Patent Description:
Biopsy diagnostics and treatment often include the performing of a biopsy, such as a breast biopsy, in which a specimen or sample of tissue is removed from the patient at the biopsy site for pathological examination, tests and analysis. Obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. For example, a breast biopsy may be taken where a suspicious lump or swelling is noticed in a breast. Examination of tissue samples taken by the biopsy is of particular significance in the diagnosis and treatment of breast cancer.

After the biopsy is performed, it may take several days or weeks before the results of the examination of the sample are obtained, and still longer before an appropriate treatment decision is reached. If the decision involves surgery, it is important for the surgeon to find the location (biopsy site) in the breast from where the tumor tissue has been taken in the biopsy procedure, so that the entire tumor and possibly surrounding healthy tissue can be removed.

Various types of biopsy site markers are available, including visible markers applied externally to the patient's skin, radiographically (X-ray)-detectable tissue markers such as clips and staples, and ultrasound-detectable markers, to aid the physician in locating the biopsy site. However, such markers are not effective in filling the biopsy cavity for also providing a cosmetic benefit.

What is needed in the art is a breast biopsy marker and system that helps the physician in re-acquiring the location of the biopsy site, aids in patient healing, and/or provides a cosmetic benefit to the patient. <CIT> discloses a device for occluding a body lumen such that a reproductive lumen which includes an occluding component having an impervious barrier to provide initial occlusion of the body lumen and a permeable body to facilitate tissue ingrowth which provides long-term occlusion of the body lumen is disclosed. <CIT> discloses an apparatus for closure of an opening or isolation of a structure in a cardiovascular system. The apparatus includes an occluding segment, a delivery segment and a control segment.

The present invention provides a breast biopsy marker and system that helps the physician in re-acquiring the location of the biopsy site, aids in patient healing, and/or provides a cosmetic benefit to the patient.

The presently claimed invention is defined in independent claim <NUM>. Further developments of the herein claimed invention are described in the dependent claims.

An advantage of the present invention is that the breast biopsy marker helps the physician in re-acquiring the location of the biopsy site and provides a cosmetic benefit to the patient.

Another advantage of the present invention is that the breast biopsy marker may aid in healing by providing internal applied pressure at the biopsy site and a biodegradable scaffold / support for the tissue to heal around.

Another advantage of the present invention is that the breast biopsy marker may provide a cosmetic benefit to the patient by inflating the biopsy cavity.

Another advantage is that the breast biopsy marker is that it may be immediately placed and inflated following the biopsy through the existing biopsy tract, without the need for a new or future incision or puncture for marker placement.

Another advantage is that materials for the breast biopsy marker may be selected so as to provide both short term and long term imaging visibility in multiple imaging modalities.

The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of an embodiments of the invention taken in conjunction with the accompanying drawings, wherein:.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

Referring now to the drawings, and more particularly to <FIG>, there is shown a breast biopsy marker system <NUM> which generally includes a syringe <NUM>, a marker catheter <NUM>, and an elongate stylet <NUM>.

Syringe <NUM> is configured to carry a gel material <NUM>, such as a hydrogel. Syringe <NUM> may include, for example, a cylinder <NUM> having a chamber <NUM>-<NUM> and a plunger <NUM> having a piston <NUM>-<NUM> disposed in chamber <NUM>-<NUM> proximal to gel material <NUM>. Cylinder <NUM> of syringe <NUM> has an injection port <NUM>-<NUM> that is connectable to marker catheter <NUM>. Syringe <NUM> configured to deliver gel material <NUM> into marker catheter <NUM>, as will be described in more detail below.

While in the present embodiment syringe <NUM> is shown as having a single chamber <NUM>-<NUM> that is configured to carry a pre-prepared gel as gel material <NUM>, those skilled in the art will recognize that syringe <NUM> may be modified to have multiple (e.g., dual) chambers that contain the constituent component parts for forming a gel after the constituent component parts are combined. Accordingly, as used herein, the term "gel material" is intended to be interpreted broadly to include both pre-prepared gels and the constituent component parts which when combined, e.g., mixed, form a gel.

