U.S. patent application number 17/227635 was filed with the patent office on 2021-07-29 for apparatus and methods for delivering therapeutic agents.
This patent application is currently assigned to COOK MEDICAL TECHNOLOGIES LLC. The applicant listed for this patent is COOK MEDICAL TECHNOLOGIES LLC. Invention is credited to Richard W. Ducharme.
Application Number | 20210228852 17/227635 |
Document ID | / |
Family ID | 1000005510556 |
Filed Date | 2021-07-29 |
United States Patent
Application |
20210228852 |
Kind Code |
A1 |
Ducharme; Richard W. |
July 29, 2021 |
APPARATUS AND METHODS FOR DELIVERING THERAPEUTIC AGENTS
Abstract
The present embodiments provide apparatus and methods suitable
for delivering a therapeutic agent to a target site. The apparatus
generally comprises at least one container for holding a
therapeutic agent, and a pressure source for facilitating delivery
of the therapeutic agent. In one embodiment, the pressure source
may be placed in selective fluid communication with a proximal
region of the container and fluid from the pressure source may flow
through at least a portion of the container to urge the therapeutic
agent through container towards the target site. In an alternative
embodiment, the container and the pressure source may be coupled to
first and second inlet ports of a connecting member, respectively,
such that the therapeutic agent flows through an outlet port of the
connecting member and towards the target site.
Inventors: |
Ducharme; Richard W.;
(Pleasant Gap, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COOK MEDICAL TECHNOLOGIES LLC |
Bloomington |
IN |
US |
|
|
Assignee: |
COOK MEDICAL TECHNOLOGIES
LLC
Bloomington
IN
|
Family ID: |
1000005510556 |
Appl. No.: |
17/227635 |
Filed: |
April 12, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15804331 |
Nov 6, 2017 |
10994110 |
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17227635 |
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12435574 |
May 5, 2009 |
9839772 |
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15804331 |
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61050906 |
May 6, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 37/00 20130101;
A61M 5/1409 20130101; A61M 39/24 20130101; A61B 1/018 20130101;
A61M 5/16881 20130101; A61M 39/223 20130101 |
International
Class: |
A61M 37/00 20060101
A61M037/00; A61B 1/018 20060101 A61B001/018; A61M 5/14 20060101
A61M005/14; A61M 5/168 20060101 A61M005/168 |
Claims
1-20. (canceled)
21. Apparatus suitable for delivering at least one therapeutic
agent to a target site, the apparatus comprising: a connecting
member having first and second inlet ports and an outlet port; at
least one container for holding a therapeutic agent, wherein the
first inlet port of the connecting member is selectively coupled to
the container; pressurized fluid adapted to flow through the second
inlet port of the connecting member; at least one tube member
having proximal and distal ends, wherein proximal end of the tube
member is coupled to the outlet port of the connecting member, and
the distal end of the tube member is sized to be placed in fluid
communication with a target site, wherein the flow of the
pressurized fluid through the second inlet port and the outlet port
is adapted to urge the therapeutic agent in a direction away from
the container and through the first inlet port and the tube member
for delivery of the therapeutic agent to the target site; and a
valve disposed distal to the container and proximal to the tube
member to selectively inhibit flow of the therapeutic agent through
the distal region of the container and into the first inlet port
without inhibiting flow from the pressure source through the second
inlet port; and wherein the therapeutic agent comprises a
powder.
22. The apparatus of claim 21 wherein the container comprises a
distal end segment that is compressible relative to a proximal end
segment.
23. The apparatus of claim 21 wherein the outlet port of the
connecting member is aligned along a substantially longitudinal
axis, while at least one of the first and second inlet ports is
disposed at an angle with respect to the longitudinal axis.
24. The apparatus of claim 23 wherein both the first and second
inlet ports are disposed at an angle with respect to the
longitudinal axis of the outlet port.
25. The apparatus of claim 23 wherein at least one of the angles
ranges from about 20 to about 70 degrees with respect to the
longitudinal axis.
26. The apparatus of claim 21 wherein the second inlet port of the
connecting member is disposed in closer proximity to the outlet
port, relative to the positioning of the first inlet port with
respect to the outlet port.
27. The apparatus of claim 21 wherein the pressurized fluid
originates from a pressure source comprising a compressed gas
dispenser.
28. The apparatus of claim 27 further comprising a regulating valve
disposed between the pressure source and the connecting member.
29. The apparatus of claim 21 wherein the container comprises a
syringe having proximal and distal regions, wherein the distal
region is adapted to be coupled to the first inlet port of the
connecting member, and wherein the proximal region comprises a
plunger.
