Patent Description:
The use of markers used after breast biopsies to mark the location where the biopsied tissue was removed is described in the following <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT> and <CIT>.

In some contexts, a marker biopsy site marker is used to identify a biopsy site after a biopsy procedure. In some examples such biopsy site markers can be deployed at a biopsy site through a biopsy needle using a side-deploy marker delivery device. In this configuration, the marker delivery device includes a side aperture that corresponds to the side aperture of the biopsy needle. Thus, in such configurations the marker delivery device includes a cannula that is inserted through a biopsy needle. Because of the length of the biopsy needle, the cannula of the marker delivery device may be relatively long and flexible. This can in turn make manipulation of the cannula while maintaining sterility difficult. Accordingly, in some contexts, it may be desirable to include various features to aid with manipulation of the cannula of the marker delivery device while maintaining sterility of the cannula. While several systems and methods have been made and used for marking a biopsy site, it is believed that no one prior to the inventor has made or used the invention described in the appended claims.

<CIT> discloses a biopsy marker applier include a slider used to control the depth of insertion of the biopsy marker.

While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements. In the drawings some components or portions of components are shown in phantom as depicted by broken lines.

It may be beneficial to be able to mark the location or margins of a lesion, whether temporarily or permanently, prior to or immediately after removing or sampling it. Marking prior to removal may help to ensure that the entire lesion is excised, if desired. Alternatively, if the lesion were inadvertently removed in its entirety, marking the biopsy site immediately after the procedure would enable reestablishment of its location for future identification.

Once a marker is positioned at a biopsy site, it may be desirable for the marker to remain visible under ultrasound. It may also be desirable to make the marker readily identifiable relative to other structural features of a patient. For instance, it may be desirable for the marker to be distinguishable under ultrasound visualization from microcalcifications to avoid inadvertently characterizing the marker as a microcalcification during subsequent ultrasonic examinations. Generally, microcalcifications are used in the field to identify suspicious lesions or masses. Thus, it is generally desirable for the ultrasound view to be distinguishable as a marker and not inadvertently identified as a new mass.

Aspects presented herein relate to devices and procedures for manufacturing a marker for percutaneously marking a biopsy cavity (<NUM>) having surrounding tissue (<NUM>), as shown in <FIG>. For instance, as seen in <FIG>, a marker (<NUM>) may be initially placed in the biopsy cavity (<NUM>) to facilitate relocation of the biopsy site. Marker (<NUM>) may comprise a carrier (<NUM>) and a marker element (<NUM>). Carrier (<NUM>) generally includes a bioabsorbable marker material (<NUM>). Thus, carrier (<NUM>) is generally configured for absorption into a patient after placement of marker (<NUM>) within the biopsy cavity (<NUM>). In some examples, carrier (<NUM>) can include a plurality of microbubbles to enhance visualization of carrier (<NUM>) under ultrasound. As will be described in greater detail below, marker material (<NUM>) is generally bioabsorbable such that marker material (<NUM>) may be generally absorbed into the patient's tissue over time. In the present example, marker material (<NUM>) comprises a hydrogel that is initially in a dehydrated state. Although a hydrogel is used in the present example, it should be understood that in other examples marker material (<NUM>) may comprise other known bioabsorbable materials.

In the present example, marker (<NUM>) further includes a marker element (<NUM>) that is generally not bioabsorbable. Marker element (<NUM>) may comprise a radiopaque or echogenic marker embedded within the bioabsorbable marker material (<NUM>) of carrier (<NUM>). For instance, marker element (<NUM>) may comprise metal, hard plastic, or other radiopaque or hyperechoic materials known to those of ordinary skill in the art in view of the teachings herein. In other examples, marker (<NUM>) may be formed without a marker element (<NUM>). In still other examples, marker (<NUM>) may be formed with only marker element (<NUM>) such that carrier (<NUM>) is omitted and marker element (<NUM>) is in a "bare" form. In other words, in some examples marker (<NUM>) is formed of only carrier (<NUM>) as a bare clip.

Marker material (<NUM>) is generally expandable once disposed within a patient at a biopsy site. As shown in <FIG>, the initially dehydrated marker material (<NUM>) may absorb fluid from the surrounding tissue (<NUM>) into which it is inserted. In response to this absorption of fluid, maker material (<NUM>) may swell, thereby permitting carrier (<NUM>) to fill a cavity formed at a biopsy site by removal of tissue samples during a biopsy procedure. Biodegradable materials may be particularly suitable in applications where it is desired that natural tissue growth be permitted to completely or partially replace the implanted material over time. Accordingly, biocompatibility is ensured and the natural mechanical parameters of the tissue are substantially restored to those of the pre-damaged condition.

Marker (<NUM>) may be inserted into the body either surgically via an opening in the body cavity (<NUM>), or through a minimally invasive procedure using such devices as a catheter, introducer or similar type insertion device. Marker (<NUM>) may be delivered immediately after removal of the tissue specimen using the same device used to remove the tissue specimen itself. Follow-up noninvasive detection techniques, such as x-ray mammography or ultrasound may then be used by the physician to identify, locate, and monitor the biopsy cavity site over a period of time via marker (<NUM>).

