Quick cycle biopsy system

• US 8,702,622 B2
• Filed: 08/10/2011
• Issued: 04/22/2014
• Est. Priority Date: 01/31/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: McCullough, Adam B., Kalis, Robert W.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US13/206,817
• Publication Number:
  US 20110295150A1
• Time in Patent Office: 986 Days
• Field of Search: 600/562, 600564-568, 606/170, 606/171
• 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

Abstract

A method for extracting a tissue sample includes altering the pressure inside the lumen of a cannula to facilitate extraction of a tissue sample from the cannula. One aspect of the invention includes a biopsy apparatus comprising a valve for controlling the pressure inside the lumen of the cannula. In one variation, the pressure/vacuum generating device is connected to a cannula with a closed distal end and an orifice located on a circumferential surface of said cannula. A cutting sheath is slidably disposed over said cannula. The valve may be provided between the pressure/vacuum generating device and the cannula to control the pressure within the lumen of the cannula.

Claims

1. A biopsy apparatus comprising:

a housing having a proximal end and a distal end;

a cannula positioned in the housing to extend through the distal end of the housing, the cannula having a closed penetrating tip and an orifice located on a circumferential surface of said cannula, said orifice is configured to receive a tissue sample into a lumen of said cannula;

a cutting sheath positioned in the housing to extend through the distal end of the housing, the cutting sheath being slidably and coaxially disposed over said cannula, said sheath is adapted to seal the opening of said orifice;

a pressure generating device positioned in the housing and connected to a proximal portion of said cannula for altering a pressure in the lumen of said cannula, the pressure generating device configured to selectively generate each of a positive pressure and a negative pressure;

a valve positioned in the housing and positioned in fluid communication between said cannula and said pressure generating device, configured to control a fluid flow between the lumen of said cannula and said pressure generating device such that each of the positive pressure and the negative pressure selected is controlled by the valve;

a valve actuator positioned in the housing and coupled to the valve to operate the valve; and

an electronic system control coupled to the valve actuator and

configured to control the valve actuator to close the valve to build up each of the selected positive pressure and negative pressure.

2. The biopsy apparatus according to claim 1, wherein a stopper is positioned in said lumen of said cannula in a location proximal to said orifice, said stopper is adapted to partially obstruct said lumen and prevent said sample of tissue from migrating to a proximal end of said cannula.

3. The biopsy apparatus according to claim 1, wherein said pressure generating device comprises a single acting cylinder with a piston slidably disposed within said cylinder for displacing a volume of said fluid, a port positioned at a first end of said cylinder is connected to said valve, and an orifice on said cylinder is configured to allow air inflow into the cylinder when said piston is displaced to a second end of said cylinder.

4. A biopsy device for taking tissue samples, comprising:

a housing having a proximal end and a distal end, the housing containing an electric power source and a tension slide connected to the power source, wherein the tension slide is brought into a cocked position against the action of a spring by the power source;

a removable element configured for coupling into the housing, comprising;

a biopsy cannula unit, comprising a hollow biopsy cannula positioned in the housing to extend through the distal end of the housing, the hollow biopsy cannula having a sample removal chamber and a penetrating tip, and a cutting sheath positioned in the housing to extend through the distal end of the housing, the cutting sheath being slidably and coaxially disposed over said cannula;

a pressure generating device positioned in the housing, the pressure generating device configured to selectively generate each of a positive pressure and a negative pressure;

a valve positioned in the housing, the valve coupled in fluid communication between the pressure generating device and the biopsy cannula unit such that each of the positive pressure and the negative pressure selected is controlled by the valve; and

a first connection element that extends between the biopsy cannula unit and the valve, and configured to provide fluid communication from the valve to the biopsy cannula unit;

a valve actuator positioned in the housing and coupled to the valve to operate the valve; and

an electronic system control coupled to the valve actuator and

configured to control the valve actuator to close the valve to build up each of the selected positive pressure and negative pressure.

5. The biopsy device according to claim 4, wherein the biopsy cannula unit is arranged on the tension slide and further comprising a control panel, wherein said control panel is connected to a plurality of actuators, wherein a slide actuator controls both the tension slide and the cutting sheath.

6. The biopsy device according to claim 4, wherein the electronic system control controls the opening of the valve via the valve actuator.

7. The biopsy device according to claim 4, wherein the valve is connected in fluid communication with a distal end of the pressure generating device.

8. The biopsy device according to claim 4, wherein the valve is configured to receive a vacuum from the pressure generating unit and provide a controlled application of the vacuum to the biopsy cannula unit.

9. A biopsy device for taking tissue samples, comprising:

a housing containing an electric power source and a tension slide connected to the power source, wherein the tension slide is brought into a cocked position against the action of a spring by the power source;

a biopsy cannula unit, comprising a hollow biopsy cannula, having a sample removal chamber, and a cutting sheath, wherein the biopsy cannula unit is arranged on the tension slide;

a pressure generating device positioned in the housing, the pressure generating device configured to selectively generate each of a positive pressure and a negative pressure, the pressure generating device comprises a syringe unit having a syringe body and a plunger positioned in the syringe body, the syringe body having a ventilation opening in an upper part thereof which may be opened to dissipate a created vacuum by retraction of the plunger;

a spindle actuator configured to move the plunger in a forward and a reverse direction;

a valve positioned in the housing and interposed between the cannula and the pressure generating device, and configured such that each of the positive pressure and the negative pressure selected is controlled by the valve;

a valve actuator positioned in the housing and coupled to the valve to operate the valve; and

an electronic system control coupled to the valve actuator and

configured to control the valve actuator to close the valve to build up each of the selected positive pressure and negative pressure.

10. The biopsy device according to claim 9, further comprising at least one DC motor with secondary planet gearing contained within the housing, wherein the controllable spindle actuator is powered by the motor.

11. The biopsy device according to claim 10, wherein the transmission from the planet gearing to the spindle occurs via a single-stage gearing, and wherein a threaded spindle nut mounted on the syringe unit housing carries a toothed crown.

12. The biopsy device according to claim 11, wherein the motor with secondary planet gearing is controlled by measuring the speed of revolution such that the plunger in a first step is moved from a distal end of the housing to a first point adjacent but distal the ventilation opening, in a second step is moved first proximal the ventilation opening to open the ventilation opening and dissipate the created vacuum and then distal back to the first point to close the ventilation opening, and in a third step is moved in a distal direction to create excess pressure, the first, second and third steps being coordinated with the controlling of the sample removal and the ejecting of the sample.

13. The biopsy device according to claim 12, wherein the speed of revolution of the motor is measured by a photocell permanently arranged on a motor housing and a pickup arranged on a motor shaft, and wherein the speed of revolution of the motor is compared against a nominal value previously stored in electronic components of the biopsy device and used to trigger control of the spindle actuator.