Biopsy markers with anchoring capabilities

Abstract

A biopsy marker having a spring-loaded anchor. The biopsy marker includes an insertion orientation and an anchoring orientation. The lateral span / cross-sectional area of ​​the marker is configured to change when transitioning between the insertion orientation and the anchoring orientation. In an embodiment, the spring-loaded anchor is configured to spring around a predefined rotation axis. Embodiments of the biopsy marker may be comprised of a single-wire construction.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This nonprovisional application claims priority to provisional application No. 62 / 963,707, filed on January 21, 2020, by the same inventor, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES.”

[0003] This non-provisional application claims priority to non-provisional application No. 16 / 877,720, filed on May 19, 2020 by the same inventor, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES” (now U.S. Patent No. 10,842,591, which claims priority to provisional application No. 62 / 963,707, filed on January 21, 2020 by the same inventor, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES”.

[0004] This non-provisional application also claims priority to application No. 17 / 076,096, entitled “BIOPSYMARKER WITH ANCHORING CAPABILITIES,” filed on October 21, 2020 by the same inventor (which claims priority to non-provisional application No. 16 / 877,720, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES,” filed on May 19, 2020 by the same inventor (now U.S. Patent No. 10,842,591, which claims priority to provisional application No. 62 / 963,707, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES,” filed on January 21, 2020 by the same inventor).

[0005] This non-provisional application claims priority to application No. 16 / 943,582, filed on July 30, 2020, by the same inventor, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES”, and claims priority to non-provisional application No. 16 / 877,720, filed on May 19, 2020, by the same inventor, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES” (now U.S. Patent No. 10,842,591, which claims priority to provisional application No. 62 / 963,707, filed on January 21, 2020, by the same inventor, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES”). Technical Field

[0006] The present invention relates generally to biopsy markers. More particularly, the present invention relates to a biopsy marker having a spring-loaded anchoring capability. Background Art

[0007] Biopsy markers are used as a means of identifying the location of tissue at some later date. Typically, the marker is placed in or near the tissue of interest after the biopsy procedure. The marker can then be identified at a later date using imaging equipment such as an X-ray machine.

[0008] Typically, metal biopsy markers are used alone or in combination with bioabsorbable markers. Metal markers are not absorbed by the body and can be easily found using imaging equipment. However, metal markers tend to migrate within tissues. If a marker migrates from its intended location, the marker will no longer identify the biopsy site. The marker becomes effectively useless.

[0009] Therefore, there is a need for a biopsy marker that has an active anchoring means that ensures that the biopsy marker does not migrate from the biopsy site, is simple, easy to manufacture, and easy to use. However, given the overall technology considered when making the present invention, it is not obvious to a person skilled in the art of the present invention how the shortcomings of the prior art can be overcome.

[0010] All cited publications are incorporated herein by reference in their entirety. In addition, in the event that the definition and use of a term in a reference incorporated herein by reference is inconsistent or contradictory with the definition of that term provided herein, the definition of that term provided herein shall prevail and the definition of that term in the reference shall no longer apply.

[0011] Although certain aspects of conventional technology have been discussed to facilitate the disclosure of the present invention, applicant in no way denies these aspects of technology and contemplates that the claimed invention may encompass one or more of the conventional technology aspects discussed herein.

[0012] The present invention can solve one or more problems and deficiencies of the prior art discussed above. However, it is expected that the present invention may prove to be useful for solving other problems and deficiencies in multiple technical fields. Therefore, the claimed invention should not be construed as limited to solving any specific problem or defect discussed herein.

[0013] Where, in this specification, a document, act or item of knowledge is referred to or discussed, such reference or discussion is not an admission that the document, act or item of knowledge, or any combination thereof, was at the priority date, was publicly available, was known to the public, was part of the common general knowledge, or otherwise constituted prior art under applicable legal provisions; or was known to be relevant to an attempt to solve any problem addressed in this specification. Summary of the invention

[0014] The new, useful and non-obvious invention now satisfies the long-standing but heretofore unmet need for a simple, easy-to-manufacture and easy-to-use biopsy marker with an active anchoring means that ensures the biopsy marker does not migrate from the biopsy site.

[0015] Embodiments of the present invention include a biopsy marker having a bioabsorbable component and a non-bioabsorbable component. The non-bioabsorbable component includes a body segment having a predefined nonlinear shape. In an embodiment, the body segment resides at least partially within the bioabsorbable component. The non-absorbable component also includes a spring component residing between the anchoring arm and the body segment.

[0016] The biopsy marker includes an insertion orientation and an anchoring orientation. In some embodiments, the insertion orientation includes a cross-sectional area of ​​the biopsy marker being less than a cross-sectional area of ​​the biopsy marker in the anchoring orientation. The insertion orientation also includes an anchoring arm being subjected to an external force to overcome a spring force from a spring member. The anchoring orientation includes an anchoring arm being subjected to no external force and the spring member causing the anchoring arm to spring outward to increase the cross-sectional area of ​​the biopsy marker.

[0017] Embodiments include a non-linear stent segment at the distal end of the anchoring arm. In embodiments, the stent includes j-hook or barb-like features to better anchor to the patient's tissue.

[0018] In some embodiments, the body section has a coil shape. In some embodiments, the spring member is a torsion spring. In other embodiments, the spring member is an elbow torsion spring.

[0019] In some embodiments, the non-bioabsorbable component is made of a metallic material. In some embodiments, the non-bioabsorbable component is made of a single continuous wire. In some embodiments, the bioabsorbable component is composed of an expandable material that can dehydrate to reduce its size and can hydrate to increase its size.

[0020] Some embodiments include the body section residing within the bioabsorbable component when the bioabsorbable component is in a dehydrated state. Additionally, a beam extends between the body section and the spring member. The length of the beam is greater than the distance between the body section and the outer surface of the bioabsorbable component when in the dehydrated state, such that the spring member resides outside the bioabsorbable component when in the dehydrated state.

[0021] Some embodiments include a second spring member residing between the second anchoring arm and the body segment. The insertion orientation also includes the second anchoring arm being subjected to an external force to overcome the spring force from the second spring member, and the anchoring orientation also includes the second anchoring arm being free of external force and the second spring member causing the second anchoring arm to spring outward to increase the cross-sectional area of ​​the biopsy marker.

[0022] Some embodiments of the present invention include a non-bioabsorbable component of a biopsy marker created from a single wire. In an embodiment, the single wire has a circular cross-sectional shape. Some embodiments include a single wire having a non-circular cross-sectional shape that can affect the direction and amount of the spring force. In some embodiments, the non-bioabsorbable component has a coil-shaped body segment. A beam extends from the body segment to a spring component that resides between the anchoring arm and the body segment.

