U.S. patent application number 14/381787 was filed with the patent office on 2015-01-15 for perfusion-occlusion device.
This patent application is currently assigned to Medical Device Works NV. The applicant listed for this patent is MEDICAL DEVICE WORKS NV. Invention is credited to Emmanuel J. Bartholome, Joop Fierens, Eric Thierry Jean Marcoux, Kevin Jason Nackard.
Application Number | 20150018762 14/381787 |
Document ID | / |
Family ID | 47754558 |
Filed Date | 2015-01-15 |
United States Patent
Application |
20150018762 |
Kind Code |
A1 |
Fierens; Joop ; et
al. |
January 15, 2015 |
PERFUSION-OCCLUSION DEVICE
Abstract
The present application provides a device for the simultaneous
or the separate perfusion and occlusion of a vessel comprising a
body having a distal end, a proximal end, a single lumen (66, 80)
extending between the proximal end and the distal end, and at least
one opening (63,72) which is in fluid communication with the lumen
for delivering a therapeutic treatment to a vessel; and at least
one expandable balloon (65,70,81) coupled with the body of the
device, said balloon is provided with an interior which is in fluid
communication with the lumen of the device through at least one
opening (68, 69, 70), said opening is provided with at least one
valve (71) which is movable from a closed position, in which fluid
communication of the lumen with the interior of the balloon is
prevented, to an open position in which the lumen is in fluid
communication with the interior of the balloon.
Inventors: |
Fierens; Joop; (Dworp,
BE) ; Nackard; Kevin Jason; (Flagstaff, AZ) ;
Marcoux; Eric Thierry Jean; (Wemmel, BE) ;
Bartholome; Emmanuel J.; (Uccle, BE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDICAL DEVICE WORKS NV |
Brussel |
|
BE |
|
|
Assignee: |
Medical Device Works NV
Brussel
BE
|
Family ID: |
47754558 |
Appl. No.: |
14/381787 |
Filed: |
March 1, 2013 |
PCT Filed: |
March 1, 2013 |
PCT NO: |
PCT/EP2013/054203 |
371 Date: |
August 28, 2014 |
Current U.S.
Class: |
604/99.02 |
Current CPC
Class: |
A61B 2017/12054
20130101; A61M 1/3621 20130101; A61B 17/1204 20130101; A61M 25/007
20130101; A61B 17/12036 20130101; A61B 2017/00893 20130101; A61M
1/34 20130101; A61M 5/142 20130101; A61M 2205/3303 20130101; A61M
1/32 20130101; A61M 1/3615 20140204; A61M 1/3613 20140204; A61B
17/12109 20130101; A61M 25/10183 20131105; A61M 25/1018 20130101;
A61M 25/10 20130101; A61M 2025/1052 20130101; A61M 2025/105
20130101; A61B 17/12136 20130101; A61B 17/12172 20130101; A61M
1/3455 20130101; A61M 25/0074 20130101; A61B 2017/1205 20130101;
A61M 1/367 20130101; A61M 25/0075 20130101; A61N 5/1002 20130101;
A61M 2205/3344 20130101 |
Class at
Publication: |
604/99.02 |
International
Class: |
A61M 1/36 20060101
A61M001/36; A61M 25/00 20060101 A61M025/00; A61B 17/12 20060101
A61B017/12 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 1, 2012 |
EP |
12157765.4 |
Claims
1. A device for the simultaneous or the separate perfusion and
occlusion of a vessel comprising: a body having a distal end (X), a
proximal end (Y), a single lumen extending between the proximal end
(Y) and the distal end (X), and at least one opening which is in
fluid communication with the lumen for delivering a therapeutic
treatment to a vessel; and at least one expandable balloon coupled
with the body of the device, wherein said balloon is provided with
an interior which is in fluid communication with the lumen of the
device through at least one opening, wherein said opening is
provided with at least one valve which is movable from a closed
position, in which fluid communication of the lumen with the
interior of the balloon is prevented, to an open position in which
the lumen is in fluid communication with the interior of the
balloon.
2. The device according to claim 1, wherein the valve is movable
from a closed position to an open position in which said valve is
completely contained outside the lumen of the device and inside the
interior of the balloon.
3. The device according to claim 1, wherein the valve is movable
from a closed position to an open position in which said valve is
at least partially contained inside the lumen of the device.
4. The device according to claim 1, wherein the valve is selected
from the group consisting of pressure-sensitive valve, mechanically
steered valve and magnetically steered valve.
5. The device according to claim 1, wherein the open position, in
which the valve is at least partially contained inside the lumen of
the device, is obtained by creating a negative pressure inside the
lumen for deflating the balloon.
6. The device according to claim 1, wherein the diameter of the
lumen at the distal end (X) is reduced by at least 10% compared to
the diameter of the lumen at the proximal end (Y).
7. The device according to claim 1, wherein the diameter of the
lumen at the distal end (X) is of from 1 mm to 3 mm.
8. The device according to claim 1, wherein the perfusion rate is
at least 50 ml/min.
9. The device according to claim 1, wherein the opening, which is
in fluid communication with the lumen for delivering a therapeutic
treatment to a vessel, is positioned proximal to the proximal end
(Y) of the balloon and/or distal to the distal end (X) of the
balloon.
10. The device according to claim 1, wherein the distal end (X) is
a closed end.
11. The device according to claim 1, wherein the body is made of a
material selected from the group consisting of silicone, polyvinyl
chloride and rubber.
