Hollow curved superelastic medical needle and method

• US 8,747,359 B2
• Filed: 11/08/2011
• Issued: 06/10/2014
• Est. Priority Date: 12/09/1998
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Pakter, Robert L., Morris, Edward J.
• Primary Examiner(s): Mendez, Manual
• Application Number:
  US13/291,282
• Publication Number:
  US 20120123427A1
• Time in Patent Office: 945 Days
• Field of Search: 604/272, 604/207, 604/117, 604/273, 604/274, 604/93.01, 604/164.01
• US Class Current: 604/164.01
• 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 compromising an infusion 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 compromise 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 non-coring coaxial needle assembly including an outer needle cannula and an introducer stylet receivable coaxially within the outer needle cannula;

the outer needle cannula having a lumen and a first distal tip, the first distal tip having a bevel;

the introducer stylet having a second distal tip, the second distal tip having a bevel;

a first hub attached to the outer needle cannula;

a second hub attached to the introducer stylet; and

wherein the second hub is adapted to lock to the first hub so as to maintain the introducer stylet coaxially received within the outer needle cannula with the bevel of the first tip aligned with the bevel of the second tip.

2. A needle assembly according to claim 1, wherein the bevel of the first tip extends from a first lateral side of the outer needle cannula to a second, opposite lateral side of the outer needle cannula, and the bevel of the second tip extends from a first lateral side of the introducer stylet to a second, opposite lateral side of the introducer stylet.

3. A method for delivering material to an inner region of a vertebral body, comprising:

advancing an inner needle through a substantially straight outer needle cannula having a distal opening within the vertebral body, the inner needle having a lumen and a preformed bend portion which, in an unconstrained condition, defines a bend proximate to a distal tip portion of the inner needle;

wherein during said advancing the preformed bend portion of the inner needle is constrained to a substantially straight configuration while received within the outer needle cannula;

causing the preformed bend portion of the inner needle to exit the distal opening of the outer needle cannula so as to no longer be constrained by the outer needle cannula and advance in a path that diverges from the longitudinal axis of the outer needle cannula; and

delivering material into the vertebral body from the lumen of the inner needle.

4. The method of claim 3, wherein the inner needle has a needle cannula comprised of superelastic material.

5. The method of claim 4, wherein the superelastic material is a superelastic nickel-titanium alloy.

6. The method of claim 4 wherein a distal tip of the inner needle is deflected at an angle between about 30°

and about 110°

when the inner needle is in an unconstrained condition.

7. The method of claim 4 wherein a distal tip of the inner needle is deflected at an angle between about 60°

and about 90°

when the inner needle is in an unconstrained condition.

8. The method of claim 3, wherein the material is bone cement.

9. A method for providing access to an inner region of a vertebral body to deliver material to the inner region, comprising:

penetrating the vertebral body with a substantially straight, non-coring coaxial needle assembly including an outer needle cannula having a longitudinal axis and a stylet coaxially received within the outer needle cannula;

removing the stylet from the outer needle cannula so as to leave a distal tip of the outer needle cannula within the vertebral body;

advancing an inner needle through the outer needle cannula, the inner needle having a lumen and a preformed bend portion which, in an unconstrained condition, defines a bend proximate to a distal tip portion of the inner needle;

wherein during said advancing the preformed bend portion of the inner needle is constrained to a substantially straight configuration while received within the outer needle cannula; and

causing the preformed bend portion of the inner needle to exit a distal opening of the outer needle cannula so as to no longer be constrained by the outer needle cannula and advance in a path that diverges from the longitudinal axis of the outer needle cannula.

10. The method of claim 9, wherein the inner needle has a needle cannula comprised of superelastic material.

11. The method of claim 10, wherein the superelastic material is a superelastic nickel-titanium alloy.

12. The method of claim 11, wherein the material is bone cement.

13. The method of claim 10 wherein a distal tip of the inner needle is deflected at an angle between about 30°

and about 110°

when the inner needle is in an unconstrained condition.

14. The method of claim 10 wherein a distal tip of the inner needle is deflected at an angle between about 60°

and about 90°

when the inner needle is in an unconstrained condition.