Systems and methods for deploying a biosensor in conjunction with a prosthesis

• US 6,416,474 B1
• Filed: 03/10/2000
• Issued: 07/09/2002
• Est. Priority Date: 03/10/2000
• Status: Expired due to Term

• Current Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Original Assignee: Ramon Medical Technologies Limited
• Inventors: Penner, Avi, Wolinsky, Lone
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/522,370
• Time in Patent Office: 851 Days
• Field of Search: 600/309, 600/325, 600/327, 600/332, 600/337, 600/339, 600/341-342, 600/360, 600/372, 600/373, 600/420-424, 600/431-435, 600/462, 600/466-470, 600/478, 600/505, 600/581, 600/485, 623/1--, 606/108, 604/96.01, 604/103.02
• US Class Current: 600/309
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02014 Determining aneurysm
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

A biosensor for monitoring pressure or other physical parameters at an aneurysm site is mountable to a tubular prosthesis that is expandable between contracted and enlarged conditions. A loop, having the biosensor attached thereto, is securable around the prosthesis. An apparatus is used to deliver the loop to an aneurysm site that includes a catheter having a connector on its distal end for detachably securing the loop thereto. The prosthesis is advanced in a contracted state to the aneurysm, and the apparatus, with the loop connected thereto, is advanced to the aneurysm site. The loop and the prosthesis are positioned coaxially with respect to one another, and the prosthesis is expanded towards its enlarged condition, thereby engaging the loop around the prosthesis and engaging the prosthesis with a wall of the blood vessel at the treatment site.

Claims

1. A method for implanting a biosensor at a treatment site within a body lumen of a patient, comprising:

advancing a tubular prosthesis in a contracted state within the body lumen to the treatment site;

advancing a substantially enclosed loop to the treatment site, the loop including a biosensor attached thereto;

positioning the loop and the prosthesis coaxially with respect to one another at the treatment site; and

expanding the prosthesis towards an enlarged condition, thereby substantially engaging the loop around the prosthesis and substantially engaging the prosthesis with a wall of the blood vessel at the treatment site.

2. The method of claim 1, wherein the loop is advanced to the treatment site within a lumen of a delivery apparatus, the loop being detachably secured to the delivery apparatus.

3. The method of claim 2, further comprising deploying the loop from the delivery apparatus before positioning the loop around the prosthesis.

4. The method of claim 3, further comprising releasing the loop from the delivery apparatus after positioning the loop around the prosthesis.

5. The method of claim 4, wherein the loop is released from the delivery device after the prosthesis is expanded towards its enlarged condition.

6. The method of claim 1, wherein the step of positioning the loop comprises:

expanding the loop across the treatment site before the prosthesis is advanced to the treatment site; and

advancing the prosthesis through the loop upon advancement of the prosthesis to the treatment site.

7. The method of claim 1, wherein the prosthesis is advanced to the treatment site mounted to a distal end of a delivery device, and wherein the loop is advanced coaxially over the delivery device to the treatment site.

8. The method of claim 1, wherein the treatment site comprises an aneurysm.

9. The method of claim 8, wherein the biosensor is disposed within an aneurysmal sac at least partially defined by the aneurysm after the prosthesis is expanded to its enlarged condition.

10. An apparatus for delivering a biosensor to a treatment site within a body lumen, comprising:

a catheter having a proximal end and a distal end adapted for introduction into the body lumen;

an attachment loop having a biosensor attached thereto; and

a connector on the distal end of the catheter for detachably securing the attachment loop to the catheter, said connector comprising a wire extending through the catheter, the wire having a distal portion at the distal end of the catheter that is intertwined with the attachment loop to substantially secure the loop to the distal end of the catheter.

11. The apparatus of claim 10, further comprising an actuator on the proximal end of the catheter for detaching the attachment loop from the connector.

12. The apparatus of claim 11, wherein the actuator comprises a handle on a first end of the wire disposed at the proximal end of the catheter, the handle configured for pulling the distal portion of the wire from the distal end of the catheter towards the proximal end, thereby releasing the attachment loop therefrom.

13. The apparatus of claim 10, wherein the attachment loop comprises a ring attached thereto for receiving the wire therethrough.

14. The apparatus of claim 10, further comprising:

a tubular prosthesis expandable between a contracted condition for facilitating introduction into the body lumen, and an enlarged condition for contacting a wall of the body lumen at the treatment site; and

a delivery device for directing the prosthesis to the treatment site in its contracted condition, the delivery device having a cross-section substantially smaller than a cross-section of the attachment loop, thereby facilitating positioning the loop coaxially with respect to the prosthesis before the prosthesis is deployed from the delivery device.

15. The apparatus of claim 14, wherein the attachment loop has a size for substantially securing the loop to the prosthesis in its enlarged condition.

16. The apparatus of claim 14, wherein the attachment loop comprises a ring or sleeve formed from a substantially elastic material, the ring or sleeve having a relaxed state having a cross-section smaller than the prosthesis in its enlarged condition.

17. The apparatus of claim 14, wherein the attachment loop comprises a substantially inelastic thread having a cross-section similar to the prosthesis in its enlarged condition.

18. The apparatus of claim 10, further comprising a sheath slidable over the catheter, the sheath being configured for receiving the attachment loop therein.

