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Title:
VASCULAR ACCESS SYSTEM WITH REINFORCEMENT MEMBER
Document Type and Number:
WIPO Patent Application WO/2015/094514
Kind Code:
A1
Abstract:
A system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient is provided. The system includes a blood conduit having a proximal portion configured to be attached to an artery. The system also includes a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced there through to a location spaced apart from the insertion site. Moreover, the system includes a reinforcement member positioned at least partially about the blood conduit in at least one of the distal portion, the proximal portion, or a combination thereof.

Inventors:
GALE DAVID (US)
TOMKO DANIEL (US)
ARNOLD STACY (US)
KATRAGADDA VENKATA (US)
Application Number:
PCT/US2014/064968
Publication Date:
June 25, 2015
Filing Date:
November 11, 2014
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
CRYOLIFE INC (US)
International Classes:
A61F2/06; A61M1/36
Domestic Patent References:
WO2012125927A22012-09-20
WO2013036643A22013-03-14
WO2012034108A12012-03-15
WO2013021215A12013-02-14
WO2009114713A22009-09-17
WO2001039700A12001-06-07
Foreign References:
US8079973B22011-12-20
US20060064159A12006-03-23
US20130338559A12013-12-19
US6102884A2000-08-15
US7762977B22010-07-27
US8079973B22011-12-20
US8534033B22013-09-17
US20130060268A12013-03-07
US20090076587A12009-03-19
Attorney, Agent or Firm:
KING, Kevin W. et al. (999 Peachtree Street N, Atlanta Georgia, US)
Download PDF:
Claims:
CLAIMS

We claim:

1. A system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient, comprising:

a blood conduit which comprises:

a proximal portion configured to be attached to an artery, and a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced therethrough to a location spaced apart from the insertion site; and

a plurality of reinforcement members positioned at least partially about the blood conduit in at least one of the distal portion, the proximal portion, or a combination thereof.

2. The system of claim 1, further comprising a connector configured to couple the distal portion to the proximal portion.

3. The system of claim 1, wherein the plurality of reinforcement members comprise one or more of: a braided structure, a woven structure, an intraluminal stent- type structure, a coil structure, a laser cut tube structure, a linked reinforcement tube structure, a series of interconnected hard segments, a corrugated tube structure, axial projections, radial projections, axial or radial channels, or a combination thereof.

4. The system of claim 1 , wherein at least one of the plurality of reinforcement members is positioned between an inner surface and an outer surface of the blood conduit.

5. The system of claim 1, wherein at least one of the plurality of reinforcement members is positioned about an inner surface of the blood conduit.

6. The system of claim 1 , wherein at least one of the plurality of reinforcement members is positioned about an outer surface of the blood conduit.

7. The system of claim 1, wherein at least one of the plurality of reinforcement members extends beyond a distal end of the blood conduit.

8. The system of claim 1, wherein at least one of the plurality of reinforcement members extends beyond a proximal end of the blood conduit.

9. A system for providing a continuous flow of blood between a first vascular segment and a second vascular segment in a cardiovascular system of a patient, the system comprising:

an inflow component and an outflow component, which together define a lumen therethrough, wherein the inflow component is configured to be attached to the first vascular segment, and wherein the outflow component is configured to be attached to the second vascular segment, whereby continuous flow is provided through the lumen between the first vascular segment and the second vascular segment; and

a reinforcement member positioned at least partially about the lumen in at least one of the inflow component, the outflow component, or a combination thereof, wherein the reinforcement member comprises one or more of: a linked reinforcement tube structure, a series of interconnected hard segments, a corrugated tube structure, axial projections, radial projections, axial or radial channels, or a combination thereof.

10. The system of claim 9, further comprising a connector configured to couple the inflow component to the outflow component.

11. The system of claim 9, wherein the reinforcement member is positioned between an inner surface and an outer surface of a wall of the inflow and outflow components defining the lumen.

