U.S. patent application number 12/616518 was filed with the patent office on 2010-03-04 for prosthetic valve with vessel engaging member.
This patent application is currently assigned to COOK INCORPORATED. Invention is credited to Brian C. Case, Jacob A. Flagle, Andrew K. Hoffa.
Application Number | 20100057201 12/616518 |
Document ID | / |
Family ID | 33490671 |
Filed Date | 2010-03-04 |
United States Patent
Application |
20100057201 |
Kind Code |
A1 |
Flagle; Jacob A. ; et
al. |
March 4, 2010 |
PROSTHETIC VALVE WITH VESSEL ENGAGING MEMBER
Abstract
Medical devices for implantation in a body vessel are provided.
Each medical device comprises a main body, a valve, and a vessel
engaging member. The vessel engaging member is disposed on an outer
surface of the main body. Kits including a plurality of vessel
engaging members for use with one or more valve members are also
provided. The vessel engaging members have varying radial
dimensions, allowing assembly of medical devices having varying
radial dimensions. Methods of treating a patient using medical
devices according to the invention are also provided.
Inventors: |
Flagle; Jacob A.;
(Bloomington, IN) ; Case; Brian C.; (Bloomington,
IN) ; Hoffa; Andrew K.; (Bloomington, IN) |
Correspondence
Address: |
BUCHANAN INTELLECTUAL PROPERTY OFFICE LLC
P.O. BOX 700
PERRYSBURG
OH
43552-0700
US
|
Assignee: |
COOK INCORPORATED
Bloomington
IN
|
Family ID: |
33490671 |
Appl. No.: |
12/616518 |
Filed: |
November 11, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10857403 |
May 28, 2004 |
7628804 |
|
|
12616518 |
|
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|
|
60473911 |
May 28, 2003 |
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Current U.S.
Class: |
623/2.16 ;
623/2.1; 623/2.12; 623/2.13; 623/2.42 |
Current CPC
Class: |
A61F 2/2475 20130101;
A61F 2/2418 20130101; A61F 2220/0033 20130101; A61F 2230/0078
20130101; A61F 2/2412 20130101; A61F 2220/005 20130101; A61F 2/07
20130101 |
Class at
Publication: |
623/2.16 ;
623/2.1; 623/2.12; 623/2.42; 623/2.13 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A medical device kit, comprising: a valve member comprising a
main body defining a passageway and a valve disposed in the
passageway, the valve adapted to permit fluid flow through the
passageway in a first direction and to substantially prevent fluid
flow through the passageway in a second, opposite direction; a
plurality of vessel engaging members, each of the plurality of
vessel engaging members comprising inner and outer edges, defining
an aperture adapted to receive the main body, and having a radial
dimension extending from the inner edge to the outer edge; at least
one vessel engaging member of the plurality of vessel engaging
members being separate from the valve member in said medical device
kit; and at least two vessel engaging members of the plurality of
vessel engaging members comprising different radial dimensions;
wherein the main body of the valve member is adapted to be
independently disposed in the aperture of each vessel engaging
member of the plurality of vessel engaging members to form a
medical device adapted for implantation in a body vessel, the
medical device having an outer diameter based on the radial
dimension of the vessel engaging member defining the aperture in
which the main body is disposed.
2. The medical device kit of claim 1, wherein the main body
comprises a self-expanding support frame.
3. The medical device kit of claim 1, wherein each vessel engaging
member of the plurality of vessel engaging members comprises a
disc-shaped member.
4. The medical device kit of claim 1, wherein each vessel engaging
member of the plurality of vessel engaging members further
comprises a bioremodellable material.
5. The medical device kit of claim 1, wherein each vessel engaging
member of the plurality of vessel engaging members further
comprises a hydrogel.
6. The medical device kit of claim 1, wherein each vessel engaging
member of the plurality of vessel engaging members further
comprises an extracellular matrix material.
7. The medical device kit of claim 1, wherein each vessel engaging
member of the plurality of vessel engaging members further
comprises small intestine submucosa.
8. The medical device of claim 1, wherein the valve comprises a
leaflet attached to the main body.
9. The medical device kit of claim 8, wherein the leaflet is
adapted to move between a first position to permit fluid flow
through the passageway in the first direction and a second position
to substantially prevent fluid flow through the passageway in the
second, opposite direction.
10. The medical device kit of claim 8, wherein the leaflet
comprises a bioremodellable material.
11. The medical device kit of claim 8, wherein the leaflet
comprises an extracellular matrix material.
12. The medical device kit of claim 8, wherein the leaflet
comprises small intestine submucosa.
13. The medical device kit of claim 8, wherein the valve further
comprises a second leaflet attached to the main body.
14. The medical device kit of claim 10, wherein the first and
second leaflets individually move between first and second
positions to cooperatively permit fluid flow through the passageway
in the first direction and substantially prevent fluid flow through
the passageway in the second, opposite direction.
15. The medical device kit of claim 1, wherein at least three
vessel engaging members of the plurality of vessel engaging members
comprise different radial dimensions.
16. The medical device kit of claim 1, wherein the aperture of each
vessel engaging member of the plurality of vessel engaging members
has an aperture diameter; and wherein the aperture diameters of all
vessel engaging members of the plurality of vessel engaging members
are the same.
17. The medical device kit of claim 1, wherein the aperture of each
vessel engaging member of the plurality of vessel engaging members
has an aperture diameter; and wherein two vessel engaging members
of the plurality of vessel engaging members comprise different
aperture diameters.
18. The medical device kit of claim 17, wherein the main body has a
first outer diameter; further comprising a second main body having
a second outer diameter; and wherein the first outer diameter is
different than the second outer diameter.
