Patent Description:
The present disclosure relates generally to medical devices. More specifically, the present disclosure relates to biopsy needle assemblies configured for use with tissue biopsy devices.

The document <CIT> relates to a biopsy device for obtaining tissue samples while preserving the relational aspects of the tissue substructure and architecture. The biopsy device comprises a cannula housing and a spring activated sharpened blade which is slideable engageable with the cannula housing.

The document <CIT> relates to a device for transcutaneous biopsy comprising needle means provided with handle at a proximal end thereof and provided with cutting edge at a distal end thereof, mandrel means which may be inserted into said needle means, said needle means comprising a substantially cylindrical hollow body having a substantially constant inner diameter; the device comprises blocking means suitable for blocking a sample of tissue inside said needle means, said blocking means being slidably coupled inside said needle means.

The document <CIT> relates to a biopsy instrument including a tube having a finger-like projection at one end and a canula slidably disposed in the tube. After insertion of the biopsy instrument into a tissue, the tube is displaced on the canula so that the projection passes through an aperture in the canula to sever the tissue sample in the canula bore from the tissue. The projection retains the severed sample in the canula bore during withdrawal of the biopsy instrument from the tissue. A holding and control assembly having a first and second spring is provided for moving the tube and canula in a forward direction to penetrate the tissue and then substantially consecutively moving the tube in the forward direction to sever and retain the sample in the canula bore.

The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. The drawings depict only typical embodiments, which embodiments will be described with additional specificity and detail in connection with the drawings in which:.

Tissue biopsy devices may be configured to retrieve tissue samples from various locations within a patient's body. For example, a biopsy device may comprise a biopsy needle assembly, or needle assembly, including tubular members, cutting members, trocars, cannulae, and/or other components configured to access and sever a tissue sample. The needle assembly may be advanced to a location within the body through the skin of the patient (percutaneous access) or may be advanced through a body lumen or other structure. Furthermore, a biopsy device may comprise a handle or actuator configured to displace or deflect at least a portion of the needle assembly such that the needle assembly severs the targeted tissue sample.

Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments.

It will be appreciated that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another.

The phrases "coupled to" and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component.

The directional terms "distal" and "proximal" are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest the practitioner during use. As specifically applied to the syringe portion of an inflation device, the proximal end of the syringe refers to the end nearest the handle and the distal end refers to the opposite end, the end nearest the inlet/outlet port of the syringe. Thus, if at one or more points in a procedure a physician changes the orientation of a syringe, as used herein, the term "proximal end" always refers to the handle end of the syringe (even if the distal end is temporarily closer to the physician).

"Tissue" is used in its broadest sense, to refer to any tissue or substance within the human body.

<FIG> illustrate different views of a biopsy device and related components. In certain views each biopsy device may be coupled to, or shown with, additional components not included in every view. Further, in some views only selected components are illustrated, to provide detail into the relationship of the components. Some components may be shown in multiple views, but not discussed in connection with every view. Disclosure provided in connection with any figure is relevant and applicable to disclosure provided in connection with any figure or embodiment.

<FIG> is a perspective view of a biopsy device <NUM>. The biopsy device <NUM> is comprised of two sub-assemblies, a handle assembly <NUM> and a biopsy needle assembly <NUM>. Both sub-assemblies will be described in detail below.

<FIG> is a perspective view of a portion of the biopsy needle assembly <NUM>, and <FIG> is a cross-sectional view of the portion of the biopsy needle assembly <NUM> of <FIG>. As illustrated, the needle assembly <NUM> comprises an outer tubular member <NUM> comprising a distal end portion <NUM>. The distal end portion <NUM> of the outer tubular member <NUM>, is configured to cut or sever a first portion of a tissue sample. For example, advancement of the outer tubular member <NUM> through a tissue sample may core or cut the tissue sample and create a tube-like cut into the tissue, as further discussed below.

