Marker delivery assemblies and methods of assembling the same

Abstract

A marker delivery assembly includes a housing, a marker positioned within the housing, and a delivery cannula coupled to the housing distal to the marker. The marker delivery assembly also includes a pusher rod configured to extend through a proximal end of the housing to engage the marker and push the marker along the delivery cannula.

Description

MARKER DELIVERY ASSEMBLIES AND METHODS OF ASSEMBLING THE SAMETECHNICAL FIELD

[0001] The present specification generally relates to marker delivery assemblies and methods of assembling the same, and more particularly to a marker delivery assembly for delivery of markers to a biopsy site.BACKGROUND

[0002] During biopsy sample acquisition, particularly with respect to breast biopsy, it may be desirable to place or leave a marker within a biopsy site, such that it may be determined where a biopsy had been taken. During biopsy sample acquisition, the marker may be delivered to a biopsy site via a cannula. However, depending on how the biopsy site is positioned relative to the cannula it may be difficult to anchor a marker in a position as desired, which may lead to marker movement or inaccurate placement. Another challenging aspect of typical marker delivery devices is that inclusion of various components in a single assembly results in large, bulky packaging, which may result in increased material usage, increased shipping prices, and decreased storage capabilities of facilities and hospitals utilizing the marker delivery devices.

[0003] Accordingly, a need exists for alternative marker delivery devices that result in more accurate marker placement and more economical packaging and / or easier storage.SUMMARY

[0004] The present embodiments address the above referenced concerns. In particular, the present disclosure is directed to marker delivery assemblies and methods for more accurate marker positioning at the biopsy site. Additionally, some embodiments are directed to marker delivery assemblies with valves which may maintain sterility of the marker prior to use and allow for better storage.

[0005] In one embodiment, a marker delivery assembly includes a housing, a marker positioned within the housing, and a delivery cannula coupled to the housing distal to the marker. The marker delivery assembly also includes a pusher rod configured to extend through a proximal end of the housing to engage the marker and push the marker along the delivery cannula.

[0006] In another embodiment, a marker delivery assembly includes a housing including a proximal end and a distal end, a first valve positioned adjacent the proximal end, and a secondvalve positioned adjacent the distal end. The marker delivery assembly also includes a marker positioned within the housing between the first valve and the second valve, a delivery cannula coupled to the housing distal to the marker, and a pusher rod configured to extend through the proximal end of the housing to engage the marker and push the marker along the delivery cannula..

[0007] In yet another embodiment, a method of assembling a marker delivery assembly includes positioning a marker within a housing, coupling a delivery cannula to the housing distal to the marker, and providing a pusher rod, wherein the pusher rod is configured to engage the marker to push the marker distally through the delivery cannula from the housing.

[0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0010] FIG. 1 schematically depicts a marker delivery assembly, shown partially in crosssection, including a housing and a delivery cannula uncoupled from the housing, according to one or more embodiments shown and described herein;

[0011] FIG. 2 schematically depicts the marker delivery assembly of FIG. 1, where the delivery cannula is coupled to the housing, according to one or more embodiments shown and described herein;

[0012] FIG. 3 schematically depicts the marker delivery assembly of FIG. 1, where the marker is positioned within the delivery cannula, according to one or more embodiments shown and described herein;

[0013] FIG. 4 schematically depicts the delivery cannula of FIG. 3, where the marker is partially exiting the delivery cannula, according to one or more embodiments shown and described herein;

[0014] FIG. 5 schematically depicts the delivery cannula of FIG. 3, where the marker is has exited the delivery cannula into a biopsy site, according to one or more embodiments shown and described herein; and

[0015] FIG. 6 schematically depicts a flowchart illustrating method of assembling a marker delivery assembly, according to one or more embodiments shown and described herein.DETAILED DESCRIPTION