[0023] The non-bioabsorbable component has an insertion configuration and an anchoring configuration. The non-bioabsorbable component has a smaller cross-section when in the insertion configuration than when in the anchoring configuration. In other words, when viewed from an end view (i.e., in line with the longitudinal axis), the non-bioabsorbable component spans outwardly more relative to the longitudinal axis of the biopsy marker when in the anchoring orientation than when in the insertion orientation. The insertion configuration includes the anchoring arms being subjected to an external force to overcome the spring force from the spring member, and the anchoring configuration includes the anchoring arms being free of external force and the spring member causing the anchoring arms to spring outward to increase the cross-sectional area / span of the biopsy marker in the lateral / radial direction.

[0024] In one embodiment, the non-bioabsorbable component includes a second beam extending from the main body section to a second spring member connected to the second anchoring arm. The insertion orientation also includes the second anchoring arm being subjected to an external force to overcome the spring force from the second spring member. The anchoring orientation also includes the second anchoring arm being unforced and the second spring member causing the anchoring arm to spring outward to increase the cross-sectional area / span of the non-bioabsorbable component.

[0025] Some embodiments of the biopsy marker include a bioabsorbable component that can be dehydrated to reduce its size and hydrated to increase its size. The non-bioabsorbable component is composed of a body segment having a predefined nonlinear shape, wherein the body segment resides at least partially within the bioabsorbable component. A first beam extends from the body segment to a first spring member residing between the first anchoring arm and the first beam. The first beam also includes a length greater than the distance between the body segment and the outer surface of the bioabsorbable component when in a dehydrated state, so that the first spring member resides outside the bioabsorbable component when in a dehydrated state. A second beam extends from the body segment to a second spring member residing between the second anchoring arm and the second beam. The second beam also includes a length greater than the distance between the body segment and the outer surface of the bioabsorbable component when in a dehydrated state, so that the second spring member resides outside the bioabsorbable component when in a dehydrated state.

[0026] The marker further comprises an insertion orientation and an anchoring orientation. The insertion orientation comprises a lateral span of the biopsy marker that is less than a lateral span of the biopsy marker when in the anchoring orientation. The insertion orientation comprises a first anchoring arm and a second anchoring arm, each of the first anchoring arm and the second anchoring arm being subjected to an external force to overcome a respective spring force from the first spring member and the second spring member, and

[0027] The anchoring orientation includes the first and second anchoring arms being free of external forces and the first and second spring members springing the first and second anchoring arms outward to increase the lateral span of the biopsy marker.

[0028] Some embodiments of the biopsy marker include a bioabsorbable component having a hydrated state and a dehydrated state, wherein the size of the bioabsorbable component increases when transitioning from the dehydrated state to the hydrated state. The non-bioabsorbable component is composed of a body segment having a predefined nonlinear shape, and the body segment resides at least partially within the bioabsorbable component. The non-bioabsorbable component also includes a first beam extending from the body segment to a first spring member. The length of the first beam is greater than the distance between the body segment and the outer surface of the bioabsorbable component when in the dehydrated state, so that the first spring member resides outside the bioabsorbable component when in the dehydrated state. In addition, the first spring member resides between the first anchoring arm and the first beam. When hydrated, the size of the bioabsorbable component increases to an amount that causes the bioabsorbable component to apply force to the first anchoring arm. The force applied by the bioabsorbable component exceeds the spring force of the first spring member and causes the first anchoring arm to move to an anchoring orientation.

[0029] In some embodiments, anchor orientation includes movement of one or more anchor arms toward a central longitudinal axis of the biopsy marker.

[0030] Some embodiments include a second beam extending between the body segment and the second spring member. The length of the second beam is greater than the distance between the body segment and the outer surface of the bioabsorbable component when in a dehydrated state, so that the second spring member resides outside the bioabsorbable component when in a dehydrated state. The second spring member resides between the second anchoring arm and the second beam. When the bioabsorbable component is hydrated, the bioabsorbable component applies a force to the second anchoring arm. The force applied by the bioabsorbable component exceeds the spring force of the second spring member and moves the second anchoring arm to an anchoring orientation. When the biopsy marker has been deployed in the patient's body, the anchoring position of the second anchoring arm and the anchoring position of the first anchoring arm together clamp the patient tissue between the first anchoring arm and the second anchoring arm.

[0031] In some embodiments, the body section has a coil shape. In some embodiments, the non-bioabsorbable component is made of a metallic material. In some embodiments, the non-bioabsorbable component is made of a single continuous wire.

[0032] In some embodiments, the spring member is an elbow torsion spring having a smaller cross-sectional area than the adjacent first beam and the adjacent first anchoring arm.Some embodiments include a hollow section bored into the dehydrated bioresorbable member, wherein the first beam passes through the hollow section.

[0033] In some embodiments, when transitioning from a dehydrated state to a hydrated state, the bioabsorbable component increases in size, softens, and liquefies to a certain extent. In addition, when in a dehydrated state, the main body segment and at least a portion of the first anchoring arm reside within the outer surface of the bioabsorbable component, whereby the dehydrated bioabsorbable component applies a force on the first anchoring arm that is greater than the spring force of the first spring member, so that the portion of the first anchoring arm that resides within the outer surface of the dehydrated bioabsorbable component remains within the outer surface of the dehydrated bioabsorbable component. When in a hydrated state, the bioabsorbable component applies a smaller force on the first anchoring arm than the force applied by the dehydrated bioabsorbable component. The smaller force is less than the spring force of the first spring member, thereby causing the first anchoring arm to move to an anchoring orientation when the bioabsorbable component transitions from a dehydrated state to a hydrated state.

[0034] In some embodiments, the second beam extends between the main body section and the second spring member. When in a dehydrated state, the main body section and at least a portion of the second anchoring arm reside within the outer surface of the bioabsorbable component, whereby the dehydrated bioabsorbable component applies a force on the second anchoring arm that is greater than the spring force of the second spring member, so that the portion of the second anchoring arm that resides within the outer surface of the dehydrated bioabsorbable component remains within the outer surface of the dehydrated bioabsorbable component. When in a hydrated state, the bioabsorbable component applies a smaller force on the second anchoring arm than the force applied by the dehydrated bioabsorbable component. The smaller force is less than the spring force of the second spring member, thereby causing the second anchoring arm to similarly move to an anchoring orientation when the bioabsorbable component transitions from a dehydrated state to a hydrated state. In an embodiment, the anchoring orientation includes the first anchoring arm and the second anchoring arm springing outward to increase the lateral span of the biopsy marker.

[0035] Some embodiments include a hollow section bored into the dehydrated bioresorbable component, wherein the first beam and / or the second beam passes through the hollow section.

[0036] These and other important objects, advantages and features of the present invention will become clear as the disclosure proceeds.