Marker (<NUM>) of the present example is large enough to be readily visible to a clinician under x-ray or ultrasonic viewing, for example; yet small enough to be able to be percutaneously deployed into the biopsy cavity and to not cause any difficulties with the patient. Although examples are described in connection with treatment and diagnosis of breast tissue, aspects presented herein may be used for markers in any internal, tissue, e.g., in breast tissue, lung tissue, prostate tissue, lymph gland tissue, etc..

The hydration of the marker material (<NUM>) of carrier (<NUM>) by the natural moisture of the tissue surrounding it causes expansion of the polymer and thus minimizes the risk of migration. The growing hydrogel based marker material (<NUM>) centers marker (<NUM>) in the biopsy cavity as it grows. As the hydrogel expands, naturally-present moisture from the surrounding tissue, the hydration enables increasing sound through transmission, appears more and more hypoechoic and is easy to visualize on follow up ultrasound studies.

The hydrated hydrogel marker material (<NUM>) of carrier (<NUM>) may also be used to frame permanent marker (<NUM>). The hypoechoic nature of the hydrated marker material (<NUM>) enables ultrasound visibility of the permanent marker (<NUM>) within the hydrogel hydrated marker material (<NUM>) because the permanent marker (<NUM>) is outlined as a specular reflector within a hypoechoic hydrated marker having a waterlike nonreflective substrate.

In some examples it may be desirable to deploy marker (<NUM>) described above within the body cavity (<NUM>) using certain marker delivery devices. For instance, <FIG> and <FIG> show an exemplary marker delivery device (<NUM>) which includes an elongate outer cannula (<NUM>) having a marker exit, such as side opening (<NUM>) formed adjacent to, but spaced proximally from, the distal end of the cannula (<NUM>). It should be understood that the term "cannula" used herein refers a hollow tube or sheath.

A grip (<NUM>) can be provided at the proximal end of cannula (<NUM>). A push rod (<NUM>) can be provided, with push rod (<NUM>) extending coaxially in cannula (<NUM>) such that push rod (<NUM>) is configured to translate within cannula (<NUM>) to displace one or more markers through side opening (<NUM>) (see <FIG>). Rod (<NUM>) may have sufficient rigidity in compression to push a marker from an internal lumen (<NUM>) of cannula (<NUM>) out through opening (<NUM>), yet be relatively flexible in bending. A plunger (<NUM>) is coupled at the proximal end of rod (<NUM>) for forcing rod (<NUM>) distally in cannula (<NUM>) to deploy a marker out of cannula (<NUM>).

A user may grasp grip (<NUM>) with two fingers, and may push on plunger (<NUM>) using the thumb on the same hand, so that marker delivery device (<NUM>) is operated by a user's single hand. A spring (not shown) or other feature may be provided about rod (<NUM>) to bias rod (<NUM>) proximally relative to grip (<NUM>) and cannula (<NUM>).

<FIG> shows a cross-sectional view of a distal portion of the marker delivery device (<NUM>). As can be seen, a biopsy marker (<NUM>) similar to marker (<NUM>) described above is disposed within internal lumen (<NUM>) of cannula (<NUM>). In the present example, marker (<NUM>) comprise a biodegradable or otherwise resorbable marker material (<NUM>), such as a generally cylindrically shaped body of collagen, hydrogel, or etc., and a metallic, generally radiopaque permanent marker or marker element (<NUM>) (shown in phantom) disposed within or otherwise carried by marker material (<NUM>).

Cannula (<NUM>) may be formed of any suitable metallic or non-metallic material. In some versions, cannula (<NUM>) is formed of a thin walled hollow tube formed of a suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer, such as Polyether block amide (PEBA), such as is known under the tradename PEBAX. Cannula (<NUM>) may be formed of PEBAX, and may be substantially transparent to visible light and X-ray.

Side opening (<NUM>) may be formed by cutting away a portion of the wall of cannula (<NUM>). Side opening (<NUM>) communicates with an internal lumen (<NUM>) of cannula (<NUM>). Side opening (<NUM>) may extend axially (in a direction parallel to the axis of lumen (<NUM>)) from a proximal opening end (164A) to a distal opening end (164B), as illustrated in <FIG>.

In the present example, distal tip (<NUM>) extends from the distal end of cannula (<NUM>) and is rounded as shown in <FIG>. Referring to <FIG>, the distal end of cannula (<NUM>) is closed by a unitary endpiece (<NUM>), with a portion of endpiece (<NUM>) extending into internal lumen (<NUM>) of cannula (<NUM>). Endpiece (<NUM>) may be a molded or cast component. Endpiece (<NUM>) comprises a tip (<NUM>), a ramp (<NUM>) having a ramp surface (<NUM>), and a marker engaging element (<NUM>). Ramp surface (<NUM>) aids in directing marker (<NUM>) from internal lumen (<NUM>) through side opening (<NUM>). Marker engaging element (<NUM>) helps to retain marker (<NUM>) in internal lumen (<NUM>) until the user intends to deploy marker (<NUM>).

