Biopsy devices and methods

• US 20040097981A1
• Filed: 07/31/2003
• Published: 05/20/2004
• Est. Priority Date: 08/01/2002
• Status: Active Grant

• Current Assignee: James E. Selis
• Original Assignee: James E. Selis
• Inventors: Selis, James E.
• Granted Patent: US 7,670,350 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

An improved system for mammography analysis and methods of using the same. In one aspect, a clip comprises a first portion and at least one additional second portion connected to the first portion, the first and second portions adapted for elastic deformation for engaging tissue. In anther aspect, an improved actuator for performing a breast biopsy is used to deploy a clip. In yet another aspect of the invention, there is contemplated a system for marking an evacuated breast cyst.

Claims

1. An improved clip, comprising:

a. a first portion that is straight, arcuate or a combination thereof; and

b. at least one additional second portion that is straight, arcuate or a combination thereof, and which is connected to the first portion at an apex, the first and second portions adapted to permit the clip to compress to fit within a tube of a delivery device and to elastically deform upon exiting the tube for engaging tissue.

2. The clip of claim 1, wherein the clip is a wire that elastically deforms relative to the apex upon exiting the tube wire, wherein the wire material is selected from a surgical stainless steel, titanium, a nickel containing metal, or a bio-compatible polymer.

3. The clip of claim 2, wherein the clip is adapted to be deployed to a predetermined site in the presence or absence of an applied vacuum.

4. The clip of claim 3, wherein the first or second or both portions are further configured with at least one end having a barbed portion.

5. The clip of claim 1, wherein the clip is made of a memory shape material, has a largest dimension of less than about 1 cm, is configured for insertion into a breast tissue, and wherein upon exiting the delivery device the first and second portions are configured to engage the breast tissue such that the clip becomes substantially immobile and is observable through ultrasound devices, mammography devices or both.

6. An improved device for deploying a clip, comprising:

a. a gripping portion having two opposing finger grips attached to a hub portion;

b. a tube joined with the hub portion, the tube having defined at one end portion a side hole and a ramp or an end hole; and

c. a driver having an actuator member in driving relation therewith;

wherein upon translation of the actuator member the driver advances through the hub portion and the tube to advance a clip located in the tube toward and along the ramp for expulsion through the respective hole, wherein the device does not include a lock for preventing deployment.

7. The device of claim 6, wherein the hub portion has a luer lock mechanism for the attachment of the tube to the hub portion.

8. The device of claim 7, further comprising a needle spaced apart and concentrically located about the tube.

9. The device of claim 6, further comprising an indicator for providing physical or audible feedback that any clip has been fully deployed from the tube.

10. The device of claim 6, further comprising a visual indicator to indicate the position of the tube.

11. The device of claim 6, wherein the device is adapted for cyst aspiration.

12. The device of claim 6, further comprising an alignment notch in the hub portion.

13. The device of claim 6, wherein the actuator requires only one hand to deploy the clip from the tube.

14. The device of claim 13, wherein the device is configured to be used ambidextrously.

15. The device of claim 6, wherein the finger grips are semicircular or substantially cirular.

16. The device of claim 6, wherein the clip comprises:

a. a first portion that is straight, arcuate or a combination thereof; and

b. at least one additional second portion that is straight, arcuate or a combination thereof, the first and second portions adapted to fit within the tube of a delivery device and to elastically deform relative to each other upon exiting the tube for engaging tissue.

17. A method for marking an evacuated breast cyst, comprising the steps of:

a. inserting a needle into a fluid filled breast cyst;

b. removing fluid from the breast cyst for collapsing the walls of the breast cyst; and

c. pushing the actuator and driver along the inside portion of the needle resulting in the insertion of a clip into a breast cyst to mark the same;

wherein the clip comprises;

i) a first portion that is straight, arcuate or a combination thereof; and

ii) at least one additional second portion that is straight, arcuate or a combination thereof, and which is connected to the first portion at an apex, the first and second portions adapted to fit within a tube of a delivery device and to elastically deform about the apex upon exiting the tube for engaging tissue.

18. The method of claim 17, wherein only one hand is required for the insertion of the needle and the marking of breast cyst and wherein the device is configured to be used ambidextrously.

19. The method of claim 17, wherein the needle has a caliber of 18 gauge or larger and the cyst is aspirated in the absence of a stylet.

20. The method of claim 19, wherein the needle has a side hole for aspirating the cyst, and through which the clip can be deployed.