[0016] The figures herein generally illustrate various embodiments of a marker delivery assembly with a housing and a delivery cannula, and / or a method which may be used to assemble the marker delivery assembly. For instance in embodiments, a marker delivery assembly includes housing, a marker, a delivery cannula, and a pusher rod. The marker may be positioned within the housing and the delivery cannula may be coupled to the housing distal to the marker. The pusher rod may extend through a proximal end of the housing to engage the marker and push the marker along the delivery cannula. Accordingly, users of the marker delivery assembly as provided herein may accurately place the marker in a subject’s tissue. Moreover, a plurality of legs on the marker may curve outward from the delivery cannula, anchoring the marker within the tissue. Inclusion of the a fluid port may provide irrigation or lubrication to through the delivery cannula, while a valve may prevent liquid from exiting a proximal end or distal end of the housing. These and additional benefits will be described in greater detail below.

[0017] Within the context of the present disclosure, “proximal,” “a proximal end,” “a proximal portion,” “a proximal end portion,” and “a proximal length” of, for example, a marker delivery assembly, designate an end, portion, end portion, length of the marker delivery assembly intended to be nearer an operator and further from the subject, when the device is in use by the operator.

[0018] Within the context of the present disclosure, “distal,” “a distal end,” “a distal portion,” “a distal end portion,” and “a distal length” of, for example, a marker delivery assembly, designate an end, portion, end portion, length of the marker delivery assembly intended to be nearer the subject and further from the operator, when the device is in use by the operator.

[0019] In the accompanying figures, the proximal side or direction is designated by P and the distal side or direction is designated by D.

[0020] Referring now to FIG. 1, a marker delivery assembly 100 is generally depicted. As will be described in greater detail herein, the marker delivery assembly 100 may generally include a housing 102, a marker 104 within the housing 102, a delivery cannula 106 coupled to the housing 102 distal to the marker 104, and a pusher rod 108 configured to extend through a proximal end 101 of the housing 102 to engage the marker 104 and push the marker 104 along the delivery cannula 106. The marker delivery assembly 100 may include a greater or fewer number of components without departing from the scope of the present disclosure. For example, the marker delivery assembly 100 may further include a valve, a fluid inlet line 112, etc.

[0021] A cross-section of the housing 102 is depicted in FIG. 1. The housing 102 may include the proximal end 101 and a distal end 103 (as indicated by P and D in FIG 1, respectively). The housing 102 may be exterior to a subject during a marker delivery procedure conducted by the user, while the delivery cannula 106 may be inserted into the subject during the marker delivery procedure. The housing 102 may be a hollow body which defines a housing lumen 111, within which the marker 104 may be positioned. The housing 102 may be made of any suitable material for such, but not limited to, polyeurethane, carbon fiber, metals, a combination thereof, etc.

[0022] The proximal end 101 of the housing 102 may define a housing inlet 113 providing access to the housing lumen 111. At the distal end 103 of the housing 102 may be a housing outlet 115 providing egress from the housing lumen 111. Accordingly, the housing lumen 111 may extend from the housing inlet 113 to the housing outlet 115 thereby providing a continuous lumen through the housing 102. Formed as part of the distal end 103 or surrounding the distal end 103 may be a connector hub 117. The connector hub 117 may be configured to receive a mating connector end of the delivery cannula 106, described in greater detail below. For example, the connector hub 117 may be part of a luer type connector, such as a female connector end of a luer connector. However, various connections between the connector hub 117 and the delivery cannula are contemplated and possible including, but not limited to, press-fittings, threaded fittings, etc.

[0023] In embodiments, and to maintain sterility of the marker 104 within the housing lumen 111 and / or prevent unwanted release of the marker 104 from the housing lumen 111, the housing may 102 may include one or more valves positioned within the housing lumen 111. For example, a first valve 110A may be positioned at or adjacent the proximal end 101 and a second valve HOB may be positioned at or adjacent the distal end 103. Accordingly, the marker 104 may be positioned between the first valve 110A and the second valve 110B during storage within thehousing 102. In embodiments, the valves 110A / 11 OB may be one way valves or flaps which allow for proximal to distal opening, but prevent distal to proximal opening. In embodiments, the valves 110A / 11 OB may be hemostasis valves, solenoid valves, fluid isolation valves, or any other suitable valves.