Referring to <FIG>, the biopsy needle assembly <NUM> further comprises a cutting member <NUM>, wherein the cutting member <NUM> is at least partially slidably disposed within the outer tubular member <NUM>. As depicted, the cutting member <NUM> comprises a distal end portion <NUM>. The distal end portion <NUM> of the cutting member <NUM> is configured to displace toward the longitudinal axis of the outer tubular member to cut or sever a distal end portion, or second portion, of the tissue sample. For example, a practitioner, such as a medical doctor, may identify a tissue in a patient to be extracted or sampled from the patient (i.e., for further analysis). The outer tubular member <NUM> can core or cut into the identified tissue sample and create a tube-like cut into the tissue, thus cutting or severing a first portion of the tissue sample. Subsequently, in some embodiments, the cutting member <NUM> can be configured to cut or sever a distal end of the tissue sample, or second portion of the tissue sample. Upon severing each of the first and the second portions of the tissue sample, the tissue sample may be separated from surrounding body tissue and the tissue sample may be extracted or removed from the patient, at least in part, by the biopsy needle assembly <NUM>.

Referring again to <FIG>, the needle assembly <NUM> can further comprise a trocar <NUM>, wherein the cutting member <NUM> may be slidably disposed around the trocar <NUM>. The trocar <NUM> can also comprise a distal end portion <NUM>. In some embodiments, the trocar <NUM>, and/or the distal end portion <NUM> of the trocar <NUM>, may be configured to facilitate advancement or displacement of the needle assembly <NUM> through body tissue to a position at or adjacent an identified tissue sample. For example, a practitioner can advance the trocar through the skin and/or tissue of a patient to a position at or adjacent to the site of an identified tissue sample. As the trocar is advanced, the trocar may displace the skin and/or tissue such that a pathway is generated through the skin and/or tissue that may ease advancement of other components of the needle assembly <NUM> to the position at or adjacent to the site of the tissue sample.

<FIG> is a perspective view of the outer tubular member <NUM> of <FIG>, <FIG> is a detail view of the distal end portion <NUM> of the outer tubular member <NUM> of <FIG> taken through line 3B, and <FIG> is a cross-section view of the distal end portion <NUM> of the outer tubular member <NUM> of <FIG>. The outer tubular member <NUM> comprises the distal end portion <NUM> and a proximal end portion <NUM>. As depicted, the outer tubular member <NUM> comprises a lumen <NUM> along at least a portion of a length of the cutting member <NUM>. The distal end portion <NUM> of the outer tubular member <NUM> is configured to sever the first portion of the tissue sample. For example, the distal end portion <NUM> of the outer tubular member <NUM> may generate or make a tube-shaped cut into or through a body tissue.

The distal end portion <NUM> of the outer tubular member <NUM> of <FIG> comprises a plurality of points <NUM>, the points <NUM> forming a cutting or penetrating edge. The cutting or penetrating edge may be sharp such that the outer tubular member <NUM>, and/or the distal end portion <NUM> of the outer tubular member <NUM>, is configured to cut or sever at least a portion of the tissue sample. Other cutting arrangements and mechanisms are also contemplated. For example, the distal end portion <NUM> of the outer tubular member <NUM> may comprise an annular blade or sharpened edge configured to cut or sever tissue. In the illustrated embodiment, the distal end portion <NUM> of the outer tubular member <NUM> comprises three points <NUM>. In other embodiments, the distal end portion <NUM> of the outer tubular member <NUM> may comprise one or two points <NUM>, while in yet other embodiments, the distal end portion <NUM> of the outer tubular member <NUM> may comprise four, five, six, or more points <NUM>. Distal end portions <NUM> of outer tubular members <NUM> comprising any number of points <NUM> are within the scope of this disclosure.

In some embodiments, at least a portion of the outer tubular member <NUM>, or the distal end portion <NUM> of the outer tubular member <NUM>, may be configured to allow or permit the outer tubular member <NUM> to more easily advance or be displaced through the body tissue.

