Biopsy device

• US 4,919,146 A
• Filed: 10/25/1988
• Issued: 04/24/1990
• Est. Priority Date: 10/25/1988
• Status: Expired due to Fees

• Current Assignee: Medrad Incorporated Kappa Manor II Kappa Manor Drive Pittsburgh PA 15238
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Rhinehart, Edward, Sanctis, Michael W., Machek, James E.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Shay, Randy
• Application Number:
  US07/261,746
• Time in Patent Office: 546 Days
• Field of Search: 128/305.1, 128/749, 128/751-755, 128/757, 128/758, 128/760, 128/763, 128/765, 604/22, 604/27, 604/51, 604/164, 604/181, 604/187, 604/188, 604/218, 604/222, 604/228, 604/240
• US Class Current: 600/565
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/04 Endoscopic instruments

Abstract

A biopsy device utilizes three components: a housing having an attached cannula, a drill bit/plunger component which is mounted in the housing so that the drill bit portion, having a cutting tip, extends through the cannula, the plunger snugly fitting within the housing, and a rotational energy element which couples with the drill bit/plunger component to enable the impartation of rotational motion to the cutting tip. Both drilling and aspirating action are utilized to retrieve a biopsy sample. In operation, the tissue to be sampled is punctured by a biopsy needle, the cannula of which is connected to the biopsy device. Thereafter, rotational energy is imparted to the drill bit/plunger component, causing tissue to be accumulated on the cutting tip. Once a sufficient amount of tissue has been accumulated, the rotational energy element and plunger/drill bit component are displaced in a proximal direction from the housing to cause the sample to be aspirated into the cannula syringe. The biopsy device is withdrawn from the tissue, and the sample is retrieved by exerting longitudinal pressure in a distal direction on the rotational energy element and, in turn, the drill bit/plunger component.

Claims

1. A device for obtaining biopsy samples, said device comprising:

a housing having proximal and distal ends and a distal tip terminating the distal end, a cannula having proximal and distal ends mounted at the distal end of said housing, the distal tip of said housing being open;

a drill bit/plunger component slidably mounted in said housing, said drill bit/plunger component including a plunger and a drill bit having proximal and distal ends with a cutting tip at the distal end of said drill bit, said drill bit extending through said plunger in a fluid-tight seal, said drill bit/plunger component being sized to fit within said housing such that when said drill bit/plunger component is inserted in said housing, said drill bit passes through said cannula and such that when said plunger abuts the distal end of said housing, said cutting tip extends beyond the distal end of said cannula,

a rotational energy element for providing rotational energy to said drill bit/plunger component,

coupling means for coupling said rotational energy element to said drill bit/plunger component, and

means for actuating said rotational energy element so as to impart rotational movement to said coupling means and said component.

2. The device according to claim 1, wherein said housing is a syringe housing.

3. The device according to claim 2, wherein said housing is made of glass.

4. The device according to claim 1, wherein said rotational energy element includes motor means for generating said rotational energy and switch means connected to said motor means for actuating said motor means.

5. The device according to claim 1, wherein said rotational energy element includes means to drive said rotatable coupling so that said coupling and said cutting tip rotate at a rate between 60 to about 800 revolutions per minute.

6. The device according to claim 1, wherein said means for actuating said rotational energy element comprises a battery mounted on an external portion of said rotational energy element and a contact mounted on an external portion of the proximal end of said housing such that when said battery contacts said contact, rotational energy is imparted to said rotational energy element.

7. The device according to claim 1, wherein said cutting tip includes a blade which is helically shaped.

8. The device according to claim 1, wherein said coupling means which couples said rotational energy element to said drill bit/plunger component comprises an opening with threads, and wherein said rotational energy element comprises a pin with laterally extending tabs so that said pin is inserted into said opening and rotated one-half turn relative to said opening for engaging said laterally extending tabs into said threads.

9. The device according to claim 1, wherein said housing is made of clear plastic.

10. The device according to claim 1, wherein said cannula and said drill bit are made of medical grade stainless steel materials.