[0037] The present invention accordingly comprises the features of construction, combination of elements and arrangement of parts which will be exemplified in the disclosure set forth hereinafter, and the scope of the invention will be indicated in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] For a more complete understanding of the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0039] Figure 1A is a front view of an embodiment of the present invention.

[0040] Figure 1B is a top view of an embodiment of the present invention.

[0041] Figure 1C is a side view of an embodiment of the present invention.

[0042] Figure 2A is an embodiment of the present invention in an insertion configuration within a delivery device.

[0043] Figure 2B is an embodiment of the present invention that exits the distal end of the delivery device.

[0044] Figure 3A is a front view of an embodiment of a non-absorbable component.

[0045] Figure 3B is a top view of an embodiment of a non-absorbable component.

[0046] Figure 3C is a side view of an embodiment of a non-absorbable component.

[0047] Figure 4A is a front view of an embodiment of the present invention.

[0048] Figure 4B is a top view of an embodiment of the present invention.

[0049] Figure 4C Is from Figure 4A Close-up view of detail C.

[0050] Figure 4D is a side view of an embodiment of the present invention.

[0051] Figure 5 is a front view of an embodiment of the present invention.

[0052] Fig. 6A is a front view of an embodiment of a non-absorbable component.

[0053] Figure 6B is a top view of an embodiment of a non-absorbable component.

[0054] Figure 6C is a side view of an embodiment of a non-absorbable component.

[0055] Fig.6D yes Fig. 6A , wherein the bioabsorbable component is shown in both a dehydrated stage and a hydrated stage.

[0056] Fig. 6E yes Figure 6B , in which a bioresorbable component is shown in both a dehydrated stage and a hydrated stage.

[0057] Fig. 6F yes Figure 6C , wherein the bioresorbable component is shown in both a dehydrated stage and a hydrated stage.

[0058] Fig. 7A is a front view of an embodiment of a non-absorbable component.

[0059] Figure 7B is a top view of an embodiment of a non-absorbable component.

[0060] Figure 7C is a side view of an embodiment of a non-absorbable component.

[0061] Fig.7D yes Fig. 7A , wherein the bioabsorbable component is shown in both a dehydrated stage and a hydrated stage.

[0062] Fig. 7E yes Figure 7B , in which a bioresorbable component is shown in both a dehydrated stage and a hydrated stage.

[0063] Figure 7F yes Figure 7C , wherein the bioresorbable component is shown in both a dehydrated stage and a hydrated stage.

[0064] Figure 8 is a front view of an embodiment of the present invention.

[0065] Fig. 9A is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a dehydrated state.

[0066] Fig. 9B Is from Fig. 9A Close-up of the details of Z.

[0067] Fig. 9C is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a hydrated state.

[0068] Fig. 10A is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a dehydrated state.

[0069] Fig. 10B Is from Fig. 10A Close-up of the details of Z.

[0070] Fig. 10C is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a hydrated state.

[0071] Fig.11A is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a dehydrated state.

[0072] Fig. 11B is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a hydrated state.

[0073] Fig. 12A is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a dehydrated state.

[0074] Fig. 12B is a front view of an embodiment of the present invention, wherein the bioabsorbable component is shown in a hydrated state. DETAILED DESCRIPTION

[0075] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings which form a part of this disclosure and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It should be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the invention.

[0076] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0077] As used herein, "substantially perpendicular" shall mean that two objects or axes are completely or nearly perpendicular, i.e., at least within five or ten degrees of perpendicular, or more preferably within less than one degree of perpendicular. Similarly, the term "substantially parallel" shall mean that two objects or axes are completely or nearly parallel, i.e., at least within five or ten degrees of parallel, and more preferably within less than one degree of parallel.

[0078] As used herein, the terms "subject," "patient," or "organism" include humans and animals (eg, mice, rats, pigs, cats, dogs, and horses).

[0079] 1, embodiments of the present invention include a biopsy marker comprised of a bioabsorbable / biodegradable component 101 and a non-absorbable component 103. In some embodiments, at least a portion of the non-absorbable component 103 resides within the bioabsorbable component 101. In some embodiments, as will be explained herein, at least a main body section 102 of the non-absorbable component 103 resides within the bioabsorbable component 101 and is non-linear and / or multi-dimensional to prevent the non-absorbable component 103 from sliding out of the bioabsorbable component 101.

[0080] In a certain embodiment, the bioabsorbable component 101 is composed of an expandable material such as a hydrogel, which will expand when in contact with the patient's internal tissue or biological fluid. In some embodiments, the bioabsorbable component 101 is composed of any bioabsorbable material, including but not limited to polyglycolic acid (PGA), polylactic acid (PLA), a sugar-based composition, a starch-based composition or a bio-based composition such as collagen, a hydrogel or any combination of the above. In some embodiments, the bioabsorbable component 101 is a biological plug designed to close an opening or hole somewhere in the patient's body. The bioabsorbable component can be of any size and can generally be of any shape. In one embodiment, the bioabsorbable component 101 is cylindrical in shape and has a dehydrated cross-sectional size that is generally equal to the cross-sectional area of ​​the internal lumen of the delivery device 202 as shown in Figure 2.

[0081] In some embodiments, at least a portion of the non-absorbable component 103 is composed of one or more metallic materials, including but not limited to nitinol, titanium, and stainless steel. After the bioabsorbable component 101 is absorbed or decomposed, the non-absorbable component 103 will remain in the patient's body for a long time. The non-absorbable component 103 facilitates easy identification of the biopsy marker 100 using imaging equipment, including but not limited to an X-ray machine, a CT scanner, an ultrasound machine, or an MRI machine. Some embodiments include at least a main body section 102 of the non-absorbable component 103 composed of a material that can be identified by at least one imaging machine.

[0082] 1-3, embodiments of the present invention include a body section 102 of a non-bioabsorbable component 103 residing within a bioabsorbable component 101. The body section 102 has a uniquely identifiable shape that (1) provides a means of ensuring that the non-bioabsorbable component 103 cannot be easily removed from the bioabsorbable component 101 composed of a soft material such as a hydrogel, and (2) facilitates easy identification of the biopsy marker 100 using an imaging device.

[0083] In some embodiments, the body segment 102 is designed to have a size and shape that cannot pass through the tunnels / ducts in the bioabsorbable component 101 in which the beams 104 reside without destroying at least one of the ducts. In some embodiments, the body segment 102 is designed to have a size and shape that is larger in cross-section than the ducts in the bioabsorbable component 101 in which the beams 104 reside. The beams 104 provide a structural connection between the body segment 102 and the anchoring component. If the body segment 102 is the same size and shape as one or more beams 104, the body segment 102 may more easily leave the bioabsorbable component 101 and potentially cause the two components to separate from each other before the bioabsorbable component 101 is absorbed. For the same reason, the body segment 102 generally has a size and shape that is larger in cross-section than one or more beams 104. In some embodiments, the body segment 102 has a non-linear shape for the same reason.