12. The device according to claim 1, wherein the valves are made of
the same material as the body of the device.
13. The device according to claim 1, wherein the valves are made of
a material different than the material of the body of the
device.
14. The device according to claim 1, wherein the balloon is made of
the same material as the body and/or the valves of the device.
15. The device according to claim 1, wherein the balloon is made of
a material different than the material of the body and/or the
valves of the device.
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to the field of
medical treatment systems. More particularly, the present invention
relates to a device for delivering a therapeutic agent to a vessel
and thereby to an organ blood flow.
BACKGROUND
[0002] Perfusion devices are largely used to deliver a therapeutic
treatment to a vessel and thereby to an organ blood flow. Said
devices are preferred as they provide minimal invasive tools to
allow repetitive perfusion procedures in a relatively short time.
Several devices have been developed for the perfusion of a vessel
and thereby to an organ blood flow.
[0003] US 2010/0222637 discloses a catheter comprising a body, at
least one expandable balloon and at least one sensor coupled with
the body. The body of the catheter comprises a proximal open end, a
distal end, a lumen extending between the proximal open end and the
distal end, and a plurality of orifices disposed thereon. Each of
the orifices is in fluid communication with the lumen of the
catheter body. The body of the catheter is configured for placement
within a venous vessel. Each of the at least one expandable
balloons of the catheter is coupled with the body and comprises an
interior that is in fluid communication with the lumen. Further,
each expandable balloon is adapted to move between an expanded
configuration and a deflated configuration. The body of the
catheter may further comprise one or more pores disposed thereon to
facilitate fluid communication between the lumen and the interior
of each of the expandable balloons. Each of the at least one
expandable balloons may be adapted to move from the deflated
configuration to the expanded configuration when a fluid flows
through the lumen of the body, through the one or more pores, and
into the interior of the expandable balloon.
[0004] US 2004/0249401 discloses a medical device comprising an
ultrasonic probe having a proximal end, a distal end and a
longitudinal axis there between; a catheter surrounding the
ultrasonic probe, the catheter having a proximal end, a distal end
and longitudinal axis there between; an inflation lumen located
along the longitudinal axis of the catheter; and a balloon
supported by the catheter, an inner surface of the balloon is in
communication with the inflation lumen. The catheter comprises a
catheter tip at the distal end of the catheter and a plurality of
fenestrations along a longitudinal axis of the catheter. The
balloon engages the catheter at an at least one engagement position
along the longitudinal axis of the catheter. A connective tubing
engages the catheter at the port and the connective tubing can be
opened or closed with one or more valves. The connective tubing is
used to deliver a medium to inflate the balloon.
[0005] The devices of the prior art only allow for the simultaneous
perfusion and occlusion of a vessel. When the perfusion is stopped,
the occluding element of the device, in general an inflatable
balloon, is deflated thereby terminating the occlusion. The
perfused therapeutic agent will be partially conveyed to the
patient's non-targeted organs through the systemic blood flow. This
is disadvantageous for the patient as (i) it leads to a dilution of
the perfused therapeutic agent dose which inhibits the effect on
the targeted organ (ii) it limits the maximum dose that can be
perfused to a targeted organ to the maximum dose leaked out of said
organ which can be accepted by other non-targeted organs of the
patient's body (iii) the agent will have not enough time to bond to
the diseased tissue of the organ, indeed said agent needs optimum
conditions to bond or settle in the organ to be treated. In
addition, some therapeutic agents are more effective at specific
conditions, such as administration at a temperature which is
different from the systemic temperature. It is hence beneficial to
occlude the vessel for a certain period of time after the
therapeutic agent has been delivered. Surgical perfusions wherein
blood flow is controlled by clamping off the blood vessel provide a
solution for the above mentioned problems. However, said surgical
perfusions are invasive traumatic methods, expensive and cannot be
repeated on short term. Therefore, there is a need to provide a
device for the simultaneous or the separate perfusion and occlusion
of a vessel.
[0006] An object of the present invention is to provide a solution
to overcome at least part of the above mentioned disadvantages. The
invention thereto aims to provide a device for the perfusion or the
occlusion of a vessel.
SUMMARY OF THE INVENTION
[0007] The present invention provides a device for the simultaneous
or the separate perfusion and occlusion of a vessel. The device
comprises a body having a distal end a proximal end, a single lumen
extending between the proximal end and the distal end, and at least
one opening which is in fluid communication with the lumen for
delivering a therapeutic treatment to a vessel; and at least one
expandable balloon coupled with the body of the device, said
balloon is provided with an interior which is in fluid
communication with the lumen of the device through at least one
opening of the lumen, said opening is provided with at least one
valve which is movable from a closed position, in which fluid
communication of the lumen with the interior of the balloon is
prevented, to an open position in which the lumen is in fluid
communication with the interior of the balloon. In a further
preferred embodiment, the interior of the balloon is in fluid
communication with the lumen of the device through a plurality of
openings of the lumen. In a preferred embodiment each of said
openings, allowing fluid communication between the balloon interior
and the lumen, is provided with a valve.
[0008] In a preferred embodiment, the valves are movable from a
closed position to an open position in which said valves are
completely contained outside the lumen of the device and inside the
interior of the balloon.
[0009] In a preferred embodiment, the valves are movable from a
closed position to an open position in which said valves are at
least partially contained inside the lumen of the device. The open
position, in which the valves are at least partially contained
inside the lumen of the device, is obtained by creating a negative
pressure inside the lumen for deflating the balloon.
