SPRING-EJECTED BIOPSY MARKER

Abstract

A device for inserting a marker into tissue at a biopsy site including an elongate shaft that moves conjointly with a plunger, and a spring secured to the distal end of the shaft. The device may comprise a cannula configured to receive a distal end of the shaft, and with a crimp, dimples, or other features formed near the shaft's distal end. The cannula may comprise a lateral aperture where a marker may be ejected from the lumen thereof. A ramp portion may be formed in communication with the lateral aperture, and the ramp portion may comprise a preselected slope that controls the angle at which the marker is ejected.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. patent application Ser No. 14/534,952, entitled “SPRING-EJECTED BIOPSY MARKER,” filed on Nov. 6, 2014, and U.S. Provisional Patent Application No. 62/134,715, entitled “Biopsy Marker Delivery Device,” filed on Mar. 18, 2015, both of which are expressly incorporated by reference herein in their entirety.

TECHNICAL FIELD

This invention relates, generally, to devices that insert biopsy markers at biopsy sites. More particularly, it relates to a device that employs a spring to eject a marker into tissue from a lateral aperture of the device.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in various medical procedures using a variety of devices. Biopsy devices may be used under stereotactic guidance, ultrasound guidance, Magnetic Resonance Imaging (MRI) guidance, Positron Emission Mammography (PEM) guidance, Breast Specific Gamma Imaging (BSGI) guidance, or otherwise. For instance, some biopsy devices may be fully operable by a user using a single hand, and with a single insertion, to capture one or more biopsy samples from a patient. In addition, some biopsy devices may be tethered to a vacuum module and/or control module, such as for communication of fluids (e.g., pressurized air, saline, atmospheric air, vacuum), for communication of power, and/or for communication of commands and the like. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected with another device.

Merely example biopsy devices and biopsy system components are disclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No. 5,928,164, entitled “Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued Jul. 27, 1999; U.S. Pat. No. 6,017,316, entitled “Vacuum Control System and Method for Automated Biopsy Device,” issued Jan. 25, 2000; U.S. Pat. No. 6,086,544, entitled “Control Apparatus for an Automated Surgical Biopsy Device,” issued Jul. 11, 2000; U.S. Pat. No. 6,626,849, entitled “MRI Compatible Surgical Biopsy Device,” issued Sep. 11, 2003; U.S. Pat. No. 7,442,171, entitled “Remote Thumbwheel for a Surgical Biopsy Device,” issued Oct. 8, 2008; U.S. Pat. No. 7,648,466, entitled “Manually Rotatable Piercer,” issued Jan. 19, 2010; U.S. Pat. No. 7,854,706, entitled “Clutch and Valving System for Tetherless Biopsy Device,” issued Dec. 1, 2010; U.S. Pat. No. 7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device,” issued May 10, 2011; U.S. Pat. No. 8,118,755, entitled “Biopsy Sample Storage,” issued Feb. 21, 2012; U.S. Pat. No. 8,206,316, entitled “Tetherless Biopsy Device with Reusable Portion,” issued Jun. 26, 2012; U.S. Pat. No. 8,241,226, entitled “Biopsy Device with Rotatable Tissue Sample Holder,” issued Aug. 14, 2011; , and U.S. Pat. No. 8,702,623, entitled “Biopsy Device with Discrete Tissue Chambers,” issued Apr. 22, 2014. The disclosure of each of the above-cited U.S. Patents is incorporated by reference herein.

Additional example biopsy devices and biopsy system components are disclosed in U.S. Pat. Pub. No. 2008/0146962, entitled “Biopsy System with Vacuum Control Module,” published Jun. 19, 2008; U.S. Pat. Pub. No. 2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,” published Sep. 4, 2008; U.S. Pub. No. 2013/0041256, entitled “Access Chamber and Markers for Biopsy Device,” published Feb. 14, 2013; U.S. Pub. No. 2013/0053724, entitled “Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber,” published Feb. 28, 2013; U.S. Pub. No. 2013/0150751, entitled “Biopsy Device with Slide-In Probe,” published Jun. 13, 2013; U.S. Pub. No. 2013/0324882, entitled “Control for Biopsy Device,” published Dec. 5, 2013; and U.S. Pub. No. 2014/0039343, entitled “Biopsy System,” published Feb. 6, 2014. The disclosure of each of the above-cited U.S. Patent Application Publications is incorporated by reference herein.

In some settings, it may be desirable to mark the location of a biopsy site for future reference. For instance, one or more markers may be deposited at a biopsy site before, during, or after a tissue sample is taken from the biopsy site. Example marker deployment tools include the MAMMOMARK™, MICROMARK®, and CORMARK™ brand devices from Devicor Medical Products, Inc. of Cincinnati, Ohio. Further example devices and methods for marking a biopsy site are disclosed in U.S. Pub. No. 2009/0209854, entitled “Biopsy Method,” published Aug. 20, 2009; U.S. Pub. No. 2009/0270725, entitled “Devices Useful in Imaging,” published Oct. 29, 2009; U.S. Pub. No. 2010/0049084, entitled “Biopsy Marker Delivery Device,” published Feb. 25, 2010; U.S. Pub. No. 2011/0071423, entitled “Flexible Biopsy Marker Delivery Device,” published Mar. 24, 2011; U.S. Pub. No. 2011/0071424, entitled “Biopsy Marker Delivery Device,” published Mar. 24, 2011; U.S. Pub. No. 2011/0071391, entitled “Biopsy Marker Delivery Device with Positioning Component,” published Mar. 24, 2011; U.S. Pat. No. 6,228,055, entitled “Devices for Marking and Defining Particular Locations in Body Tissue,” issued May 8, 2001; U.S. Pat. No. 6,371,904, entitled “Subcutaneous Cavity Marking Device and Method,” issued Apr. 16, 2002; U.S. Pat. No. 6,993,375, entitled “Tissue Site Markers for In Vivo Imaging,” issued Jan. 31, 2006; U.S. Pat. No. 6,996,433, entitled “Imageable Biopsy Site Marker,” issued Feb. 7, 2006; U.S. Pat. No. 7,044,957, entitled “Devices for Defining and Marking Tissue,” issued May 16, 2006; U.S. Pat. No. 7,047,063, entitled “Tissue Site Markers for In Vivo Imaging,” issued May 16, 2006; U.S. Pat. No. 7,229,417, entitled “Methods for Marking a Biopsy Site,” issued Jun. 12, 2007; and U.S. Pat. No. 7,465,279, entitled “Marker Device and Method of Deploying a Cavity Marker Using a Surgical Biopsy Device,” issued Dec. 16, 2008. The disclosure of each of the above-cited U.S. Patents and U.S. Patent Application Publications is incorporated by reference herein.

