Method and apparatus for measuring flow through a lumen

• US 9,427,305 B2
• Filed: 01/24/2014
• Issued: 08/30/2016
• Est. Priority Date: 01/24/2013
• Status: Active Grant

• Current Assignee: ALIO Incorporated
• Original Assignee: Graftworx, LLC
• Inventors: Kuraguntla, David John, Gupta, Samit Kumar, Rushenberg, Robert Lawrence
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/163,991
• Publication Number:
  US 20140214149A1
• Time in Patent Office: 949 Days
• Field of Search: 623/1.13, 623/1.15, 623/1.34, 600/347, 600/486, 600/488, 600/505
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

A prosthesis for monitoring a characteristic of flow includes a first tubular prosthesis having a lumen and a sensor for detecting the characteristic of flow through the lumen. The sensor may be covered with another tubular prosthesis or by a layer of material in order to insulate the sensor from the fluid flow. A pocket may be formed between the tubular prosthesis and the adjacent layer of material or prosthesis and the sensor may be disposed in the pocket.

Claims

1. A prosthesis for monitoring a characteristic of flow, said prosthesis comprising:

a first tubular prosthesis having proximal and distal ends; and

a lumen extending therebetween;

a second tubular prosthesis having a lumen extending therethrough,

a non-optical sensor for detecting a characteristic of fluid flowing through the lumen of the first tubular prosthesis; and

a layer of material provided over the sensor, sealingly coupling the sensor to a surface of the first tubular prosthesis without embedding the sensor within the first tubular prosthesis, wherein the sensor is insulated from contact with fluid flowing through the lumen;

wherein the second tubular prosthesis is coaxially mounted to the first tubular prosthesis such that the non-optical sensor is not interposed between the first and second tubular prosthesis.

2. The prosthesis of claim 1, wherein the second tubular prosthesis is a stent.

3. The prosthesis of claim 1, wherein the first tubular prosthesis is fixedly attached to the second tubular prosthesis.

4. The prosthesis of claim 1, wherein the first tubular prosthesis is integral with the second tubular prosthesis.

5. The prosthesis of claim 1, wherein the first tubular prosthesis is sintered to the second tubular prosthesis.

6. The prosthesis of claim 1, wherein the first tubular prosthesis is sutured to the second tubular prosthesis.

7. The prosthesis of claim 1, wherein the first tubular prosthesis has a first length and the second tubular prosthesis has a second length substantially the same as the first length.

8. The prosthesis of claim 1, wherein the first tubular prosthesis has a first length and the second tubular prosthesis has a second length shorter than the first length.

9. The prosthesis of claim 1, wherein the first tubular prosthesis has a first length and the second tubular prosthesis has a second length longer than the first length.

10. The prosthesis of claim 1, wherein the first tubular prosthesis is discrete from the second tubular prosthesis.

11. The prosthesis of claim 1, wherein the sensor is disposed circumferentially around the first and/or the second tubular prosthesis.

12. The prosthesis of claim 11, wherein the first or the second tubular prosthesis has a longitudinal axis, and wherein the sensor is orthogonal to the longitudinal axis.

13. The prosthesis of claim 1, wherein the sensor comprises a plurality of sensors disposed circumferentially around the first and/or the second tubular prosthesis.

14. The prosthesis of claim 1, wherein the sensor comprises a plurality of discrete sensors circumferentially disposed around the first and/or the second tubular prosthesis, and wherein the plurality of discrete sensors are disposed in a common plane.

15. The prosthesis of claim 1, wherein the sensor comprises a plurality of discrete sensors disposed axially along the first and/or the second tubular prosthesis.

16. The prosthesis of claim 15, wherein the plurality of discrete sensors are disposed substantially parallel to a longitudinal axis of the first and/or the second tubular prosthesis.

17. The prosthesis of claim 1, wherein the sensor comprises first and second annular bands circumferentially disposed around the first and/or the second tubular prosthesis, and wherein the first annular band is axially separated from the second annular band.

18. The prosthesis of claim 17, wherein the first or the second annular band forms a closed loop.

19. The prosthesis of claim 1, wherein the sensor comprises a plurality of elongated sensors, the plurality of elongated sensors axially oriented along the first and/or the second tubular prosthesis.

20. The prosthesis of claim 1, wherein the first tubular prosthesis is a tubular prosthetic vascular graft.

21. The prosthesis of claim 1, wherein the fluid is blood and the fluid flowing through the lumen is blood flow through the prosthesis.

22. The prosthesis of claim 1, wherein the first tubular prosthesis is formed primarily from polyethylene terephthalate, polyester or ePTFE.

23. The prosthesis of claim 1, wherein the first tubular prosthesis is a stent-graft.

24. The prosthesis of claim 1, wherein the sensor comprises a piezoelectric sensor or a doppler sensor.

25. The prosthesis of claim 1, wherein the sensor detects thermal properties of the fluid flow, stress, strain, or pressure exerted on the first tubular prosthesis by the fluid flow.

26. The prosthesis of claim 1, wherein the characteristic sensed by the sensor comprises velocity or flow rate of the fluid flow, or occlusion, degree of occlusion, stenosis, or degree of stenosis.

27. The prosthesis of claim 26, wherein the velocity is determined indirectly from the sensed characteristic.

28. The prosthesis of claim 26, wherein the velocity is determined directly from the sensed characteristic.

29. The prosthesis of claim 1, wherein the sensor is configured to capture a plurality of characteristics of the fluid flow in the lumen of the first tubular prosthesis.

30. The prosthesis of claim 1, wherein the sensor comprises a plurality of sensors disposed on the first tubular prosthesis.

31. The prosthesis of claim 30, wherein the plurality of sensors comprise a first sensor and a second sensor, wherein the first sensor is configured to capture a first characteristic of the fluid flow in the lumen of the first tubular prosthesis, and wherein the second sensor is configured to capture a second characteristic of the fluid flow in the lumen of the first tubular prosthesis.

32. The prosthesis of claim 31, wherein the first characteristic is different than the second characteristic.

33. The prosthesis of claim 31, wherein the first characteristic and the second characteristics are portions of a single signal.

34. The prosthesis of claim 31, wherein the first sensor is disposed in a first orientation relative to the first tubular prosthesis, and wherein the second sensor is disposed in a second orientation relative to the first tubular prosthesis, and wherein the first orientation is different than the second orientation.

35. The prosthesis of claim 30, wherein the plurality of sensors are helically disposed around the first tubular prosthesis.

36. The prosthesis of claim 1, wherein the first tubular prosthesis has a longitudinal axis, and wherein the sensor is disposed substantially parallel to the longitudinal axis.

37. The prosthesis of claim 1, wherein the first tubular prosthesis has a longitudinal axis, and wherein the sensor is disposed transverse to the longitudinal axis.

38. The prosthesis of claim 1, wherein the sensor comprises a plurality of undulating elongated elements disposed over the first tubular prosthesis.

39. The prosthesis of claim 38, wherein the sensor has a collapsed configuration sized for delivery of the sensor and an expanded configuration adapted to substantially match an anatomy in which the sensor is deployed, and wherein in the expanded configuration the sensor forms a closed annular band.

40. The prosthesis of claim 1, wherein the sensor is disposed circumferentially around the first tubular prosthesis to form a closed annular band therearound.

41. The prosthesis of claim 1, wherein the sensor is partially disposed circumferentially around the first tubular prosthesis to form an open annular band therearound.