Breast Biopsy Markers and Systems

Abstract

A 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 coupled to the distal tube portion by a frangible coupling device. The distal tube portion has a one-way valve located in the lumen. The bioabsorbable balloon is fixedly connected 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 of 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 disconnecting the frangible coupling device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] none. Technical Field

[0003] The present invention relates to a breast biopsy device, and more particularly, to a breast biopsy marker and system. Background Art

[0004] Biopsy Diagnostic and therapeutic procedures often involve the performance of a biopsy, such as a breast biopsy, in which a sample or specimen of tissue is removed from a patient at the biopsy site for pathological examination, testing, and analysis. Tissue samples obtained through biopsy and subsequent examination are often used to diagnose cancer and other malignancies, or to confirm that a suspicious lesion or tumor is not malignant. For example, a breast biopsy may be performed if a suspicious lump or swelling is found in the breast. Examination of tissue samples obtained through a biopsy is particularly important in the diagnosis and treatment of breast cancer.

[0005] After a biopsy is performed, it may take days or weeks for the results of the sample to be available and even longer for an appropriate treatment decision to be made. If the decision involves surgery, it is important for the surgeon to locate the location in the breast where the tumor tissue removed during the biopsy was located (the biopsy site) so that the entire tumor and possibly surrounding healthy tissue can be removed.

[0006] Various types of biopsy site markers are available, including visible markers applied to the exterior of the patient's skin, radiographic (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 ineffective in providing a cosmetic benefit while filling the biopsy cavity.

[0007] There is a need in the art for a breast biopsy marker and system that assists the physician in relocating the biopsy site, aids in patient healing, and / or provides a cosmetic benefit to the patient. Summary of the invention

[0008] The present invention provides a breast biopsy marker and system that assists the physician in relocating the biopsy site, assists in patient healing, and / or provides cosmetic benefits to the patient.

[0009] In one form, the present invention is directed to a breast biopsy marker comprising 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 coupled to the distal tube portion by a frangible coupling. The distal tube portion has a one-way valve located in the lumen. The bioabsorbable balloon is fixedly connected 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 of 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 disconnecting the frangible coupling.

[0010] Another form of the present invention relates to a breast biopsy marking system, which includes a catheter shaft, a bioabsorbable balloon, a syringe and an elongated stylet. The catheter shaft has a lumen, a proximal tube portion and a distal tube portion. The proximal tube portion is coupled to the distal tube portion by a frangible coupling device. The distal tube portion has a one-way valve located in the lumen. The bioabsorbable balloon is fixedly connected 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 position distal to the one-way valve of the distal tube portion of the catheter shaft. The syringe is configured to carry a gel material. The syringe has an injection port that can be connected to the proximal tube portion of the catheter shaft. The syringe is configured to deliver the gel material to the bioabsorbable balloon through the lumen of the catheter shaft. The elongated stylet is configured to be inserted into the lumen of the catheter shaft to disconnect the frangible coupling device of the catheter shaft after the bioabsorbable balloon is inflated by the gel material delivered by the syringe, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

[0011] One advantage of the present invention is that the breast biopsy marker helps the physician to relocate the biopsy site and provides a cosmetic benefit to the patient.

[0012] Another advantage of the present invention is that the breast biopsy marker can assist in tissue healing by providing internal applied pressure at the biopsy site as well as providing a biodegradable scaffold / support for the surrounding tissue.

[0013] Another advantage of the present invention is that the breast biopsy marker can provide a cosmetic benefit to the patient by allowing the biopsy cavity to expand.

[0014] Another advantage is that the breast biopsy marker can be placed and expanded immediately after the biopsy within an existing biopsy tract without requiring a new or future incision or puncture to place the marker.

[0015] Another advantage is that the material of the breast biopsy marker can be selected to provide both short-term and long-term imaging visibility in multiple imaging modalities. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The above and other features and advantages of the present invention and the manner in which these features and advantages are achieved will become more apparent, and the present invention will be better understood, with reference to the following description of the embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0017] Figure 1 is an exploded view of a breast biopsy marking system according to one aspect of the present invention, wherein the bioabsorbable balloon of the marking catheter is in a collapsed state;

[0018] Figure 2 yes Figure 1 A side view of a labeled catheter with the bioresorbable balloon in an expanded state;

[0019] Figure 3 is along Figure 2 The 3-3 line intercept Figure 2 An enlarged cross-sectional view of a labeled catheter; and

[0020] Figure 4 is along Figure 3 The 4-4-4-4 line intercepted Figure 3 A cross-sectional view of a labeled catheter.

