Biopsy device and method

Abstract

A biopsy device and method are disclosed. The biopsy device may include a needle assembly and a carrier. The needle assembly may include a cutting cannula and a needle stylet. The needle stylet may include a body that forms a longitudinal conduit. The needle stylet may further include a notch in the body and an aperture along the notch. The carrier may include a housing configured to slidably receive the needle stylet, the housing including a proximal end and a distal end. The carrier may further include an extraction conduit extending from the proximal end toward the distal end and a storage container fluidly coupled to the extraction conduit and a vacuum source. When the pump is actuated, the tissue sample is moved from the notch to the extraction conduit, and when the vacuum source is actuated, the tissue sample is extracted along the extraction conduit into the storage container.

Description

Technical Field

[0001] Cross-reference This application claims priority to U.S. Provisional Patent Application No. 63 / 367,787, filed Jul. 6, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002] Biopsy needles and related devices can be used to sample and / or collect tissue.

Summary of the Invention

[0003] In one general aspect, the present disclosure provides a biopsy assembly comprising a needle assembly including a cutting cannula and a needle stylet. The needle stylet includes a body forming a longitudinal conduit fluidly coupled to a pump. The needle stylet further includes a notch provided in the body and an aperture along the notch. The aperture forms an opening that extends laterally through the body to the longitudinal conduit. The biopsy assembly further includes a carrier including a housing configured to slidably receive the needle stylet, the housing having a proximal end and a distal end. The carrier further includes an extraction conduit extending from the proximal end to the distal end and a storage container fluidly coupled to the extraction conduit and a vacuum source. The cutting cannula is movable distally relative to the notch to excise a tissue sample and movable proximally to release the tissue sample. When the pump is actuated, the tissue sample is moved from the notch to the extraction conduit, and when the vacuum source is actuated, the tissue sample is extracted along the extraction conduit into the storage container.

[0004] In another aspect, the present disclosure provides a biopsy assembly comprising a needle assembly, the needle assembly comprising a hollow body forming a longitudinal conduit, a solid distal face, a lateral notch, and an inner stylet comprising a through-hole defined to penetrate the hollow body along the lateral notch. The needle assembly further comprises a cutting cannula slidably disposed around the inner stylet. The biopsy assembly further comprises a carrier comprising a housing configured to slidably receive the needle assembly, the housing having a proximal end and a distal end. The carrier further comprises an extraction conduit extending from the proximal end toward the distal end and a storage container fluidly coupled to a vacuum source.

[0005] In another aspect, the present disclosure provides a method for performing a biopsy, the method comprising advancing a biopsy needle and a cutting cannula into tissue, the advancing comprising advancing the biopsy needle having a notch configured to receive a tissue sample, and releasing the tissue sample by retracting the cutting cannula proximally past the notch, and discharging the tissue sample from the notch into the extraction conduit by pumping fluid through the biopsy needle into an aperture defined along the notch. The method further comprises pulling the tissue sample into a storage container fluidly coupled to the extraction conduit by creating a vacuum in the extraction conduit.

Brief Description of the Drawings

[0006] The novel features of the various aspects are set forth in detail in the appended claims. However, aspects described with respect to both structure and method of operation may be best understood by reference to the following description when considered in conjunction with the accompanying drawings.

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[0017] The accompanying drawings are not intended to be drawn to scale. Throughout the several views, corresponding reference numerals indicate corresponding parts. For clarity, not all components in each figure may be labeled. The examples described herein illustrate certain embodiments of the invention in one form, and such examples are not to be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION OF THE INVENTION

[0018] Biopsy is a procedure that often involves removing a tissue sample from the body and examining the tissue sample. For example, the tissue sample can be examined for various diseases. One type of biopsy is a needle biopsy, which involves inserting a needle into the patient's body (e.g., through the skin) to collect tissue from a suspect area. Needle biopsy techniques include core needle biopsy (CNB) techniques and vacuum-assisted biopsy (VAB) techniques.

[0019] CNB can use needles thinner than those of VAB, resulting in less invasiveness and / or reducing the accompanying bleeding and / or discomfort. For example, needles for CNB are typically from 18 gauge to 14 gauge, while needles for VAB are typically from 14 gauge to 7 gauge (e.g., with an outer diameter of 2.1 mm to 4.6 mm). As a result, CNB can, in certain instances, reduce surgical complications compared to VAB. For example, the risk of bleeding associated with needles of larger diameter can be higher in VAB compared to CNB, especially. In the paper "Ultrasound-guided diagnostic breast biopsy methodology: a retrospective comparison of the 8-gauge vacuum-assisted biopsy approach versus the spring-loaded 14-gauge core biopsy approach" by S. Povoski, R. Jimenez, and W. Wang in World Journal of Surgical Oncology, 2011; Vol. 9, pages 87 - 101, which is hereby incorporated by reference in its entirety, the authors found that for benign tumors, VAB using an 8-gauge needle has a higher risk of bleeding after treatment than CNB using a 14-gauge needle, but for malignant lesions, there is no difference between these techniques.

[0020] VAB devices are used in combination with a vacuum system and can enlarge the tissue samples obtainable per insertion. However, several studies have shown that the differences between CNB technology and VAB technology are not statistically significant. For example, VAB using a 14-gauge automated gun can obtain more tissue in a shorter period than CNB, but the results indicate that the use of VAB technology is usually not necessary for diagnosis. Using VAB technology can, in some cases, enhance the reliability in removing malignant tumors, but a second biopsy is often recommended regardless of the biopsy method.

