DEVICES AND METHODS FOR ASSISTING VALVE FUNCTION, REPLACING VENOUS VALVES, AND PREDICTING VALVE TREATMENT SUCCESS

• US 20130073025A1
• Filed: 07/02/2012
• Published: 03/21/2013
• Est. Priority Date: 09/16/2011
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Granted Patent: US 10,238,483 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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. 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 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.

2. The endograft valve device of claim 1, further comprising:

a second portion having a second portion proximal end defining a second portion proximal end aperture and a second portion distal end defining a second portion distal end aperture, the second portion tapering toward the second portion distal end so that the second portion distal end aperture has a relatively smaller cross-sectional area than the second portion proximal end aperture when the valve device is expanded, wherein the distal end of the first portion is adjacent to the second portion proximal end, and wherein the valve portion is positioned at or near the second portion proximal end.

3. The endograft valve device of claim 1, wherein the collapsed configuration is sized so that the endograft body may fit within the luminal organ, and wherein the expanded configuration is sized so that the endograft body may be securely positioned within the luminal organ upon expansion.

4. The endograft valve device 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.

5. The endograft valve device 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, an outer portion of the endograft body contacts the luminal organ, and wherein an inner portion of the endograft body is configured to permit fluid to flow therethrough.

6. The endograft valve device of claim 5, wherein the outer portion defines an outer portion selected from the group consisting of an outer portion wall and an outer portion relative surface, and wherein the inner portion is selected from the group consisting of an inner portion wall and an inner portion relative surface.

7. The endograft valve device 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.

8. The endograft valve device 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 an inner portion or an 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.

9. The endograft valve device of claim 1, wherein the endograft body is comprises of a biologically-compatible material selected from the group consisting of polytetrafluoroethylene, Gore-Tex®

, a nickel titanium alloy, and/or nitinol.

10. The endograft valve device 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.

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

12. A method of preparing a digital model of a vein, the method comprising the steps of:

obtaining data indicative to a patient'"'"'s venous geometry at a first location within the patient;

obtaining data indicative of a flow velocity of blood within a vein of the patient at or near the first location;

preparing at least one digital model of the vein of the patient using the data indicative to the patient'"'"'s venous geometry and/or the data indicative of the flow velocity to obtain patient venous data; and

using the patient venous data for at least one test purpose, the at least one test purpose selected from the group consisting of i) determining whether the patient is suitable for a valve procedure based at least in part on the patient venous data and ii) testing one or more virtual valve device configurations in at least one simulation using the digital model.

13. The method of claim 12, wherein the steps of obtaining data are performed using a device selected from the group consisting of a duplex ultrasound device, an impedance wire, and impedance catheter, an impedance device comprising a device body and at least four electrodes positioned thereon, the at least four electrodes comprising two electrodes configured to excite an electric field and two electrodes configured to obtain a conductance measurement within the electric field.

14. The method of claim 12, wherein the step of using the patient venous data is performed by using the patient venous data for the at least one test purpose of determining whether the patient is suitable for the valve procedure based at least in part on the patient venous data, and wherein the method further comprises the step of:

incorporating data indicative of at least one valve into the digital model;

wherein the determination of whether the patient is suitable for the valve procedure based at least in part on information selected from the group consisting of i) the patient venous data and the data indicative of at least one valve, and ii) patient venous data indicative of flow and shear stress, and wherein an ultimate determination is based upon a comparison of the patient venous data indicative of flow and shear stress to at least one threshold.

15. The method of claim 12, wherein the step of using the patient venous data is performed by using the patient venous data for the at least one test purpose of testing one or more virtual valve device configurations in at least one simulation using the digital model, and wherein the method further comprises the steps of:

adjusting the one or more virtual valve device configurations and retesting the adjusted one or more virtual valve device configurations; and

preparing a physical valve device based upon at least one of the adjusted one or more virtual valve device configurations.

16. An external assist device, 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 device 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.

17. The device of claim 16, 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 device 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 device, and the blood flows through the blood vessel at the first location at a second rate or rate range during operation of the device, wherein the second rate or rate range is faster than the first rate or rate range.

18. The device of claim 16, 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.

19. The device of claim 16, wherein when the device is positioned distal to a blood vessel valve selected from the group consisting of a native valve and a prosthetic valve, operation of the device causes blood to flow through the vessel valve toward the device.

20. The device of claim 16, 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.