Tunneling guidewire

• US 9,682,221 B2
• Filed: 08/15/2016
• Issued: 06/20/2017
• Est. Priority Date: 03/17/2014
• Status: Active Grant

• Current Assignee: Arkis BioSciences, Inc. (Integra LifeSciences Holdings Corporation)
• Original Assignee: Arkis BioSciences, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: Seaver, Chad Eric, Arnott, James Chris, Killeffer, James Alexander
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US15/237,024
• Publication Number:
  US 20160346523A1
• Time in Patent Office: 309 Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A medical device tunneling system, and a method of using the same, to subcutaneously route trocars, also commonly referred to as tunnelers, or introducers, having a cannula, stylet, and a guidewire stylet, inside a patient during a surgical procedure, such as a ventriculoperitoneal hydrocephalus shunt implantation, from a proximal entry point to a distal end point, in order to subcutaneously route and implant a medical device, such as shunt tubing, in a patient.

Claims

1. A tunneling guidewire system for subcutaneously routing tubing within a human patient, comprising:

a cannula defining a hollow passage; and

a guidewire extendable through the hollow passage of the cannula;

wherein the guidewire comprises a stiffness, k, between about 100,000 and 30,000,000 Newtons per meter for extravascularly routing the guidewire.

2. The tunneling guidewire system of claim 1, wherein the guidewire comprises a proximal end and a distal end, the proximal end being coupled to a stylet, the stylet and the guidewire being removably disposable within the hollow passage of the cannula.

3. The tunneling guidewire system of claim 2, wherein the guidewire is permanently affixed to the stylet.

4. The tunneling guidewire of claim 2, wherein at least a portion of the stylet has a first outer diameter and at least a portion of the guidewire has a second outer diameter that is less than the first outer diameter.

5. The tunneling guidewire system of claim 2, wherein the cannula, guidewire, and stylet consist of stainless steel.

6. The tunneling guidewire system of claim 1, wherein the guidewire comprises a tip comprising an endpoint loop.

7. The tunneling guidewire system of claim 1, wherein the cannula comprises a first end, a second end, a first portion associated with the first end, and a second portion associated with the second end, wherein the second portion comprises a bend such that the second end is located at a point between 0 degrees and 45 degrees from an axis aligned with the first portion.

8. The tunneling guidewire system of claim 1, wherein the guidewire comprises a handle adjacent a proximal end of the guidewire, wherein the guidewire is steerable via the handle.

9. The tunneling guidewire of claim 8, wherein the cannula comprises a proximal end and a distal end, and the guidewire handle has an outer perimeter that is larger than an inner diameter of the proximal end of the cannula, wherein the guidewire handle cannot pass through the proximal end of the cannula.

10. The tunneling guidewire of claim 9, wherein the guidewire handle is a T-shaped handle.

11. The tunneling guidewire system of claim 1, wherein the guidewire is pre-bent such that a portion of the guidewire comprises a minimum bend radius of about one centimeter.

12. The tunneling guidewire system of claim 11, wherein the portion of the guidewire that is pre-bent is pre-bent to substantially match the parietal bone radius of a patient'"'"'s skull.

13. The tunneling guidewire system of claim 1, wherein the guidewire comprises a tensile strength range from about 300 mega-pascals to about 3,500 mega-pascals.

14. The tunneling guidewire system of claim 1, wherein the guidewire comprises a Young'"'"'s modulus of at least 30 giga-pascals, but not more than about 400 giga-pascals.

15. The tunneling guidewire system of claim 1, wherein the guidewire comprises a tip defining an eyelet.

16. The tunneling guidewire system of claim 1, wherein a distal end of the guidewire comprises a tip, the tip comprising a proximal end, a distal end, and an intermediate portion between the proximal end and the distal end, wherein an outer perimeter of the intermediate portion is greater than an outer perimeter of the proximal end and an outer perimeter of the distal end.

17. The tunneling guidewire system of claim 1, wherein the cannula and guidewire comprise stainless steel.

18. A tunneling guidewire system for subcutaneously routing tubing within a patient, the system comprising:

a cannula defining hollow passage; and

a guidewire-stylet comprising a guidewire portion and a stylet portion, the guidewire portion being coupled to the stylet portion, the guidewire-stylet being extendable through the hollow passage of the cannula, wherein the guidewire portion comprises a stiffness, k, between about 100,000 and 30,000,000 Newtons per meter for extravascularly routing the guidewire portion.

19. The tunneling guidewire system of claim 18, wherein at least a portion of the guidewire portion is pre-bent to substantially match the parietal bone radius of a patient'"'"'s skull, and wherein the pre-bent portion of the guidewire portion is straightened when disposed within the cannula and bent when disposed outside of the cannula.

20. The tunneling guidewire system of claim 19, wherein the pre-bent portion of the guidewire portion comprises a tip, the tip defining an opening for receiving a drainage tube.

21. The tunneling guidewire system of claim 18, wherein the stylet portion comprises a proximal end and a distal end, and the guidewire portion extends from the distal end of the stylet portion, and a handle is coupled to the proximal end of the stylet portion, the handle having an outer perimeter that is greater than an inner diameter of the cannula such that the handle cannot pass through the cannula.