Family ID: |
1000005507874 |
Appl. No.: |
17/207194 |
Filed: |
March 19, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15926911 |
Mar 20, 2018 |
10952883 |
|
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17207194 |
|
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62473740 |
Mar 20, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2025/1061 20130101;
A61B 17/12109 20130101; A61F 2/958 20130101; A61B 17/12136
20130101; A61B 2017/00243 20130101; A61B 2090/064 20160201; A61M
2025/105 20130101; A61M 25/1011 20130101; A61B 17/1204 20130101;
A61B 2017/00084 20130101; A61M 2025/0037 20130101; A61M 25/104
20130101; A61M 25/0032 20130101 |
International
Class: |
A61F 2/958 20060101
A61F002/958; A61M 25/10 20060101 A61M025/10; A61M 25/00 20060101
A61M025/00 |
Claims
1. A combined stent delivery and occlusion device comprising: a
proximal manifold including: an infusion port; and a stent balloon
inflation port; a catheter extending distally from the manifold and
defining an infusion lumen in fluid communication with the infusion
port, and an inflation lumen in fluid communication with the stent
balloon inflation port; a therapeutic agent port in fluid
communication with a therapeutic agent lumen further defined by the
catheter and leading to a distal end of the catheter; a stent
balloon near the distal end of the catheter and surrounding the
catheter, the stent balloon in fluid communication with the
inflation lumen; and a stent surrounding the stent balloon.
2. The combined stent delivery and occlusion device of claim 1,
wherein the stent balloon, when inflated, serves as an occlusion
balloon, blocking blood flow through a vessel in which the stent
balloon is inflated.
3. The combined stent delivery and occlusion device of claim 1,
wherein the therapeutic agent port is located distal of the
manifold.
4. The combined stent delivery and occlusion device of claim 1,
further comprising an occlusion balloon.
5. The combined stent delivery and occlusion device of claim 4,
wherein the occlusion balloon is located distal of the stent
balloon.
6. The combined stent delivery and occlusion device of claim 4,
wherein the proximal manifold further includes an occlusion balloon
inflation port.
7. The combined stent delivery and occlusion device of claim 6,
wherein the catheter further defines an occlusion balloon inflation
lumen.
8-16. (canceled)
17. The combined stent delivery and occlusion device of claim 4,
wherein the occlusion balloon is located proximal of the stent
balloon.
18. The combined stent delivery and occlusion device of claim 4,
wherein the occlusion balloon has different properties than the
stent balloon.
19. The combined stent delivery and occlusion device of claim 4,
wherein the infusion lumen is configured to accommodate a rapid
exchange guidewire.
20. A combined stent delivery and occlusion system comprising: a
proximal manifold including: an infusion port; a stent balloon
inflation port; and an occlusion balloon inflation port; a catheter
extending distally from the manifold and defining an infusion lumen
in fluid communication with the infusion port, a stent balloon
inflation lumen in fluid communication with the stent balloon
inflation port, and an occlusion balloon inflation lumen in fluid
communication with the occlusion balloon inflation port; a
guidewire having one or more sensors; a stent balloon near a distal
end of the catheter and surrounding the catheter, the stent balloon
in fluid communication with the stent balloon inflation lumen; a
stent surrounding the stent balloon; and an occlusion balloon near
the distal end of the catheter and surrounding the catheter, the
occlusion balloon in fluid communication with the occlusion balloon
inflation lumen; wherein the infusion lumen is configured to
accommodate the guidewire.
21. The combined stent delivery and occlusion system of claim 20,
further comprising a therapeutic agent port in fluid communication
with a therapeutic agent lumen further defined by the catheter and
leading to the distal end of the catheter.
22. The combined stent delivery and occlusion system of claim 21,
wherein the occlusion balloon and the stent balloon are fixed
relative to a longitudinal direction of the catheter.
23. The combined stent delivery and occlusion system of claim 21,
wherein the occlusion balloon is located distal of the stent
balloon.
24. The combined stent delivery and occlusion system of claim 21,
wherein the occlusion balloon has different properties than the
stent balloon.
