Breast biopsy markers and systems

Abstract

The breast biopsy marker includes a catheter shaft and a bioabsorbable balloon. The catheter shaft has a lumen, a proximal tube portion, and a distal tube portion. The proximal tube portion is joined to the distal tube portion by a weak link. The distal tube portion has a one-way valve positioned within the lumen. The bioabsorbable balloon is fixedly coupled to the distal tube portion to define a balloon assembly. The bioabsorbable balloon is configured to be in fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve in the distal tube portion of the catheter shaft. The balloon assembly is configured to be separated from the proximal tube portion of the catheter shaft by breaking the weak link.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] None

[0002] The present invention relates to breast biopsy devices and, more particularly, to breast biopsy markers and systems. [Background technology]

[0002]

[0003] Biopsy diagnosis and treatment often involves performing a biopsy, such as a breast biopsy, in which a specimen or sample of tissue is removed from a patient at a biopsy site for pathological examination, testing, and analysis. Obtaining a tissue sample via biopsy and subsequent testing is typically used in the diagnosis of cancer and other malignancies, or to confirm that a suspected lesion or tumor is not malignant. For example, a breast biopsy may be performed when a suspicious lump or swelling is found in the breast. Examination of the tissue sample obtained via biopsy is particularly important in the diagnosis and treatment of breast cancer.

[0003]

[0004] After a biopsy is performed, it may take days or weeks for the results of testing the sample to become available, and even longer for an appropriate treatment decision to be reached. If this decision involves surgery, it is important for the surgeon to locate the location in the breast where the tumor tissue was taken during the biopsy procedure (the biopsy site) so that the entire tumor and possibly some surrounding healthy tissue can be removed.

[0004]

[0005] Various types of biopsy site markers are available to assist physicians in locating the biopsy site, including visible markers applied externally to the patient's skin, radiographically (with X-rays) detectable tissue markers such as clips and staples, and ultrasound detectable markers. However, such markers are not effective at filling the biopsy cavity and also providing a cosmetic benefit. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0006] There is a need in the art for breast biopsy markers and systems that assist the physician in recapturing the location of the biopsy site, aid in patient healing, and / or provide a cosmetic benefit to the patient. [Means for solving the problem]

[0006]

[0007] The present invention provides a breast biopsy marker and system that assists the physician in recapturing the location of the biopsy site, aids in patient healing, and / or provides a cosmetic benefit to the patient.

[0007]

[0008] In one form, the present invention is directed to a breast biopsy marker including a catheter shaft and a bioabsorbable balloon. The catheter shaft has a lumen, a proximal tube portion, and a distal tube portion. The proximal tube portion is joined to the distal tube portion by a weak link. The distal tube portion has a one-way valve positioned within the lumen. The bioabsorbable balloon is fixedly coupled to the distal tube portion to define a balloon assembly. The bioabsorbable balloon is configured to be in fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve in the distal tube portion of the catheter shaft. The balloon assembly is configured to be separated from the proximal tube portion of the catheter shaft by breaking the weak link.

[0008]

[0009] The invention in another form is directed to a breast biopsy marker system including a catheter shaft, a bioabsorbable balloon, a syringe, and an elongated stylet. The catheter shaft has a lumen, a proximal tube section, and a distal tube section. The proximal tube section is joined to the distal tube section by a frangible link. The distal tube section has a one-way valve positioned within the lumen. The bioabsorbable balloon is fixedly coupled to the distal tube section to define a balloon assembly. The bioabsorbable balloon is configured to be in fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve of the distal tube section of the catheter shaft. The syringe is configured to hold a gel material. The syringe has an injection port connectable to the proximal tube section of the catheter shaft. The syringe is configured to deliver the gel material through the lumen of the catheter shaft and into the bioabsorbable balloon. The elongated stylet is configured to be inserted into the lumen of the catheter shaft to break a weak link in the catheter shaft and separate the proximal tube portion of the catheter shaft from the balloon assembly following expansion of the bioabsorbable balloon with a gel material delivered by a syringe.

[0009]

[0010] One advantage of the present invention is that the breast biopsy markers aid the physician in recapturing the location of the biopsy site and provide a cosmetic benefit to the patient.

