Patent Description:
As an example of systems utilizing needles, endoscopic ultrasound biopsy systems with exchangeable biopsy needles allow biopsy samples to be obtained from potentially cancerous pulmonary nodules under radial ultrasound guidance. These systems may include exchangeable needles to eliminate the need for the entire system to be removed from the patient, e.g., through the endoscope working channel, after each biopsy sample is taken. Exchangeable needles may improve procedure time by allowing a second biopsy sample to be taken after the previous sample is expelled for analysis, and may improve efficiency by maintaining the ultrasound image of the target nodule throughout the procedure. Once the needle is removed from the biopsy system, the exposed needle tip may pose a puncture/needle-stick risk to medical professionals in the operating room and/or technicians in the diagnostic laboratory. In addition, the tortuous anatomies within which exchangeable needle systems are deployed may result in puncture/skiving of the delivery catheter wall by the sharpened end of the biopsy needle. This skiving may result in a partial or incomplete biopsy sample and/or prevent the biopsy needle from completely retracting into the delivery catheter, thereby further promoting the potential for a puncture/needle stick.

<CIT> discloses a biopsy device including an ultrasonic probe, a display, an actuator, and a needle assembly. The actuator is configured to move the needle assembly in a distal direction relative to the ultrasonic probe and through the channel of the ultrasonic probe from a retracted position to a deployed position.

<CIT> discloses a minimally invasive system comprising an elongate sheath and an elongate instrument slidably disposed within a lumen of the sheath. The sheath includes a flexible tube portion including a plurality of slots, a sheath element, and a rigid tube section, wherein the flexible tube portion is fixedly coupled to a distal end of the sheath element, and the rigid tube section is fixedly coupled to a distal end of the flexible tube. The lumen extends through the sheath element, the flexible tube portion, and the rigid tube section and defines a longitudinal axis of the sheath. The instrument includes a rigid distal portion adapted to slide between a retracted configuration in which the rigid distal portion is retracted within the rigid tube section and an extended configuration in which the rigid distal portion at least partially extends from the rigid tube section.

A variety of advantageous medical outcomes may therefore be realized by the systems and/or methods of the present disclosure, which provide the combined benefits of a biopsy needle assembly that may be exchangeable, may prevent or eliminate puncture or skiving of the delivery catheter during a biopsy procedure, and may shield the exposed sharpened needle tip while still allowing the biopsy sample to be expelled for analysis.

The invention is defined in claim <NUM> and claim <NUM>. Aspects, embodiments and examples of the present disclosure which do not fall under the scope of the appended claims do not form part of the invention and are merely provided for illustrative purposes.

The present disclosure is not limited to the particular embodiments described herein. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

Although embodiments of the present disclosure are described with specific reference to medical systems for acquiring biopsy samples from a pulmonary nodule under radial ultrasound guidance, it should be appreciated that such systems may be used in a variety of medical procedures where there is a need for exchangeable or single-use needle assemblies that shield the exposed needle tip while still allowing the needle tip to be accessible, including, for example, in endoscopy procedures, intravenous procedures, etc..

As used herein, the term "distal" refers to the end farthest away from the medical professional when introducing a device into a patient, while the term "proximal" refers to the end closest to the medical professional when introducing a device into a patient.

In various embodiments, the present disclosure relates to devices to shield the exposed tip of an exchangeable biopsy needle following removal from the patient. Referring to <FIG>, in one embodiment, a needle assembly <NUM> (e.g., biopsy needle assembly) of the present disclosure may include a biopsy needle <NUM> slidably disposed within a sheath <NUM>. The sheath <NUM> may include a proximal end <NUM>, a distal end <NUM> and a lumen <NUM> extending therebetween. In various embodiments, the sheath <NUM> may include an outer dimension d<NUM> and an inner dimension d<NUM> (e.g., of lumen <NUM>). The needle <NUM> may include proximal end <NUM>, a sharpened distal end <NUM> and a lumen <NUM> extending therebetween. In various embodiments, the biopsy needle <NUM> may include an outer dimension d<NUM> less than the inner dimension d<NUM> of the lumen <NUM> of sheath <NUM>.