19. A medical device kit, comprising: a plurality of valve members,
each valve member of the plurality of valve members comprising a
main body having an outer diameter and defining a passageway, and a
valve disposed in the passageway, the valve adapted to permit fluid
flow through the passageway in a first direction and to
substantially prevent fluid flow through the passageway in a
second, opposite direction; a plurality of vessel engaging members,
each of the plurality of vessel engaging members comprising inner
and outer edges, defining an aperture adapted to receive the main
body, and having a radial dimension extending from the inner edge
to the outer edge; at least one vessel engaging member of the
plurality of vessel engaging members being separate from the valve
member in said medical device kit; at least two vessel engaging
members of the plurality of vessel engaging members comprising
different radial dimensions; and at least two valve members of the
plurality of valve members comprising different outer diameters;
wherein the main body of each valve member is adapted to be
independently disposed in the aperture of each vessel engaging
member of the plurality of vessel engaging members to form a
medical device adapted for implantation in a body vessel, the
medical device having a device outer diameter based on the radial
dimension of the vessel engaging member defining the aperture in
which the main body is disposed.
20. A method of treating a patient, comprising: providing a medical
device kit according to claim 1; determining an inner diameter of a
body vessel of said patient at a point of treatment; selecting a
suitable vessel engaging member from the plurality of vessel
engaging members based on the determined inner diameter; disposing
the main body of the valve member in the aperture of the selected
vessel engaging member to form a medical device adapted for
implantation in the body vessel at the point of treatment; and
implanting the medical device at the point of treatment in the body
vessel.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/857,403, filed on May 28, 2004, which
claims priority to U.S. Provisional Application Ser. No.
60/473,911, filed on May 28, 2003. Each of these applications is
hereby incorporated into this disclosure in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices. More
particularly, the invention relates to medical devices for
implantation in a body vessel.
BACKGROUND OF THE INVENTION
[0003] Many vessels in animals transport fluids from one bodily
location to another. Frequently, fluid flows in a unidirectional
manner along the length of the vessel. Varying fluid pressures over
time, however, can introduce a reverse flow direction in the
vessel. In some vessels, such as mammalian veins, natural valves
are positioned along the length of the vessel and act as one-way
check valves that open to permit the flow of fluid in the desired
direction, and quickly close upon a change in pressure, such as a
transition from systole to diastole, to prevent fluid flow in a
reverse direction, i.e., retrograde flow.
[0004] While natural valves may function for an extended time, some
may lose effectiveness, which can lead to physical manifestations
and pathology. For example, venous valves are susceptible to
becoming insufficient due to one or more of a variety of factors.
Over time, the vessel wall may stretch, affecting the ability of
the valve leaflets to close. Furthermore, the leaflets may become
damaged, such as by formation of thrombus and scar tissue, which
may also affect the ability of the valve leaflets to close. Once
valves are damaged, venous valve insufficiency may be present,
which can lead to discomfort and possibly ulcers in the legs and
ankles.
[0005] Current treatments for venous valve insufficiency include
surgical techniques in which valves are bypassed or replaced with
autologous sections of veins with competent valves. These
techniques are generally undesirable because they represent a
relatively invasive approach to treating valve insufficiency.
[0006] Minimally invasive techniques and instruments for placement
of intraluminal medical devices have developed over recent years. A
wide variety of treatment devices that utilize minimally invasive
technology has been developed and includes stents, stent grafts,
occlusion devices, infusion catheters and the like. Minimally
invasive intravascular devices have especially become popular with
the introduction of coronary stents to the U.S. market in the early
1990's. Coronary and peripheral stents have been proven to provide
a superior means of maintaining vessel patency, and have become
widely accepted in the medical community. Furthermore, the use of
stents has been extended to treat aneurysms and to provide
occlusion devices, among other uses.
[0007] Recently, prosthetic valves have been developed that use a
support frame such as a stent. Frequently, a graft member is
attached to the support frame and provides a valve function to the
device. For example, the graft member can be in the form of a
leaflet that is attached to a stent and movable between first and
second positions. In a first position, the valve is open and allows
fluid flow to proceed through a vessel in a first direction, and in
a second direction the valve is closed to prevent fluid flow in a
second, opposite direction. An example of this type of prosthetic
valve is described in commonly owned U.S. Pat. No. 6,508,833, to
Pavcnik for a MULTIPLE-SIDED INTRALUMINAL MEDICAL DEVICE, which is
hereby incorporated by reference in its entirety. In other examples
of prosthetic valves, a tube that terminates in valve portions is
attached to one or more support frames to form a valve. The valve
portions open to permit fluid flow in a first direction in response
to fluid pressure on one side of the portions, and close to prevent
fluid flow in a second, opposite direction in response to fluid
pressure on opposite sides of the portions. An example of this
configuration is provided in U.S. Pat. No. 6,494,909 to Greenhalgh
for AN ENDOVASCULAR VALVE, which is hereby incorporated by
reference in its entirety.
[0008] One challenge in the development of prosthetic valves is the
sizing of the valves. The body vessels in which the valves are
placed exist in various sizes and configurations in any given
patient population. For example, prosthetic venous valves are
designed for placement within a vein of a patient. These body
vessels exist in a variety of sizes and have a high degree of
elasticity. Accordingly, there is a need for medical devices, kits,
and methods that are capable of being adapted to vessels of various
sizes.
SUMMARY OF EXEMPLARY EMBODIMENTS OF THE INVENTION
[0009] The invention provides medical devices for implantation in a
body vessel.