The distal end portion <NUM> comprises a distal opening <NUM> and a proximal opening <NUM>. The openings <NUM>, <NUM> are axially aligned and are spaced from about <NUM> inch to <NUM> inch apart. The spacing is dependent upon the diameter of the outer tubular member <NUM>. For example, if the outer diameter of the outer tubular member is equivalent to a <NUM> gauge needle then the spacing is approximately <NUM> inch and for a <NUM> gauge needle the spacing is approximately <NUM> inch. The distal opening <NUM> may be a rectangular-shape, oval-shape, crescent-shape with the crescent opening directed distally or proximally, square-shape, or any other suitable shape. The distal opening <NUM> may have an axial length range of from <NUM> inch to <NUM> inch. The width of the distal opening <NUM> may be equivalent to approximately <NUM> degrees of the diameter of the outer tubular member <NUM>. The diameter of the outer tubular member may range from <NUM> gauge (<NUM> inch) to <NUM> gauge (<NUM> inch). Therefore, the width of the distal opening <NUM> may range from approximately <NUM> inch for an <NUM> gauge outer tubular member <NUM> to <NUM> inch for a <NUM> gauge outer tubular member <NUM>. <NUM> inch = <NUM>.

The proximal opening <NUM> may be a rectangular-shape with the long side of the proximal opening <NUM> oriented parallel to the longitudinal axis of the outer tubular member <NUM>. The proximal opening <NUM> may extend from proximal to a taper <NUM> to distal of the taper <NUM> at the distal end portion <NUM>. The width of the proximal opening <NUM> may be approximately equivalent to the width of the distal opening <NUM>. The openings <NUM>, <NUM> may be formed in the outer tubular member by any suitable manufacturing technique, such as machining, grinding, laser cutting, electrical discharge machining, etc. The taper <NUM> may reduce the diameter of the distal end portion <NUM> aproximately <NUM> gauge. For example, if the outer tubular member is equivalent to an <NUM> gauge needle at the proximal end portion <NUM> then the diameter of the distal end portion <NUM> distal to the taper <NUM> is approximately equivalent to an <NUM> gauge needle. The taper <NUM> may be formed utilizing any suitable manufacturing method, such as stretching, swaging, etc..

Also, as illustrated, the outer tubular member <NUM> can comprise a plurality of indicia <NUM> configured to indicate to the practitioner a distance that the outer tubular member <NUM> has advanced into a body tissue (for clarity not all indicia <NUM> are labeled). For example, each indicium <NUM> may be positioned <NUM> apart; thus, if the practitioner displaces the outer tubular member <NUM> into a body tissue up to the third indicia <NUM> from the distal end portion <NUM> of the outer tubular member <NUM>, it may indicate to the practitioner that approximately <NUM> of the outer tubular member <NUM> has been displaced into the body tissue. In some embodiments, the indicia <NUM> may comprise a plurality of substantially evenly spaced annular lines, marks, or grooves on an outside surface of the outer tubular member <NUM>. In certain embodiments, the indicia <NUM> may comprise a plurality of tick marks or the indicia may not be evenly spaced. Embodiments of any configuration of indicia are contemplated.

A portion or portions of at least one of the components of the biopsy needle assembly, including, but not limited to, the outer tubular member <NUM>, the indicia <NUM>, the cutting member, and/or the trocar, may also comprise a radiopaque material and/or an echogenic material. A radiopaque material (for example, in combination with a fluoroscope) may aid the practitioner in directing or displacing the needle assembly to a desired or predetermined position within the body tissue of the patient. Bismuth, gold, or other radiopaque materials alone, or in combination, may be used. An echogenic material (for example, in combination with ultrasound) may analogously aid the practitioner in directing or displacing the needle assembly to a desired or predetermined position within the body tissue of the patient. Surface disruptions such as texturing, grooves, dimples, or a combination of materials may also be used.

