Patent Application
20230000587
A number of patients will have breast biopsies because of irregular mammograms and palpable abnormalities. Biopsies can include surgical excisional biopsies and stereotactic and ultrasound guided needle breast biopsies. In the case of image directed biopsy, the radiologist or other physician may take a small sample of the irregular tissue for laboratory analysis. If the biopsy proves to be malignant, additional surgery (e.g., a lumpectomy or a mastectomy) may be required. In the case of needle biopsies, the patient may return to the radiologist a day or more later, and the biopsy site (the site of the lesion) may need to be relocated in preparation for the surgery. An imaging system, such as ultrasound, magnetic resonance imaging (MM) or x-ray may be used to locate the biopsy site. In order to assist the relocation of the biopsy site, a marker may be placed at the time of the biopsy.
The use of markers used after breast biopsies to mark the location where the biopsied tissue was removed is described in the following U.S. Patents: U.S. Pat. No. 6,083,524, “Polymerizable biodegradable polymers including carbonate or dioxanone linkages,” issued Jul. 4, 2000; U.S. Pat. No. 6,162,241, “Hemostatic tissue sealants,” issued Dec. 4, 2000; U.S. Pat. No. 6,270,464, “Biopsy localization method and device,” issued Aug. 7, 2001; U.S. Pat. No. 6,356,782, “Subcutaneous cavity marking device and method,” issued Mar. 12, 2002; U.S. Pat. No. 6,605,294, “Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels,” issued Aug. 12, 2003; U.S. Pat. No. 8,600,481, “Subcutaneous cavity marking device,” issued Dec. 3, 2013 and U.S. Pat. No. 8,939,910, “Method for enhancing ultrasound visibility of hyperechoic materials”, issued Jan. 27, 2015. All of these U.S. Patents are incorporated by reference in their entirety.
Once a marker is placed at a biopsy site, the marker can later be relocated to identify the biopsy site in subsequent follow-up procedures. In some contexts, a placed marker may not completely correspond to the biopsy site when the marker is relocated. For instance, the marker may migrate to another nearby location during the intervening time between the biopsy procedure and subsequent follow up procedures. Migration of the biopsy site marker can cause difficulties when identifying the biopsy site during subsequent follow-up procedures. Accordingly, it may be desirable to incorporate features into a marker to maintain the marker in a fixed position over time.
While several systems and methods have been made and used for marking a biopsy site, it is believed that no one prior to the inventor has made or used the invention described in the appended claims.
While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements. In the drawings some components or portions of components are shown in phantom as depicted by broken lines.
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
It may be beneficial to be able to mark the location or margins of a lesion, whether temporarily or permanently, prior to or immediately after removing or sampling it. Marking prior to removal may help to ensure that the entire lesion is excised, if desired. Alternatively, if the lesion were inadvertently removed in its entirety, marking the biopsy site immediately after the procedure would enable reestablishment of its location for future identification.
Once a marker is positioned at a biopsy site, it may be desirable for the marker to remain visible under ultrasound. It may also be desirable to make the marker readily identifiable relative to other structural features of a patient. For instance, it may be desirable for the marker to be distinguishable under ultrasound visualization from microcalcifications to avoid inadvertently characterizing the marker as a microcalcification during subsequent ultrasonic examinations. Generally, microcalcifications are used in the field to identify suspicious lesions or masses. Thus, it is generally desirable for the ultrasound view to be distinguishable as a marker and not inadvertently identified as a new mass.
Aspects presented herein relate to devices and procedures for manufacturing a marker for percutaneously marking a biopsy cavity (10) having surrounding tissue (30), as shown in
In the present example, marker (100) further includes a marker element (12) that is generally not bioabsorbable. Marker element (12) may comprise a radiopaque or echogenic marker embedded within the bioabsorbable marker material (122) of carrier (120). For instance, marker element (12) may comprise metal, hard plastic, or other radiopaque or hyperechoic materials known to those of ordinary skill in the art in view of the teachings herein. In other examples, marker (100) may be formed without a marker element (12). In still other examples, marker (100) may be formed with only marker element (12) such that carrier (120) is omitted and marker element (12) is in a “bare” form. In other words, in some examples marker (100) is formed of only carrier (120) as a bare clip.