[0010] In one exemplary embodiment, a medical device according to
the invention comprises a main body having an outer surface and
defining a passageway therethrough. A valve is disposed in the
passageway and adapted to permit fluid flow through the passageway
in a first direction and substantially prevent fluid flow through
the passageway in a second, opposite direction. A vessel engaging
member is disposed on the outer surface of the main body.
[0011] In one exemplary embodiment, a medical device according to
the invention comprises a main body having an outer surface and
defining a passageway therethrough. A valve is disposed in the
passageway and adapted to permit fluid flow through the passageway
in a first direction and substantially prevent fluid flow through
the passageway in a second, opposite direction. Means for engaging
said body vessel are disposed on the outer surface of the main
body.
[0012] In one exemplary embodiment, a medical device according to
the invention comprises a prosthetic valve having a stent and a
tubular valve body disposed in a passageway defined by the stent. A
vessel engaging member is disposed around the stent.
[0013] The invention also provides delivery devices. In one
embodiment, a delivery device according to the invention comprises
an elongate member comprising a distal end and a prosthetic valve
according to the invention disposed on the distal end. A sheath can
be disposed around the prosthetic valve and the elongate
member.
[0014] The invention also provides kits. In one embodiment, a kit
according to the invention comprises a valve member comprising a
main body defining a passageway and a valve disposed in the
passageway. The valve is adapted to permit fluid flow through the
passageway in a first direction and substantially prevent fluid
flow through the passageway in a second, opposite direction. The
kit also comprises a plurality of vessel engaging members. Each of
the plurality of vessel engaging members comprises inner and outer
edges and defines an opening adapted to receive the main body of
the valve member. Each of the plurality of vessel engaging members
has a dimension extending from the inner edge to the outer edge.
Two of the plurality of vessel engaging members comprise different
dimensions.
[0015] The invention also provides methods of treating a patient.
In one embodiment, a method of treatment according to the invention
comprises providing a kit according to the invention; determining
an inner diameter of a body vessel at a point of treatment;
selecting a vessel engaging member having a suitable dimension;
disposing the main body of a valve member in the opening of the
vessel engaging member to form a medical device; and implanting the
medical device at the point of treatment.
[0016] The invention includes other embodiments within the scope of
the claims, and variations of all embodiments, and is limited only
by the claims made by the applicants. Additional understanding of
the invention can be obtained by referencing the detailed
description of exemplary embodiments of the invention, below, and
the appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a perspective view, partially broken away, of a
medical device according to a first embodiment of the
invention.
[0018] FIG. 2 is a sectional view of the medical device of FIG. 1
within a body vessel with the valve in an open configuration.
[0019] FIG. 3 is a sectional view of the medical device of FIG. 1
within a body vessel with the valve in a closed configuration.
[0020] FIG. 4 is a perspective view, partially broken away, of a
medical device according to a second embodiment of the
invention.
[0021] FIG. 5 is a sectional view of a medical device according to
a third embodiment of the invention within a body vessel.
[0022] FIG. 6 is a perspective view, partially broken away, of a
medical device according to a fourth embodiment of the
invention.
[0023] FIG. 7 is a perspective view, partially broken away, of a
medical device according to a fifth embodiment of the invention
within a body vessel.
[0024] FIG. 8 is a perspective view, partially broken away, of a
medical device according to a sixth embodiment of the invention
within a body vessel.
[0025] FIG. 9 is a sectional view of a catheter according to an
embodiment of the invention.
[0026] FIG. 10 is a schematic illustrating a kit according to an
embodiment of the invention.
[0027] FIG. 11 is a flowchart of a method of treating a patient
according to an embodiment of the invention.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION
[0028] The following detailed description and appended drawings
describe and illustrate various exemplary embodiments of the
invention. The description and drawings serve to enable one skilled
in the art to make and use the invention, and are not intended to
limit the scope of the invention, or its protection, in any
manner.
[0029] The invention provides medical devices for implantation in a
body vessel, catheters, kits, and methods of treating patients that
utilize medical devices according to the invention.
[0030] FIGS. 1 through 3 illustrate a medical device 10 according
to a first embodiment of the invention. The device 10 is an
implantable medical device that comprises a main body 12, a valve
14, and a vessel engaging member 16.
[0031] As used herein, the term "implantable" refers to an ability
of a medical device to be positioned at a location within a body,
such as within a body vessel. Furthermore, the terms "implantation"
and "implanted" refer to the positioning of a medical device at a
location within a body, such as within a body vessel.
[0032] The main body 12 has proximal 18 and distal 20 ends and
defines a passageway 22 extending between the ends 18, 20. The
passageway 22 provides a path for fluid flow through main body 12.
An inner surface 24 of the main body 12 bounds the passageway 22,
and an outer surface 26 defines the exterior of the main body 12.
The main body 12 and the passageway 22 need not have any particular
length, and the lengths can be optimized for a particular point of
treatment.
[0033] Any suitable structure defining a passageway can be utilized
as the main body 12. Examples of suitable structures include,
without limitation, composite tubular structures, such as polymeric
tubular structures, wire form structures, such as self-expandable
stents, and balloon expandable stents, such as those cut from
tubular members. Self-expandable and balloon expandable stents have
a first, unexpanded configuration and a second, expanded
configuration, which facilitates delivery and implantation by
percutaneous techniques.
