Thermal energy application for prevention and management of endoleaks in stent-grafts

• US 9,468,517 B2
• Filed: 02/08/2011
• Issued: 10/18/2016
• Est. Priority Date: 02/08/2010
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US13/577,161
• Publication Number:
  US 20130035751A1
• Time in Patent Office: 2,079 Days
• Field of Search: 623 115- 138
• US Class Current: 1/1
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

Apparatus (10) is provided, which includes an endovascular stent-graft (20) and a heating device (22) that is coupled to the stent-graft (20). The stent-graft (20) is configured to be implanted in at least one blood vessel in a vicinity of an aneurysm (102). The heating device (22) is configured to apply, to a region (24) external to the stent-graft (20), thermal energy sufficient to coagulate blood flowing into the aneurysm (102). Other embodiments are also described.

Claims

1. Apparatus comprising:

an endovascular stent-graft, configured to be implanted in at least one blood vessel in a vicinity of an aneurysm, and shaped so as to define a lumen having an axial length when in a radially-expanded state; and

a heating device, which is coupled to the stent-graft, which is (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, (iii) is configured to apply, to a region external to the stent-graft, thermal energy sufficient to coagulate blood flowing into the aneurysm, and which (iv) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) at least one sensor that is coupled to an external surface of the lumen.

2. The apparatus according to claim 1, wherein the heating device is configured to set a level of the thermal energy to increase an average temperature in the region by between 3 and 7 degrees C.

3. The apparatus according to claim 1, wherein the heating device is configured to increase an average temperature within the lumen by no more than 2 degrees C.

4. The apparatus according to claim 1, wherein the one or more heating elements have respective surfaces that apply the thermal energy, wherein the heating elements are collectively are positioned along a longitudinal portion of the lumen, and wherein a combined total area of the surfaces is between 1% and 10% of an average cross-sectional area of the lumen along the longitudinal portion.

5. The apparatus according to claim 1, wherein the heating device comprises circuitry that is configured to drive the one or more heating elements to apply the thermal energy such that an average energy consumption rate over all five-second periods of heating does not exceed 5 W.

6. The apparatus according to claim 1, wherein the heating device is configured to apply the thermal energy at a maximum energy consumption rate of between 0.5 and 2 W.

14. The apparatus according to claim 1, wherein the stent-graft comprises a stent and a graft coupled to the stent, which stent and graft are generally tubular when the stent-graft is in an radially-expanded state, and wherein the stent comprises a plurality of structural stent elements, and wherein the heating device drives an electrical current through a portion of the structural stent elements in order to apply the thermal energy.

15. The apparatus according to claim 1, wherein the heating device is configured with one or more electrical parameters that are set to coagulate the blood flowing into the aneurysm, the parameters selected from the group consisting of:

timing of the application of the thermal energy, and amplitude of the thermal energy.

30. The apparatus according to claim 1, wherein the one or more heating elements are collectively positioned along no more than 10% of the axial length of the lumen.

31. The apparatus according to claim 30, wherein all of the heating elements are positioned within a distance of an upstream end of the lumen, measured along an axis of the lumen, which distance is no more than 10% of the axial length of the lumen.

7. Apparatus comprising:

an endovascular stent-graft, configured to be implanted in at least one blood vessel in a vicinity of an aneurysm, and shaped so as to define a lumen having an axial length when in a radially-expanded state; and

a heating device, which is coupled to the stent-graft, which is (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, (iii) is configured to apply, to a region external to the stent-graft, thermal energy sufficient to coagulate blood flowing into the aneurysm, and which (iv) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) a temperature sensor, and circuitry which is configured to monitor at least a temperature of blood external to the lumen using the temperature sensor, and to drive the one or more heating elements to apply the thermal energy responsively to the at least one monitored temperature.

8. The apparatus according to claim 7, wherein the circuitry is configured to maintain the temperature of the blood external to the lumen at between a minimum and a maximum temperature, the minimum temperature between 39 and 41 degrees C., and the maximum temperature between 41 and 45 degrees C.

12. The apparatus according to claim 7, wherein the temperature sensor is coupled to an external surface of the lumen.

9. Apparatus comprising:

an endovascular stent-graft, configured to be implanted in at least one blood vessel in a vicinity of an aneurysm, and shaped so as to define a lumen having an axial length when in a radially-expanded state; and

a heating device, which is coupled to the stent-graft, which is (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, (iii) is configured to apply, to a region external to the stent-graft, thermal energy sufficient to coagulate blood flowing into the aneurysm, and which (iv) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) a temperature sensor and circuitry which is configured to;

monitor, using the temperature sensor, at least one temperature selected from the group consisting of;

a temperature of blood flowing within the lumen, and a temperature of blood external to the lumen,

drive the one or more heating elements to apply the thermal energy responsively to the at least one monitored temperature, and

set at least one heating parameter responsively to the at least one temperature, so as to selectively coagulate the blood flowing into the aneurysm without causing substantial coagulation of the blood flowing within the lumen.