Marker material (122) is generally expandable once disposed within a patient at a biopsy site. As shown in
Marker (100) may be inserted into the body either surgically via an opening in the body cavity (30), or through a minimally invasive procedure using such devices as a catheter, introducer or similar type insertion device. Marker (100) may be delivered immediately after removal of the tissue specimen using the same device used to remove the tissue specimen itself. Follow-up noninvasive detection techniques, such as x-ray mammography or ultrasound may then be used by the physician to identify, locate, and monitor the biopsy cavity site over a period of time via marker (100).
Marker (100) of the present example is large enough to be readily visible to a clinician under x-ray or ultrasonic viewing, for example; yet small enough to be able to be percutaneously deployed into the biopsy cavity and to not cause any difficulties with the patient. Although examples are described in connection with treatment and diagnosis of breast tissue, aspects presented herein may be used for markers in any internal, tissue, e.g., in breast tissue, lung tissue, prostate tissue, lymph gland tissue, etc.
The hydration of the marker material (122) of carrier (120) by the natural moisture of the tissue surrounding it causes expansion of the polymer and thus minimizes the risk of migration. The growing hydrogel-based marker material (122) centers marker (100) in the biopsy cavity as it grows. As the hydrogel expands, naturally present moisture from the surrounding tissue, the hydration enables increasing sound through transmission, appears more and more hypoechoic and is easy to visualize on follow up ultrasound studies.
The hydrated hydrogel marker material (122) of carrier (120) may also be used to frame permanent marker (12). The hypoechoic nature of the hydrated marker material (122) enables ultrasound visibility of the permanent marker (12) within the hydrogel hydrated marker material (122) because the permanent marker (12) is outlined as a specular reflector within a hypoechoic hydrated marker having a water-like nonreflective substrate.
In some examples it may be desirable to deploy marker (100) described above within the body cavity (30) using certain marker delivery devices. For instance,
A grip (166) can be provided at the proximal end of cannula (162). A push rod (168) can be provided, with push rod (168) extending coaxially in cannula (162) such that push rod (168) is configured to translate within cannula (162) to displace one or more markers through side opening (164) (see
A user may grasp grip (166) with two fingers, and may push on plunger (170) using the thumb on the same hand, so that marker delivery device (160) is operated by a user's single hand. A spring (not shown) or other feature may be provided about rod (168) to bias rod (168) proximally relative to grip (166) and cannula (162).
Cannula (162) may be formed of any suitable metallic or non-metallic material. In some versions, cannula (162) is formed of a thin walled hollow tube formed of a suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer, such as Polyether block amide (PEBA), such as is known under the tradename PEBAX. Cannula (162) may be formed of PEBAX, and may be substantially transparent to visible light and X-ray.
Side opening (164) may be formed by cutting away a portion of the wall of cannula (162). Side opening (164) communicates with an internal lumen (165) of cannula (162). Side opening (164) may extend axially (in a direction parallel to the axis of lumen (165)) from a proximal opening end (164A) to a distal opening end (164B), as illustrated in
In the present example, distal tip (172) extends from the distal end of cannula (162) and is rounded as shown in
Marker engaging element (240) is disposed within internal lumen (165), and at least a portion of marker engaging element (240) is disposed distally of proximal end (164A) of side opening (164). Marker engaging element (240) extends along a portion of the floor of cannula (162) under opening (164) such that marker engaging element (240) is positioned to reinforce the portion of cannula (162) in which opening (164) is formed. For instance, by positioning marker engaging element (240) underneath opening (164), as shown in
As shown in
As shown in
Referring to
In some examples it may be desirable to include certain features within a marker similar to marker (100) to reduce a risk of the marker to migrate when placed within tissue. For instance, some markers may be prone to migration after placement of a biopsy site due to movement of tissue in the intervening time between marker placement and subsequent follow-up procedures. As a result, such markers may introduce challenges with identifying the biopsy site during subsequent follow-up procedures. Accordingly, it may be desirable to incorporate features into a marker similar to marker (100) to maintain the marker in a fixed position within tissue over time. Although several examples are described herein that incorporate the features outlined above, it should be understood that various alternative combinations can be used without departing from the basic principles described herein.
