Custom length stylet

Patent metadata

Field	Value
Publication number	US-12097335-B2
Application number	US-201916552613-A
Country	US
Kind code	B2
Filing date	Aug 27, 2019
Priority date	Aug 27, 2019
Publication date	Sep 24, 2024
Grant date	Sep 24, 2024

Abstract

A custom length stylet assembly for meeting medical device length tolerances. The custom length stylet assembly including a stylet wire having a length extending between a distal end and a proximal end, stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, the stylet handle further defining a proximately positioned track and tab, the track configured to retain a bent proximal end portion of the stylet wire, the length of the stylet wire selected during assembly of the stylet assembly to conform to the corresponding length of a body implantable lead within a predefined tolerance, the tab of the stylet handle melted into the track, thereby securely fastening stylet wire to the stylet handle to inhibit rotation or dislodgement.

First claim

What is claimed is:

1. A stylet assembly for use in positioning a body implantable lead, the stylet assembly comprising:
a stylet wire configured to extend through a lumen of the body implantable lead, the stylet wire having a length extending between a distal end and a proximal end; and
a stylet handle configured to serve as a user grip for manipulation of the stylet wire, the stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, such that a distal portion of the stylet wire extends distally from a distal end of the stylet handle, the stylet handle further defining a proximately positioned track integrally connected to and extending from the longitudinally oriented throughbore and a tab, the track configured to retain a bent proximal end portion of the stylet wire,
wherein the length of the stylet wire is selected during assembly of the stylet assembly to conform to a corresponding length of the body implantable lead within a predefined tolerance, and the tab of the stylet handle is arranged and configured to melt into the track to securely fasten the stylet wire to the stylet handle and inhibit rotation of the stylet wire relative to the stylet handle, wherein the stylet wire does not extend through the tab when the tab is unmelted.

2. The stylet assembly of claim 1 , wherein the stylet wire is constructed of a tungsten metal alloy.

3. The stylet assembly of claim 1 , wherein the bent proximal end portion of the stylet wire includes a bend of between about 45 degrees and about 90 degrees.

4. The stylet assembly of claim 1 , wherein the stylet wire is constructed of a stainless steel metal alloy.

5. The stylet assembly of claim 1 , wherein the bent proximal end portion of the stylet wire includes a bend of between about 90 degrees and about 180 degrees.

6. The stylet assembly of claim 1 , wherein the stylet handle is constructed of plastic.

7. The stylet assembly of claim 1 , wherein the stylet handle includes an orientation member configured to provide a rotational orientation reference to a user during positioning of the body implantable lead.

8. The stylet assembly of claim 7 , wherein the orientation member is a flat surface positioned on an otherwise cylindrical portion of the stylet handle.

9. The stylet assembly of claim 7 , wherein the orientation member is a keyed member extending radially outward from a cylindrical portion of the stylet handle.

10. The stylet assembly of claim 1 , wherein the track extends from a first end in the longitudinally oriented throughbore to a second end at an outer edge of the stylet handle.

11. A lead kit for the insertion and positioning of an implantable neurostimulator lead into a body of a patient, the lead kit comprising:
an implantable neurostimulator lead having a proximal end configured to be operably coupled to a medical device and a distal end configured to be positioned in communication with body tissue of the patient for electrical stimulation thereof, the implantable neurostimulator lead including—
an electrical conductor extending between the proximal end and the distal end of the implantable neuro stimulator lead,
an electrode head affixed to the distal end having one or more electrodes in communication with the electrical conductor, the electrode head configured to be exposed to the body tissue for the supply of an electrical impulse thereto, and
a body defining a longitudinally oriented lumen extending between the proximal end and a lumen termination point in proximity to the distal end; and

a stylet assembly for use in positioning the implantable neurostimulator lead into the body of the patient, the stylet assembly including—
a stylet wire configured to extend through the lumen of the implantable neurostimulator lead, the stylet wire having a length extending between a distal end and a proximal end; and
a stylet handle configured to serve as a user grip for manipulation of the stylet wire, the stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, such that a distal portion of the stylet wire extends distally from a distal end of the stylet handle, the stylet handle further defining a proximately positioned track integrally connected to and extending from the longitudinally oriented throughbore and a tab, the track configured to retain a bent proximal end portion of the stylet wire,
wherein the length of the stylet wire is selected during assembly of the stylet assembly to conform to a corresponding length of the body implantable lead within a predefined tolerance, and the tab of the stylet handle is arranged and configured to melt into the track to securely fasten the stylet wire to the stylet handle and inhibit rotation of the stylet wire relative to the stylet handle, wherein the stylet wire does not extend through the tab when the tab is unmelted.

12. The lead kit of claim 11 , wherein the stylet wire is constructed of a tungsten metal alloy.

13. The lead kit of claim 11 , wherein the bent proximal end portion of the stylet wire includes a bend of between about 45 degrees and about 90 degrees.

14. The lead kit of claim 11 , wherein the stylet wire is constructed of a stainless steel metal alloy.

15. The lead kit of claim 11 , wherein the bent proximal end portion of the stylet wire includes a bend of between about 90 degrees and about 180 degrees.

16. The lead kit of claim 11 , wherein the stylet handle is constructed of plastic.

17. The lead kit of claim 11 , wherein the stylet handle includes an orientation member configured to provide a rotational orientation reference to a user during positioning of the body implantable lead.

18. The lead kit of claim 17 , wherein the orientation member is a flat surface positioned on an otherwise cylindrical portion of the stylet handle.

19. The lead kit of claim 17 , wherein the orientation member is a keyed member extending radially outward from a cylindrical portion of the stylet handle.

20. The lead kit of claim 11 , wherein the track extends from a first end in the longitudinally oriented throughbore to a second end at an outer edge of the stylet handle.

Assignees

• Medtronic Inc

Inventors

• Kregel Elizabeth
• Miller Thomas I
• Vargas Jason
• Patel Jayesh

Classifications

• A61B17/3468

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61B2017/00955

  thermoplastic · CPC title

• A61B2017/00831

  Material properties · CPC title

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61N1/37518

  Anchoring of the implants, e.g. fixation · CPC title