[0034] The structure of the main body 12 can be formed from a
variety of materials, and need only be biocompatible, or able to be
made biocompatible. Examples of suitable materials include, without
limitation, stainless steel, nickel titanium (NiTi) alloys, e.g.,
Nitinol, other shape memory and/or superelastic materials,
polymers, and composite materials. A resorbable material can also
be used for the main body 12. As used herein, the term "resorbable"
refers to the ability of a material to be absorbed into a tissue
and/or body fluid upon contact with the tissue and/or body fluid. A
number of resorbable materials are known in the art, and any
suitable resorbable material can be used. Examples of suitable
types of resorbable materials include resorbable homopolymers,
copolymers, or blends of resorbable polymers. Specific examples of
suitable resorbable materials include poly-alpha hydroxy acids such
as polylactic acid, polylactide, polyglycolic acid (PGA), or
polyglycolide; trimethylene carbonate; polycaprolactone; poly-beta
hydroxy acids such as polyhydroxybutyrate or polyhydroxyvalerate;
or other polymers such as polyphosphazines, polyorganophosphazines,
polyanhydrides, polyesteramides, polyorthoesters, polyethylene
oxide, polyester-ethers (e.g., polydioxanone) or polyamino acids
(e.g., poly-L-glutamic acid or poly-L-lysine). There are also a
number of naturally derived resorbable polymers that may be
suitable, including modified polysaccharides, such as cellulose,
chitin, and dextran, and modified proteins, such as fibrin and
casein.
[0035] The main body 12 need not have any particular configuration,
and the tubular configuration of the illustrated embodiment is
exemplary in nature. The specific configuration and composition of
the structure chosen for the main body 12 will depend on several
factors, including the size of the body vessel in which the medical
device 10 will be implanted, the quantity of fluid passed through
the body vessel under normal physiological conditions, the quantity
of fluid desired to be passed through the main body 12 following
implantation in the body vessel, and the desired implantation
technique. Those skilled in the art can determine an appropriate
structure for the main body 12 based on all or some of these
factors, and other factors.
[0036] The structure chosen for the main body 12 should provide a
structure to which the valve 14 can be attached. The valve 14 can
be attached to the main body 12 in any suitable manner, such as by
attachment elements, including sutures and adhesives, as well as
friction, and other suitable fastening mechanisms and/or
techniques. The main body 12 can include a portion 28 of the outer
surface 26 that is impervious to fluid flow. When present, the
impervious portion 28 can extend to the same axial length as the
valve 14. Also, the impervious portion 28 can extend axially beyond
the valve 14. This configuration encourages fluid to flow through
the valve 14 and minimizes fluid flow that passes through the body
vessel in which the device 10 is implanted without passing through
the valve 14. The impervious portion 28 can be a portion of the
main body 12 itself, such as a portion of a tubular member, or it
can be a separately attached member. Also, an impervious material
can be used to form the valve 14 to achieve the desired result.
[0037] As best illustrated in FIG. 1, a graft member 30 can be
attached to main body 12. In this embodiment, the graft member 30
comprises the impervious portion 28 and extends from the proximal
end 18 to the distal end 20 of the main body 12. Any suitable graft
material can be used to form the graft member 30. The specific
material chosen should provide the impervious portion 28, if
desired. Examples of suitable graft materials include polymers,
such as polyurethane and polytetrafluoroethylene (PTFE), and
natural materials, such as an extracellular matrix (ECM) material
or other bioremodellable material. Small intestine submucosa (SIS)
is particularly well-suited for use as the graft member 30 at least
due to its ability to remodel and become incorporated into host
tissue. Also, the graft member 30 can have any suitable
configuration, including tubular and sheet configurations, and can
be attached to any surface of the main body 12, including either or
both of the inner 24 and outer 26 surfaces. Similar to the valve
14, the graft member 30 can be attached to the main body 12 in any
suitable manner.
[0038] The valve 14 is disposed in the passageway 22 and is adapted
to permit fluid flow through the passageway 22 in a first direction
32 and substantially prevent fluid flow through the passageway 22
in a second, opposite direction 33, i.e., retrograde flow. The
valve 14 can be any suitable valve that is able to provide the
desired ability to permit fluid flow in the first direction 32 and
substantially prevent fluid flow in the second, opposite direction
33. Examples of suitable valves include valves formed by attachment
of one or more valve leaflets to a support frame, such as the
prosthetic valves described in U.S. Pat. No. 6,508,833 to Pavcnik
for a MULTIPLE-SIDED INTRALUMINAL MEDICAL DEVICE.
[0039] Examples of suitable materials for the valve 14 include
flexible materials, natural materials, synthetic materials, and
combinations thereof. Examples of suitable natural materials
include collagen, extracellular matrix (ECM) materials, such as
submucosa, and other bioremodellable materials, such as bovine
pericardium. Small intestine submucosa (SIS) is particularly
well-suited for use as the graft members 14, 16. Other examples of
ECM materials that can be used for the graft member include stomach
submucosa, liver basement membrane, urinary bladder submucosa,
tissue mucosa, and dura mater. ECMs are particularly well-suited
materials for use in the graft member, at least because of their
abilities to remodel and become incorporated into adjacent tissues.
These materials can provide a scaffold onto which cellular
in-growth can occur, eventually allowing the material to remodel
into a structure of host cells. Examples of suitable synthetic
materials include polymeric materials, such as polypropylene,
polyurethane, and expanded polytetrafluoroethylene (ePTFE).
[0040] Tubular valves are also suitable for use in medical devices
according to the invention. As best illustrated in FIG. 1, the
valve 14 can comprise a valve formed at one end 34 of a tubular
body 36. The valve 14 can be formed by forming valve portions 38,
40 on one end 34 of the tubular body 36. The valve portions 38, 40
can be formed by attaching the tubular body 36 to the main body 12
in the illustrated configuration, or in any other suitable
configuration that forms valve portions 38, 40. Any suitable
attachment element and/or technique can be used to attach the
tubular body 36 to the main body 12 and to form the valve portions
38, 40, such as sutures, adhesives, bonding, and the like. The
specific attachment element and/or technique chosen will depend on
several factors, including the materials and form of the valve 14
and the main body 12.
