Devices and methods for assisting valve function, replacing venous valves, and predicting valve treatment success

• US 10,238,483 B2
• Filed: 07/02/2012
• Issued: 03/26/2019
• Est. Priority Date: 09/16/2011
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): Ou, Jing
• Application Number:
  US13/539,607
• Publication Number:
  US 20130073025A1
• Time in Patent Office: 2,458 Days
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

Devices and methods for assisting valve function, replacing venous valves, and predicting valve treatment successes. In at least one embodiment of an endograft valve device of the present disclosure, the device comprises an endograft body configured for expansion from a collapsed configuration to an expanded configuration within a luminal organ and comprising a first portion having a proximal end defining a proximal end aperture and a distal end defining a distal end aperture, the first portion tapering toward the distal end so that the distal end aperture has a relatively smaller cross-sectional area than the proximal end aperture when the valve device is expanded, and a valve portion positioned at or near the distal end of the first portion, the valve portion configured to receive fluid flowing through the distal end aperture of the first portion.

Claims

1. A system, including an endograft valve device, comprising:

an endograft body configured for expansion from a collapsed configuration to an expanded configuration within a luminal organ, the endograft body comprising a length and an outer portion for contacting the luminal organ along the length of the endograft body when the endograft body is in the expanded configuration and an inner portion positioned within the outer portion, wherein the outer portion defines an outer portion wall surface and wherein the inner portion defines an inner portion wall surface and wherein a tapered wall thickness is defined between the inner and outer portion wall surfaces, and wherein the inner portion wall surface further defines a lumen therethrough, the inner portion comprising;

a first portion having a proximal end defining a proximal end aperture and a distal end defining a distal end aperture, the first portion tapering toward the distal end so that the distal end aperture has a relatively smaller cross-sectional area than the proximal end aperture when the valve device is expanded, and wherein the first portion has a tapered wall thickness that has a greater wall thickness at the distal end than at the proximal end;

a second portion further defining the lumen therethrough and extending between a second portion proximal end and a second portion distal end, the second portion proximal end having a cross-sectional area and defining a second portion proximal end aperture in fluid communication with the distal end aperture of the first portion, the second portion distal end defining a second portion distal end aperture, and the lumen tapering toward the second portion distal end in the second portion so that the second portion distal end aperture has a relatively smaller cross-sectional area than the second portion proximal end aperture when the endograft body is expanded and configured such that fluid received therein through the second portion proximal end aperture and flowing therethrough increases in velocity between the second portion proximal end and the second portion distal end, and wherein the second portion has a tapered wall thickness that has a greater wall thickness at the second portion distal end than at the second portion proximal end, and wherein the distal end of the first portion is adjacent to the second portion proximal end and the cross-sectional area of the second portion proximal end is greater than the cross-sectional area of the second portion proximal end aperture; and

a valve portion positioned at or near the distal end of the first portion and at or near the second portion proximal end, the valve portion configured to receive fluid flowing through the distal end aperture of the first portion.

2. The system of claim 1, wherein the collapsed configuration is sized so that the endograft body fits within the luminal organ, and wherein the expanded configuration is sized so that the endograft body is securely positioned within the luminal organ upon expansion.

3. The system of claim 1, wherein the valve portion is coupled to a portion of the endograft body selected from the group consisting of the first portion at or near the distal end of the first portion and the second portion at or near the second portion proximal end, and wherein the valve portion comprises one or more leaflets.

4. The system of claim 1, wherein the endograft body is sized and shaped to fit around a body selected from the group consisting of a guidewire, a catheter, and a balloon catheter configured to expand the endograft body due to balloon inflation, and wherein when the endograft body is expanded within the luminal organ, the inner portion of the endograft body is configured to permit fluid to flow therethrough.

5. The system of claim 1, wherein when the endograft body is expanded within the luminal organ, fluid flowing through the first portion increases in velocity as the fluid approaches the valve portion and increases shear stresses at the valve portion.

6. The system of claim 1, further comprising:

an anti-clotting agent positioned upon at least a portion of the endograft valve device, wherein the anti-clotting agent is positioned upon at least the inner portion or the outer portion of the endograft valve device, and wherein the anti-clotting agent is selected from the group consisting of heparin, thrombomodulin, and/or endothelial cell protein C.

7. The system of claim 1, wherein the endograft body is comprised of a biologically-compatible material selected from the group consisting of polytetrafluoroethylene, Gore-Tex®

, a nickel titanium alloy, and/or nitinol.

8. The system of claim 1, further comprising:

a guidewire; and

a catheter;

wherein the catheter is configured to fit around the guidewire, and wherein the endograft valve device is configured to fit around the catheter.

9. The system of claim 1, wherein the endograft valve device comprises a venous endograft valve device configured to fit within a vein.

10. The system of claim 1, further comprising:

a cuff configured to fit around a blood vessel and further configured to periodically compress the blood vessel; and

a processor operably coupled to the cuff, the processor configured to control a compression rate and a relaxation rate;

wherein when the cuff is positioned around the blood vessel at a first location, operation of the processor causes the cuff to compress the blood vessel and relax compression of the blood vessel, whereby relaxation at the relaxation rate causes blood to move through the blood vessel at the first location.

11. The system of claim 10, wherein the compression rate is slower than the relaxation rate, wherein the processor is configured so that the compression rate and the relaxation rate can be changed to a different compression rate and a different relaxation rate, and wherein when the cuff is positioned around the blood vessel at a first location, the blood flows through the blood vessel at the first location a first rate or rate range without operation of the cuff, and the blood flows through the blood vessel at the first location at a second rate or rate range during operation of the cuff, wherein the second rate or rate range is faster than the first rate or rate range.

12. The system of claim 10, further comprising:

a power source operably coupled to the cuff either directly or indirectly using a connector, the power source configured to provide power to the cuff and/or the processor to facilitate compression and relaxation of the cuff.

13. The system of claim 10, wherein when the cuff is positioned distal to a blood vessel valve selected from the group consisting of a native valve and a prosthetic valve, operation of the cuff causes blood to flow through the vessel valve toward the cuff.

14. The system of claim 10, wherein relaxation of compression causes the blood to flow through the blood vessel at a faster rate than a native blood flow rate, and wherein the processor is configured to cause the cuff to alternatively compress the blood vessel at a first rate and to relax compression of the blood vessel at a second rate, wherein the second rate is faster than the first rate.