[0010] In a preferred embodiment, the valves are selected from the
group comprising pressure-sensitive valve, mechanically steered
valves and magnetically steered valves. Preferably said valves are
pressure-sensitive valves.
[0011] In a preferred embodiment, the diameter of the lumen at the
distal end is reduced by at least 10% compared to the diameter of
the lumen at the proximal end. In a preferred embodiment, the
diameter of the lumen at the distal end is of from 1 mm to 3
mm.
[0012] In a preferred embodiment, the perfusion rate of the device
is at least 50 ml/min. In a preferred embodiment, the distal end of
the device is a closed end. The proximal end of the device is an
open end.
[0013] In a preferred embodiment, the opening, which is in fluid
communication with the lumen for delivering a therapeutic treatment
to a vessel, is positioned proximal to the proximal end of the
balloon and/or distal to the distal end of the balloon.
[0014] In a preferred embodiment, the body is made of a material
selected from the group comprising silicone, polyvinyl chloride and
rubber. In a preferred embodiment, the valves are made of the same
material as the body of the device.
[0015] In a preferred embodiment, the valves are made of a material
different than the material of the body of the device.
[0016] In a preferred embodiment, the balloon is made of the same
material as the body and/or the valves of the device.
[0017] In a preferred embodiment, the balloon is made of a material
different than the material of the body and/or the valves of the
device.
[0018] The device of the present invention presents several
advantages. The device is of a small size and is flexible which
allows its introduction into tortuous vessels to be positioned
close to or in an organ. Hence, the device allows the simultaneous
or the separate perfusion AND occlusion of very small and tortuous
vessels. Said small device allows high rate perfusions and provides
for minimal invasive perfusion. In addition, the device is a single
lumen device which reduces its cost as less material will be used
for the production. Furthermore, the device of the present
invention provides a tool for the simultaneous perfusion and
occlusion of a vessel and for the separate occlusion of the vessel
when the perfusion is terminated, thereby enhancing the efficiency
of the delivered therapeutic agent.
DESCRIPTION OF THE FIGURES
[0019] FIG. 1 illustrates an embodiment of the second medical
device in the expanded state comprising a tubular member (dumb-bell
shaped) attached to a catheter. FIG. 1A shows a transverse
cross-section across the catheter where the pusher means is a
pusher rod. FIG. 1B shows a transverse cross-section across the
catheter where the pusher means is formed from the wall of the
inner tube.
[0020] FIG. 1C illustrates another embodiment of the second medical
device in the expanded state comprising a tubular member (dumb-bell
shaped) attached to a catheter. The liner is attached to the inner
wall of the tubular member.
[0021] FIG. 1D illustrates a side view of another embodiment of the
second medical device wherein the distal end of the inner tube have
a cup or a spoon shape
[0022] FIG. 1E illustrates a top view of the same embodiment
[0023] FIG. 1F illustrates a cross-section view along A-A shown in
FIG. 1D.
[0024] FIG. 1G illustrates another embodiment of the second medical
device in the expanded state wherein the device has a bell
shape.
[0025] FIG. 2A illustrates an embodiment of the second medical
device of FIG. 1 where the tubular member is in its collapsed,
compressed state and is provided with a closed tip.
[0026] FIG. 2B illustrates another embodiment of the second medical
device of FIG. 1 where the tubular member is in its collapsed,
compressed state and is provided with a conical closed tip.
[0027] FIG. 3 illustrates the second medical device which has been
placed in situ, wherein: A illustrates a liner on the exterior of
the carrier, and B illustrates a liner on the interior of the
carrier.
[0028] FIG. 3 C and D illustrate the use of the second medical
device for the delivery of a therapeutic agent to the right and
left lung respectively.
[0029] FIG. 3 E and F illustrate the use of the second medical
device having a bell shape for the delivery of a therapeutic agent
to the right and left lung respectively.
[0030] FIG. 4 illustrates an embodiment of the kit wherein the
first medical device, the second medical device and the separation
device are used for delivering a therapeutic agent and removing the
therapeutic agent excess from the liver.
[0031] FIG. 5 illustrates the second medical device when introduced
in the vena cava.
[0032] FIG. 6 illustrates an embodiment showing the position of the
separation device within the second medical device.
[0033] FIG. 7 illustrates another embodiment showing the position
of the separation device within the second medical device.
[0034] FIG. 8 detailed schematic illustration of the first medical
device.
[0035] FIG. 9 detailed schematic illustration of an embodiment of
the third medical device.
[0036] FIG. 10 detailed schematic illustration of another
embodiment of the third medical device.
[0037] FIG. 11A and FIG. 11B illustrates an embodiment of the first
medical device.
[0038] FIG. 11C, FIG. 11D and FIG. 11E illustrate an embodiment of
the first medical device wherein each opening allowing fluid
communication of the lumen with the interior of the balloon is
provided with a valve.
[0039] FIG. 11F illustrates an embodiment of the first medical
device wherein the lumen diameter at the distal end of the device
is not reduced compared to the proximal diameter of the lumen and
wherein each opening allowing fluid communication of the lumen with
the interior of the balloon is provided with a valve, said valves
are pressure-controlled or pressure sensitive.
[0040] FIG. 11G illustrates an embodiment of the first medical
device wherein the lumen diameter at the distal end of the device
is not reduced compared to the proximal diameter of the lumen and
wherein each opening allowing fluid communication of the lumen with
the interior of the balloon is provided with a valve, said valves
controlled using an internal plug.