[0041] FIGS. 2 and 3 illustrate the medical device 10 according to
the first embodiment positioned within a body vessel 50. In FIG. 2,
the valve 14 is in an open configuration. In this configuration,
the valve 14 permits fluid flow through the passageway 22 in a
first direction 32. In the closed configuration, illustrated in
FIG. 3, the valve 14 substantially prevents fluid flow through the
passageway 22 in a second, opposite direction 33. The valve 14 can
alternate between the open and closed configurations. The mechanism
by which the valve 14 alternates between these configurations will
depend on the type of valve used. When a tubular valve is used,
such as the valve 14 illustrated in FIGS. 1 through 3, the valve
portions 38, 40 can move in response to changes in direction of
fluid flow and/or fluid pressure to accomplish the transition from
the open configuration to the closed configuration, and vice
versa.
[0042] The vessel engaging member 16 provides a means for engaging
a body vessel in which the medical device 10 is implanted. The
vessel engaging member 16 defines an aperture 42 and has inner 44
and outer 46 edges. A dimension 48, such as a radial thickness,
extends from the inner edge 44 to the outer edge 46. The main body
12 is disposed in the aperture 42. The vessel engaging member 16
substantially prevents fluid flow through the body vessel in which
the device 10 is implanted apart from the fluid flow that moves
through the valve 14. Accordingly, the vessel engaging member 16 is
dimensioned and configured to have a suitable fit with the main
body 12. Specifically, the aperture 42 should be dimensioned and
configured to provide an appropriate fit between the vessel
engaging member 16 and the main body 12. The fit should
substantially prevent fluid flow through the interface between the
member 16 and main body 12, and should be sufficiently stable to
prevent any significant movement of the main body 12 relative to
the vessel engaging member 16 under physiological conditions
following implantation of the device 10 in a body vessel. To
achieve an appropriate fit, the aperture 42 can be dimensioned such
that friction between the member 16 and the main body 12 is
sufficient. As illustrated in FIG. 1, a centrally-located aperture
42 of an appropriate dimension and configuration provides a
suitable fit. To ensure an effective fit, the aperture 42 can have
a diameter that is slightly smaller than an outer diameter of the
main body 12. Also, the vessel engaging member 16 can be attached
to the main body in any appropriate manner, such as by adhesives or
other bonding mechanisms.
[0043] The vessel engaging member 16 is also dimensioned and
configured to have a suitable fit with the inner wall of a body
vessel in which the device 10 is implanted. FIGS. 2 and 3
illustrate the medical device 10 of the first embodiment implanted
within a body vessel 50. The outer edge 46 of the vessel engaging
member 16 can be dimensioned and configured to mimic the surface of
the inner wall 52 of the vessel 50. The devices of the present
invention are particularly well suited for use as prosthetic venous
valves. Accordingly, the vessel engaging member 16 can be
dimensioned and configured to provide a suitable fit with the inner
wall of an animal vein of interest. As illustrated in FIGS. 1
through 3, a disc-shaped vessel engaging member 16 provides a
suitable configuration for use in veins.
[0044] To ensure a suitable fit between the vessel engaging member
16 and the body vessel 50, the vessel engaging member 16 can have a
diameter that is slightly larger than an inner diameter of the body
vessel 50 at a particular point of treatment. Animal veins,
including human veins, have elastic properties and are able to
alter their shape by expansion or other mechanisms to accommodate
an appropriately-sized article implanted within the vein. A vessel
engaging member 16 with a diameter slightly larger than an inner
diameter of a vein in which the device 10 is being implanted will
remain at a point of treatment within the vein due to friction
between the vessel engaging member 16 and the inner wall of the
vein. This dimensioning of the vessel engaging member 16 may also
enhance the fit between the member 16 and the main body 12 due to
compression of the inner edge 44 on the main body 12 arising from
force exerted on the member 16 by the body vessel. The specific
diameter chosen for the vessel engaging member 16 will depend on
several factors, including the extent to which the vein at a
particular point of treatment can after its shape to accommodate
the medical device 10.
[0045] Any suitable material can be used to form the vessel
engaging member 16. The material chosen need only be biocompatible,
or be able to be made biocompatible, and provide the desired
properties described herein. The material chosen also should be
substantially impervious to fluid flow through the material, unless
it is desired to allow fluid flow through the body vessel
independent of the valve 14. The specific material chosen for the
vessel engaging member 16 will depend on several factors, including
the environment in which the device 10 will be placed, the nature
of the fluid(s) to which the device 10 will be exposed, the nature
of the body vessel in which the device 10 will be implanted, and
the desired delivery technique for implanting the device 10.
Examples of suitable materials include synthetic materials, such as
polymers, including polyurethane and polytetrafluoroethylene, and
gels, and natural materials, such as ECM materials. Hydrogel
materials are particularly well-suited for use in the vessel
engaging member 16.
[0046] FIG. 4 illustrates a medical device 110 according to a
second embodiment of the invention. The device 110 illustrated in
FIG. 4 is similar to the device 10 illustrated in FIGS. 1 through
3, except as detailed below. Thus, the device 110 of this
embodiment includes a main body 112, a valve 114, and a vessel
engaging member 116. The main body 112 has a proximal 118 and a
distal 120 end, and defines a passageway 122 extending between the
ends 118, 120. An inner surface 124 of the main body 112 bounds the
passageway 122, and an outer surface 126 defines the exterior of
the main body 112. A graft member 130 is disposed on the main body
112 and defines an impervious portion 128 of the main body 112.
