Device and method for safe location and marking of a biopsy cavity

• US 9,669,113 B1
• Filed: 12/23/1999
• Issued: 06/06/2017
• Est. Priority Date: 12/24/1998
• Status: Expired due to Fees

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Sutton, Douglas S., Sirimanne, D. Laksen, Fawzi, Natalie V., Lebovic, Gail S., Conston, Stanley R., Wilson, Peter M., Morrissey, Anne B., Bush, Mary Elizabeth
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): Weatherby, Ellsworth
• Application Number:
  US98/692,82
• Time in Patent Office: 6,375 Days
• Field of Search: 600436, 600564, 600567, 600585
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2090/3912 Body cavities
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3962 palpable
• 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 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/006 Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
• CPC Class Codes: A61K 49/0409 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
• CPC Class Codes: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes

Abstract

Cavity and sentinel lymph node marking devices, marker delivery devices, and methods are disclosed. More particularly, upon insertion into a body, the cavity marking device and method enable one to determine the center, orientation, and periphery of the cavity by radiographic, mammography, echogenic, or other noninvasive imaging techniques. A composition and method are disclosed for locating the sentinel lymph node in a mammalian body to determine if cancerous cells have spread thereto. The composition is preferably a fluid composition consisting of a carrier fluid and some type of contrast agent; alternatively, the contrast agent may itself be a fluid and therefore not need a separate carrier fluid. This composition is capable of (1) deposition in or around a lesion and migration to and accumulation in the associated sentinel node, and (2) remote detection via any number of noninvasive techniques. Also disclosed is a method for remotely detecting the location of a sentinel node by (1) depositing a remotely detectable fluid in or around a lesion for migration to and accumulation in the associated sentinel node and (2) remotely detecting the location of that node with a minimum of trauma and toxicity to the patient. The composition and method may serve to mark a biopsy cavity, as well as mark the sentinel lymph node. The marking methods also may combine any of the features as described with the marking device and delivery device.

Claims

1. A delivery device for delivering a marking device to a target site, said delivery device comprising:

an elongate member having a distal portion and a proximal portion with a lumen extending between the distal and proximal portions, said distal portion of said elongate member configured to seat the marking device and advance the marking device within said distal portion to the target site;

an ejector coupled to said elongate member, said ejector configured to disengage the marking device from said distal portion;

a marking device preloaded in said elongate member distal portion, for delivery through the lumen;

wherein said marking device comprises a first component and a second component, the first component is a wound arrangement of bioabsorbable suture material and the second component is a unitary piece of metal forming a marker, wherein the second component is carried and supported by the wound arrangement of the first component, and

wherein the wound arrangement of the first component includes multiple passes of the suture material through the second component to form a plurality of loops, each loop having a first end that extends from a first side of the second component and a second end that extends from a second side of the second component opposite the first side,

wherein the plurality of loops comprises at least 10 loops forming a loosely would ball shape and wherein the marker is positioned at a geometric center of the ball shape.

2. A marking device comprising:

a first component being a wound arrangement of bioabsorbable suture material;

a second component being a unitary piece of metal forming a marker; and

wherein the first component includes multiple passes of the suture material forming a body defined by the wound arrangement of the suture material with the second component carried and supported by the body, and

wherein the wound arrangement of the first component includes multiple passes of the suture material through the second component to form a plurality of loops, each loop having a first end that extends from a first side of the second component and a second end that extends from a second side of the second component opposite the first side,

wherein the plurality of loops comprises at least 10 loops forming a loosely would ball shape and wherein the marker is positioned at a geometric center of the ball shape.

3. A marking device comprising:

a delivery device having an elongate member with a lumen;

a first component being a bioabsorbable suture material;

a second component being a unitary piece of metal forming a marker; and

wherein the first component includes multiple passes of the suture material forming a wound arrangement of the suture material with the second component carried and supported by the wound arrangement, and

wherein the wound arrangement of the first component includes multiple passes of the suture material through the second component to form a plurality of loops, each loop having a first end that extends from a first side of the second component and a second end that extends from a second side of the second component opposite the first side,

wherein the plurality of loops comprises at least 10 loops forming a loosely would ball shape and wherein the marker is positioned at a geometric center of the ball shape.

4. A biopsy marking apparatus for marking a target site within the breast, the apparatus comprising:

a delivery device having an elongate member with a lumen;

an echogenic body comprising a wound arrangement of bioabsorbable material; and

a radiopaque marker carried and supported within the wound arrangement of the echogenic body, the marker having a recognizable shape distinguishable from calcifications, wherein the wound arrangement of the first component includes multiple passes of a suture material through the radiopaque marker to form a plurality of loops, each loop having a first end that extends from a first side of the radiopaque marker and a second end that extends from a second side of the radiopaque marker opposite the first side,

wherein the plurality of loops comprises at least 10 loops forming a loosely would ball shape and wherein the marker is positioned at a geometric center of the ball shape,

wherein the echogenic body is disposed within the lumen of the delivery device and deployable from the delivery device to the target site.