Large sample low aspect ratio biopsy needle

• US 10,149,664 B2
• Filed: 08/14/2012
• Issued: 12/11/2018
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Anderson, Tyson D., Almazan, Daniel O., Talpade, Dnyanesh A.
• Primary Examiner(s): Kremer, Matthew
• Application Number:
  US13/585,238
• Publication Number:
  US 20130023789A1
• Time in Patent Office: 2,310 Days
• Field of Search: 600564-568, 606170, 606171
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence

Abstract

A high aspect ratio biopsy needle achieves reliable performance with large solid sample size by means of a variety of features and combinations thereof, including support to prevent bending, reinforcement of the needle, and cutting edges arranged to resist deformation.

Claims

1. A biopsy device, comprising:

a cylindrical hollow stylet having a proximal portion, and having a distal end portion with a closed distal end and a sample recess configured to define a side opening distal to the proximal portion to receive biopsy samples;

a mounting member configured to support the proximal portion of the cylindrical hollow stylet at multiple points such that bending of the proximal portion is resisted by the mounting member supporting the proximal portion at at least three discontinuous spaced support points, the cylindrical hollow stylet coincides with each of the at least three discontinuous spaced support points; and

a longitudinal reinforcement insert having a longitudinal length, the longitudinal reinforcement insert positioned within the cylindrical hollow stylet inside the proximal portion of the cylindrical hollow stylet and immovably connected to the cylindrical hollow stylet, the longitudinal reinforcement insert having an elongate channel that extends along the longitudinal length of the longitudinal reinforcement insert within the proximal portion of the cylindrical hollow stylet and is configured to maintain a fluid passageway through the cylindrical hollow stylet, the longitudinal reinforcement insert having a continuous extent portion along the longitudinal length that coincides with each of the at least three discontinuous spaced support points, such that the longitudinal reinforcement insert and the cylindrical hollow stylet resist bending, wherein the longitudinal reinforcement insert has a distal terminal end proximal to the side opening.

2. The biopsy device of claim 1, wherein the longitudinal reinforcement insert is immovably affixed at spaced positions to the cylindrical hollow stylet, and a portion of the longitudinal reinforcement insert internal to the cylindrical hollow stylet has a non-circular cross-sectional shape configured to effect the fluid passageway across the longitudinal reinforcement insert.

3. The biopsy device of claim 1, wherein the sample recess is a longitudinal opening in a side wall of the cylindrical hollow stylet, the longitudinal opening having longitudinally oriented cutting edges on lateral sides of the longitudinal opening, wherein each of the longitudinally oriented cutting edges has a height that is between 2.5 and 4 times a wall thickness of the side wall, the longitudinally oriented cutting edges define a pair of angled opposed inside surfaces, and each of the longitudinally oriented cutting edges define an apex angle measured from a respective inside surface of the pair of angled opposed inside surfaces of the longitudinally oriented cutting edges.

4. The biopsy device of claim 1, wherein the distal terminal end of the longitudinal reinforcement insert has a beveled surface;

and wherein the beveled surface coincides with the sample recess.

5. A biopsy device, comprising:

a hollow stylet having a side wall and a distal end portion with a sample recess extending through the side wall to define a sample chamber, and a proximal end portion proximal to the sample recess, the distal end portion and the proximal end portion being disposed on a longitudinal axis;

a mounting structure configured to define at least three discontinuous longitudinally spaced support points, the hollow stylet simultaneously coinciding with each of the at least three discontinuous longitudinally spaced support points; and

a longitudinal reinforcement having a distal terminal end, the longitudinal reinforcement having at least one longitudinal channel along the longitudinal axis, the longitudinal reinforcement located at the proximal portion of the hollow stylet, the distal terminal end of the longitudinal reinforcement being proximal to the sample recess, the longitudinal reinforcement configured to maintain a fluid passageway through the hollow stylet via the at least one longitudinal channel, and the longitudinal reinforcement having a continuous extent portion configured to reinforce the hollow stylet at the at least three discontinuous longitudinally spaced support points of the mounting structure.

6. The biopsy device of claim 5, wherein one of the at least three discontinuous longitudinally spaced support points is included in an axially-elongated support element located at a distal end of the mounting structure.

7. The biopsy device of claim 5, wherein the hollow stylet has a first cross-sectional shape, and the longitudinal reinforcement is a longitudinal insert having a portion positioned internal to the hollow stylet, the portion having a second cross-sectional shape different from the first cross-sectional shape of the hollow stylet.

8. The biopsy device of claim 5, wherein the hollow stylet has a central lumen, the central lumen defining an inner surface, wherein the longitudinal reinforcement is a longitudinal insert having an outer surface, and the longitudinal insert is positioned in the central lumen at the proximal end portion of the hollow stylet, wherein the outer surface of the longitudinal insert is immovably affixed to the inner surface of the central lumen of the hollow stylet.