30. The apparatus of claim 21 further comprising a needle coupled
to the distal end of the tube member.
31. Apparatus suitable for delivering at least one therapeutic
agent to a target site, the apparatus comprising: a connecting
member having first and second inlet ports and an outlet port; at
least one container for holding a therapeutic agent, wherein the
first inlet port of the connecting member is selectively coupled to
the container; pressurized fluid adapted to flow through the second
inlet port of the connecting member; at least one tube member
having proximal and distal ends, wherein proximal end of the tube
member is coupled to the outlet port of the connecting member, and
the distal end of the tube member is sized to be placed in fluid
communication with a target site, wherein the provision of the
pressurized fluid through the second inlet port and the outlet port
is adapted to urge the therapeutic agent in a direction away from
the container and through the first inlet port and the tube member
for delivery of the therapeutic agent to the target site; wherein
the outlet port of the connecting member is aligned along a
substantially longitudinal axis, while at least one of the first
and second inlet ports is disposed at an angle with respect to the
longitudinal axis, wherein at least one of the angles ranges from
about 20 to about 70 degrees with respect to the longitudinal axis,
and wherein the therapeutic agent comprises a powder.
32. The apparatus of claim 31, further comprising a valve disposed
distal to the container and proximal to said tube member to
selectively inhibit flow of the therapeutic agent through the
distal region of the container and into the first inlet port
without inhibiting flow from the pressure source through the second
inlet port.
33. The apparatus of claim 31 wherein the container comprises a
distal end segment that is compressible relative to a proximal end
segment.
34. The apparatus of claim 31 wherein the second inlet port of the
connecting member is disposed in closer proximity to the outlet
port, relative to the positioning of the first inlet port with
respect to the outlet port.
35. The apparatus of claim 31 wherein the pressurized fluid
originates from a pressure source comprising a compressed gas
dispenser.
36. The apparatus of claim 35 further comprising a regulating valve
disposed between the pressure source and the connecting member.
37. The apparatus of claim 31 further comprising syringe having
proximal and distal regions, wherein the distal region is adapted
to be coupled to the first inlet port of the connecting member, and
wherein the proximal region comprises a plunger.
38. The apparatus of claim 31 further comprising a needle coupled
to the distal end of the tube member.
39. Apparatus suitable for delivering at least one therapeutic
agent to a target site, the apparatus comprising: at least one
container for holding a therapeutic agent, the container having an
outlet end; pressurized fluid adapted to flow past the outlet end
of the container, wherein the pressurized fluid does not flow
through the container; at least one tube member having proximal and
distal ends, wherein the proximal end of the tube member is
disposed distal to the outlet end of the at least one container,
and wherein the distal end of the tube member is sized to be placed
in fluid communication with a target site, wherein the flow of the
pressurized fluid past the outlet end of the container is adapted
to urge the therapeutic agent in a direction away from the
container and through the tube member for delivery of the
therapeutic agent to the target site; and a valve disposed distal
to the container and proximal to the tube member to selectively
inhibit flow of the therapeutic agent through the distal region of
the container and into the tube member; and wherein the therapeutic
agent comprises a powder.
40. The apparatus of claim 39 wherein the pressurized fluid
originates from a pressure source comprising a compressed gas
dispenser.
Description
PRIORITY CLAIM
[0001] This invention claims the benefit of priority of U.S.
Provisional Application Ser. No. 61/050,906, entitled "Apparatus
and Methods for Delivering Therapeutic Agents," filed May 6, 2008,
the disclosure of which is hereby incorporated by reference in its
entirety.
BACKGROUND
[0002] The present embodiments relate generally to medical devices,
and more particularly, to apparatus and methods for delivering
therapeutic agents to a target site.
[0003] There are several instances in which it may become desirable
to introduce therapeutic agents into the human or animal body. For
example, therapeutic drugs or bioactive materials may be introduced
to achieve a biological effect. The biological effect may include
an array of targeted results, such as inducing hemostasis, sealing
perforations, reducing restenosis likelihood, or treating cancerous
tumors or other diseases.
[0004] Many of such therapeutic agents are injected using an
intravenous (IV) technique and via oral medicine. While such
techniques permit the general introduction of medicine, in many
instances it may be desirable to provide localized or targeted
delivery of therapeutic agents, which may allow for the guided and
precise delivery of agents to selected target sites. For example,
localized delivery of therapeutic agents to a tumor may reduce the
exposure of the therapeutic agents to normal, healthy tissues,
which may reduce potentially harmful side effects.