Referring also to <FIG> and <FIG>, marker catheter <NUM> includes a catheter shaft <NUM> and a bioabsorbable balloon <NUM>. Bioabsorbable balloon <NUM> may be made from a polymer, such as for example, a poly(glycolide-co-lactide) (PGLA) material, and optionally, may include at least one radiopaque and ultrasonically visible marker element <NUM>-<NUM>, e.g., a titanium ribbon, that is imbedded in the PGLA material, so as to provide both short term and long term imaging visibility in multiple imaging modalities.

Catheter shaft <NUM> includes a lumen <NUM>, a proximal tube portion <NUM>, and a distal tube portion <NUM>. Proximal tube portion <NUM> may be made, for example, of a non-biodegradable material. Distal tube portion <NUM> may be made, for example, of a non-biodegradable material and optionally may include a non-biodegradable component, e.g., etching, that provides permanent ultrasound visibility, thus yielding long term imaging visibility under ultrasound. The non-biodegradable material of proximal tube portion <NUM> may be, for example, a PEBAX® brand polymer (PEBAX is a registered trademark of the Arkema France Corporation France). The non-biodegradable material and component of distal tube portion <NUM> may be, for example, polyvinyl alcohol.

In accordance with an aspect of the present invention, proximal tube portion <NUM> is joined to distal tube portion <NUM> by a frangible link <NUM>. Distal tube portion <NUM> includes a one-way valve <NUM>, e.g., a check valve, such as a pivotable flap, that is located in lumen <NUM>, and a side wall orifice <NUM>-<NUM> in fluid communication with lumen <NUM>. Injection port <NUM>-<NUM> of syringe <NUM> is releasably connectable, e.g., by a Luer or friction connection, to proximal tube portion <NUM> of catheter shaft <NUM> to facilitate delivery of gel material <NUM> into lumen <NUM> of catheter shaft <NUM>.

In the present embodiment, with reference to <FIG>, proximal tube portion <NUM> has a first end portion <NUM>-<NUM> and a hub portion <NUM>-<NUM>, and distal tube portion <NUM> has a second end portion <NUM>-<NUM> having a proximal end surface <NUM>-<NUM>. Second end portion <NUM>-<NUM> of distal tube portion <NUM> is positioned inside first end portion <NUM>-<NUM> of proximal tube portion <NUM>, such that first end portion <NUM>-<NUM> of proximal tube portion <NUM> radially overlaps second end portion <NUM>-<NUM> of distal tube portion <NUM> to define an overlap region <NUM>. As such, proximal end surface <NUM>-<NUM> of distal tube portion <NUM> is proximally exposed in lumen <NUM> of catheter shaft <NUM>.

Frangible link <NUM> joins proximal tube portion <NUM> to distal tube portion <NUM> and may be located at overlap region <NUM> between proximal tube portion <NUM> and distal tube portion <NUM>. For example, frangible link <NUM> may join proximal tube portion <NUM> to distal tube portion <NUM> by a breakable connection that is connected to each of proximal end surface <NUM>-<NUM> of second end portion <NUM>-<NUM> of distal tube portion <NUM> and proximal tube portion <NUM>. In the present embodiment, for example, frangible link <NUM> is a spot weld.

Referring to <FIG>, bioabsorbable balloon <NUM> is fixedly connected, e.g., via adhesive, laser welding, or shrink tubing, to distal tube portion <NUM> to define a balloon assembly <NUM>. Syringe <NUM> is configured to deliver gel material <NUM> through lumen <NUM> of catheter shaft <NUM> to bioabsorbable balloon <NUM>. Bioabsorbable balloon <NUM> has a deflated state <NUM> (see <FIG>) and an inflated state <NUM> (see <FIG>). In the deflated state <NUM>, balloon assembly <NUM> of marker catheter <NUM> may be inserted into a biopsy cavity, e.g., a breast biopsy cavity, of a patient.