SUMMARY OF THE INVENTION

Aspects of the present invention relate to devices and systems, as well as methods of making and using the same, that comprise a push rod, such as a plunger and/or a shaft, a tube or other cannula, a ramp portion, a lateral aperture, and a spring extending over at least a portion of the shaft. According to some aspects of the present invention, the device may be configured to eject a marker with the same amount of force each time it is used. In some aspects, the present device may operate independently of any force applied by a user and ensures a uniform, repeatable placement of the marker.

Additional advantages and novel features of these aspects will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or upon learning by practice of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of an example marker delivery device, in accordance with aspects of the present invention.

FIG. 2 depicts a cross-sectional view of the distal end of the marker delivery device of FIG. 1, with the cross-section taken along line 2-2 of FIG. 1.

FIG. 3A depicts a side elevational view of the distal end of a shaft of the marker delivery device of FIG. 1.

FIG. 3B depicts a partial cross-sectional view of the distal end of the marker delivery device of FIG. 1, with the shaft and spring in an initial proximal position.

FIG. 3C depicts a partial cross-sectional view of the distal end of the marker delivery device of FIG. 1, with the shaft and spring partially advanced distally.

FIG. 3D depicts a partial cross-sectional view of the distal end of the marker delivery device of FIG. 1, with the shaft and spring fully advanced distally.

FIG. 4 depicts a cross-sectional view of a cannula of the marker delivery device of FIG. 1, with the cross-section taken along line 4-4 of FIG. 2.

FIG. 5 depicts a perspective view of an example marker for use with the marker delivery device of FIG. 1.

FIG. 6. depicts a perspective view of another example marker for use with the marker delivery device of FIG. 1.

FIG. 7 depicts a perspective view of yet another example marker for use with the marker delivery device of FIG. 1.

FIG. 8 depicts a perspective view of an example alternative cannula for use with the marker delivery device of FIG. 1.

FIG. 9 depicts a cross-sectional view of the cannula of FIG. 8, with the cross-section taken along line 9-9 of FIG. 8.

FIG. 10 depicts a perspective view of an example alternative marker delivery device, in accordance with aspects of the present invention.

FIG. 11A depicts a side elevational view of the marker delivery device of FIG. 9, with a plunger in an unactuated position.

FIG. 11B depicts another side elevational view of the marker delivery device of FIG. 9, with the plunger in a partially actuated position.

FIG. 11C depicts yet another side elevational view of the marker delivery device of FIG. 9, with the plunger in a fully actuated position.

FIG. 12 depicts a perspective view of another example alternative marker delivery device, in accordance with aspects of the present invention.

FIG. 13 depicts a cross-sectional view of the marker delivery device of FIG. 12, with the cross-section taken along line 13-13 of FIG. 12.

FIG. 14 depicts an end view of a cannula of the marker delivery device of FIG. 12.

FIG. 15 depicts a perspective view of another example alternative cannula for use with the marker delivery device of FIG. 1.

FIG. 16 depicts a cross-sectional view of the cannula of FIG. 15, with the cross-section taken along line 16-16 of FIG. 15.

FIG. 17A depicts a side elevation view of one various features of an example device with a broken-away part to indicate that the length of the structure may be any preselected length, in accordance with aspects of the present invention.

FIG. 17B depicts a longitudinal sectional view taken along line 1B-1B in FIG. 17A.

FIG. 17C depicts an enlarged view of the distal end of the structure depicted in FIG. 17B.

FIG. 17D depicts an alternative aspect where dimples replace the annular crimp of FIG. 1A.

FIG. 18A diagrammatically depicts an aspect of the present device in side elevation.

FIG. 18B depicts a longitudinal, side elevation sectional view of the structure depicted in FIG. 18A.

FIG. 18C depicts a longitudinal, top plan sectional view of the structure depicted in FIG. 18A.

FIG. 19 depicts a side elevation view of various features of an example device, in accordance with aspects of the present invention.

DETAILED DESCRIPTION

The following description of certain examples of various aspect of the present invention should not be used to limit the scope hereof. Other examples, features, aspects, variations, and advantages of the technology 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 technology. As will be realized, aspects of the invention are capable of other different and obvious implementations, all without departing from the scope hereof. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

FIGS. 1-4 show a marker delivery device (10) that may be used with a biopsy device or targeting set to deliver a marker to a biopsy site. Marker delivery device (10) comprises a body (20) and a cannula (40). As shown in FIG. 1, body (20) comprises an elongate housing (22), a grip (24), a resilient member (26), and a plunger (28). Housing (22) couples body (20) to cannula (40). Additionally, housing (22) may enclose other operational components of marker deliver device (10), such as seals, springs, bushings, or other operational components that may be apparent to those of ordinary skill in the art in view of the teachings herein.

Grip (24) is positioned at the proximal end of housing (22) and is configured to be grasped by fingers of a user, for example. As will be described in greater detail below, grip (24) is generally configured to permit marker delivery device (10) to be operated with a single hand of a user. Grip (24) of the present example is of integral construction with housing (22). Although in other examples, grip (24) may be alternatively separate from housing (22).