[0005] Localized delivery of therapeutic agents has been performed
using catheters and similar introducer devices. By way of example,
a catheter may be advanced towards a target site within the
patient, then the therapeutic agent may be injected through a lumen
of the catheter to the target site. Typically, a syringe or similar
device may be used to inject the therapeutic agent into the lumen
of the catheter. However, such a delivery technique may result in a
relatively weak stream of the injected therapeutic agent.
[0006] Moreover, it may be difficult or impossible to deliver
therapeutic agents in a targeted manner in certain forms, such as a
powder form, to a desired site. For example, if a therapeutic
powder is held within a syringe or other container, it may not be
easily delivered through a catheter to a target site in a localized
manner that may also reduce potentially harmful side effects.
SUMMARY
[0007] The present embodiments provide apparatus and methods
suitable for delivering a therapeutic agent to a target site. The
apparatus generally comprises at least one container for holding a
therapeutic agent, and a pressure source for facilitating delivery
of the therapeutic agent.
[0008] In one embodiment, the pressure source may be placed in
selective fluid communication with a proximal region of the
container. Fluid from the pressure source may flow through at least
a portion of the container to urge the therapeutic agent through a
distal region of the container and towards the target site.
[0009] At least one tube member, such as a catheter, may be used to
facilitate delivery of the therapeutic agent from the container to
the target site. The tube member may be placed in fluid
communication with the distal region of the container. In use,
fluid from the pressure source urges the therapeutic agent through
the distal region of the container, through the tube member, and
then distally towards the target site.
[0010] The pressure source may comprise a compressed gas dispenser.
Tubing may be disposed between the pressure source and the
container, and optionally, a pressure relief valve may be disposed
between the pressure source and the container. The pressure relief
valve may ensure that the fluid from the pressure source flows
through the container at a predetermined pressure.
[0011] In various other embodiments, a connecting member having
first and second inlet ports and an outlet port is disclosed. The
container and the pressure source may be coupled to the first and
second inlet ports of the connecting member, respectively. In use,
the provision of fluid from the pressure source through the second
inlet port may suction the therapeutic agent from the container in
a direction through the first inlet port. The fluid and the
therapeutic agent then may flow through the outlet port of the
connecting member and towards the target site. In this embodiment,
at least one tube member may be coupled to the outlet port of the
connecting member to facilitate delivery of the therapeutic agent
from the connecting member to the target site.
[0012] In any of the embodiments disclosed, the distal region of
the tube member may comprise an anti-reflux valve to inhibit flow
of foreign substances, such as blood, proximally back into the
system. The tube member also may be used in conjunction with a
needle and may be configured to be delivered through a working
lumen of an endoscope or similar device.
[0013] Other systems, methods, features and advantages of the
invention will be, or will become, apparent to one with skill in
the art upon examination of the following figures and detailed
description. It is intended that all such additional systems,
methods, features and advantages be within the scope of the
invention, and be encompassed by the following claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The invention can be better understood with reference to the
following drawings and description. The components in the figures
are not necessarily to scale, emphasis instead being placed upon
illustrating the principles of the invention. Moreover, in the
figures, like referenced numerals designate corresponding parts
throughout the different views.
[0015] FIG. 1 is a schematic view of apparatus in accordance with a
first embodiment.
[0016] FIG. 2 is a side view illustrating selected components of an
exemplary high pressure fluid source.
[0017] FIG. 3 is a perspective view of the distal end of an
exemplary end-viewing endoscope that may be used in conjunction
with the system of FIG. 1.
[0018] FIG. 4 is a perspective view of the distal end of an
exemplary side-viewing endoscope that may be used in conjunction
with the system of FIG. 1.
[0019] FIG. 5 is a schematic view of apparatus in accordance with
an alternative embodiment.
[0020] FIG. 6 is a schematic view of apparatus in accordance with a
further alternative embodiment.
[0021] FIG. 7 is a schematic view of apparatus in accordance with
yet a further alternative embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] In the present application, the term "proximal" refers to a
direction that is generally towards a physician during a medical
procedure, while the term "distal" refers to a direction that is
generally towards a target site within a patient's anatomy during a
medical procedure.
[0023] Referring now to FIG. 1, a first embodiment of a system
suitable for delivering one or more therapeutic agents is shown. In
this embodiment, the system 20 comprises at least one container 30
that is configured to hold a therapeutic agent 38, and further
comprises at least one pressure source 50. At least one connecting
member 70 may be placed in fluid communication with the container
30 and the pressure source 50, as explained in further detail
below.