[0021] Corresponding reference numerals indicate corresponding parts throughout the several views.The examples set out herein illustrate at least one embodiment of the invention, and these examples should not be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION

[0022] Referring now to the drawings, in particular Figure 1 , a breast biopsy marking system 10 is shown, which generally includes a syringe 12, a marking catheter 14 and an elongated stylet 16.

[0023] The syringe 12 is configured to carry a gel material 18, such as a hydrogel. For example, the syringe 12 may include a barrel 20 having a chamber 20-1 and a plunger 22 having a piston 22-1 disposed in the chamber 20-1 proximate to the gel material 18. The barrel 20 of the syringe 12 has an injection port 20-2 that can be connected to the marking catheter 14. The syringe 12 is configured to deliver the gel material 18 into the marking catheter 14, as will be described in more detail below.

[0024] Although in the present embodiment, the syringe 12 is shown as having a single chamber 20-1 configured to carry a pre-prepared gel as the gel material 18, those skilled in the art will recognize that the syringe 12 can be modified to have multiple (e.g., dual) chambers containing multiple components to form a gel after the components are combined. Therefore, 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).

[0025] Also refer to Figure 2 and Figure 3 , the marker catheter 14 includes a catheter shaft 24 and a bioabsorbable balloon 26. The bioabsorbable balloon 26 can be made of a polymer, such as a poly(lactide-co-glycolide) (PGLA) material, and optionally can include at least one radiopaque and ultrasound-visible marker element 26-1, such as a titanium band, embedded in the PGLA material to provide both short-term imaging visibility and long-term imaging visibility in multiple imaging modalities.

[0026] The catheter shaft 24 includes a lumen 28, a proximal tube portion 30, and a distal tube portion 32. The proximal tube portion 30 can be made of, for example, a non-biodegradable material. The distal tube portion 32 can be made of, for example, a non-biodegradable material, and can optionally include a non-biodegradable component that provides permanent ultrasound visibility, such as by etching, thereby creating long-term imaging visibility under ultrasound. The non-biodegradable material of the proximal tube portion 30 can be, for example, PEBAX is a registered trademark of Arkema France Corporation France. The non-biodegradable material and composition of the distal tube portion 32 may be, for example, polyvinyl alcohol.

[0027] According to one aspect of the invention, the proximal tube portion 30 is joined to the distal tube portion 32 by a frangible coupling 34. The distal tube portion 32 includes a one-way valve 36, such as a pivotable flap, located in the lumen 28, and includes a sidewall orifice 32-1 in fluid communication with the lumen 28. The injection port 20-2 of the syringe 12 is releasably connected to the proximal tube portion 30 of the catheter shaft 24, such as by a Luer or friction connection, to facilitate delivery of the gel material 18 into the lumen 28 of the catheter shaft 24.

[0028] In this embodiment, refer to Figure 2-4The proximal tube portion 30 has a first end 30-1 and a seat 30-2, and the distal tube portion 32 has a second end 32-2, and the second end has a proximal end surface 32-3. The second end 32-2 of the distal tube portion 32 is positioned inside the first end 30-1 of the proximal tube portion 30, so that the first end 30-1 of the proximal tube portion 30 overlaps with the second end 32-2 of the distal tube portion 32 in the radial direction to define an overlapping area 38. In this way, the proximal end surface 32-3 of the distal tube portion 31 is exposed proximally in the lumen 28 of the catheter shaft 24.

[0029] The frangible connection device 34 joins the proximal tube portion 30 to the distal tube portion 32 and is located at the overlap region 38 between the proximal tube portion 30 and the distal tube portion 32. For example, the frangible connection device 34 may join the proximal tube portion 30 to the distal tube portion 32 by a frangible connection portion connected 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 the present embodiment, for example, the frangible connection device 34 is a spot weld.

[0030] Reference Figure 1-4 The bioabsorbable balloon 26 is fixedly connected to the distal tube portion 32, such as by adhesive, laser welding or shrink tubing, to define a balloon assembly 40. The syringe 12 is configured to deliver the gel material 18 to the bioabsorbable balloon 26 through the lumen 28 of the catheter shaft 24. The bioabsorbable balloon 26 has a collapsed state 42 (see Figure 1 ) and expansion state 44 (see Figure 2-4 ). In the collapsed state 42, the balloon assembly 40 of the marker catheter 14 can be inserted into a biopsy cavity, such as a breast biopsy cavity, of a patient.

