Endoscopic ultrasound-guided notched biopsy needle

Patent metadata

Field	Value
Publication number	US-9986981-B2
Application number	US-201514703146-A
Country	US
Kind code	B2
Filing date	May 4, 2015
Priority date	Apr 6, 2010
Publication date	Jun 5, 2018
Grant date	Jun 5, 2018

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.

First claim

The invention claimed is:

1. A tissue-sampling needle device, comprising:
an elongate tubular cannula including a cannula wall defining a longitudinal cannula lumen constructed to receive a tissue sample;
a distal beveled end of the cannula including a long side and a short side;
a notch through the cannula wall, open to the cannula lumen and configured to collect a tissue core sample;
where the notch is disposed proximally of, and adjacent to, the beveled distal cannula end and is generally centered radially opposite the short beveled end side;
where a distal end of the notch includes a generally parabolic distal lip defined by a portion of the cannula wall, including a proximal-facing cutting edge that extends proximally from a distal-most end of the notch such that a central distal lip portion including the cutting edge is disposed more proximally than lip end portions
that transition directly, at an acute angle relative to a longitudinal central axis, from the central lip portion to, and
that are continuous with,

generally longitudinal lateral sides of the notch, which join together to form a parabolic proximal end of the notch;
where the parabolic proximal end of the notch and the generally parabolic distal lip are joined by a pair of radiused transition curves forming the lip end portions between the generally longitudinal lateral sides;
where the cannula proximal of, across, and distal of the notch, including the cutting edge, includes a uniform outer diameter;
where the cannula lumen lacks any inner cutting member for movably transecting the notch; and
wherein the cannula is configured as sufficiently flexible and sufficiently long for passage through a working channel of a peroral surgical visualization device to a duodenum of a patient.

2. The device of claim 1 , wherein the cannula comprises a 19-gauge needle including an inner diameter of about 0.9 mm (about 0.037 inches), wherein the notch occupies about one-half of an outer circumference of the cannula.

3. The device of claim 1 , further comprising a solid stylet disposed through, and occupying substantially an entire cross-sectional area of, at least a lengthwise portion of the cannula lumen, where the solid stylet completely occludes the lumen and the notch in a first operational state of the device.

4. The device of claim 3 , where a distal end of the stylet is beveled to align with the distal beveled cannula end in a substantially coplanar manner.

5. The device of claim 3 , where a distal end of the stylet is rounded.

6. The device of claim 1 , further comprising a pattern of echogenic surface features disposed immediately adjacent to and proximal of the notch.

7. The device of claim 6 , wherein the echogenic surface features comprise dimples in the cannula wall.

8. The device of claim 1 , further comprising a solid stylet disposed removably through, and occupying substantially an entire cross-sectional area of and an entire length of the cannula lumen without extending substantially beyond a distalmost end terminus of the cannula, such that the solid stylet completely occludes the lumen and the notch.

9. The device of claim 1 , wherein the cannula comprises a selected one of a 19-gauge needle, 22-gauge needle, or 25-gauge needle, wherein the notch occupies about one-half of an outer circumference of the cannula.

10. The device of claim 1 , where the distal beveled end of the cannula is open to the cannula lumen.

11. The device of claim 1 , comprising a consistent inner diameter of the cannula along an entire length of the cannula lumen, including across the notch.

12. A notched aspiration biopsy needle, comprising:
a flexible elongate tubular cannula sized no larger than 19-gauge, including a cannula wall defining a cannula lumen configured to communicate with a proximal source of suction;
wherein the cannula lumen extends longitudinally through the cannula;
a distal beveled end of the cannula including a long side and a short side;
a notch through the cannula wall, open to the cannula lumen and configured to collect a tissue core sample;
wherein the notch is disposed proximally adjacent to the beveled distal cannula end and is generally centered in longitudinal alignment with the long beveled end side and opposite the short beveled end side;
wherein the notch includes a cutting edge defined by a proximal-facing portion of the cannula wall, where the cutting edge is both longitudinally and radially arcuate such that a center-most portion of the cutting edge
is more proximally disposed than are lateral-end portions of the cutting edge; and
is nearer to a distal-most open portion of the notch than to a proximal-most portion of the notch,

where said proximal-most portion of the notch is parabolic, and the proximal-facing edge of the notch transitions from the cutting edge directly, at an acute angle relative to a longitudinal central axis, to and through a pair of radiused lip-ends to the parabolic proximal-most portion of the notch, where the radiused lip-ends have a radius of curvature equal to about one-eightieth of a distance between a proximal-most end of the notch and a proximal-most edge of the cutting edge; and
wherein the cannula is configured as sufficiently flexible and sufficiently long for passage through a working channel of a peroral surgical visualization device to a duodenum of a patient.

13. The needle of claim 12 , 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 rounded and a lateral side of the stylet fully obscures the notch when the distal end of stylet is distal of the notch.

14. A method of tissue collection comprising the steps of:
providing a tissue-sampling needle device comprising:
an elongate tubular cannula including a cannula wall defining a longitudinal cannula lumen constructed to receive a tissue sample;
a distal beveled end of the cannula including a long side and a short side:
a notch through the cannula wall, open to the cannula lumen and configured to collect a tissue core sample;
where the notch is disposed proximally of, and adjacent to, the beveled distal cannula end and is generally centered radially opposite the short beveled end side;
where a distal end of the notch includes a generally parabolic distal lip defined by a portion of the cannula wall, including a proximal-facing cutting edge that extends proximally from a distal-most end of the notch such that a central distal lip portion including the cutting edge is disposed more proximally than lip end portions
that transition directly, at an acute angle relative to a longitudinal central axis, from the central lip portion to, and
that are continuous with,

generally longitudinal lateral sides of the notch, which join together to form a parabolic proximal end of the notch;
where the parabolic proximal end of the notch and the generally parabolic distal lip are joined by a pair of radiused transition curves forming the lip end portions between the generally longitudinal lateral sides;
where the cannula proximal of, across, and distal of the notch, including the cutting edge, includes a uniform outer diameter; and
where the cannula lumen lacks any inner cutting member for movably transecting the notch;

directing the distal beveled end of the cannula into a target site;
applying suction to the needle lumen in a manner drawing tissue into the needle lumen through the notch; and
moving the needle proximally in a manner engaging the proximally-facing cutting edge with the target site such t

Assignees

• Cook Medical Technologies Llc

Inventors

• Schembre Drew B
• Clancy Michael S
• Chmura Kevin

Classifications

• A61B8/481

  involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream · CPC title

• A61B8/0841

  for locating instruments · CPC title

• A61B1/24

  for the mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth · CPC title

• A61B1/018

  for receiving instruments · CPC title

• A61B10/0275 Primary

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