[0024] The container 30 may comprise any suitable size and shape
for holding a therapeutic agent 38. In one embodiment, the
container 30 may comprise a syringe having a reservoir 32. A
plunger 40 having a main body 42, a proximal handle 43, and a
distal head member 44 may be disposed for longitudinal movement
within the reservoir 32, preferably in a manner such that the
distal head member 44 forms a substantial sealing engagement with
an inner surface of the container 30.
[0025] The container 30 may comprise a hollow proximal region 34,
through which the therapeutic agent 38 and the plunger 40 may be
loaded, as shown in FIG. 1. The container 30 further may comprises
a distal region 36 that is configured to be coupled to a first
inlet port 72 associated with the connecting member 70, thereby
enabling fluid communication between the container 30 and the
connecting member 70.
[0026] The container 30 also may comprise measurement indicia 39,
which allow a user to determine a quantity of the therapeutic agent
38 that is held within the container 30. Optionally, a valve member
47 may be disposed between the reservoir 32 of the container 30 and
the connecting member 70, as shown in FIG. 1, to selectively permit
and inhibit fluid communication between the container 30 and the
connecting member 70, as described in greater detail below.
[0027] The pressure source 50 may comprise one or more components
capable of producing or furnishing a fluid having a desired
pressure. In one embodiment, the pressure source 50 may comprise a
pressurized fluid, such as a liquid or gas. For example, as shown
in FIG. 2, the pressure source 50 may comprise a housing 51 that
covers a pressurized fluid cartridge 52 of a selected gas or
liquid, such as carbon dioxide, nitrogen, or any other suitable gas
or liquid that may be compatible with the human body. The
pressurized fluid cartridge 52 may contain the gas or liquid at a
relatively high, first predetermined pressure, for example, around
1,800 psi inside of the cartridge. The fluid may flow from the
pressurized fluid cartridge 52 through a pressure regulator, such
as regulator valve 58 having a pressure outlet 59, as depicted in
FIGS. 1-2, which may reduce the pressure to a lower, second
predetermined pressure. Solely by way of example, the second
predetermined pressure may be in the range of about 30 to about 80
psi, although any suitable pressure may be provided for the
purposes described below.
[0028] An actuator, such as a button, may be used to selectively
actuate the pressure source 50. The pressurized fluid may flow from
the pressurized fluid cartridge 52, and subsequently through the
regulator valve 58 using an adapter 54. The adapter 54 may be
configured to be sealingly coupled to the pressurized fluid
cartridge 52, as shown in FIG. 2. Further, the adapter 54 may be
coupled to tubing 56, which allows the pressurized fluid to flow
into the regulator valve 58. A proximal end 62 of a different
tubing 60 is adapted to be coupled to the regulator valve 58, as
shown in FIG. 2, thereby enabling the pressurized fluid to flow
through the regulator valve 58 and into the tubing 60 at the lower,
second predetermined pressure.
[0029] The pressure source 50 optionally may comprise one or more
commercially available components. Solely by way of example, the
pressurized fluid cartridge 52 may comprise a disposable carbon
dioxide cartridge, such as the Visage.RTM. commercial dispenser
manufactured by Helen of Troy.RTM., El Paso, Tex. The pressure
source 50 therefore may comprise original or retrofitted components
capable of providing a fluid or gas into the tubing 60 at a desired
regulated pressure.
[0030] Referring still to FIG. 1, the connecting member 70 of the
system 20 may comprise multiple ports configured to selectively
permit and inhibit fluid communication between the various
components. In one embodiment, the connecting member 70 comprises
first and second inlet ports 72 and 74 and an outlet port 76. As
noted above, the distal region 36 of the container 30 may be
coupled to the first inlet port 72 of the connecting member 70,
thereby enabling selective fluid communication between the
container 30 and the connecting member 70, as depicted in FIG. 1.
Any suitable coupling mechanism may be employed, for example, the
distal region 36 of the container 30 may be configured to form a
frictional fit with the first inlet port 72, or may comprise a
threaded engagement or similar coupling arrangement. Similarly, a
distal end 64 of the tubing 60 may be coupled to the second inlet
port 74 of the connecting member 70 using any suitable coupling
mechanism or arrangement.
[0031] In the embodiment of FIG. 1, the second inlet port 74 and
the outlet port 76 are generally aligned with a longitudinal axis L
of the connecting member 70, while the first inlet port 72 is
disposed at an angle .alpha..sub.1 with respect to the longitudinal
axis L. However, as will be described further below, the connecting
member may employ different shapes such that various components may
be disposed at different angles with respect to the connecting
member.