An actuation mechanism <NUM> may be disposed along a proximal portion of the needle assembly <NUM>. The actuation mechanism <NUM> may include a housing <NUM>, comprising a channel <NUM> formed within a distal portion of the housing <NUM> (e.g., along a longitudinal axis of the housing) and a chamber <NUM> formed within a proximal portion of the housing <NUM>. A spring <NUM> may be disposed within, and extend along a longitudinal length of, the chamber <NUM>. A push button <NUM> may be engaged with the proximal portion of the housing <NUM> and configured to move between a plurality of distally advanced and proximally retracted positions within the chamber <NUM>. In various embodiments, the proximal portion of the housing <NUM> may include one or more surface features 132a configured to engage one or more corresponding surface features 139a formed along the distal portion of the push button <NUM>. The surface features 132a, 139a may be configured to contact each other to maintain the push button <NUM> within the housing <NUM> (e.g., prevent separation) when the push button <NUM> is in the proximally retracted configuration. In various embodiments, the surface features 132a, 139a may include one or more inward and outward extending tabs (respectively) disposed in various patterns (including a fully circumferential patterns) along the respective proximal and distal ends of the housing <NUM> and push button <NUM>. In addition, or alternatively, the housing <NUM> and push button <NUM> may include a variety of configurations to prevent unintended separation, including, for example, corresponding thread or luer-lock connector configurations, and the like.

A proximal portion <NUM> of the sheath <NUM> may be immovably attached or affixed to the distal portion of the housing <NUM>. In various embodiments, the proximal portion <NUM> of the sheath <NUM> may be bonded, adhered and/or integrally formed with at least a portion of the channel <NUM> of housing <NUM>. A proximal portion <NUM> of the needle <NUM> may extend proximally beyond the proximal end <NUM> of the sheath <NUM>, and through the spring <NUM> within the chamber <NUM>, such that the proximal end <NUM> of the needle <NUM> contacts (or is adjacent to) an inner surface of the push button <NUM>. In various embodiments, the proximal end <NUM> of the needle <NUM> may be attached to a stylet <NUM> extending through an opening (not shown) formed within a proximal end of the push button <NUM>. The stylet <NUM> may extend through all, or a portion, of the lumen <NUM> of the needle <NUM>. The stylet may obstruct or occlude the lumen <NUM>, e.g., as the needle is advanced through narrow and tortuous body passages. The stylet <NUM> may be removed to provide access to the lumen <NUM>, e.g., to expel or aspirate a biopsy sample, or to inject a fluid into or around the target pulmonary nodule.

In various embodiments, the push button <NUM> may be distally advanced/depressed, e.g., under the force applied by a thumb and forefinger of a user, to compress the spring <NUM> within the chamber <NUM>, thereby distally advancing the needle <NUM> relative to the sheath <NUM> such that the sharpened distal end <NUM> of the needle <NUM> moves from a first position (e.g., shielded, retracted or protected position) within the lumen <NUM> proximal to the distal end <NUM> the sheath <NUM> (<FIG>), to a second position (e.g., exposed, extended, unprotected) distally beyond (e.g., positioned distal to) the distal end <NUM> of the sheath <NUM> (<FIG>). Similarly, the push button <NUM> may be proximally retracted/released, e.g., by removing or reducing the distal force exerted by the user, such that the spring <NUM> returns to the relaxed (e.g., non-compressed) position, thereby retracting the sharpened distal end <NUM> of the needle <NUM> into the lumen <NUM> of the sheath <NUM>.

Referring to <FIG>, in one embodiment, a needle assembly <NUM> (e.g., biopsy needle assembly) of the present disclosure may include a sheath <NUM> and needle <NUM>, e.g., as depicted in <FIG>, with the exception that the sheath <NUM> is slidably disposed around at least a portion of the needle <NUM>. The sheath <NUM> may include a proximal end <NUM>, a distal end <NUM> and a lumen <NUM> extending therebetween. The sheath <NUM> may include an outer dimension d<NUM> and an inner dimension d<NUM> (e.g., of lumen <NUM>). The needle <NUM> may include a proximal end <NUM>, a sharpened distal end <NUM> and a lumen <NUM> extending therebetween. The biopsy needle may include an outer dimension d<NUM> less than the inner dimension d<NUM> of the lumen <NUM> of sheath <NUM>.

An actuation mechanism <NUM> may be disposed along a proximal portion of the needle assembly <NUM>. The actuation mechanism <NUM> may include a housing <NUM>, a channel <NUM> may extend through/along a length (e.g., longitudinal axis) of the housing <NUM> and a slot or opening <NUM> may extend through a wall of the housing <NUM> in communication with (e.g., opening into) a distal portion of the channel <NUM>. An arm <NUM> (e.g., slider arm, trigger, finger grip, etc.) may extend through the slot <NUM> of the housing <NUM> such that a first end 236a of the arm <NUM> extends into, or is substantially coextensive with, the channel <NUM> and a second end 236b of the arm extends outside the housing <NUM>.