[0041] FIG. 11H illustrates an embodiment of the first medical
device wherein the lumen diameter at the distal end of the device
is not reduced compared to the proximal diameter of the lumen and
wherein each opening allowing fluid communication of the lumen with
the interior of the balloon is provided with a valve, said valves
are magnetically controlled.
[0042] FIG. 12A and FIG. 12B longitudinal cross-section view of the
first medical device
[0043] FIG. 13 illustrates an embodiment of the third medical
device.
[0044] FIG. 14 is a schematic view of a system that can be used to
perfuse a medical treatment through an organ. The system can be
controlled by an algorithm.
[0045] FIG. 15 is a flowchart of an algorithm that can be used to
control the perfusion system of FIG. 14.
[0046] FIG. 16A shows a vessel having a lesion
[0047] FIG. 16B shows the second retrievable medical device
introduced in the vessel having a lesion.
DETAILED DESCRIPTION OF THE INVENTION
[0048] Unless otherwise defined, all terms used in disclosing the
invention, including technical and scientific terms, have the
meaning as commonly understood by one of ordinary skill in the art
to which this invention belongs. By means of further guidance, term
definitions are included to better appreciate the teaching of the
present invention.
[0049] As used herein, the following terms have the following
meanings:
[0050] "A", "an", and "the" as used herein refers to both singular
and plural referents unless the context clearly dictates otherwise.
By way of example, "a compartment" refers to one or more than one
compartment.
[0051] "About" as used herein referring to a measurable value such
as a parameter, an amount, a temporal duration, and the like, is
meant to encompass variations of +/-20% or less, preferably +/-10%
or less, more preferably +/-5% or less, even more preferably +/-1%
or less, and still more preferably +/-0.1% or less of and from the
specified value, in so far such variations are appropriate to
perform in the disclosed invention. However, it is to be understood
that the value to which the modifier "about" refers is itself also
specifically disclosed.
[0052] "Comprise," "comprising," and "comprises" and "comprised of"
as used herein are synonymous with "include", "including",
"includes" or "contain", "containing", "contains" and are inclusive
or open-ended terms that specifies the presence of what follows
e.g. component and do not exclude or preclude the presence of
additional, non-recited components, features, element, members,
steps, known in the art or disclosed therein.
[0053] The recitation of numerical ranges by endpoints includes all
numbers and fractions subsumed within that range, as well as the
recited endpoints.
[0054] The expression "% by weight" (weight percent), here and
throughout the description unless otherwise defined, refers to the
relative weight of the respective component based on the overall
weight of the formulation.
[0055] The term "therapeutic agent" is used herein to refer to a
treatment fluid or particles delivered to a patient's organ.
[0056] The terms "particles", "microspheres" and "beads" are used
herein as synonyms and refer to an object that is substantially
spherical in shape and has a diameter less than 1 millimeter. The
term "glass" refers to a hard, brittle, non-crystalline, inorganic
substance, which is usually transparent; glasses are often made by
fusing silicates with soda, as described by Webster's New World
Dictionary. Ed. Guralnik, D B 1984.
[0057] The terms "inflow" and "outflow" herein refer respectively
to the blood flowing inside an organ and the blood flowing outside
an organ.
[0058] The present invention provides a device for the simultaneous
or the separate perfusion and occlusion of a vessel. Said device is
herein also called first retrievable medical device. The device
comprises a body having a distal end a proximal end, a single lumen
extending between the proximal end and the distal end, and at least
one opening which is in fluid communication with the lumen for
delivering a therapeutic treatment to a vessel; and at least one
expandable balloon coupled with the body of the device, said
balloon is provided with an interior which is in fluid
communication with the lumen of the device through at least one
opening of the lumen, said opening is provided with at least one
valve which is movable from a closed position, in which fluid
communication of the lumen with the interior of the balloon is
prevented, to an open position in which the lumen is in fluid
communication with the interior of the balloon. In a further
preferred embodiment, the interior of the balloon is in fluid
communication with the lumen of the device through a plurality of
openings of the lumen.
[0059] The device of the present invention is suitable to be used
in a kit for the delivery a therapeutic agent to an organ blood
flow and the removal of the excess of said therapeutic agent from
said organ blood flow. The kit comprises:
[0060] (a) optionally the therapeutic agent,
[0061] (b) a first retrievable medical device, for delivering said
therapeutic agent into the organ artery blood, comprising a
catheter and an injection device such as a syringe, said catheter
have a proximal end, a distal end and a lumen; the distal end is in
fluid communication with the proximal end via the lumen; said
injection device is suitable to be connected to the proximal end of
the catheter,
[0062] (c) a second retrievable medical device for isolating the
organ vein blood, having a distal end and a proximal end; said
second medical device comprises a catheter at the distal end
suitable for deploying a self-expanding hollow tubular member at
the proximal end of the device; the proximal end of the tubular
member is attached to the distal end of the catheter ; said tubular
member is configured to expand radially to form a central part
flanked by two annular ridges, a distal annular ridge and a
proximal annular ridge; the tubular member comprises a
liquid-impermeable area disposed with one or more fluid ports for
the collection of organ vein and two liquid-permeable regions, one
distal to the distal annular ridge and one proximal to the proximal
annular ridge so forming a passageway between the distal end and
the proximal end of the tubular member for the flow the organ blood
devoid of therapeutic agent, whereby the liquid-impermeable area is
disposed in an area defined by the region flanked by the annular
ridges, the distal annular ridge and at least part of the proximal
annular ridge for isolating organ vein blood containing therapeutic
agent excess from the organ blood flow devoid of therapeutic agent,
and
[0063] (d) a separation device comprising at least one filter able
to separate the therapeutic agent excess from the organ vein blood,
having an inlet for the organ vein blood having a particle excess
and an outlet for filtered organ vein blood.