[0032] The system 20 further may comprise one or more tube members
for delivering the therapeutic agent 38 to a target site. For
example, the tube member may comprise a catheter 90 having a
proximal end 92 that may be placed in fluid communication with the
outlet port 76 of the connecting member 70 using a suitable
coupling mechanism or arrangement. The catheter 90 further
comprises a distal end 94 that may facilitate delivery of the
therapeutic agent 38 to a target site, as set forth below. The
catheter 90 may comprise a flexible, tubular member that may be
formed from one or more semi-rigid polymers. For example, the
catheter may be manufactured from polyurethane, polyethylene,
tetrafluoroethylene, polytetrafluoroethylene, fluorinated ethylene
propylene, nylon, PEBAX or the like.
[0033] The system 20 further may comprise a needle 95 suitable for
penetrating tissue. As shown in the embodiment of FIG. 1, the
needle 95 may be coupled to the distal end 94 of the catheter 90 to
form a sharp, distal region configured to pierce through a portion
of a patient's tissue, or through a lumen wall to perform a
translumenal procedure. In FIG. 1, the needle 95 may be formed as
an integral component with the catheter 90, i.e., such that distal
movement of the catheter 90 causes distal advancement of the needle
95. In this embodiment, a relatively sharp needle tip may be
affixed to the distal tip of the catheter 90, e.g., using an
adhesive, to form a needle-shaped element at the distal end of the
catheter. Alternatively, a separate needle configured to be
inserted through a lumen of the catheter 90 may be employed.
[0034] In operation, the system of FIG. 1 may be used to deliver
the therapeutic agent 38 to a target site within a patient's body.
In a first step, the distal end 94 of the catheter 90 may be
positioned in relatively close proximity to the target site. The
catheter 90 may be advanced to the target site using an open
technique, a laparoscopic technique, an intraluminal technique,
using a gastroenterology technique through the mouth, colon, or
using any other suitable technique.
[0035] The catheter 90 may comprise one or more markers (not
shown), which may be disposed near the distal end of the catheter
90. The markers may be configured to be visualized under
fluoroscopy or other imaging techniques to facilitate location of
the distal end 94 of the catheter 90. If the needle 95 is integral
to the catheter 90, the needle 95 also may be visualized using the
imaging techniques, thereby allowing placement of the distal end 94
of the catheter 90 in close proximity to the target site. If
desired, the catheter 90 may be advances through a working lumen of
an endoscope, as explained in further detail in FIGS. 3-4
below.
[0036] When the catheter 90 is positioned at the desired location,
the pressure source 50 may be actuated. For example, a suitable
actuator may be coupled to the pressurized fluid cartridge 52 to
release a relatively high pressure fluid. As noted above, the
pressurized fluid may flow through a regulator valve 58 and through
the tubing 60, as depicted in FIG. 1. Fluid injected through the
tubing 60 may flow at a desired pressure and rate. For example, the
regulator valve 58 may automatically set the pressure for fluid
flow, or alternatively, a control mechanism coupled to the
pressurized fluid cartridge 52 and/or the regulator valve 58 may be
activated by a user to set the desired pressure for fluid flow into
the tubing 60. Such a control mechanism also may be used to
variably permit fluid flow into the tubing 60, e.g., fluid from the
pressurized fluid cartridge 52 may flow into the tubing 60 at a
desired time interval, for example, a predetermined quantity of
fluid per second. Moreover, the control mechanism may be
pre-programmed to deliver a predetermined amount of the therapeutic
agent, depending on the type, viscosity, and other properties of
the agent. Empirical information, such as a table of pressure, time
and delivered quantity, may be stored and used for the different
agents or procedures.
[0037] Fluid from the pressure source 50 flows through the tubing
60, through the second inlet port 74 of the connecting member 70,
and then through the outlet port 76 of the connecting member 70 and
through a lumen of the catheter 90. Fluid may exit the distal end
94 of the catheter 90, for example, through a bore formed in the
needle 95.
[0038] As fluid from the pressure source 50 passes through the
connecting member 70, a localized low pressure system will be
provided in the vicinity of the second inlet port 72 in accordance
with Bernoulli's principle of fluid dynamics. The low pressure
system formed by the presence of the pressurized fluid passing
through the connecting member 70 will form a strong suction force
when it passes by the second inlet port 72. As a result, the
therapeutic agent 38 may be suctioned out of the reservoir 32 of
the container 30 and through the second inlet port 72. Moreover,
the therapeutic agent 38 may be carried through the outlet port 76
of the connecting member 70 by the pressurized fluid, and
subsequently through the catheter 90, thereby delivering the
therapeutic agent 38 to the target site at a desired pressure.
[0039] The therapeutic agent 38 may be drawn out of the reservoir
32 by the mere presence of the pressurized fluid flow through the
connecting member 70, i.e., with minimal or no user intervention.