[0010]

[0011] Another advantage of the present invention is that the breast biopsy marker can aid healing by providing internally applied pressure at the biopsy site, providing a biodegradable scaffold / support for the tissue to heal around.

[0011]

[0012] Another advantage of the present invention is that the breast biopsy markers can provide a cosmetic benefit to the patient by enlarging the biopsy cavity.

[0012]

[0013] Another advantage is that the breast biopsy marker can be immediately placed and extended following the biopsy through the existing biopsy tract without the need for a new or future incision or puncture for marker placement.

[0013]

[0014] Another advantage is that the breast biopsy marker material can be selected to provide both short-term and long-term image visibility in multiple imaging modalities.

[0014]

[0015] These and other features and advantages of the invention, as well as the manner of obtaining them, will become more apparent and the invention will be better understood by referring to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0015] [Figure 1]

[0016] FIG. 2 is an exploded view of a breast biopsy marker system according to one embodiment of the present invention, with the bioabsorbable balloon of the marker catheter in a deflated state. [Diagram 2]

[0017] FIG. 2 is a side view of the marker catheter of FIG. 1 with the bioabsorbable balloon in an expanded state. [Diagram 3]

[0018] 3 is an enlarged cross-sectional view of the marker catheter of FIG. 2 taken along line 3-3 of FIG. 2. [Figure 4]

[0019] 4 is a cross-sectional view of the marker catheter of FIG. 3 taken along line 4-4-4-4 of FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016]

[0020] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate at least one embodiment of the invention, and such examples are not to be construed as limiting the scope of the invention in any way.

[0017]

[0021] Referring now to the drawings, and more particularly to FIG. 1, there is shown a breast biopsy marker system 10 generally comprising a syringe 12, a marker catheter 14, and an elongated stylet 16.

[0018]

[0022] The syringe 12 is configured to hold a gel material 18, such as a hydrogel. The syringe 12 may include, for example, a cylinder 20 having a chamber 20-1 and a plunger 22 having a piston 22-1 disposed within the chamber 20-1 proximally relative to the gel material 18. The cylinder 20 of the syringe 12 has an injection port 20-2 connectable to the marker catheter 14. As described in more detail below, the syringe 12 is configured to deliver the gel material 18 into the marker catheter 14.

[0019]

[0023] In this embodiment, syringe 12 is shown as having a single chamber 20-1 configured to hold a pre-prepared gel as gel material 18, however, one of ordinary skill in the art will recognize that syringe 12 may be modified to have multiple (e.g., two) chambers containing components to form a gel after the components are combined. Thus, as used herein, the term "gel material" is intended to be broadly interpreted to include both pre-prepared gels and components that form a gel when combined, e.g., mixed, with one another.

[0020]

[0024] 2 and 3, the marker catheter 14 includes a catheter shaft 24 and a bioabsorbable balloon 26. The bioabsorbable balloon 26 may be made from a polymer, such as, for example, a poly(glycolide-co-lactide) (PGLA) material, and may optionally include at least one radiopaque and ultrasound-visible marker element 26-1, such as a titanium ribbon, embedded in the PGLA material to provide both short-term and long-term image visibility in multiple imaging modalities.

[0021]

[0025] The catheter shaft 24 includes a lumen 28, a proximal tube section 30, and a distal tube section 32. The proximal tube section 30 may be made of, for example, a non-biodegradable material. The distal tube section 32 may be made of, for example, a non-biodegradable material and may optionally include non-biodegradable components, for example, etching, that provide permanent ultrasound visibility resulting in long-term image visibility under ultrasound. The non-biodegradable material of the proximal tube section 30 may be, for example, a PEBAX® brand polymer (PEBAX is a registered trademark of Arkema France Corporation France). The non-biodegradable material and components of the distal tube section 32 may be, for example, polyvinyl alcohol.

[0022]

[0026] According to one aspect of the invention, the proximal tube portion 30 is joined to the distal tube portion 32 by a frangible link 34. The distal tube portion 32 includes a one-way valve 36, such as a pivotable flap, e.g., a check valve, positioned within the lumen 28 and a sidewall orifice 32-1 in fluid communication with the lumen 28. The injection port 20-2 of the syringe 12 is releasably connectable to the proximal tube portion 30 of the catheter shaft 24, e.g., by a luer or friction connection, to facilitate delivery of the gel material 18 into the lumen 28 of the catheter shaft 24.