Resilient member (26) is disposed between grip (24) and plunger (28). In particular, resilient member (26) of the present example comprises a leaf spring having two openings (27) in either end of resilient member (26). Openings (27) are configured to slidably receive a shaft (30). As will be described in greater detail below, shaft (30) is slidable relative to body (10) to selectively eject a marker (60) from marker delivery device (10). Although resilient member (26) is shown as a leaf spring, it should be understood that in other examples any other suitable resilient device may be used such as a coil spring.

Plunger (28) is positioned at the proximal end of shaft (30). Generally, plunger (28) is configured to be pushed by a user to actuate shaft (30) distally relative to body (20) and cannula (40). Additionally, as shown, plunger (28) abuts resilient member (26), such that resilient member (26) may return shaft (30) to the proximal position shown in FIG. 1 after a user has actuated marker delivery device via plunger (28). As will be described in greater detail below, plunger (28) and grip (24) are together configured such that a user may grasp grip (24) with two fingers (e.g., index finger and middle finger) and push plunger (28) with another finger (e.g., thumb), for example. It should be understood that, although not shown, plunger (28) may be equipped with a plunger lock or other locking feature to permit a user to ratchet or lock plunger (28) at a given position (e.g., to lock plunger (28) at a proximal position and/or to lock plunger (28) at a distal position, etc.). Suitable locking features may include a resilient latching arm, a bayonet latching feature, a threaded feature, etc.

Cannula (40) is comprised of an elongate tubular shaft extending distally from housing (22). Generally, cannula (40) extends distally for a length suitable for insertion into a biopsy device or targeting set such that cannula (40) may extend to a biopsy site to deliver marker (60). In the present example, the distal end of cannula (40) includes a lateral aperture (42) and a distal tip (44). As shown in FIG. 1, lateral aperture (42) is positioned proximally of the distal end of cannula (40). As will be understood, the particular position of lateral aperture (42) relative to the distal end of cannula (40) is configured such that lateral aperture (42) may align with a corresponding lateral aperture of a needle of a biopsy device.

As best seen in FIG. 2, distal tip (44) is inserted into the distal end of cannula (40) and extends longitudinally into at least a portion of lateral aperture (42). The proximal end of distal tip (44) includes a ramp portion (46). As will be described in greater detail below, ramp portion (46) is configured to direct marker (60) from a cannula lumen (48) that extends longitudinally through cannula (40) and is in communication with lateral aperture (42).

Cannula lumen (48) extends from the proximal end of cannula (40) to the distal end of cannula (40). Although not shown in FIG. 2, it should be understood that in some examples cannula lumen (48) may extend into housing (22), such that shaft (30) of body (20) may be in communication with lumen. In particular, as can be seen in FIG. 2, shaft (30) extends thorough body (20) and into cannula (40) before terminating near the distal end of cannula (40). As will be described in greater detail below, shaft (30) is slidably disposed within cannula lumen (48) to engage marker (60) thereby driving marker (60) up ramp portion (46) and out of lateral aperture (42). In some aspects, the slope of the ramp portion (46) may control the angle at which marker (60) is ejected from the lumen of cannula (48).

Although shaft (30) of the present example is shown as being disposed coaxially within cannula lumen (48), in other examples shaft (30) may terminate within body (20) and a separate member, shaft, or rod may extend into cannula lumen (48).

According to some aspects of the present invention, as shown in FIG. 17A, the device may comprise a plunger (172) having an enlarged proximal end (171), which may serve as a handle for a user, for example. As shown in FIG. 17B, proximal end (173a) of elongate shaft (16) may be received within bore (172a) formed with plunger (172) and may be secured thereto so that the shaft (173) moves conjointly with plunger (172).

In this aspect, an elongate cannula (174) may slidingly receive the distal end of shaft (173). As shown in FIG. 17C, according to some aspects, an annular crimp (174a) may be formed in cannula (174) near its distal end. According to some aspects, the cannula (174) may comprise a lateral aperture (174b) where a marker (176) is ejected from the lumen of cannula (174).

As can be seen in FIG. 3A, the distal end of shaft (30) of the present example includes a spring (90) extending over at least a portion of the distal end of shaft (30). In particular, spring (90) of this example comprises a multi-pitch coil spring that is coaxial with at least a portion of shaft (30), which is configured to generate a force of between 1.9 and 2.4 lbs of force per 1/10 inch of compression, for example. In the present example, spring (90) is comprised of biocompatible stainless steel, although any other suitable biocompatible material may be used. Spring (90) comprises a first pitch region (92), a second pitch region (94), and a third pitch region (96). First pitch region (92) and third pitch region (96) comprise a pitch that is substantially the same. It should be understood that the term “pitch” used herein refers generally to the spacing between each coil of spring (90). For instance, the pitch of first pitch region and third pitch region (96) may be relatively small relative to the pitch of second pitch region (94). The term “pitch” may also be understood to relate to the particular number of coils per a unit of axial distance (e.g., coils per inch).

The spacing between each coil of spring (90) in first pitch region (92) and third pitch region (96) of the present example may be relatively small or approximately zero, such that each coil of first pitch region (92) and third pitch region (96) is touching or nearly touching. As will be described in greater detail below, such a pitch may result in very little compression of first pitch region (92) and third pitch region (96) when spring (90) is being compressed. However, the spacing between each coil of spring (90) in second pitch region (94) may be relatively large in comparison to the spacing between each coil of spring (90) in first pitch region (92) and third pitch region (96). Accordingly, second pitch region (94) may compress much more relative to first pitch region (92) and third pitch region (96) when spring (90) is compressed. Although pitch regions (92, 94, 96) are shown as having particular pitches, it should be understood that each pitch region may have any other suitable pitch as will be apparent to those of ordinary skill in the art in view of the teachings herein.