Marker engaging element (<NUM>) is disposed within internal lumen (<NUM>), and at least a portion of marker engaging element (<NUM>) is disposed distally of proximal end (164A) of side opening (<NUM>). Marker engaging element (<NUM>) extends along a portion of the floor of cannula (<NUM>) under opening (<NUM>) such that marker engaging element (<NUM>) is positioned to reinforce the portion of cannula (<NUM>) in which opening (<NUM>) is formed. For instance, by positioning marker engaging element (<NUM>) underneath opening (<NUM>), as shown in <FIG>, element (<NUM>) helps to stiffen cannula (<NUM>) in the region where wall of cannula (<NUM>) is cut to form opening (<NUM>). As shown in <FIG>, marker engaging element (<NUM>) extends from the proximal most portion of ramp surface (<NUM>), and does not extend proximally of side opening (<NUM>), though in other embodiments, a portion of element (<NUM>) may extend proximally of opening (<NUM>).

As shown in <FIG>, marker engaging element (<NUM>) is in the form of a step having a generally uniform thickness (T) along element's (<NUM>) axial length, except that element (<NUM>) has a tapered proximal end (<NUM>). Tapered proximal end (<NUM>) forms an included angle with the longitudinal axis of lumen (<NUM>) (included angle with a horizontal line in <FIG>) of about <NUM> degrees, while ramp surface (<NUM>) forms an included angle with the longitudinal axis of about <NUM> degrees. Of course, any number of other suitable angles may be used.

As shown in <FIG>, an upwardly facing surface (<NUM>) (surface facing opening (<NUM>)) of marker engaging element (<NUM>) extends distally to contact ramp surface (<NUM>), so that there is not a space or gap between surface (<NUM>) and ramp surface (<NUM>). Such an arrangement is advantageous to reduce the possibility that marker (<NUM>), upon moving past marker engaging element (<NUM>), may become lodged between marker engagement element (<NUM>) and ramp (<NUM>). In some versions, marker engaging element (<NUM>), ramp (<NUM>), and/or tip (<NUM>) are formed of, or include, a material that is relatively more radiopaque than the wall of cannula (<NUM>). For instance, where element (<NUM>), ramp (<NUM>), and tip (<NUM>) are formed as an integral endpiece (<NUM>), endpiece (<NUM>) may include a radiopaque additive, such as barium sulfate. For instance, endpiece (<NUM>) may be a component molded of PEBAX, with about <NUM> percent by weight barium sulfate added to the molten PEBAX mold composition. The relatively more radiopaque marker engaging element (<NUM>), ramp (<NUM>), and tip (<NUM>) may be useful in distinguishing the position of those components using radiographic imaging. Also, where ramp (<NUM>) and/or step of engaging element (<NUM>) are positioned in association with opening (<NUM>), the addition of a radiopaque material can help identify the position of opening (<NUM>), and the position of marker (<NUM>) relative to opening (<NUM>) before, during, or after deployment of marker (<NUM>).

Referring to <FIG>, marker delivery device (<NUM>) is used to deploy a marker (<NUM>) to mark a biopsy location within a patient. In <FIG>, a cannular biopsy needle (<NUM>) is shown having a closed distal end with piercing tip (<NUM>) and a lateral tissue receiving aperture (<NUM>). Marker delivery device (<NUM>) is introduced to a biopsy site through biopsy needle (<NUM>), which may be the same needle (<NUM>) used to collect a tissue sample from the biopsy site. Biopsy needle (<NUM>) may be of the type used with single insertion, multiple sample vacuum assisted biopsy devices.

<FIG> shows the distal end of marker delivery device (<NUM>) disposed within needle (<NUM>). Needle (<NUM>) may be positioned in tissue, and a biopsy sample may be obtained through lateral aperture (<NUM>), thereby providing a biopsy cavity adjacent lateral aperture (<NUM>). Then, after the tissue sample has been obtained and transferred proximally through needle (<NUM>), and without removing needle (<NUM>) from the patient's tissue, marker delivery device (<NUM>) is inserted into a proximal opening in needle (<NUM>). In <FIG>, needle (<NUM>) and marker delivery device (<NUM>) are positioned such that opening (<NUM>) of cannula (<NUM>) and lateral aperture (<NUM>) of needle (<NUM>) are substantially aligned axially and circumferentially. Then, with marker delivery device (<NUM>) and needle (<NUM>) so positioned at the biopsy site, push rod (<NUM>) is advanced to deploy marker (<NUM>) up ramp surface (<NUM>), through opening (<NUM>), and then through lateral aperture (<NUM>), into the biopsy cavity.

In some examples it may be desirable to retain the sterility of certain portions of a marker delivery device similar to marker delivery device (<NUM>) described above. For instance, a marker delivery device can generally be supplied to an operator in sterile packaging such that the entire marker delivery device is in a sterile condition prior to use. During use, certain components may contact a patient. Thus, it may be desirable to maintain sterility of those components. In particular, as described above, a cannula similar to cannula (<NUM>) can be inserted into a biopsy needle, targeting device, introducer, or other component or assembly disposed within a patient. Because of this, the cannula may at some point contact the patient during a marking procedure. Thus, it may be desirable to use methods and components along with the cannula to avoid disrupting the sterility thereof.