19. The apparatus of claim 18, wherein the attachment loop is biased to assume an open configuration upon release from the sheath.

20. An apparatus for delivering a biosensor to a treatment site within a body lumen, comprising:

a catheter having a proximal end and a distal end adapted for introduction into the body lumen;

an attachment loop having a biosensor attached thereto, said biosensor extending radially outward from the loop; and

a connector on the distal end of the catheter for detachably securing the attachment loop to the catheter.

21. The apparatus of claim 20, further comprising an actuator on the proximal end of the catheter for detaching the attachment loop from the connector.

22. The apparatus of claim 21, wherein the connector comprises a wire extending through the catheter, the wire having a distal portion at the distal end of the catheter that is intertwined with the attachment loop to substantially secure the attachment loop to the distal end of the catheter.

23. The apparatus of claim 22, wherein the actuator comprises a handle on a first end of the wire disposed at the proximal end of the catheter, the handle configured for pulling the distal portion of the wire from the distal end of the catheter towards the proximal end, thereby releasing the attachment loop therefrom.

24. The apparatus of claim 22, wherein the attachment loop comprises a ring attached thereto for receiving the wire therethrough.

25. The apparatus of claim 20, further comprising:

a tubular prosthesis expandable between a contracted condition for facilitating introduction into the body lumen, and an enlarged condition for contacting a wall of the body lumen at the treatment site; and

a delivery device for directing the prosthesis to the treatment site in its contracted condition, the delivery device having a cross-section substantially smaller than a cross-section of the attachment loop, thereby facilitating positioning the attachment loop coaxially with respect to the prosthesis before the prosthesis is deployed from the delivery device.

26. The apparatus of claim 25, wherein the attachment loop has a size for substantially securing the attachment loop to the prosthesis in its enlarged condition.

27. The apparatus of claim 25, wherein the attachment loop comprises a ring or sleeve formed from a substantially elastic material, the ring or sleeve having a relaxed state having a cross-section smaller than the prosthesis in its enlarged condition.

28. The apparatus of claim 25, wherein the attachment loop comprises a substantially inelastic thread having a cross-section similar to the prosthesis in its enlarged condition.

29. The apparatus of claim 20, further comprising a sheath slidable over the catheter, the sheath being configured for receiving the attachment loop therein.

30. The apparatus of claim 29, wherein the attachment loop is biased to assume an open configuration upon release from the sheath.

31. An apparatus for monitoring a physical parameter at an aneurysmal site within a blood vessel lumen comprising:

a tubular prosthesis expandable between a contracted condition for facilitating introduction of the prosthesis into the lumen of the blood vessel, and an enlarged condition for contacting a wall of the blood vessel lumen;

a substantially enclosed attachment loop having a size for securing the attachment loop coaxially around the prosthesis in its enlarged condition; and

a biosensor attached to the attachment loop and extending radially outward from the attachment loop for positioning the biosensor within an aneurysmal sac.

32. The apparatus of claim 31, wherein the biosensor is a sensor selected from the group consisting of a pressure sensor, a temperature sensor, a pH sensor, a blood sugar sensor, a blood oxygen sensor, a motion sensor, an acceleration sensor, a force sensor, a strain sensor, an acoustics sensor, a moisture sensor, an osmolarity sensor, a light sensor, a turbidity sensor, a radiation sensor, an electromagnetic field sensor, a chemical sensor, an ionic sensor, and an enzymatic sensor.

33. An apparatus for use with a tubular prosthesis in monitoring a physical parameter at a site within a body lumen, comprising:

a substantially enclosed attachment loop configured for attachment to an outer circumference of the prosthesis; and

a biosensor attached to the attachment loop, said biosensor extending radially outward from the attachment loop.

34. The apparatus of claim 33, wherein the attachment loop comprises a ring or sleeve formed from a substantially elastic material, the ring or sleeve having a relaxed state having a cross-section smaller than the prosthesis in an enlarged condition.

35. The apparatus of claim 34, wherein the elastic material has an elasticity such that the ring or sleeve applies a radially inward pressure of between about 5-60 mm Hg against the prosthesis in an enlarged condition when the ring or sleeve is substantially secured thereto.

36. The apparatus of claim 33, wherein the attachment loop comprises a substantially inelastic thread having a cross-section similar to the prosthesis in an enlarged condition.

37. The apparatus of claim 36, wherein the thread has a cross-section about 5-30 percent larger than a cross-section of the prosthesis in an enlarged condition.

38. The apparatus of claim 33, wherein the attachment loop is biased to assume a substantially open configuration.

39. The apparatus of claim 33, wherein the attachment loop is compressible to facilitate its insertion into a delivery device.

40. The apparatus of claim 33, wherein the attachment loop comprises a connector thereon for cooperating with a mating connector on a device for delivering the attachment loop within the body lumen.

41. The apparatus of claim 33, wherein the biosensor is a sensor selected from the group consisting of a pressure sensor, a temperature sensor, a pH sensor, a blood sugar sensor, a blood oxygen sensor, a motion sensor, a flow sensor, a velocity sensor, an acceleration sensor, a force sensor, a strain sensor, an acoustics sensor, a moisture sensor, an osmolarity sensor, a light sensor, a turbidity sensor, a radiation sensor, an electromagnetic field sensor, a chemical sensor, an ionic sensor, and an enzymatic sensor.