A proximal portion <NUM> of the sheath <NUM> may be slidably/movably disposed within the distal portion of the channel <NUM>. The first end 236a of the arm <NUM> may be attached to, or integrally formed with, the distal end <NUM> of the sheath <NUM>. A proximal portion <NUM> of the needle <NUM> may extend proximally beyond the proximal end <NUM> of the sheath <NUM> and through the remaining (e.g., proximal portion) of the channel <NUM> such that the proximal end <NUM> of the needle <NUM> contacts (or is adjacent to) an inner surface of the housing <NUM>. In various embodiments, the proximal end <NUM> of the needle <NUM> may be attached to a stylet <NUM> extending through an opening (not shown) formed within a proximal end of the housing <NUM>. As above, the stylet <NUM> may extend through all, or a portion, of the lumen <NUM> of the needle <NUM>. The stylet may obstruct or occlude the lumen <NUM>, e.g., as the needle is advanced through narrow and tortuous body passages. The stylet <NUM> may be removed to provide access to the lumen <NUM>, e.g., to expel or aspirate a biopsy sample, or to inject a fluid into or around the target pulmonary nodule.

In various embodiments, the arm <NUM> may be proximally retracted along the slot <NUM>, e.g., under the force applied by a thumb and forefinger of a user, thereby proximally retracting the sheath <NUM> relative to the needle <NUM> such that the sharpened distal end <NUM> of the needle <NUM> moves from a first position (e.g., shielded, retracted or protected position) within the lumen <NUM> proximal to the distal end <NUM> the sheath <NUM> (<FIG>), to a second position (e.g., exposed, extended, unprotected) distally beyond the distal end <NUM> of the sheath <NUM> (<FIG>). Similarly, the arm <NUM> may be distally advanced along the slot <NUM> such that the sheath <NUM> moves along the needle <NUM> to position/reposition the distal end <NUM> of the sheath <NUM> distally beyond the sharpened distal end <NUM> of the needle <NUM>.

In various embodiments, a spring (not shown) may be disposed within a portion of the channel <NUM> proximally beyond the proximal end of the sheath <NUM>, and with the proximal portion of the needle <NUM> extending through the spring, as discussed above. As the arm <NUM> is proximally retracted along the slot <NUM>, the spring may compress within the channel <NUM> to expose the sharpened distal end <NUM> of the needle <NUM>. The arm <NUM> and sheath <NUM> may then return to the first position by partially or fully releasing the pressure exerted on the arm <NUM> such that the spring <NUM> returns to the relaxed (e.g., non-compressed) position.

Referring to <FIG>, in one embodiment, a system <NUM> of the present disclosure may include a needle assembly <NUM>, <NUM> slidably disposed within a dual-lumen catheter <NUM>. In various embodiments, the dual-lumen catheter <NUM> may include a proximal end <NUM>, a distal end <NUM>, a first lumen <NUM> and a second lumen <NUM> extending therebetween. The first lumen <NUM> may include an inner dimension d<NUM> sized and configured to receive the outer dimension d<NUM> of the sheath <NUM> of the needle assembly <NUM>, <NUM>. The second lumen <NUM> may include an inner dimension d<NUM> sized and configured to receive a radial ultrasound probe (not shown).

Referring to <FIG>, the sheath <NUM> and needle <NUM> of the needle assembly <NUM>, <NUM> may be advanced in the first position (<FIG>, <FIG>) through the first lumen <NUM> to position the distal end <NUM> of the sheath <NUM> adjacent to (or substantially coextensive with) the distal end <NUM> of the dual-lumen catheter <NUM>.

Referring to <FIG>, in one embodiment, the needle assembly <NUM> may be moved from the first to second position, e.g., by distally advancing push button <NUM> (as discussed above) to advance the sharpened distal end <NUM> of the needle <NUM> distally beyond the respective distal ends <NUM>, <NUM> of the sheath <NUM> and dual-lumen catheter <NUM>. Still referring to <FIG>, in another embodiment, the needle assembly <NUM> may be moved from the first to second position, e.g., by proximally retracting the arm <NUM> and sheath <NUM> (as discussed above), to such that the sharpened distal end <NUM> of the needle <NUM> extends distally beyond the distal end <NUM> of the sheath <NUM> within the first lumen <NUM> of the dual-lumen catheter <NUM>. The needle assembly <NUM>, including the exposed sharpened distal end <NUM> of the needle <NUM> may then be further distally advanced through the first lumen <NUM> while maintaining the arm <NUM> and sheath <NUM> in the second position, such that the sharpened distal end <NUM> of the needle <NUM> distally beyond the distal end <NUM> of the dual-lumen catheter <NUM>.

