Vacuum timing algorithm for biopsy device

• US 7,938,786 B2
• Filed: 11/20/2007
• Issued: 05/10/2011
• Est. Priority Date: 12/13/2006
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Ritchie, Paul G., Speeg, Trevor W. V., Hibner, John A., Parihar, Shailendra K., Dannaher, William D., Weikel, Robert F. Jr.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C.
• Application Number:
  US11/942,764
• Publication Number:
  US 20080228103A1
• Time in Patent Office: 1,267 Days
• Field of Search: 600/562, 600/563, 600/564, 600/565, 600/566, 600/567, 600/568
• US Class Current: 600/566
• 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 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/0019 Means for setting or varying the pulse width
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61M 1/72 Cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/78 Means for preventing overflow or contamination of the pumping systems combined with drainage containers A61M1/60
• CPC Class Codes: A61M 1/782 using valves with freely moving parts, e.g. float valves
• CPC Class Codes: A61M 1/784 by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

A biopsy system has a cutter defining a cutter lumen along an axis. One conduit in the system is configured to provide fluid communication along the cutter lumen axis; while another conduit in the system is configured to provide fluid communication lateral to the cutter lumen axis. The system may be operated in a variety of modes, including a sample cycle, a clear probe cycle, a cutter positioning cycle, an aspirate cycle, and a maintenance vacuum pulse cycle. The operational modes are selectable by a user. Depending on the mode selected by the user, the communication of vacuum, saline, or atmospheric air through the conduits, or the sealing of the conduits, will vary as a function of the axial position of the cutter.

Claims

1. A method of controlling a biopsy device to obtain a tissue sample, wherein the biopsy device comprises a cannula having a first lumen, a second lumen, and a transverse tissue receiving aperture defined by a distal edge and a proximal edge, wherein the first lumen is in fluid communication with the second lumen through at least one opening, wherein tissue receiving aperture is in fluid communication with the first lumen, the biopsy device further comprising a cutter translatable relative to the cannula, the cutter defining a cutter lumen, wherein the cutter is disposed in the first lumen, the method comprising:

(a) retracting the cutter proximally, from a position distal to the distal edge of the aperture to a first position proximal to the distal edge of the aperture;

(b) drawing a vacuum through the cutter lumen during at least part of the act of retracting the cutter proximally, to draw tissue through the aperture;

(c) drawing a vacuum through the second lumen during at least part of the act of retracting the cutter proximally;

(d) advancing the cutter distally to a position distal to the distal edge of the aperture to complete a cutting stroke to sever tissue drawn through the aperture;

(e) reciprocating the cutter at least once after completion of the cutting stroke, wherein the act of reciprocating comprises retracting the cutter proximally to a second position proximal to the distal edge of the aperture and advancing the cutter to a position distal to the distal edge of the aperture, wherein the second position proximal to the distal edge of the aperture is distal to the first position proximal to the distal edge of the aperture; and

(f) venting the second lumen to atmosphere during at least part of the act of reciprocating the cutter at least once after completion of the cutting stroke, wherein the acts of reciprocating the cutter and venting the second lumen to atmosphere facilitate communication of the severed tissue proximally through the cutter lumen;

wherein steps (a) through (f) are all performed as part of a single tissue sampling cycle to obtain a single tissue sample.

2. The method of claim 1, wherein the first position proximal to the distal edge of the aperture is distal to the proximal edge of the aperture.

3. The method of claim 1, wherein the second position proximal to the distal edge of the aperture is distal to the first position proximal to the distal edge of the aperture.

4. The method of claim 1, wherein the aperture has a longitudinal mid-point between the distal edge and the proximal edge, wherein the second position proximal to the distal edge of the aperture is distal to the longitudinal mid-point.

5. The method of claim 4, wherein the first position proximal to the distal edge of the aperture is proximal to the longitudinal mid-point.

6. The method of claim 1, wherein the second lumen is external to the cutter and parallel to the cutter.

7. The method of claim 1, further comprising communicating saline through the second lumen.

8. The method of claim 7, wherein the act of communicating saline through the second lumen is performed during at least part of the act of advancing the cutter distally.

9. The method of claim 1, further comprising venting the second lumen to atmosphere during at least part of the act of advancing the cutter distally.

10. The method of claim 6, wherein the cannula further comprises a wall at least partially separating the second lumen from the cutter, wherein the wall has a plurality of openings formed therethrough.

11. The method of claim 10, wherein the plurality of openings comprises a first opening proximal to the distal edge of the aperture and a second opening proximal to the first opening, wherein the second position proximal to the distal edge of the aperture is longitudinally positioned between the first opening and the second opening.

12. A method of controlling a biopsy device to clear a tissue sample lodged within the biopsy device, wherein the biopsy device comprises a cannula having a first lumen, a second lumen, and a transverse tissue receiving aperture defined by a distal edge and a proximal edge, wherein the first lumen is in fluid communication with the second lumen through at least one opening, wherein tissue receiving aperture is in fluid communication with the first lumen, the biopsy device further comprising a cutter translatable relative to the cannula, the cutter defining a cutter lumen, wherein the cutter is disposed in the first lumen, the method comprising:

(a) reciprocating the cutter at least twice, wherein the act of reciprocating comprises;

(i) retracting the cutter proximally a first time, from a position distal to the distal edge of the aperture to a position proximal to the distal edge of the aperture,

(ii) advancing the cutter distally a first time, from the position proximal to the distal edge of the aperture to the position distal to the distal edge of the aperture,

(iii) retracting the cutter proximally a second time, from the position distal to the distal edge of the aperture to the position proximal to the distal edge of the aperture, and

(iv) advancing the cutter distally a second time, from the position proximal to the distal edge of the aperture to the position distal to the distal edge of the aperture;

(b) drawing a vacuum through the cutter lumen during at least part of the act of reciprocating the cutter;

(c) communicating saline through the second lumen during the act of retracting the cutter proximally the first time and during the act of advancing the cutter distally the first time, wherein the act of communicating saline through the second lumen comprises communicating saline distally through the second lumen and proximally through the cutter lumen; and

(d) venting the second lumen to atmosphere during the act of retracting the cutter proximally the second time and during the act of advancing the cutter distally the second time.

13. The method of claim 12, wherein the second lumen is external to the cutter and parallel to the cutter.