In this embodiment, the user simply may load the desired
therapeutic agent 38 into the reservoir 32, then load the plunger
40 into the proximal region 34 of the container 30. The provision
of the pressurized fluid flow through the connecting member 70 may
suction the therapeutic agent 38 from the reservoir 32 and may urge
the plunger 40 in a distal direction until the contents of the
container 30 are dispensed.
[0040] In addition to the automatic withdrawal of the therapeutic
agent 38 from the container 30 in accordance with Bernoulli's
principle, a user may manually actuate the proximal handle 43 of
the plunger 40 to dispense the therapeutic agent 38. For example,
in this instance, after a user has loaded a desired amount of the
therapeutic agent 38 into the reservoir 32, the user may manually
actuate the proximal handle 43 of the plunger 40 to dispense the
therapeutic agent 38 from the container 30 and at least partially
into interior regions of the connecting member 70 and/or the
catheter 90. The plunger 40 may be manually actuated in this manner
before, during or after the pressure source 50 has been actuated to
deliver pressurized fluid through the connecting member 70 and the
catheter 90.
[0041] As noted above, a valve member 47 optionally may be disposed
between the reservoir 32 of the container 30 and the connecting
member 70, as shown in FIG. 1. A user may selectively actuate the
valve member 47 to periodically permit and inhibit fluid
communication between the container 30 and the connecting member
70. The valve member 47 also may serve as a "shut-off" safety
mechanism to inhibit withdrawal of the therapeutic agent 38 from
the reservoir 32, even when pressurized fluid is flowing through
the connecting member 70.
[0042] As noted above, a control mechanism coupled to the pressure
source 50 may variably permit fluid flow into the tubing 60 from
the pressurized fluid cartridge 52 at a desired time interval, for
example, a predetermined quantity of fluid per second. In this
manner, pressurized fluid may flow through the connecting member 70
periodically, and the therapeutic agent 38 may be suctioned from
the reservoir 32 and delivered to a target site at a predetermined
interval or otherwise periodic basis.
[0043] The system 20 may be used to delivery the therapeutic agent
38 in a wide range of procedures and the therapeutic agent 38 may
be chosen to perform a desired function upon ejection from the
distal end 94 of the catheter 90. Solely by way of example, and
without limitation, the provision of the therapeutic agent 38 may
be used for providing hemostasis, closing perforations, performing
lithotripsy, treating tumors and cancers, treat renal dialysis
fistulae stenosis, vascular graft stenosis, and the like. The
therapeutic agent 38 can be delivered during procedures such as
coronary artery angioplasty, renal artery angioplasty and carotid
artery surgery, or may be used generally for treating various other
cardiovascular, respiratory, gastroenterology or other conditions.
The above-mentioned systems also may be used in transvaginal,
umbilical, nasal, and bronchial/lung related applications.
[0044] For example, if used for purposes of hemostasis, thrombin,
epinephrine, or a sclerosant may be provided to reduce localized
bleeding. Similarly, if used for closing a perforation, a fibrin
sealant may be delivered to a localized lesion. In addition to the
hemostatic properties of the therapeutic agent 38, it should be
noted that the relatively high pressure of the fluid and
therapeutic agent, by itself, may act as a mechanical tamponade by
providing a compressive force, thereby reducing the time needed to
achieve hemostasis.
[0045] The therapeutic agent 38 may be selected to perform one or
more desired biological functions, for example, promoting the
ingrowth of tissue from the interior wall of a body vessel, or
alternatively, to mitigate or prevent undesired conditions in the
vessel wall, such as restenosis. Many other types of therapeutic
agents 38 may be used in conjunction with the system 20.
[0046] The therapeutic agent 38 may be delivered in any suitable
form. For example, the therapeutic agent 38 may comprise a powder,
liquid, gel, aerosol, or other substance. Advantageously, the
pressure source 50 may facilitate delivery of the therapeutic agent
38 in any one of these forms.
[0047] The therapeutic agent 38 employed also may comprise an
antithrombogenic bioactive agent, e.g., any bioactive agent that
inhibits or prevents thrombus formation within a body vessel. Types
of antithrombotic bioactive agents include anticoagulants,
antiplatelets, and fibrinolytics. Anticoagulants are bioactive
materials which act on any of the factors, cofactors, activated
factors, or activated cofactors in the biochemical cascade and
inhibit the synthesis of fibrin. Antiplatelet bioactive agents
inhibit the adhesion, activation, and aggregation of platelets,
which are key components of thrombi and play an important role in
thrombosis. Fibrinolytic bioactive agents enhance the fibrinolytic
cascade or otherwise aid in dissolution of a thrombus. Examples of
antithrombotics include but are not limited to anticoagulants such
as thrombin, Factor Xa, Factor VIIa and tissue factor inhibitors;
antiplatelets such as glycoprotein IIb/IIIa, thromboxane A2,
ADP-induced glycoprotein IIb/IIIa, and phosphodiesterase
inhibitors; and fibrinolytics such as plasminogen activators,
thrombin activatable fibrinolysis inhibitor (TAFI) inhibitors, and
other enzymes which cleave fibrin.