In use, and by way of example, a needle biopsy system <NUM> of the present disclosure may be inserted into a pulmonary passage of a patient through a working channel of an endoscope and adjacent to a target pulmonary nodule. The stylet <NUM> may then be removed from the lumen of the biopsy needle <NUM>, and the sharpened distal end <NUM> of the needle <NUM> advanced distally beyond the distal end <NUM> of the dual-lumen catheter <NUM> into the target pulmonary nodule (as discussed above). The user may distally deploy the needle <NUM> into the target pulmonary nodule as many times as necessary to acquire sufficient tissue for analysis. When the user determines that the biopsy needle contains a sufficient amount of tissue from the target pulmonary nodule, the needle assembly <NUM>, <NUM> may be returned to the first position (e.g., with the sharpened distal end <NUM> positioned proximal to the distal end <NUM> of the sheath <NUM>), and the needle assembly <NUM>, <NUM> proximally withdrawn from the first lumen <NUM> of the dual-lumen catheter <NUM>. The sharpened distal end <NUM> of the needle is therefore shielded from the user and/or ancillary personnel immediately upon removal from the sheath <NUM>. In various embodiments, the needle assembly <NUM>, <NUM> may be removed from within the first lumen <NUM> of the dual-lumen catheter <NUM> without changing the position of the dual-lumen catheter <NUM> and radial ultrasound probe relative to the target pulmonary nodule.

In various embodiments, the tissue sample may then be expelled from the needle assembly while the sharpened distal end <NUM> remains safely housed within the sheath <NUM>. Alternatively, the sharpened distal end <NUM> of the needle <NUM> may be advanced distally beyond the distal end <NUM> of the sheath <NUM> prior to expelling the tissue sample. The needle assembly <NUM>, <NUM> may then be proximally retracted into the sheath <NUM>, and the needle assembly <NUM>, <NUM> re-introduced through the first lumen <NUM> of the dual-lumen catheter <NUM> to acquire an additional biopsy sample from the same, or a different, pulmonary nodule. Alternatively, one or more different needle assemblies <NUM>, <NUM> may be introduced through the first lumen <NUM> of the dual-lumen catheter <NUM> while the biopsy sample is being expelled from the original needle assembly <NUM>, <NUM>. The ability to obtain multiple additional biopsy samples from the same or different pulmonary nodule while the biopsy sample is expelled from the original (e.g., first needle assembly) may further improve procedure time, efficiency and accurate/reliable diagnostic results.

In various embodiments, the respective inner and outer dimensions (d<NUM>-d<NUM>) of the sheath <NUM>, needle <NUM> and first lumen <NUM> may be configured to minimize or prevent puncture or skiving of the sheath <NUM> and/or dual-lumen catheter <NUM> by the sharpened distal end <NUM> of the needle <NUM>, e.g., within narrow and tortuous body passages in which the needle biopsy system <NUM> may be bent or torqued at a variety of angles during biopsy sample collection. Referring to <FIG>, in one embodiment, the inner dimension d<NUM> of the first lumen <NUM> and the outer dimension d<NUM> of the sheath <NUM> may be separated by a distance d<NUM> (e.g., approximately <NUM> inch) configured to allow the needle assembly <NUM>, <NUM> to move smoothly (e.g., with low or minimal friction) within the first lumen <NUM> with minimal lateral movement of the needle assembly <NUM>, <NUM>, e.g., which might contribute to puncture or skiving of the sheath <NUM> and/or dual-lumen catheter <NUM> during biopsy sample collection or expulsion.

In various embodiments, the sheath <NUM> may comprise a variety of low friction materials along all or a portion of the length of the sheath to minimize friction between the first lumen <NUM> of the dual-lumen catheter <NUM> and/or biopsy needle <NUM>. The sheath <NUM> may be formed entirely from these low friction materials, or provided as inner and/or outer coatings of the sheath. Non-limiting examples of low-friction materials includes, Pebax, loaded Pebax, BaSO<NUM>, PTFE, Mediglide™, Polymide, PEEK and glass-fiber reinforced PEEK. In addition, or alternatively, the first and/or second lumens <NUM>, <NUM> of the dual-lumen catheter <NUM> may include a coating or liner of any of these low friction materials. In addition, or alternatively, at least a portion of the sheath <NUM> may comprise an optically translucent material (e.g., glass, plastic, rubber, etc.) to allow a user to visualize the sharpened end the needle <NUM> and/or biopsy sample disposed therein.