Referring particularly to <FIG>, when injection port <NUM>-<NUM> of syringe <NUM> is connected to proximal tube portion <NUM> of catheter shaft <NUM>, then bioabsorbable balloon <NUM> of balloon assembly <NUM> is coupled in fluid communication with syringe <NUM> via lumen <NUM> of catheter shaft <NUM>. Accordingly, upon actuation of syringe <NUM>, e.g., by depressing plunger <NUM>, gel material <NUM> is delivered into bioabsorbable balloon <NUM> so as to inflate bioabsorbable balloon <NUM>. In the present embodiment, bioabsorbable balloon <NUM> is configured for fluid communication with lumen <NUM> of catheter shaft <NUM> at a location distal to one-way valve <NUM> of distal tube portion <NUM> of catheter shaft <NUM>. Accordingly, gel material <NUM> may be inserted into bioabsorbable balloon <NUM> through one-way valve <NUM> and side wall orifice <NUM>-<NUM> of distal tube portion <NUM> of catheter shaft <NUM> to effect the inflated state <NUM> of bioabsorbable balloon <NUM>, wherein one-way valve <NUM> is configured to prevent a return from the inflated state <NUM> to the deflated state <NUM>. In other words, as bioabsorbable balloon <NUM> of balloon assembly <NUM> is being inflated with gel material <NUM>, then one-way valve <NUM> of distal tube portion <NUM> of catheter shaft <NUM> of balloon assembly <NUM> prevents a backflow of gel material <NUM>, such that bioabsorbable balloon <NUM> is retained in a permanent inflated state <NUM>.

Elongate stylet <NUM> is configured, e.g., as an elongate tube or rod, for insertion into lumen <NUM> of catheter shaft <NUM> to break frangible link <NUM> so as to separate proximal tube portion <NUM> of catheter shaft <NUM> from balloon assembly <NUM>. In particular, elongate stylet <NUM> is configured for insertion into lumen <NUM> of catheter shaft <NUM> to break frangible link <NUM> of catheter shaft <NUM> following inflation of bioabsorbable balloon <NUM> with gel material <NUM> delivered by the syringe <NUM>, so as to separate proximal tube portion <NUM> of catheter shaft <NUM> from balloon assembly <NUM>.

For example, elongate stylet <NUM> is inserted into, and is advanced in, lumen <NUM> in proximal tube portion <NUM> of catheter shaft <NUM> such that distal end <NUM>-<NUM> of elongate stylet <NUM> engages proximal end surface <NUM>-<NUM> of second end portion <NUM>-<NUM> of distal tube portion <NUM> and/or frangible link <NUM>. Elongate stylet <NUM> then may be further advanced, e.g., e.g., <NUM> to <NUM> millimeters, with a sufficient force so as to break frangible link <NUM>, thereby separating proximal tube portion <NUM> from balloon assembly <NUM>. After frangible link <NUM> is broken, then proximal tube portion <NUM> may be withdrawn from the patient while balloon assembly <NUM>, in the inflated state <NUM>, remains in the biopsy cavity of the patient.

Claim 1:
A breast biopsy marker catheter (<NUM>), comprising:
a catheter shaft (<NUM>) having a lumen (<NUM>), a proximal tube portion (<NUM>), and a distal tube portion (<NUM>), the proximal tube portion (<NUM>) being joined to the distal tube portion (<NUM>) by a frangible link (<NUM>), the distal tube portion having a one-way valve (<NUM>) located in the lumen (<NUM>); and
a bioabsorbable balloon (<NUM>) fixedly connected to the distal tube portion (<NUM>) to define a balloon assembly (<NUM>), the bioabsorbable balloon (<NUM>) configured for fluid communication with the lumen (<NUM>) of the catheter shaft (<NUM>) at a location distal to the one-way valve (<NUM>) of the distal tube portion (<NUM>) of the catheter shaft, the balloon assembly (<NUM>) configured to be separated from the proximal tube portion (<NUM>) of the catheter shaft by breaking the frangible link (<NUM>).