LARGE SAMPLE LOW ASPECT RATIO BIOPSY NEEDLE

• US 20100030108A1
• Filed: 10/23/2007
• Published: 02/04/2010
• 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.
• Granted Patent: US 8,262,586 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• 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 generally cylindrical hollow stylet having a distal end with a sample recess configured to receive biopsy samples, and a proximal portion;

a mounting member configured to support the proximal portion of the stylet such that bending of the proximal portion is resisted by the mounting member supporting the proximal portion at least three support points therealong;

a longitudinal reinforcement affixed at multiple affixation points to the stylet and extending along a substantial fraction of the stylet and also extending between the at least three support points, such that the reinforcement also resists bending.

2. The device of claim 1, wherein the at least three support points are included in a continuous series of points of contact between the longitudinal reinforcement and the mounting member.

3. The device of claim 1, wherein the stylet has a working length from the distal end that extends axially of the mounting member when held thereby.

4. The device of claim 1, wherein the sample recess has cutting edges extending parallel to an axis joining the distal end and the proximal portion, the cutting edges being on lateral sides of the longitudinal recess.

5. The device of claim 1, wherein the cutting edges define an apex angle of about 40°

.

17. The biopsy device of claim 1, wherein the longitudinal insert is affixed within the stylet along a substantial fraction of the working length.

18. The biopsy device of claim 17, wherein the longitudinal insert is affixed between the recess and a position distal of the proximal end.

6. A biopsy device, comprising:

a generally cylindrical hollow stylet having a uniform wall thickness, an inner diameter, an outer diameter, and a longitudinal axis;

the stylet having a distal end with a sample recess configured to receive biopsy samples, and a proximal end, the distal and proximal ends being disposed on the axis;

a mounting portion by which the stylet is supported, the stylet having a working length from the distal end that extends distally of the mounting structure when supported thereby;

a longitudinal recess forming a sample chamber and positioned adjacent the distal end extending axially a distance of between 10 and 25% of the working length;

the longitudinal recess having cutting edges extending parallel to the axis on lateral sides of the longitudinal recess;

the cutting edges having a depth, perpendicular to the axis, of between 2.5 and 4 times the wall thickness;

the distance between the cutting edges being less than the outer diameter and greater than the inner diameter; and

a longitudinal insert providing additional reinforcement to the stylet, wherein the longitudinal insert is affixed within the stylet along a substantial fraction of the working length.

9. The biopsy device of claim 6, wherein the longitudinal insert is affixed within the stylet along most of the working length between the recess and a position distal of the proximal end.

11. The biopsy device of claim 6, wherein the ratio of the diameter to the wall thickness is less than 15.

7. (canceled)

8. (canceled)

10. (canceled)

12-16. -16. (canceled)

19-43. -43. (canceled)

44. A biopsy device, comprising:

a generally cylindrical hollow stylet having a distal end with a sample recess configured to receive biopsy samples, and a proximal end, the distal and proximal ends being disposed on an axis;

a mounting structure configured to support a proximal portion of the stylet such that bending of the proximal portion is resisted by supporting the proximal portion at multiple points along the proximal portion, wherein the multiple points are a continuous series of points of contact between an axially-elongated support element within the mounting structure.

46. The device of claim 44, wherein the axially-elongated support element is located at a distal end of the mounting structure.

47. The device of claim 44, wherein the stylet has a working length from the distal end that extends distally of the mounting structure when supported thereby;

48. The device of claim 44, wherein the longitudinal recess has cutting edges extending parallel to the axis on lateral sides of the longitudinal recess.

49. The device of claim 48, wherein the cutting edges define an apex angle of about 40°

.

50. The device of claim 48, wherein the distance between the cutting edges is less than the outer diameter and greater than the inner diameter.

51. The biopsy device of claim 44, further comprising a longitudinal insert providing additional reinforcement to the stylet.

52. The biopsy device of claim 51, wherein the longitudinal insert is affixed within the stylet along a substantial fraction of the working length.

53. The biopsy device of claim 51, wherein the longitudinal insert is affixed within the stylet along a most of the working length between the recess and a position distal of the proximal end.

58. The device of claim 44, further comprising a vacuum pump capable of drawing a vacuum of at least 21 in. Hg in the stylet.

45. (canceled)

54-57. -57. (canceled)

59-65. -65. (canceled)

66. A biopsy device, comprising:

a generally cylindrical hollow stylet having a distal end with a sample recess configured to receive biopsy samples, and a proximal portion;

a mounting member configured to support the proximal portion of the stylet such that bending of the proximal portion is resisted by the mounting member supporting the proximal portion at least three support points therealong,

wherein the cylindrical hollow stylet has a first portion coinciding with the sample recess having a first wall thickness and a second portion proximal of the sample chamber and continuous to and between the at least three support points with a second wall thickness, the second wall thickness being greater than the first wall thickness.

72. The device of claim 66, wherein the stylet has a working length from the distal end that extends axially of the mounting member when held thereby.

73. The device of claim 66, wherein the sample recess has cutting edges extending parallel to an axis joining the distal end and the proximal portion, the cutting edges being on lateral sides of the longitudinal recess.

74. The device of claim 66, wherein the cutting edges define an apex angle of about 40°

.

67-71. -71. (canceled)

75-78. -78. (canceled)