[0064] The kit, devices and method of the present invention will be
further detailed for a treatment of the liver and/or the lungs.
However, any other organ can be treated using the kit, devices and
method of the present invention. For liver treatment, the kit is
intended to control blood flow in and/or out of the hepatic veins,
while maintaining continuous blood flow through the inferior vena
cava. The kit is used to collect the hepatic vein outflow in order
to filter chemotherapy, particles or a fluid treatment or any other
therapeutic agent.
[0065] Therapeutic Agent
[0066] The therapeutic agent of can be a treatment fluid or
particles or beads containing said treatment. Particles are known
for the person skilled in the art and for instance described in US
2004/197264, the content of which is incorporated herein by
reference. The particles comprise a material selected from the
group consisting of glass, polymer and resin; a first radioisotope
that emits a therapeutic [beta]-particle; and a second radioisotope
that emits a diagnostic [gamma]-ray; wherein the atomic number of
the first radioisotope is not the same as the atomic number of the
second radioisotope. In a preferred embodiment of the present
invention, the particles are beads comprising a radioactive
element, preferably polymer or glass beads. It is to be understood
that the therapeutic agent can be used with any device suitable to
deliver said agent to an organ blood flow.
[0067] The particles are used to treat organ tumors. The particles
are delivered into the organ blood flow through an artery of the
organ to be treated. The radioactive particles are selectively
implanted in the microvascular supply of the tumor wherein they
become trapped. The particles emit beta radiation for a certain
period of time which will kill the tumor.
[0068] The particles might be used to treat liver cancer for
instance. Patients with primary or metastatic tumors can be treated
by radio-embolization via a catheter which tip is placed in the
hepatic artery. A direct injection of beads into the tumor is also
possible using a needle. The spheres eventually lodge in the
microvasculature of the liver and tumor, remaining until the
complete decay of the radioisotope.
[0069] The diameter of said particles is in the range from about
1-500 micrometers, preferably 2-400 micrometers, more preferably
4-300 micrometers, most preferably 5-200 micrometers. The diameter
of said particles can be any value comprised within the mentioned
ranges.
[0070] In a further preferred embodiment, the size of the particles
is comprised between 10 and 300 micrometers, preferably between 15
and 200 micrometers, more preferably between 20 and 60 micrometers,
most preferably the particles size is around 30 micrometers.
[0071] Preferably the diameter of said particles is comprises
between 50 and 70 micrometers, more preferably between 40 and 60
micrometers, most preferably around 30 micrometers.
[0072] First Retrievable Medical Device
[0073] The first medical device (26, FIG. 4) of the present
invention is a device used for the introduction of the therapeutic
agent into the patient's body, more in particular into an organ
blood flow of the patient. The therapeutic agent may be
administered to the patient through the use of syringes or
catheters either alone or in combination with vasoconstricting
agents or by any other means of administration that effectively
causes the microspheres to become embedded in the cancerous or
tumor-bearing tissue (U.S. Pat. No. 5,302,369; incorporated herein
by reference).
[0074] The device can be used for the simultaneous or the separate
perfusion and occlusion of a vessel, thereby occluding and/or
delivering a therapeutic agent to an organ blood flow while
occluding the natural inflow. Said device comprises a body having a
distal end; a proximal end; a single lumen through which a fluid is
delivered to said vessel, said lumen is extending between the
proximal end and the distal end; and at least one opening which is
in fluid communication with the lumen for delivering a therapeutic
treatment to the vessel and thereby to the organ blood flow. In a
preferred embodiment, the body of the device is provided with a
plurality of openings which are in fluid communication with the
lumen for delivering a therapeutic treatment to the vessel and
thereby to the organ blood flow.
[0075] The device also comprises at least one expandable balloon
coupled with the body of the device, said balloon is provided with
an interior which is in fluid communication with the lumen of the
device through at least one opening, said opening is provided with
at least one valve which is movable from a closed position in which
fluid in the lumen is prevented from flowing to the interior of the
balloon to an open position, in which fluid in the lumen flows to
the interior of the balloon, thereby moving the balloon from a
deflated configuration to an inflated configuration. The valve is
herein movable from a closed position to an open position wherein
the valve is completely contained outside the lumen of the device
and inside the interior of the balloon.
[0076] The presence of valves is advantageous as the device allows
maintaining the balloon in expanded state even if the perfusion
flow and/or pressure is low or is inexistent. This is in
contradiction with the devices of the prior art wherein the balloon
is deflated as soon as the perfusion is stopped or when the
perfusion fluid and/or pressure is very low.
[0077] The valve is also movable from a closed position in which
fluid in the interior of the balloon is prevented from flowing to
the lumen, to an open position in which fluid flows from the
interior of the balloon to lumen of the device, thereby moving the
balloon from an inflated configuration to a deflated configuration.
The valve is herein movable from a closed position to an open
position wherein the valve is at least partially contained inside
the lumen of the device.
[0078] In a preferred embodiment, the lumen of the device is
provided with a plurality of openings which are in fluid
communication with the interior of the balloon. Each of said
openings is provided with at least one valve.
