Hyperechogenic needles

• US 8,628,475 B2
• Filed: 06/22/2011
• Issued: 01/14/2014
• Est. Priority Date: 06/24/2010
• Status: Active Grant

• Current Assignee: CDW Investments, LLC
• Original Assignee: CDW Investments, LLC
• Inventors: Wang, Clement D.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/166,383
• Publication Number:
  US 20110319758A1
• Time in Patent Office: 937 Days
• Field of Search: 600/458, 600/459, 600/462, 600/463, 600/464, 600/561, 600/562, 600/564
• US Class Current: 600/458
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 8/0841 for locating instruments

Abstract

A hyperechogenic needle includes a rigid shaft, which can be a hollow metal cannula, having a hyperechogenic particulate material affixed on an outer surface of the shaft that provides for visualization of the needle in two-dimensional (2D) ultrasound, particularly when the needle is in a position forming a non-90° angle between the longitudinal axis and the direction of the ultrasound waves in the two-dimensional ultrasound plane. The hyperechogenic particulate material can be covered by a polymeric coating or embedded in a polymeric material to provide a hyperechogenic layer. The polymeric coating and polymeric material can be electrically non-conductive or electrically conductive.

Claims

1. A needle effective for guided positioning in soft tissue of a patient with the aid of a real-time two-dimensional ultrasonic imaging apparatus, the needle comprising:

a rigid shaft having a longitudinal axis, a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, said distal end including a tip portion defining a point;

a hyperechogenic layer affixed to said shaft along at least a portion of the outer surface;

wherein said hyperechogenic layer comprises a polymeric material having a hyperechogenic particulate material dispersed therein;

wherein said hyperechogenic particulate material is operable in response to a beam of ultrasound waves in a two-dimensional ultrasound plane to produce an image of said needle when said needle is in a position forming a non-90°

angle between the longitudinal axis and the direction of the ultrasound waves in the two-dimensional ultrasound plane; and

wherein said hyperechogenic particulate material comprises a particulate talc material.

2. The needle in accordance with claim 1 wherein said particulate talc material has an average particle size of from about 2 to about 18 microns.

3. The needle in accordance with claim 1 wherein said polymeric material comprises a thermoplastic polymer material.

4. The needle in accordance with claim 1 wherein said polymeric material comprises a member selected from the group consisting of polyurethane, polyethylene, nylon, polytetrafluoroethylene, polyvinyl chloride, polypropylene, polyester, parylene, silicone and polyethylene terephthalate.

9. The needle in accordance with claim 1 wherein said hyperechogenic particulate material further comprises a calcium-containing material.

10. The needle in accordance with claim 9 wherein said calcium-containing material comprises particulate calcium carbonate.

11. The needle in accordance with claim 10 wherein said particulate calcium carbonate comprises a member selected from the group consisting of ground calcium carbonate and precipitated calcium carbonate.

12. The needle in accordance with claim 9 wherein said calcium-containing material comprises a member selected from the group consisting of calcium phosphate and hydroxyapatite.

5. A needle effective for guided positioning in soft tissue of a patient with the aid of a real-time two-dimensional ultrasonic imaging apparatus, the needle comprising:

a rigid shaft having a longitudinal axis, a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, said distal end including a tip portion defining a point;

a hyperechogenic particulate material affixed to said shaft along at least a portion of the outer surface, said hyperechogenic particulate material operable in response to a beam of ultrasound waves in a two-dimensional ultrasound plane to produce an image of said needle when said needle is in a position forming a non-90°

angle between the longitudinal axis and the direction of the ultrasound waves in the two-dimensional ultrasound plane; and

a polymeric coating positioned over at least a portion of said shaft and covering said hyperechogenic particulate material, the polymeric coating having a lubricious external surface;

wherein said hyperechogenic particulate material comprises a particulate talc material.

6. The needle in accordance with claim 5 wherein said particulate talc material has an average particle size of from about 2 to about 18 microns.

7. The needle in accordance with claim 5 wherein said particulate talc material comprises platy talc.

8. The needle in accordance with claim 5 wherein said polymeric coating comprises polyethylene terephthalate.

13. The needle in accordance with claim 5 wherein the particulate material is a surface coated particulate material.

14. The needle in accordance with claim 13 wherein the surface coated particulate material includes a stearic acid coating.

15. The needle in accordance with claim 5 wherein said shaft comprises surgical grade steel.

16. The needle in accordance with claim 5 wherein said shaft further includes an inner surface defining a lumen through said shaft.

17. The needle in accordance with claim 5 wherein at least a portion of said hyperechogenic particulate material is positioned between said shaft and said polymeric coating.

18. The needle in accordance with claim 5 wherein at least a portion of said hyperechogenic particulate material is dispersed in said polymeric coating.

19. The needle in accordance with claim 18 wherein said hyperechogenic particulate material is dispersed in said polymeric coating at a concentration of from about 5 to about 25 weight percent.

20. The needle in accordance with claim 5 wherein said needle comprises a friction lowering material affixed to said lubricious external surface.

21. The needle in accordance with claim 5

wherein said needle is configured for use in blocking a nerve of a patient using simultaneous electrical nerve stimulation and two-dimensional ultrasound visualization of the nerve;

and

wherein said polymeric coating composes an insulating layer covering at least a portion of said shaft.

22. The needle in accordance with claim 21 wherein said polymeric coating covers at least a portion of said hyperechogenic particulate material.

23. The needle in accordance with claim 21 wherein said shaft is electrically conductive, said polymeric layer covers substantially all of said shaft except not said tip portion.

24. The needle in accordance with claim 21 wherein said shaft is electrically conductive, said polymeric layer covers substantially all of said shaft.

25. The needle in accordance with claim 21 wherein said polymeric coating comprises a member selected from the group consisting of polyurethane, polyethylene, nylon, polytetrafluoroethylene, polyvinyl chloride, polypropylene, polyester, parylene and silicone.

26. The needle in accordance with claim 21 wherein said polymeric coating comprises a polyethylene terephthalate.

27. The needle in accordance with claim 5 wherein said tip comprises a bevel.