[0084] The exemplary depicted shape of the body section 102 is in the form of a coil. The coil depicted in FIGS. 1-4 includes three interconnected concentric circles; however, some embodiments have a coil consisting of two interconnected concentric circles (see Figure 56) to reduce the size of the marker and ultimately the size of the delivery device. Embodiments have a body segment 102 comprised of a single concentric circle or a body segment 102 comprised of a U-shape extending between a first beam 104a and a second beam 104b to further reduce the size of the biopsy marker 100 and allow the surgeon to insert the marker using a smaller delivery device. In some embodiments, the body segment 102 can be any non-linear shape, including but not limited to a horseshoe, a sine wave, and an M-shape.

[0085] 1-3 , the body segment 102 has a central longitudinal axis 114 that is generally oriented perpendicularly relative to the central longitudinal axis 112 of the biopsy marker 100. As depicted in FIG4 , some embodiments include a coil-shaped body segment 102 oriented such that the central axis 114 of the coil is coaxial with the central longitudinal axis 112 of the biopsy marker 100. Some embodiments include a central coil axis 114 at an angle between 0 and 90 degrees relative to the longitudinal axis 112 of the biopsy marker 100.

[0086] In some embodiments, the integrated concentric circles that make up the coil are closely spaced to minimize the size of the body segment 102. However, the spacing between the integrated concentric circles can be adjusted based on the desired size of the body segment 102 and the desired amount of resistance to movement within the bioabsorbable component 101, as created by varying the spacing of the integrated concentric circles. The size of the circles that make up the coil can also be adjusted based on the desired size of the body segment 102 and the desired amount of resistance to movement within the bioabsorbable component 101, as created by varying the size of the integrated concentric circles.

[0087] The size of the body segment 102 can also be adjusted as needed to fit a particular delivery device 202. Depending on the insertion area within the patient, the cross-sectional area of ​​the internal lumen of the delivery device 202 can vary. Ultimately, the cross-sectional size of the body segment 102 (relative to the longitudinal axis 112 of the biopsy marker 100) will be equal to or less than the cross-sectional area of ​​the internal lumen of the delivery device 202. In an embodiment, the size of the body segment 102 extending in a direction parallel to the longitudinal axis 112 of the biopsy marker 100 will be equal to or less than the length 100 of the bioabsorbable component 101 extending in a direction parallel to the longitudinal axis 112 of the biopsy marker. Likewise, embodiments include a body segment 102 extending outward in a lateral direction (i.e., perpendicular to the longitudinal axis 112) that is less than or equal to the size of the bioabsorbable component 101 in the same direction.

[0088] In some embodiments, the body segment 102 has a shape that is not a coil shape. In some embodiments, the shape of the body segment 102 is a shape that enables the entire non-absorbable component 103 to be composed of a single continuous wire. In some embodiments, the shape of the body segment 102 is a shape that enables the body segment 102, the beam 104, the spring 106, and the anchoring arm 108 to be composed of a single wire. In some embodiments, the shape of the body segment 102 is a shape that enables the body segment 102, the beam 104, and the spring 106 to be composed of a single wire. In some embodiments, the shape of the body segment 102 is a shape that enables the body segment 102 and the beam 104 to be composed of a single wire. In some embodiments, the shape of the body segment 102 is a shape that can be composed of a single wire.

[0089] Some embodiments of the present invention include multiple biopsy markers, each of which has a significantly different variation in the shape of the body segment 102. The variation in the shape of the body segment 102 between different biopsy markers allows multiple biopsy markers to be inserted into a patient, wherein each biopsy marker remains significantly different when viewed by an imaging device. For example, the coil shape, the number of coils, the orientation of the coils, the size of the coils, the size of the concentric circles of the coils, or the spacing between circles within the coils can be adjusted to ensure that the various biopsy markers can be distinguished from each other using an imaging device. Similarly, different shapes of body segments 102 can be used between various biopsy markers. For example, different biopsy markers can have body segments 102 shaped as a coil, a horseshoe, a sine wave, an M shape, etc. Preferably, the shape is a shape that can be generated by manipulating or bending a single wire.

[0090] The biopsy marker 100 of the present invention also includes at least one beam 104 extending away from the body segment 102 toward the spring 106. The one or more beams 104 provide a mechanical interconnection between the body segment 102 and the spring 106. In some embodiments, the one or more beams 104 extend in a direction substantially parallel to the longitudinal axis 112 of the biopsy marker 100. Extension in this direction helps limit the cross-sectional area of ​​the biopsy marker 100. Some embodiments include beams 104 extending from the body segment 102 in a direction that is not substantially parallel to the longitudinal axis 112.

[0091] As depicted in FIGS. 1-4 , some embodiments include two beams 104a, 104b. In FIGS. 1-3 , the two beams 104a, 104b extend in substantially the same direction. Alternatively, FIG. 4 shows how some embodiments include beams 104a, 104b extending in substantially opposite directions. Some embodiments may have more than two beams 104 and therefore more than 2 springs 106, anchoring arms 108, and brackets 110.

[0092] In some embodiments, beams 104a, 104b may have the same length as shown in FIG. 4, or may be Figure 5 Depicted with different lengths. For different length beams 104a, 104b, the springs 106a, 106b reside at different locations along the length of the biopsy marker 100 and therefore occupy less space in the lateral / radial direction (i.e., perpendicular to the longitudinal axis 112) than if the springs 106a, 106b occupied the same location along the longitudinal extent of the biopsy marker 100. Ultimately, this reduction in space allows for the use of a smaller diameter delivery device 202.

[0093] Some embodiments, such as those depicted in Figures 6 and 7, include a single beam 104 extending between the body section 102 and the spring 106. In some embodiments, as depicted in Figure 6, the beam 104 extends in a direction generally perpendicular to the central longitudinal axis 114 of the body section 102. As depicted in Figure 7, some embodiments include the beam 104 extending in a direction generally parallel to the central longitudinal axis 114 of the body section 102.

[0094] In some embodiments, as depicted in FIGS. 6 and 7 , one or more springs 106 reside outside of the bioabsorbable component 101 when the bioabsorbable component 101 is in a dehydrated state prior to and initially during the process of inserting the biopsy marker 100 into a patient. Since the one or more springs 106 reside outside of the bioabsorbable component 101a when in the dehydrated state, the length of the one or more beams 104 is greater than the distance between the body section 102 and the outer surface (such as the longitudinal end) of the bioabsorbable component 101a when in the dehydrated state. In some embodiments, the length of the beams 104 is sufficient to ensure that the stent 110 resides longitudinally outside of the longitudinal end of the bioabsorbable component 101 when in the hydrated state 101b. In some embodiments, as Figure 8 As depicted, the length of the beam 104 is greater than the distance between the body section 102 and the longitudinal ends of the bioabsorbable component 101 when in a hydrated state as identified by reference numeral 101b.