A. Exemplary Biopsy Site Marker with Extendable Sides
Marker element (512) of the present example is composed of nitinol. In certain embodiments, marker element (512) is composed of a nitinol mesh, wire, or stint like material. Additionally, in some examples marker element (512) can be configured to promote tissue ingrowth. For instance, in some examples, marker element (512) is composed of a nitinol mesh wherein the holes of the mesh are large enough so the tissue can grow through the holes, which fixes element marker (512) to the tissue. Similarly, marker element (512) can comprise a variety of materials such as metal, hard plastic, and/or etc.
Marker element (512) of the present example is configured to have a general “V” shape. In particular, marker element (512) of the present example comprises first arm (530) (also may be referred to as a “first portion”) and second arm (540) (also may be referred to as a “second portion”) joined along an edge and extending out, forming the “V” shape. Further, a first tine (535) is joined to first arm (530) to extend outwardly from first arm (530) and a second tine (545) is joined to second arm (540) to extend outwardly from second arm (540). In some examples, tines (535, 545) may also be referred to as an anchor, a ground, and/or etc. Each of arms (530, 540) and tines (535, 545) may have a thickness and width as required to maintain the shape of marker element (512). In some examples, tines (535, 545) are configured to have rough or sharp edges to enhance tines (535, 545) ability to grip surfaces such as tissue.
Marker element (512) is configured to be compressible so that the acute angle between first arm (530) and second arm (540) will become smaller when a force is applied inwardly to first arm (530) and/or second arm (540). Additionally, marker element (512) is resiliently biased such that marker element (512) is configured to transition from a compressed state (
Although marker element (512) of the present example is configured with a “V” shape, it should be understood that various alternative shapes may be used. For instance, in one alternative configuration of marker element (512), the shape of marker element (512) may be of an irregular shape referred to as a “target.” In this configuration, marker element (512) may be formed of one or more wires defining two opposing tightly wound coils. The two tightly wound coils may be aligned along a common axis with a loose coil joining the two opposing tightly wound coils together. The tightly wound coils may be formed by the one or more wires being wound in circular or oval-shaped coils positioned closely together. The loose coil may be a section of wire joining the two coils. The loose coil itself may include one or more coils as it extends from one tightly wound coil to the other. In this configuration, when marker element (512) is viewed from the side (e.g., angle of view parallel to the common axis), the tightly wound coils may appear as a circular or oval-shaped outline of the “target.” Meanwhile, the loose coil may appear as an S-shaped pattern extending from one side of the circular or oval-shaped outline to the other. In some versions of the “target,” the loose coil may also include one or more thick or round portions to make the center of the “target” more readily identifiable.
In another alternative configuration of marker element (512), the shape of marker element (512) may be of a “3D M” shape. In this configuration, marker element (512) may be formed of a flat sheet material similar to the “V” shape described above. However, unlike the “V” shape, the “3D M” shape may include two additional bends to form an M or W shape when viewed from one side. Thus, a total of three bends may be used. The three bends may together define a four discrete sections of material. In some examples, one or more sections may include one or more cut-outs, bores, or openings therein. Such a cut-out may be desirable to improve visualization from the top or bottom of the M-shaped pattern using an imaging medium such as x-ray where depth visualization may be difficult.
In yet another alternative configuration of marker element (512), the shape of marker element (512) may be of a “double loop” shape. In this configuration, marker element (512) may be formed of one or more wires. The one or more wires may define two circular or oval-shaped loops joined together. To improve visualization, the two loops may be oriented at different angles. For instance, a first loop may define a first plane and a second loop may define a second plane. In some examples, the first plane may be offset from the second plane by approximately 90 degrees. From above, this configuration may have the appearance of a cross. In other examples, the particular angle of offset may be varied such as the first plane and second plane being offset by approximately 45 degrees to have an X-shape when viewed from the top.
In still another alternative configuration of marker element (512), the shape of marker element (512) may be of a “funnel.” In this configuration, marker element (512) may be formed of one or more wires. The one or more wires may define a helical or spiral pattern, with the diameter of the helical or spiral pattern decreasing with each successive coil, thereby forming a frustoconical-shaped pattern. When viewed from above, such a configuration may have a 2 dimensional spiral appearance.