10. Apparatus comprising:

an endovascular stent-graft, configured to be implanted in at least one blood vessel in a vicinity of an aneurysm, and shaped so as to define a lumen having an axial length when in a radially-expanded state; and

a heating device, which is coupled to the stent-graft, which is (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, (iii) which is configured to apply, to a region external to the stent-graft, thermal energy sufficient to coagulate blood flowing into the aneurysm, and which (iv) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) a blood flow sensor, and circuitry which is configured to monitor at least one blood flow parameter of blood external to the lumen using the blood flow sensor, and to drive the one or more heating elements to apply the thermal energy responsively to the at least one monitored blood flow parameter.

11. Apparatus comprising:

an endovascular stent-graft, configured to be implanted in at least one blood vessel in a vicinity of an aneurysm, and shaped so as to define a lumen having an axial length when in a radially-expanded state; and

a heating device, which is coupled to the stent-graft, which is (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, (iii) which is configured to apply, to a region external to the stent-graft, thermal energy sufficient to coagulate blood flowing into the aneurysm, and which (iv) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) a blood flow sensor, and circuitry which is configured to;

monitor, using the blood flow sensor, at least one blood flow parameter selected from the group consisting of;

a blood flow parameter of blood flowing within the lumen, and a blood flow parameter of blood external to the lumen, and

set at least one heating parameter responsively to the at least one monitored blood flow parameter, so as to selectively coagulate the blood flowing into the aneurysm without causing substantial coagulation of the blood flowing within the lumen.

13. Apparatus comprising:

an endovascular stent-graft, configured to be implanted in at least one blood vessel in a vicinity of an aneurysm, and shaped so as to define a lumen having an axial length when in a radially-expanded state; and

a heating device, which is coupled to the stent-graft, which is (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, (iii) which is configured to apply, to a region external to the stent-graft, thermal energy sufficient to coagulate blood flowing into the aneurysm, and which (iv) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) at least one sensor positioned in a vicinity of an upstream end of the lumen.

16. A method comprising:

identifying that a patient has an aneurysm; and

in response to the identifying, activating an implanted heating device to apply, to a region external to an endovascular stent-graft implanted in at least one blood vessel of the patient in a vicinity of the aneurysm, which region is upstream of the aneurysm, thermal energy sufficient to coagulate blood flowing into the aneurysm,

wherein the endovascular stent-graft is shaped so as to define a lumen having an axial length when in a radially-expanded state, and wherein the heating device is coupled to the stent-graft, and (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, and (iii) comprises (a) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (b) at least one sensor that is coupled to an external surface of the lumen.

17. The method according to claim 16, wherein identifying comprises ascertaining that the patient is at risk of suffering from a type I endoleak, and wherein activating comprises activating the heating device to apply the thermal energy to coagulate the blood so as to reduce or prevent the type I endoleak.

18. The method according to claim 16, wherein identifying comprises ascertaining that the patient suffers from a type I endoleak, and wherein activating comprises activating the heating device to apply the thermal energy to coagulate the blood so as to treat the type I endoleak.

22. The method according to claim 16, wherein activating comprises activating the heating device to apply the thermal energy at a level that selectively coagulates the blood flowing into the aneurysm without causing substantial coagulation of blood flowing within the lumen.

23. The method according to claim 16, wherein activating comprises activating the heating device to increase an average temperature within the lumen by no more than 2 degrees C.

24. The method according to claim 16, wherein the aneurysm is selected from the group consisting of:

an abdominal aortic aneurysm and an iliac artery aneurysm, and wherein activating comprises activating the heating device to apply the thermal energy sufficient to coagulate the blood flowing into the selected aneurysm.

25. The method according to claim 16, activating comprises activating the heating device to monitor at least one blood flow parameter of blood external to the lumen, and to apply the thermal energy responsively to the at least one monitored blood flow parameter.

26. The method according to claim 16, wherein activating comprises:

activating the heating device to monitor at least one blood flow parameter selected from the group consisting of;

a blood flow parameter of blood flowing within the lumen, and a blood flow parameter of blood external to the lumen; and

activating the heating device to set at least one heating parameter responsively to the at least one monitored blood flow parameter, so as to selectively coagulate the blood flowing into the aneurysm without causing substantial coagulation of the blood flowing within the lumen.

27. The method according to claim 16, wherein activating comprises activating the heating device to monitor at least a temperature of blood external to the lumen, and to apply the thermal energy responsively to the at least one monitored temperature.