25. A combined stent delivery and occlusion system comprising: a
proximal manifold including: an infusion port; a stent balloon
inflation port; and an occlusion balloon inflation port; a catheter
extending distally from the manifold and defining an infusion lumen
in fluid communication with the infusion port, a stent balloon
inflation lumen in fluid communication with the stent balloon
inflation port, and an occlusion balloon inflation lumen in fluid
communication with the occlusion balloon inflation port;
measurement technology mounted on the catheter; a stent balloon
near a distal end of the catheter and surrounding the catheter, the
stent balloon in fluid communication with the stent balloon
inflation lumen; a stent surrounding the stent balloon; and an
occlusion balloon near the distal end of the catheter and
surrounding the catheter, the occlusion balloon in fluid
communication with the occlusion balloon inflation lumen.
26. The combined stent delivery and occlusion system of claim 25,
further comprising a therapeutic agent port in fluid communication
with a therapeutic agent lumen further defined by the catheter and
leading to the distal end of the catheter.
27. The combined stent delivery and occlusion system of claim 26,
wherein the infusion lumen is configured to accommodate a rapid
exchange guidewire
28. The combined stent delivery and occlusion system of claim 27,
wherein the occlusion balloon is located distal of the stent
balloon.
29. The combined stent delivery and occlusion system of claim 27,
wherein the occlusion balloon has different properties than the
stent balloon.
Description
RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 15/926,911, filed Mar. 20, 2018, now U.S. Pat.
No. 10,952,883, which claims priority to Provisional Patent
Application Ser. No. 62/473,740, filed Mar. 20, 2017, entitled
Combined Stent Reperfusion System, the entire contents of each of
which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The coronary microcirculation is critical for normal cardiac
function, and myocardial infarction (MI) with subsequent ischemic
cardiomyopathy are the most common causes of cardiac morbidity and
mortality. Microvascular obstruction and no reflow are the
principal causes of post-MI heart failure, adverse LV remodelling,
scar/aneurysm formation and arrhythmias.
[0003] Recent publications by Hervas and Bulluck, incorporated by
reference herein, have documented that the fundamental trigger for
MVO is the reperfusion itself. I.e., it is the reopening of the
coronary artery which triggers formation of MVO and MVO in itself
is an independent predictor for patient outcomes in acute heart
attack patients. Thus, there is a need for a method and device that
targets the reduction of reperfusion injury, thus potentially
reducing the formation of MVO.
[0004] Technologies have been recently developed to diagnose and
treat MVO and are described in U.S. Pat. No. 10,315,016 and PCT
Application Ser. No. PCT/US2017/012181, both to Schwartz et al. and
entitled System and Method for Treating MVO. The entireties of
these references are incorporated by reference herein. These
references describe an easy-to-use, reliable technology that
simultaneously measures and treats coronary MVO (STEM, NSTEMI UA,
Stable Angina etc.) in the catheterization lab. The technology, if
desired, can be used independently for coronary and microvascular
diagnosis, separately for treatment if desired.
ASPECTS AND SUMMARY OF THE INVENTION
[0005] The present invention provides a technology that combines
the delivery of a coronary stent with a system for treating
microvascular obstructions while avoiding reperfusion injuries.
[0006] One aspect of the invention pertains to the placement of a
stent using an occlusion and perfusion catheter to diagnose and
treat microvascular obstruction/no reflow, and to avoid reperfusion
injury. According to this aspect, a catheter is provided with a
stent placed over a balloon delivery system and is used for re
vascularizing the heart and/or other organs including, but not
limited to, the brain, lungs, kidneys, muscles, intestines etc.
[0007] The catheter may be placed over a
pressure/temperature-sensing guidewire to allow for real-time
measurement of distal vessel pressure and temperatures, i.e. distal
to the balloon delivery system. Alternatively, the measurement
technology may be mounted directly to the delivery catheter.
[0008] In one aspect, the catheter has an infusion lumen, which can
infuse cardioprotective or therapeutic agents into the coronary
circulation.
[0009] Another aspect of the invention is a system that can infuse
cardio-protective and/or therapeutic agents into the
microcirculation before a stent delivery balloon is collapsed. In
this way the stent balloon, while inflated, acts as an occlusion
balloon. Furthermore, the catheter lumen is available to deliver a
cardio-protective agent to reduce the potential negative effect of
the reintroduction of blood flow when the balloon is deflated.
After deflation, the stent remains in place to promote continued
epicardial perfusion of the coronary tree.
[0010] Yet another aspect of the invention provides a stent
delivery balloon with an occlusion balloon. These two balloons may
have different properties.
[0011] In one embodiment the stent delivery balloon and the
occlusion balloon may be mounted on a catheter shaft. They may be
fixed longitudinally to the shaft or may be mounted such that the
longitudinal position is adjustable to offer more accurate
placement.
