Sub-mucosal medical device implantation

• US 20060095079A1
• Filed: 10/29/2004
• Published: 05/04/2006
• Est. Priority Date: 10/29/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Application Number:
  US10/977,501
• Publication Number:
  US 20060095079A1
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

In general, the invention is directed to devices and methods for use in sub-mucosal implantation of medical devices such as electrical stimulators and physiological sensors. An implantation instrument includes a probe defining a cavity, and a vacuum channel to apply vacuum pressure to draw tissue into the cavity. Once the tissue is captured within the cavity, a needle is advanced through the probe to define an implantation pocket. Then, a medical device, such as an electrical stimulator or sensor, is advanced through the probe and into the pocket. In this manner, a medical device can be quickly and securely implanted at a desired tissue site within a patient.

Claims

1. A method for implanting a medical device, the method comprising:

applying vacuum pressure to a mucosal layer to draw a portion of the mucosal tissue layer and a portion of a sub-mucosal layer into a vacuum cavity defined by an implantation instrument; and

introducing a medical device into the portion of the sub-mucosal tissue layer drawn into the vacuum cavity, wherein the medical device includes an electrically powered medical device.

2. The method of claim 1, wherein applying vacuum pressure comprises applying the vacuum pressure directly to the mucosal layer via a vacuum port associated with the implantation instrument.

3. The method of claim 1, wherein introducing a medical device includes injecting fluid into the portion of the sub-mucosal tissue layer to form an implantation pocket, and placing the medical device within the implantation pocket.

4. The method of claim 3, wherein injecting fluid includes advancing a hollow stylet along a length of a working channel within the implantation instrument, forcing a distal tip of the stylet into the portion of the sub-mucosal tissue layer, and injecting the fluid via the stylet.

5. The method of claim 3, wherein introducing the medical device further includes withdrawing the stylet, advancing a push rod along the length of the working channel within the implantation instrument to push the medical device into the implantation pocket.

6. The method of claim 1, wherein the medical device includes an electrical stimulator.

7. The method of claim 6, wherein the electrical stimulator includes one or more electrodes, a pulse generator, a power source, and a wireless telemetry interface.

8. The method of claim 6, wherein the stimulator is a neurostimulator.

9. The method of claim 1, wherein the medical device includes a substantially capsule-shaped housing sized for implantation within the sub-mucosal tissue layer.

10. The method of claim 1, wherein the medical device includes a physiological sensing device.

11. The method of claim 10, wherein the sensing device includes a sensor, a power source, and a wireless telemetry interface.

12. The method of claim 1, wherein the vacuum cavity has a depth of approximately 5 to approximately 15 mm.

13. The method of claim 12, wherein the vacuum cavity has a length of approximately 5 to approximately 40 mm and a width of approximately 5 to approximately 15 mm.

14. The method of claim 1, wherein the implantation instrument defines a working channel that defines an opening in the vacuum cavity, and the opening is disposed at a depth selected for access to the sub-mucosal tissue layer.

15. The method of claim 1, further comprising repetitively applying vacuum pressure to additional portions of the mucosal tissue layer and introducing additional medical devices to implant a plurality of medical devices in different portions of the sub-mucosal tissue layer.

16. The method of claim 15, wherein at least one of the medical devices includes an electrical stimulator and at least one of the medical devices includes a physiological sensing device.

17. A system for implantation of a medical device, the system comprising:

an elongated delivery tube;

a probe coupled to a distal end of the delivery tube;

a vacuum cavity defined by the probe to apply vacuum pressure to a mucosal layer to draw a portion of the mucosal tissue layer and a portion of a sub-mucosal layer into a vacuum cavity defined by an implantation instrument;

a vacuum channel to apply the vacuum pressure to the vacuum cavity;

an electrically powered medical device; and

a working channel to introduce the medical device into the portion of the sub-mucosal tissue layer drawn into the vacuum cavity.

18. The system of claim 17, further comprising a plurality of vacuum ports defined by the vacuum cavity to apply the vacuum pressure directly to the mucosal tissue layer.

19. The system of claim 17, further comprising a hollow stylet, for introduction along a length of the working channel, to inject fluid into the portion of the sub-mucosal tissue layer to form an implantation pocket.

20. The system of claim 19, further comprising a push rod, for introduction along the length of the working channel, to push the medical device into the implantation pocket.

21. The system of claim 17, wherein the medical device includes an electrical stimulator.

22. The system of claim 21 wherein the electrical stimulator includes one or more electrodes, a pulse generator, a power source, and a wireless telemetry interface.

23. The system of claim 21, wherein the stimulator is a neurostimulator.

24. The system of claim 17, wherein the stimulator includes a substantially capsule-shaped housing sized for implantation within the sub-mucosal tissue layer.

25. The system of claim 17, wherein the medical device includes a physiological sensing device.

26. The system of claim 25, wherein the sensing device includes a sensor, a power source, and a wireless telemetry interface.

27. The system of claim 17, wherein the vacuum cavity has a depth of approximately 5 to approximately 15 mm.

28. The system of claim 27, wherein the vacuum cavity has a length of approximately 5 to approximately 40 mm and a width of approximately 5 to approximately 15 mm.

29. The system of claim 17, wherein the working channel defines an opening in the vacuum cavity, and the opening is disposed at a depth selected for access to the sub-mucosal tissue layer.

30. A system for implantation of a medical device, the system comprising:

an electrically powered implantable medical device; and

an implantation instrument including;

tissue securing means,

means for drawing mucosal tissue and sub-mucosal tissue into the tissue securing means, and

means for introducing the medical device into the sub-mucosal tissue drawn into the tissue securing means.

31. The system of claim 30, wherein the drawing means includes means for applying vacuum pressure to the mucosal tissue.

32. The system of claim 30, wherein the introducing means includes a working channel defined by the implantation instrument and a push rod to push the medical device through the working channel and into the sub-mucosal tissue drawn into the tissue securing means.

33. The system of claim 30, wherein the tissue securing means includes a vacuum cavity, and the means for drawing mucosal tissue and sub-mucosal tissue into the tissue securing means includes means for applying vacuum pressure to the vacuum cavity.

34. The system of claim 30, wherein the introducing means further includes a stylet means for injecting fluid into the portion of the sub-mucosal tissue layer to form an implantation pocket.

35. The system of claim 30, wherein the medical device includes an electrical stimulator.

36. The system of claim 35 wherein the electrical stimulator includes one or more electrodes, a pulse generator, a power source, and a wireless telemetry interface.

37. The system of claim 35, wherein the stimulator is a neurostimulator.

38. The system of claim 30, wherein the medical device includes a substantially capsule-shaped housing sized for implantation within the sub-mucosal tissue layer.

39. The system of claim 30, wherein the medical device includes a physiological sensing device.

40. The system of claim 30, wherein the sensing device includes a sensor, a power source, and a wireless telemetry interface.