First pitch region (92) and third pitch region (96) of the present example each comprise 24 to 25 coils, although first pitch region (92) and third pitch region (96) may contain any suitable number of coils. Although first pitch region (92) and third pitch region (96) are configured to undergo little compression relative to second pitch region (94) when spring (90) is compressed, it should be understood that first pitch region (92) and third pitch region (96) may still be configured to flex laterally, such that shaft (30) may still exhibit some lateral movement within cannula (40) while maintaining contact with marker (60) via spring (90). It should also be understood from the foregoing that, due to the difference between the pitch of second pitch region (94) and the pitch of first and second pitch regions (92, 96), for example, second pitch region (94) may compress first (and to a greater extend) than first and second pitch regions (92, 96) when spring (90) encounters a longitudinally compressive load, such as during actuation of plunger (28).

According to some aspects of the present invention, as shown in FIG. 17B and 170, spring (20) may be secured to the distal end of shaft (174). According to some aspects, the spring may comprise only two pitch regions (175b and 175c). I n some aspects, the coils may be tightly packed relative to one another at the distal end of the spring in pitch region (175c). According to some aspects, the proximal pitch region (175b) may comprise loosely packed coils. It should be appreciated that the spring with two pitch regions may function similarly to the spring with three pitch regions, as will be described in more detail below.

Turning back to FIG. 3A, as will be described in greater detail below, spring (90) may be generally fixedly secured to shaft (30), such that spring (90) first contacts marker (60) and then compresses as shaft (30) is advanced such that shaft (30) may eventually contact marker (60). In the present example, spring (90) is shown as being fixedly secured to shaft (30) at a point proximal to the distal end of shaft (30), such that only a portion of first pitch region (92) extends distally from the distal end of shaft (30). Of course, in other examples any suitable portion of spring (90) may extend from the distal end of shaft (30). Spring (90) of the present example may be fixedly secured to shaft (30) by laser welding, for example. In other examples, shaft (30) may simply include an annular protrusion or a plurality of protrusions that may prevent spring (90) from sliding proximally along shaft (30). In yet other examples, shaft (30) may include an annular protrusion or plurality of protrusions that may be configured to secure spring (90) via a press or interference fit. In yet other examples, other suitable features or methods of securing spring (90) to shaft (30) may be used, such as by screws, pins, or adhesives, as will be apparent to those of ordinary skill in the art in view of the teachings herein.

As shown in FIG. 17B, the device may comprise an annular detent (175a) weld formed integrally with shaft (173) and secures the proximal end of the spring to said shaft (173) so that said spring does not slide with respect to said shaft.

As shown in FIG. 3A, marker (60) of the present example comprises a biodegradable or otherwise resorbable body (62). Resorbable body (62) may be of a generally cylindrically shape and may be comprised of collagen, hydrogel, and/or any other suitable material(s). Resorbable body (62) may include a metallic (e.g., titanium), generally radiopaque marker element (64) (shown in phantom) disposed within or otherwise carried by resorbable body (62). The marker element (64) of the present example is shaped as a coil spring, although it should be understood that marker element (64) may have any other shape suitable for enhancing radiographic visability. It should also be understood that metal is just one merely illustrative example of a kind of material that may be used to form marker element (64). Various other suitable materials that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

In some instances it may be desirable to equip marker delivery device (10) with certain marker (60) retaining features to selectively secure marker (60) within cannula (40). For instance, cannula (40) of the present example includes two retaining dimples (50) disposed within cannula lumen (48) proximally of lateral aperture (42). As can best be seen in FIG. 4, dimples (50) may be disposed near the bottom of cannula (40) away from lateral aperture (42). Dimples (50) may be hemispherical in shape and protrude inwardly within cannula lumen (48), for example. Accordingly, dimples (50) may be configured to engage at least a portion of marker (60) to retain marker (60) within cannula lumen (48). However, because resorbable body (62) is comprised of collagen, hydrogel, and/or other deformable material(s), marker (60) may exhibit relatively elastic properties, such that marker (60) may be selectively forced past dimples (50) by shaft (30). Alternatively, marker (60) may be undersized relative to the inner diameter of cannula (40), such that marker (60) may be pushed upwardly and over dimples (50) when shaft (30) pushes marker (60). Although cannula (40) is shown as comprising two dimples (50), it should be understood that in other examples cannula (40) may comprise any other suitable number of dimples (50).

As shown in FIG. 17D, two circumferentially spaced apart dimples (174d) may be formed in cannula (174). Defining the top of cannula (174) as shown in FIG. 17D as being the zero degree)(0° position, a first dimple may be positioned approximately at the one hundred thirty five degree)(135° position and the second dimple may be positioned approximately at the two hundred twenty five degree)(225° position. According to some aspects, an annular crimp (174a) may be formed by a large number of closely spaced dimples. However, the preferred number of equidistantly, circumferentially spaced apart dimples may be as few as two, as depicted, to as many as eight or more. According to some aspects, if eight dimples are selected, for example, there may be one dimple at the zero degree)(0° position and one dimple every forty five degrees)(45° thereafter about the circumference of cannula (174).

Additionally or alternatively, dimples (50) may comprise other shapes besides a hemispherical shape. For instance, dimples (50) may be pyramidal, cubic, rhombic, or any other suitable shape as will be apparent to those of ordinary skill in the art in view of the teachings herein. As another merely illustrative example, an annular protrusion or crimp may extend inwardly in lumen (48), as a substitute for dimples (50). In yet another merely illustrative example, a relatively flexible flap or tab of integral construction with cannula (40) may extend inwardly in lumen (48), as yet another substitute for dimples (50).