12. The system of claim 9, wherein the reinforcement member is positioned about an inner surface of the wall.

13. The system of claim 9, wherein the reinforcement member is positioned about an outer surface of the wall.

14. The system of claim 9, wherein the reinforcement member extends beyond a distal end of the lumen.

15. The system of claim 9, wherein the reinforcement member extends beyond a proximal end of the lumen.

16. A blood conduit for fluidly coupling a first vascular segment to a second vascular segment, the blood conduit comprising:

a first conduit configured to be attached to the first vascular segment;

a second conduit configured to be attached to the second vascular segment, whereby continuous flow is provided through a lumen between the first vascular segment and the second vascular segment; and

a plurality of reinforcement members positioned at least partially in at least one of the first conduit, the second conduit, or a combination thereof.

17. The blood conduit of claim 16, further comprising a connector configured to couple the first conduit to the second conduit.

18. The blood conduit of claim 16, wherein the plurality of reinforcement members comprise one or more of: a braided structure, a woven structure, an intraluminal stent-type structure, a coil structure, a laser cut tube structure, a linked reinforcement tube structure, a series of interconnected hard segments, a corrugated tube structure, axial projections, radial projections, axial or radial channels, or a combination thereof.

19. The blood conduit of claim 16, wherein the plurality of reinforcement members comprises reinforcement members positioned at two or more discrete locations about the first conduit, the second conduit, or a combination thereof.

20. The blood conduit of claim 16, wherein the plurality of reinforcement members is positioned between an inner surface and an outer surface of a wall of the first and second conduits defining the lumen.

21. A method for providing a continuous flow of blood between two locations in a cardiovascular system of a patient, the method comprising:

attaching a proximal portion of a blood conduit an artery;

inserting a distal portion of the blood conduit into a blood vessel at an insertion site and to be advanced therethrough to a location spaced apart from the insertion site; and reinforcing the blood conduit with a plurality of reinforcement members positioned at least partially about the blood conduit in at least one of the distal portion, the proximal portion, or a combination thereof.

Description:
VASCULAR ACCESS SYSTEM WITH REINFORCEMENT MEMBER

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present disclosure claims priority to and the benefit of U.S. provisional patent application No. 61/919,097, filed on 20 December 2013, which is incorporated by reference herein in its entirety.

FIELD

[0002] The present disclosure relates to a fluid-carrying conduit, such as an implantable vascular conduit, comprising one or more reinforcement members.

BACKGROUND

[0003] In the United States, approximately 400,000 people have end-stage renal disease requiring chronic hemodialysis. Permanent vascular access sites for performing hemodialysis may be formed by creating an arteriovenous (AV) anastomosis whereby a vein is attached to an artery to form a high-flow shunt or fistula. A vein may be directly attached to an artery, but it may take 6 to 8 weeks before the venous section of the fistula has sufficiently matured to provide adequate blood flow for use with hemodialysis. Moreover, a direct anastomosis may not be feasible in all patients due to anatomical considerations.

[0004] Other patients may require the use of artificial graft material to provide an access site between the arterial and venous vascular systems. Patency rates of grafts are still not satisfactory, as the overall graft failure rate remains high. Temporary catheter access is also an option. However, the use of temporary catheter access exposes the patient to an additional risk of bleeding and infection, as well as discomfort.

[0005] Vascular access systems are known in the art. For example, U.S. Patent 6, 102,884 to Squitieri, U.S. Patent 7,762,977 to Porter, and U.S. Patent 8,079,973 to Harrig et al. describe implantable blood conduit systems which include (i) an extravascular blood conduit that has a proximal end adapted to couple with a first vascular segment of a patient and a distal end adapted to be inserted into a second vascular segment of the patient; (ii) a catheter having a proximal portion and a distal portion that, when implanted, floats freely within the second vascular segment; and (iii) a connector for fluidly coupling the proximal end of the blood conduit with the catheter with the proximal portion. It would be desirable to provide improved and/or alternative conduits or catheters that eliminate or at least minimize kinking, compression, or other obstructions.

SUMMARY

[0006] Some or all of the above needs and/or problems may be addressed by certain embodiments disclosed herein. For example, in certain embodiments, a system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient is provided. The system includes a blood conduit having a proximal portion configured to be attached to an artery. The system also includes a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced therethrough to a location spaced apart from the insertion site. Moreover, the system includes a reinforcement member positioned at least partially about the blood conduit in at least one of the distal portion, the proximal portion, or a combination thereof.