<FIG> is a perspective view of the cutting member <NUM> of FIG. 1B, <FIG> is a detail view of the distal end portion <NUM> of the cutting member <NUM> of <FIG> taken through line 4B, and <FIG> is a cross-section view of the distal end portion <NUM> of the cutting member <NUM> of <FIG>. As depicted, the cutting member <NUM> may comprise a lumen along at least a portion of a length of the cutting member <NUM>. The cutting member <NUM> comprises the distal end portion <NUM> and a proximal end portion <NUM>. The distal end portion <NUM> of the cutting member <NUM>, is configured to cut or sever the distal end portion, or second portion, of the tissue sample, as described above. At least a portion of the distal end portion <NUM> of the cutting member <NUM> is configured to displace inward toward the central axis of the outer tubular member <NUM> to cut or sever the distal end portion, or second portion, of the tissue sample. For example, as stated above, the outer tubular member <NUM> may generate a tube-like cut into the body tissue, severing the first portion of the tissue sample, and the cutting member <NUM> may be configured to cut or sever the tissue sample at a distal end of the tissue sample, severing the second portion of the tissue sample, at or adjacent a distal end of the tube-like cut made by the outer tubular member <NUM>. For example, the cutting member <NUM> may be configured to cut or sever the distal end portion, or second portion, of the tissue sample at the same longitudinal position as the distal end of the tube-like cut made by the outer tubular member <NUM>. In other embodiments, the cutting member <NUM> may be configured to cut or sever the distal end portion, or second portion, of the tissue sample at a position less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, or less than <NUM> from the distal end of the tube-like cut made by the outer tubular member <NUM>. In various embodiments, the cutting member <NUM> may be configured to cut or sever the distal end portion, or second portion, of the tissue sample at a clinically relevant position from the distal end of the tube-like cut made by the outer tubular member <NUM>. The cutting member <NUM> may also be configured to cut or sever the second portion of the tissue sample at other positions relative to the distal end of the tube-like cut made by the outer tubular member <NUM>.

With continued reference to <FIG>, the cutting member <NUM> comprises a finger or tab <NUM> configured to extend longitudinally from the proximal end portion <NUM>. In some configurations, the tab <NUM> and the cutting member <NUM> may be integrally formed from a single piece of material. The cutting member <NUM> and tab <NUM> may be formed from any suitable material, such as stainless steel, shape memory metal, etc. In certain embodiments, the tab <NUM> may comprise a distal portion <NUM> configured to be disposed into the lumen <NUM> of the outer tubular member <NUM> such that the distal portion <NUM> cuts or severs the second tissue portion. In some embodiments, the end of the distal portion <NUM> may be squared off, concave, convex, serrated, arrow shaped, barbed, or any other suitable shape to sever or cut the second portion of the tissue sample. The distal portion <NUM> may be longitudinally curved such that the tab <NUM> is directed from the outside of the outer tubular member <NUM> through the distal opening <NUM> of the outer tubular member <NUM>. The curve may direct the tab <NUM> through the distal opening <NUM> at an angle ranging from <NUM> degrees to <NUM> degrees dependent upon the length of the distal opening <NUM>. For example, if the distal opening <NUM> is configured with a long length the angle the tab <NUM> enters the distal opening <NUM> may be shallow and if the distal opening <NUM> has a short length the angle of entrance of the tab <NUM> into the distal opening <NUM> may be steep. The curved portion of the tab <NUM> may be formed by threading the straight tab <NUM> into the distal opening <NUM> and then extending the tab <NUM> against the proximal and distal edges of the distal opening <NUM> such that the tab <NUM> curls in a similar manner to curling a ribbon against a scissor blade. Alternatively, the curved portion of the tab <NUM> may be formed using any suitable technique, such as stamping, rolling, etc. The curved tab <NUM> may be disposed through the distal opening <NUM> and into the lumen <NUM> of the outer tubular member <NUM> past the central axis of the outer tubular member <NUM> or at least <NUM>% of the diameter of the lumen <NUM> of the outer tubular member <NUM> in order to cut or sever the second portion of the tissue sample.

