MEDICAL DEVICE SYSTEM AND APPARATUS FOR GUIDING THE PLACEMENT OF A SUBCUTANEOUS DEVICE

• US 20100030228A1
• Filed: 04/29/2009
• Published: 02/04/2010
• Est. Priority Date: 07/31/2008
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Havel, William J.
• Application Number:
  US12/432,014
• Publication Number:
  US 20100030228A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/0003 of parts of the instruments
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes

Abstract

An apparatus for guiding advancing of a subcutaneous medical device to a desired implant site that includes a strap extending along a length from a proximal end to a distal end, a handle orientation member positioned at the proximal end of the strap, and a handle capable of being selectively positioned at one of a plurality of orientations along the handle member.

Claims

1. An apparatus for guiding placement of a subcutaneous medical device, the apparatus comprising:

a strap extending along a length from a proximal end to a distal end;

a handle orientation member positioned at the proximal end of the strap; and

a handle capable of being selectively positioned at one of a plurality of orientations along the handle member.

2. The apparatus of claim 1, further comprising a fixation member positioned along the handle, wherein the handle orientation member comprises:

a first side wall having a first attachment member to detachably receive the fixation member;

a second side wall having a second attachment member to detachably receive the fixation member; and

a third side wall having a third attachment member to detachably receive the fixation member.

3. The apparatus of claim 2, wherein the first side wall, the second side wall and the third side wall are oriented at predetermined relative angles corresponding to the plurality of orientations.

4. The apparatus of claim 2, wherein fixation member comprises a threaded screw, and the first attachment member, the second attachment member and the third attachment member comprise a threaded port to receive the fixation member.

5. The apparatus of claim 2, further comprising:

a first flange and a second flange extending along a portion of the length of the strap;

a base portion extending along a portion of the length of the strap between the first flange and the second flange; and

an indentation extending from the proximal end to the distal end of the strap, the indentation formed by the first flange, the second flange, and the base portion, wherein the first flange and the second flange include curved bottom portions that make contact with and compress a tissue layer to position the tissue layer within the indentation during the placement of the subcutaneous device.

6. The apparatus of claim 5, wherein the indentation is formed by a first sidewall portion of the first flange, a second sidewall portion of the second flange positioned opposite the first sidewall portion, and a bottom wall of the base portion extending between the first sidewall portion and the second sidewall portion, wherein the first sidewall portion and the second sidewall portion have curved portions extending within the indentation.

7. The apparatus of claim 5, further comprising:

a tunneling tool to form a space between a first plane of tissue and a second plane of tissue; and

a channel extending through the strap, the channel configured for shaping the tunneling tool to conform to a patient'"'"'s body outside of a patient'"'"'s body before the tunneling tool is inserted into the patient'"'"'s body.

8. The apparatus of claim 5, further comprising:

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue; and

a conductive surface along the base portion of the indentation for measuring an impedance between the first conductive surface and the tip of the tunneling tool to provide a depth of the tip of the tunneling tool beneath the first plane of tissue.

9. The apparatus of claim 5, further comprising:

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue; and

a first conductive surface along the first flange for measuring a first impedance between the first conductive surface and the tip of the tunneling tool; and

a second conductive surface along the second flange for measuring a second impedance between the second conductive surface and the tip of the tunneling tool, wherein the first impedance and the second impedance provide a lateral position of the tip of the tunneling tool between the first conductive surface and the second conductive surface.

10. The apparatus of claim 5, further comprising:

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue;

a first electrode positioned along the base portion;

a second electrode positioned along the first flange;

a third electrode positioned along the second flange; and

a fourth electrode positioned along the tip of the tunneling tool, wherein a first impedance measurement between the first electrode and the fourth electrode provides a depth of the tip beneath the first plane of tissue, and wherein a second impedance measurement between the second electrode and the fourth electrode and a third impedance measurement between the third electrode and the fourth electrode provide a lateral position of the tip between the second electrode and the third electrode.

