Apparatus for the percutaneous marking of a lesion

• US 8,579,931 B2
• Filed: 09/29/2011
• Issued: 11/12/2013
• Est. Priority Date: 06/17/1999
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Chesbrough, Richard M., Field, Steven E., Goosen, Ryan L., Zerfas, Jeff, Davis, Richard E.
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US13/248,279
• Publication Number:
  US 20120022369A1
• Time in Patent Office: 775 Days
• Field of Search: 606/185, 606/130, 606/116, 604/63, 604/164, 604/264, 600/434
• US Class Current: 606/185
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

A biopsy marking apparatus for placing a radiopaque marker at the location of a percutaneous biopsy. The biopsy marking apparatus comprises an introducer in combination with a radiopaque marker. The introducer ejects the radiopaque marker at the location of the biopsy. The introducer is configured to completely eject the radiopaque marker and prevent it from being subsequently drawn into the introducer as the introducer is removed from the biopsied tissue mass. The radiopaque marker has enhanced radiopaque characteristics and enhanced non-migration characteristics.

Claims

1. A marking apparatus for the percutaneous placement of an imaging marker at a location in a tissue mass to facilitate subsequent determination of the location of the tissue mass, the marking apparatus comprising:

a handle having a proximal handle end and a hollow interior that extends distally from the proximal handle end;

a cannula mounted to the handle and configured to extend from the handle, the cannula being configured to define a lumen open to the hollow interior of the handle, a distal end of the cannula forming an insertion tip with an axial opening at the insertion tip;

a stylet having a proximal end with a proximal tip and a distal end, slidably received within the lumen for movement between a ready position and an extended position, where, in the ready position, the distal end of the stylet is spaced inwardly from the insertion tip to define a marker recess between the distal end of the stylet and the axial opening, and in the extended position the distal end of the stylet extends at least into the marker recess;

an imaging marker disposed completely within the marker recess to be expelled through the axial opening by movement of the stylet from the ready position to the extended position, wherein the imaging marker has no lead long enough to extend from the interior of the tissue mass to the exterior of the tissue mass when the imaging marker has been placed in the tissue mass; and

an actuator having a plunger connected to the proximal end of the stylet, and configured to move the stylet from the ready position to the extended position to expel the imaging marker, the plunger configured to project proximally from the hollow interior at the proximal handle end, the plunger in its entirety having an exterior surface that is of uniform diameter and has an outer perimeter that is smaller than an outer perimeter of the handle,

whereby the marking apparatus has the handle, the cannula, the stylet, and the actuator combined as a single unitary self-contained device, and is configured to be grasped and operated by a single hand of a user, and

wherein the actuator comprises the plunger slidably and rotatably mounted to the handle, and further includes a safety that comprises a channel provided on one of the handle and the plunger and a catch provided on the other of the handle and the plunger and configured such that when the catch and channel are rotationally aligned, the plunger can move the stylet from the ready position to the extended position, and configured such that when the catch and the channel are rotationally mis-aligned, the plunger cannot move the stylet from the ready position to the extended position.

2. The marking apparatus according to claim 1, and the handle further comprising a grip portion having an enlarged diameter portion against which the user'"'"'s fingers can bear during the insertion of the cannula into the tissue mass.

3. The marking apparatus according to claim 2, the handle further comprising a tapered nose portion extending from grip portion, wherein the junction of the tapered nose portion and the grip portion define the enlarged diameter portion.

4. The marking apparatus according to claim 2, wherein the handle includes an annular concave surface that terminates in a swelling to form the enlarged diameter portion.

5. The marking apparatus according to claim 1, wherein the stylet is slidably mounted to the handle and configured such that the stylet is not readily removable from the handle after the expulsion of the imaging marker from the marker recess.

6. The marking apparatus according to claim 1, further comprising a stop configured to prevent the ready removal of the stylet from the handle.

7. The marking apparatus according to claim 1, wherein the imaging marker includes an interior hollow portion thereof forming an air trap to enhance the ultrasound characteristic of the imaging marker.

8. The marking apparatus according to claim 1, wherein the imaging marker includes an anchor about which a tissue mass can prolapse to aid in fixing the position of the imaging marker within the tissue mass.

9. The marking apparatus according to claim 1, wherein the imaging marker comprises a wire-form body.

10. The marking apparatus according to claim 1, wherein the imaging marker comprises a pair of legs, each of the legs having a first end and a second end, and a bight portion connecting the first ends of the legs and at least one of the second ends of the legs forming an anchor, wherein each of the legs approaches the other leg in a direction from the bight portion to the respective second end and wherein each of the second ends of the legs comprises a tip projecting away from a longitudinal axis of the respective leg to form an anchor.