Impact biopsy device and method of use

• US 9,392,998 B2
• Filed: 01/17/2014
• Issued: 07/19/2016
• Est. Priority Date: 01/18/2013
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Snow, Jeremy W.
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US14/157,935
• Publication Number:
  US 20140207021A1
• Time in Patent Office: 914 Days
• Field of Search: 600564-567
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0241 for prostate
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms

Abstract

An impact biopsy device is disclosed. The impact biopsy device may be configured to displace various cutting elements, such as an outer tubular member and cutting element and a cannula to sever a tissue sample from a patient. The impact biopsy device may comprise an actuation system configured to transfer displacement or force to the cutting elements by the impact of an element on another element.

Claims

1. A tissue biopsy device, comprising:

a handle configured to be grasped by a user;

a needle assembly comprising a cannula, the needle assembly operably coupled to the handle, the needle assembly configured to sever a tissue sample; and

an actuator assembly operably coupled to the handle and needle assembly, the actuator assembly comprising;

a biasing member;

a traveling member configured to be displaced by the biasing member when the actuator assembly is actuated;

a follower; and

an impact member coupled to the needle assembly, the impact member configured to displace at least a portion of the needle assembly when the traveling member impacts the impact member;

wherein the cannula is fixedly coupled to the follower, the follower is releasably coupled to the impact member, and the follower is configured to decoupled from the impact member such that the impact member travels a longer distance than the follower when the device is actuated.

2. The biopsy device of claim 1, wherein the traveling member is displaced over a distance before impacting the impact member.

3. The biopsy device of claim 1, wherein the biasing member does not directly exert a force on the impact member when the device is actuated.

4. The biopsy device of claim 1, wherein kinetic energy associated with the traveling member is transferred to the impact member to accelerate the impact member when the device is actuated.

5. The biopsy device of claim 1, wherein the needle assembly further comprises an outer tubular member, and wherein the outer tubular member is fixedly coupled to the impact member and the cannula is releasably coupled to the impact member.

6. The biopsy device of claim 5, further comprising an adjustable stop member operably coupled to the handle, the adjustable stop member configured to stop the movement of the impact member with respect to the adjustable stop member after the traveling member impacts the impact member, and wherein a longitudinal position of the adjustable stop member is adjustable over a continuous range.

7. The biopsy device of claim 6, wherein the adjustable stop member comprises a first portion configured to rotate without longitudinal displacement and a second portion configured to displace longitudinally as the first portion is rotated.

8. The biopsy device of claim 6, wherein contact between the adjustable stop member and the follower decouples the cannula base from the impact member.

9. A tissue biopsy device comprising:

a handle configured to be graspable by a user;

a biasing member operably coupled to the handle, the biasing member configured to store potential energy when the biopsy device is in a primed configuration;

a traveling member operably coupled to the handle, the traveling member disposed such that the potential energy stored in the biasing member is at least partially converted to kinetic energy associated with the traveling member when the biopsy device is actuated;

an impact member operably coupled to the handle and to the biasing member, the device configured such that the traveling member impacts the impact member when the biopsy device is actuated such that the impact member is displaced relative to the handle and;

a follower;

wherein the impact member is coupled to the follower when the biopsy device is in a primed configuration and wherein the follower is initially displaced with the impact member when the device is actuated and

wherein the follower decouples from the impact member such that the follower travels a shorter longitudinal distance than the impact member when the biopsy device is acutated.

10. The biopsy device of claim 9, wherein the traveling member is disposed adjacent the biasing member when the biopsy device is in a primed configuration and wherein the traveling member is displaced over a first longitudinal distance when the biopsy device is actuated.

11. The biopsy device of claim 10, wherein the traveling member is not in contact with the impact member before displacement over the first longitudinal distance.

12. The biopsy device of claim 11, wherein the biasing member is exerting a biasing force on the traveling member when the traveling member impacts the impact member.

13. The biopsy device of claim 10, wherein the impact member is displaced over a second longitudinal distance after the traveling member impacts the impact member.

14. The biopsy device of claim 13, wherein the second longitudinal distance is adjustable over a continuous range.

15. The biopsy device of claim 13, wherein the follower decouples from the impact member before the impact member is displaced over the entire second longitudinal distance such that the follower travels a shorter longitudinal distance than the second longitudinal distance when the biopsy device is actuated.

16. The biopsy device of claim 15, wherein the impact member is coupled to an outer tubular member comprising a cutting element and the follower is coupled to a cannula.

17. The biopsy device of claim 13, wherein the follower decouples from the impact member such that the follower travels a longer longitudinal distance than the second longitudinal distance when the biopsy device is actuated.

18. A method of obtaining a tissue sample through actuation of a biopsy device, the method comprising:

releasing a traveling member such that the traveling member is displaced a first longitudinal distance along the biopsy device;

impacting the traveling member with an impact member such that the impact member is displaced a second longitudinal distance along the biopsy device;

displacing a follower releasably coupled to the impact member and decoupling the follower from the impact member such that the follower travels a shorter distance the second longitudinal distance; and

displacing a first cutting member coupled to the impact member such that the cutting member severs a first portion of the tissue sample.

19. The method of claim 18, further comprising storing potential energy in a biasing member prior to releasing the traveling member.

20. The method of claim 18, further comprising storing energy in a chamber of compressed gas prior to releasing the traveling member.

21. The method of claim 18, further comprising displacing a second cutting member, releasably coupled to the impact member, the second cutting member displaced such that the second cutting member severs a second portion of the tissue sample.

22. The method of claim 21, wherein the first cutting member is displaced a distance substantially equal to the second longitudinal distance and second cutting member is displaced a distance less than the second longitudinal distance.

23. The method of claim 22, wherein the second cutting member is automatically decoupled from the impact member after the impact member travels a portion of the second longitudinal distance.

24. The method of claim 18, further comprising adjusting the biopsy device to control the length of tissue sample by adjusting the position of a stop member, over a continuous range, relative to the handle wherein the stop member interacts with the impact member.

25. The method of claim 24, further comprising adjusting the length of the tissue sample over range between 2 mm and 35 mm.

26. The method of claim 22, wherein the second cutting member is coupled to the follower.