Biopsy apparatus

• US 8,986,222 B2
• Filed: 05/21/2014
• Issued: 03/24/2015
• Est. Priority Date: 11/06/2000
• Status: Expired due to Fees

• Current Assignee: Suros Surgical Systems Incorporated (Hologic Incorporated)
• Original Assignee: Hologic Incorporated
• Inventors: Miller, Michael E., Mark, Joseph L., Butcher, Charles
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US14/283,558
• Publication Number:
  US 20140257134A1
• Time in Patent Office: 307 Days
• Field of Search: 600562-568
• US Class Current: 600/565
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• 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
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

A disposable tissue removal device comprises a “tube within a tube” cutting element mounted to a handpiece. The inner cannula of the cutting element defines an inner lumen and terminates in an inwardly beveled, razor-sharp cutting edge. The inner cannula is driven by both a rotary motor and a reciprocating motor. At the end of its stroke, the inner cannula makes contact with the cutting board to completely sever the tissue. An aspiration vacuum is applied to the inner lumen to aspirate excised tissue through the inner cannula and into a collection trap that is removably mounted to the handpiece. The rotary and reciprocating motors are hydraulically powered through a foot pedal operated hydraulic circuit. The entire biopsy device is configured to be disposable. In one embodiment, the cutting element includes a cannula hub that can be connected to a fluid source, such as a valve-controlled saline bag.

Claims

1. A tissue biopsy device, comprising:

a housing;

an outer cannula having an open proximal end, a closed distal end, a tissue receiving opening formed in a wall thereof adjacent the closed distal end, a cutting board disposed in the outer cannula between the tissue receiving opening and the closed distal end, and an outer cannula lumen extending between the open proximal end and the cutting board;

an inner cannula slidably disposed within the outer cannula lumen, the inner cannula having an open distal end and an inner cannula lumen; and

a hub coupled to the outer cannula adjacent the open proximal end thereof, the hub further coupled to the housing, thereby coupling the outer cannula to the housing,

wherein the hub and the housing define an unobstructed leak path therebetween, such that the open proximal end of the outer cannula, and thereby the outer cannula lumen and tissue receiving opening, are in constant fluid communication with atmosphere external of the housing via the unobstructed leak path, regardless of a position of the inner cannula relative to the cutting board.

2. The tissue biopsy device of claim 1, wherein the outer cannula and the inner cannula define an annular space therebetween that is in fluid communication with the unobstructed leak path.

3. The tissue biopsy device of claim 1, wherein, when the inner cannula is retracted away from the cutting board, the open distal end of the inner cannula and the inner cannula lumen are in fluid communication with the unobstructed leak path.

4. The tissue biopsy device of claim 1, wherein, when (i) the inner cannula is retracted away from the cutting board, (ii) a cut tissue sample is disposed in the inner cannula lumen, and (iii) a first vacuum source is placed in communication with an open proximal end of the inner cannula, the unobstructed leak path relieves a second vacuum formed distal of the cut tissue sample.

5. The tissue biopsy device of claim 1, wherein, when the inner cannula is in contact with the cutting board, fluid communication between the inner cannula lumen and the unobstructed leak path is blocked.

6. A tissue biopsy device, comprising:

a housing;

an outer cannula having an open proximal end, a closed distal end, a tissue receiving opening formed in a wall thereof adjacent the closed distal end, a cutting board disposed in the outer cannula between the tissue receiving opening and the closed distal end, and an outer cannula lumen extending between the open proximal end and the cutting board; and

an inner cannula slidably disposed within the outer cannula lumen, the inner cannula having an open distal end and an inner cannula lumen,

wherein a proximal portion of the outer cannula is coupled to the housing in a manner forming an unobstructed leak path, such that the outer cannula lumen and tissue receiving opening are in constant fluid communication with atmosphere external of the housing via the unobstructed leak path, regardless of a position of the inner cannula relative to the cutting board.

7. The tissue biopsy device of claim 6, wherein the outer cannula and the inner cannula define an annular space therebetween that is in fluid communication with the unobstructed leak path.

8. The tissue biopsy device of claim 6, wherein, when the inner cannula is retracted away from the cutting board, the open distal end of the inner cannula and the inner cannula lumen are in fluid communication with the unobstructed leak path.

9. The tissue biopsy device of claim 6, wherein, when (i) the inner cannula is retracted away from the cutting board, (ii) a cut tissue sample is disposed in the inner cannula lumen, and (iii) a first vacuum source is placed in communication with an open proximal end of the inner cannula, the unobstructed leak path relieves a second vacuum formed distal of the cut tissue sample.

10. The tissue biopsy device of claim 6, wherein, when the inner cannula is in contact with the cutting board, fluid communication between the inner cannula lumen and the unobstructed leak path is blocked.

11. The tissue biopsy device of claim 6, wherein the open proximal end of the outer cannula, and thereby the outer cannula lumen and tissue receiving opening, are in constant fluid communication with atmosphere external of the housing via the unobstructed leak path.