While it is desirable to maintain sterility of the cannula, it may also be desirable to provide a means for readily manipulating the cannula. For instance, the cannula can in some circumstances be relatively small and diameter and flexible. This configuration can make the cannula challenging to manipulate. Challenges can be compounded when the cannula is manipulated into small spaces such as the proximal end of a needle, tissue sample holder, introducer or other conduits or passageways. Thus, it is desirable to both maintain the sterility of the cannula while also permitting ease of manipulation. Although several specific features that satisfy these conditions are described herein, it should be understood that various alternative features or combinations of features can be used without departing from the general concepts described herein.

<FIG> depicts a marker delivery device (<NUM>) that is substantially similar to marker delivery device (<NUM>) described above. For instance, like marker delivery device (<NUM>), marker delivery device (<NUM>) of the present example includes an elongate outer cannula (<NUM>) having a side opening or marker exit (<NUM>). Outer cannula (<NUM>) includes a distal tip (<NUM>) and is generally sized to slidably fit within a cutter or needle of a biopsy device (<NUM>), as will be described in greater detail below. Similarly, the length of cannula (<NUM>) is generally sized to correspond to the length of a corresponding cutter or needle. It should be understood that in some examples the particular length of cannula (<NUM>) can be greater than the length of a cutter or needle. For instance, in some examples the proximal end of a cutter or needle can be coupled to a tissue sample holder or other tissue collection device. In such examples, the length of cannula (<NUM>) can have a length suitable to extend through both needle /cutter and various tissue collection devices.

Like with marker delivery device (<NUM>), marker delivery device (<NUM>) of the present example includes a grip (<NUM>) at the proximal end of cannula (<NUM>). Similarly, a push rod (<NUM>) can be provided, with push rod (<NUM>) extending coaxially in cannula (<NUM>) and extending proximally from grip (<NUM>). Like push rod (<NUM>) described above, push rod (<NUM>) of the present example is configured to translate within cannula (<NUM>) to displace one or more markers through side opening (<NUM>). Push rod (<NUM>) generally can have sufficient rigidity in compression to push a marker from an internal lumen (not shown) of cannula (<NUM>) out through opening (<NUM>), yet be relatively flexible in bending. A plunger (<NUM>) is coupled at the proximal end of push rod (<NUM>) for forcing push rod (<NUM>) distally in cannula (<NUM>) to deploy a marker out of cannula (<NUM>).

Like with grip (<NUM>) described above, an operator can grasp grip (<NUM>) with two fingers, and push on plunger (<NUM>) using the thumb on the same hand, so that marker delivery device (<NUM>) is operated by a single hand. A spring (not shown) or other resilient feature may be provided about push rod (<NUM>) to bias push rod (<NUM>) proximally relative to grip (<NUM>) and cannula (<NUM>).

Unlike marker delivery device (<NUM>) described above, marker delivery device (<NUM>) of the present example further includes a sterile guide (<NUM>). It should be understood that the term "sterile" used in connection with "guide" herein refers to how the sterile guide (<NUM>) is used to preserve one or more components of a marker delivery device such as cannula (<NUM>). In other words, the term "sterile guide" is not intended to imply that any component of sterile guide (<NUM>) is sterile or should remain sterile. Instead, as will be described in greater detail below, various components of sterile guide (<NUM>) are configured for gasping directly by an operator to avoid grasping other components of a marker delivery device such as cannula (<NUM>).

As best seen in <FIG>, sterile guide (<NUM>) includes a body (<NUM>) with a grasping element or grip feature (<NUM>) extending therefrom. Body (<NUM>) is generally configured to receive cannula (<NUM>). In particular, body (<NUM>) defines a bore (<NUM>) extending through a central axis of body (<NUM>). Bore (<NUM>) is generally sized to receive cannula (<NUM>). As will be described in greater detail below, the inner diameter of bore (<NUM>) is slightly oversized relative to the outer diameter of cannula (<NUM>) such that body (<NUM>) is axially slidable along the length of cannula (<NUM>). In some examples, bore (<NUM>) can be configured to have a slight interference fit with cannula (<NUM>) to permit some sliding of body (<NUM>) along the length of cannula (<NUM>) while providing at least some resistance to sliding. Such a configuration can permit body (<NUM>) to be placed at a selected position and remain at said position until body (<NUM>) is moved to another position. In some examples, this interference fit can be further facilitated by body (<NUM>) being constructed of a flexible material such as elastomer. In this configuration, body (<NUM>) can act as a resilient stopper to maintain a position on cannula (<NUM>) but still slide when a force is applied by an operator.

Grip feature (<NUM>) is generally configured as an elongate wing extending from one side of body (<NUM>). Grip feature (<NUM>) is generally sized for grasping by a user and includes a plurality of ribs (<NUM>) to promote gripping. It should be understood that grip feature (<NUM>) can take on a variety of forms provided grip feature (<NUM>) provides a suitable means to grip body (<NUM>). For instance, in other examples, grip feature (<NUM>) can include multiple wings extending from opposing sides of body (<NUM>). In addition, or in the alternative, grip feature (<NUM>) or features can also be curved or rounded. Of course, various alternative configurations for grip feature (<NUM>) will be apparent to those of ordinary skill in the art in view of the teachings herein.