[0007] Other embodiments, aspects, and features of the disclosure will become apparent to those skilled in the art from the following detailed description, the accompanying drawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The structure and method of using the devices, systems, and methods described herein will be better understood with the following detailed description of embodiments, along with the accompanying illustrations, which are not necessarily drawn to scale.

[0009] FIG. 1 schematically depicts an example embodiment of a vascular access system.

[0010] FIG. 2 schematically depicts an example embodiment of a vascular access system.

[0011] FIG. 3 schematically depicts an example embodiment of a vascular access system.

[0012] FIG. 4 schematically depicts an example embodiment of a vascular access system.

[0013] FIG. 5 schematically depicts an example embodiment of a vascular access system.

[0014] FIG. 6 schematically depicts an example embodiment of a vascular access system. [0015] FIG. 7 schematically depicts an example embodiment of a vascular access system.

[0016] FIG. 8 schematically depicts an example embodiment of a vascular access system.

DETAILED DESCRIPTION

[0017] Improved hemodialysis and vascular access systems and methods have been developed. In a broad sense, certain embodiments include systems and methods for providing one or more fluid-carrying conduits, such as an implantable vascular conduit. The fluid-carrying conduits may be arteriovenous (AV) shunts or catheters in various embodiments. For example, the embodiments described herein may improve flow between points in a patient's vasculature. In some instances, the vascular access system described herein may include a first portion of a blood-carrying conduit configured for use as an inflow component and a second portion of the blood-carrying conduit configured for use as an outflow component. Techniques for reinforcing the inflow and outflow components are provided.

[0018] In certain embodiments, the techniques for reinforcing the inflow and outflow components improve over, and/or build upon, the techniques described in U.S. Patent No. 8,079,973, U.S. Patent No. 8,534,033, and U.S. Application Publication No. 2013/0060268, which are all hereby incorporated by reference in their entirety.

[0019] The inflow component can be any of a variety of blood conduits that are able to receive blood into the vascular access system from the patient's vasculature. Such blood conduits can have a construction similar to a vascular graft made of ePTFE (expanded polytetrafluoroethylene), Dacron, or other suitable materials. Any suitable graft material may be used. Other suitable materials can include a material that is biocompatible with an artery and is non-thrombogenic or minimally thrombogenic. The inflow component may be adapted for attachment to an artery. For example, the inflow component may be attached to a brachial artery by an end-to-side anastomosis. In some instances, the inflow component preferably is adapted for long-term attachment to an artery, although short-term applications may also be implemented.

[0020] In a preferred embodiment, the inflow component includes a region suitable for repeated needle access. For example, a length of the inflow component can be configured to be pierced by a needle to enable blood to be withdrawn from and returned to the system, e.g., for hemodialysis. [0021] The outflow component can be any of a variety of blood conduits that are able to return blood from the vascular access system to a patient's vascular system. In some instances, the outflow component includes a catheter for returning blood to the patient's vasculature. As used herein, "catheter" is a broad term that includes any blood- carrying conduit that can be at least partially inserted into a blood vessel and advanced therein to a selected location, including into the atrium or elsewhere. In some instances, the outflow component is attached by an end-to-side anastomosis to a vein. In other instances, the outflow component extends into a vein or into the central venous system. In certain embodiments, the outflow component is adapted such that at least a distal end portion thereof can freely float within a vascular segment when the vascular access system is applied to a patient. The inflow component and the outflow component may be made of the same material or different materials.

[0022] FIG. 1 illustrates one embodiment of a vascular access system 50 having a plurality of components assembled together to define a lumen 60. The lumen 60 provides a blood conduit or pathway configured to shunt blood from a first vascular segment to a second vascular segment. The vascular access system 50 has a proximal end 54 and a distal end 58 and a lumen 60 that extends between the proximal end 54 and the distal end 58. In some embodiments, the proximal end 54 is adapted to couple with (e.g., attached to) a first vascular segment, and the distal end 58 can be adapted to be coupled with (e.g., inserted into) a second vascular segment. The lumen 60 preferably extends between the proximal end 54 and the distal end 58. The lumen 60 can also be accessed from outside the patient to facilitate dialysis or other treatment.