The tab <NUM> is configured to extend through the proximal opening <NUM> from the lumen <NUM> of the outer tubular member <NUM> to the outside of the outer tubular member <NUM>. Prior to activation of the biopsy device <NUM>, the distal end of the tab <NUM> may be disposed partially into the distal opening <NUM> such that the distal end does not catch tissue as the biopsy needle assembly <NUM> is inserted into the patient's tissue. The length of the proximal opening <NUM> is configured to allow for axial displacement of the cutting member <NUM> and tab <NUM> such that the tab <NUM> passes through the distal opening <NUM> and past the central axis of the lumen <NUM> of the outer tubular member <NUM> to cut or sever the second portion of the tissue sample.

<FIG> depict cross-sectional views of portions of the outer tubular member <NUM> and the cutting member <NUM> of <FIG> in a first configuration and a second configuration, respectively. <FIG> shows a portion of the biopsy needle assembly <NUM> in the first or ready configuration. At least a portion of the distal end portion <NUM> of the cutting member <NUM> is positioned proximal to at least a portion of the distal end portion <NUM> of the outer tubular member <NUM>. The tab <NUM> extends distally from a lumen <NUM> of the outer tubular member <NUM> and through the proximal opening <NUM> such that the distal end of the tab <NUM> is disposed partially within the distal opening <NUM> such that the distal end of the tab <NUM> does not catch tissue as the biopsy needle assembly <NUM> is inserted into the tissue of the patient. <FIG> shows a portion of the biopsy needle assembly in a second or activated configuration. The cutting member <NUM> is translated distally within the outer tubular member <NUM>. A portion of the tab <NUM> is extending through the distal opening <NUM> such that the distal end of the tab <NUM> extends at least to the central axis of the outer tubular member <NUM>. In this configuration, the tab <NUM> is configured to cut or sever a second portion of a tissue sample.

<FIG> is a perspective view of the trocar <NUM> of <FIG> and <FIG> is a detail view of the distal end portion <NUM> of the trocar <NUM> of <FIG> taken through line 6B. The cutting member <NUM>, as described above, may be slidably disposed around the trocar <NUM>. In some embodiments, the trocar <NUM> may be fixed with respect to an actuator or handle <NUM> as described below in connection with <FIG>. Further, as depicted, the trocar <NUM> comprises the distal end portion <NUM> and a proximal end portion <NUM>. The distal end portion <NUM>, as illustrated, can be substantially sharp. In some embodiments, the trocar <NUM>, and/or the distal end portion <NUM> of the trocar <NUM>, may be configured to facilitate movement of the biopsy needle assembly <NUM> through body tissue. For example, as described above, a practitioner or user can advance the trocar <NUM> through the skin and/or tissue of a patient to a position at or adjacent to the site of an identified tissue sample. As the trocar <NUM> is advanced, the trocar <NUM> may displace the skin and/or tissue such that a pathway is generated through the skin and/or tissue that may ease advancement of other components of the needle assembly <NUM> to the position at or adjacent to the site of the tissue sample.

<FIG> is a perspective exploded view of the tissue biopsy device <NUM> of <FIG>. The tissue biopsy device <NUM> can comprise a needle assembly <NUM> operatively coupled to a handle <NUM>, or actuator. For example, at least a portion of at least one of the proximal end portions <NUM>, <NUM>, <NUM> of the outer tubular member <NUM>, the cutting member <NUM>, and/or the trocar <NUM> may be operatively coupled to the handle <NUM>. The handle <NUM> may be configured to actuate at least one of the outer tubular member <NUM>, the cutting member <NUM>, and/or the trocar <NUM> to cut or sever the tissue sample from the body of a patient. In some embodiments, the handle <NUM> may be configured to actuate at least the outer tubular member <NUM> and the cutting member <NUM> to cut or sever the tissue sample from the body. The handle <NUM> may also be configured to retract the needle assembly <NUM> from the body and/or to extract the tissue sample from the body of a patient. It is within the scope of this disclosure to couple embodiments of the biopsy needle assembly, as described herein, to any type of handle or actuator. A handle or actuator can have springs and can displace components of the needle assembly <NUM> relative to each other. A series of steps or displacements of the components of the tissue biopsy device <NUM> can be effectuated in response to a single input or trigger by a practitioner. Various handles or actuators may be used with the biopsy needle assemblies disclosed herein. For example, <CIT> and titled "Impact Biopsy Device and Method of Use," which is considered the closest prior art to the present invention, discloses handles and actuators that may be used in connection with the biopsy needle assemblies disclosed here.