[0095] The present invention also includes a non-absorbable component 103 having at least one spring-loaded anchor comprised of a spring component 106 (also referred to as "spring 106"), anchoring arms 108, and a stent 110. The springs 106 are located at the ends of the beams 104 opposite the ends attached to or integral with the body section 102 of the biopsy marker 100. The springs 106 allow their respective anchoring arms 108 to actively spring into an anchored position to secure the biopsy marker 100 at the biopsy site.

[0096] At least the spring 106 is constructed of an elastic material, such as nitinol, titanium, or stainless steel, so that the biopsy marker 100 can be pushed into an insertion configuration and then can rebound to an anchoring configuration when disposed in a patient's body. In some embodiments, the spring member 106, the anchoring arms 108, and the support 110 are constructed of one or more elastic materials. In other embodiments, the entire non-absorbable member 103 is constructed of one or more elastic materials.

[0097] As shown in FIGS. 1 to 3 , the springs 106 are depicted as torsion springs. The first end of each torsion spring is integrated with the beam 104, and the second end of each torsion spring is integrated with the anchoring arm 108. However, embodiments of the spring assembly may include active springs of other designs known to those of ordinary skill in the art, including but not limited to elbow torsion springs, annular springs, leaf springs, helical springs, compression springs, leaf springs, etc. The springs 106 include a rest position in which the angle between the corresponding beam 104 and the corresponding anchoring arm 108 is not equal to 180 degrees.

[0098] As depicted in FIGS. 4 to 9 , the spring 106 is an elbow torsion spring. The elbow torsion spring is easier to manufacture when the non-bioabsorbable component 103 is composed of a single wire. The elbow torsion spring 106 has a rest position in which the angle between the corresponding beam 104 and the corresponding anchoring arm 108 is not equal to 180 degrees. However, the elbow torsion spring may bend away from its rest position when subjected to external forces.

[0099] In an embodiment, the spring 106 is designed so that the angle between the beam 104 and the anchoring arm 108 is about 125 degrees when the spring 106 is in the rest position. Some embodiments include springs 106 having a rest position in which the angle between the beam 104 and the anchoring arm 108 is between 90 degrees and 180 degrees. Some embodiments include springs 106 having a rest position in which the angle between the beam 104 and the anchoring arm 108 is between 100 degrees and 160 degrees. Some embodiments include springs 106 having a rest position in which the angle between the beam 104 and the anchoring arm 108 is sufficient to ensure that the scaffold 110 is located outside the hydrogel in both the hydrated state and the dehydrated state.

[0100] In an embodiment, the spring components 106 include structures that define hinge / rotation axes disposed between their respective beams 104 and anchoring arms 108. In other words, the spring capacity is associated with structural components and features other than simply bending the elastic member.

[0101] As previously explained, the spring 106 allows the non-bioabsorbable component 103 to be manipulated into the insertion configuration. In the insertion configuration, the anchoring arms 108 and, in turn, the stent 110 are manipulated under a force greater than the spring force of the spring 106. The anchoring arms 108 and, in turn, the stent 110 are urged toward the central longitudinal axis 112 to reduce the cross-sectional area of ​​the biopsy marker 100 so that the biopsy marker 100 fits within the interior lumen of the delivery device 202, as shown in FIG. Figure 2A The delivery device 202 can be any needle, catheter, or any other biologically insertable tubular structure that can be inserted into a patient to deliver the biopsy marker 100 to the biopsy site. In some embodiments, the spring 106 is adapted to allow the anchoring arms 108 and the stent 110 to be urged toward the central longitudinal axis 112 until the cross-sectional area of ​​the non-absorbable component 103 is equal to or less than the cross-sectional area of ​​the bioabsorbable component 101.

[0102] When the biopsy marker 100 is inserted into the patient, the biopsy marker 100 is pushed out of the delivery device 202 using, for example, a plunger device 204, and the anchoring arms 108 and, in turn, the stent 110 are moved into position as shown in FIG. Figure 2B The depicted anchoring arm 108 springs into the anchoring configuration under the spring force from the spring 106 upon exiting the interior lumen of the delivery device 202. In the anchoring configuration, the lateral / radial span (i.e., cross-sectional area) of the biopsy marker 100 is greater than the cross-sectional area when the biopsy marker 100 is in the insertion configuration. Typically, the anchoring arms 108 will spring outward away from the central longitudinal axis 112. Depending on the elasticity of the material of the non-absorbable component 103 or the elastic force of the spring 106 and / or the density of the surrounding tissue in which the biopsy marker 100 is deposited, one or more of the anchoring arms 108 will return to their respective positions or spring outward until the elastic force of the spring 106 equals the force of the tissue on the anchoring assembly.

[0103] In some embodiments, when the bioabsorbable component 101 is in a dehydrated state, the spring 106 resides on the exterior of the bioabsorbable component 101. In a certain embodiment, when the bioabsorbable component 101 is in a hydrated state, the spring 106 resides on the exterior of the bioabsorbable component 101. In a certain embodiment, the spring 106 resides on the exterior of the bioabsorbable component 101 when the bioabsorbable component 101 is in a dehydrated state but not when the bioabsorbable component 101 is in a hydrated state.

[0104] One or more anchoring arms 108 extend further than one or more springs 106 in a direction away from the main body section 102. The anchoring arms 108 are designed to engage tissue in the patient and protrude one or more stents 110 further from the main body section 102 to engage tissue in the patient. Depending on the embodiment, the biopsy marker 100 may have one or more anchoring arms 108. Typically, the biopsy marker 100 will have one anchoring arm 108 per spring 106.

[0105] In some embodiments, the length of anchoring arm 108 is greater than or equal to the distance between spring 106 and the edge of bioabsorbable component 101 when in a hydrated state (in the same direction when anchoring arm 108 is in a resting position). Thus, stent 110 engages the patient's tissue rather than bioabsorbable component 101. In some embodiments with more than one anchoring arm 108, the length of one anchoring arm is greater than the length of another anchoring arm, so that stents 110 are longitudinally spaced apart from each other and can therefore occupy less lateral / radial space when in an insertion orientation.

[0106] In some embodiments, anchoring arm 108 is a continuation of a single thread from which the rest of non-absorbable component 103 is comprised. In some embodiments, anchoring arm 108 has the same cross-sectional size as portions of non-absorbable component 103. In some embodiments, anchoring arm 108 has a larger cross-sectional size than the rest of non-absorbable component 103 to help anchoring arm 108 engage the patient's tissue.

