Tool for insertion of implanatable monitoring device and method

• US 6,412,490 B1
• Filed: 08/27/1999
• Issued: 07/02/2002
• Est. Priority Date: 07/11/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lee, Brian B.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/384,176
• Time in Patent Office: 1,040 Days
• Field of Search: 604/19, 604/22, 604/36, 604/59, 604/264, 604/285, 604/57, 606/129, 606/170, 600/114, 600/585, 128/200.26, 128/207.29, 128/897
• US Class Current: 128/897
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A minimally invasive implant, means for insertion, and description of how to most efficiently use it are described n several embodiments. This implant preferably has a segmented looping memory for storing triggered physiologic events. Preferred events for setting autotriggers to record physiologic signals occurring during events include arrhythmias and syncopal events. Preferably the device can function without a microprocessor. An outside device or other patient activated manual trigger is included. Auto triggers and manually set triggers may be of different sizes. The preferred physiologic events are ECG signals. Electrode spacing can be critical. Additional sensors may be provided to the device. Preferred communications with the device is through telemetry such as is used for pacemakers and other implanted devices.

Claims

1. A system for locating the appropriate insertion positioning for an implantable device having two electrodes for monitoring an ECG in a body such that use of said system indicates the substantially optimum ECG monitoring position for implant prior to implant in a non-invasive manner, said system having electrode means for measuring ECG signals on the surface of a body, means for moving the electrodes to various other positions on the body and means for comparing the ECG output signal at said various locations.

2. A tool for inserting an implantable medical device for monitoring a physiologic condition, comprising:

a rigid device having a handle, connecting a shaft to a blade member, said handle formed as a grip for manually directing said blade to cut a surface of a body, said shaft having formed thereon a residing location for retaining said implantable medical device against one surface of said blade.

3. The tool set forth in claim 2 further comprising a pushing member near said handle member for urging said implantable medical device from said residing location.

4. The tool set forth in claim 3 further comprising a release mechanism for releasing said implantable medical device from said residing location connected to said pushing member.

5. The tool set forth in claim 3 wherein said pushing member is connected in operative association with a release mechanism) for releasing said implantable medical device from said residing location.

6. The tool as set forth in claim 2, further comprising a suture needle holding fixture connected to rigid device for positioning said suture needle so as to puncture tissue behind said blade member and wherein said suture needle is connected to a suture that runs through a suture connector in said implantable medical device.

7. The tool as set forth in claim 2 wherein said blade member and shaft form a Trocar.

8. The tool set forth in claim 7 wherein said shaft member further comprises a tube member for containing said implantable medical device.

9. A method for inserting an implantable medical device into a subcutaneous location under the skin of a living body comprising the steps:

providing a tool having a shaft, an end member coupled to a distal end of said shaft, and a pushing member coupled to said shaft at a proximal location to said end member;

loading said tool with the implantable medical device such that said implantable medical device is retained between said end member and said pushing member;

cutting the skin of said living body at a location above the intended situs of said subcutaneous location with a blade coupled to said end member;

inserting the tool into said subcutaneous location;

releasing said implantable medical device from said tool; and

withdrawing said tool.

10. The method of claim 9, wherein said step of inserting said tool into said subcutaneous location further comprises puncturing tissue with a suture threaded needle, said method further comprising,

after inserting said tool into said subcutaneous location,

drawing a suture through and from in said punctured tissue and tying off said suture so as to secure one end of said implantable medical device in proximity to said punctured tissue.

11. A method of implanting a medical monitoring device into a living body comprising;

puncturing a skin of said living body to form a hole therein with a Trocar-like device loaded with said medical monitoring device,

pushing a shaft of said Trocar like device into said hole,

disengaging said medical monitoring device from said Trocar like device, and

withdrawing said Trocar like device from said hole.