<FIG> depicts the handle <NUM> comprising a body member <NUM>, a priming handle <NUM>, a retention tube <NUM>, a spring <NUM>, traveler member <NUM>, a follower member <NUM>, a spacer <NUM>, a threaded portion <NUM> and a cap <NUM>. The trocar <NUM> is coupled to the retention tube <NUM>, the outer tubular member <NUM> is coupled to the follower member <NUM>, and the cutting member <NUM> is coupled to the traveler member <NUM>. The traveler member <NUM> is releasably coupled to the follower member <NUM>. The follower member <NUM> and the traveler member <NUM> are slidably disposed within the retention tube <NUM>. The traveler member <NUM> and the follower member <NUM> are configured to effectuate the sequential linear movement of the cutting member <NUM> and the outer tubular member <NUM> as a tissue sample is collected in the biopsy needle assembly.

In some embodiments, in use, the handle <NUM> is primed for activation when the practitioner pulls the priming handle <NUM> proximally to compress the spring <NUM>. The biopsy needle assembly <NUM> is inserted into the tissue of the patient such that the biopsy needle assembly <NUM> is adjacent to the tissue to be sampled. The handle <NUM> is activated by the practitioner allowing the spring <NUM> to decompress. The spring <NUM> applies an axial force to the traveler member <NUM> causing the traveler member <NUM>, the follower member <NUM>, the outer tubular member <NUM>, and the cutting member <NUM> to be disposed distally together while the trocar <NUM> remains stationary. This movement causes the outer tubular member <NUM> and the cutting member <NUM> to enter the target tissue with the first portion of the tissue sample being cut or severed and retained within the distal portion of the lumen <NUM> of the outer tubular member <NUM>. Linear movement of the follower member <NUM> and the outer tubular member <NUM> is stopped when the follower member <NUM> abuts the proximal end of the threaded portion <NUM>. When the follower member <NUM> abuts the threaded portion <NUM> the traveler member <NUM> is released from engagement to the follower member <NUM> allowing the traveler member <NUM> and the cutting member <NUM> to continue to move distally. Distal movement of the traveler member <NUM> and the cutting member continues until the traveler member <NUM> abuts the proximal end of the spacer <NUM> which is disposed between the traveler member <NUM> and the follower member <NUM>. The additional movement of the traveler member <NUM> and the cutting member <NUM> causes the tab <NUM> to pass through the distal opening <NUM> of the outer tubular member <NUM> and into the lumen <NUM> of the outer tubular member <NUM> such that the tissue sample within the outer tubular member <NUM> is cut or severed by the tab <NUM>. The additional distance the traveler member <NUM> and the cutting member <NUM> travel is determined by the length of the spacer <NUM>. The spacer <NUM> length allows the tab <NUM> to stop movement within the lumen <NUM> of the outer tubular member <NUM> when the distal end of the tab <NUM> is between the central axis and opposite wall of the outer tubular member <NUM>.

For instance, an exemplary tissue biopsy device may comprise a first elongate member configured to be advanced into a body tissue, for example, an elongate member analogous to the trocar <NUM> of <FIG>. The tissue biopsy device may further comprise a second elongate member, wherein the second elongate member is disposed around the first elongate member, and wherein the second elongate member is configured to sever a first portion of a tissue sample, for example, an elongate member analogous to the outer tubular member <NUM> of <FIG>. Additionally, the tissue biopsy device may comprise a third elongate member, wherein the third elongate member may be movably disposed within the second elongate member and around the first elongate member, and wherein the third elongate member is configured to sever a second portion of the tissue sample at or adjacent a distal-most point of a distal end portion of the second elongate member, for example, an elongate member analogous to the cutting member <NUM> of <FIG>. In some embodiments, the third elongate member may be configured to cut or sever the second portion of the tissue sample at the same longitudinal position as the distal-most point of the distal end portion of the second elongate member. In other embodiments the third elongate member may be configured to cut or sever the second portion of the tissue sample at an optimized position from the distal-most point of the distal end portion of the second elongate member. The third elongate member may also be configured to cut or sever the second portion of the tissue sample at other positions relative to the distal-most point of the distal end portion of the second elongate member. The third elongate member may also be configured to retain the second portion of the tissue sample within the needle assembly <NUM> when the needle assembly <NUM> is withdrawn from the tissue of the patient. Further, the tissue biopsy device may comprise an actuator, for example, an actuator analogous to the handle <NUM> of <FIG>. The actuator may be configured to displace or deflect at least one of the second elongate member and the third elongate member such that the tissue sample is severed. The actuator may also be configured to retract each of the first elongate member, the second elongate member, the third elongate member, and/or the tissue sample from the body of a patient.