[0047] The valve 114 is disposed in the passageway 122 and is
adapted to permit fluid flow through the passageway 122 in a first
direction 132, and substantially prevent fluid flow through the
passageway 122 in a second, opposite direction (not illustrated in
FIG. 4). The valve 114 is formed at one end 134 of a tubular body
136, and includes valve portions 138, 140.
[0048] The vessel engaging member 116 is disposed on the outer
surface 126 of the main body 112 and defines an aperture 142. The
main body 112 is disposed in the aperture 142. The vessel engaging
member 116 has inner 144 and outer 146 edges and a radial dimension
148 that extends from the inner 144 to the outer 146 edges. In this
embodiment, the radial dimension 148 for any given pair of points
on the inner 144 and outer 146 edges is different than the radial
dimension for any different set of points on the edges 144,
146.
[0049] In this embodiment, the aperture 142 comprises an opening in
the vessel engaging member that is continuous with the outer edge
146 of the vessel engaging member 116. This positioning of the
aperture 142 allows the main body 112 to be positioned near an
inner wall of a vessel in which the device 110 is implanted, which
may be desirable to avoid a diseased portion of a vessel, to bypass
a blockage of the vessel, or for other reasons.
[0050] FIG. 5 illustrates a sectional view of a medical device 210
according to a third embodiment of the invention within a body
vessel 250. The device 210 illustrated in FIG. 5 is similar to the
device 10 illustrated in FIGS. 1 through 3, except as detailed
below. Thus, the device 210 of this embodiment includes a main body
212, a valve 214, and a vessel engaging member 216. The main body
212 has a proximal 218 and a distal 220 end, and defines a
passageway 222 extending between the ends 218, 220. An inner
surface 224 of the main body 212 bounds the passageway 222, and an
outer surface 226 defines the exterior of the main body 212. A
graft member 230 is disposed on the main body 212 and defines an
impervious portion 228 of the main body 212.
[0051] The valve 214 is disposed in the passageway 222 and is
adapted to permit fluid flow through the passageway 222 in a first
direction (not illustrated in FIG. 5), and substantially prevent
fluid flow through the passageway 222 in a second, opposite
direction 233. The valve 214 is formed at an end 234 of a tubular
body 236, and includes valve portions 238, 240.
[0052] The vessel engaging member 216 is disposed on the outer
surface 226 of the main body 212 and defines an aperture 242. The
main body 212 is disposed in the aperture 242. The vessel engaging
member 216 has inner 244 and outer 246 edges and a radial dimension
248 that extends from the inner 244 to the outer 246 edges.
[0053] In this embodiment, the medical device 10 includes
structural features 260 that pierce at least a portion of the wall
of a body vessel 250. As used herein, the term "pierce" refers to a
passing into a thickness of a wall of a body vessel. The thickness
can be any partial or the complete thickness of the wall. The
structural features 260 can comprise barbs, which are well known in
the stent art. Also, the structural features 260 can be positioned
on the vessel engaging member 216, as illustrated in FIG. 5, or at
any other position on the medical device 210 that enables their
interaction with the body vessel 250. Furthermore, any suitable
number of structural features 260 can be included. In other
embodiments, structural features that frictionally engage, but do
not pierce, the vessel wall are includes in the medical device. For
example, the outer surface of the vessel engaging member can define
one or more raised bumps or indentations.
[0054] FIG. 6 illustrates a medical device 310 according to a
fourth embodiment of the invention within a body vessel 350. The
device 310 illustrated in FIG. 6 is similar to the device 10
illustrated in FIGS. 1 through 3, except as detailed below. Thus,
the device 310 of this embodiment includes a main body 312, a valve
314, and a vessel engaging member 316. The main body 312 has a
proximal 318 and a distal 320 end, and defines a passageway 322
extending between the ends 318, 320. An inner surface 324 of the
main body 312 bounds the passageway 322, and an outer surface 326
defines the exterior of the main body 312. A graft member 330 is
disposed on the main body 312 and defines an impervious portion 328
of the main body 312.
[0055] The valve 314 is disposed in the passageway 322 and is
adapted to permit fluid flow through the passageway 322 in a first
direction (not illustrated in FIG. 6), and substantially prevent
fluid flow through the passageway 322 in a second, opposite
direction 333. The valve 314 is formed at an end 334 of a tubular
body 336, and includes valve portions 338, 340.
[0056] The vessel engaging member 316 is disposed on the outer
surface 326 of the main body 312 and defines an aperture 342. The
main body 312 is disposed in the aperture 342. The vessel engaging
member 316 has inner 344 and outer 346 edges and a radial dimension
348 that extends from the inner 344 to the outer 346 edges.
[0057] In this embodiment, the vessel engaging member 316 defines
an opening 362 adapted to permit a controlled amount 363 of fluid
flow through the body vessel in the second, opposite direction 333.
The controlled amount 363 of fluid flow is a portion of the fluid
flow in the second, opposite direction 333. It may be desirable to
permit this controlled amount 363 of fluid flow in the second,
opposite direction 333 for a variety of reasons. For example, it
may reduce, minimize or eliminate pooling of fluid in and around
the device 310 during periods of closure of the valve 314.
[0058] As illustrated in FIG. 6, the vessel engaging member 316 can
define a plurality of the openings 362. When a plurality of
openings 362 is utilized, the openings 362 can be arranged in any
suitable pattern. An equidistant spacing between all openings 362
provides a suitable pattern and may maximize the efficiency of
moving the controlled amount 363 of fluid flow through the vessel
engaging member 316.