11. The apparatus of claim 5, further comprising:

a tunneling tool to form a space between a first plane of tissue and a second plane of tissue;

a first mark positioned along the strap; and

a second mark positioned along the tunneling tool, wherein the first mark is configured to be aligned with the second mark to indicate a location for placement of the tunneling tool.

12. The apparatus of claim 5, further comprising a tunneling tool to form a space between a first plane of tissue and a second plane of tissue, wherein the strap comprises a bipole electrode configured to indicate a location for placement of the tunneling tool.

14. The apparatus of claim 1, further comprising a fixation member positioned along the handle, wherein the handle orientation member comprises:

a first side wall having a first attachment member to detachably receive the fixation member;

a second side wall having a second attachment member to detachably receive the fixation member; and

a third side wall having a third attachment member to detachably receive the fixation member.

15. The apparatus of claim 14, wherein the first side wall, the second side wall and the third side wall are oriented at predetermined relative angles corresponding to the plurality of orientations.

16. The apparatus of claim 14, wherein fixation member comprises a threaded screw, and the first attachment member, the second attachment member and the third attachment member comprise a threaded port to receive the fixation member.

17. The apparatus of claim 14, wherein the indentation is formed by a first sidewall portion of the first flange, a second sidewall portion of the second flange positioned opposite the first sidewall portion, and a bottom wall of the base portion extending between the first sidewall portion and the second sidewall portion, wherein the first sidewall portion and the second sidewall portion have curved portions extending within the indentation.

18. The apparatus of claim 14, further comprising:

a tunneling tool to form a space between a first plane of tissue and a second plane of tissue; and

a channel extending through the strap, the channel configured for shaping the tunneling tool to conform to a patient'"'"'s body outside of a patient'"'"'s body before the tunneling tool is inserted into the patient'"'"'s body.

19. The apparatus of claim 14, further comprising:

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue; and

a conductive surface along the base portion of the indentation for measuring an impedance between the first conductive surface and the tip of the tunneling tool to provide a depth of the tip of the tunneling tool beneath the first plane of tissue.

20. The apparatus of claim 14, further comprising:

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue; and

a first conductive surface along the first flange for measuring a first impedance between the first conductive surface and the tip of the tunneling tool; and

a second conductive surface along the second flange for measuring a second impedance between the second conductive surface and the tip of the tunneling tool, wherein the first impedance and the second impedance provide a lateral position of the tip of the tunneling tool between the first conductive surface and the second conductive surface.

21. The apparatus of claim 14, further comprising:

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue;

a first electrode positioned along the base portion;

a second electrode positioned along the first flange;

a third electrode positioned along the second flange; and

a fourth electrode positioned along the tip of the tunneling tool, wherein a first impedance measurement between the first electrode and the fourth electrode provides a depth of the tip beneath the first plane of tissue, and wherein a second impedance measurement between the second electrode and the fourth electrode and a third impedance measurement between the third electrode and the fourth electrode provide a lateral position of the tip between the second electrode and the third electrode.

22. The apparatus of claim 14, further comprising:

a tunneling tool to form a space between a first plane of tissue and a second plane of tissue;

a first mark positioned along the strap; and

a second mark positioned along the tunneling tool, wherein the first mark is configured to be aligned with the second mark to indicate a location for placement of the tunneling tool.

23. The apparatus of claim 14, further comprising a tunneling tool to form a space between a first plane of tissue and a second plane of tissue, wherein the strap comprises a bipole electrode configured to indicate a location for placement of the tunneling tool.

13. An apparatus for guiding placement of a subcutaneous medical device, the apparatus comprising:

a strap extending along a length from a proximal end to a distal end;

a handle orientation member positioned at the proximal end of the strap;

a handle capable of being selectively positioned at one of a plurality of orientations along the handle member;

a first flange and a second flange extending along a portion of the length of the strap;

a base portion extending along a portion of the length of the strap between the first flange and the second flange; and

an indentation extending from the proximal end to the distal end of the strap, the indentation formed by the first flange, the second flange, and the base portion, wherein the first flange and the second flange include curved bottom portions that make contact with and compress a tissue layer to position the tissue layer within the indentation during the placement of the subcutaneous device.