[0023] In certain embodiments, as illustrated in FIG. 1, the vascular access system 50 includes a connector 70 adapted to fluidly connect a first conduit 62, such as an inflow component or graft, and a second conduit 66, such as an outflow component or catheter, to form the lumen 60. In certain embodiments, the first conduit 62 extends from the proximal end 54 toward the distal end 58, and the second conduit extends from the distal end 58 toward the proximal end 54. The connector 70 can be positioned between the first conduit 62 and the second conduit 66 such that a distal portion of the first conduit 62 is configured to be connected to a proximal portion of the connector 70, and a proximal portion of the second conduit 66 is configured to be connected to a distal portion of the connector 70. The connector 70 and/or the first conduit 62 and/or the second conduit 66 can be provided and/or integrated with one or more connecting devices to connect or enhance the security of the connection between the first conduit 62 and the second conduit 66. In some instances, the connector 70 is omitted, and the first conduit 62 and the second conduit 66 are integral. That is, the first conduit 62 and the second conduit 66 may be a single piece.

[0024] In certain embodiments, the wall defining the lumen 60 includes a reinforcement member 52. The reinforcement member 52 may comprise a braided structure, a woven structure, an intra-luminal stent-type structure, a coil structure, a laser cut tube structure, a linked reinforcement tube structure, a series of interconnected hard segments, a corrugated tube structure, axial projections, radial projections, axial or radial channels, or the like. The reinforcement member 52 may be any suitable structure. IThe reinforcement member 52 generally is biocompatible. The reinforcement member 52 may be formed of nitinol or another nickel titanium alloy, cobalt chrome, polyether ether ketone (PEEK) or another thermoplastic polymer, a ceramic, silicone, or another suitable material or composite thereof. The reinforcement member 52 may be made of or coated with any suitable biocompatible material. FIG. 1 depicts the reinforcement member 52 partially (in a partial cutaway view) for clarity.

[0025] The reinforcement member 52 can extend to the proximal end 54 and/or toward the distal end 58 of the lumen 60. That is, the first conduit 62, the second conduit 66, or a combination thereof may include the reinforcement member 52. In some instances, the first conduit 62 includes the reinforcement member 52 and the second conduit 66 does not include a reinforcement member, or vice versa. In some instances, the reinforcement member 52 is configured to at least partially resist radial compression of the lumen 60. Also, the reinforcement member 52 can be configured to at least partially provide resistance to kinking of the lumen 60. In this manner, the reinforcement member 52 may ensure that fluid is able to flow through the lumen 60 unobstructed or with minimal obstruction.

[0026] In certain embodiments, the reinforcement member 52 includes a proximal end 56 and a distal end 64. The reinforcement member 52 can extend along the lumen 60 such that the proximal end 56 of the reinforcement member 52 extends to or beyond the proximal end 54 of the lumen 60. Similarly, the reinforcement member 52 can extend along the lumen 60 such that the distal end 64 of the reinforcement member 52 extends to or beyond the distal end 58 of the lumen 60. The reinforcement member 52 may be positioned at any location between or beyond the proximal end 54 of the lumen 60 and/or the distal end 58 of the lumen 60. [0027] The reinforcement member 52 can be disposed, partially or completely, about the circumference of the lumen 60. For example, certain segments of the lumen 60 may be completely surrounded by the reinforcement member 52, while other segments of the lumen 60 may be partially surrounded by the reinforcement member 52. In other instances, certain portions of the lumen 60 may not include the reinforcement member 52.

[0028] FIG. 2 depicts the reinforcement member 52 embedded within the wall defining the lumen 60. In one embodiment, the reinforcement member 52 is embedded in the wall defining the lumen 60 such that an outer surface 68 of the wall defining the lumen 60 surrounds the reinforcement member 52. In some instances, the reinforcement member 52 is disposed radially outward of an inner surface 72 of the wall defining the lumen 60. In this manner, in certain embodiments, the reinforcement member 52 is disposed between the inner surface 72 and the outer surface 68 of the wall defining the lumen 60. In some instances, the reinforcement member 52 is disposed within the wall defining the lumen 60 such that the outer surface 68 and/or the inner surface 72 of the wall defining the lumen 60 are substantially smooth.