B. Exemplary Biopsy Site Marker with Dissolvable Carrier
As with marker element (12) described above, marker element (612) of the present example is configured as non-absorbable. However, unlike marker element (12), marker element (612) of the present example includes multiple a marker materials (622, 624). Marker materials (622, 624) of the present examples are generally configured to have varying material properties that effect the retraction and/or expansion thereof such that marker (600) can transition from a relatively large or extended volume to a relatively small volume. For instance, in the present example an outer marker material (622) is disposed around a structure of inner marker material (624). As will be described in greater detail below, outer marker material (622) is generally configured to dissolve over time within a patient to thereby providing a means for rapidly retracting the length of marker (600). In some examples, outer marker material (622) may also expand before dissolving, in such examples, this material property may be used to expand inner marker material (624) initially to lodge one or more anchor features of inner marker material (624) into tissue to initially anchor marker element (612) within tissue.
Marker materials (622, 624) are generally positioned in filled or layered arrangement. For instance, in some examples both marker materials (622, 624) form a prolate spheroid shape when in a dehydrated condition. In this configuration, inner marker material (624) forms a structural wound spring core that is wrapped by a filler marker material (622) also with a prolate spheroid form. Thus, marker (600) generally defines an elongate prolate spheroid configuration. In the present configuration, inner marker material (624) is shown as being centrally positioned within filler marker material (622). However, it should be understood that in other examples inner marker material (624) can have a variety of positions within filler marker material (622). Additionally, it should be understood that in other examples inner marker material (624) may be in the form of a rectangular spring, wherein both the marker material (622, 624) form a mirrored wedge, with a profile as shown in
As described above, filler marker material (622) is generally absorbable such that filler marker material (622) is configured to degrade over time within a patient. Filler marker material (622) in the present example is formed of any suitable bioabsorbable material such as hydrogel, collagen, and/or etc. Additionally, such materials can be configured to have varying absorption properties. For instance, in some examples, filler marker material (622) can be configured to absorb relatively slowly over time leading to slow contraction of inner marker material (624). Yet in other examples, filler marker material (622) can be configured to absorb relatively quickly over time leading to rapid contraction of inner marker material (624).
In use, marker (600) is initially placed as shown in
These expansion and/or retraction properties, together with the geometry of inner marker material (624) and dissolving outer marker material (622), result in marker (600) retracting in size. In some examples, the volume of marker (600) can retract to 2/3 to 1/2 size. As a consequence, the retraction of outer marker material (622) can grip the biopsy cavity such that inner marker material (624) can act as an anchor to hold marker (600) at a given position within tissue. For instance, during retraction, folds of tissue can become trapped within the spaces defined by inner marker material (624) that were previously filled by filler marker material (622).
In the present example, the approximate profile of marker (600) remains generally cylindrical and/or prolate spheroid in shape. Alternatively, the shape of marker (600) after at least some hydration can be characterized as spring-shaped. Of course, various other alternative profiles can be formed using the present configuration. For instance, in other examples the initial geometry of outer marker material (622) can be varied to influence the profile of marker (600) after at least some hydration. In addition, it should be understood that the particular shape and/or size of marker (600) can change throughout the course of hydration. For instance, marker (600) can start in the position shown in
C. Exemplary Biopsy Site Marker with One Directional Screw
Unlike marker (100) described above, marker (700) of the present example is configured as a bare marker such that a structure similar to carrier (120) is not included. As will be described in greater detail below, in some uses this bare configuration can be desirable to promote engagement between marker element (712) and tissue. However, in other examples, marker element (712) may be used with a carrier such as carrier (120) discussed above.
Marker element (712) of the present example is composed of nitinol. In some examples, marker element (712) is composed of a nitinol mesh, wire, or stint like material. Additionally, in some examples marker element (712) can be configured to promote tissue ingrowth. For instance, in such examples, marker element (712) is composed of a nitinol mesh wherein the holes of the mesh are large enough so the tissue can grow through the holes, which fixes element marker (712) to the tissue. In still other examples, marker element (712) can comprise a variety of materials such as metal, hard plastic, and/or etc.
As with marker element (12) described above, marker element (712) of the present example is configured to be non-absorbable. However, unlike marker element (12), marker element (712) of the present example is configured to be screwed into tissue of biopsy site and includes an angled barb or tab (730) at one end of screw marker element (712) to prevent unscrewing or backout when placed in tissue. Marker materials (722) of the present example is generally configured to have material properties that support the structure with sufficient rigidity that marker (700) can be screwed into tissue of biopsy site. Marker material (722) generally forms a helical or spiral shape to define marker element (712), as well as tab (730) at the end of the spiral form.
