Method and apparatus for measuring flow through a lumen

• US 10,542,931 B2
• Filed: 07/26/2016
• Issued: 01/28/2020
• Est. Priority Date: 01/24/2013
• Status: Active Grant

• Current Assignee: ALIO Incorporated
• Original Assignee: GraftWorx, Inc.
• Inventors: Kuraguntla, David John, Gupta, Samit Kumar, Rushenberg, Robert Lawrence
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/220,222
• Publication Number:
  US 20160331312A1
• Time in Patent Office: 1,281 Days
• Field of Search: 600505, 600347, 600454, 600486, 600488, 623 115, 623 113, 623 134
• 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 method for monitoring flow through a prosthesis, said method comprising:

providing a first tubular prosthesis having a first lumen therethrough and a first sensor coupled to and helically disposed around the first tubular prosthesis and a second tubular prosthesis having a second sensor helically disposed there around, said second tubular prosthesis coaxially mounted to the first tubular prosthesis such that the first sensor does not intersect the second sensor, wherein the first and second sensors sense one of stress exerted on the prosthesis or strain exerted on the prosthesis, and outputting data related to the sensed stress or strain;

coupling the prosthesis to a fluid path in a patient so that fluid flows through the prosthesis;

determining occlusion by directly measuring, with the sensor, one of stress or strain exerted on the prosthesis;

transmitting data representative of the measured stress or strain to a receiver disposed extracorporeally relative to the patient; and

outputting the data.

2. The method of claim 1, wherein the prosthesis is a prosthetic vascular graft.

3. The method of claim 1, wherein the prosthesis is a stent or a stent-graft.

4. The method of claim 1, wherein the fluid path comprises a blood flow path.

5. The method of claim 1, wherein transmitting the data comprises wirelessly transmitting the data.

6. The method of claim 1, further comprising:

reviewing the sensed data;

determining whether flow through the prosthesis is adequate based on the sensed data; and

performing a blockage clearing procedure on the prosthesis if the flow is inadequate.

7. The method of claim 6, wherein the blockage clearing procedure comprises an angioplasty, atherectomy or administration of a thrombolytic agent.

8. The method of claim 1, further comprising indicating the necessity of additional diagnostic testing of the prosthesis.

9. The method of claim 1, wherein the data comprises an acoustic signal.

10. The method of claim 1, further comprising pairing the prosthesis with an external device.

11. The method of claim 1, wherein the step of coupling the prosthesis to a fluid path comprises forming an anastomosis between a proximal end or a distal end of the prosthesis and the fluid path.

12. The method of claim 1, wherein the step of coupling the prosthesis to a fluid path positioning the prosthesis between a native vessel and another graft or a second native vessel.

13. The method of claim 1, wherein the step of coupling the prosthesis to a fluid path positioning the prosthesis between ends of a native vessel.

14. The method of claim 1, wherein the step of coupling the prosthesis to a fluid path coupling an end of the prosthesis to a side of a native vessel or native conduit.

15. The method of claim 1, wherein the step of coupling the prosthesis to a fluid path slidably engaging the prosthesis over a native vessel or another prosthesis.

16. The method of claim 1, wherein the fluid flow is blood flow.

17. The method of claim 1, wherein the fluid flow is urine flow, cerebrospinal fluid flow or other non-blood flow.

18. The method of claim 1, wherein the step of outputting the data comprises sending the data to a bedside monitor coupled to the Internet.

19. The method of claim 1, further comprising a step of interrogating the prosthesis using an enabled device.

20. The method of claim 19, wherein the enabled device comprises a pacemaker, an implantable device, bedside monitor, a glucose meter, a blood pressure meter, a smart phone, a smart watch, or an Internet connected device.

21. The method of claim 1, further comprising inductively providing power to the prosthesis.

22. A method for monitoring flow through a prosthesis, said method comprising:

providing a tubular prosthesis having a lumen therethrough and a longitudinal axis parallel to the lumen, a sensor operatively coupled with the prosthesis, the sensor directly measuring one of stress exerted on the prosthesis or strain exerted on the prosthesis, and outputting data related to the measured stress or strain, wherein the sensor comprises a first sensor oriented in a direction parallel to the longitudinal axis and a second sensor oriented in a direction orthogonal to the longitudinal axis;

coupling the prosthesis to a fluid path in a patient so that fluid flows through the prosthesis;

determining occlusion by directly measuring with the sensor one of stress or strain exerted on the prosthesis;

transmitting data representative of the measured stress or strain to a receiver disposed extracorporeally relative to the patient; and

outputting the data.

23. The method of claim 22, further comprising:

reviewing the sensed data;

determining whether flow through the prosthesis is adequate based on the sensed data; and

performing a blockage clearing procedure on the prosthesis if the flow is inadequate.

24. The method of claim 23, wherein the blockage clearing procedure comprises an angioplasty, atherectomy or administration of a thrombolytic agent.

25. The method of claim 22, wherein the step of coupling the prosthesis to a fluid path comprises forming an anastomosis between a proximal end or a distal end of the prosthesis and the fluid path.

26. The method of claim 22, wherein the step of coupling the prosthesis to a fluid path comprises positioning the prosthesis between a native vessel and another graft or a second native vessel.

27. The method of claim 22, wherein the step of coupling the prosthesis to a fluid path comprises positioning the prosthesis between ends of a native vessel.

28. The method of claim 22, wherein the step of coupling the prosthesis to a fluid path comprises coupling an end of the prosthesis to a side of a native vessel or native conduit.

29. The method of claim 22, wherein the step of coupling the prosthesis to a fluid path comprises slidably engaging the prosthesis over a native vessel or another prosthesis.

30. The method of claim 22, further comprising an enabled device, the enabled device interrogating the prosthesis.

31. The method of claim 30, wherein the enabled device comprises a pacemaker, an implantable device, bedside monitor, a glucose meter, a blood pressure meter, a smart phone, a smart watch, or an Internet connected device.

32. The method of claim 22, further comprising inductively providing power to the prosthesis.