Sterile guide (<NUM>) is generally configured to couple to grip (<NUM>) of marker delivery device (<NUM>). In particular, as best seen in <FIG>, marker delivery device (<NUM>) includes a retainer (<NUM>) extending distally from grip (<NUM>). Retainer (<NUM>) is generally cylindrical in shape and is configured to fit within bore (<NUM>) of sterile guide (<NUM>).

To facilitate fastening of sterile cover to retainer (<NUM>), retainer (<NUM>) includes a circular rib (<NUM>) extending from the outer surface of the cylindrical shape of retainer (<NUM>). Correspondingly, the interior of bore (<NUM>) includes one or more feature to receive rib (<NUM>) and fasten thereto. In particular, as best seen in <FIG>, bore (<NUM>) includes a counterbore face (<NUM>) extending inwardly into bore (<NUM>). Counterbore face (<NUM>) is generally configured to abut the distal face of rib (<NUM>). Proximally of counterbore face (<NUM>), body (<NUM>) tapers inwardly to provide at least a partial interference fit with rib (<NUM>). It should be understood that in the present example, body (<NUM>) can be formed of a generally flexible material to facilitate flexion of body (<NUM>) to increase the diameter of bore (<NUM>) as body (<NUM>) is pulled from retainer (<NUM>). In addition, or in the alternative, in some examples rib (<NUM>) includes a resilient or flexible material to likewise flex as body (<NUM>) is pulled from retainer.

In some examples, rib (<NUM>) or body (<NUM>) can be configured to provide feedback when coupling. For instance, rib (<NUM>) or body (<NUM>) may be configured to provide tactile feedback during coupling. In addition, or in alternative, rib (<NUM>) or body (<NUM>) may be configured to provide an audible snap or crack during coupling to provide an indication that sterile guide (<NUM>) is secured to retainer (<NUM>).

<FIG> and <FIG> show an exemplary use of sterile guide (<NUM>). As can be seen in <FIG>, sterile guide (<NUM>) is initially pulled distally from retainer (<NUM>) of marker delivery device (<NUM>). This pulling motion releases sterile guide (<NUM>) from retainer (<NUM>) such that sterile guide (<NUM>) is free to slide axially down the length of cannula (<NUM>). At this stage, marker delivery device (<NUM>) can be pulled from associated packaging or otherwise be manipulated around a procedure room by gasping both grip (<NUM>) and sterile guide (<NUM>) using grip feature (<NUM>). Thus, sterile guide (<NUM>) is generally placed towards distal tip (<NUM>) of cannula (<NUM>), but can be placed in any other suitable position along the length of cannula (<NUM>).

Once sterile guide (<NUM>) is positioned as desired, an operator can use sterile guide (<NUM>) to manipulate cannula (<NUM>) into a biopsy device, biopsy needle, targeting set, introducer, or other components associated with a patient. One merely exemplary example of manipulation is show in <FIG>. As can be seen, sterile guide (<NUM>) is used to manipulate distal tip (<NUM>) of cannula (<NUM>) into a marking port (<NUM>) of a tissue sample holder (<NUM>) that is attached to a proximal end of a biopsy probe (<NUM>) of a biopsy device (<NUM>). In particular, an operator can grasp grip feature (<NUM>) to manipulate cannula (<NUM>) without physically touching cannula (<NUM>). Due to the positioning of sterile guide (<NUM>) proximate the distal end of cannula (<NUM>), movement of distal tip (<NUM>) is easily controlled to position distal tip (<NUM>) into port (<NUM>). It should be understood that in some examples, biopsy device (<NUM>) can be constructed in accordance with at least some of the teachings of <CIT>.

Although not shown, it should be understood that tissue sample holder (<NUM>) of the present example is rotatable to align port (<NUM>) with a cutter of biopsy device (<NUM>). The cutter is disposed within a needle similar to needle (<NUM>) described above that extends distally from probe (<NUM>). Thus, the cutter can act as a conduit between port (<NUM>) and the needle so that cannula (<NUM>) can be used to deploy marker (<NUM>) through side opening (<NUM>). Although marker delivery device (<NUM>) and sterile guide (<NUM>) of the present example are shown as being used in connection with biopsy device (<NUM>), it should be understood that in other examples the combination of marker delivery device (<NUM>) and sterile guide (<NUM>) can be used with a variety of other biopsy devices or other medical instruments. For instance, in some examples cannula (<NUM>) can be inserted directly into a cutter under the direction of sterile guide (<NUM>). In other examples, cannula (<NUM>) can be inserted using sterile guide (<NUM>) through a basket-style tissue sample holder constructed in accordance with the teachings of <CIT>. In still other examples, cannula (<NUM>) can be inserted using sterile guide (<NUM>) through an introducer constructed in accordance with the teachings of <CIT>. In yet other examples, the combination of marker delivery device (<NUM>) and sterile guide (<NUM>) can be used with various alternative devices as will be apparent to those of ordinary skill in the art in view of the teachings herein.