[0024] In embodiments, the housing 102 may include one or more ports such as a fluid inlet port 121 and a fluid outlet port 123. As will be described in greater detail herein, fluid may be pumped into and out of the housing lumen 111. In embodiments, the fluid inlet port 121 may be positioned distal to the first valve 110A and proximal to the second valve HOB. In embodiments, the fluid inlet port 121 may be positioned adjacent the first valve 110A. In embodiments, the fluid outlet port 123 may also be positioned distal to the first valve 110A and proximal to the second valve HOB, such as adjacent the second valve 110B, as shown. However, other positionings of the fluid inlet port 121 and fluid outlet port 123 are contemplated and possible.

[0025] The delivery cannula 106 may also include a proximal end 105 and a distal end 107. The delivery cannula 106 is generally a long tubular member defining a cannula lumen 122. The proximal end 105 may define a cannula inlet 124 providing access to the cannula lumen 122. At the distal end 107 of the delivery cannula 106 may be a cannula outlet 125 providing egress from the cannula lumen 122. Accordingly, the cannula lumen 122 may extend from the cannula inlet 124 to the cannula outlet 125 thereby providing a continuous lumen through the delivery cannula 106. The distal end 107 of the delivery cannula 106 may be uniform, such that the cannula outlet 125 is substantially circular in cross-section, as depicted in FIG. 1. In other embodiments, as depicted in FIG. 2, the distal end 107 of the delivery cannula 106 may include a bevel 119, such that the cannula outlet 125 is tapered. The delivery cannula 106 may formed of a flexible or rigid material. In embodiments, the delivery cannula 106 may be made of polyurethane, carbon fiber, metals, a combination thereof, or any other suitable material.

[0026] In embodiments, the distal end 107 of the delivery cannula 106 may be bent such that the cannula inlet 124 and the cannula outlet 125 are not coaxial with one another, but are instead angled relative to one another (such as between 0 and 180 degrees, such as between 10 and 150 degrees, such as 90 degrees, though other angles are contemplated and possible). The bend in the delivery cannula 106 may be smooth or curved (as opposed to angular) to support smooth transition of the marker 104 through the delivery cannula 106 to the cannula outlet 125. Bending of the delivery cannula 106 may allow for more accurate placement of the marker 104into tissue 202 of a biopsy site 204 as the marker 104 leaves the distal end 107 of the delivery cannula 106 (as discussed further below).

[0027] In embodiments, formed as part of the proximal end 105 or surrounding the proximal end 105 of the delivery cannula 106 may be a mating connector 126. The mating connector 126 may be configured to be received by the connector hub 117 of the housing 102, described above, and such as illustrated in FIG. 2. For example, the mating connector 126 may be part of a luer type connector, such as a male connector end of a luer connector. Accordingly, the mating connector 126 of the delivery cannula 106 may be received within the connector hub 117 of the housing 102 to couple the housing 102 to the delivery cannula 106. However, and as noted above various connections between the housing 102 and the delivery cannula 106 are contemplated and possible including, but not limited to, press-fittings, threaded fittings, etc.

[0028] As noted herein, the marker 104 may be positioned within the housing lumen 111 of the housing 102. The marker 104 may be sized so as to be slidable within the housing lumen 111 and the delivery cannula 106, such that the marker 104 may slide through the housing 102 and the delivery cannula 106 when pushed by the pusher rod 108. In embodiments, the marker 104 may be any suitable type marker such as to mark the biopsy site 204 within a body of a subject. For example, the marker 104 may be made of Nitinol, stainless steel, titanium, Inconel 625, or BioDur 108, or any other suitable material. The marker 104 may also be coated with various materials to help with visibility of the marker 104 within the body / tissue. In embodiments, the marker 104 may be coated with tantalum, tungsten, a combination thereof, or any other suitable material.