[0012] Another aspect of the invention is a method of reperfusing
using a catheter having a stent delivery balloon and an occlusion
balloon. The method begins by placing a catheter into the artery,
preferably over a rapid exchange wire with pressure and
temperature-sensing capabilities at a distal end of the guide wire.
The occlusion balloon is then inflated to avoid reperfusion. The
stent is then delivered by inflating the stent delivery balloon.
Once the stent is in place, the stent delivery balloon is deflated.
The occlusion balloon remains inflated to prevent reperfusion from
occurring. A cardio-protective agent is then infused through the
infusion lumen of the catheter. During this time, the effect of the
cardio-protective agent is measured with the pressure/temperature
sensor. Once the cardio-protective effect is achieved, the
occlusion balloon is deflated. After the blood reperfuses, the
degree of microvascular damage can be measured and potentially
treated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] These and other aspects, features and advantages of which
embodiments of the invention are capable of will be apparent and
elucidated from the following description of embodiments of the
present invention, reference being made to the accompanying
drawings, in which
[0014] FIG. 1 is a perspective view of an embodiment of a single
balloon inflation system of the invention;
[0015] FIG. 2 is a section view taken along lines A-A of FIG.
1;
[0016] FIG. 3 is a section view taken along lines B-B of FIG.
1;
[0017] FIG. 4 is a perspective view of an embodiment of a single
balloon inflation system of the invention;
[0018] FIG. 5 is a section view taken along lines A-A of FIG. 1;
and,
[0019] FIG. 6 is a section view taken along lines B-B of FIG.
1.
DESCRIPTION OF EMBODIMENTS
[0020] Specific embodiments of the invention will now be described
with reference to the accompanying drawings. This invention may,
however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein; rather,
these embodiments are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of the
invention to those skilled in the art. The terminology used in the
detailed description of the embodiments illustrated in the
accompanying drawings is not intended to be limiting of the
invention. In the drawings, like numbers refer to like
elements.
[0021] FIG. 1 shows a single balloon embodiment 10 of a delivery
system of the invention. The delivery system 10 includes a manifold
12 at a proximal end that includes an infusion port 14 and a stent
balloon inflation port 16. The manifold tapers to a flexible
catheter 20 that proximally contains two lumens--an infusion lumen
22 that is in fluid communication with the infusion port 14 and an
inflation lumen 24 that is in fluid communication with the balloon
inflation port 16.
[0022] FIG. 2 is a cross section of the catheter 20 taken along
section lines A-A of FIG. 1. FIG. 2 shows the infusion lumen 22 and
the inflation lumen 24.
[0023] Proceeding distally in FIG. 1, there is shown a therapeutic
agent or Rx port 30 that leads to an Rx lumen 32 in the catheter
20. FIG. 3 shows a cross section of the catheter 20 taken along
section lines B-B of FIG. 1. It can thus be seen that distal of the
Rx port, the catheter has three lumens, an infusion lumen 22, an
inflation lumen 24 and an Rx lumen 32.
[0024] Distal of the Rx port 30 is a balloon 40 with a stent 42.
The balloon 40 is in fluid communication with the inflation lumen
24 such that fluid passing distally through the inflation lumen 24
terminates in the balloon 40.
[0025] A stent 42 surrounds the balloon 40 and is expanded thereby
when the balloon 40 in inflated. The stent 42, due to its memory
properties, remains expanded after the balloon 40 deflates. Thus,
deflating balloon 40 results in separation of the stent 42.
[0026] Distal of the balloon 40 is the distal end 50 of the
catheter 20. The distal end 50 includes an open end of the infusion
lumen 22.
[0027] In use, the delivery device 10 involves routing the catheter
20 over a guide wire 49 to the target site. The infusion lumen 22
is used as a guidewire lumen while the device 10 is being advanced
to the target site. The guidewire preferably includes a pressure
and temperature sensor 51 to provide real-time measurement of
distal vessel pressures and temperatures at a location distal of
the balloon delivery system.
[0028] Once the device 10 has reached its target location, the
balloon 40 is inflated causing the stent 42 to expand against the
native tissue. The inflation of the balloon 40 also results in an
occlusion of the vessel.
[0029] While the balloon 40 remains inflated and the vessel
occluded, a cardio-protective agent is infused via the infusion
port 30 and through the infusion lumen 32, exiting the lumen 32 at
the distal end 50 of the catheter, downstream of the occlusion
balloon 40. The cardio-protective agent reduces the potential
negative effects of reintroducing blood flow when the balloon 40 is
deflated.
