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

• US 20100030230A1
• 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., Bonner, Matthew D., Nikolski, Vladimir P.
• Application Number:
  US12/432,052
• Publication Number:
  US 20100030230A1
• 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 guiding placement of a subcutaneous medical device 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, an orientation member extending along the strap to limit a predetermined radius of curvature of the strap, 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

6. A medical device system for guiding placement of a subcutaneous medical device 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;

an orientation member extending along the strap to limit a predetermined radius of curvature of the strap; 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.

1. A medical device system for guiding placement of a subcutaneous medical device comprising:

a tunneling tool to form a space between the a first plane of tissue and a second plane of tissue for positioning the subcutaneous medical device;

a strap extending along a length from a proximal end to a distal end to guide the tunneling tool between the first and second plane of tissue;

an orientation member extending along the strap to limit a predetermined radius of curvature of the strap.

2. The medical device system of claim 1, wherein the predetermined radius of curvature corresponds to a portion of the strap that is advanced along a patient'"'"'s side to the spine of the patient.

3. The medical device system of claim 1, wherein the orientation member comprises:

a plurality of adjacent segments, each of the plurality of segments extending from a first end to a second end;

a plurality of interconnecting members, each of the plurality of interconnecting members positioned between the first end of one segment of the plurality of segments and the second end of another segment of the plurality of segments adjacent to the one segment of the plurality of segments.

4. The medical device system of claim 3, wherein each segment of the plurality of segments include a first angled portion extending at a first predetermined angle between an interconnecting member of the plurality of interconnecting members and a bottom side, and a second angled portion extending at a second predetermined angle between the interconnecting member and a top side.

5. The medical device system of claim 4, wherein the orientation member is advanced between a first position corresponding to adjacent first angled portions being engaged, a second position corresponding to adjacent first and second angled portions being equally relatively spaced, and a third position corresponding to adjacent second angled portions being engaged.

7. The system of claim 6, wherein the orientation member is positioned in one of the first flange and the second flange.

8. The medical device system of claim 6, wherein the orientation member is positioned in the base portion.

9. The medical device system of claim 6, wherein the orientation member comprises:

a plurality of adjacent segments, each of the plurality of segments extending from a first end to a second end;

a plurality of interconnecting members, each of the plurality of interconnecting members positioned between the first end of one segment of the plurality of segments and the second end of another segment of the plurality of segments adjacent to the one segment of the plurality of segments.

10. The medical device system of claim 9, wherein each segment of the plurality of segments include a first angled portion extending at a first predetermined angle between an interconnecting member of the plurality of interconnecting members and a bottom side, and a second angled portion extending at a second predetermined angle between the interconnecting member and a top side.

11. The medical device system of claim 10, wherein the orientation member is advanced between a first position corresponding to adjacent first angled portions being engaged, a second position corresponding to adjacent first and second angled portions being equally relatively spaced, and a third position corresponding to adjacent second angled portions being engaged.

12. The medical device system of claim 11, 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.

13. The medical device system of claim 11, 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.

14. The medical device system of claim 11, 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.

15. The medical device system of claim 11, 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.

16. The medical device system of claim 11, 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.

14-1. The medical device system of claim 11, 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.

17. A medical device system for guiding placement of a subcutaneous medical device 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;

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;

an orientation member extending along the strap to limit a predetermined radius of curvature of the strap; 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.

18. The medical device system of claim 17, wherein the orientation member comprises:

a plurality of adjacent segments, each of the plurality of segments extending from a first end to a second end;

a plurality of interconnecting members, each of the plurality of interconnecting members positioned between the first end of one segment of the plurality of segments and the second end of another segment of the plurality of segments adjacent to the one segment of the plurality of segments.

19. The medical device system of claim 18, wherein each segment of the plurality of segments include a first angled portion extending at a first predetermined angle between an interconnecting member of the plurality of interconnecting members and a bottom side, and a second angled portion extending at a second predetermined angle between the interconnecting member and a top side.

20. The medical device system of claim 19, wherein the orientation member is advanced between a first position corresponding to adjacent first angled portions being engaged, a second position corresponding to adjacent first and second angled portions being equally relatively spaced, and a third position corresponding to adjacent second angled portions being engaged.