[0079] The device will be further described as a device having
openings provided with pressure-sensitive valves. However, it is to
be understood that any other valves known to the person skilled in
the art are suitable to be used and are enclosed by the
description. Said valves can for instance be mechanically steered
valves or magnetically steered valves.
[0080] In a preferred embodiment, the distal end of the device is a
closed end. The proximal end is an open end suitable to be
connected to at least one injection means for injecting the
therapeutic agent into the lumen of the device. Said injection
means can be a syringe or any other means known to the person
skilled in the art. In a further preferred embodiment, the device
is provided at its proximal end with a grip area to facilitate the
handling of the device by the practitioner. Said grip are can be of
any design and any material known to the person skilled in the
art.
[0081] The first retrievable medical device (26, FIG. 4) is
preferably a catheter. For liver tumor treatment, said catheter
will be introduced in the hepatic artery (HA). The insertion of
said catheter occurs via the right femoralis artery into the
hepatic communis artery.
[0082] The openings, which are in fluid communication with the
lumen for delivering a therapeutic treatment to a vessel or an
organ blood flow, can be positioned proximal to the proximal end of
the balloon. This means that the openings are positioned on the
body of the device between the proximal end of the device and the
balloon. Said openings can be positioned distal to the distal end
of the balloon, meaning that the openings are positioned on the
body of the device between the balloon and the distal end of the
device. Said openings can also be positioned distal to the distal
end of the balloon and proximal to the proximal end of the
balloon.
[0083] In a preferred embodiment, the first medical device (26,
FIG. 4) allows shunt debits in the range of 10-500 cc/min allowing
slow supply of agents with unwanted tissue reactions, like spasms,
and higher flows for bolus treatments.
[0084] In a preferred embodiment, the perfusion rate of the device
is at least 20 ml/min, preferably at least 40 ml/min, more
preferably at least 50 ml/min, even more preferably at least 70
ml/min, most preferably at least 80 ml/min or at least any value
comprised between the mentioned values. The perfusion rate is at
most 90 ml/min, preferably at most 110 ml/min, more preferably at
most 120 ml/min, even more preferably at most 130 ml/min, even more
more preferably at most 150 ml/min, even most preferably at most
180 ml/min, even most preferably at most 200 ml/min or at most any
value comprised between the mentioned values.
[0085] In a preferred embodiment, the first medical device has a
small size and is a flexible device such as it can be positioned
following torturous pathways. The diameter of said device is
comprised between 1 and 5 mm, preferably between 1.5 and 4 mm, more
preferably between 1.6 and 3 mm, most preferably between 5 F
(=about 1.67 mm) and 7 F (=about 2.3 mm).
[0086] In a preferred embodiment, the lumen diameter at the distal
end of the device is reduced by at least 10%, compared to the
diameter of the lumen at the proximal end of the device. The lumen
diameter at the distal end of the device is preferably reduced by
at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or any value
comprised between these values, compared to the lumen diameter at
the proximal end of the device. The lumen diameter reduction is
advantageous as it creates, in a short time, a pressure inside the
lumen leading to a fast expansion of the balloon due to the entry
of the fluid in the interior of the balloon through the opening of
the device body which is in fluid communication with said
balloon.
[0087] In a preferred embodiment, the diameter of the lumen at the
distal end is of from 1 mm to 3 mm, preferably from 1.2 mm to 2.5
mm, more preferably from 1.5 to 2 mm.
[0088] The length of the device is about 600 mm, preferably about
700 mm, more preferably about 800 mm, most preferably about 900 mm,
even most preferably about 1000 mm. The length of the device allows
the positioning of the device close to, or in, an organ. The device
provides for the control of the blood flow through the targeted
organ and provides a non-limited infusion/perfusion debit.
[0089] In a preferred embodiment, the length of the device having a
reduced lumen diameter is of from 50 to 300 mm, preferably from 70
to 250 mm, more preferably from 100 to 200 mm, most preferably
about 150 mm. The balloon can be coupled to the body of the device
where the lumen has a reduced diameter or to the body of the device
where the diameter of the lumen is not reduced.
[0090] The device is shown in FIG. 11A and comprises a grip area
67, a proximal end Y, a distal end X, a single lumen 66 and at
least one balloon 65. The expansion of the balloon is induced and
controlled by the infusion/perfusion liquid. The device can
occlude, at least partly and/or temporarily, the vessel to control
the blood flow and to inject a therapeutic agent into that organ in
flow rates of at least 20 ml/min. During delivery of the
therapeutic agent into the vessel, the infusion/perfusion liquid
containing said therapeutic agent flow in the lumen 66 and inflates
the balloon 65 by flowing through the openings 68 and 69 (FIG. 11A)
to the interior of the balloon 65.
[0091] FIG. 11B shows another embodiment of the catheter wherein
the openings 70' allow the flow of the infusion/perfusion liquid to
the interior of the balloon leading to the expansion of said
balloon 70. Said openings are provided with a plurality of valves
71 as shown in FIG. 11C, 11D and 11E. Said valves 71 are located on
the surface of the openings. When the perfusion liquid is injected,
a pressure in created in the lumen of the device. Said pressure is
created in a short time as the distal end of lumen has a reduced
diameter compared to its proximal end. The pressurized liquid
forces the valves, initially in a closed position shown in FIG.