[0031] Special reference Figure 2-4, when the injection port 20-2 of the syringe 12 is connected to the proximal tube portion 30 of the catheter shaft 24, the bioabsorbable balloon 26 of the balloon assembly 40 is in fluid communication with the syringe 12 via the lumen 28 of the catheter shaft 24. Therefore, when the syringe 12 is actuated, for example, by pressing the plunger 22, the gel material 18 is delivered into the bioabsorbable balloon 26 to expand the bioabsorbable balloon 26. In the present embodiment, the bioabsorbable balloon 26 is configured to be in fluid communication with the lumen 28 of the catheter shaft 24 at a position distal to the one-way valve 36 of the distal tube portion 32 of the catheter shaft 24. Therefore, the gel material 18 can be inserted into the bioabsorbable balloon 26 via the one-way valve 36 and the sidewall orifice 32-1 of the distal tube portion 32 of the catheter shaft 24 to achieve the expanded state 44 of the bioabsorbable balloon 26, wherein the one-way valve 36 is configured to prevent returning from the expanded state 44 to the collapsed state 42. In other words, when the bioabsorbable balloon 26 of the balloon assembly 40 is inflated by 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 the gel material 18 from flowing back, so that the bioabsorbable balloon 26 remains in a permanent expanded state 44 .

[0032] The elongated stylet 16 is configured as, for example, an elongated tube or rod, and is used to be inserted into the lumen 28 of the catheter shaft 24 to disconnect the frangible connection device 34, thereby separating the proximal tube portion 30 of the catheter shaft 24 from the balloon assembly 40. In particular, the elongated stylet 16 is configured to be inserted into the lumen 28 of the catheter shaft 24 to disconnect the frangible connection device 34 of the catheter shaft 24 after the bioabsorbable balloon 26 is inflated by the gel material 18 delivered by the syringe 12, thereby separating the proximal tube portion 30 of the catheter shaft 24 from the balloon assembly 40.

[0033] For example, the elongated stylet 16 is inserted into the lumen 28 in the proximal tube portion 30 of the catheter shaft 24 and advanced in the lumen 28 so that the distal end 16-1 of the elongated stylet 16 engages the proximal end surface 32-3 of the second end 32-2 of the distal tube portion 32 and / or the frangible coupling device 34. The elongated stylet 16 can then be further advanced with sufficient force, such as by 0.5 mm to 2 mm, to break the frangible coupling device 34, thereby separating the proximal tube portion 30 from the balloon assembly 40. After the frangible coupling device 24 is broken, the proximal tube portion 30 can be withdrawn from the patient while the balloon assembly 40 is in the expanded state 44 and remains in the patient's biopsy cavity.

[0034] When the bioabsorbable balloon 26 is absorbed, the gel material 18 contained in the bioabsorbable balloon 26 will degrade in the patient's body within 12 to 18 months. In some embodiments, for example, the gel material 18 can be, for example, a hydrogel based on polyethylene glycol (PEG), sodium hyaluronate (hyaluronic acid), or aloe vera gel. Sodium hyaluronate has the benefit of promoting wound healing and can be modified to exhibit thermosetting properties. The thermosetting properties of the gel material 18 would be ideal because it allows the material to be in a liquid state in order to expand and then thicken to a gel-like consistency once body temperature is reached. This allows the minimum amount of pressure to be applied to expand the bioabsorbable balloon 26. In some embodiments, PEG would be an ideal material due to its long-term, predictable degradation timeline and its ultrasonic visibility characteristics. Aloe vera products also have the benefit of promoting wound healing, but thermosetting functions are not considered.

[0035] The following items are also relevant to the present invention.

[0036] In one embodiment, the present invention relates to a breast biopsy marker (assembly) comprising 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 coupled to the distal tube portion by a brittle (breakable) coupling device and / or a coupling device configured to break, separate and / or separate. The distal tube portion may have a one-way valve located in the lumen. The bioabsorbable balloon is (fixedly) connected 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 position distal to the one-way valve of the distal tube portion of the catheter shaft. The balloon assembly and / or the breast biopsy marker (assembly) is configured so that the balloon assembly can be separated from the proximal tube portion of the catheter shaft by disconnecting the brittle coupling device.

[0037] In any embodiment, the bioabsorbable balloon can have a collapsed state and an expanded state.Alternatively or additionally, the gel material can be configured to be inserted into the bioabsorbable balloon through a one-way valve of the distal tube portion of the catheter shaft to achieve the expanded state of the bioabsorbable balloon.

[0038] In any embodiment, the proximal tube portion of the catheter shaft has a first end. The distal tube portion has a second end with a proximal end surface. The second end of the distal tube portion can be positioned inside the first end of the proximal tube portion so that the first end of the proximal tube portion radially overlaps the second end of the distal tube portion to define an overlap region and so that the proximal end surface of the distal tube portion can be proximally exposed in the lumen of the catheter shaft.