[0059] The dimensions, configuration, and number of the openings
362 can be optimized based upon the vessel in which the device 310
is implanted. The size and configuration selected will depend on
several factors, including the vessel size, typical flow volumes
and rates, and others. The opening 362 should be sized to allow a
desired amount flow in the second, opposite direction to occur,
while remaining sufficiently small to still allow the medical
device 310 to act as a valve. Thus, the opening 362 can be sized so
as not to allow a majority of retrograde flow to pass through the
opening.
[0060] The opening 362 can be sized to mimic the degree of
retrograde flow--the leakiness--that flows through a natural valve
located at or near the point of treatment. In these embodiments,
the dimensions of the opening 362 can be determined and optimized
based upon the vessel in which the device 310 is to be placed. For
example, in prosthetic venous valve embodiments, the total open
area of the opening 362 can be less than about 50% of the
cross-sectional area of the vessel, or less than about 25% of the
total cross-sectional area of the vessel. In one example, a device
is configured for placement in a vessel having a total
cross-sectional area of about 50 mm.sup.2. In this example, the
opening 362 has a total open area of about 10 mm.sup.2.
[0061] In devices including multiple openings 362 that permit a
controlled amount 363 of fluid flow in the second, opposite
direction 333 to flow through the vessel in which the device 310 is
implanted, the total open area of all openings 362 can be optimized
as described above, but it is not necessary that the individual
openings 362 have open areas of the same size.
[0062] FIG. 7 illustrates a medical device 410 according to a fifth
embodiment of the invention within a body vessel 450. The device
410 illustrated in FIG. 7 is similar to the device 10 illustrated
in FIGS. 1 through 3, except as detailed below. Thus, the device
410 of this embodiment includes a main body 412, a valve 414, and a
vessel engaging member 416. The main body 412 has a proximal (not
illustrated in FIG. 7) and a distal 420 end, and defines a
passageway 422 extending between the ends 418, 420. An inner
surface 424 of the main body 412 bounds the passageway 422, and an
outer surface 426 defines the exterior of the main body 412. A
graft member 430 is disposed on the main body 412 and defines an
impervious portion 328 of the main body 312.
[0063] The valve 414 is disposed in the passageway 422 and is
adapted to permit fluid flow through the passageway 422 in a first
direction 432, and substantially prevent fluid flow through the
passageway 422 in a second, opposite direction (not illustrated in
FIG. 7). The valve 414 is formed at one end 434 of a tubular body
436, and includes valve portions 438, 440.
[0064] The vessel engaging member 416 is disposed on the outer
surface 426 of the main body 412. The vessel engaging member 416
has first 470 and second 472 ends. The first end 472 defines a
first opening 474 having a first inner diameter, and the second end
472 defines a second opening 476 having a second inner diameter.
The first inner diameter is greater than the second inner diameter.
The second end 472 is disposed on the outer surface 426 of the main
body. This configuration of the vessel engaging member 416 provides
a manifold that collects fluid flowing through the body vessel 450
in the first direction 432 and directs the flow into the main body
412 and toward the valve 414. A graft material, such as SIS and
other bioremodellable materials, is particularly well-suited for
use as the vessel engaging member 416 in medical devices according
to this embodiment of the invention.
[0065] FIG. 8 illustrates a medical device 510 according to a sixth
embodiment of the invention within a body vessel 550. The device
510 illustrated in FIG. 8 is similar to the device 410 illustrated
in FIG. 7, except as detailed below. Thus, the device 510 of this
embodiment includes a main body 512, a valve 514, and a vessel
engaging member 516. The main body 512 has proximal and distal ends
(not illustrated in FIG. 8), and defines a passageway 522 extending
between the ends. An inner surface 524 of the main body 512 bounds
the passageway 522, and an outer surface 526 defines the exterior
of the main body 512. A graft member 530 is disposed on the main
body 512 and defines an impervious portion 528 of the main body
512.
[0066] The valve 514 is disposed in the passageway 522 and is
adapted to permit fluid flow through the passageway 522 in a first
direction 532, and substantially prevent fluid flow through the
passageway 522 in a second, opposite direction (not illustrated in
FIG. 8). The valve 514 is formed at an end 534 of a tubular body
536, and includes valve portions 538, 540.
[0067] In this embodiment, the medical device 510 includes first
516 and second 580 vessel engaging members. Both vessel engaging
member 516, 580 are disposed on the outer surface 526 of the main
body 512. The first vessel engaging member 516 has first 570 and
second 572 ends. The first end 572 defines a first opening 574
having a first inner diameter, and the second end 572 defines a
second opening 576 having a second inner diameter. The first inner
diameter is greater than the second inner diameter. The second end
572 is disposed on the outer surface 526 of the main body. This
configuration of the first vessel engaging member 516 provides a
manifold that collects fluid flowing through the body vessel 550 in
the first direction 532 and directs the flow into the main body 512
and toward the valve 514.
[0068] The second vessel engaging member 580 has third 582 and
fourth 584 ends. The third end defines a third opening 586 having a
third inner diameter, and the fourth end 584 defines a fourth
opening 588 having a fourth inner diameter. The third inner
diameter is greater than the fourth inner diameter. The fourth end
584 is disposed on the outer surface 526 of the main body 512. This
configuration of the second vessel engaging member 580 provides a
manifold that directs fluid exiting the valve 514 and main body 512
into the body vessel 550.