<FIG> are schematic in nature. In other words, the figures show the functional and operational relationships of a portion of the biopsy needle assembly <NUM> upon use in a patient, but the figures are not intended to indicate any particular structure or spatial disposition of any tissue, organ, body component, or group of body components in the patient. Additionally, the schematic representations herein may be drawn to show internal tissues and/or organs of the patient without explicitly designating cross-sections or cutaways of the tissues and/or organs. For example, a body tissue may be schematically shown with the biopsy needle assembly disposed therein without indicating a cross-section portion or cutaway of a portion of the body tissue. <FIG> are schematic representations of cross-sectional views of the portion of the needle assembly <NUM> of <FIG> in a first configuration, a second configuration, a third configuration, and a fourth configuration respectively.

<FIG> illustrates the outer tubular member <NUM>, the cutting member <NUM>, and the trocar <NUM> of the needle assembly <NUM> advanced into a body tissue <NUM>, as shown by the arrow, in the first configuration. In some embodiments, a practitioner may determine a tissue sample to obtain. As such, the distal end portion <NUM> of the trocar <NUM> may be disposed to a position at or adjacent a proximal end portion of the predetermined tissue sample. In the first configuration, the sharp end of the trocar extends distally beyond the distal end portion <NUM> of the outer tubular member <NUM> and the distal end portion <NUM> of the cutting member <NUM> such that the trocar may cut a path through the patient's tissue. The distal end of the tab <NUM> is at least partially disposed within the distal opening <NUM> of the outer tubular member <NUM> such that the distal end does not catch tissue as the needle assembly <NUM> is inserted into the patient's tissue.

<FIG> illustrates the outer tubular member <NUM>, the cutting member <NUM>, and the trocar <NUM> of the needle assembly <NUM> advanced into a body tissue <NUM>, as shown by the arrow, in the second configuration. The outer tubular member <NUM> and the cutting member <NUM> are displaced distally into the tissue to be sampled. As depicted, such displacement of the outer tubular member <NUM> can sever a first portion of a tissue sample <NUM>. In some embodiments, the outer tubular member <NUM> can be displaced distally relative to the trocar <NUM>, such that the distal end portion <NUM> of the outer tubular member <NUM> is extended a distance, or stroke length, into the body tissue <NUM> relative to the trocar <NUM>. The length D1, as identified in <FIG>, represents the stroke length, as described above.

<FIG> illustrates the outer tubular member <NUM>, the cutting member <NUM>, and the trocar <NUM> of the needle assembly <NUM> advanced into a body tissue <NUM>, as shown by the arrow, in the third configuration. The cutting member <NUM> is displaced distally relative to the outer tubular member <NUM>. Displacement of the cutting member <NUM> may result in at least the distal end of the tab <NUM> severing a second portion <NUM> of the tissue sample <NUM> at or adjacent a distal-most point of the distal end portion <NUM> of the outer tubular member <NUM>. For example, the cutting member <NUM> may be configured to cut or sever the second portion <NUM> of the tissue sample <NUM> at the optimized position from the distal-most point of the distal end portion <NUM> of the outer tubular member <NUM>. The cutting member <NUM> may also be configured to cut or sever the second portion <NUM> of the tissue sample <NUM> at the same longitudinal position as the distal-most point of the distal end portion <NUM> of the outer tubular member <NUM>. The cutting member <NUM> may also be configured to cut or sever the second portion <NUM> of the tissue sample <NUM> at other positions relative to the distal-most point of the distal end portion <NUM> of the outer tubular member <NUM>.

