Biopsy device incorporating an adjustable probe sleeve

• US 7,481,775 B2
• Filed: 03/29/2006
• Issued: 01/27/2009
• Est. Priority Date: 03/04/2005
• Status: Expired due to Fees

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Weikel, Robert F. Jr., Andrisek, John R., Payne, Gwendolyn Perez
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Pani; John
• Application Number:
  US11/391,805
• Publication Number:
  US 20060200042A1
• Time in Patent Office: 1,035 Days
• Field of Search: 600562-568, 600/585, 606167-173, 604/22
• US Class Current: 600/567
• 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

Devices and methods for varying the size of a tissue sample in a biopsy device are disclosed. The biopsy device includes a needle with a tissue aperture and an inner cutter which translates within the needle. The inner cutter may be controlled to selectively block the aperture thereby varying the sample size. A half cylindrical sleeve may be resiliently attached to the exterior of the needle in order to block the aperture. The sleeve includes gripping flanges on its bottom surface, and a beveled distal tip configured to avoid damage from the inner cutter. The distal tip may include an inner metallic guide or may be heightened to avoid contact with the cutter.

Claims

1. A device for selectively blocking a proximal portion of a side aperture in a needle of a core biopsy instrument having a cutter that translates across the side aperture to sever prolapsed tissue, wherein the needle of the core biopsy instrument comprises a longitudinal axis, the device comprising:

a half cylindrical tube portion having an inner contour corresponding to both the side aperture and a proximate upper portion of the needle of the core biopsy instrument, wherein a distal portion of the half cylindrical tube portion comprises an inner recessed contour sized to avoid contact with the cutter of the core biopsy instrument, wherein the half cylindrical tube portion comprises a proximal end and a distal end, wherein the half cylindrical tube portion terminates at the distal end in a beveled edge;

a first gripping flange attached to the half cylindrical tube portion positioned to resiliently lock to an underside of a proximate lower portion of the needle, wherein the first gripping flange comprises a proximal edge and a distal edge, wherein the first gripping flange extends between the proximal edge and the distal edge;

a second gripping flange attached to the half cylindrical tube portion positioned to resiliently lock to an underside of a proximate lower portion of the needle, wherein the second gripping flange comprises a proximal edge and a distal edge, wherein the second gripping flange extends between the proximal edge and the distal edge, wherein the second gripping flange is longitudinally staggered relative to the first gripping flange such that the proximal edge of the second gripping flange is positioned distally relative to the distal edge of the first gripping flange;

a finger flange attached to a proximal portion of the half cylindrical tube portion sized for manual longitudinal positioning of the half cylindrical tube portion relative to the side aperture; and

a pair of flanking horizontal tabs attached to the half cylindrical tube portion positioned proximally of the finger flange adjacent to the proximal end of the half cylindrical tube portion, wherein the pair of flanking horizontal tabs are fixed in a substantially horizontal plane;

wherein the half cylindrical tube portion is configured to slidably translate along the longitudinal axis of the needle of the core biopsy instrument thereby blocking at least a proximal portion of the side aperture.

2. The device of claim 1, wherein the half cylindrical tube portion comprises a transparent material.

3. The device of claim 1, wherein the half-cylindrical tube portion comprises a magnetic resonance imaging compatible material.

4. The device of claim 1, wherein the half cylindrical tube portion further comprises measurement indicia.

5. The device of claim 1 wherein the second gripping flange is positioned distal to the first gripping flange.

6. The device of claim 5 wherein the finger flange is longitudinally positioned between the first gripping flange and the second gripping flange.

7. The device of claim 1 wherein the transparent half cylindrical tube portion comprises an interior cavity, wherein the transparent half cylindrical tube portion further comprises a first lower lateral edge and a second lower lateral edge, wherein the transparent half cylindrical tube portion further comprises a first side recess along the first lower lateral edge and a second side recess along the second lower lateral edge, wherein the first side recess is laterally across from the second side recess, wherein the first side recess and the second side recess are in communication with the interior cavity, wherein the transparent half cylindrical tube portion further comprises a rectangular recessed area along the first lower lateral edge.

8. The device of claim 7 wherein the first gripping flange extends unsupported from the first lower lateral edge of the half cylindrical tube portion, wherein the first gripping flange extends from the first lower lateral edge between the rectangular recessed area on a distal end and the first side recess on a proximal end;

and

the second gripping flange extends unsupported from the second lower lateral edge of the half cylindrical tube portion, wherein the second gripping flange extends from the second lower lateral edge between the second side recess on a distal end and the proximal end of the transparent half cylindrical tube portion on a proximal end.