[0023]

[0027] In this embodiment, referring to Figures 2-4, the proximal tube portion 30 has a first end portion 30-1 and a hub portion 30-2, and the distal tube portion 32 has a second end portion 32-2 having a proximal end surface 32-3. The second end portion 32-2 of the distal tube portion 32 is positioned within the first end portion 30-1 of the proximal tube portion 30 such that the first end portion 30-1 of the proximal tube portion 30 radially overlaps with the second end portion 32-2 of the distal tube portion 32 to define an overlap region 38. Thus, the proximal end surface 32-3 of the distal tube portion 32 is exposed proximally within the lumen 28 of the catheter shaft 24.

[0024]

[0028] The frangible link 34 joins the proximal tube portion 30 to the distal tube portion 32 and may be positioned in an overlap region 38 of the proximal tube portion 30 and the distal tube portion 32. For example, the frangible link 34 may join the proximal tube portion 30 to the distal tube portion 32 by a breakable connection coupled to each of the proximal end surface 32-3 of the second end portion 32-2 of the distal tube portion 32 and the proximal tube portion 30. In this embodiment, for example, the frangible link 34 is a spot weld.

[0025]

[0029] 1-4, the bioabsorbable balloon 26 is fixedly coupled to the distal tube portion 32, for example by adhesive, laser welding, or shrink tubing, to define a balloon assembly 40. The syringe 12 is configured to deliver a gel material 18 through the lumen 28 of the catheter shaft 24 to the bioabsorbable balloon 26. The bioabsorbable balloon 26 has a deflated state 42 (see FIG. 1) and an expanded state 44 (see FIGS. 2-4). In the deflated state 42, the balloon assembly 40 of the marker catheter 14 can be inserted into a biopsy cavity of a patient, for example a breast biopsy cavity.

[0026]

[0030] 2-4 , when the injection port 20-2 of the syringe 12 is coupled to the proximal tubular portion 30 of the catheter shaft 24, then the bioabsorbable balloon 26 of the balloon assembly 40 is coupled in fluid communication with the syringe 12 via the lumen 28 of the catheter shaft 24. Thus, when the syringe 12 is actuated, for example by depressing the plunger 22, the gel material 18 is delivered to the bioabsorbable balloon 26, causing it to expand. In this embodiment, the bioabsorbable balloon 26 is configured to be in fluid communication with the lumen 28 of the catheter shaft 24 at a location distal to the one-way valve 36 of the distal tubular portion 32 of the catheter shaft 24. Thus, the gel material 18 can be inserted through the one-way valve 36 of the distal tube portion 32 of the catheter shaft 24 and through the sidewall orifice 32-1 into the bioabsorbable balloon 26 to effect an expanded state 44 of the bioabsorbable balloon 26, with the one-way valve 36 configured to prevent reversion from the expanded state 44 back to the deflated state 42. In other words, when the bioabsorbable balloon 26 of the balloon assembly 40 is being expanded with the gel material 18, the one-way valve 36 of the distal tube portion 32 of the catheter shaft 24 of the balloon assembly 40 prevents backflow of the gel material 18, thereby maintaining the bioabsorbable balloon 26 in a permanently expanded state 44.

[0027]

[0031] The elongated stylet 16 is configured, for example, as an elongated tube or rod, for insertion into the lumen 28 of the catheter shaft 24 to break the weak links 34 and separate the proximal tube portion 30 of the catheter shaft 24 from the balloon assembly 40. Specifically, the elongated stylet 16 is configured to be inserted into the lumen 28 of the catheter shaft 24 to break the weak links 34 of the catheter shaft 24 and separate the proximal tube portion 30 of the catheter shaft 24 from the balloon assembly 40 following expansion of the bioabsorbable balloon 26 with the gel material 18 delivered by the syringe 12.