11B, to be in an open position in which they are completely
contained outside the lumen and inside the interior of the balloon
as shown in FIG. 11C. The pressurized liquid opens the
pressure-sensitive valves 71 and accumulates in the interior of the
balloon 70 thereby inflating it as illustrated by the arrows in
FIG. 11C. When the injection of the perfusion liquid is terminated
the valves 71 close and the balloon remains in an inflated state
(FIG. 11D). This allows maintaining the occlusion of the vessel
after completion of the perfusion and before retrieving the device
from the vessel. Optimal conditions, such as time and temperature,
can hence be provided to ensure an optimal use of the therapeutic
agent. When the device is to be retrieved at the end of the
treatment, a negative pressure is created inside the lumen of the
device which leads to the opening of the valves 71 inside the lumen
and to the deflation of the balloon 70 (FIG. 11E). The valves are
made of any suitable flexible material such as but not limited to
silicone. A pull can be provided in the device to control the
opening and closing of the valves.
[0092] FIG. 12A shows the device when the balloon 81 is not in an
expanded state, i.e. in a deflated state. The lumen 80 diameter is
reduced at one end 82 which is the distal end X of the catheter.
The narrowed end can be provided with a conical tip. Reducing the
diameter at one end of the catheter, i.e. the distal end, leads to
a pressure increase during the perfusion and/or delivery of the
therapeutic agent. The latter accelerates the expansion of the
balloon. The diameter reduction ensures that the balloon segment
will expand at minimal defined flows. The diameter at the end 82 of
the catheter is reduced by at least 10%, 20%, 30%, 40%, 50%, 60%,
70%, 80%, 90% or any value comprised between these values, compared
to the diameter of the lumen to assure the expansion of the balloon
during perfusion. FIG. 12B shows the catheter when the balloon 81
is in an expanded state due to the flow of the infusion/perfusion
liquid in the lumen 80. Said infusion/perfusion liquid creates a
pressure inside the lumen due to the reduced diameter at the distal
end. Said fluid and fluid pressure leads to the inflation of the
balloon 81.
[0093] In other embodiments, at least one guidewire and/or other
means can be used to increase and/or lower the perfusion fluid
pressure inside the lumen of the device, thereby opening the valves
leading to the inflation of the balloon or to the deflation of the
balloon.
[0094] FIG. 11F illustrates an embodiment of the first medical
device wherein the lumen diameter at the distal end X of the device
is not reduced compared to the proximal diameter Y of the lumen.
Each opening allowing fluid communication of the lumen with the
interior of the balloon 70 is provided with a valve 71; said valves
are pressure-controlled or pressure sensitive. Having a non-reduced
lumen will increase the flow of the perfusate compared to use of a
device having a reduced lumen diameter at the distal end of the
device. This allows a reduction of the perfusion time.
[0095] In a preferred embodiment, the tip 151 of the device is
provided with a guidewire 150 having a means 152 for locking the
tip 151 to the catheter. Said means can for instance be a knot or
any other means known to the person skilled in the art. When
perfusion starts, the pressure inside the lumen 166 will increase
due to the presence of the closed tip 151. The valves 171 will open
and the fluid will accumulate in the balloon leading to the
inflation of said balloon 170. The guidewire can then be moved in a
direction which is from the proximal end Y to the distal end X of
the device X. By moving the guidewire, the tip 151 will be unlocked
and moved in the same direction as the guidewire and away from the
catheter body. This leads to the decline of the pressure inside the
lumen 166 which results in the closure of the valves 171. The
perfusion rate of the organ is ensured by the opening created when
the tip is pushed away from the catheter body but also because said
opening has the same diameter as the lumen. At the end of the
perfusion procedure, the guide wire 150 is pulled back until the
tip 151 is locked to the catheter body. The pressure can be reduced
inside the lumen and/or a negative pressure can be created inside
said lumen 166, thereby deflating the balloon 170. The device with
the guidewire and the tip can then be retrieved from the subject's
body.
[0096] FIG. 11G illustrate an embodiment of the first medical
device wherein the lumen diameter at the distal end X of the device
is not reduced compared to the proximal diameter Y of the lumen.
Each opening allowing fluid communication of the lumen with the
interior of the balloon 70 is provided with a valve 71, said valves
controlled using an internal plug.
[0097] In a preferred embodiment, the device is positioned in the
desired vessel using a retrievable guidewire. Said guidewire is
afterwards retrieved and a rod 154 with a plug 153 is introduced in
the lumen 166 of the device. The plug 153 will occlude the distal
end of the lumen. The size of said plug 153 is smaller than the
lumen 166 of the catheter. Preferably the diameter of said plug is
at least 1% smaller than the diameter of said lumen 166. When
perfusion starts, the pressure inside the lumen 166 will increase
due to the presence of the plug 153. The valves 172 will open and
the fluid will accumulate in the balloon leading to the inflation
of said balloon 170. The rod 154 and the plug 153 can then be
retrieved from the device. This leads to the decline of the
pressure inside the lumen 166 which results in the closure of the
valves 172. The perfusion rate of the organ is ensured by the
opening created when the rod 154 and the plug 153 are retrieved
from the catheter body but also because said opening has the same
diameter as the lumen. At the end of the perfusion procedure, the
rod 154 and the plug 153 are inserted in the catheter via the lumen
166. The pressure can be reduced inside the lumen and/or a negative
pressure can be created inside said lumen 166, thereby deflating
the balloon 170. The rod 154, the plug 153 and the device can then
be retrieved from the subject's body. In a preferred embodiment,
the rod 154 is permanently fixed to the plug 153. In another
preferred embodiment, the rod 154 is dismountably fixed to the plug
153. This allows the adaptation of the plug size to different
devices having different lumen diameter.