According to some aspects, as shown in FIG. 18A-C, cannula (174) may comprise a flap (177), which is hidden from view in the side elevation view of FIG. 18A, and is visible in the longitudinal, side elevation sectional view of FIG. 18B and the longitudinal, top plan sectional view of FIG. 18C. According to some aspects, flap (177) and cannula (174) may be formed integrally with one another, and said flap may provide a detent, for example, that resists proximal-to-distal displacement of marker (176) by the shaft, e.g., flap (177) may perform a similar function as an annular crimp or dimples described herein. According to some aspects, this flap (177) may be employed when marker (176) is formed of a material that is not flexible and resilient, for example.

As shown in FIG. 19, according to some aspects, a protuberance or bulge (26) may be formed in the lumen of cannula (174), said bulge performing a similar function as flap (177). For example, both bulge (178) and flap (177) may be configured to flatten as a rigid marker (176) is pushed over these features.

FIGS. 3B-3D show an example use of marker delivery device (10). As can be seen in FIG. 3B, marker (60) is initially disposed inside cannula lumen (42) proximal to dimples (50). A user may then insert cannula (40) into a biopsy device or targeting set to deliver marker (60) at a biopsy site, with the biopsy device or targeting set already being positioned in tissue at the biopsy site. Cannula (40) may be positioned such that lateral aperture (42) is angularly and longitudinally aligned with a complementary lateral aperture of the needle or cannula of the biopsy device or targeting set. Once cannula (40) has been inserted into a biopsy device or targeting set and has been properly positioned therein, a user may initiate deployment by grasping grip (24) and pressing plunger (28) with a single hand or, alternatively, multiple hands, for example.

As plunger (28) is pressed distally, shaft (30) may be advanced distally relative to cannula (40) and body (20), as shown by the progression between FIGS. 3B and 3C. As the distal end of shaft (30) approaches marker (60), spring (90) may initially contact marker (60). As shown in FIGS. 3B and 3C, such contact may compress spring (90) as shaft (30) is advanced further, thereby storing potential energy within spring (90).

Additional advancement of shaft (30) may eventually lead to direct contact between marker (60) and the distal end of shaft (30). As can be seen in FIG. 3C, the distal end of shaft (30) may be generally aligned with the distal end of spring (90) at this stage. Once such direct contact is initiated, shaft (30) will begin to push marker (60) distally within cannula (40), thereby advancing marker (60) distally past and/or over dimples (50) and out of lateral aperture (42). Once marker (60) is distal of dimples (50), spring (90) may begin to expand via the potential energy generated during compression of spring (90). Such expansion of spring (90) may finally advance marker (60) laterally up ramp portion (46) of distal tip (44), out through lateral aperture (42) and into the biopsy site, as can be seen in FIG. 3D. It should be understood that first pitch region (92) may flex over dimples (50), extending past dimples (50). Thus, for example, the configuration of spring (90) may allow spring (90) to laterally deflect within lumen (48) in order for spring (90) to advance beyond dimples (50) without requiring any lateral deflection of shaft (30) within lumen. The coils forming first pitch region (92) may simply slide relative to each other in order to pass over dimples (50). In variations where dimples are arranged along a greater angular extent within lumen (48) (e.g., as in cannula (640) described below)), spring (90) may still deform to pass distally beyond dimples (50). For instance, the coils forming first pitch region (92) may slide relative to each other and tilt obliquely relative to the longitudinal axis of lumen (48) in order to reduce the effective outer diameter of spring (90), thereby allowing spring (90) to pass through the space defined between the dimples.

FIG. 5 shows an example alternative marker (160) that may be used in addition to or in lieu of marker (60) as described above. Marker (160) of the present example is substantially similar to marker (60). For instance, like with marker (60), marker (160) may comprise biodegradable or otherwise resorbable body (162). Resorbable body (162) may be of a generally cylindrical shape and may be comprised of collagen, hydrogel, and/or any other suitable material(s). Like resorbable body (62) described above, resorbable body (162) may include a metallic, generally radiopaque marker element (164) disposed within or otherwise carried by resorbable body (162). However, unlike marker element (64), marker element (164) of the present example may comprise a disc shaped central member (166) (shown in phantom) with three elongate protrusions (168) protruding radially outwardly from central member (166) and out of resorbable body (162). It should also be understood that metal is just one merely illustrative example of a kind of material that may be used to form marker element (164). Various other suitable materials that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

In some examples, elongate protrusions (168) may protrude radially outwardly from central member (166) to provide friction against the interior of cannula (40). Thus, for example, elongate protrusions (168) may be configured to contact the interior of cannula (40). Such a configuration may be used in conjunction with, or in lieu of, dimples (50), for example, to maintain marker (160) within cannula (40) to thereby prevent marker (160) from inadvertently falling out of cannula (40). Additionally, elongate protrusions (168) may engage tissue at the biopsy site to secure marker (160) at the biopsy site, thereby preventing marker (160) migration.

FIG. 6 shows another example alternative marker (260) that may be used in addition to or in lieu of marker (60) as described above. Marker (260) of the present example may be substantially similar to marker (60). For instance, like with marker (60), marker (260) may comprise biodegradable or otherwise resorbable body (262). However, unlike resorbable body (62), resorbable body (262) may comprise a hybrid of at least two materials. For instance, resorbable body (262) of the present example may comprise a generally cylindrically shaped collagen middle portion (261), two hydrogel intermediate portions (263), and two collagen end portions (265). Like resorbable body (62) described above, resorbable body (262) may include a metallic, generally radiopaque marker element (264) (shown in phantom) disposed within or otherwise carried by resorbable body (262). However, unlike marker element (64), marker element (264) of the present example may generally be rectangular with a central twist (266) so as to be configured to enhance the radiographic visibility of marker element (264). It should also be understood that metal is just one merely illustrative example of a kind of material that may be used to form marker element (264). Various other suitable materials that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