[0039] In the embodiments of paragraph 0037, the frangible connection device that joins the proximal tube portion to the distal tube portion can be located at the overlap region.

[0040] In the embodiment of paragraph 0037, a frangible connection device that joins the proximal tube portion to the distal tube portion may be connected to each of the proximal tube portion and the proximal tube portion.

[0041] In any embodiment, the frangible connection means may be a spot weld.

[0042] Optionally, for use with any of the embodiments, an elongate stylet can be configured to be inserted into the lumen of a catheter shaft to break the frangible connection device, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

[0043] In any embodiment, the bioresorbable balloon may be made of a PGLA material and optionally further include at least one radiopaque and / or ultrasound visible marker element embedded in the PGLA material.

[0044] In any embodiment, the proximal tube portion can 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.

[0045] In the embodiments of paragraph 0043, the non-biodegradable material of the proximal tube portion may be a PEBAX brand polymer and / or the non-biodegradable component of the distal tube portion may be polyvinyl alcohol.

[0046] In another embodiment, the present invention relates to a breast biopsy marking 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 0035 and / or may have a lumen, a proximal tube portion and a distal tube portion. The proximal tube portion is coupled to the distal tube portion by a frangible coupling device. The distal tube portion may have a one-way valve located in the lumen. The bioabsorbable balloon may be the bioabsorbable balloon of paragraph 0035 and / or may be (fixedly) connected 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 position distal to the one-way valve of the distal tube portion of the catheter shaft. The syringe may be configured to carry a gel material. The syringe may have an injection port that may be connected or connectable to the proximal tube portion of the catheter shaft. The syringe may be configured to deliver the gel material to the bioabsorbable balloon through the lumen of the catheter shaft. The elongated stylet can be configured to be inserted into the lumen of the catheter shaft to disconnect the frangible coupling device of the catheter shaft after the bioabsorbable balloon is inflated by the gel material delivered by the syringe, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly. The system can be configured so that the elongated stylet can disconnect the frangible coupling device of the catheter shaft after the bioabsorbable balloon is inflated by the gel material delivered by the syringe, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

[0047] In any system embodiment, the bioabsorbable balloon can have a collapsed state and an expanded state. Alternatively or additionally, the gel material can be configured to be inserted into the bioabsorbable balloon through a one-way valve of the distal tube portion of the catheter shaft to achieve the expanded state of the bioabsorbable balloon. The one-way valve can be configured to prevent returning from the expanded state to the collapsed state.

[0048] In any system embodiment, the proximal tube portion of the catheter shaft has a first end. The distal tube portion may have a second end having a proximal end surface. The second end of the distal tube portion may be positioned within the first end of the proximal tube portion such that the first end of the proximal tube portion radially overlaps the second end of the distal tube portion to define an overlap region and such that the proximal end surface of the distal tube portion may be proximally exposed within the lumen of the catheter shaft.

[0049] In a system embodiment of paragraph 0047, the frangible connection device that joins the proximal tube portion to the distal tube portion can be located at an overlap area between the proximal tube portion and the distal tube portion.

[0050] In a system embodiment of paragraph 0047, a frangible connection device that joins the proximal tube portion to the distal tube portion can be connected to each of the proximal tube portion and the proximal end surface of the second end of the distal tube portion.

[0051] In any system embodiment, the frangible connection device may be a spot weld.

[0052] In any system embodiment, the elongated stylet can be configured as an elongated tube or rod that can be inserted into the lumen of the catheter shaft to break the frangible connection device, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

[0053] In any of the system embodiments, the bioresorbable balloon may be made of a PGLA material and may optionally further include at least one radiopaque and / or ultrasound visible marker element that may be embedded in the PGLA material.

[0054] In any of the system embodiments, the proximal tube portion can 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.

[0055] In an embodiment of the system of paragraph 0053, the non-biodegradable material of the proximal tube portion can be a PEBAX brand polymer, and / or the non-biodegradable component of the distal tube portion can be polyvinyl alcohol.

[0056] 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. Therefore, the present application is intended to cover any variation, use or adaptation thereof using the general principles of the present invention. In addition, the present application is intended to cover changes relative to the present disclosure within the known or customary practice of the field to which the present invention belongs and within the scope of the appended claims.