11. A method for obtaining a biopsy tissue sample, said method comprising the steps of:

puncturing said tissue to effect a passageway for a biopsy device while inserting a hollow cannula,

providing a device having a housing with an open distal tip and a drill bit/plunger component including a plunger and a drill bit having a cutting tip, said drill bit extending through said plunger, said component being located in said housing such that a distal portion of said drill bit extends through said open distal tip and said plunger abuts the distal tip, said plunger having a diameter greater than the diameter of said distal tip,

coupling the proximal end of said cannula to the open distal tip of said hosing such that said cutting tip passes through and extends beyond the distal end of said cannula,

providing a rotational energy element capable of producing rotational energy,

coupling said rotational energy element to said drill bit/plunger component by means of a rotatable coupling,

actuating said rotational energy element to cause said coupling and said drill bit to rotate,

collecting a biopsy tissue sample on said cutting tip,

aspirating said sample into said cannula by retracting said rotational energy element and said drill bit/plunger component in a proximal direction,

withdrawing said cannula and drill bit from the tissue, and

depositing said biopsy sample by exerting pressure on said rotational energy element and, in turn, said drill bit/plunger component in a distal direction.

12. The method according to claim 11, further comprising the step of detaching said rotational energy element from said drill bit/plunger component and disposing of said housing and drill bit/plunger component.

13. The method according to claim 11, wherein said step of actuating said rotational energy element further comprises actuating a motor powered by a battery by switching an on/off switch means connected to said battery for actuating said motor.

14. The method according to claim 11, wherein said rotational energy element delivers rotational energy to said rotatable coupling so that said coupling and said cutting tip rotate at a rate between about 60 and about 800 revolutions per minute.

15. The method according to claim 11, further comprising the step of maintaining rotational movement of said rotational energy element while aspirating said sample.

16. The method according to claim 11, wherein said step of coupling said cannula to said housing further comprises coupling said cannula to said housing by a first coupling means and wherein said step of coupling said rotational energy element to said drill bit/plunger comprises coupling said rotational energy element to said drill bit/plunger component by a second coupling means.

17. The method according to claim 11, wherein said collecting step takes between 1 and about 10 seconds.

18. A biopsy device comprising:

a syringe housing having an open distal end,

a cannula mounted on said distal end of said housing,

coupling means slidably mounted in said housing for transmitting a rotational drive force, said coupling means including a plunger and drill means extending distally through said plunger, said open distal end of said housing and said cannula for collecting a biopsy sample, and

drive means connected to said coupling means for rotating said coupling means to collect a biopsy sample when said plunger is slid in a distal direction to project said drill bit beyond a distal end of said cannula and cut tissue from a biopsy site.

19. A biopsy device as in claim 18, wherein said drive means is slidably mounted in said housing.

20. A biopsy device as in claim 19, wherein said drive means includes a connector threadingly engaging said coupling means for moving said coupling means when said drive means is moved within said housing.

21. A method of obtaining a biopsy sample from tissue, said method comprising:

puncturing tissue with a stylet and cannula at a biopsy site from which a biopsy sample is to be taken,

inserting a rotating drill means through said cannula to extend from a distal end of said cannula for rotating a drill bit to collect a biopsy sample, and

withdrawing said rotating drill means from said biopsy site while aspirating said biopsy site.

22. A method of obtaining a biopsy sample as in claim 21, wherein during aspiration of the biopsy site, liquid is withdrawn into a syringe housing.

23. A method of obtaining a biopsy sample as in claim 22, and further comprising the step of mounting said drill means on a coupling which is rotatably mounted in said housing.

24. A method of obtaining a biopsy sample as in claim 21, wherein the puncturing of the tissue is done with a biopsy needle which includes said stylet and said cannula.

25. A method of obtaining a biopsy sample as in claim 21, wherein said drill means includes cutting means for collecting the biopsy sample.