[0029] In the depicted embodiment, the marker 104 may include a hub 128 and a plurality of legs 118 extending from the hub 128. The hub 128 may provide a base structure from which the plurality of legs 118 extend. In some embodiments, the hub 128 may include a connector 120 which may allow for releasable engagement with the pusher rod 108 for example to allow for recapture and / or repositioning of the marker 104. For example, the connector 120 may be a hook, ring, threaded connector, magnet, or the like.

[0030] The plurality of legs 118 extend distally from the hub 128. In some embodiments, the plurality of legs 118 may curve radially outward, as depicted in FIG. 1. In embodiments, the plurality of legs 118 may be spring biased to expand radially outward, so as to curve into a pierce the tissue 202 as the marker 104 is ejected from the delivery cannula 106, as depicted in FIG. 5.The plurality of legs 118 may be on a proximal end or a distal end of the marker 104. The plurality of legs 118 may include any number of legs 118, such as two or more, three or more, four or more, etc. The plurality of legs 118 may be evenly spaced apart, such that the same amount of distance is between each of the plurality of legs 118, or the plurality of legs 118 may be unevenly spaced from one another. The plurality of legs 118 may further include hooks or may bend into hook shapes at a distal end of the plurality of legs 118 to further secure the marker 104 within the tissue 202. The plurality of legs 118 may include surface enhancements such as ridges to aid in securing the legs to the tissue 202. While the plurality of legs 118 may include sharp tips, in some embodiments the plurality of legs 118 may be rounded at the tip of each leg. The plurality of legs 118 may be made of Nitinol, stainless steel, titanium, Inconel 625, or BioDur 108, or any other suitable material. The hub 128 and the plurality of legs 118 may be made of the same or different material.

[0031] As noted above, the marker delivery assembly 100 may further include the pusher rod 108 configured to extend through the proximal end 101 of the housing 102 to engage the marker 104 along the delivery cannula 106. As such, the pusher rod 108 may be as long as or longer than a combination of a combined longitudinal length of the housing 102 and the delivery cannula 106, such that the pusher rod 108 may push the marker 104 through the housing 102 and out of the distal end 107 of the delivery cannula 106. The pusher rod 108 may be formed of any suitable material (plastic, metal, etc.) for pushing the marker 104 out of the delivery cannula 106. In embodiments the pusher rod 108 may be flexible, such that the pusher rod 108 conform or bend around bent parts (i.e., the distal end 107) of the delivery cannula 106.

[0032] In some embodiments, the pusher rod 108 may include a marker connector 109 for releasably connecting with the connector 120 of the marker 104. For example, the marker connector 109 may be any device which may releasably mate with the connector 120, such as a hook, loop, magnet, etc. The marker connector 109 may allow for positioning, twisting, or otherwise modifying an orientation of the marker 104. In some embodiments, the marker connector 109 may be used to recapture a marker 104 after placement into the tissue 202.

[0033] In embodiments, the marker delivery assembly 100 may further include the fluid inlet line 112 and / or the fluid outlet line 114 coupled to the housing 102 such as at the fluid inlet port 121 and / or the fluid outlet port 123. The fluid inlet line 112 may be fluidically coupled to a fluid reservoir, such as a syringe or other fluid container, which may contain, for example, saline, water, etc. In embodiments, a first pump 130 may be included to push fluid through the fluid inletline 112, into the housing 102, down the delivery cannula 106, and into the biopsy site 204. As such, the fluid inlet line 112 may provide irrigation or lubrication for the marker 104 to travel through the housing 102 and the delivery cannula 106. The fluid outlet line 114 may be fluidically coupled to a receptacle for receiving waste fluid. For example, the fluid outlet line 114 may be used for draining excess fluid such as provided via the fluid inlet line 112 or if bleeding at the biopsy site 204 occurs. For example, a syringe, a second pump 132, or similar device may be coupled to the fluid outlet line 114 for removal of excess fluid. In some embodiments, only a single port and line may be used as both an inlet line and an outlet line.