Claims

1. A breast biopsy marker, comprising: a catheter shaft having a lumen, a proximal tube portion and a distal tube portion, the proximal tube portion being coupled to the distal tube portion by a frangible coupling, the distal tube portion having a one-way valve located in the lumen; and A bioabsorbable balloon fixedly connected to the distal tube portion to define a balloon assembly, the bioabsorbable balloon being 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 balloon assembly being configured to be separated from the proximal tube portion of the catheter shaft by disconnecting the frangible connection device, wherein the bioabsorbable balloon is in fluid communication with the lumen via a sidewall aperture of the catheter shaft.

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

3. The breast biopsy marker according to any one of claims 1 to 2, comprising: said proximal tube portion having a first end; the distal tube portion having a second end portion having a proximal end surface, and wherein the second end of the distal tube portion is positioned inside the first end of the proximal tube portion so that the first end of the proximal tube portion overlaps radially with the second end portion of the distal tube portion to define an overlapping area, and so that the proximal end surface of the distal tube portion is exposed proximally in the lumen of the catheter shaft.

4. The breast biopsy marker according to claim 3, wherein: The frangible connection joining the proximal tube portion to the distal tube portion is located in the overlap region.

5. The breast biopsy marker according to claim 3, wherein: The frangible connection device that joins the proximal tube portion to the distal tube portion is connected to each of the proximal end surface of the second end of the distal tube portion and the proximal tube portion.

6. The breast biopsy marker according to claim 1 or 2, wherein: The frangible connection means is a spot weld.

7. The breast biopsy marker of claim 1 or 2, comprising an elongated stylet configured to be inserted into the lumen of the catheter shaft to disconnect the frangible connection device, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

8. The breast biopsy marker according to claim 1 or 2, wherein: The bioresorbable balloon is made of a PGLA material and further includes at least one radiopaque and ultrasound-visible marker element embedded in the PGLA material.

9. The breast biopsy marker according to claim 1 or 2, 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.

10. The breast biopsy marker according to claim 9, wherein: The non-biodegradable component of the distal tube portion is polyvinyl alcohol.

11. A breast biopsy marking system, comprising: a catheter shaft having a lumen, a proximal tube portion and a distal tube portion, the proximal tube portion being coupled to the distal tube portion by a frangible coupling, the distal tube portion having a one-way valve located in the lumen; a bioabsorbable balloon fixedly connected to the distal tube portion to define a balloon assembly, the bioabsorbable balloon being 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; a syringe configured to carry 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 to the bioabsorbable balloon; and A slender stylet is configured to be inserted into the lumen of the catheter shaft to disconnect the frangible connection device of the catheter shaft after the bioabsorbable balloon is inflated by the gel material delivered by the syringe, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

12. The breast biopsy marking system of claim 11, wherein: The bioabsorbable balloon has a collapsed state and an expanded state, and wherein the gel material is configured to be inserted into the bioabsorbable balloon through the one-way valve of the distal tube portion of the catheter shaft to achieve the expanded state of the bioabsorbable balloon, and the one-way valve is configured to prevent returning from the expanded state to the collapsed state.

13. The breast biopsy marking system according to any one of claims 11 to 12, comprising: said proximal tube portion having a first end; the distal tube portion having a second end portion having a proximal end surface, and wherein the second end of the distal tube portion is positioned inside the first end of the proximal tube portion, so that the first end of the proximal tube portion overlaps with the second end of the distal tube portion radially to define an overlapping area, and so that the proximal end surface of the distal tube portion is exposed proximally in the lumen of the catheter shaft.

14. The breast biopsy marking system of claim 13, wherein: The frangible connection joining the proximal tube portion to the distal tube portion is located at the overlap region between the proximal tube portion and the distal tube portion.

15. The breast biopsy marking system of claim 13, wherein: The frangible connection device that joins the proximal tube portion to the distal tube portion is connected to each of the proximal end surface of the second end of the distal tube portion and the proximal tube portion.

16. The breast biopsy marking system according to claim 11 or 12, wherein: The frangible connection means is a spot weld.

17. The breast biopsy marking system according to claim 11 or 12, wherein: The elongated stylet is constructed as an elongated tube or rod for being inserted into the lumen of the catheter shaft to disconnect the frangible connection device, thereby separating the proximal tube portion of the catheter shaft from the balloon assembly.

18. The breast biopsy marking system according to claim 11 or 12, wherein: The bioresorbable balloon is made of a PGLA material and further includes at least one radiopaque and ultrasound-visible marker element embedded in the PGLA material.

19. The breast biopsy marking system according to claim 11 or 12, 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.

20. The breast biopsy marking system of claim 19, wherein: The non-biodegradable component of the distal tube portion is polyvinyl alcohol.

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