[0107] In some embodiments, the anchor arms 108 have a circular cross-section. In some embodiments, the anchor arms 108 have a non-circular cross-sectional shape to increase friction with the patient's tissue and ultimately help the anchor arms 108 engage the patient's tissue. In some embodiments, the anchor arms 108 have an outer surface with friction increasing elements or friction increasing materials to help the anchor arms 108 engage the patient's tissue.

[0108] The present invention also includes one or more stents 110 located at the distal ends of the anchoring arms 108. Some embodiments include a stent 110 attached to or integrated with each anchoring arm 108. The stent 110 provides another anchoring means and structural support for tissue growth after deployment. Tissue growth on and around the stent 110 helps prevent the biopsy marker 100 from migrating away from the biopsy site.

[0109] In an embodiment, each support 110 has a non-linear shape. In some embodiments, the support 110 has a ring shape. Figure 4CAs depicted in the figure, the distal-most end 116 of the stent 110 extends beyond the anchoring arm 108 when the ring shape is formed. The distal end 116 extending beyond the anchoring arm 108 or other portion of the stent 110 ensures that the distal end 116 is better able to hook into the patient's tissue. In addition, the ring shape is designed to leave a hole 118 through which tissue can grow to better grip on the stent 110. Other embodiments may not include the distal-most end 116 extending beyond the anchoring arm 108 and / or may not include the hole 118.

[0110] In such Figure 1B In some embodiments best depicted in FIG. 1 , the distal end 116 of each stent 110 is looped inwardly toward the central longitudinal axes 112 and 114. Figure 4B In some embodiments best depicted in FIG. 1 , the distal end 116 of each stent 110 loops outwardly in the same direction away from the central longitudinal axes 112 and 114. In some embodiments, the distal end 116 of each stent 110 loops outwardly in opposite directions away from the central longitudinal axes 112 and 114. Figure 5 In some embodiments best depicted in FIG, the distal end 116 of each stent 110 is looped outwardly away from the central longitudinal axes 112 and 114 and away from each other. The orientation of the loop and the direction of the distal ends 116 are optimized to reduce the lateral / radial space occupied by the stent 110 when in the insertion orientation. Thus, the cross-section of the internal lumen, and therefore the delivery device 202 in general, can be reduced to limit the size of the opening in the patient's body.

[0111] In some embodiments, a stent 110 is included that has a barb-like shape or a J-hook shape at the distal end 116. The barb-like shape or the J-hook shape of the distal end 116 is oriented in a manner that prevents the anchoring arm 108 from moving back toward the insertion orientation or toward the insertion site. In some embodiments, the stent 110 is any non-linear shape that prevents the anchoring arm 108 from moving back toward the insertion orientation or toward the insertion site.

[0112] In some embodiments, stent 110 is a continuation of a single thread from which other portions of non-absorbable component 103 are comprised. In some embodiments, stent 110 has the same cross-sectional size as portions of non-absorbable component 103. In some embodiments, stent 110 has a larger cross-sectional size than other portions of non-absorbable component 103 to help stent 110 engage the patient's tissue. In some embodiments, stent 110 has a circular cross-section. In some embodiments, stent 110 has a cross-sectional shape that is non-circular to increase friction with the patient's tissue and ultimately help stent 110 engage the patient's tissue. In some embodiments, stent 110 has an outer surface with friction increasing elements or friction increasing materials to help stent 110 engage the patient's tissue.

[0113] During operation, the biopsy marker 100 of the present invention is of a size and shape that can be inserted into a patient using a biocompatible delivery device 202. The biopsy marker 100 is pushed into Figure 2A In the insertion orientation, the anchor arms 108 are pushed into a position where the cross-sectional area of ​​the biopsy marker 100 is reduced to fit within the interior lumen of the delivery device 202. This position includes the anchor arms 108 being folded upward and toward the body section 102 in some embodiments (not shown) or as shown in FIG. Figure 2A The body section 102 is shown folded downward and away so that the angle between the beam 104 and the anchoring arm 108 is at or near 180 degrees. The biopsy marker 100 is then pushed into the inner lumen of the delivery device 202, and the inner lumen holds the biopsy marker 100 in the insertion orientation.

[0114] The delivery device 202 is already in place or inserted into position at the biopsy site. Therefore, the entry point into the biopsy site is typically the size of the cross-sectional area of ​​the delivery device 202. The biopsy marker 100 can then be pushed out of the distal end of the delivery device 202, and upon leaving the delivery device 202, the anchoring arms 108 actively spring outward into a resting position (or as close to the resting position as the patient's tissue allows) and the biopsy marker 100 anchors itself into the tissue at the biopsy site. In the anchoring orientation, the span / cross-sectional area of ​​the biopsy marker 100 is greater than the cross-sectional area of ​​the delivery device 202. Therefore, when the biopsy marker 100 is in the anchoring orientation, the biopsy marker cannot leave the entry point and enter the biopsy site. The active spring action into the anchoring orientation ensures that the biopsy marker 100 will remain at its insertion point.

[0115] In some embodiments, such as Figure 5 , FIG. 6D to FIG. 6F and FIG. 7D to FIG. 7FAs best depicted in , the bioabsorbable component 101 is an expandable material, such as a hydrogel. The bioabsorbable component 101 serves at least two purposes. One purpose is to assist in imaging. By disposing the biopsy marker 100 in a hydrogel or another absorbable substance, the biopsy marker 100 is more easily visible during an ultrasound scan after being embedded in the patient's body. Ultrasound imaging can show air and water well, so the bioabsorbable component 101 appears as a black area in the ultrasound image. Since at least the main body section 102 is disposed within the hydrogel of the bioabsorbable component 101, the hydrogel surrounds the main body section 102 during the curing process to bind the components together. The metal structure of the non-bioabsorbable component 103 residing within the bioabsorbable component 101 appears as white air and provides an easily identifiable contrast to locate the biopsy marker 100. Therefore, the imaging device can easily identify the biopsy marker 100.

[0116] Another function of the bioabsorbable component 101 is related to its expandable nature. Before and during insertion, the bioabsorbable component is in a dehydrated state which can be identified by reference numeral 101a, such as FIG. 6D to FIG. 6F and FIG. 7D to FIG. 7F The size / surface area of ​​the bioabsorbable component 101 is smaller in the dehydrated stage compared to the hydrated stage. The use of an expandable bioabsorbable component 101 allows the biopsy marker to be reduced in size for insertion into a patient and to expand upon deployment to fill a hole or void in the patient's tissue.