In various embodiments, the sharpened distal end <NUM> of the needle <NUM> may include a needle grind configured to further reduce the potential for puncture or skiving of the sheath <NUM> and/or dual-lumen catheter <NUM>. For example, the needle <NUM> may include a three-point "Francine" needle grind, in which the sharpened points of the needle <NUM> extend slightly inward toward the lumen of the needle to further minimize the potential for puncture or skiving of the sheath or dual-lumen catheter. In addition to reducing friction, these low friction materials and/or coatings may further reduce the likelihood or ability of the sharpened distal end of the needle to puncture or skive the sheath and/or dual-lumen catheter. To further reduce the puncture or skiving of the sheath and/or dual-lumen catheter, in various embodiments, the needle <NUM> may be formed from or otherwise include a variety of flexible and/or kink-resistant materials (e.g., Nitnol, etc.) along all, or a portion of, the length of the needle <NUM>.

In various embodiments, the sheath <NUM> may be formed from or include a variety of metallic, plastic, fiber or composite materials, or combinations thereof, along all or a portion of the length of the sheath. Such materials may provide the requisite mechanical strength for insertion of the sheath <NUM> into, and removal from, the tortuous path of the dual-lumen catheter <NUM> within the body, and/or minimize the potential for skiving by the sharpened distal end <NUM> of the needle <NUM>. As will be understood by those of skill in the art, such metallic, plastic, fiber and/or composite materials may also reduce or eliminate the tendency of the sheath <NUM> to compress and/or stretch during insertion into, and removal from the dual-lumen catheter <NUM>.

In addition, or alternatively, one or more slots or grooves may be included (e.g., laser slotted) along all or various portions of the length of the sheath <NUM> and/or dual-lumen catheter <NUM> to further increase the flexibility of the needle biopsy system <NUM>, e.g., within tortuous body passages. In various embodiments, the sheath <NUM> is not limited to unitary or solid configurations, but may be formed from a hypotube, coil and/or braid along all or a portion of the length of the sheath.

In various embodiments, the sheath <NUM> and first lumen <NUM> of the dual-lumen catheter <NUM> are not limited to circular configurations, but may include a variety of cross-sectional shapes and/or geometries, including, for example, elliptical, oval or star-shaped geometries. In various embodiments, these geometries may minimize the surface area of the sheath <NUM> in contact with the inner wall of first lumen <NUM> the dual-lumen catheter <NUM>, thereby further reducing friction and the potential for puncture or skiving by the sharpened distal end <NUM> of the needle <NUM>.

The needle assemblies <NUM>, <NUM> of the present disclosure are in no way limited to systems that include dual-lumen catheters, but may be employed in a variety of single or multi-lumen catheters, including by way of non-limiting example, triple-lumen catheters, quadruple-lumen catheters and the like. In addition, the systems of the present disclosure are in no way limited to use with radial ultrasound probes, but may include a variety of imaging modalities, including, for example, linear ultrasound probes, etc. Alternatively, the systems of the present disclosure may be used in standalone procedures that do not include any form of imaging modality or probe.

Claim 1:
A needle assembly (<NUM>), comprising:
a sheath (<NUM>) comprising a proximal end (<NUM>), a distal end (<NUM>) and a lumen (<NUM>) extending therebetween;
a needle (<NUM>) disposed within the lumen of the sheath, the needle comprising a proximal (<NUM>) end and a sharpened distal end (<NUM>); and
an actuation mechanism (<NUM>) disposed along a proximal portion of the needle assembly, the actuation mechanism (<NUM>) comprising a housing (<NUM>), a channel (<NUM>) formed within a distal portion of the housing (<NUM>), a spring (<NUM>) disposed within a chamber (<NUM>) of the housing (<NUM>) and a push button (<NUM>) engaged with a proximal portion of the housing (<NUM>), the push button (<NUM>) configured to move from a first position to a second position within the housing (<NUM>);
wherein a proximal portion (<NUM>) of the sheath (<NUM>) is immovably disposed within the channel (<NUM>) of the housing;
wherein a proximal portion of the needle (<NUM>) extends through the spring (<NUM>);
wherein the needle (<NUM>) moves in a distal direction relative to the sheath (<NUM>) when the push button (<NUM>) moves distally within the chamber (<NUM>) and the needle (<NUM>) moves in a proximal direction relative to the sheath (<NUM>) when the push button (<NUM>) moves proximally within the chamber (<NUM>).