[0029] In other instances, as depicted in FIG. 3, the reinforcement member 52 is disposed on or about the outer surface 68 of the wall defining the lumen 60. For example, the reinforcement member 52 may surround, project or protrude from the outer surface 68 of the wall defining the lumen 60. In some instances, the reinforcement member 52 may be coated with a protective layer of material.

[0030] In yet other instances, as depicted in FIG. 4, the reinforcement member 52 is disposed radially inward of the inner surface 72 of the wall defining the lumen 60. For example, the reinforcement member 52 may be positioned about or protrude inward from the inner surface 72 of the wall defining the lumen 60. The reinforcement member 52 may be configured to prevent or substantially minimize kinking, crushing, and/or other phenomena that can cause at least partial collapse of the lumen 60. In this manner, fluid flow within the lumen 60 is unobstructed or at least substantially unobstructed. In some instances, the reinforcement member 52 is coated with a protective layer of material so as to provide a smooth inner surface of the wall(s) defining lumen 60.

[0031] As noted above, in certain embodiments, the reinforcement member 52 is an axial projection. That is, the reinforcement member may be elongated and extend about the lumen 60 and in a direction substantially parallel to the lumen 60. For example, as depicted in FIG 5, the reinforcement member 52 includes one or more axial projections 74 extending from the proximal end 54 of the lumen 60 to the distal end of the lumen 60 or anywhere therebetween. In some instances, the axial projections 74 extend beyond the proximal end 54 of the lumen 60 and/or the distal end 58 of the lumen 60. In other instances, the axial projections 74 are located at any point between the proximal end 54 of the lumen 60 and the distal end 58 of the lumen 60. The axial projections 74 may comprise elongated protrusions, ribs, struts, etc., or the like oriented in and/or on the wall defining the lumen 60, along the length of the lumen 60. In some instances, the axial projections 74 are positioned between the inner surface 72 and the outer surface 68 of the wall defining the lumen 60. In other instances, the axial projections 74 extend radially outward from the outer surface 68 of the wall defining the lumen 60. For example, the axial projections 74 may be extruded from the outer surface 68 of the wall defining the lumen 60. In yet other instances, the axial projections 74 extend radially inward from the inner surface 72 of the wall defining the lumen 60. The axial projections 74 may be spaced apart from one another about the circumference of the lumen 60. Any number of axial projections 74 may be used. In embodiments, a device may have as few as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 12 axial projections, as many as 20, 30, 40, 50, 60, 80, or 100 axial projections, or a number of axial projections within a range of any combination of these numbers.

[0032] In certain embodiments, the axial projections 74 are substantially linear. In other embodiments, the axial projections 74 are curved. For example, the axial projections 74 may form a spiral about the lumen 60. In another example, the axial projections 74 may each be curved in a wave-like configuration about the lumen 60. The axial projections 74 may be any shape or combination of shapes.

[0033] FIG. 6 depicts the reinforcement member 52 comprising a number of radial projections 76. The radial projections 76 may be spaced apart from one another between the proximal end 54 of the lumen 60 to the distal end 58 of the lumen 60. In some instances, the radial projections 76 is transverse to the length of the lumen 60 or located at another angle relative to the lumen 60. The radial projections 76 may be located at any point between the proximal end 54 of the lumen 60 and the distal end of the lumen 60. The radial projections 76 may include circular protrusions, ribs, struts, etc., or the like. Each of the radial projections 76 may be substantially uniform (such as in a single plane) or curved (such as wave-like). In some instances, the radial projections 76 are positioned between the inner surface 72 and outer surface 68 of the wall defining the lumen 60. In other instances, the radial projections 76 extend radially outward from the outer surface 68 of the wall defining the lumen 60. For example, the radial projections 76 may protrude from the outer surface 68 of the wall defining the lumen 60. In yet other instances, the radial projections 76 extend radially inward from the inner surface 72 of the wall defining the lumen 60. The radial projections 76 may be spaced apart from one another along the axial length of the lumen 60. Any number of radial projections 76 may be used. In embodiments, a device may have as few as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 12 radial projections, as many as 20, 30, 40, 50, 60, 80, or 100 radial projections, or a number of radial projections within a range of any combination of these numbers.