[0117] like Fig.7D and Fig. 7E As depicted, bioabsorbable component 101 can expand up to twice in length and 2.67 times in diameter when hydrated. In some embodiments, bioabsorbable component 101 can expand between 1.5 and 3 times in length. In some embodiments, bioabsorbable component 101 can expand between 1.5 and 3 times in diameter. In some embodiments, bioabsorbable component 101 expands in one direction. In some embodiments, bioabsorbable component 101 expands in two directions. In some embodiments, bioabsorbable component 101 expands in all directions.

[0118] Referring now to FIG. 9, one embodiment includes a dehydrated state (see Fig. 9A ) of the bioabsorbable component 101, in which the springs 106 reside outside the outer surface of the bioabsorbable component 101 in the dehydrated state. The springs 106 have a specific spring force that is predetermined based on the composition of the bioabsorbable component 101. As the bioabsorbable component 101 hydrates and increases in size ( Fig. 9C101b), which contacts the anchoring arm 108 and applies a force to the anchoring arm 108, the force overcoming the spring force causing the anchoring arm 108 to rotate about the spring 106 into the anchoring position (at Fig. 9C ).

[0119] like Fig. 9B As depicted, in some embodiments, the spring 106 may have a reduced cross-sectional area to provide a locally weakened region having a lesser spring force than if the cross-sectional area remained constant relative to the cross-sectional area of ​​the anchoring arms 108 and beam 104. In some embodiments, the reduced cross-sectional area is in the form of a notch 120. However, alternative methods and designs may be used to reduce the cross-sectional area of ​​the spring 106 compared to the cross-sectional area of ​​the anchoring arms 108 and beam 104. Additionally, different cross-sectional shapes of the spring member 106 may be used to modify the spring force of the spring member 106, including but not limited to square, rectangular, triangular, and oval shapes.

[0120] In some embodiments, the spring 106 can be constructed of an alternative material compared to the anchoring arms 108 and / or beams 104. The alternative material or composition of the spring 106 can be designed to be more compliant / less rigid than the material or composition of the anchoring arms 108 and / or beams 104. Additionally, the bending stiffness of the spring 106 is calculated based on the composition of the bioabsorbable component 101. In some embodiments, the bending stiffness is limited to a bending stiffness that allows the bioabsorbable component 101 to overwhelm the spring 106 during the hydration process. Fig. 9A and Fig. 9C This process is contemplated. The bioabsorbable component 101 hydrates and increases in size. The hydrated bioabsorbable component 101b contacts the anchoring arms 108 and applies a force to the anchoring arms 108 that overcomes the bending stiffness or spring force of the spring 106, causing the anchoring arms 108 to clamp inward and grasp the patient's tissue.

[0121] As already explained, the bioabsorbable component 101 is designed to change size when hydrated. The exact composition, size, and shape can be adjusted to ensure that when the bioabsorbable component 101 is hydrated and a force is applied to the anchoring arms 108, the anchoring arms 108 can move from the insertion position to the anchoring position. In addition, the exact composition, size, and shape can be adjusted to change the total amount that the anchoring arms 108 can move when they are transformed into their respective anchoring positions. In some embodiments, the bioabsorbable component 101 is a hydrogel. However, the exact composition can vary depending on the intended use, functional parameters, and the size, shape, and design of the non-absorbable component.

[0122] Referring now to FIG. 10 , an embodiment of the present invention has a similar overall design and functionality as the embodiment depicted in FIG. 9 , however, the bioabsorbable component 101 has a hollow section 122. The hollow section 122 is spaced apart from the body section 102 to ensure that the body section 102 remains contained within the hydrogel 101. The beams 104a and / or 104b extend through the hollow section 122 and the hollow section 122 is open toward the spring 106 and / or the anchoring arm 108. The hollow section 122 reduces the amount of the bioabsorbable component 101 that can interact with the anchoring arm 108. In other words, the bioabsorbable component 101 applies less force to the anchoring arm 108 during the hydration process than would be applied in the absence of the hollow section 122, similar to the embodiment shown in FIG. 9 . Thus, when the only difference is the inclusion of the hollow section 122, the anchoring arms clamp inward less, which can be seen by comparing the hollow section 122 to the anchoring arm 108. Fig. 9C and Fig. 10C see.

[0123] The hollow sections 122 may be designed to limit the range of pivoting of the anchoring arms toward each other, or may allow for the use of a weaker spring member 106. Regardless of the intent, the spring force / bending stiffness of the spring 106; the size, location, and composition of the hollow sections 122 / bioabsorbable member 101; and / or the desired movement of the anchoring arms 108 may be adjusted and optimized as needed for any given situation.

[0124] Fig. 9A and Fig. 10A A dehydrated bioabsorbable component 101a having a generally elongated cylindrical shape is depicted, with beams 106 extending through the bottom surface of the dehydrated bioabsorbable component 101a. When the bioabsorbable component 101 is hydrated, the anchoring arms 108 clamp inwardly toward the central longitudinal axis of the bioabsorbable component 101. However, this orientation is not the only possible orientation. In some embodiments, the beams 106 extend through the outer surface of the dehydrated bioabsorbable component 101a in a different orientation, and when the bioabsorbable component 101 is hydrated, the anchoring arms 108 clamp inwardly toward each other to grasp the patient's tissue.

[0125] The shape and design of the spring 106 can be any shape and design according to the present invention.In addition, the position of the spring can be offset from the main body section 102 or be at the same general distance as the main body section, as described herein with respect to other embodiments.

[0126] Similarly, the brackets 110 , beams 104 , and body section 102 may be designed according to the various embodiments described herein.

[0127] Some embodiments of the non-absorbable component 103 have several spring / bend segments extending between the main body segment 102 and the stent 110 to create a complex non-linear anchoring shape. In addition, the bioabsorbable component 101 includes various features, shapes and / or compositions to operably interact with the spring / bend segments to create a complex non-linear anchoring shape.

[0128] Referring now to FIG. 11 , an embodiment of the present invention includes a spring 106 and at least a portion of an anchoring arm 108 residing within a dehydrated bioabsorbable component 101a. When in a dehydrated state, the bioabsorbable component 101 has greater rigidity and is more solidified. Additionally, the spring 106 has a spring force less than a threshold amount to ensure that the anchoring arm 108 remains within the dehydrated bioabsorbable component 101a.

[0129] The bioabsorbable component 101 softens when it transitions to a hydrated state, which typically occurs when the anchoring device is implanted. Additionally, the threshold spring force of the spring 106 is greater than the force exerted by the hydrated bioabsorbable component 101a on the anchoring arms 108. Thus, when the bioabsorbable component 101 is hydrated, the spring 106 forces the anchoring arms 108 outwardly away from each other into their respective anchoring positions. Fig.11A (Dehydrated / Inserted state) and Fig. 11B This transition can be seen when the hydrated / anchored state is reached.

[0130] The spring force / bending stiffness of the spring 106; the size, location, and composition of the bioabsorbable component 101; and / or the desired movement of the anchoring arms 108 can be adjusted and optimized as needed for any given situation.