Once cannula (<NUM>) is inserted into port (<NUM>) or any other suitable component, sterile guide (<NUM>) can be slid proximally along cannula (<NUM>) back to retainer (<NUM>). Sterile guide (<NUM>) can then be re-coupled to retainer (<NUM>) for storage while marking is performed. After marking, sterile guide (<NUM>) can then be again de-coupled from retainer (<NUM>) to provide assistance to an operator with removal of cannula (<NUM>) from port (<NUM>) or any other suitable component. After the procedure is complete, marker delivery device (<NUM>) and sterile guide (<NUM>) can together be disposed of.

<FIG> depict a marker delivery device (<NUM>) that is substantially similar to marker delivery device (<NUM>) described above. For instance, like marker delivery device (<NUM>), marker delivery device (<NUM>) of the present example includes an elongate outer cannula (<NUM>) having a side opening or marker exit (<NUM>). Outer cannula (<NUM>) includes a distal tip (<NUM>) and is generally sized to slidably fit within a cutter or needle of biopsy device (<NUM>), as will be described in greater detail below. Similarly, the length of cannula (<NUM>) is generally sized to correspond to the length of a corresponding cutter or needle. It should be understood that in some examples the particular length of cannula (<NUM>) can be greater than the length of a cutter or needle. For instance, in some examples the proximal end of a cutter or needle can be coupled to a tissue sample holder or other tissue collection device. In such examples, the length of cannula (<NUM>) can have a length suitable to extend through both needle /cutter and various tissue collection devices.

As with marker delivery device (<NUM>) described above, marker delivery device (<NUM>) of the present example further includes a sterile guide (<NUM>). It should be understood that unless otherwise noted herein, sterile guide (<NUM>) of the present example is substantially similar to sterile guide (<NUM>) described above. As will be described in greater detail below, at least a portion of sterile guide (<NUM>) of the present example is generally configured to pivot and temporarily deform in shape to aid in detachment from grip (<NUM>).

As best seen in <FIG> and <FIG>, sterile guide (<NUM>) includes a body (<NUM>) with a grasping element or grip feature (<NUM>) extending therefrom. Body (<NUM>) is generally configured to receive cannula (<NUM>). In particular, body (<NUM>) defines a bore (<NUM>) extending through a central axis of body (<NUM>). Bore (<NUM>) is generally sized to receive cannula (<NUM>).

The interior of body (<NUM>) defined by bore (<NUM>) is shown in greater detail in <FIG>. As can be seen, a proximal portion of body (<NUM>) includes a plurality of ribs (<NUM>) extending inwardly from the interior surface of body (<NUM>) defined by bore (<NUM>). Meanwhile, a distal portion of body (<NUM>) includes a cannula grip (<NUM>) extending inwardly relative to the interior surface of body (<NUM>). As will be described in greater detail below, ribs (<NUM>) are generally configured to engage at least a portion of grip (<NUM>) to provide an interference or friction fit between body (<NUM>) and grip (<NUM>). In the present example, three ribs (<NUM>) are shown on a single side of body (<NUM>). Although not shown, it should be understood that the upper side of body (<NUM>) includes a substantially similar configuration with respect to ribs (<NUM>). Thus, it should be understood that body (<NUM>) of the present example includes six ribs (<NUM>) with three ribs (<NUM>) arranged at equal distances on each side (e.g., upper and lower) of body (<NUM>). Although body (<NUM>) of the present example is shown as having a specific number of ribs (<NUM>), it should be understood that in other examples, any suitable number of ribs (<NUM>) can be used to provide a friction or interference fit between body (<NUM>) and grip (<NUM>).

Ribs (<NUM>) of the present example are integral with body (<NUM>). Accordingly, ribs (<NUM>) have generally substantially similar material properties as body (<NUM>). However, it should be understood that in other examples, ribs (<NUM>) can be configured as separate components attached to body (<NUM>). For instance, in some examples, ribs (<NUM>) can be configured as elastomeric portions attached to body (<NUM>) by adhesive bonding, mechanical bonding or any other suitable means.

Cannula grip (<NUM>) is generally configured to provide an interference or friction fit between body (<NUM>) and outer cannula (<NUM>). In particular, cannula grip (<NUM>) defines a semi-circular surface in bore (<NUM>) that generally corresponds to the outer diameter of outer cannula (<NUM>). In the present example, this semi-circular surface is slightly undersized relative to the outer diameter of outer cannula (<NUM>) to thereby provide an interference or friction fit. Although not show, it should be understood that cannula grip (<NUM>) having a substantially similar surface is included on the upper portion of body (<NUM>). Thus, it should be understood that the cannula grip (<NUM>) on each side of body (<NUM>) cooperates with the other to generally provide an interference or friction fit with outer cannula (<NUM>). As will be described in greater detail below, this configuration is generally configured to permit body (<NUM>) to have a selective locking function when used with outer cannula (<NUM>). In other words, body (<NUM>) is generally configured such that body (<NUM>) can be selectively positioned at a given axial position by an operator along the length of outer cannula (<NUM>) and then remain in such a position until changed by an operator.