[0034] In certain embodiments, as depicted in FIG. 7, the reinforcement member 52 includes a number of interconnected reinforcement structures (such as tubes or the like). For example, the reinforcement member 52 may include a number of interconnected tubes 78 that collectively extend from the proximal end 54 of the lumen 60 to the distal end 58 of the lumen 60. The interconnected tubes 78 may reinforce the wall defining the lumen 60 while enabling, or at least without substantially impeding, the flexibility of the vascular access system. In some instances, the interconnected tubes 78 extend beyond the proximal end 54 of the lumen 60 and/or the distal end 58 of the lumen 60. In other instances, the interconnected tubes 78 are located at any point between the proximal end 54 of the lumen 60 and the distal end 58 of the lumen 60. The cross section of the interconnected tubes 78 may be any shape, including rectangular, circular, triangular, etc., or the like. In some instances, the interconnected tubes 78 are positioned between the inner surface 72 and the outer surface 68 of the wall defining the lumen 60. In other instances, the interconnected tubes 78 are positioned around the outer surface 68 of the wall defining the lumen 60. In yet other instances, the interconnected tubes 78 are positioned radially inward of the inner surface 72 of the wall defining the lumen 60. The interconnected tubes 78 may be connected by any suitable means 79, including pins, universal joints, pivots, inextensible tethers, cables, etc., or the like. Any suitable number of interconnected tubes 78 may be used.

[0035] The reinforcement members 52 also may include interconnected hard segments along a length of the conduit. For example, at least a portion of an end of the interconnected hard segments may overlap adjacent hard segments (similar to the shell of an armadillo).

[0036] The illustrated embodiments of the reinforcement member 52 are but a few of many envisioned. For example, the reinforcement member 52 may be a braided structure, an intraluminal stent-type structure, a coil structure, a laser cut tube structure, a number of axial and/or radial grooves or channels, a series of linked reinforcement tube structures, a series of interconnected hard segments, a corrugated tube structure, one or more axial projections, one or more radial projections, any combination thereof, or the like. The reinforcement member 52 may be any number and/or type of structure. The reinforcement member 52 may be positioned between the inner surface 72 and the outer surface 68 of the wall defining the lumen 60, about the outer surface 68 of the wall defining the lumen 60, about the inner surface 72 of the wall defining the lumen 60, or a combination thereof.

[0037] The configuration of the reinforcement member 52 can be varied along the length and/or the circumference of the lumen 60. For example, one or more different types of reinforcement members 52 may be disposed between or beyond the proximal 54 and distal ends 58 of the lumen 60. In some instances, the flexibility, kink resistance, axial strength, and/or radial strength of the lumen 60 may be varied along the length of the lumen 60 by selectively coupling different reinforcement members 52, such as a braided structure, a cardiac stent-type structure, a coil structure, a laser cut tube structure, a linked reinforcement tube structure, a series of interconnected hard segments, a corrugated tube structure, axial projections, radial projections, no reinforcement structure, or the like. For example, the reinforcement member 52 may be varied or the characteristics of the reinforcement member 52 may be varied (such as, for example, a pic count of a braided structure) along the length and/or the circumference of the lumen 60. In some instances, certain portions of the lumen 60 do not include a reinforcement member 52, or the reinforcement members 52 cover only one or more subsections of the lumen 60.

[0038] In embodiments, it may be particularly advantageous to include a combination of two or more different types and/or regional positions of the reinforcement members. For example, one type of reinforcement member may be positioned about a distal end of the lumen and a second type of reinforcement member may be positioned about the proximal end of the lumen. The type and characteristics of the reinforcement members may vary depending on their location. FIG. 8 depicts the lumen 60 defined by a wall structure that includes three different reinforcement members: a first reinforcement member 80, a second reinforcement member 82, and a third reinforcement member 84. Additional or fewer reinforcement members may be used in other embodiments. In some instances, the first reinforcement member 80, the second reinforcement member 82, and the third reinforcement member 84 are different types of reinforcement members. In other instances, the first reinforcement member 80, the second reinforcement member 82, and the third reinforcement member 84 are the same type of reinforcement member. The various reinforcement members 52 may be positioned in any arrangement about the lumen 60. For example, the various reinforcement members 52 may be spaced apart from one another or positioned adjacent to one another. Moreover, in some instances, at least a portion of the wall defining the lumen 60 includes no reinforcement member. For example, a portion of the lumen 60 between the first reinforcement member 80 and the second reinforcement member 82 has no reinforcement member.

