Lead positioning and finned fixation system

Patent metadata

Field	Value
Publication number	US-9717900-B2
Application number	US-201514712073-A
Country	US
Kind code	B2
Filing date	May 14, 2015
Priority date	Jun 29, 2012
Publication date	Aug 1, 2017
Grant date	Aug 1, 2017

Abstract

A therapy assembly configured for at least partial insertion in a living body. At least one fixation structure is attached to the therapy delivery element proximate the electrodes. The fixation structure is configured to collapse radially inward and wrap circumferentially around the therapy delivery element to a collapsed configuration when inserted into a lumen of an introducer. The fixation structures deploy to a deployed configuration when the introducer is retracted. The fixation structure includes major surfaces generally parallel with, and extending radially outward from, a central axis of the therapy delivery element, proximal edge surface oriented toward the proximal end, and a distal edge surface oriented toward the distal end. The proximal and distal edge surfaces provide generally symmetrical resistance to displacement of the therapy delivery element within the living body in either a proximal direction or a distal direction along the central axis.

First claim

What is claimed is:

1. A therapy assembly configured for at least partial insertion in a living body, comprising:
a therapy delivery element including:
a proximal end including at least one electrical contact configured to electrically couple with an implantable pulse generator; and
a distal end including at least one electrode electrically coupled to the at least one electrical contact; and

at least one fixation structure attached to the therapy delivery element proximate the at least one electrode, the at least one fixation structure being configured to:
collapse radially inwardly and wrap circumferentially around the therapy delivery element in a collapsed configuration; and
deploy in a deployed configuration in which the at least one fixation structure unwraps and extends radially outwardly from the therapy delivery element, wherein the at least one fixation structure includes:
major surfaces generally parallel with, and extending generally radially outwardly from, a central axis of the therapy delivery element;
a proximal fixation end including a proximal edge surface oriented substantially toward the proximal end of the therapy delivery element; and
a distal fixation end including a distal edge surface oriented substantially toward the distal end of the therapy delivery element, wherein the proximal fixation end is a free-floating end, wherein the free-floating end includes an edge surface that is substantially perpendicular to the central axis of the therapy delivery element.

2. The therapy assembly of claim 1 , comprising an introducer including a lumen configured to receive the therapy delivery element therein, wherein the at least one fixation structure is configured to collapse radially inwardly in the collapsed configuration with insertion of the at least one fixation structure of the therapy delivery element within the introducer, the at least one fixation structure being configured to deploy in the deployed configuration with removal of the introducer from around the at least one fixation structure.

3. The therapy assembly of claim 1 , wherein the proximal edge surface and the distal edge surface are configured to provide generally symmetrical resistance to displacement of the therapy delivery element in either a proximal direction or a distal direction along the central axis when the therapy delivery element is implanted within the living body.

4. The therapy assembly of claim 1 , wherein the at least one fixation structure includes a plurality of fixation structures configured to collapse radially inwardly and wrap circumferentially around the therapy delivery element into the collapsed configuration in a non-overlapping configuration.

5. The therapy assembly of claim 1 , wherein the at least one fixation structure includes an inner edge disposed proximate the therapy delivery element and an outer edge disposed radially outwardly from the inner edge.

6. The therapy assembly of claim 5 , wherein the inner edge and the outer edge of the at least one fixation structure are substantially parallel with the central axis of the therapy delivery element.

7. The therapy assembly of claim 1 , wherein the free-floating end is free to shift with respect to the proximal end of the therapy delivery element.

8. The therapy assembly of claim 1 , wherein the proximal fixation end is configured to fold during a removal of the therapy delivery element.

9. The therapy assembly of claim 8 , wherein the proximal fixation end is configured to fold toward the major surfaces of the fixation structures during the removal of the therapy delivery element.

10. A therapy assembly configured for at least partial insertion in a living body, comprising:
a therapy delivery element including:
a proximal end including at least one electrical contact configured to electrically couple with an implantable pulse generator; and
a distal end including at least one electrode electrically coupled to the at least one electrical contact; and

a plurality of fixation structures attached to the therapy delivery element proximate the at least one electrode, each of the fixation structures being configured to:
collapse radially inwardly and wrap circumferentially around the therapy delivery element in a collapsed configuration; and
deploy in a deployed configuration in which each of the fixation structures unwraps and extends radially outwardly from the therapy delivery element, wherein each of the fixation structures includes:
major surfaces generally parallel with, and extending generally radially outwardly from, a central axis of the therapy delivery element;
a proximal fixation end including a proximal edge surface oriented substantially toward the proximal end of the therapy delivery element; and
a distal fixation end including a distal edge surface oriented substantially toward the distal end of the therapy delivery element, wherein the proximal fixation end is a free-floating end, and wherein the free-floating end includes an edge surface that is substantially perpendicular to the central axis of the therapy delivery element.

11. The therapy assembly of claim 10 , comprising an introducer including a lumen configured to receive the therapy delivery element therein, wherein each of the plurality of fixation structures is configured to collapse radially inwardly in the collapsed configuration with insertion of the fixation structures of the therapy delivery element within the introducer, the fixation structures being configured to deploy in the deployed configuration with removal of the introducer from around the fixation structures.

12. The therapy assembly of claim 10 , wherein each fixation structure of the plurality of fixation structures is configured to collapse radially inwardly and wrap circumferentially around the therapy delivery element into the collapsed configuration in a non-overlapping configuration.

13. The therapy assembly of claim 10 , wherein the proximal and distal edge surfaces are configured to provide generally symmetrical resistance to displacement of the therapy delivery element in either a proximal direction or a distal direction along the central axis when the therapy delivery element is implanted within the living body.

14. The therapy assembly of claim 10 , wherein the free-floating end is free to shift with respect to the proximal end of the therapy delivery element.

15. The therapy assembly of claim 10 , wherein the proximal fixation end is configured to fold during a removal of the therapy delivery element.

16. A therapy assembly configured for at east partial insertion in a living body, comprising:
a therapy delivery element including:
a proximal end including at least one electrical contact configured to electrically couple with an implantable pulse generator; and
a distal end including at least one electrode electrically coupled to the at least one electrical contact;

an introducer including a lumen configured to receive the therapy delivery element within the lumen; and
a plurality of fixation structures attached to the therapy delivery element proximate the at least one electrode, each of the fixation structures being configured to:
collapse radially inwardly and wrap circumferentially in a non-overlapping configuration around the therapy delivery element in a collapsed configuration with insertion of the fixation structures of the therapy delivery element within the introducer; and
deploy in a deployed configuration in which each of the fixation structures unwraps and extends radially outwardly from the therapy delivery element with removal of the introducer from

Assignees

• Nuvectra Corp

Inventors

• Swoyer John M
• Finley James
• Kane Lawrence

Classifications

• A61N1/3605 Primary

  Implantable neurostimulators for stimulating central or peripheral nerve system · CPC title

• A61N1/36053

  adapted for vagal stimulation (A61N1/36114 takes precedence) · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/05 Primary

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title