Methods, Tools, and Assemblies for Implantation of Medical Leads Having Distal Tip Anchors

• US 20130103049A1
• Filed: 10/23/2012
• Published: 04/25/2013
• Est. Priority Date: 10/25/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonde, Eric H.
• Granted Patent: US 10,086,190 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

Medical leads include distal tip anchors that are retained by fixation mechanisms of implantation tools. The fixation mechanism may include a fixed body that has features retaining the distal tip anchor. The fixation mechanism may include a movable body that can apply tension to the distal tip anchor to force the distal tip anchor to be released from the features of the fixed body. The movable body may include an axial portion that is received by an axial hole of the fixed body to allow for axial movement of the movable body to release the distal tip anchor. The fixation mechanism may instead include an elongated flexible body that passes through the distal tip anchor and is attached to the fixed body. Tension applied to the elongated body creates a releasing motion of the distal tip anchor to free the distal tip anchor from the features of the fixed body.

Claims

1. A method of preparing a medical lead having a distal tip anchor for implantation, comprising:

placing a body of the medical lead into an open area of a tool; and

attaching the distal tip anchor to a fixation mechanism on a distal tip of the tool such that the medical lead is held in a fixed position relative to the tool, the fixation mechanism having a first state and a second state, the first state providing fixation of the medical lead by contact with a feature of a fixed body of the fixation mechanism to maintain the lead in the fixed position and the second state providing release of the medical lead from the fixed position by contact with a movable body of the fixation mechanism, the movable body having an axial portion that engages an axial hole of the fixed body allowing the movable body to move axially relative to the fixed body.

2. The method of claim 1, wherein the movable body of the fixation mechanism comprises a plunger connected to a distal end of a pull ribbon.

3. The method of claim 2, wherein the plunger moves axially in response to force applied to a proximal end of the pull ribbon to contact and move at least a portion of the distal tip anchor so as to release the distal tip anchor from the fixed feature

4. The method of claim 2, wherein the fixed body include an axial slot and wherein the plunger resides at least partially within the axial slot.

5. The method of claim 4, further comprising limiting axial movement of the plunger by contacting the plunger to an abutment at an end of the axial slot.

6. The method of claim 1, wherein the feature of the fixed body contacts a proximal region of the distal tip anchor.

7. A method of preparing a medical lead having a distal tip anchor for implantation, comprising:

placing a body of the medical lead into an open area of a tool; and

attaching the distal tip anchor to a fixation mechanism on a distal tip of the tool such that the medical lead is held in a fixed position relative to the tool, the fixation mechanism having a fixed body and an elongated flexible body with a distal end attached to a top of the fixed body, the fixation mechanism having a first state and a second state, the first state providing fixation of the medical lead to maintain the lead in the fixed position by having the distal tip anchor restrained by a feature of the fixed body with an elongated flexible body present between the body of the medical lead and a surface of the tool while passing through the distal tip anchor, and the second state providing release of the medical lead from the fixed position by the elongated flexible body having an applied tension to impart a releasing motion to the distal tip anchor.

8. The method of claim 7, wherein the elongated flexible body comprises a pull ribbon.

9. The method of claim 7, wherein the applied tension imparts tension to the distal tip anchor to cause the releasing motion so that a proximal region of the distal tip anchor releases from the feature of the fixed body.

10. A medical assembly, comprising:

a medical lead having a lead body including a distal tip anchor and a plurality of electrodes in proximity to the distal tip anchor; and

a tool having a tool body with an open area and having a distal tip fixation mechanism, the lead body being present within the open area and the distal tip anchor being attached to the distal tip mechanism to provide a fixed position of the lead relative to the tool, the fixation mechanism having a first state and a second state, the first state providing fixation of the medical lead by contact with a feature of a fixed body of the fixation mechanism to maintain the lead in the fixed position and the second state providing release of the medical lead from the fixed position by contact with a movable body of the fixation mechanism, the movable body having an axial portion that engages an axial hole of the fixed body allowing the movable body to move axially relative to the fixed body.

11. The medical assembly of claim 10, wherein the movable feature of the fixation mechanism comprises a plunger connected to a distal end of a pull ribbon.

12. The medical assembly of claim 11, wherein the plunger moves axially in response to force applied to a proximal end of the pull ribbon to contact and move at least a portion of the distal tip anchor so as to release the distal tip anchor from the fixed feature.

13. The medical assembly of claim 11, wherein the fixed body includes an axial slot and wherein the plunger resides at least partially within the axial slot.

14. The medical assembly of claim 13, wherein an abutment at an end of the axial slot contacts the plunger to limit axial movement of the plunger.

15. The medical assembly of claim 10, wherein the fixed feature contacts a proximal region of the distal tip anchor.

16. A medical assembly, comprising:

a medical lead having a lead body including a distal tip anchor and a plurality of electrodes in proximity to the distal tip anchor; and

a tool having a tool body with an open area and having a distal tip fixation mechanism, the lead body being present within the open area and the distal tip anchor being attached to the distal tip mechanism to provide a fixed position of the lead relative to the tool, the fixation mechanism having a fixed body and an elongated flexible body with a distal end attached to a top of the fixed body, the fixation mechanism having a first state and a second state, the first state providing fixation of the medical lead to maintain the lead in the fixed position by having the distal tip anchor restrained by a feature of the fixed body with an elongated flexible body present between the body of the medical lead and a surface of the tool while passing through the distal tip anchor, and the second state providing release of the medical lead from the fixed position by the elongated flexible body having an applied tension to impart a releasing motion to the distal tip anchor.

17. The medical assembly of claim 16, wherein the elongated flexible body comprises a pull ribbon.

18. The medical assembly of claim 16, wherein the applied tension imparts tension to the distal tip anchor to cause the releasing motion so that a proximal region of the distal tip anchor releases from the feature of the fixed body.

19. A method of testing stimulation, comprising:

tunneling a distal tip of a tool to a target stimulation site, the tool having a fixation mechanism on the distal tip and having an open area, with a lead body of a medical lead being present within the open area and with a distal tip anchor of the medical lead being attached to the tool by the fixation mechanism, and with at least one distal electrode of the medical lead being exposed from the tool;

connecting a proximal end of the medical lead to a medical stimulation device, the proximal end having a proximal connector that makes electrical connection with an electrical connector of the medical stimulation device, with a filar electrically connecting the proximal connector to the distal electrode; and

applying stimulation energy from the medical stimulation device to the distal electrode while the medical lead is present within the open area of the tool.

20. A medical lead introducer tool, comprising:

a tool body with an open area; and

a distal tip fixation mechanism present at a distal tip of the tool body, the fixation mechanism having a first state and a second state, the first state providing fixation of the medical lead by contact with a feature of a fixed body of the fixation mechanism to maintain the lead in the fixed position and the second state providing release of the medical lead from the fixed position by contact with a movable body of the fixation mechanism, the movable body having an axial portion that engages an axial hole of the fixed body allowing the movable body to move axially relative to the fixed body.

21. A medical lead introducer tool, comprising:

a tool body with an open area; and

a distal tip fixation mechanism present at a distal tip of the tool body, the fixation mechanism having a fixed body and an elongated flexible body with a distal end attached to a top of the fixed body, the fixation mechanism having a first state and a second state, the first state providing fixation of the medical lead to maintain the lead in the fixed position by having the distal tip anchor restrained by a feature of the fixed body with an elongated flexible body present between the body of the medical lead and a surface of the tool while passing through the distal tip anchor, and the second state providing release of the medical lead from the fixed position by the elongated flexible body having an applied tension to impart a releasing motion to the distal tip anchor.