[0034] As noted above, the marker delivery assembly 100 may also include a valve, which may be coupled to the housing 102 proximal to the marker 104, distal to the marker 104, or both. For example, and as described above, there may be a first valve 110A proximal to the marker 104 and a second valve HOB distal to the marker 104. The first valve 110A may be adjacent to the proximal end 101 of the housing 102, while the second valve HOB may be adjacent to the distal end 103 of the housing 102. The marker 104 may be placed into the housing 102 through the proximal end 101 of the housing 102 or distal end 103 of the housing 102. As such, the marker 104 may pass through the first valve 110A or the second valve 110B. The first valve 110A may also allow the pusher rod 108 to advance through the first valve 110A and, thus, allow the pusher rod 108 to push the marker 104 through the housing 102 and the delivery cannula 106. Similarly, the second valve 110B may allow for the marker 104 and the pusher rod 108 to advance through the second valve 110B when the pusher rod 108 advances the marker 104 through the housing 102.

[0035] While the valves allow advancement of the marker 104 and the pusher rod 108, the valves 110A, 110B, when undisturbed, may assist in maintaining sterility of the marker 104 prior to delivery. In some embodiments, the valves 110A, 110B may inhibit fluid from exiting the housing 102 through the valves. That is, the valves may inhibit unwanted fluid leakage such as in a proximal direction out of the housing 102.

[0036] FIG. 1 depicts the marker delivery assembly 100 in an unassembled state, where the housing 102 is not coupled to the delivery cannula 106. FIG. 2 depicts the marker delivery assembly 100 in an assembled state where the housing 102 is coupled to the delivery cannula 106. The housing 102 may couple to the delivery cannula 106 in a variety of manners as noted above. For example, and as described above, the delivery cannula 106 and the housing 104 may couple to one another via a variety of means such as via a luer-type connection, press-fit connection, orthrough any number of couplers (e.g., fasteners, bolts, etc.). One advantage of a luer-type connection may be that the luer-type connection may provide a watertight / leak free / leak resistant seal between the housing 102 and the delivery cannula 106, such that no or little fluid escapes at the connection between the housing 102 and the delivery cannula.

[0037] By providing the marker delivery assembly 100 in an initially disassembled configuration as illustrated in FIG. 1, the housing 102 and the delivery cannula 106 may be packaged or arranged in a non-inline or linear configuration relative to one another, which may allow for smaller, more economical packaging, and / or smaller storage space requirements. Accordingly, the housing 102 and the delivery cannula 106 may be packaged on top of one another, at an angle to one another, etc. In some embodiments, the marker delivery assembly 100 in an initially disassembled configuration may also allow for the housing 102 and the delivery cannula 106 to be packaged separately. Separate packaging of the housing 102 and the delivery cannula 106 may permit an operator, user, or warehouse to store the marker delivery assembly 100 more efficiently. For example, the larger packages accommodating the housing 102 and the delivery cannula 106 in the assembled state may be difficult to store in a storage area. In contrast, when the housing 102 and the delivery cannula 106 are packaged separately in smaller packaging, or packaged together adjacent to one another, as opposed to longitudinally aligned with one another, the housing 102 and the delivery cannula 106 may be stored in separate areas or packed / arranged in various configurations in the operator storage area, allowing for more efficient and economic storage.

[0038] Referring again to FIG. 1 , the marker 104 may be positioned within the housing 102. The marker 104 may be prepositioned within the housing 102 such that a user does not have to insert the marker 104 into the housing 102 when conducting the marker delivery procedure. In other embodiments, the marker 104 may be packaged separately from the housing 102, such that the user may insert the marker 104 into the housing 102 through the proximal end 101 of the housing 102 and through the first valve 110A when the user is conducting the marker delivery procedure. In other embodiments, the marker 104 may be inserted into the housing 102 through the distal end 103 of the housing 102 and the second valve HOB; in such embodiments, the plurality of legs 118 may be more easily placed into the housing because the plurality of legs 118 would naturally curve outward when the marker 104 is placed into the housing 102 and the plurality of legs 118 are facing the distal end 103 of the housing 102.