In some embodiments of the present disclosure, the configuration of the distal end portion <NUM> of the cutting member <NUM> with respect to the distal end portion <NUM> of the outer tubular member <NUM> may be such that the distal end of the tissue sample <NUM> is severed at or adjacent the distal end portion <NUM> of the outer tubular member <NUM>. In certain configurations, the distal end portion <NUM> of the cutting member <NUM> can pass through the distal opening <NUM> of the outer tubular member <NUM> such that the distal end portion <NUM> of the cutting member <NUM> is configured to sever the second portion <NUM> of the tissue sample <NUM>. As described above, severing the second portion <NUM> of the tissue sample <NUM> may comprise displacing at least a portion of the distal end portion <NUM> of the cutting member <NUM> toward a central axis of the cutting member <NUM>.

In some embodiments, actuation of the outer tubular member <NUM> and/or the cutting member <NUM> may be effectuated by a handle or actuator, such as handle <NUM> of <FIG>. In certain embodiments, displacement of the outer tubular member <NUM> may occur prior to the displacement of the cutting member <NUM>. In certain other embodiments, displacement of the outer tubular member <NUM> and the cutting member <NUM> may occur substantially simultaneously. The position of the trocar may remain substantially stationary during the displacement of each of the outer tubular member <NUM> and the cutting member <NUM>. Other timing and/or sequences of the displacement of each of the outer tubular member <NUM> and the cutting member <NUM> are also contemplated.

Upon severing of the tissue sample <NUM>, as illustrated in <FIG>, each of the trocar, the outer tubular member <NUM>, the cutting member <NUM>, and the trocar <NUM> may be retracted from the body tissue <NUM> of the patient with the tissue sample <NUM> retained within the lumen <NUM> of the outer tubular member <NUM> by the tab <NUM>. In certain embodiments, relative positions of each of the trocar <NUM>, the outer tubular member <NUM>, and the cutting member <NUM> may be substantially maintained upon the retraction of the each of the trocar <NUM>, the outer tubular member <NUM>, and the cutting member <NUM> from the body tissue <NUM>. The tab <NUM> of the cutting member may act as a barrier to retain the tissue sample <NUM> within the lumen <NUM> of the outer tubular member <NUM> during retraction of the biopsy needle assembly <NUM>.

Claim 1:
A biopsy needle assembly (<NUM>) configured for use with a tissue biopsy device (<NUM>), the biopsy needle assembly comprising:
an outer tubular member (<NUM>) comprising a distal end portion (<NUM>) configured to sever a first portion of a tissue sample, wherein the outer tubular member (<NUM>) further comprises a lumen (<NUM>); and
a cutting member (<NUM>) slidably disposed within the outer tubular member (<NUM>), wherein the cutting member (<NUM>) comprises a distal end portion (<NUM>), and wherein the distal end portion (<NUM>) of the cutting member is configured to displace toward a central axis of the outer tubular member (<NUM>) to sever a second portion of the tissue sample; and
wherein the distal end portion (<NUM>) of the cutting member (<NUM>) further comprises a tab (<NUM>),
characterized in that the distal end portion (<NUM>) of the outer tubular member (<NUM>) further comprises a proximal opening (<NUM>) and a distal opening (<NUM>), wherein the tab (<NUM>) is configured to extend out of the lumen (<NUM>) of the outer tubular member (<NUM>) through the proximal opening (<NUM>) and into the lumen (<NUM>) of the outer tubular member (<NUM>) through the distal opening (<NUM>), and wherein displacement of a portion of the tab (<NUM>) into the lumen (<NUM>) of the outer tubular member (<NUM>) from outside the outer tubular member (<NUM>) is configured to sever the second portion of the tissue sample.