28. The method according to claim 16, wherein activating comprises:

activating the heating device to monitor at least one temperature selected from the group consisting of;

a temperature of blood flowing within the lumen, and a temperature of blood external to the lumen; and

activating the heating device to set at least one heating parameter responsively to the at least one monitored temperature, so as to selectively coagulate the blood flowing into the aneurysm without causing substantial coagulation of the blood flowing within the lumen.

29. The method according to claim 16, wherein the method further comprises monitoring at least one blood flow parameter from an extracorporeal location, and wherein activating comprises activating the heating device to apply the thermal energy responsively to the at least one monitored blood flow parameter.

32. The method according to claim 16, wherein all of the heating elements are positioned within a distance of an upstream end of the lumen, measured along an axis of the lumen, which distance is no more than 10% of the axial length of the lumen, and wherein activating an implanted heating device comprises activating the heating elements to apply the thermal energy to the region upstream of the aneurysm.

43. The method according to claim 16, wherein the one or more heating elements are collectively positioned along no more than 10% of the axial length of the lumen.

19. A method comprising:

implanting, in at least one blood vessel of a patient in a vicinity of an aneurysm, (a) an endovascular stent-graft, which is shaped so as to define a lumen having an axial length when in a radially-expanded state, (b) and a heating device that is coupled to the stent-graft and (i) is incorporated into the stent-graft during manufacture of the stent-graft, (ii) is configured to assume a radially-compressed state with the stent-graft, and (iii) comprises (i) one or more heating elements that collectively are positioned along no more than 20% of the axial length of the lumen, and (ii) at least one sensor that is coupled to an external surface of the lumen; and

activating the heating device to apply, to a region external to the stent-graft and upstream of the aneurysm, thermal energy sufficient to coagulate blood flowing into the aneurysm.

20. The method according to claim 19, wherein activating comprises:

ascertaining that the patient has is at risk of suffering from a type I endoleak; and

activating the heating device to apply the thermal energy to coagulate the blood so as to reduce or prevent the type I endoleak.

21. The method according to claim 19, wherein activating comprises:

ascertaining that the patient suffers from a type I endoleak; and

activating the heating device to apply the thermal energy to coagulate the blood so as to treat the type I endoleak.

33. The method according to claim 19, wherein the stent-graft is shaped so as to define at least one lumen when in a radially-expanded state, and wherein activating comprises activating the heating device to apply the thermal energy at a level that selectively coagulates the blood flowing into the aneurysm without causing substantial coagulation of blood flowing within the lumen.

34. The method according to claim 19, wherein activating comprises activating the heating device to increase an average temperature within the lumen by no more than 2 degrees C.

35. The method according to claim 19, wherein the aneurysm is selected from the group consisting of:

an abdominal aortic aneurysm and an iliac artery aneurysm, and wherein activating comprises activating the heating device to apply the thermal energy sufficient to coagulate the blood flowing into the selected aneurysm.

36. The method according to claim 19, wherein activating comprises activating the heating device to monitor at least one blood flow parameter of blood external to the lumen, and to apply the thermal energy responsively to the at least one monitored blood flow parameter.

37. The method according to claim 19, wherein activating comprises:

activating the heating device to monitor at least one blood flow parameter selected from the group consisting of;

a blood flow parameter of blood flowing within the lumen, and a blood flow parameter of blood external to the lumen; and

activating the heating device to set at least one heating parameter responsively to the at least one monitored blood flow parameter, so as to selectively coagulate the blood flowing into the aneurysm without causing substantial coagulation of the blood flowing within the lumen.

38. The method according to claim 19, wherein activating comprises activating the heating device to monitor at least a temperature of blood external to the lumen, and to apply the thermal energy responsively to the at least one monitored temperature.

39. The method according to claim 19, wherein activating comprises:

activating the heating device to monitor at least one temperature selected from the group consisting of;

a temperature of blood flowing within the lumen, and a temperature of blood external to the lumen; and

activating the heating device to set at least one heating parameter responsively to the at least one monitored temperature, so as to selectively coagulate the blood flowing into the aneurysm without causing substantial coagulation of the blood flowing within the lumen.

40. The method according to claim 19, wherein the method further comprises monitoring at least one blood flow parameter from an extracorporeal location, and wherein activating comprises activating the heating device to apply the thermal energy responsively to the at least one monitored blood flow parameter.

41. The method according to claim 19, wherein all of the heating elements are positioned within a distance of an upstream end of the lumen, measured along an axis of the lumen, which distance is no more than 10% of the axial length of the lumen, and wherein activating an implanted heating device comprises activating the heating elements to apply the thermal energy to the region upstream of the aneurysm.

42. The method according to claim 19, wherein the one or more heating elements are collectively positioned along no more than 10% of the axial length of the lumen.