FIG. 7 shows yet another example alternative marker (360) that may be used in addition to or in lieu of marker (60) as described above. Marker (360) of the present example may be substantially similar to marker (60). For instance, like with marker (60), marker (360) may comprise biodegradable or otherwise resorbable body (362). However, unlike resorbable body (62), resorbable body (362) may comprise a hybrid of at least two materials. For instance, resorbable body (362) of the present example may comprise a generally cylindrically shaped collagen outer shell (361) with a hydrogel inner core (363). Like resorbable body (62) described above, resorbable body (362) may include a metallic, generally radiopaque marker element (364) (shown in phantom) disposed within or otherwise carried by resorbable body (362). However, unlike marker element (64), marker element (364) of the present example may be generally rectangular with a central twist (366) so as to be configured to enhance the radiographic visibility of marker element (364). It should also be understood that metal is just one merely illustrative example of a kind of material that may be used to form marker element (364). Various other suitable materials that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

FIGS. 8 and 9 show an example alternative cannula (440) that may be incorporated into biopsy marker device (10) described above. Cannula (440) of the present example may be substantially similar to cannula (40) described above, except as otherwise noted herein. For instance, cannula (440) comprises an elongate tubular shaft (441), which includes a lateral aperture (442) proximal of a distal tip (444) and a cannula lumen (448) extending through cannula (440). However, unlike cannula (40), cannula (440) may include a metal sheath (452) disposed over at least a portion of the distal tip of cannula (440). It should also be understood that metal is just one merely illustrative example of a kind of material that may be used to form sheath (452). Various other suitable materials that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein. Metal sheath (452) may be configured to provide structural reinforcement to the distal end of cannula (440). For instance, metal sheath (452) may prevent the distal end of cannula (440) from buckling or otherwise deforming during use of cannula (440). In addition or in the alternative, when cannula (440) is formed of a material having less hardness than metal sheath (452), metal sheath (452) may prevent the relatively softer material of cannula (440) from being scraped or shaven by an edge defining a lateral aperture of a biopsy needle in which cannula (440) is inserted.

Lateral aperture (442) of the present example may be integrated into both cannula (440) and metal sheath (452). As shown in FIG. 8, lateral aperture (442) is cut out of cannula (440) and metal sheath (452) at an angle such that cannula (440) and metal sheath (452) together form aligned beveled edges (445, 454, 456). For example, metal sheath (452) may include a distal beveled edge (454) and a proximal beveled edge (456). Distal beveled edge (454) of metal sheath (452) may be aligned with a ramp portion (446) of distal tip (444), with both distal beveled edge (454) and ramp portion (446) being oriented at substantially similar angles. Similarly, proximal beveled edge (456) of metal sheath (452) may be aligned with a beveled proximal edge (445) of cannula, with both proximal edges (445, 456) being oriented at substantially similar angles.

Beveled edges (445, 454, 456) and ramp portion (446) may be beveled at an angle suitable to reduce trauma to tissue while still maintaining lateral aperture (442) at a large enough dimension for markers (60, 160, 260, 360) to pass thereby. In the present example, the bevel angle of distal beveled edge (454) and ramp portion (446) is steeper relative to the bevel angle of proximal beveled edges (456, 445). Although a particular relationship between distal beveled edge (454) and ramp portion (446), and proximal beveled edges (445, 456) is shown, it should be understood that no limitation to the example shown is intended, and in other examples the respective bevel angles may be varied as will be understood by those of ordinary skill in the art in view of the teachings herein.

As shown in FIG. 9, distal tip (444) of the present example is integral with shaft (441). Distal tip (444) and shaft (441) may be configured to receive metal sheath (452), such that metal sheath (452) provides support to distal tip (444). In some variations, metal sheath (452) may be attached to distal tip (444) and shaft (441) by overmolding, for example, such that distal tip (444) and shaft (441) are injection molded into metal sheath (452). In other examples, metal sheath (452) may simply be attached to distal tip (444) and shaft (441) by adhesive bonding, mechanical fastening, or any other suitable fastening.

Metal sheath (452) of the present example comprises a metallic biocompatible material, such as stainless steel, titanium, and/or any other suitable metal(s). However, no limitation to only these examples is intended. For instance, in other examples, metal sheath (452) may comprise a plastic that is relatively dense relative to shaft (441) and distal tip (444). In yet other examples, metal sheath (452) may comprise a ceramic material. In still other examples, metal sheath (452) may be comprised of any other suitable material as will be apparent to those of ordinary skill in the art.

FIGS. 10-11C show an example alternative marker delivery device (510) that is similar to marker delivery device (10) described above. For instance, marker delivery device (510) may comprise a body (520) and a cannula (540). Body (520) may comprise an elongate housing (522), a grip (524), and a plunger (528). Housing (522) may e substantially similar to housing (22) described above. However, unlike housing (22), housing (522) of the present example may include additional components that are configured to provide multiple actuation positions for plunger (528), as will be described in greater detail below.

Similar to plunger (28) described above, plunger (528) of the present example may be positioned at the proximal end of a shaft (530) that extends longitudinally through body (520) and cannula (540). Also similarly to plunger (28) described above, plunger (528) of the present example may be used in conjunction with grip (524) for one handed actuation of marker delivery device (510), for example. However, unlike plunger (28), plunger (528) of the present example may be configured to have multiple actuation positions, as will be described in greater detail below.

Cannula (540) may be substantially similar to cannula (40) described above and may be comprised of an elongate tubular shaft extending distally from housing (522). Generally, cannula (540) may extend distally for a length suitable for insertion into a biopsy device or targeting set, such that cannula (540) may extend to a biopsy site to deliver any one of the markers (60, 160, 260, 360) described herein through a lateral aperture (542) near the distal end of cannula (540).

FIGS. 11A-11C show an example operational mode of marker delivery device (510). As can be seen in FIG. 11A, plunger (528) of body (520) begins in an initial, proximal position. When plunger (528) is disposed in the initial position, marker delivery device (510) may be inserted into a biopsy device or targeting set to position lateral aperture (542) of cannula (540) at a biopsy site, for example, with lateral aperture (542) being longitudinally and angularly alignable with a similar lateral aperture of the biopsy device or targeting set.