[0030] Once the desired cardio-protective effect has been achieved,
as measured by the pressure/temperature sensor on the guidewire,
the balloon 40 is deflated, allowing normal blood reperfusion of
the coronary circulation. The stent 42 remains in place and secures
continued epicardial perfusion of the coronary tree. After blood
reperfusion is complete, the degree of microvascular damage can be
measured and potentially treated as described in the incorporated
references.
[0031] FIG. 4 shows a dual balloon embodiment 110 of a delivery
system of the invention. The delivery system 110 includes a
manifold 112 at a proximal end that includes an infusion port 114,
a stent balloon inflation port 116, and an occlusion balloon
inflation port 118. The manifold tapers to a flexible catheter 120
that proximally contains three lumens--an infusion lumen 122 that
is in fluid communication with the infusion port 114, a stent
balloon inflation lumen 124 that is in fluid communication with the
stent balloon inflation port 116, and an occlusion balloon
inflation lumen 126 that is in fluid communication with the
occlusion balloon inflation port 118.
[0032] FIG. 5 is a cross section of the catheter 120 taken along
section lines A-A of FIG. 4. FIG. 5 shows the infusion lumen 122
and the inflation lumen 124.
[0033] Proceeding distally in FIG. 6, there is shown a therapeutic
agent or Rx port 130 that leads to an Rx lumen 132 in the catheter
20. FIG. 6 shows a cross section of the catheter 20 taken along
section lines B-B of FIG. 4. It can thus be seen that distal of the
Rx port, the catheter has four lumens, the infusion lumen 122, the
inflation lumen 124, the occlusion lumen 126, and an Rx lumen
132.
[0034] Distal of the Rx port 130 is a balloon 140 with a stent 142.
The balloon 140 is in fluid communication with the inflation lumen
124 such that fluid passing distally through the inflation lumen
124 terminates in the balloon 140.
[0035] A stent 142 surrounds the balloon 140 and is expanded
thereby when the balloon 140 in inflated. The stent 142, due to its
memory properties, remains expanded after the balloon 140 deflates.
Thus, deflating balloon 140 results in separation of the stent
142.
[0036] Distal of the balloon 140 is an occlusion balloon 144. The
occlusion balloon 144 is in fluid communication with the occlusion
lumen 126 such that fluid passing distally through the occlusion
lumen 126 terminates in the balloon 144.
[0037] Distal of the balloon 144 is the distal end 150 of the
catheter 120. The distal end 150 includes an open end of the
infusion lumen 122.
[0038] In use, the delivery device 110 involves routing the
catheter 120 over a guide wire 149 to the target site. The infusion
lumen 122 is used as a guidewire lumen while the device 110 is
being advanced to the target site. The guidewire preferably
includes a pressure and temperature sensor 151 to provide real-time
measurement of distal vessel pressures and temperatures at a
location distal of the balloon delivery system.
[0039] Once the device 110 has reached its target location, the
occlusion balloon 144 is inflated to occlude the vessel and prevent
reperfusion.
[0040] Next the stent balloon 140 is inflated causing the stent 142
to expand against the native tissue. The stent balloon 140 is then
deflated, separating the stent 142 from the device.
[0041] While the occlusion balloon 144 remains inflated and the
vessel occluded, a cardio-protective agent is infused via the
infusion port 130 and through the infusion lumen 132, exiting the
lumen 132 at the distal end 150 of the catheter, downstream of the
occlusion balloon 144. The cardio-protective agent reduces the
potential negative effects of reintroducing blood flow when the
balloon 144 is deflated.
[0042] Once the desired cardio-protective effect has been achieved,
as measured by the pressure/temperature sensor on the guidewire,
the occlusion balloon 144 is deflated, allowing normal blood
reperfusion of the coronary circulation. The stent 142 remains in
place and secures continued epicardial perfusion of the coronary
tree. After blood reperfusion is complete, the degree of
microvascular damage can be measured and potentially treated as
described in the incorporated references.
[0043] Although the invention has been described in terms of
particular embodiments and applications, one of ordinary skill in
the art, in light of this teaching, can generate additional
embodiments and modifications without departing from the spirit of
or exceeding the scope of the claimed invention. Accordingly, it is
to be understood that the drawings and descriptions herein are
proffered by way of example to facilitate comprehension of the
invention and should not be construed to limit the scope
thereof.
* * * * *