Unlike sterile guide (<NUM>) described above, sterile guide (<NUM>) of the present example is generally configured to flex and/or deform to facilitate coupling and decoupling with grip (<NUM>). To permit such flexing and/or deformation, body (<NUM>) of the present example is generally slotted. As can be seen, body (<NUM>) is bisected by a pair of slots (<NUM>) oriented on opposing sides of body (<NUM>) and extending therethrough. Thus, as noted above, body (<NUM>) is separated into a lower and upper portion, yet each portion generally corresponds to the other. As will be described in greater detail below, slots (<NUM>) generally permit the upper portion of body (<NUM>) and lower portion of body (<NUM>) to pivot away from each other to selectively engage and disengage the interference or friction fit between body (<NUM>) and grip (<NUM>) and/or outer cannula (<NUM>).

As with sterile guide (<NUM>) described above, sterile guide (<NUM>) of the present example includes a grip feature (<NUM>). Like grip feature (<NUM>) described above, grip feature (<NUM>) of the present example is generally configured to promote gripping by an operator to move sterile guide (<NUM>) along the length of outer cannula (<NUM>). However, unlike grip feature (<NUM>) described above, grip feature (<NUM>) of the present example is generally configured to manipulate at least a portion of body (<NUM>) to actuate certain features of body (<NUM>) that will be described in greater detail below.

As best seen in <FIG>, grip feature (<NUM>) includes a connector or connecting member (<NUM>) extending between a pair of arms (<NUM>). Connecting member (<NUM>) is generally positioned between arms (<NUM>) to act as a pivot for arms (<NUM>). As will be described in greater detail below, this configuration generally permits arms (<NUM>) to be squeezed together by an operator to pivot body (<NUM>) from a neutral closed configuration to an open configuration. In view of this configuration, it should be understood that the thickness, height, and relative position of connecting member (<NUM>) are all configured to promote pivoting of arms (<NUM>) and body (<NUM>). For instance, the thickness of connecting member (<NUM>) is generally thick enough to promote separation of arms (<NUM>), yet thin enough to provide some flexibility. Similarly, connecting member (<NUM>) is configured with a sufficient height to provide a setoff distance between arms (<NUM>) suitable to provide clearance for pivoting. Finally, the connecting member (<NUM>) is positioned relative to an outside end of each arm (<NUM>) to provide sufficient leverage for pivoting.

In some configurations, the various parameters of connecting member (<NUM>) can be at least partially determined by the material of connecting member (<NUM>). For instance, in the present example, sterile guide (<NUM>) is formed entirely of ABS plastic. As a result, the thickness, height, and relative position of connection member (<NUM>) can all be configured to reflect the specific hardness and elasticity of ABS plastic. In other examples, connection member (<NUM>) can comprise a different material relative to other portions of sterile guide (<NUM>). By way of example only, in some examples, connecting member (<NUM>) can be formed of an elastomer with greater flexibility relative to ABS plastic. In such examples, the particular configuration of connection member (<NUM>) can be adjusted to reflect such increased flexibility.

Arms (<NUM>) project outwardly from connection member (<NUM>). As noted above, arms (<NUM>) are generally configured to pivot about connecting member (<NUM>) to move body (<NUM>) from a neutral closed configuration to an open configuration. To facilitate this pivoting, arms (<NUM>) are generally configured with sufficient stiffness to avoid bending during pivoting. To promote stiffness, each arm (<NUM>) includes a strut (<NUM>) projecting inwardly from an interior surface of each arm (<NUM>). Each strut (<NUM>) is generally configured as an elongate rectangular projection. In addition, each strut (<NUM>) is offset relative to the other to prevent contact between struts (<NUM>) during pivoting of arms (<NUM>).

Sterile guide (<NUM>) is generally configured to couple to grip (<NUM>) of marker delivery device (<NUM>). In particular, as best seen in <FIG>, marker delivery device (<NUM>) includes a retainer (<NUM>) extending distally from grip (<NUM>). Retainer (<NUM>) of the present example is generally cylindrical in shape and is configured to fit within bore (<NUM>) of sterile guide (<NUM>). However, unlike retainer (<NUM>) described above, retainer (<NUM>) of the present example omits a structure similar to rib (<NUM>). Instead, retainer (<NUM>) defines a relatively smooth surface.

As best seen in <FIG>, sterile guide (<NUM>) is configured to fasten to retainer (<NUM>) of grip (<NUM>) by an interference or compression fit. In particular, <FIG> shows sterile guide (<NUM>) with body (<NUM>) in the neutral closed position referred to above. In this position, ribs (<NUM>) contact retainer (<NUM>) with some resiliency provided by connection member (<NUM>). This configuration provides sufficient friction between ribs (<NUM>) and retainer (<NUM>) to hold sterile guide (<NUM>) in position on grip (<NUM>). Similarly, the cannula grip (<NUM>) on each side of body (<NUM>) contacts outer cannula (<NUM>) with some resiliency provided by connection member (<NUM>). This configuration likewise provides sufficient friction between each cannula grip (<NUM>) and outer cannula (<NUM>) to hold sterile guide (<NUM>) in position on outer cannula (<NUM>).