Once marker delivery device (510) is positioned within a biopsy device or targeting set, a user may desire to place marker (60, 160, 260, 360) at the biopsy site. To so place marker (60, 160, 260, 360), a user may advance plunger (528) to a partially actuated position as shown in FIG. 11B. In the present example, housing (522) includes various components that are configured to advance shaft (530) to eject marker (60, 160, 260, 360) from lateral aperture (542) when plunger (528) is advanced to the partially actuated position.

In some instances, it may be desirable to rotate cannula (540) within a biopsy device or targeting set after deployment of marker (60, 160, 260, 360). For instance, after deployment of marker (60, 160, 260, 360), marker (60, 160, 260, 360) may remain relatively close to lateral aperture (542) of cannula (540), such that it may be possible for at least a portion of marker (60, 160, 260, 360) to re-enter lateral aperture (542). In such a case, removal of marker delivery device (510) may cause damage to marker (60, 160, 260, 360), for example, because marker (60, 160, 260, 360) may become caught between lateral aperture (542) and a corresponding lateral aperture of a biopsy device or targeting set. Accordingly, marker delivery device (510) may be generally configured to selectively rotate cannula (540), for example, to facilitate removal of cannula (540) without a marker (60, 160, 260, 360) becoming lodged between lateral aperture (542) and a corresponding lateral aperture in a biopsy device or targeting set.

As shown in FIG. 11C, plunger (528) is advanced to a fully actuated position to initiate rotation of cannula (540) relative to body (520). It should be understood that to achieve such functionally, the inside of housing (522) may include springs, levers, gears, cams or other mechanical apparatuses that may be assembled to cause rotation of cannula (540). Various components and features that may be used to provide such rotation of cannula (540) relative to body (520) in response to full advancement of plunger (528) relative to body (520) will be apparent to those of ordinary skill in the art in view of the teachings herein. It should be understood that in the present example, the aforementioned components of housing (522) may be configured to rotate cannula (540) 180° relative to body (520), for example. In other examples, housing (522) may be configured to rotate cannula (540) any suitable angle relative to body. By way of example only, housing (522) may be configured to rotate cannula (540) 90°, 270°, or any other suitable radial distance.

Once plunger (528) has been advanced to the fully actuated position to rotate cannula (540), for example, marker delivery device (510) may be removed from the biopsy device or targeting set. Alternatively, in some examples, marker delivery device (510) may be equipped to deploy multiple markers (60, 160, 260, 360). In such examples, housing (522) may be optionally configured to return cannula (540) to its original position for deployment of another marker (60, 160, 260, 360) upon retraction of plunger (528). The sequence described above may be again reinitiated. It should be understood that, although the sequence described above is described as comprising two discrete advancements of plunger (528) by a user, in other examples plunger (528) may be optionally advanced in a single stroke. In such an example, among other things, marker (60, 160, 260, 360) may be deployed and then cannula (540) may be immediately rotated thereafter.

FIGS. 12-14 show another example alternative marker delivery device (610) that is similar to marker delivery device (10) described above. For instance, marker delivery device (610) may comprises a body (620) and a cannula (640). Body (620) may comprises an elongate housing (622), a grip (624), and a plunger (628). Housing (622), grip (624), and plunger (628) may be substantially similar to housing (22), grip (24), and plunger (28) described above, such that the individual details of such components will not be repeated at this point of the description.

Cannula (640) may be substantially similar to cannula (40) described above, in that cannula (640) may be comprised of an elongate tubular shaft extending distally from housing (522). Generally, as shown in FIGS. 12-14, cannula (640) extends distally for a length suitable for insertion into a biopsy device or targeting set, such that cannula (640) may extend to a biopsy site to deliver any one of the markers (60, 160, 260, 360) described herein. However, unlike cannula (40), cannula (640) of the present example may lack a lateral aperture. Instead, cannula (640) may comprise, for example, an open distal tip (644) that is in communication with a cannula lumen (628) extending through cannula (640). Thus, cannula (640) may be configured to deploy a marker (60) longitudinally out through open distal tip (644).

As can best be seen in FIGS. 13 and 14, cannula (640) may further comprise a plurality of dimples (650) similar to dimples (50) of cannula (40). For example, dimples (650) may generally be configured to selectively retain marker (60) within cannula (240). Dimples (650) may comprise a hemispherical shape that is substantially similar to dimples (50) described above. However, unlike cannula (40) as shown above, cannula (640) of the present example may comprise three dimples (650). As can be seen in FIG. 14, dimples (650) may be oriented at equal distances around the inner diameter of cannula (640). It should be understood that, like with dimples (50) described above, dimples (650) of the present example may comprise any other suitable shape and/or configuration as will be apparent to those of ordinary skill in the art in view of the teachings herein.

FIGS. 15 and 16 show an example alternative cannula (740) that may be incorporated into biopsy marker device (10) described above. Cannula (740) of the present example may be substantially similar to cannula (40) described above, except as otherwise noted herein. For instance, cannula (740) of this example may comprise an elongate tubular shaft (741), which may include a lateral aperture (742) proximal to a distal tip (744). Shaft (741) may further define a cannula lumen (748), which extends through cannula (740) and is in communication with lateral aperture (742). Unlike cannula (40), lateral aperture (742) of cannula (740) may have a tear drop shape that widens as lateral aperture (742) extends proximally. Thus, for example, the distal portion of lateral aperture (742) may be narrower than the proximal portion of lateral aperture (742). It should be understood that, in some examples, at least a portion of lateral aperture (742) (e.g., the distal portion of lateral aperture (742)) may also be sized slightly smaller relative to lateral aperture (42) described above. Such sizing may permit lateral aperture (742) to accommodate a smaller marker, for example.