[0039] As depicted in FIGS. 1-5, the marker 104 is pushed by the pusher rod 108 to translate the marker 104 toward the distal end 103 of the housing 102 and the distal end 107 of the delivery cannula 106 so that the marker 104 may be deployed in the biopsy site 204 of the tissue 202. The pusher rod 108 may be configured to be advanced through the first valve 110A and engage the marker 104 (FIG. 2); push the maker 104 through the second valve HOB, out of the housing 102, and into the delivery cannula 106 (FIG. 3); push the marker 104 to the distal end 107 of the delivery cannula 106 (FIG. 4); and push the marker 104 out of the delivery cannula 106 and into the tissue 202 of the biopsy site 204 (FIG. 5). In some embodiments, pusher rod 108 may also move the marker 104 in a proximal direction or otherwise reposition the marker 104, such as by interacting with the marker connector 109 with the connector 120 described above.

[0040] The connector 120 may also allow for the marker 104 to be moved within the tissue 202 once the marker 104 has exited the distal end 107 of the delivery cannula 106. In an exemplary embodiment, the user may mistakenly place the marker 104 at the wrong location within the tissue 202 (i.e., at a location that is not the biopsy site 204). In such a situation, the marker connector 109 of the pusher rod 108 may engage to the connector 120 of the marker 104 and the marker 104 may be pulled with the pusher rod 108. The marker 104 may be pulled to another location within the tissue 202. In some embodiments, the marker 104 may be pulled back into the distal end 107 of the delivery cannula 106. This may be helpful when the desired biopsy site 204 is a larger distance away from the location at which the marker 104 has already been deployed.

[0041] When the marker 104 is fully within the housing 102 or the delivery cannula 106, the plurality of legs 118 may curve outward and be in contact with the inner diameter of either the housing 102 or the delivery cannula 106. As the marker 104 is near the opening at the distal end 107 of the delivery cannula 106, as depicted in FIG. 4, the plurality of legs 118 may be configured to curve outward from the delivery cannula 106 as the marker 104 is deployed into the tissue 202, as depicted in FIG. 5. Once the plurality of legs 118 of marker 104 partially exit the delivery cannula 106, the entirety of the marker 104 may exit the delivery cannula 106 because the plurality of legs 118 may grip the tissue 202 and bend outward to advance the marker 104 out of the delivery cannula 106. In some embodiments, the pusher rod 108 may need to push the marker 104 out of the delivery cannula 106 if the forces generated by the plurality of legs 118 are not sufficient to pull the marker 104 out of the delivery cannula 106.

[0042] The biopsy site 204 may include an incision formed within the tissue 202, which may be formed via a biopsy device (e.g., such as via a BD EleVation™ device, EnCOR Ensprie™,or similar device). Depending on how the biopsy site 204 is positioned relative to the delivery cannula 106 it may be difficult to anchor the marker 104 at the biopsy site 204 to the tissue 202 with a traditional, straight delivery cannula. Accordingly, using a straight delivery cannula as opposed to a bent delivery cannula as described herein, may lead to unwanted movement of the marker 104 or inaccurate placement. As described herein, the distal end 107 of the delivery cannula 106 may be bent / curved, which may allow the marker 104 to be directed into the tissue 202 surrounding the biopsy site 204 to be better anchored.

[0043] FIG. 6 depicts a flowchart illustrating a method 600 of assembling the marker delivery assembly 100. In block 602, the method may include positioning the marker 104 within the housing 102. Block 604 may include coupling the delivery cannula 106 to the housing 102 distal to the marker 104. The method may also include positioning the pusher rod 108 within the housing 102 in block 606.

[0044] Referring to block 608 in FIG. 6, the method may further include coupling a first valve 110A to the proximal end 101 of the housing 102 such that the marker 104 is positioned within the housing 102 distal to the first valve 110A. In other embodiments, the method may include coupling the second valve 110B to the distal end 103 of the housing 102 such that the marker 104 is positioned within the housing 102 proximal to the second valve 110B in block 610. The method may also include coupling both the first valve 110A and the second valve 110B to the housing 102 at the proximal end 101 and the distal end 103 of the housing 102, respectively, such that the marker 104 is positioned between the first valve 110A and the second valve HOB. When the marker 104 is within the housing 102, the method 600 may also include coupling the pusher rod 108 to the marker 104 within the housing 102 at block 612.