[0069] The first 516 and second 580 vessel engaging members create
a void region 590 in the vessel 550. The void region 590 is
excluded from the flow pattern of fluid through the vessel 550 due
to the configuration of the device 510. The void region 590 can be
used for anchoring the device 510 to the vessel 550, such as by
structural features discussed above, or by sutures or other
securement means applied to the exterior of the vessel 550. Also,
the void region 590 can be used to exclude a portion of the body
vessel 550 from fluid flow, such as a diseased portion of the
vessel 550.
[0070] FIG. 9 illustrates a delivery device 600 according to an
embodiment of the invention. The delivery device 600 comprises a
suitable elongate member 602 known to those skilled in the art. The
elongate member 602 has a distal tip 604 and defines an external
surface 606. A medical device 610 according to the present
invention is disposed on the distal tip 604 by passing the tip 604
through the passageway 622 of the main body 612 of the device 610.
The delivery device 600 can include a sheath 608 disposed over the
elongate member 602. The sheath 608 is a hollow member that defines
a lumen 609 that receives the elongate member 602. The sheath 608
can be disposed over the medical device 610 to maintain the device
610 in a radially compressed configuration. In this configuration,
the vessel engaging member 616 is compressed between the sheath 608
and the main body 612 of the medical device 610. In this
arrangement, the catheter 600 can be navigated through a body
vessel according to techniques well known in the art. Once the
medical device is positioned at a point of treatment, the sheath
608 can be withdrawn to allow the medical device to change to a
radially expanded configuration. Following the deployment of the
medical device 610, the catheter can be withdrawn from the point of
treatment, leaving the medical device 610 implanted. If the medical
device 610 is a balloon expandable device, the elongate member 602
can define an inflation lumen for a balloon on which the medical
device 610 is mounted, as is known in the art.
[0071] Further, the elongate member 602 can define a guidewire
lumen 607 that facilitates navigation of the member 602 through a
body vessel by accommodating a previously placed guidewire. If
included, the guidewire lumen 607 can extend along the entire
length of the elongate member 602, or only along a portion of the
length, as in a rapid exchange arrangement known in the art. A
catheter according to this aspect of the invention can facilitate
placement of multiple prosthetic valves in a single vessel by
allowing for rapid exchange of one catheter carrying a medical
device according to the invention for another without removal of a
previously placed guidewire. This may be particularly desirable in
prosthetic venous valve embodiments because it may be desirable to
place two or more such devices in a single vessel during a single
treatment.
[0072] FIG. 10 illustrates a kit 700 according to the invention.
The kit 700 comprises a valve member 702 and a plurality of vessel
engaging members 704. The valve member 702 comprises a main body
706 defining a passageway 708 and a valve 710 disposed in the
passageway 708 and can be any suitable main body and valve
combination according to the invention, including those detailed in
the context of exemplary embodiments above. The valve 710 is
adapted to permit fluid flow through the passageway 708 in a first
direction, and substantially prevent fluid flow through the
passageway 708 in a second, opposite direction. As illustrated in
FIG. 10, the kit 700 can include a plurality of valve members 702.
Also, the kit 700 can further include a catheter to facilitate
implantation of the medical device.
[0073] Each vessel engaging member 704 has inner 712 and outer 714
edges, and defines an aperture 716 adapted to receive a valve
member 702. Also, each vessel engaging member defines a radial
dimension extending between its inner 712 and outer 714 edges.
[0074] Two of the plurality of vessel engaging members 704 have
different radial dimensions extending between their respective
inner 712 and outer 714 edges. The kit illustrated in FIG. 10
includes three vessel engaging members 704 having three different
dimensions 718, 720, and 722. Also, the vessel engaging members 704
of the kit 700 illustrated in FIG. 10 all have apertures 716 of the
same diameter 724. If a plurality of valve members is included in a
kit, and two valve members have main bodies of different outer
diameters, the diameters of the apertures 716 could be varied in a
manner similar to that of the radial dimensions 718, 720, 722.
[0075] A medical device in accordance with the present invention
can be made by disposing a valve member 702 in the aperture 716 of
one of the plurality of vessel engaging members 704. The kit 700
allows a user to assemble a medical device according to the present
invention with a dimension suitable for an application of interest.
For example, a clinician can assemble a medical device having a
vessel engaging member 704 with a dimension appropriate for
implantation of the device in a vein of a patient. The dimension
can be determined by determining the inner diameter of the vein at
a point of treatment.
[0076] The invention also provides methods of treating a patient.
FIG. 11 provides a flow chart illustrating one method 800 according
to the invention. In this method, step 802 comprises providing a
kit according to the invention. Another step 804 comprises
determining an inner diameter of a body vessel at a point of
treatment. This step can be accomplished by any appropriate vessel
sizing technique known in the art. Another step 806 comprises
selecting a suitable vessel engaging member from the plurality of
vessel engaging members in the kit. The selected vessel engaging
member must have a dimension that is appropriate for the treatment
based upon the inner diameter determined in step 804. The selection
of an appropriate vessel engaging member can take into account the
ability of the vessel to after its shape to accommodate an
implanted article, as explained above. Another step 808 comprises
disposing the main body of a selected valve member from the kit in
the aperture of the selected vessel engaging member to form a
medical device according to the invention. Another step 810
comprises implanting the assembled medical device at the point of
treatment in the body vessel. A step 812 of percutaneously
delivering the medical device to the point of treatment can also be
included. Step 812 can be accomplished by appropriate percutaneous
techniques known in the art.
[0077] The foregoing description of exemplary embodiments of the
invention includes the best mode for practicing the invention. It
is intended to aid in the understanding of the invention, and not
to limit the invention or its protection in any manner.
* * * * *