As can be seen in FIG. 16, cannula (740) may also vary from cannula (40) in that distal tip (744) may comprise a compound ramp portion (746). For example, distal tip (744) may comprise three discrete ramp portions (743, 745, 747) and two relatively flat portions (749, 751). Ramp portions (743, 745, 747) are shown in FIG. 16 as being ramped at similar angles, although the particular angle of each ramp portion (743, 745, 747) may be varied in other examples. Generally, ramp portions (743, 745, 747) may be configured to progressively deflect a marker (not shown) through lateral aperture (742). Such a progressive deflection may be desirable, for example, to prevent the marker from exiting cannula (740) prematurely and to prevent the marker from re-entering lateral aperture (742) after the marker has been delivered to a biopsy site.

Flat portions (749, 751) may be generally parallel along their planar flat area to the longitudinal axis of cannula (740), for example. Flat portions (749, 751) may be configured to provide spacing between ramp portions (743, 745, 747) and to alter the trajectory as the marker moves from ramp portion (743, 745, 474) to ramp portion (743, 745, 747). For instance, in an example use, the marker may first travel up a first ramp portion (743) as the marker is advanced distally. First ramp portion (743) may provide some degree of resistance to such distal motion of the marker. By way of example only, first ramp portion (743) may be configured and operable in accordance with at least some of the description in U.S. Pat. No. 8,532,747, entitled “Biopsy Marker Delivery Device,” issued Sep. 10, 2013, the disclosure of which is incorporated by reference herein.

Once the marker has passed first ramp portion (743), the marker may travel along a first flat portion (749), then travel up a second ramp portion (745) at an angle generally parallel to the angle of second ramp portion (745). Second ramp portion (745) may provide a cam surface, thereby ejecting the marker through lateral aperture (742). A second flat portion (751) may prevent the marker from re-entering lateral aperture (742). When cannula (740) is removed from a biopsy device or targeting set, a third ramp portion (747) may deflect any portion of the marker that may remain in lateral aperture (742) fully out of lateral aperture (742). In addition to or in lieu of the foregoing, and by way of example only, compound ramp portion (746) may be constructed and operable in accordance with at least some of the description of U.S. Pub. No. 2014/0276037, entitled “Biopsy Site Marker Applier,” published Sep. 18, 2014, the disclosure of which is incorporated by reference herein.

The present invention has been disclosed with respect to a biopsy marker deployer device. However, various features and components disclosed in the figures may be employed in devices useful with radioisotope applications, as in PEM, BSGI, and other imaging methods that may employ a radioisotope or other radiation source, for example, in connection with imaging a biopsy procedure.

Aspects of the devices disclosed herein are generally designed to be disposed of after a single use, but could be designed to be used multiple times. After forming the marker, and inserting the marker into the deployer, for example the biopsy device may be sterilized. The device may then be placed in a package, such as plastic or TYVEK bag.

The packaged biopsy device may then be placed in a field of radiation, such as gamma radiation, x-rays, or high-energy electrons to sterilize the device and packaging. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

While the aspects described herein have been described in conjunction with the example aspects outlined above, various alternatives, modifications, variations, improvements, and/or substantial equivalents, whether known or that are or may be presently unforeseen, may become apparent to those having at least ordinary skill in the art. Accordingly, the example aspects, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the disclosure. Therefore, the disclosure is intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and/or substantial equivalents.

Thus, the claims are not intended to be limited to the aspects shown herein, but are to be accorded the full scope consistent with the language of the claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.”

It is understood that the specific order or hierarchy of the processes/flowcharts disclosed is an illustration of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy in the processes/flowcharts may be rearranged. Further, some features/steps may be combined or omitted. The accompanying method claims present elements of the various features/steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Further, the word “example” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “example” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more. Combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” include any combination of A, B, and/or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, where any such combinations may contain one or more member or members of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

1-20. (canceled)

21. A marker delivery device comprising:

a delivery cannula having a distal end including a lateral aperture;

a distal tip attached to the distal end of the delivery cannula, a proximal end of the distal tip having a ramp portion inclined toward the lateral aperture, at least one biopsy marker being receivable within the delivery cannula proximate to the lateral aperture;

a push rod having a first end disposed at least partially within the tube, wherein the push rod is movable in a direction toward the distal end of the tube to engage the received at least one biopsy marker; and

a marker stop located between the received at least one biopsy marker and the lateral aperture.

22. The marker delivery device of claim 21, wherein the marker stop includes a plurality of bumps.

23. The marker delivery device of claim 22, wherein the plurality of bumps are located on a side circumferentially away from the lateral aperture.

24. The marker delivery device of claim 23, wherein the plurality of bumps includes two bumps respectively located at a same circumferential offset from the lateral aperture.

25. The marker delivery device of claim 24, wherein the two bumps are respectively located approximately 135 degrees in each circumferential direction from the lateral aperture.

26. The marker delivery device of claim 22, wherein the plurality of spaced apart bumps are approximately circumferentially equidistant from each other.

27. The marker delivery device of claim 21, wherein the marker stop includes an at least partially circumferentially extending rib.

28. The marker delivery device of claim 21, wherein the marker stop includes a flexible flap.

29. The marker delivery device of claim 21, wherein the marker stop includes a resilient bulge.

30. The marker delivery device of claim 21, further comprising:

a resilient member extending from the first end of the push rod, wherein the resilient member is configured to engage the received at least one biopsy marker when the push rod travels in a direction toward the distal end so as to drive the at least one biopsy marker through the lateral aperture of the tube.

31. The marker delivery device of claim 30, wherein the resilient member comprises a spring having at least a first pitch region of coils and a second pitch region of coils, wherein the coils of the first pitch region are more compactly spaced relative to the second pitch region.

32. The marker delivery device of claim 30, wherein the resilient member is configured to laterally deflect within the delivery cannula so as to allow travel of the push rod beyond the marker stop without requiring any lateral deflection of the push rod within the delivery cannula.