<FIG> and <FIG> show an exemplary use of sterile guide (<NUM>). As can be seen in <FIG>, sterile guide (<NUM>) is initially pulled distally from retainer (<NUM>) of marker delivery device (<NUM>). This pulling motion is combined with an operator squeezing arms (<NUM>) of sterile guide (<NUM>) together. Squeezing arms (<NUM>) generates a pivoting action at connection member (<NUM>), which drives the upper and lower portion of body (<NUM>) apart to expand slots (<NUM>). This effectively expands the diameter of bore (<NUM>) to reduce friction between ribs (<NUM>) and retainer (<NUM>), and between cannula grip (<NUM>) and outer cannula (<NUM>). Consequently, sterile guide (<NUM>) can be released from retainer (<NUM>) and can be freely slid axially down the length of outer cannula (<NUM>). At this stage, marker delivery device (<NUM>) can be pulled from associated packaging or otherwise be manipulated around a procedure room by gasping both grip (<NUM>) and sterile guide (<NUM>) using grip feature (<NUM>). Thus, sterile guide (<NUM>) can generally be placed towards distal tip (<NUM>) of outer cannula (<NUM>), but can be placed in any other suitable position along the length of outer cannula (<NUM>). At any desirable stage, the axial position of sterile guide (<NUM>) can be fixed along outer cannula (<NUM>) by releasing the pressure or squeezing applied to arms (<NUM>). This permits friction to increase between cannula grip (<NUM>) and outer cannula (<NUM>). However, it should be understood that arms (<NUM>) can still be used to manipulate outer cannula (<NUM>) while sterile guide (<NUM>) remains locked in position.

Once sterile guide (<NUM>) is positioned as desired, an operator can use sterile guide (<NUM>) to manipulate outer cannula (<NUM>) into a biopsy device, biopsy needle, targeting set, introducer, or other components associated with a patient. One merely exemplary example of manipulation is show in <FIG>. As can be seen, sterile guide (<NUM>) is used to manipulate distal tip (<NUM>) of outer cannula (<NUM>) into marking port (<NUM>) of tissue sample holder (<NUM>) that is attached to a proximal end of biopsy probe (<NUM>) of biopsy device (<NUM>). In particular, an operator can grasp grip feature (<NUM>) to manipulate outer cannula (<NUM>) without physically touching outer cannula (<NUM>). Due to the positioning of sterile guide (<NUM>) proximate the distal end of outer cannula (<NUM>), movement of distal tip (<NUM>) is easily controlled to position distal tip (<NUM>) into port (<NUM>). It should be understood that in some examples, biopsy device (<NUM>) can be constructed in accordance with at least some of the teachings of <CIT>.

Although not shown, it should be understood that tissue sample holder (<NUM>) of the present example is rotatable to align port (<NUM>) with a cutter of biopsy device (<NUM>). The cutter is disposed within a needle similar to needle (<NUM>) described above that extends distally from probe (<NUM>). Thus, the cutter can act as a conduit between port (<NUM>) and the needle so that outer cannula (<NUM>) can be used to deploy marker (<NUM>) through side opening (<NUM>). Although marker delivery device (<NUM>) and sterile guide (<NUM>) of the present example are shown as being used in connection with biopsy device (<NUM>), it should be understood that in other examples the combination of marker delivery device (<NUM>) and sterile guide (<NUM>) can be used with a variety of other biopsy devices or other medical instruments. For instance, in some examples, outer cannula (<NUM>) can be inserted directly into a cutter under the direction of sterile guide (<NUM>). In other examples, outer cannula (<NUM>) can be inserted using sterile guide (<NUM>) through a basket-style tissue sample holder constructed in accordance with the teachings of <CIT>. In still other examples, outer cannula (<NUM>) can be inserted using sterile guide (<NUM>) through an introducer constructed in accordance with the teachings of <CIT>. In yet other examples, the combination of marker delivery device (<NUM>) and sterile guide (<NUM>) can be used with various alternative devices as will be apparent to those of ordinary skill in the art in view of the teachings herein.

Claim 1:
An apparatus for delivery of a biopsy marker to a biopsy site, the apparatus comprising:
(a) a grip (<NUM>, <NUM>) and a cannula (<NUM>, <NUM>) extending distally from the grip (<NUM>, <NUM>), the cannula (<NUM>, <NUM>) having a lumen extending at least partially therethrough and a marker exit opening in the cannula communicating with the lumen;
(b) at least one biopsy marker disposed in the lumen for deployment through the marker exit opening; and
(c) a sterile guide (<NUM>, <NUM>) including a body (<NUM>, <NUM>) defining a bore (<NUM>, <NUM>) and being configured to slide along the cannula (<NUM>, <NUM>), wherein the sterile guide (<NUM>, <NUM>) further includes a radially extending grasping feature (<NUM>, <NUM>) of unitary construction with the body (<NUM>, <NUM>), characterized in that the grasping feature (<NUM>, <NUM>) includes one or more arms (<NUM>) projecting laterally from the body (<NUM>, <NUM>), wherein the bore (<NUM>, <NUM>) is configured to receive the cannula (<NUM>, <NUM>) and at least a portion of the grip (<NUM>, <NUM>), wherein the body (<NUM>, <NUM>) is configured to selectively transition between a closed configuration and an open configuration, wherein the body (<NUM>, <NUM>) is configured to fasten to the grip (<NUM>, <NUM>) when in the closed configuration, wherein the body (<NUM>, <NUM>) is configured to slide along the cannula (<NUM>, <NUM>) when in the open configuration.