As best seen in
As noted above, tab (730) of marker (700) can take on a variety of forms. For instance,
As similarly described above with respect to tab (730), tab (770) is generally configured to enhance the grip of tissue by marker element (752). Tab (770) of the present example can take on a variety of forms. For instance, as shown in
D. Exemplary Biopsy Site Marker with One Directional Coil
Unlike marker (100) described above, marker (800) of the present example is configured as a bare marker such that a structure similar to carrier (120) is not included. As will be described in greater detail below, in some uses this bare configuration can be desirable to promote engagement between marker element (812) and tissue. However, in other examples, marker element (812) may be used with a carrier such as carrier (120) discussed above.
Marker element (812) of the present example is composed of nitinol. In some examples, marker element (812) is composed of a nitinol mesh, wire, or stint like material. In other examples, marker element (812) can be configured to promote tissue ingrowth. For instance, in such examples, marker element (812) is composed of a nitinol mesh wherein the holes of the mesh are large enough so the tissue can grow through the holes, which fixes element marker (812) to the tissue. In still other examples, marker element (812) can comprise a variety of materials such as metal, hard plastic, and/or etc.
As with marker element (12) described above, marker element (812) of the present example is configured to be non-absorbable. However, unlike marker element (12), marker element (812) of the present example is configured to be screwed into tissue of biopsy site and includes an undercut tab (830) at one end of screw marker element (812) to prevent unscrewing or backout when placed in tissue. Marker materials (822) of the present examples are generally configured to have material properties that support the structure with sufficient rigidity that marker (800) can be screwed into tissue of biopsy site. Marker material (822) generally forms a helical or coil shape to define marker element (812), as well as tab (830) at the end of the spiral form. In the present example marker element (812) cross-section can be circular or triangular as best shown in
As best seen in
As noted above, tab (830) of marker (800) can take on a variety of forms. For instance,
As similarly described above with respect to tab (830), tab (870) is generally configured to enhance the grip of tissue by marker element (852). Tab (870) of the present example can take on a variety of forms. For instance, as shown in
E. Exemplary Biopsy Site Marker with Serrated Screw
Marker element (912) of the present example is composed of nitinol. In some examples, marker element (912) is composed of a nitinol mesh, wire, or stint like material. Additionally, marker element (912) can be configured to promote tissue ingrowth. For instance, in such examples, marker element (912) is composed of a nitinol mesh wherein the holes of the mesh are large enough so the tissue can grow through the holes, which fixes element marker (912) to the tissue. Similarly, marker element (912) can comprise a variety of materials such as metal, hard plastic, and/or etc.
As with marker element (12) described above, marker element (912) of the present example is non-absorbable. However, unlike marker element (12), marker element (912) of the present example is configured to be screwed into tissue of biopsy site and includes serrated edge (930) along a helical edge of the marker element (912) to prevent unscrewing or backout when placed in tissue. Marker materials (922) of the present examples are generally configured to have material properties that support the structure with sufficient rigidity that marker (900) can be screwed into tissue of biopsy site. Marker material (922) generally forms a helical cone shape to define marker element (912), as well as serrated edge (930) along the edges of the conical form as shown. In the present example marker element (912) height and width can be any dimensions suitable for the biopsy procedure. In the present example serrated edge (930) can be non-uniform and along a single edge. It should be understood that in other examples serrated edge (930) can take on a variety of alternative shapes, such as uniform serrations or multiple edges.
As seen in
F. Exemplary Biopsy Site Marker with Barbs
Marker element (1012) of the present example is composed of nitinol. In some examples, marker element (1012) is composed of a nitinol mesh, wire, or stint like material. Additionally, marker element (1012) can be configured to promote tissue ingrowth. For instance, in such examples, marker element (1012) is composed of a nitinol mesh wherein the holes of the mesh are large enough so the tissue can grow through the holes, which fixes element marker (1012) to the tissue. In still other examples, marker element (1012) can comprise a variety of materials such as metal, hard plastic, and/or etc.
