Endoscopic biopsy needle with coil sheath

Patent metadata

Field	Value
Publication number	US-9629617-B2
Application number	US-201414195333-A
Country	US
Kind code	B2
Filing date	Mar 3, 2014
Priority date	Mar 5, 2013
Publication date	Apr 25, 2017
Grant date	Apr 25, 2017

Abstract

A notched tissue-collection needle configured similarly to a fine-needle-aspiration needle is provided with a cutting edge disposed in the notch and configured to excise tissue into the notch for collection. A stylet may be provided through a lumen of the needle during introduction into a patient body. The needle may be provided with echogenicity-enhancing features. A coated-wire sheath through which the needle is slidably disposed includes an overcoating that is thicker along a distal length and thinner along a proximal length.

First claim

The invention claimed is:

1. A biopsy needle assembly configured to collect histological samples via a surgical visualization device, the assembly comprising:
an elongate notched needle cannula including a distal notch open through the elongate notched needle cannula to a longitudinal needle lumen, which longitudinal needle lumen extends through the elongate notched needle cannula; and
an elongate sheath;
where the elongate sheath comprises a longitudinal sheath lumen through which the elongate notched needle cannula is slidably disposed;
where the elongate sheath includes a generally cylindrical body defining the longitudinal sheath lumen, the generally cylindrical body including:
a coiled coated-wire tube extending proximally from a distal body end, wherein the coiled coated-wire tube includes a plurality of adjacent coils;
a sheath overcoating around the coiled coated-wire tube; and

where the coiled coated-wire tube has a substantially consistent outer diameter along an entire length of the coiled coated-wire tube, the elongate notched needle cannula has a substantially consistent outer diameter along an entire length of the elongate notched needle cannula, and the sheath overcoating includes a first thickness along a distal sheath length, the sheath overcoating includes a second thickness along a proximal sheath length, and where the first thickness is greater than the second thickness such that the first thickness causes an outer diameter of the distal sheath length to be larger than an outer diameter of the proximal sheath length, wherein the sheath overcoating is in contact with and extends contiguously between the plurality of adjacent coils along the distal sheath length and along the proximal sheath length.

2. The assembly of claim 1 , where the sheath overcoating comprises nylon.

3. The assembly of claim 1 , where the outer diameter of the distal sheath length is about 5% to about 20% greater than the outer diameter of the proximal sheath length.

4. The assembly of claim 1 , where a wire that forms the coiled coated-wire tube is coated with PTFE or another lubricious polymer.

5. The assembly of claim 1 , where the elongate notched needle cannula includes a beveled distal end tip, and the distal notch is located radially opposite and longitudinally proximal of the beveled distal end tip.

6. The assembly of claim 1 , wherein the distal notch is aligned within the distal sheath length when a distal end tip of the elongate notched needle cannula is aligned with or near a distal sheath end.

7. The assembly of claim 1 , where the outer diameter of the distal sheath length is effective to limit endoscope elevator deflection of the elongate sheath to less than deflection allowed by the outer diameter of the proximal sheath length.

8. The assembly of claim 1 , where the distal sheath length extends about 10 mm to about 50 mm from a distal sheath end.

9. The assembly of claim 1 , further comprising a stylet removably disposed through the longitudinal needle lumen.

10. The assembly of claim 1 , where the elongate sheath comprises stainless steel wire coated with PTFE and wound to form a consistent-diameter tube.

11. The assembly of claim 1 , where the sheath overcoating includes extruded nylon continuously forming the outer diameter f the distal sheath length, the outer diameter proximal sheath length, and a smooth, non-stepped transition therebetween.

12. The assembly of claim 1 , where the sheath overcoating is effective to limit gapping between adjacent coils of the coiled coated-wire tube during manipulation of the coiled coated-wire tube.

13. The assembly of claim 1 , wherein the elongate notched needle cannula includes a consistent outer diameter along at least a distal length of the elongate notched needle cannula from distal of the distal notch, across the distal notch, and proximal of the distal notch.

14. The assembly of claim 1 , wherein the elongate notched needle cannula includes a pattern of echogenic surface features disposed immediately adjacent to and proximal of the distal notch.

15. The assembly of claim 1 , wherein the elongate notched needle cannula is configured as a 20-gauge needle including an echogenically dimpled surface adjacent the distal notch.

16. The assembly of claim 15 , where the coiled coated-wire tube of the elongate sheath comprises PTFE-coated stainless steel wire and the sheath overcoating comprises nylon.

17. A notched aspiration biopsy needle device, comprising:
a flexible elongate tubular cannula sized no larger than 19-gauge, including a cannula wall defining a cannula lumen, which cannula lumen is configured to communicate with a proximal source of suction;
wherein the cannula lumen extends longitudinally through the flexible elongate tubular cannula;
a distal beveled end of the flexible elongate tubular cannula including a long side and a short side;
a notch through the cannula wall, the notch being open to the cannula lumen;
wherein the notch is disposed proximally adjacent to the distal beveled end and is generally centered in longitudinal alignment with the long side of the distal beveled end and opposite the short side of the distal beveled end;
wherein the notch includes an arcuate cutting edge defined by a distal-facing portion of the cannula wall which distal-facing portion of the cannula wall
is within the circumference of the cannula wall, and
extends into the notch; and

an elongate sheath;
where the elongate sheath comprises a longitudinal sheath lumen through which the flexible elongate tubular cannula is slidably disposed;
where the sheath includes a generally cylindrical body defining the longitudinal sheath lumen, the generally cylindrical body including:
a coiled coated-wire tube extending proximally from a distal body end, wherein the coiled coated-wire tube includes a plurality of adjacent coils;
a sheath overcoating around the coiled coated-wire tube; and

where the coiled coated-wire tube has a substantially consistent outer diameter along an entire length of the coiled coated-wire tube, the flexible elongate tubular cannula has a substantially consistent outer diameter along an entire length of the flexible elongate tubular cannula, and the sheath overcoating includes a first thickness along a distal sheath length, the sheath overcoating includes a second thickness along a proximal sheath length, and where the first thickness is greater than the second thickness such that the first thickness causes an outer diameter of the distal sheath length to be larger than an outer diameter of the proximal sheath length, wherein the sheath overcoating is in contact with and extends contiguously between the plurality of adjacent coils along the distal sheath length and along the proximal sheath length.

18. The needle device of claim 17 , further comprising a stylet disposed through, and occupying substantially an entire cross-sectional area of, at least a lengthwise portion of the cannula lumen, wherein a distal end of the stylet is configured not to extend beyond the distal beveled end of the flexible elongate tubular cannula.

19. The needle device of claim 17 , wherein the flexible elongate tubular cannula is configured as sufficiently long and flexible for passage through a working channel of a peroral surgical visualization device to a target site within a patient abdomen.

20. The needle device of claim 17 , further comprising a pattern of echogenic surface features disposed immediately adjacent to and proximal of the notch.

Assignees

• Cook Medical Technologies Llc

Inventors

• Leahy Ronan
• Clancy Michael S

Classifications

• A61B1/018

  for receiving instruments · CPC title

• A61B10/04 Primary

  Endoscopic instruments, e.g. catheter-type instruments · CPC title

• A61B10/0275

  with sample notch, e.g. on the side of inner stylet · CPC title

• A61B2010/045

  Needles (pointed biopsy devices with vacuum aspiration A61B10/0283) · CPC title

• A61B8/12

  in body cavities or body tracts, e.g. by using catheters · CPC title