Medical device system and apparatus for guiding the placement of a subcutaneous device

• US 8,998,929 B2
• Filed: 04/29/2009
• Issued: 04/07/2015
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Havel, William J., Nikolski, Vladimir P.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/432,028
• Publication Number:
  US 20100030229A1
• Time in Patent Office: 2,169 Days
• Field of Search: 606/129, 606/159, 606/108, 606/1, 606/41, 606201-204, 604115-117, 604/508, 604/523, 607/115, 607/116, 607/117, 607/118, 607/119, 607/120, 607/149, 607/152, 607/122, 206714-718, 220/280, 428/34.1, 428/35.7, 428/35.9, 428/40.1, 428/156
• 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

A medical device system for advancing a subcutaneous device to a desired implant site that includes a strap extending along a length from a proximal end to a distal end, 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.

Claims

1. A medical device system for advancing a subcutaneous device to a desired implant site, the apparatus comprising:

a strap having a major length extending from a proximal end to a distal end;

a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;

a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange; and

an indentation extending from the proximal end to the distal end along the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during the placement of the subcutaneous device;

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue as the tunneling tool is inserted into an incision in a patient'"'"'s body; and

a channel extending though the strap from the proximal end to the distal end along the major length of the strap; and

wherein the strap is configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted along the indentation and into the space between the first plane of tissue and the second plane of tissue of the patient'"'"'s body; and

means for attaching the bottom portions to a patient'"'"'s skin that comprises an adhesive.

2. The system of claim 1, wherein the second sidewall portion of the second flange is positioned opposite the first sidewall portion, wherein the first sidewall portion and the second sidewall portion have curved portions extending within the indentation.

3. The system of claim 1, further comprising:

a conductive surface along the base portion of the indentation for measuring an impedance between the 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.

4. The system of claim 1, further comprising:

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.

5. The system of claim 1, further comprising:

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.

6. The system of claim 1, further comprising:

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.

7. The system of claim 1, wherein the strap comprises a bipole electrode configured to indicate a location for placement of the tunneling tool.

8. The system of claim 1, wherein the strap comprises a semi-stiff material such that the first flange and the second flange are conformable to a patient'"'"'s body.

9. The system of claim 1, wherein the strap is adapted to be positioned along an intercostal space with the proximal end adjacent an incision site and the distal end adjacent a target location of a subcutaneous tool when it is advanced subcutaneously along the indentation.

10. A medical device system for advancing a subcutaneous device to a desired implant site, the apparatus comprising:

a strap having a major length extending from a proximal end to a distal end;

a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;

a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange; and

an indentation extending from the proximal end to the distal end along the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during placement of the subcutaneous device;

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue as the tunneling tool is inserted into an incision in a patient'"'"'s body; and

a channel extending though the strap from the proximal end to the distal end along the major length of the strap; and

wherein the strap is configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted along the indentation and into the space between the first plane of tissue and the second plane of tissue of the patient'"'"'s body; and

means for attaching the bottom portions to a patient'"'"'s skin that comprises bands attached to the strap.

11. A medical device system for advancing a subcutaneous device to a desired implant site, the apparatus comprising:

a strap having a major length extending from a proximal end to a distal end;

a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;

a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange; and

an indentation extending from the proximal end to the distal end along the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during placement of the subcutaneous device;

a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue as the tunneling tool is inserted into an incision in a patient'"'"'s body; and

a channel extending though the strap from the proximal end to the distal end along the major length of the strap; and

wherein the strap is configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted along the indentation and into the space between the first plane of tissue and the second plane of tissue of the patient'"'"'s body; and

a vacuum system coupled to the strap for pulling the patient'"'"'s skin upward to be positioned within the indentation.

12. A medical device system for advancing a subcutaneous device to a desired implant site, the system comprising:

a strap having a major length extending from a proximal end to a distal end and comprising a material from the proximal end to the distal end of the strap, and that conforms to a patient'"'"'s body when the strap is attached to the patient'"'"'s body;

a hollow channel extending through the material a tunneling tool, the strap configured as a mechanical guide for guiding the placement of the tunneling tool as the tunneling tool is inserted into the patient'"'"'s body prior to inserting the tunneling tool into the patient'"'"'s body;

a first flange comprising a first sidewall portion and a second flange comprising a second sidewall portion, the first flange and the second flange extending along the major length of the strap from the proximal end to the distal end;

a base portion extending along the major length of the strap from the proximal end to the distal end, the base portion comprising a bottom wall extending from the first sidewall portion of the first flange to the second sidewall portion of the second flange;

an indentation extending from the proximal end to the distal end of the major length of the strap, the indentation formed by the first sidewall portion, the second sidewall portion, and the base portion, wherein the first flange and the second flange include bottom portions that make contact with and compress a tissue layer to position the tissue layer towards the base portion within the indentation as the subcutaneous device further advances the tissue layer to be positioned against one or more of the first sidewall portion, the second sidewall portion and the base portion of the indentation during placement of the subcutaneous device in a space created by the tunneling tool between a first plane of tissue and a second plane of tissue after the tunneling tool has been advanced into the patient'"'"'s body through an incision and along the indentation of the strap; and

means for attaching the bottom portions to a patient'"'"'s skin that comprises an adhesive.