As with marker element (12) described above, marker element (1012) of the present example is configured to prevent absorption into a patient after placement of marker (1000). However, unlike marker element (12), marker element (1012) of the present example is configured to be attached to tissue of biopsy site and includes one or more barbs (1030) at one end of marker element (1012) to prevent migration of marker element (1012) when placed in tissue. Marker materials (1022) of the present examples are generally configured to have material properties that support the structure with sufficient rigidity that marker (1000) can prevent migration of the marker element (1012) from the biopsy site. Marker material (1022) generally forms a shaft (1040), an engagement body (1050) at a proximal end, and one or more barbs (1030) at a distal end. In the present example shaft (1040) can be circular or triangular. It should be understood that in other examples shaft (1040) can take on a variety of alternative shapes.
As best seen in
The particular barbed configuration of marker element (1012) can take on a variety of forms. For instance, as shown in
G. Exemplary Biopsy Site Marker with Coiled Hooks
As with marker element (12) described above, marker element (1112) of the present example is non-absorbable. However, unlike marker element (12), marker element (1112) of the present example is configured to deploy into tissue of biopsy site and hooks (1130) which uncoil from marker element (1112) to prevent migration of marker element (1112) when placed in tissue. Marker materials (1122) of the present examples are generally configured to have material properties that support the structure with sufficient rigidity while allowing for uncoiling of hooks (1130). Marker material (1122) generally forms a center body to define marker element (1112), as well as hooks (1130) extending from marker element (1112).
As best seen in
H. Exemplary Biopsy Site Marker with Deployable Wings
As with marker element (12) described above, marker element (1212) of the present example is configured to prevent absorption into a patient after placement of marker (1200). However, unlike marker element (12), marker element (1212) of the present example is configured to deploy into tissue of biopsy site and wings (1230) which open from marker element (1212) to prevent migration of marker element (1212) when placed in tissue. Marker materials (1222) of the present examples are generally configured to have material properties that support the structure with sufficient rigidity while allowing for opening of wings (1230). Marker material (1222) generally forms a center body to define marker element (1212), as well as wings (1230) extending from marker element (1212).
As best seen in
I. Exemplary Biopsy Site Marker with Hook
As with marker element (12) described above, marker element (1312) of the present example is configured non-absorbable. However, unlike marker element (12), marker element (1312) of the present example is configured to deploy into tissue of biopsy site and a hook (1330) extending from marker element (1312) to prevent migration of marker element (1312) when placed in tissue. Marker material (1322) of the present examples is generally configured to have material properties that support the structure with sufficient rigidity while allowing for gripping of hook (1330). Marker material (1322) generally forms an elongated body to define marker element (1312), as well as wings (1330) extending from marker element (1312). In still other examples, marker element (1312) of varying shapes and/or materials can be used. Although the present example is shown and described as marker element (1312) itself forming gripping hook (1330), it should be understood that in other examples gripping hook (1330) can be formed of structures similar to carrier (120) described above. Thus, in such examples, gripping hook (1330) and/or the entire exterior of marker (1300) can be comprised of hydrogel, collagen, and/or etc.
As seen in
J. Exemplary Biopsy Site Marker with Pad Form
Marker element (1412) can also take on a wide variety of shapes, and/or sizes. For instance, in some examples, marker element (1412) can have the shape of marker element (12) shown in
As with carrier (120) described above, carrier (1420) of the present example is configured for absorption into a patient after placement of marker (1400). However, unlike carrier (120), carrier (1420) of the present example includes multiple marker materials (1422, 1424, 1426). Marker materials (1422, 1424, 1426) of the present examples are generally configured to have varying material properties that effect the material strength and time required for degradation thereof such that marker (1400) can unroll from a relatively small volume to a relatively large or extended volume. For instance, in the present example an outer marker material (1422) is disposed on outside edges of carrier (1420). A middle marker material (1424) lies inside of outer marker material (1422). Finally, an inner marker material (1426) lies along the center of carrier (1420). As will be described in greater detail below, marker materials (1422, 1424, 1426) are generally configured to be flexible enough to allow the carrier (1420) to be in a pad form to be rolled prior to deployment, as shown in
Marker materials (1422, 1424, 1426) are generally positioned in a layered arrangement, moving from an outer edge of carrier (1420) to a center. For instance, in some examples marker materials (1422, 1424, 1426) form a rolled pad when in a dehydrated condition before deployment. It should be understood that in other examples inner marker material (1426) can have a variety of positions within carrier (1420). Additionally, it should be understood that in other examples inner marker material (1426) may be in the form of a square surrounded by the middle marker material (1424), or wherein the carrier is rectangular are square in shape.