[0048] Additionally, or alternatively, the therapeutic agent 38 may
include thrombolytic agents used to dissolve blood clots that may
adversely affect blood flow in body vessels. A thrombolytic agent
is any therapeutic agent that either digests fibrin fibers directly
or activates the natural mechanisms for doing so. Examples of
commercial thrombolytics, with the corresponding active agent in
parenthesis, include, but are not limited to, Abbokinase
(urokinase), Abbokinase Open-Cath (urokinase), Activase (alteplase,
recombinant), Eminase (anitstreplase), Retavase (reteplase,
recombinant), and Streptase (streptokinase). Other commonly used
names are anisoylated plasminogen-streptokinase activator complex;
APSAC; tissue-type plasminogen activator (recombinant); t-PA;
rt-PA. While a few exemplary therapeutic agents 38 have been
listed, it will be apparent that numerous other suitable
therapeutic agents may be used in conjunction with the system 20
and delivered through the catheter 90.
[0049] Advantageously, the system 20 permits localized delivery of
a desired quantity of the therapeutic agent 38 at a desired
pressure via the pressure source 50. Since the distal end 94 of the
catheter 90 may be placed in relatively close proximity to a target
site, the system 20 provides significant advantages over
therapeutic agents delivered orally or through an IV system and may
reduce accumulation of the therapeutic agent 38 in healthy tissues,
thereby reducing side effects. Moreover, the delivery of the
therapeutic agent 38 to the target site is performed in a
relatively fast manner due to the relatively high pressure of the
fluid, thereby providing a prompt delivery to the target site
compared to previous devices.
[0050] Further, if the optional needle 95 is employed, the system
20 advantageously may be used to both perforate tissue at or near a
target site, then deliver the therapeutic agent 38 at a desired
pressure in the manner described above. For example, the needle 95
may comprise an endoscopic ultrasound (EUS) needle. Accordingly, in
one exemplary technique, a sharpened tip of the needle 95 may be
capable of puncturing through an organ or a gastrointestinal wall
or tissue, so that the therapeutic agent 38 may be delivered at a
predetermined pressure in various bodily locations that may be
otherwise difficult to access. One or more delivery vehicles, such
as an endoscope or sheath, may be employed to deliver the catheter
90 to a target site, particularly if the distal end 94 of the
catheter 90 comprises the optional needle 95.
[0051] Referring now to FIGS. 3-4, exemplary endoscopes that may be
used in conjunction with the system 20 are described. In FIG. 3, an
end-viewing endoscope 150 comprises optical elements 173 and 174
disposed on the distal end surface of the endoscope, which employ
fiber optic components for illuminating and capturing an image
distal to the endoscope. Further, a working channel 161 extends
through the distal end surface of the endoscope 150, as shown in
FIG. 3. The working channel 161 may be sized to accommodate the
catheter 90 therein for purposes of longitudinally advancing the
catheter 90 to the target site. As shown, one auxiliary lumen 162
also optionally may be provided, although greater or fewer
lumens/channels may be employed.
[0052] The endoscope 150 may be advanced through a bodily lumen
such as the alimentary canal to a position proximate the target
location. The catheter 90 then may be advanced through the working
lumen 161 of the endoscope 150. If the needle 95 is employed, a
sharpened tip 96 of the needle 95 may extend distal to the
endoscope 150, as shown in FIG. 3, and may be used to puncture
through an organ or a gastrointestinal wall or tissue. At this
time, the therapeutic agent 38 may be delivered through the
catheter 90, then through a bore 97 in the needle 95, in the manner
described above.
[0053] In FIG. 4, a side-viewing endoscope 150' is similar to the
end-viewing endoscope 150, with the main exception that optical
elements 173' and 174' are disposed on a side surface of the
endoscope 150' and capable of capturing an image to the side of the
endoscope. The endoscope 150' preferably comprises a working
channel 161', which is sized to accommodate the catheter 90 therein
for purposes of longitudinally advancing the catheter to a target
site. A guiding channel 165 may be formed near the distal surface
of the endoscope 150' to cause components advanced through the
working channel 161' to exit at a predetermined angle with respect
to a longitudinal axis of the endoscope 150'. It will be apparent
that while one working channel 161' is shown, the endoscope 150'
may comprise at least one more additional lumen or channel, such as
an auxiliary lumen.