12. A device to insert an implantable medical device under predetermined tissue of a living body, comprising:

a shaft;

a first member coupled to a distal end of the shaft, the end member including a cutting member to cut the predetermined tissue of the living body;

a second member coupled to a location of the shaft that is proximal the distal end, the first and second members being adapted to retain the implantable medical device there-between.

13. The device of claim 12, and further including a handle coupled to the shaft to direct the cutting member when cutting the predetermined tissue.

14. The device of claim 12, wherein the second member is a pushing member adapted to push the implantable medical device under the predetermined tissue.

15. The device of claim 12, and further comprising a releasing member coupled to selectively release the second member to allow the implantable medical device to be located under tissue of the living body.

16. The device of claim 12, and further including an elongated member coupled to the shaft to tie a suture to tissue of the living body.

17. The device of claim 16, further including a retrieving member coupled to the elongated member to allow the elongated member to be pulled in a proximal direction.

18. A method for inserting an implantable medical device under the skin of a living body, comprising the methods of:

a.) providing a tool having a shaft, an end member coupled to a distal end of said shaft, and a pushing member coupled to the shaft at a proximal location to the end member;

b.) retaining the implantable device between the end member and the pushing member;

c.) utilizing a blade provided by the end member to cut first predetermined tissue of the living body;

d.) inserting the tool under the tissue of the living body; and

e.) releasing the implantable medical device from the tool.

19. The method of claim 18, wherein method d.) includes the methods of:

inserting the tool into a subcutaneous location of the living body; and

creating a suture into second predetermined tissue of the living body proximate the subcutaneous location to secure the implantable medical device to the second predetermined tissue.

20. The method of claim 18, wherein method e.) includes pushing the implantable medical device from the tool.

21. The method of claim 18, wherein method c.) includes utilizing a handle coupled the shaft to direct the blade when cutting the first predetermined tissue.

22. A tool for inserting an implantable medical device for monitoring a physiologic condition, comprising:

a rigid device having a shaft coupled to a blade member and to a handle, the handle formed as a grip for manually directing the blade member to cut a surface of a body, the shaft having formed thereon a residing location for retaining the implantable medical device behind the blade member;

a pushing member located proximate the handle to urge the implantable medical device from the residing location; and

a release mechanism connected to the pushing member to release the implantable medical device from the residing location.

23. A tool for inserting an implantable medical device for monitoring a physiologic condition, comprising:

a rigid device having a shaft coupled to a blade member and coupled to a handle, the handle formed as a grip for manually directing the blade member to cut a surface of a body, said shaft having formed thereon a residing location for retaining the implantable medical device behind the blade;

a suture needle holding fixture connected to the rigid device to position a suture needle to puncture tissue behind the blade member; and

a suture connector coupled to the rigid device to hold a suture the extends to the suture needle.

24. A tool for inserting an implantable medical device for monitoring a physiologic condition, comprising:

a blade member; and

a shaft coupled to the blade member, the shaft having a handle formed as a grip to manually direct the blade member to cut a surface of a body, the shaft having formed thereon a residing location for retaining said implantable medical device behind the blade member, and wherein the blade member and the shaft form a Trocar.

25. A tool for inserting an implantable medical device for monitoring a physiologic condition, comprising:

a blade member; and

a shaft coupled to the blade member, the shaft having a handle formed as a grip to manually direct the blade member to cut a surface of a body, the shaft having formed thereon a residing location and a tube for retaining said implantable medical device behind the blade member.

26. A method for inserting an implantable medical device into a subcutaneous location under the skin of a living body, comprising the steps of:

loading a tool with the implantable medical device;

cutting the skin of said living body at a location above the intended situs of the subcutaneous location with a blade coupled to one end of the tool;

puncturing tissue with a needle threaded with a suture that is coupled to the implantable medical device;

inserting the tool into said subcutaneous location;

fastening the suture to the punctured tissue to secure the implantable medical device to the living body;

releasing the implantable medical device from the tool; and

withdrawing the tool.