As best seen in
In the present example, the approximate profile of marker (1400) remains generally rectangular in shape upon deployment, but moves from the rolled to unrolled configuration. Of course, various other alternative profiles can be formed using the present configuration. For instance, in other examples the initial geometry of marker (1400) profile can be varied to influence the expansion of marker (1400) after unrolling and at least some hydration. In addition, it should be understood that the particular shape and/or size of marker (1400) can change throughout the course of hydration. For instance, marker (1400) can start in the position shown in
The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
A biopsy site marker, comprising: a marker element, wherein the marker element includes a first arm and a second arm, wherein the first arm comprises a first tine and the second arm comprises a second tine, wherein the first arm and the second arm are each configured to be displaced outwardly when deployed to a biopsy site, wherein the first tine and the second tine are configured to engage the tissue when the first arm and the second arm are displaced outwardly.
The marker of Example 1, wherein the first and the second arm form a V-shape.
The marker of Examples 1 or 2, wherein the first tine is joined to first arm to extend outwardly from first arm and second tine is joined to second arm to extend outwardly from second arm.
The marker of any one or more of Examples 1 through 3, wherein the first and second tines include one or more rough edges configured to increase the grip of the first and second tines.
The marker of any one or more of Examples 1 through 4, wherein the marker defining an acute angle between the first arm and the second arm.
The marker of Example 5, wherein the marker is configured to be compressible such that the acute angle between the first arm and the second arm will become smaller when a force is applied inwardly to the first arm or the second arm.
The marker of Example 6, wherein the marker is configured to be expandable such that when the force is reduced or removed from the first arm or the second arm the acute angle between the first arm and the second arm becomes larger.
The marker of any one or more of Examples 1 through 7, wherein the marker is configured to be positioned in an outer cannula in a compressed state.
The marker of Example 8, wherein the marker is configured to transition from the compressed state to an expanded state when the marker is deployed from the outer cannula.
The marker of Example 9, wherein the marker is configured for deployment from the outer cannula in the compressed state.
The marker of any one or more of Examples 1 through 10, the marker element including a flat configuration defined by a sheet material being bent to form the first portion and the second portion of the marker element.
The marker of any one or more of Examples 1 through 11, wherein the marker comprises a carrier, wherein the marker element is positioned within the carrier.
The marker of Example 12, wherein the carrier comprises a first marker material configured to degrade over time in the presence of moisture.
The marker of Example 13, wherein the first marker material comprises collagen, wherein the marker element includes a second marker material, wherein the second marker material comprises hydrogel.
The marker of Example 13, wherein the first marker material comprises hydrogel.
A biopsy site marker, the biopsy site marker comprising a marker element having a resilient portion, wherein the resilient portion is configured to transition the marker element between a pre-deployment state and a deployment state, wherein the marker element is configured to grip tissue when in the deployment state.
The biopsy site marker of Example 16, wherein the marker element defines a first arm and a second arm that together form a V-shaped pattern, wherein the resilient portion is configured to flex the first arm and the second arm outwardly when transitioning from the pre-deployment state to the deployment state.
The biopsy site marker of Example 16, further comprising a carrier, the marker element forming a substantially helical pattern, the substantially helical pattern being disposed within a portion of the carrier.
The biopsy site marker of Example 18, wherein the resilient portion is incorporated into the substantially helical pattern of the marker element, wherein the resilient portion is configured to retract the length of the substantially helical pattern of the marker element when transitioning from the pre-deployment state to the deployment state.
The biopsy site marker of Examples 18 or 19, further comprising a carrier, wherein the carrier surrounds the marker element such that the carrier is configured to maintain the resilient portion in the pre-deployment state.
The biopsy site marker of Example 18, wherein the marker element includes a tab, wherein the tab is configured to secure the marker element to tissue.
The biopsy site marker of Example 21, wherein the tab defines a triangular-shaped cross-section.
The biopsy site marker of Example 21, wherein the tab defines a star-shaped cross-section.
The biopsy site marker of Example 21, wherein the tab defines a circular-shaped cross-section.
