Methods and apparatus for deploying and implantable biosensor

• US 6,699,186 B1
• Filed: 03/10/2000
• Issued: 03/02/2004
• Est. Priority Date: 03/10/2000
• Status: Expired due to Term

• Current Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Original Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Inventors: Penner, Avi, Wolinsky, Lone
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/523,414
• Time in Patent Office: 1,453 Days
• Field of Search: 600/300, 600/317, 600/454, 600/504, 600/505, 623/1.11, 606/195, 606/213, 604/514, 604/11, 604/285, 604/57
• US Class Current: 600/300
• CPC Class Codes: A61B 1/00147 Holding or positioning arrangements
• 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 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel

Abstract

An implantation device for delivering a biosensor to an implantation site in a patient'"'"'s body comprises an elongate catheter equipped with a distally located cavity sized to house a biosensor. Once the distal end of the catheter is positioned adjacent the implantation site, the biosensor is released through an opening from the cavity into the site. A removable cover, such as a thin adhesive film, may be used to retain the biosensor in the cavity, while the catheter is guided through the body to the implantation site. The implantation device may include an actuator for displacing the biosensor from the cavity into the implantation site. By way of one example, the actuator may be a piston inserted through a lumen of the catheter.

Claims

1. An implantation device for delivering a biosensor to an implantation site in a body, comprising:

an elongate catheter comprising a recess configured to carry the biosensor while the catheter is guided to the implantation site;

wherein the recess comprises a disposed indentation etched or otherwise formed on only one side of the catheter.

2. A device for delivering a biosensor to an implantation site in a body, comprising:

an elongate catheter comprising a recess configured to carry the biosensor while the catheter is guided to the implantation site; and

a retaining element configured to retain the biosensor in the recess;

wherein the retaining element comprises a retractable cover member inserted through a distal opening of the catheter.

3. The implantation device of claim 2, wherein the recess comprises a longitudinally disposed indentation formed in a side of the catheter.

4. The implantation device of claim 2, wherein the recess comprises a cavity formed in a side wall of the catheter.

5. The implantation device of claim 2, wherein the recess comprises a cavity formed in a distal tip of the catheter.

6. The implantation device of claim 2, wherein the retractable cover member comprises a thin membrane.

7. The implantation device of claim 2, wherein the retractable cover member comprises a retractable filament inserted through a distal opening of the catheter.

8. The implantation device of claim 2, further comprising a clamping mechanism adapted to secure the retaining element against the catheter.

9. The implantation device of claim 8, wherein the clamping mechanism comprises a sleeve circumferentially attached to the catheter.

10. The implantation device of claim 2, further comprising an actuator, configured to eject the biosensor from the recess.

11. The implantation device of claim 10, wherein the actuator comprises a piston.

12. The implantation device of claim 10, wherein the actuator comprises a spring.

13. The implantation device of claim 10, wherein the actuator comprises a hydraulic injector.

14. The implantation device of claim 2, wherein the retractable cover member comprises a retractable sheath.

16. The implantation device of claim 13, further comprising a handle assembly associated with the actuator, the actuator being controllable by manipulation of the handle assembly.

15. An implantation device for delivering a biosensor to an implantation site in a body, comprising:

an elongate catheter comprising a recess configured to carry the biosensor while the catheter is guided to the implantation site;

and an actuator disposed in, or adjacent to, the recess, the actuator configured to eject the biosensor from the recess;

wherein the actuator comprises a protrusion located in, or adjacent to, the recess, the protrusion positioned to displace biosensor from the recess.

17. An implantation device for delivering a biosensor to an implantation site in a body, comprising:

an elongate catheter having a recess formed in a distal end, the recess configured to carry the biosensor without significantly increasing the profile of the catheter distal end;

a retaining element configured to retain the biosensor in the recess; and

an actuator disposed in, or adjacent to, the recess, the actuator configured to eject the biosensor from the recess;

wherein the retaining element comprises a retractable cover member extending out of a distal opening of the catheter.

18. The implantation device of claim 17,

wherein the retractable cover member comprises a thin membrane at least partially covering the cavity.

19. The implantation device of claim 17, wherein the retractable cover member comprises a retractable filament inserted through a lumen of the catheter adjacent the recess, the filament extending out of a distal opening of the catheter.

20. The implantation device of claim 19,

wherein the actuator comprises a protrusion located in, or adjacent to, the recess, and

wherein a distal portion of the filament has a relatively thick profile, such that the protrusion is displaced into the recess by the distal portion as the filament is retracted through the lumen.

21. The implantation device of claim 19,

wherein the actuator comprises a protrusion located adjacent to a wall of the recess, and

wherein a distal portion of the filament has a relatively thick profile, such that the protrusion deflects the filament against the wall as the filament is retracted through the lumen, causing the biosensor to be displaced from the recess.

22. The implantation device of claim 17, further comprising a clamping mechanism adapted to secure the retaining element against the catheter, while the catheter is guided to the implantation site.

23. The implantation device of claim 22, wherein the clamping mechanism comprises a sleeve circumferentially attached to the catheter.

24. The implantation device of claim 17, wherein the retractable cover member comprises a retractable sheath.

25. A method for delivering a biosensor to an implantation site in a body, comprising:

introducing a catheter into the body, the catheter having a recessed area that houses a biosensor, a distal opening, and a retaining element that is inserted through the distal opening, the retaining element being configured to retain the biosensor in the recessed area;

advancing the catheter until the recessed area is positioned at the implantation site; and

retracting the retaining element so that the biosensor may move freely from the recessed area into the implantation site.

26. The method of claim 25, further comprising ejecting the biosensor from the recess.

27. The method of claim 25, wherein the implantation site is either an abdominal aortic aneurysm, in the iliac of a bifurcated abdominal aortic aneurysm, a thoracic aortic aneurysm, or any combination of the above.

28. The method of claim 25, wherein the catheter is guided to the implantation site in conjunction with the delivery of a stent graft.

29. The method of claim 25, wherein the biosensor comprises a sensor selected from the group consisting of a pressure sensor, a temperature sensor, a position sensor, a tactility sensor, an electrical impedance 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 electrical energy sensor, an electromagnetic field sensor, a chemical sensor, an ionic sensor, and an enzymatic sensor.

30. A method for delivering a biosensor to an implantation site in a body, comprising:

introducing a catheter into the body, the catheter having a recessed area that houses a biosensor, a distal opening, a retaining element that is inserted through the distal opening and is configured to retain the biosensor in the recessed area, and an actuator configured to displace the biosensor from the recess;

advancing the catheter until the recess is positioned at the implantation site;

retracting the cover member to allow passage of the biosensor from the recess; and

ejecting the biosensor from the recess into the implantation site with the actuator.

31. A method performed in conjunction with the method of claim 30, comprising:

inserting a stent graft in the implantation site.