[0131] The shape and design of the spring 106 can be any shape and design according to the present invention. In addition, the position of the spring can be offset from the main body section 102 or at the same general distance as the main body section, as described herein with respect to other embodiments. Similarly, the bracket 110 and the main body section 102 can be designed according to the various embodiments described herein.

[0132] FIG12 shows a variation of the embodiment shown in FIG11. The embodiment depicted in FIG12 includes a hollow section 122 that contains the spring 106 and a portion of the anchoring arm 108. The hollow section 122 has two functions. The first function is to act as a containment cavity when the bioabsorbable component 101 is dehydrated. The second function is that as the bioabsorbable component 101 hydrates, the resistance to the anchoring arm 108 is reduced compared to a non-hollow bioabsorbable component such as the component shown in FIG11.

[0133] Similar to the embodiment in Fig. 10, the hollow sections 122 in the embodiment in Fig. 12 can be designed to control the range of movement of the anchoring arms when transitioning to their respective anchoring positions. In addition, the hollow sections 122 can be designed to allow the use of weaker springs 106. Regardless of the intent, the spring force / bending stiffness of the spring member 106; the size, location, and composition of the hollow sections 122 / bioabsorbable member 101; and / or the desired movement of the anchoring arms 108 can be adjusted and optimized as needed for any given situation.

[0134] An embodiment of the present invention is a method of producing an anchoring device as depicted in Figures 11-12. The novel method includes bending a non-bioabsorbable component into a predetermined spring-loaded shape having a non-linear body segment, at least one spring component, and at least one anchoring arm. The non-bioabsorbable component is flexed under tension into an insertion orientation and the bioabsorbable component is dehydrated around at least a portion of the anchoring arm to maintain the arm in the insertion orientation. In some embodiments, the bioabsorbable component is dehydrated around at least a portion of the body segment, one or more beams, one or more springs, and one or more anchoring arms.

[0135] In some embodiments, the non-bioabsorbable component 103 is constructed entirely of a single wire construction. In some embodiments, the non-bioabsorbable component 103 is constructed of a single wire construction, wherein the wire has a generally circular cross-section. Starting from a single wire, the body section 102, beam 104, spring member 106, anchoring arm 108, and stent 110 can be constructed by bending the wire into a desired anchoring orientation. Using a single wire construction greatly reduces manufacturing time, cost, and complexity.

[0136] In some embodiments, when in a dehydrated state, the total length of the biopsy marker 100 in the longitudinal direction is between about 1 mm and 20 mm. In some embodiments, the length of the biopsy marker 100 when dehydrated is between 7.5 mm and 10 mm. In some embodiments, the length of the biopsy marker 100 when dehydrated is 5 mm and the outer diameter when dehydrated is 1.3 mm. In some embodiments, the total length of the non-bioabsorbable component 103 in the longitudinal direction is between about 1 mm and 7 mm.

[0137] The advantages set forth above as well as those that become apparent from the foregoing description are effectively obtained. As certain changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

[0138] It is also to be understood that the following claims are intended to cover all generic and specific features of the invention described herein, together with all statements of the scope of the invention which might literally be regarded as falling therein.

Claims

1. A biopsy marker, comprising: a bioabsorbable component comprised of a swellable material capable of dehydrating to reduce size and hydrating to increase size; A non-bioresorbable component, the non-bioresorbable component comprising: a body section having a predefined non-linear shape, wherein the body section resides at least partially within the bioresorbable component; a first beam extending from the body section to a first spring member; the spring member resides between the first anchor arm and the first beam; an insertion orientation and an anchoring orientation, the insertion orientation comprising a lateral span of the biopsy marker that is different than a lateral span of the biopsy marker when in the anchoring orientation; The insertion orientation includes the anchoring arm being subjected to a retention force to overcome a spring force from the spring member; and the anchoring orientation comprising the anchoring arms being free of the retaining force and the spring member springing the anchoring arms into a resting position, thereby changing the lateral span of the biopsy marker; wherein the increase in size of the bioabsorbable component when in a hydrated state causes the bioabsorbable component to apply a force to the first anchoring arm, wherein the force applied by the bioabsorbable component exceeds the spring force of the first spring component and moves the first anchoring arm to the anchoring orientation.

2. The biopsy marker of claim 1, further comprising a nonlinear stent segment at the distal end of the anchoring arm. The biopsy marker of claim 1 , wherein the body segment has a coil shape. The biopsy marker of claim 1 , wherein the spring member is a torsion spring.

5. The biopsy marker of claim 1, wherein the spring member is an elbow torsion spring. The biopsy marker of claim 1 , wherein the non-bioabsorbable component is made of a metallic material.

7. The biopsy marker of claim 1, wherein the non-bioresorbable component is comprised of a single continuous wire.

8. The biopsy marker of claim 1, further comprising: When the bioabsorbable component is in a dehydrated state, the body section resides within the bioabsorbable component; The first beam has a length greater than a distance between the body section and an outer surface of the bioabsorbable component when in the dehydrated state such that the first spring member resides outside of the bioabsorbable component when in the dehydrated state.

9. The biopsy marker of claim 1, wherein the anchoring orientation comprises movement of the anchoring arm toward a central longitudinal axis of the biopsy marker.

10. The biopsy marker of claim 8, further comprising a hollow section bored into the bioabsorbable component in a dehydrated state, wherein the first beam passes through the hollow section.

11. The biopsy marker of claim 8, further comprising: the body section and at least a portion of the first anchoring arm reside within the outer surface of the bioabsorbable component when in the dehydrated state, whereby the bioabsorbable component in the dehydrated state exerts a force on the first anchoring arm that is greater than the spring force of the first spring member, such that the portion of the first anchoring arm that resides within the outer surface of the bioabsorbable component in the dehydrated state remains within the outer surface of the bioabsorbable component in the dehydrated state; When in the hydrated state, the bioabsorbable member exerts a lesser force on the first anchoring arm than the force exerted by the bioabsorbable member when in a dehydrated state, wherein the lesser force is less than the spring force of the first spring member; and The first spring member thereby moves the first anchoring arm to the anchoring orientation when the bioabsorbable member transitions from the dehydrated state to the hydrated state.

12. The biopsy marker of claim 1, further comprising: a second beam extending from the body section to a second spring member; the second spring member resides between the second anchor arm and the second beam; The insertion orientation further comprises the second anchoring arm being subjected to a force to overcome the spring force from the spring member; and The anchoring orientation also includes the second anchoring arm being free of the force and the second spring member springing the second anchoring arm into a resting position, thereby changing the lateral span of the biopsy marker.

13. The biopsy marker of claim 12, wherein the length of the first beam and the length of the second beam are not equal.

Images