Stimulation needle apparatus and method

Patent metadata

Field	Value
Publication number	US-10244956-B2
Application number	US-201715430061-A
Country	US
Kind code	B2
Filing date	Feb 10, 2017
Priority date	Feb 12, 2016
Publication date	Apr 2, 2019
Grant date	Apr 2, 2019

Abstract

In various examples, a stimulation needle apparatus is used for selectively administering a trial stimulation to body tissue of a patient. The stimulation needle apparatus includes a cannula assembly including a cannula and a cannula hub disposed at a proximal cannula end. A stylet assembly includes a stylet sized and shaped to fit within a cannula lumen. A stylet hub is disposed at the proximal stylet end and is configured to engage with the cannula hub. With the stylet hub engaged with the cannula hub, the distal stylet end extends distally from the distal cannula end. A stylet connection is electrically coupled with the stylet and is configured to electrically couple with a stimulator device, such that, a stimulation pulse delivered by the stimulator device is conducted from the stylet connection through the stylet to the distal stylet end to administer the trial stimulation.

First claim

The invention claimed is:

1. A stimulation needle apparatus for selectively administering a trial stimulation to body tissue of a patient, the stimulation needle apparatus comprising:
a cannula assembly including:
a cannula including a cannula lumen extending along a longitudinal axis from a proximal cannula end to a distal cannula end; and
a cannula hub disposed at the proximal cannula end, wherein the cannula lumen is accessible through the cannula hub; and

a stylet assembly including:
a stylet sized and shaped to fit within the cannula lumen, the stylet including a proximal stylet end and a distal stylet end;
a stylet hub disposed at the proximal stylet end, the stylet hub being configured to engage with the cannula hub, wherein, with the stylet hub engaged with the cannula hub, the distal stylet end extends distally from the distal cannula end; and
a stylet connection electrically coupled with the stylet, the stylet connection extending from a proximal portion of the stylet hub along the longitudinal axis and is fixed onto, and in direct physical contact with, the stylet hub, wherein the stylet connection includes a conductive loop that is configured to electrically and mechanically couple with a test clip of a stimulator device, wherein, with the stimulator device electrically coupled to the stylet connection, a stimulation pulse delivered by the stimulator device is conducted from the stylet connection through the stylet to the distal stylet end to administer the trial stimulation.

2. The stimulation needle apparatus of claim 1 , wherein the cannula is insulated.

3. The stimulation needle apparatus of claim 1 , wherein the stylet hub engages with the cannula hub with a twist engagement.

4. The stimulation needle apparatus of claim 1 , wherein the cannula includes one or more depth marks.

5. The stimulation needle apparatus of claim 1 , wherein the stylet connection extends proximally from the stylet hub in a manner such that the stylet connection is free of being surrounded by the stylet hub.

6. The stimulation needle apparatus of claim 1 , wherein the distal stylet end includes a pointed tip.

7. A method comprising:
inserting a stimulation needle apparatus to a location within a patient, the stimulation needle apparatus including:
a cannula assembly including:
a cannula including a cannula lumen extending along a longitudinal axis from a proximal cannula end to a distal cannula end; and
a cannula hub disposed at the proximal cannula end, wherein the cannula lumen is accessible through the cannula hub; and

a stylet assembly including:
a stylet sized and shaped to fit within the cannula lumen, the stylet including a proximal stylet end and a distal stylet end;
a stylet hub disposed at the proximal stylet end, the stylet hub being configured to engage with the cannula hub, wherein, with the stylet hub engaged with the cannula hub, the distal stylet end extends distally from the distal cannula end; and
a stylet connection electrically coupled with the stylet, the stylet connection extending from a proximal portion of the stylet hub along the longitudinal axis and is fixed onto, and in direct physical contact with, the stylet hub, wherein the stylet connection includes a conductive loop that is configured to be electrically and mechanically coupled with a test clip of a stimulator device;

electrically coupling the stimulator device to the stylet connection via the conductive loop

and
delivering a stimulation pulse from the stimulator device to the stylet connection, the stimulation pulse being conducted from the stylet connection through the stylet to the distal stylet end to administer a trial stimulation from the distal stylet end to body tissue of the patient.

8. The method of claim 7 , wherein inserting the stimulation needle apparatus includes inserting the stimulation needle apparatus proximate a sacral nerve of the patient.

9. The method of claim 7 , comprising monitoring the patient for a response to the trial stimulation to determine whether the stimulation needle apparatus is properly placed with respect to the location.

10. The method of claim 7 , wherein the cannula is insulated to inhibit the stimulation pulse from being conducted to the body tissue through the cannula.

11. The method of claim 7 , wherein the cannula includes depth marks, such that, during when inserting the stimulation needle apparatus, a depth of insertion of the stimulation needle apparatus can be determined.

12. The method of claim 7 , wherein electrically coupling the stimulator device to the stylet connection includes attaching a connector of the stimulator device to the stylet connection, the stylet connection extending proximally from the stylet hub in a manner such that the stylet connection is free of being surrounded by the stylet hub.

13. The method of claim 7 , comprising removing the stylet from within the cannula while maintaining the location of the cannula within the patient.

14. The method of claim 13 , wherein removing the stylet from within the cannula includes disengaging the stylet hub from the cannula hub by twisting the stylet hub out of engagement with the cannula hub.

15. A stimulation needle apparatus for selectively administering a trial stimulation to body tissue of a patient, the stimulation needle apparatus comprising:
a cannula assembly including:
a cannula including a cannula lumen extending along a longitudinal axis from a proximal cannula end to a distal cannula end; and
a cannula hub disposed at the proximal cannula end, wherein the cannula lumen is accessible through the cannula hub; and

a stylet assembly including:
a stylet sized and shaped to fit within the cannula lumen, the stylet including a proximal stylet end and a distal stylet end;
a stylet hub disposed at the proximal stylet end, the stylet hub being configured to engage with the cannula hub, wherein, with the stylet hub engaged with the cannula hub via a twist engagement, the distal stylet end extends distally from the distal cannula end; and
a stylet connection electrically coupled with the stylet, the stylet connection protruding from a proximal portion of the stylet hub along the longitudinal axis and is fixed onto, and in direct physical contact with, the stylet hub, wherein the stylet connection includes a conductive loop that is configured to electrically and mechanically couple with a test clip of a stimulator device, wherein the test clip has a body and a conductive hook extendable from the body.

Assignees

• Nuvectra Corp

Inventors

• Kane Lawrence

Classifications

• A61N1/3605 Primary

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

• A61M25/06

  Body-piercing guide needles or the like · CPC title

• A61B5/6848

  Needles · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title

• A61B5/04001 Primary

  Human Necessities · mapped topic