[0054] Referring now to FIG. 5, an alternative system 220 for
delivery therapeutic agents is similar to system 20 of FIG. 1, both
in structure and general operation, with main exceptions noted
below. In FIG. 5, the alternative system 220 comprises a generally
Y-shaped connecting member 270, which has a slightly different
shape relative to the connecting member 70 of FIG. 1. Specifically,
the connecting member 270 has first and second inlet ports 272 and
274, respectively, and an outlet port 276. The outlet port 276 may
be aligned with a longitudinal axis L, as shown in FIG. 5. The
first inlet port 272 may be disposed at an angle .alpha..sub.1 with
respect to the axis of the outlet port 276, while the second inlet
port 274 may be disposed at an angle .alpha..sub.2 with respect to
the outlet port 276, as depicted in FIG. 5. The angles
.alpha..sub.1 and .alpha..sub.2 are depicted as being substantially
identical in FIG. 5, at about 25-45 degrees, which may facilitate
mixing and/or flow of the contents through the connecting member
270 and out of the outlet port 276. However, it will be apparent
that any suitable angle may be employed and that the angles
.alpha..sub.1 and .alpha..sub.2 may comprise different angles.
[0055] Referring now to FIG. 6, an alternative system 320 for
delivery therapeutic agents is shown. The alternative system 320 is
similar to system 20 of FIG. 1, both in structure and general
operation, with a main exception that alternative connecting member
370 has a first inlet port 372 aligned with the longitudinal axis
L, and a second inlet port 374 disposed at an angle .alpha..sub.2
with respect to the outlet port 376. Further, in this embodiment,
the second inlet port 374 is placed in closer proximity to the
outlet port 376, in relation to the positioning of the first inlet
port 372, as shown in FIG. 6. In this embodiment, like the others
described above, the fluid from the pressure source 50 passes
through the second inlet port 374 and into the alternative
connecting member 370 to create a localized low pressure system in
the vicinity of the first inlet port 372. The low pressure system
will form a strong suction force to suction the therapeutic agent
38 out of the reservoir 32, through the first inlet port 372 and
through the catheter 90.
[0056] Referring now to FIG. 7, an alternative system 420 for
delivery therapeutic agents is described. The alternative system
420 is similar to system 20 of FIG. 1 in general operation, with
main exceptions noted below. Notably, in the embodiment of FIG. 7,
fluid from the pressure source 50 may be passed directly through a
proximal region 434 of the container 430. In this embodiment, the
plunger of the container may be omitted. A therapeutic agent 438 is
provided within a reservoir 432 using measurement indicia 439.
Tubing 62 may be coupled between the pressure source 50 and the
proximal region 434 of the container 430. When the pressure source
50 is actuated, a high pressure fluid may flow directly through the
container 430 to urge the therapeutic agent 438 out of a distal
region 436 of the container 430 and into the catheter 90.
[0057] Additionally, in the embodiment of FIG. 7, a pressure relief
valve 470 may be disposed between the pressure source 50 and the
container 430. The pressure relief valve 470 may be similar to the
regulator valve 58 of FIG. 1, and may comprise first and second
ports 471 and 472 having an outlet valve 473 disposed therebetween.
In operation, if fluid from the pressure source 50 exceeds a
predetermined pressure, the pressure relief valve 470 may reduce
the pressure that flows out of the second port 472 and into the
container 430.
[0058] Finally, the alternative system 420 further comprises an
anti-reflux valve 480 coupled to the distal end 94 of the catheter
90, as shown in FIG. 7. In use, the anti-reflux valve 480 may be
configured to prevent blood or other foreign fluids from entering a
distal opening 482 of the valve, and then flowing proximally into
the catheter 90, which may lead to complications such as occlusion
in the system 420. While the anti-reflux valve 480 is shown in use
in the embodiment of FIG. 7, it will be apparent that it may be
used in lieu of the needle 95 in conjunction with the embodiments
of FIGS. 1, 5 and 6. Conversely, the needle 95 of the
above-mentioned embodiments may be coupled to the distal end 94 of
the catheter 90 in the embodiment of FIG. 7.
[0059] While various embodiments of the invention have been
described, the invention is not to be restricted except in light of
the attached claims and their equivalents. Moreover, the advantages
described herein are not necessarily the only advantages of the
invention and it is not necessarily expected that every embodiment
of the invention will achieve all of the advantages described.
* * * * *