[0039] The first reinforcement member 80, the second reinforcement member 82, and the third reinforcement member 84 may be positioned between the inner surface 72 and outer surface 68 of the wall defining the lumen 60, about the outer surface 68 of the wall defining the lumen 60, about the inner surface 72 of the wall defining the lumen 60, or a combination thereof. In some instances, the first reinforcement member 80, the second reinforcement member 82, and/or the third reinforcement member 84 extend partially (e.g., from 40% to 99%) or completely about the circumference of the lumen 60.

[0040] Combing various types of reinforcement members may enhance ease of use (implant or explant) while particular sections of the conduit are configured to maximize one mechanical property (such as rigidity, flexibility, kink resistant, etc.) over another.

[0041] The foregoing vascular access system can be included within a broader method of applying such a device to a patient. Such a method can involve accessing a vein in the patient into which an outflow component is to be inserted. For example, a jugular vein may be accessed in such a method. The distal end of the outflow component can be positioned distant from the access site, e.g., at any location between the access site to a chamber of the heart.

[0042] The broader method can also include coupling the proximal end of an inflow component with a vascular segment different from the insertion site, which can be a jugular vein. The inflow component can be coupled with a different vascular segment, e.g., a brachial artery, by any suitable technique. One technique involves suturing the proximal end to the artery, for example producing an end-to-side anastomosis. Attachment of the proximal end of the inflow component can be performed through a second incision formed through the skin adjacent to the vascular segment to which the inflow component is to be connected.

[0043] The foregoing devices and variants thereof enable the provision of a vascular access system. The inflow component can be attached by any means to an artery by suturing or otherwise arterialized. In other embodiments, the proximal end of the inflow component can be attached by an expandable member, which can be self- expanding or balloon expandable. A self-expanding version can include a sinusoidal circumferential member adapted to be enlarged to at least the inner size of the artery. This enlargement enables a proximal portion of the inflow conduit to expand toward the inner wall of the artery, e.g., to be pressed into engagement with an internal segment of an artery. Another technique for arterializing the inflow component involves providing a coupling structure, which can be one or more stent-like structures, such as those described for example in U.S. Application Publication No. 2009/0076587, which is incorporated by reference herein in pertinent part. For example, at least a portion of the inflow component, e.g., including at least a portion of the coupling structure, can be deployed within the vessel and the remainder of the inflow component can extend from the vessel to the outflow component.

[0044] In one embodiment, a portion of the outflow component is adapted to be inserted within a vein at an insertion site. The outflow component can have an outside diameter which is less than an inner diameter of the vein and can have at least one opening in an end thereof with at least one of the openings in the catheter section to be disposed distant from the insertion site. For example, an outlet can be within a lumen or a chamber of the heart.

[0045] In operation, blood flows from the artery through the inflow component and is returned to the venous side of the circulatory system through an opening in the outflow component. The system preferably provides laminar blood flow between the artery and the vein. In certain applications, blood flows through the vein uninterrupted around at least an outer portion of the outflow component.

[0046] Access to the system can be provided in any suitable way, such as by providing a needle having a first end coupled to a hemodialysis device and having a second end adapted for insertion directly into the inflow component. Blood may thereby be shunted from the vascular access device to a dialysis device and back to the patient's circulatory system.

[0047] Although disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of and obvious modifications and equivalents thereof. In addition, while several variations have been shown and described in detail, other modifications, which are within the scope of these disclosures, will be readily apparent to those of skill in the art. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the disclosures. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed embodiments. Thus, it is intended that the scope of at least some of the present embodiments herein disclosed should not be limited by the particular disclosed embodiments described above.