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

• US 20100030229A1
• Filed: 04/29/2009
• Published: 02/04/2010
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nikolski, Vladimir P., Havel, William J.
• Granted Patent: US 8,998,929 B2
• 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 blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• 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 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.

2. The system of claim 1, 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.

3. The system of claim 1, 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.

4. The system of claim 1, 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.

5. The system of claim 1, 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.

6. The system of claim 1, 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.

7. The system of claim 1, 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.

8. The system of claim 1, 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.

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

a first 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 first strap;

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

a first indentation extending from the proximal end to the distal end of the first strap, the first indentation formed by the first flange, the second flange, and the first base portion;

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

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

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

a second indentation extending from the proximal end to the distal end of the first strap, the first indentation formed by the first flange, the second flange, and the first base portion, wherein the first flange, the second flange, the third flange and the fourth 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.

10. The system of claim 9, wherein the first 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 first bottom wall of the first base portion extending between the first sidewall portion and the second sidewall portion, the second indentation is formed by a third sidewall portion of the third flange, a fourth sidewall portion of the fourth flange positioned opposite the third sidewall portion, and a second bottom wall of the second base portion extending between the third sidewall portion and the fourth sidewall portion, wherein the first sidewall portion and the second sidewall portion have curved portions extending within the first indentation and the third sidewall portion and the fourth sidewall portion have curved portions extending within the second indentation.

11. The system of claim 9, further comprising:

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

a first channel extending through the first strap; and

a second channel extending through the second strap, the first channel and the second channel being 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.

12. The system of claim 9, 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 positioned along one of the first base portion and the second base portion 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.

13. The system of claim 9, 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.

14. The system of claim 9, 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 first 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.

15. The system of claim 9, 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 one of the first strap and the second 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.

16. The system of claim 9, further comprising a tunneling tool to form a space between a first plane of tissue and a second plane of tissue, wherein one of the first strap and the second strap comprises a bipole electrode configured to indicate a location for placement of the tunneling tool.

17. The system of claim 9, further comprising a tunneling tool to form a space between a first plane of tissue and a second plane of tissue, wherein the first strap and the second strap form a common insertion path for insertion of the tunneling tool therein.

18. The system of claim 17, further comprising means for adjusting a spacing angle between the first strap and the second strap.

19. The system of claim 18, further comprising a conductive surface positioned along one of the first base portion and the second base portion for measuring an impedance between the conductive surface and the tunneling tool to provide a depth of the tunneling tool beneath the first plane of tissue

20. The system of claim 19, further comprising:

a first mark positioned along one of the first strap and the second 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.