[0028]

[0032] For example, the elongate stylet 16 is inserted into and advanced within the lumen 28 in the proximal tube portion 30 of the catheter shaft 24 such that the distal end 16-1 of the elongate stylet 16 engages the proximal end surface 32-3 of the second end portion 32-2 of the distal tube portion 32 and / or the frangible link 34. The elongate stylet 16 may then be advanced further, for example, 0.5-2 millimeters, with sufficient force to break the frangible link 34, thereby separating the proximal tube portion 30 from the balloon assembly 40. After the frangible link 34 is broken, the proximal tube portion 30 can then be withdrawn from the patient, leaving the balloon assembly 40 in the expanded state 44 in the patient's biopsy cavity.

[0029]

[0033] The gel material 18 contained within the bioabsorbable balloon 26 will degrade within the patient's body over a period of 12-18 months as the bioabsorbable balloon 26 is resorbed. In some implementations, for example, the gel material 18 may be, for example, a polyethylene glycol (PEG) based hydrogel, sodium hyaluronate (hyaluronic acid), or aloe vera gel. Sodium hyaluronate provides wound healing benefits and can also be modified to exhibit thermosetting properties. The thermosetting properties of the gel material 18 may be desirable as it allows the material to be in a liquid state for expansion and then thicken to a gel-like viscosity once the material reaches body temperature. This allows the bioabsorbable balloon 26 to be expanded with minimal application of pressure. In some implementations, PEG may be a desirable material due to its long, predictable degradation timeline, and its ultrasound visibility properties. Aloe vera also provides wound healing benefits but does not provide thermosetting capabilities.

[0030]

[0034] The following items also relate to the present invention:

[0031]

[0035] In one embodiment, the present invention relates to a breast biopsy marker (assembly) including a catheter shaft and a bioabsorbable balloon. The catheter shaft has a lumen, a proximal tube section, and a distal tube section. The proximal tube section is joined to the distal tube section by a weak (breakable) link and / or a link structured to break, separate and / or dejoin. The distal tube section can have a one-way valve positioned within the lumen. The bioabsorbable balloon is (fixedly) coupled to the distal tube section to define a balloon assembly. The bioabsorbable balloon can be configured to be in fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve of the distal tube section of the catheter shaft. The balloon assembly and / or the breast biopsy marker (assembly) are configured such that the balloon assembly can be separated from the proximal tube section of the catheter shaft by breaking the weak link.

[0032]

[0036] In any embodiment, the bioabsorbable balloon can have a contracted state and an expanded state. Alternatively, or in addition, a gel material can be inserted into the bioabsorbable balloon through a one-way valve in the distal tube portion of the catheter shaft to provide the expanded state of the bioabsorbable balloon.

[0033]

[0037] In any embodiment, the proximal tube portion of the catheter shaft has a first end portion. The distal tube portion has a second end portion having a proximal end surface. The second end portion of the distal tube portion can be positioned within the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region, and the proximal end surface of the distal tube portion is exposed proximally within the lumen of the catheter shaft.

[0034]

[0038] In the embodiment of paragraph 0033, the weakened link joining the proximal tube portion to the distal tube portion may be positioned in the overlap region.

[0035]

[0039] In the embodiment of paragraph 0033, the frangible link joining the proximal tube portion to the distal tube portion may be coupled to each of the proximal end surfaces of the second end portion of the distal tube portion and the proximal tube portion.

[0036]

[0040] In any embodiment, the weak link may be a spot weld.

[0037]

[0041] Optionally, for use with any embodiment, an elongated stylet may be configured to be inserted into the lumen of the catheter shaft to break the weak link and separate the proximal tube portion of the catheter shaft from the balloon assembly.

[0038]

[0042] In any embodiment, the bioabsorbable balloon may be made of a PGLA material, and optionally further comprises at least one radiopaque and / or ultrasound visible marker element embedded in the PGLA material.

[0039]

[0043] In any embodiment, the proximal tube portion may be made of a non-biodegradable material and / or the distal tube portion can include a non-biodegradable component configured to provide permanent ultrasound visibility.

[0040]

[0044] In the embodiment of paragraph 0039, the non-biodegradable material of the proximal tubing section may be a PEBAX® brand polymer and / or the non-biodegradable component of the distal tubing section may be polyvinyl alcohol.