[0098] FIG. 11H illustrate an embodiment of the first medical
device wherein the lumen diameter at the distal end X of the device
is not reduced compared to the proximal diameter Y of the lumen.
Each opening allowing fluid communication of the lumen with the
interior of the balloon 70 is provided with a valve 71, said valves
are magnetically controlled.
[0099] In a preferred embodiment, the device is positioned in the
desired vessel using a retrievable guidewire. Said guidewire is
afterwards retrieved and a rod 156 having at least one magnetic
means 157 and a stopper 155 is introduced in the lumen 166 of the
device. The size of said stopper 155 is smaller than the lumen 166
of the catheter. Preferably the diameter of said stopper is at
least 1% smaller than the diameter of said lumen 166. During the
introduction of the rod 156, the magnetic means will open the
valves 173 and the stopper 155 will occlude the distal end of the
lumen 166. When perfusion starts, the pressure inside the lumen 166
will increase due to the presence of the stopper 155. The fluid
will accumulate in the balloon leading to the inflation of said
balloon 170. The rod 156 and the stopper 155 can then be retrieved
from the device. This leads to the decline of the pressure inside
the lumen 166 which results in the closure of the valves 173. The
perfusion rate of the organ is ensured by the opening created when
the rod 156 and the stopper 155 are retrieved from the catheter
body but also because said opening has the same diameter as the
lumen.
[0100] At the end of the perfusion procedure, the rod 156 and the
stopper 155 are inserted in the catheter via the lumen 166. The
pressure can be reduced inside the lumen and/or a negative pressure
can be created inside said lumen 166, thereby deflating the balloon
170. The rod 156, the stopper 155 and the device can then be
retrieved from the subject's body. In a preferred embodiment, the
rod 156 is permanently fixed to the stopper 155. In another
preferred embodiment, the rod 156 is dismountably fixed to the
stopper 155. This allows the adaptation of the stopper size to
different devices having different lumen diameter.
[0101] In a preferred embodiment, the device according to the
present invention allows the withdrawal of fluid from the vessel or
the organ into which said device is introduced. This is due to the
fact that the balloon of the device can be maintained inflated even
in the absence of perfusion flow inside the lumen of the device.
The balloon can be maintained inflated thanks to the presence of
the valves which makes the occlusion of the vessel independednt
from the perfusate flow rate in the lumen of the device.
[0102] It is to be understood that devices comprising any type of
valve described herein is suitable to be used for the simultaneous
or the separate perfusion and occlusion of a vessel and in addition
said devices are suitable to be used for the withdrawal or drainage
of fluid from said vessel.
[0103] The device body is made of a biocompatible materials
generally applied for short term (<120 minutes) endovascular
procedures. The balloon 81 can be the most flexible part of the
catheter, for instance by having smaller wall thickness, or made
from other materials bonded to the catheter. The device according
to the present invention is a percutaneous device having a minimum
quantity of material to ensure the vessel occlusion, to increase
the flexibility and maximize the infusion/perfusion flow.
[0104] FIG. 8 shows the catheter having a guide wire 52 and a lumen
51. The balloon is substantially spherical and is positioned at the
distal end X of the device. The length c of the expanded balloon is
about 10 mm. The catheter comprises a tube 44, also called a body,
having a lumen 51. The diameter j of said tube 44 is about 2.5 mm.
The diameter e of distal end X portion of the first retrievable
medical device is about 2 mm said portion extends over a length g
of about 150 mm. The length h of the catheter is about 900 mm. The
tube 44 is provided at the proximal end Y with a female luer
adapter 49. At the distal end X, the tube 44 is provided with a
balloon that inflates when the user pushes the inflation bladder
47. The latter is provided with an inflation check valve 46 and a
male luer adapter 48. The inflation bladder 47 is connected to the
catheter via a female luer adapter 49 and a connector tube 50. It
is to be understood that the presence of the inflation bladder is
optional. The balloon of the device can be inflated by the
therapeutic agent through openings which are in fluid connection
with the interior of the balloon as described above. Said openings
can be provided with valves also as described above.
[0105] In a preferred embodiment, the guide wire can be used to
increase the perfusion pressures to support inflation or deflation
of the balloon, or can be used to trigger the valves to open or to
close.
[0106] In a preferred embodiment, the body of the device is made of
a material selected from the group comprising silicone, polyvinyl
chloride and rubber.
[0107] In a preferred embodiment, the valves are made of the same
material as the body of the device. Preferably, the valves are made
of silicone. Said valves can be made of a material different from
the material of the body of the device.
[0108] In a preferred embodiment, the balloon is made of the same
material as the body of the device and/or the valves. Said balloon
can be made of a material different from the material of the body
of the device and/or the valves.
[0109] When liver is treated for example, the main blood vessels
connected to the liver are occluded: the vena porta (PV, hepatic
portal vein) using the third retrievable medical device, hepatic
artery (HA) using the first retrievable medical device and hepatic
vein (HV) using the second retrievable medical device to achieve
site specific blood isolation and collection. The isolation of the
liver vascular system makes it possible to reach high local
chemotherapy concentration. The introduction of the third
retrievable medical device and the first medical device can be
achieved by means of an introducer sheath.
[0110] Although the present invention has been described with
reference to preferred embodiments thereof, many modifications and
alternations may be made by a person having ordinary skill in the
art without departing from the scope of this invention which is
defined by the appended claims.
* * * * *