[0045] Once assembled, the marker delivery assembly 100 may be used to deliver a marker as described above. For example, the delivery cannula 106 may be positioned at a biopsy site 204. The pusher rod 108 may then be advanced, such as through the first valve 110A into contact with the marker 104. In some embodiments, the pusher rod 108 may be releasably coupled to the marker 104 as described above. The pusher rod 108 may then be further advanced to slide the marker 104 out of the housing (such as through the second valve HOB), through the delivery cannula 106 and into the biopsy site 204. Once positioned as desired, the pusher rod 108 may be decoupled from the marker 104.

[0046] Embodiments can be further described with reference to the following numerical clauses:

[0047] 1. A marker delivery assembly including: a housing; a marker positioned within the housing; a delivery cannula coupled to the housing distal to the marker; and a pusher rod configured to extend through a proximal end of the housing to engage the marker and push the marker along the delivery cannula.

[0048] 2. The marker delivery assembly according to the previous clause, further including a valve coupled to the housing distal to the marker.

[0049] 3. The marker delivery assembly according to clause 2, wherein the valve is a hemostasis valve.

[0050] 4. The marker delivery assembly according to any of the preceding clauses, further including a fluid inlet line coupled to the housing and configured to be fluidically coupled to the delivery cannula via the housing.

[0051] 5. The marker delivery assembly according to any of the preceding clauses, wherein the marker includes a plurality of legs configured to curve outward from the delivery cannula as the marker is deployed.

[0052] 6. The marker delivery assembly according to any of the preceding clauses, wherein the marker includes a hook.

[0053] 7. The marker delivery assembly according to clause 6, wherein the pusher rod is configured to releasably engage the hook.

[0054] 8. A marker delivery assembly including: a housing including a proximal end and a distal end; a first valve positioned adjacent the proximal end; a second valve positioned adjacent the distal end; a marker positioned within the housing between the first valve and the second valve; a delivery cannula coupled to the housing distal to the marker; and a pusher rod configured to extend through the proximal end of the housing to engage the marker and push the marker along the delivery cannula.

[0055] 9. The marker delivery assembly according to the previous clause, wherein the first valve or the second valve is a hemostasis valve.

[0056] 10. The marker delivery assembly according to either of clauses 8 or 9, further including a fluid inlet line coupled to the housing and configured to be fluidically coupled to the delivery cannula via the housing.

[0057] 11. The marker delivery assembly according to any of clauses 8-10, wherein the marker includes a plurality of legs configured to curve outward from the delivery cannula as the marker is deployed.

[0058] 12. The marker delivery assembly according to any of clauses 8-11, wherein the marker includes a hook.

[0059] 13. The marker delivery assembly according to clause 12, wherein the pusher rod is configured to releasably engage the hook.

[0060] 14. A method of assembling a maker delivery assembly, the method including: positioning a marker within a housing; coupling a delivery cannula to the housing distal to the marker; and providing a pusher rod, wherein the pusher rod is configured to engage the marker to push the marker distally through the delivery cannula from the housing.

[0061] 15. The method according to claim 14, further including coupling a valve to a distal end of the housing such that the marker is positioned within the housing proximal to the valve.

[0062] 16. The method according to either of clauses 14 or 15, further including: coupling a first valve to a proximal end of the housing; and coupling a second valve to a distal end of the housing, wherein the marker is positioned between the first valve and the second valve.

[0063] 17. The method according to any of clauses 14-16, wherein coupling the delivery cannula to the housing includes coupling the delivery cannula to the housing via a luer lock.

[0064] 18. The method according to any of clauses 14-17, wherein the delivery cannula includes a bent distal end.

[0065] 19. The method according to any of clauses 14-18, further including coupling a fluid inlet line to the housing such that the fluid inlet line is fluidically coupled to the delivery cannula when the delivery cannula is assembled to the housing.