9. A device for selectively blocking a proximal portion of a side aperture in a needle of a core biopsy instrument having a cutter that translates across the side aperture to sever prolapsed tissue, comprising:

a transparent half cylindrical tube portion having an inner contour corresponding to both the side aperture and a proximate upper portion of the needle of the core biopsy instrument, the inner contour including a distal portion operatively configured to avoid damage from the cutter of the core biopsy instrument, wherein the transparent half cylindrical tube portion comprises an interior cavity, a proximal end and a distal end, wherein the transparent half cylindrical tube portion further comprises a first lower lateral edge and a second lower lateral edge;

a first gripping flange extending unsupported from the first lower lateral edge of the half cylindrical tube portion and positioned to resiliently lock to an underside of a proximate lower portion of the needle, wherein the first gripping flange distally terminates at a distal point and proximally terminates at a proximal point;

a second gripping flange extending unsupported from the second lower lateral edge of the half cylindrical tube portion and positioned to resiliently lock to an underside of a proximate lower portion of the needle, wherein the second gripping flange distally terminates at a distal point and proximally terminates at a proximal point, wherein the distal point of the second gripping flange is positioned proximally relative to the proximal point of the first gripping flange; and

a finger flange attached to a proximal portion of the half cylindrical tube portion sized for manual longitudinal positioning of the half cylindrical tube portion relative to the side aperture;

wherein the device is configured to remain attached to the needle of the core biopsy instrument while sliding in a longitudinal direction along the needle such that the device blocks at least a portion of the side aperture.

10. The device of claim 9, wherein the distal portion of the half cylindrical tube portion comprises an inner recessed contour sized to avoid contact with the cutter of the core biopsy instrument.

11. The device of claim 9, wherein the distal portion of the half cylindrical tube portion comprises an inner metallic guide resistant to damage from the cutter of the core biopsy instrument.

12. The device of claim 9 further comprising a pair of flanking horizontal tabs, wherein the flanking horizontal tabs each extend transverse to the proximal end of the half cylindrical tube portion.

13. The device of claim 9, further comprising a pair of flanking horizontal tabs attached to the half cylindrical tube portion positioned proximally of the finger flange adjacent to the proximal end of the half cylindrical tube portion, wherein the pair of flanking horizontal tabs are fixed in a substantially horizontal plane.

14. The device of claim 9 wherein the finger flange is longitudinally positioned between the first gripping flange and the second gripping flange.

15. A device for selectively blocking a proximal portion of a side aperture in a needle of a core biopsy instrument having a cutter that translates across the side aperture to sever prolapsed tissue, comprising:

a half cylindrical tube portion having an inner contour corresponding to both the side aperture and a proximate upper portion of the needle of the core biopsy instrument, wherein a distal portion of the half cylindrical tube portion comprises an inner metallic guide resistant to damage from the cutter of the core biopsy instrument, wherein a vertical portion of the inner contour is defined by a small vertical inner radius and a large vertical inner radius, wherein the small vertical inner radius is less than the large vertical inner radius, wherein the vertical portion of the contour along a first length of the half cylindrical tube portion is defined by the small vertical inner radius, wherein the vertical portion of the contour along a second length of the half cylindrical tube portion is defined by the large vertical inner radius, wherein the first length is greater than the second length, wherein the half cylindrical tube portion comprises a proximal end and a distal end, wherein the half cylindrical tube portion terminates at the distal end in an outer ramped surface, wherein the transparent half cylindrical tube portion further comprises a lower lateral edge;

a gripping flange extending unsupported from the lower lateral edge of the half cylindrical tube portion and positioned to resiliently lock to an underside of a proximate lower portion of the needle;

a first horizontal tab attached to the half cylindrical tube portion, wherein the first horizontal tab is fixed in a substantially horizontal plane;

a second horizontal tab attached to the half cylindrical tube portion, wherein the second horizontal tab is fixed in the substantially horizontal plane of the first horizontal tab; and

a finger flange attached to a proximal portion of the half cylindrical tube portion sized for manual longitudinal positioning of the half cylindrical tube portion relative to the side aperture.

16. The device of claim 15 further comprising a second gripping flange extending unsupported from a second lower lateral edge of the half cylindrical tube portion and positioned to resiliently lock to an underside of a proximate lower portion of the needle, wherein the second gripping flange is longitudinally staggered relative to the first gripping flange.