Flexible elongate surgical needle device having a tissue engaging section being of greater flexibility than an intermediate section, and methods of using the device

• US 20060189891A1
• Filed: 12/14/2005
• Published: 08/24/2006
• Est. Priority Date: 12/15/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Waller, David F., Waxman, Irving
• Granted Patent: US 7,641,638 B2
• Time in Patent Office: Days
• US Class Current: 600/564
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

Medical devices, kits, and methods for utilizing an elongate surgical needle that may be used through an endoscope working channel or through an external accessory channel device used with an endoscope are provided. The needle has a proximal end and a flexible distal end, an opening at or near the proximal end and an opening at or near the distal end, the openings defining a channel. The surgical needle distal end comprises a tissue engaging section and an intermediate section being operatively coupled in an axial direction. The tissue engaging section and intermediate section have different flexibility such that the tissue engaging section has greater flexibility than the intermediate section. Optionally, the needle distal end has a preformed bend at or near the tissue engaging section, the preformed bend capable of being constrained to a substantially linear configuration and capable of returning to the preformed configuration when unconstrained.

Claims

1. A surgical needle, comprising:

an elongate needle having a proximal end, an intermediate section, and a flexible distal end operatively coupled to the intermediate section, the proximal end comprising a proximal end opening and the distal end comprising a distal end opening, and the openings defining a channel there between; and

the distal end further comprising a tissue engaging section comprising a first material and the intermediate section comprising a second material, the first material being more flexible than the second material,

wherein the tissue engaging section has greater flexibility than the intermediate sections and

wherein the needle is suitable for delivery of one of medication and aspiration biopsy.

4. The device of claim 1 wherein the first material comprises a super-elastic alloy.

5. The device of claim 4 wherein the super-elastic alloy is selected from the group consisting of a copper-zinc-aluminum alloy, a iron-manganese-silicon alloy, a gold-cadmium alloy, a copper-aluminum alloy, a copper-aluminum-nickel alloy, and a nickel-titanium alloy.

6. The device of claim 1 wherein the tissue engaging section and the intermediate section have substantially similar cross-sectional areas.

7. The device of claim 6 wherein the tissue engaging section and the intermediate section comprise a substantially similar material and at least one of the first and second materials have been treated such that the tissue engaging section has greater flexibility than the intermediate section.

8. The device of claim 1 wherein the needle comprises a length of between about 100 cm and 250 cm.

9. The device of claim 1 wherein the needle comprises a length of between about 200 cm and 215 cm.

10. The device of claim 1 wherein the needle is a biliary biopsy needle configured for performing aspiration of tissue in a biliary tree of a patient.

11. The device of claim 1 wherein the tissue engaging section has a preformed bend capable of being constrained to a substantially linear configuration and capable of returning to the preformed bend when unconstrained.

12. The device of claim 1 further comprising an elongate sheath having an opening at a proximal end and an opening at or near a flexible distal end, the sheath openings defining a channel there between, wherein the elongate needle is slideably positioned between first and second positions within the sheath channel.

13. The device of claim 12 further comprising a stationary member and an adjustable member moveable relative to the stationary member, the stationary member having openings at proximal and distal ends defining a channel therebetween, the proximal ends of the sheath and needle being positioned proximal to the stationary member distal opening and within the stationary member channel, and the adjustable member configured to move the needle between the first and second positions.

14. The device of claim 13 wherein the adjustable member has an opening at or near a proximal end, and an opening at or near a distal end and a channel in fluid communication within the stationary member channel.

15. The device of claim 14 further comprising a stylet having a proximal end and a distal end, the stylet configured to be removably placed in the adjustable member proximal opening such that the stylet extends within the adjustable member and stationary member channels and distally within the needle channel such that the stylet proximal end is located at or near the adjustable member proximal opening and the stylet distal end is located at or near the needle distal end.

16. The device of claim 15 further comprising a syringe configured to be in communication with the adjustable member proximal opening.

2. (canceled)

3. (canceled)

17. A kit for a surgical needle device suitable for delivery of medication and aspiration biopsy, comprising:

a main body having a stationary member and adjustable member moveable between first and second positions relative to the stationary member, the adjustable member having proximal and distal openings defining a main body channel;

a syringe configured to be secured to the adjustable member proximal opening in communication with the main body channel;

an elongate sheath comprising proximal and distal ends having openings defining a sheath channel, the proximal end configured to be secured to the stationary member;

an elongate needle slideably positioned axially within the sheath channel, the needle having a proximal end comprising an opening, an intermediate section, and a flexible distal end comprising an opening, the openings defining a needle channel there between, the flexible distal end operatively coupled to the intermediate section and the proximal end configured to be secured to the adjustable member with the needle channel in communication with the main body channel, the needle distal end further comprising a tissue engaging section comprising a first material and the intermediate section comprising a second material, the first material being more flexible than the second material,

wherein the tissue engaging section has greater flexibility than the intermediate section.

18. The kit of claim 17 wherein the tissue engaging section comprises a super-elastic alloy.

19. The kit of claim 17 further comprising a packaging containing the kit.

20. A method of using a surgical needle device, comprising the steps of:

providing a surgical needle device configured to deliver at least one of medication and aspiration biopsy, the surgical needle device configured to be connected to a syringe and having an elongate needle moveable between first and second positions and having a proximal end, an intermediate section, and a flexible distal end operatively coupled to the intermediate section, the distal end comprising a tissue engaging section comprising a first material and an intermediate section comprising a second material, the distal end tissue engaging section first material having greater flexibility than the intermediate section second material;

introducing the needle distal end to a surgical site;

setting the first and second positions for the needle; and

advancing the needle distal end tissue engaging section into the surgical site.

21. The method of claim 20 further comprising the step of preparing a syringe with negative pressure and connecting the syringe to the needle device.

22. The method of claim 21 further comprising the step of aspirating the surgical site.

23. The method of claim 22 further comprising the step of replacing the syringe with a second syringe.

24. The method of claim 23 further comprising the step of aspirating the surgical site with the second syringe.

25. The method of claim 20 further comprising the step of preparing a syringe with medication.

26. The method of claim 25 further comprising the step of delivering medication to the surgical site.