[0066] 20. The method according to any of clauses 14-19, further including coupling the pusher rod to the marker within the housing.

[0067] It should now be understood that embodiments of the present disclosure are directed to devices and methods for biopsy procedures / marker delivery procedure. In embodiments, a marker delivery assembly may be utilized to position a marker at a biopsy site once the biopsy has been completed. More specifically, a marker delivery assembly includes a housing and a delivery cannula separate from the housing that may be coupled to the housing, resulting in ease of packaging and reduced storage needs of the assembly. For example, in some embodiments, a marker delivery includes a housing, a marker positioned within the housing, and a delivery cannula coupled to the housing distal to the marker. The marker delivery assembly also includes a pusher rod configured to extend through a proximal end of the housing to engage the marker and push the marker along the delivery cannula. Once the marker has been pushed to a distal end of the delivery cannula, the marker exits the distal end of the delivery cannula and is positioned at a biopsy site within tissue.

[0068] It is noted that the terms "substantially" and "about" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0069] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMS1. A marker delivery assembly comprising: a housing; a marker positioned within the housing; a delivery cannula coupled to the housing distal to the marker; and a pusher rod configured to extend through a proximal end of the housing to engage the marker and push the marker along the delivery cannula.

2. The marker delivery assembly of claim 1, further comprising a valve coupled to the housing distal to the marker.

3. The marker delivery assembly of claim 2, wherein the valve is a hemostasis valve.

4. The marker delivery assembly of claim 1, further comprising a fluid inlet line coupled to the housing and configured to be fluidically coupled to the delivery cannula via the housing.

5. The marker delivery assembly of claim 1 , wherein the marker comprises a plurality of legs configured to curve outward from the delivery cannula as the marker is deployed.

6. The marker delivery assembly of claim 1, wherein the marker comprises a hook.

7. The marker delivery assembly of claim 6, wherein the pusher rod is configured to releasably engage the hook.

8. A marker delivery assembly comprising: a housing comprising a proximal end and a distal end; a first valve positioned adjacent the proximal end; a second valve positioned adjacent the distal end; a marker positioned within the housing between the first valve and the second valve; a delivery cannula coupled to the housing distal to the marker; and a pusher rod configured to extend through the proximal end of the housing to engage the marker and push the marker along the delivery cannula.

9. The marker delivery assembly of claim 8, wherein the first valve or the second valve is a hemostasis valve.

10. The marker delivery assembly of claim 8, further comprising a fluid inlet line coupled to the housing and configured to be fluidically coupled to the delivery cannula via the housing.

11. The marker delivery assembly of claim 8, wherein the marker comprises a plurality of legs configured to curve outward from the delivery cannula as the marker is deployed.

12. The marker delivery assembly of claim 8, wherein the marker comprises a hook.

13. The marker delivery assembly of claim 12, wherein the pusher rod is configured to releasably engage the hook.

14. A method of assembling a marker delivery assembly, the method comprising:positioning a marker within a housing; coupling a delivery cannula to the housing distal to the marker; and providing a pusher rod, wherein the pusher rod is configured to engage the marker to push the marker distally through the delivery cannula from the housing.

15. The method of claim 14, further comprising coupling a valve to a distal end of the housing such that the marker is positioned within the housing proximal to the valve.

16. The method of claim 14, further comprising: coupling a first valve to a proximal end of the housing; and coupling a second valve to a distal end of the housing, wherein the marker is positioned between the first valve and the second valve.

17. The method of claim 14, wherein coupling the delivery cannula to the housing comprises coupling the delivery cannula to the housing via a luer lock.

18. The method of claim 14, wherein the delivery cannula comprises a bent distal end.

19. The method of claim 14, further comprising coupling a fluid inlet line to the housing such that the fluid inlet line is fluidically coupled to the delivery cannula when the delivery cannula is assembled to the housing.

20. The method of claim 14, further comprising coupling the pusher rod to the marker within the housing.

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