A biopsy site marker, the biopsy site marker comprising a carrier and a marker element disposed within a portion of the carrier, wherein the carrier includes a plurality of carrier elements configured in a layered arrangement, wherein the plurality of carrier elements are bioabsorbable, wherein at least one carrier element is configured to absorb at a different rate relative to another carrier element.
The biopsy site marker of Example 25, wherein the plurality of carrier elements include a collagen carrier element and a hydrogel carrier element.
The biopsy site marker of Examples 25 or 26, wherein the plurality of carrier elements form a rectangular pad, wherein the carrier elements are configured to transition from a rolled configuration to a flat configuration during hydration of at least one carrier element of the plurality of carrier elements.
The biopsy site marker of any one or more of Examples 25 through 27, wherein the marker element includes resilient portion is configured to transition the marker element between a pre-deployment state and a deployment state.
The biopsy site marker of any one or more of Examples 25 through 28, wherein the marker element defines a substantially helical shape.
The biopsy site marker of any one or more of Examples 25 through 28, wherein the marker element includes a first arm and a second arm, wherein the first arm and the second arm together define a v-shaped profile.
A biopsy site marker, comprising: a marker element, the marker element including a resilient portion and a first arm and a second arm extending outwardly from the resilient portion, the resilient portion being configured to transition the first arm and the second arm from a pre-deployment state to a deployment state.
A biopsy site marker, comprising: a marker element, the marker element including a first portion and a second portion, the first portion and the second portion each being configured to be displaced outwardly when deployed to a biopsy site, the marker element further including one or more anchors being configured to engage tissue of the biopsy site when the first portion and the second portion are displaced outwardly.
The marker of claim 1, the first and second portions forming a V-shape.
The marker of Examples 32 or 33, the one or more anchors including a first tine and a second tine, the first tine being joined to the first portion to extent outwardly from the first portion and the second tine being joined to the second portion to extend outwardly from the second portion.
The marker of any one or more of Examples 32 through 34, one or more anchors including one or more rough edges configured to increase the grip of the one or more anchors.
The marker of any one or more of Examples 32 through 35, the marker defining an acute angle between the first portion and the second portion.
The marker of Example 36, the marker being configured to be compressible such that the acute angle between the first portion and the second portion will become smaller when a force is applied inwardly to the first portion or the second portion.
The marker of Example 37, the marker being configured to be expandable such that when the force is reduced or removed from the first portion or the second portion the acute angle between the first portion and the second portion becomes larger.
The marker of any one or more of Examples 32 through 38, the marker being configured to be positioned in an outer cannula in a compressed state.
The marker of Example 39, the marker being configured to transition from the compressed state to an expanded state when the marker is deployed from the outer cannula.
The marker of Example 40, the marker being configured for deployment from the outer cannula in the compressed state.
The marker of Example 32, the one or more anchors being configured to engage the tissue to thereby anchor the marker within the tissue.
The marker of any one or more of Examples 32 through 42, the marker including a carrier, the marker element being positioned within the carrier.
The marker of Example 43, the carrier including a first marker material configured to degrade over time in the presence of moisture.
The marker of Example 44, the first marker material including collagen, the marker element including a second marker material, the second marker material including hydrogel.
The marker of Example 44, the first marker material comprises hydrogel.
A biopsy site marker, comprising: a marker element, the marker element including a helical portion defined by a plurality of coils; and a carrier, the helical portion of the marker element being at least partially disposed within the carrier, the marker element further including an anchor extending beyond an exterior of the carrier.
The biopsy site marker of Example 47, the carrier including a hydrogel, the hydrogel being configured to expand upon being hydrated from moisture at a biopsy site.
The biopsy site marker of Example 48, the anchor being configured to move along at least one axis defined by the biopsy site marker in response to expansion of the hydrogel.
The biopsy site marker of Examples 48 or 49, the plurality of coils of the marker element being configured to drive movement of the anchor along the at least one axis in response to expansion of the hydrogel.
The biopsy site marker of any one or more of Examples 47 through 50, the anchor of the marker element including a barb.
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
This application claims priority to U.S. Provisional Application Ser. No. 62/990,571, entitled “Non-Migrating Biopsy Site Identifiers,” filed on Mar. 17, 2020, the disclosure of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 62990571 | Mar 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US21/22473 | Mar 2021 | US |
| Child | 17943363 | US |