9. The biopsy device of claim 5, wherein the longitudinal reinforcement is a longitudinally continuous insert, the longitudinally continuous insert in its entirety being located within the proximal end portion of the hollow stylet and immovably affixed to the hollow stylet.

10. The biopsy device of claim 5, wherein a ratio of a diameter of the hollow stylet to a wall thickness of the hollow stylet is less than 15:

1 and greater than 4;

1.

11. The biopsy device of claim 5, wherein the hollow stylet has a working length that extends distally from the mounting structure.

12. The biopsy device of claim 5, wherein the sample recess is a longitudinal recess having cutting edges that extend parallel to the longitudinal axis on lateral sides of the longitudinal recess.

13. The biopsy device of claim 12, wherein the cutting edges have a depth, perpendicular to the longitudinal axis, of between 2.5 and 4 times a thickness of the side wall.

14. The biopsy device of claim 12, wherein each of the cutting edges has a height that is between 2.5 and 4 times a wall thickness of the side wall, the cutting edges define a pair of angled opposed inside surfaces, and each of the cutting edges define an apex angle measured from a respective inside surface of the pair of angled opposed inside surfaces of the cutting edges.

15. The biopsy device of claim 12, wherein a distance between the cutting edges is less than an outer diameter of the hollow stylet.

16. The biopsy device of claim 5, wherein the at least one longitudinal channel is a single longitudinal channel, the single longitudinal channel having a length that is the same as an entire length of the longitudinal reinforcement, and the single longitudinal channel located to pass through the longitudinal reinforcement along the entire length of the longitudinal reinforcement.

17. A biopsy device, comprising:

a mounting structure configured to define at least three discontinuous longitudinally spaced support points;

a hollow stylet having a lumen, a proximal portion, and a distal portion, the proximal portion having a proximal end, the distal portion having a side sample chamber opening configured to receive biopsy samples and a trocar tip distal to the side sample chamber opening, the hollow stylet having a fluid passageway between the proximal end and the side sample chamber opening, the proximal portion simultaneously coinciding with each of the at least three discontinuous spaced support points; and

a longitudinal reinforcement insert located in the lumen at the proximal portion of the stylet, and the longitudinal reinforcement insert being immovably affixed to the proximal portion of the hollow stylet, the longitudinal reinforcement insert having a longitudinal length, the longitudinal reinforcement insert defining a longitudinal fluid path through the longitudinal length of the longitudinal reinforcement insert, the longitudinal fluid path configured to maintain the fluid passageway between the proximal end of the proximal portion of the hollow stylet and the side sample chamber opening of the distal portion of the hollow stylet, the longitudinal reinforcement insert configured to reinforce the proximal portion of the hollow stylet at the at least three discontinuous longitudinally spaced support points of the mounting structure, wherein the longitudinal reinforcement insert has a distal terminal end proximal to the side sample chamber opening.

18. The biopsy device of claim 17, wherein the side sample chamber opening is a longitudinal opening in a side wall of the hollow stylet, the longitudinal opening having longitudinally oriented cutting edges on lateral sides of the longitudinal opening, wherein each of the longitudinally oriented cutting edges has a height that is between 2.5 and 4 times a wall thickness of the side wall, the longitudinally oriented cutting edges define a pair of angled opposed inside surfaces, and each of the longitudinally oriented cutting edges define an apex angle measured from a respective inside surface of the pair of angled opposed inside surfaces of the longitudinally oriented cutting edges.

19. The biopsy device of claim 17, further comprising a vacuum pump coupled in fluid communication with the side sample chamber opening of the hollow stylet via the longitudinal reinforcement insert at the proximal portion of the hollow stylet.

20. A biopsy device, comprising:

a hollow stylet having a single side wall and a distal end portion with a sample recess extending through the single side wall to define a sample chamber, and a proximal end portion proximal to the sample recess, the distal end portion and the proximal end portion being disposed on a longitudinal axis;

a mounting structure configured to define at least three discontinuous longitudinally spaced support points, the hollow stylet simultaneously coinciding with each of the at least three discontinuous longitudinally spaced support points; and

a longitudinal reinforcement having a length and a distal terminal end, the longitudinal reinforcement located inside the proximal portion of the hollow stylet with the distal terminal end being proximal to the sample recess of the hollow stylet, the longitudinal reinforcement being immovably connected to the single side wall of the hollow stylet and configured with an elongate passageway that extends along an entirety of the length of the longitudinal reinforcement to maintain a fluid passageway through the hollow stylet, the longitudinal reinforcement configured to reinforce the hollow stylet and simultaneously coincide with each of the at least three discontinuous longitudinally spaced support points of the mounting structure, such that the hollow stylet resists bending.

21. The biopsy device of claim 20, wherein the sample recess is a longitudinal recess having cutting edges that extend parallel to the longitudinal axis on lateral sides of the longitudinal recess, wherein the cutting edges define an apex angle of about 40°

.

22. The biopsy device of claim 20, further comprising a cutting cannula, the hollow stylet being received in the cutting cannula, the cutting cannula being movable relative to the hollow stylet.