[0041]

[0045] In another embodiment, the present invention relates to a breast biopsy marker system. The system may include a catheter shaft, a bioabsorbable balloon, a syringe, and an elongated stylet. The catheter shaft may be the catheter shaft of paragraph 0031 and / or may have a lumen, a proximal tube portion, and a distal tube portion. The proximal tube portion is joined to the distal tube portion by a frangible link. The distal tube portion may have a one-way valve positioned within the lumen. The bioabsorbable balloon may be the bioabsorbable balloon of paragraph 0031 and / or may be (fixedly) coupled to the distal tube portion to define a balloon assembly. The bioabsorbable balloon may be configured to be in fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve of the distal tube portion of the catheter shaft. The syringe may be configured to hold a gel material. The syringe may have an injection port that may be coupled or connectable to the proximal tube portion of the catheter shaft. The syringe may be configured to deliver the gel material through the lumen of the catheter shaft to the bioabsorbable balloon. The elongated stylet may be configured to be inserted into the lumen of the catheter shaft to break a weak link in the catheter shaft to separate the proximal tube portion of the catheter shaft from the balloon assembly following expansion of the bioabsorbable balloon with the gel material delivered by the syringe. The system may be configured such that the elongated stylet may break a weak link in the catheter shaft to separate the proximal tube portion of the catheter shaft from the balloon assembly following expansion of the bioabsorbable balloon with the gel material delivered by the syringe.

[0042]

[0046] In any system embodiment, the bioabsorbable balloon can have a contracted state and an expanded state. Alternatively, or additionally, a gel material can be configured to be inserted into the bioabsorbable balloon through a one-way valve in the distal tube portion of the catheter shaft to provide an expanded state for the bioabsorbable balloon. The one-way valve can be configured to prevent return from the expanded state to the contracted state.

[0043]

[0047] In any system embodiment, the proximal tube portion of the catheter shaft has a first end portion. The distal tube portion can have a second end portion having a proximal end surface. The second end portion of the distal tube portion can be positioned within the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region, and the proximal end surface of the distal tube portion is exposed proximally within the lumen of the catheter shaft.

[0044]

[0048] In the system embodiment of paragraph 0043, the frangible link joining the proximal tube portion to the distal tube portion may be positioned in the overlap region of the proximal and distal tube portions.

[0045]

[0049] In the system embodiment of paragraph 0043, the frangible link joining the proximal tube portion to the distal tube portion may be coupled to each of the proximal end surfaces of the second end portion of the distal tube portion and the proximal tube portion.

[0046]

[0050] In any system embodiment, the weak link may be a spot weld.

[0047]

[0051] In any system embodiment, the elongated stylet may be configured as an elongated tube or rod that can be inserted into the lumen of the catheter shaft to break the weak link and separate the proximal tube portion of the catheter shaft from the balloon assembly.

[0048]

[0052] In any system embodiment, the bioabsorbable balloon may be made of PGLA material and may optionally further comprise at least one radiopaque and / or ultrasound visible marker element that may be embedded in the PGLA material.

[0049]

[0053] In any system embodiment, the proximal tube portion may be made of a non-biodegradable material and / or the distal tube portion can include a non-biodegradable component configured to provide permanent ultrasound visibility.

[0050]

[0054] In the system embodiment of paragraph 0053, the non-biodegradable material of the proximal tube section may be a PEBAX® brand polymer and / or the non-biodegradable component of the distal tube section may be polyvinyl alcohol.

[0051]

[0055] Although the present invention has been described with respect to at least one embodiment, the present invention may be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or modifications of the invention using its general principles. Moreover, this application is intended to cover departures from the present disclosure that come within known or customary practice in the art to which this invention pertains and that fall within the scope of the appended claims.

Claims

1. a catheter shaft having a lumen, a proximal tube section, and a distal tube section, the proximal tube section joined to the distal tube section by a frangible link, the distal tube section having a one-way valve positioned within the lumen; a bioabsorbable balloon fixedly coupled to the distal tube portion to define a balloon assembly, the bioabsorbable balloon configured to be in fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve in the distal tube portion of the catheter shaft, the balloon assembly configured to be separated from the proximal tube portion of the catheter shaft by breaking the weak link, the bioabsorbable balloon in fluid communication with the lumen through a sidewall orifice of the catheter shaft; an elongated stylet configured to be inserted into the lumen of the catheter shaft to break the frangible link and separate the proximal tube portion of the catheter shaft from the balloon assembly; 1. A breast biopsy marker comprising:

2. 2. The breast biopsy marker of claim 1, wherein the bioabsorbable balloon has a contracted state and an expanded state and comprises a gel material configured to be inserted through the one-way valve of the distal tube portion of the catheter shaft and into the bioabsorbable balloon to provide the expanded state of the bioabsorbable balloon.

