Hollow, curved, superlastic medical needle

• US 6,592,559 B1
• Filed: 12/09/1999
• Issued: 07/15/2003
• Est. Priority Date: 12/09/1998
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pakter, Robert L., Morris, Edward J.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/457,844
• Time in Patent Office: 1,314 Days
• Field of Search: 604/523, 604/530, 604/272, 604/95.01, 604/273, 604/274, 604/158, 604/164.01, 606/113, 606/114, 606/139, 606/144, 606/148
• US Class Current: 604/272
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

A needle assembly 10 comprising a needle 11 that includes a needle cannula 13 made of a superelastic material such as nitinol. The needle cannula is cold-worked or heat annealed to produce a preformed bend 16 that can be straightened within passageway 21 of a coaxial outer cannula 12 for introduction into the body of a patient. Upon deployment from the outer cannula, the needle cannula substantially returns to the preformed configuration for the introduction or extraction of materials at areas lateral to the entry path of the needle assembly. The needle assembly can comprise a plurality of needle cannulae than can be variably arranged or configured for attaining a desired infusion pattern.

Claims

1. A needle assembly comprising:

a needle having a passageway and comprising at least one needle cannula having a distal tip, the at least one cannula, while in its unconstrained configuration, having at least one preformed bend, the at least one needle cannula able to be constrained to a second configuration, whereby at release of external constraining forces, the at least one needle cannula substantially returns to the unconstrained configuration;

wherein the needle further comprises a plane indicator proximate to a proximal end of the needle for indicating the direction of the preformed bend of the needle cannula, the plane indicator comprising a member secured to and projecting from the needle cannula and adapted to be maneuvered by a user for reorienting the needle cannula.

2. The needle assembly of claim 1, wherein the second configuration is substantially straight.

3. The needle assembly of claim 1, further comprising a coaxial outer cannula for constraining the at least one needle cannula into the second configuration.

4. The needle assembly of claim 1 wherein the at least one needle cannula comprises a superelastic material.

5. The needle assembly of claim 4 wherein the superelastic material includes a Ni—

Ti alloy.

6. The needle assembly of claim 4 whereby the at least one preformed bend is induced by mechanical deformation of the needle cannula such that the superelastic material of the at least one preformed bend includes a martensitic crystalline structure, while non-mechanically deformed portions of the needle cannula comprise a substantially austenitic crystalline structure.

7. The needle assembly of claim 1 further comprising an inner needle introducer stylet having a stylet shaft, the stylet shaft being insertable into the passageway of the needle.

8. The needle assembly of claim 7 wherein the stylet shaft comprises a flexible polymeric material.

12. The needle assembly of claim 4 whereby the at least one preformed bend is induced by mechanical deformation of the needle cannula such that the superelastic material of the at least one preformed bend includes a martensitic crystalline structure, while non-mechanically deformed portions of the needle cannula comprise a substantially austenitic crystalline structure.

13. The needle assembly of claim 1 further comprising a member for constraining the at least one needle cannula in the second configuration.

14. The needle assembly of claim 13 wherein the constraining member coextends along the at least one needle cannula.

9. A needle assembly comprising:

a needle comprising at least one needle cannula made of a superelastic material, the at least one cannula, while in its unconstrained configuration, having at least one preformed bend; and

a coaxial outer cannula having a distal end and passageway therethrough, the needle adapted to be disposed within and along the passageway of the coaxial outer cannula for constraint of the needle in the second configuration;

the needle being slidably deployable from the distal end of coaxial outer cannula whereby at release of constraining forces, the at least one needle cannula substantially returns to the unconstrained configuration;

wherein the needle further comprises a plane indicator proximate to a proximal end of the needle for indicating the direction of the preformed bend of the needle cannula, the plane indicator comprising a member secured to and projecting from the needle cannula and adapted to be maneuvered by a user for reorienting the needle cannula.

10. The needle assembly of claim 9 wherein the distal end of the coaxial outer cannula includes a sharpened tip adapted for the penetration of tissue.

11. The needle assembly of claim 9 wherein the superelastic material includes a Ni—

Ti alloy.

15. A needle assembly comprising:

a needle having a needle cannula having a distal tip, the needle cannula while in its unconstrained configuration having a preformed bend with an angle within a range from 40 to 90°

, the preformed bend further comprising mechanically-induced martensite with straight portions of said needle cannula comprised of a austenitic state Ni—

Ti alloy, the needle cannula constrainable to a second configuration that is substantially straight, whereby at release of external constraining forces, the needle cannula substantially returns to its unconstrained configuration;

a coaxial outer cannula having a distal end and a passageway therethrough, the needle adapted to be disposed within and along the passageway of the coaxial outer cannula to constrain the needle into the second configuration, the needle being slidably deployable from the distal end of coaxial outer cannula whereby at exiting from the distal end the needle cannula substantially returns to its unconstrained configuration;

an inner needle introducer stylet having a stylet shaft, the stylet shaft being insertable into the passageway of the needle; and

an outer cannula introducer stylet that is insertable into the passageway of the coaxial outer needle such that the coaxial outer needle and outer cannula introducer stylet comprise an outer needle assembly adapted for insertion into the body of a patent;

wherein the needle further comprises a plane indicator proximate to a proximal end of the needle for indicating the direction of the preformed bend of the needle cannula, the plane indicator comprising a member secured to and projecting from the needle cannula and adapted to be maneuvered by a user for reorienting the needle cannula.

16. A curved metal member comprising:

an elongate metal member having a passageway and comprising at least one cannula having a distal tip, the at least one cannula, while in its unconstrained configuration, having at least one preformed bend, the at least one cannula able to be constrained to a second configuration, whereby at release of external constraining forces, the at least one cannula substantially returns to the unconstrained configuration; and

the preformed bend further comprising mechanically-induced martensite with remaining portions of said cannula comprised of austenitic state Ni—

Ti alloy;

wherein the elongate metal member further comprises a plane indicator proximate to a proximal end of the elongate metal member for indicating the direction of the preformed bend of the cannula, the plane indicator comprising a member secured to and projecting from the cannula and adapted to be maneuvered by a user for reorienting the cannula.

17. An assembly comprising the curved metal member of claim 16 and further comprising a member for constraining the at least one cannula in the second configuration.