3. the proximal tube portion having a first end portion; the distal tube portion having a second end portion with a proximal end surface; Equipped with the second end portion of the distal tube portion is positioned within the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region and the proximal end surface of the distal tube portion is exposed proximally within the lumen of the catheter shaft.

3. A breast biopsy marker according to claim 1 or 2.

4. The breast biopsy marker of claim 3 , wherein the frangible link joining the proximal tube portion to the distal tube portion is positioned in the overlap region.

5. 4. The breast biopsy marker of claim 3, wherein the frangible link joining the proximal tube portion to the distal tube portion is coupled to the proximal end surface of the second end portion of the distal tube portion and to each of the proximal tube portions.

6. The breast biopsy marker of claim 1 , wherein the frangible link is a spot weld.

7. 7. The breast biopsy marker of claim 1, wherein the bioabsorbable balloon is made of PGLA material and further comprises at least one radiopaque and ultrasound visible marker element embedded in the PGLA material.

8. 8. The breast biopsy marker of claim 1 , wherein the proximal tube portion is made of a non-biodegradable material and the distal tube portion includes a non-biodegradable component configured to provide permanent ultrasound visibility.

9. a catheter shaft having a lumen, a proximal tube section, and a distal tube section, the proximal tube section joined to the distal tube section by a frangible link, the distal tube section having a one-way valve positioned within the lumen; a bioabsorbable balloon fixedly coupled to the distal tube portion to define a balloon assembly, the bioabsorbable balloon configured to be in fluid communication with the lumen of the catheter shaft at a location of the distal tube portion of the catheter shaft distal to the one-way valve; a syringe configured to hold a gel material, the syringe having an injection port connectable to the proximal tube portion of the catheter shaft, the syringe configured to deliver the gel material through the lumen of the catheter shaft and to the bioabsorbable balloon; an elongated stylet configured to be inserted into the lumen of the catheter shaft to break the weak link of the catheter shaft and separate the proximal tube portion of the catheter shaft from the balloon assembly following expansion of the bioabsorbable balloon with the gel material delivered by the syringe; A breast biopsy marker system comprising:

10. 10. The breast biopsy marker system of claim 9, wherein the bioabsorbable balloon has a contracted state and an expanded state, and the gel material is configured to be inserted into the bioabsorbable balloon through the one-way valve in the distal tube portion of the catheter shaft to effect the expanded state of the bioabsorbable balloon, the one-way valve configured to prevent return from the expanded state to the contracted state.

11. the proximal tube portion having a first end portion; the distal tube portion having a second end portion with a proximal end surface; Equipped with the second end portion of the distal tube portion is positioned within the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region and the proximal end surface of the distal tube portion is exposed proximally within the lumen of the catheter shaft. Breast biopsy marker system according to claim 9 or 10.

12. The breast biopsy marker system of claim 11 , wherein the frangible link joining the proximal tube portion to the distal tube portion is positioned in the overlap region between the proximal tube portion and the distal tube portion.

13. 12. The breast biopsy marker system of claim 11, wherein the frangible link joining the proximal tube portion to the distal tube portion is coupled to the proximal end surface of the second end portion of the distal tube portion and to each of the proximal tube portions.

14. 14. The breast biopsy marker system of claim 9, wherein the frangible link is a spot weld.

15. 15. The breast biopsy marker system of claim 9, wherein the elongated stylet is configured as an elongated tube or rod that is inserted into the lumen of the catheter shaft to break the weak link and separate the proximal tube portion of the catheter shaft from the balloon assembly.

16. 16. The breast biopsy marker system of claim 9, wherein the bioabsorbable balloon is made of PGLA material and further comprises at least one radiopaque and ultrasound visible marker element embedded in the PGLA material.

17. 17. The breast biopsy marker system of claim 9, wherein the proximal tube portion is made of a non-biodegradable material and the distal tube portion includes non-biodegradable components configured to provide permanent ultrasound visibility.

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