[0021] The VAB device can include a coaxial gun, and the tissue sample can return through the cannula and be retrieved outside the body (e.g., Mammotome® Tru-Core™ II automated biopsy device), or be stored in a small posterior container (e.g., Atec®, Senorx®, and Mammotome Revolve™ biopsy devices). The coaxial system can extract smaller lesions (e.g., 10 mm vs. 19 mm) and can speed up the procedure.

[0022] The mechanisms for generating vacuum pressure for VAB can be expensive, and high pressure may be required to remove obstructions / debris from the various lumens and ports in these systems.

[0023] Apart from sample size, lesion consistency is important in the biopsy procedure. For example, it is often preferred to obtain a tissue sample that is not crushed and not fragmented.

[0024] The devices and techniques of CNB and VAB are further described in the papers "MRI Vacuum-Assisted Breast Biopsies" by R. Plantade and I. Thomassin-Naggara, Diagnostic and Interventional Imaging, September 2014, Vol. 95, Issue 9, pages 779-801, and "Comparison of Automated Versus Vacuum-Assisted Biopsy Methods for Sonographically Guided Core Biopsy of the Breast" by L. Philpotts, R. Hooley, and C. Lee, American Journal of Roentgenology, February 2003, Vol. 180, Issue 2, pages 347-51, and "Differentiating Vacuum-Assisted Breast Biopsy from Core Needle Biopsy: Is It Necessary?" by S. Nakano, Y. Imawari, A. Mibu, M. Otsuka, and T. Oinuma, The British Journal of Radiology, December 2018, Vol. 91, 20180250, each of these references being hereby incorporated by reference in its entirety into this specification.

[0025] VAB can offer certain advantages, such as obtaining larger and / or more intact tissue samples, shortening the acquisition time, and / or the ability to store multiple tissue samples in a posterior container. However, existing VAB techniques use larger diameter needles and cannulas to extract and withdraw tissue samples, which may not be relatively favorable in certain situations compared to CNB techniques that use smaller diameter needles and cannulas. For example, with larger diameter needles, the incision is enlarged, which can increase the risk of one or more complications in certain cases.

[0026] As described in more detail herein, biopsy needles of smaller diameter can be used in combination with an extraction function that removes tissue samples into a posterior tissue sample storage volume along an independent extraction conduit. For example, the extraction conduit can be distinct from the biopsy needle and can extend from a distal notch in the biopsy needle to the posterior tissue sample storage volume. In certain examples, the biopsy needle can have features that facilitate the expulsion of excised and collected tissue from a distal notch in the biopsy needle. For example, a distal notch in the biopsy needle can be coupled to the posterior tissue sample storage volume external to the needle by the extraction conduit. A suction force can facilitate the expulsion of the tissue sample from the notch into the extraction conduit. In such an example, the tissue sample is not extracted through a cutting cannula and a needle stylet therein, and thus, a thinner needle similar in size to a core needle biopsy needle can be used to remove the tissue sample. As a result, bleeding and / or discomfort from the biopsy needle and associated incision can be reduced. Additionally, or alternatively, the accumulation of debris that can clog and / or at least partially occlude the vacuum port can be minimized by using an extraction conduit of larger diameter than that of a conventional VAB cannula.

[0027] In various aspects of the present disclosure, biopsy needles of smaller diameter can be the size of biopsy needles used in CNB procedures (e.g., from 14 gauge to 18 gauge), or can be of smaller diameter. For example, biopsy devices according to various aspects of the present disclosure can use a core biopsy needle that includes a plurality of compartments and is coupled to a posterior container designed to store a plurality of tissue specimens. Additionally, or alternatively, as described in more detail herein, the core biopsy needle can have features that enable the removal of tissue samples more effectively, efficiently, and in a shorter period of time than existing techniques.

[0028] In various aspects of the present disclosure, the biopsy device further includes a biopsy needle carrier, a tissue sample storage volume, an extraction conduit having a receiving portion and a connecting portion, and a vacuum source or a vacuum pressure generating device. The biopsy device can be used with both manual biopsy needle devices and automated biopsy needle devices (e.g., automated biopsy guns). In various examples, the tissue collection / incision process using the biopsy device disclosed herein is the same as that of a conventional core biopsy needle, but the extraction technique for removing the tissue sample from the needle to the tissue sample storage volume is different.

[0029] Referring mainly to FIGS. 1A-1C, the inner stylet 100 of the biopsy needle assembly 150 (FIGS. 5-7) is shown. The inner stylet 100 is similar in many respects to the inner stylet of a needle for CNB technology. For example, the inner stylet 100 can be sized to fit within a cutting cannula of 14 gauge or less. The inner stylet 100 includes a body 101, and a central longitudinal conduit 102 is defined as passing through the body 101.

[0030] The central longitudinal conduit 102 extends from the proximal end of the inner stylet 100 toward the distal end of the inner stylet 100. The distal end of the inner stylet 100 forms a face or edge 108 configured to pierce tissue together with the surrounding cutting cannula 160 (see FIG. 7A). The distal end of the inner stylet 100 is solid. In other words, the edge 108 defines a solid face for entering the tissue.

[0031] Unlike a conventional biopsy needle, the inner stylet 100 further includes a distal notch 104 defined in the body 101 and an array of apertures 106 along the distal notch 104. The apertures 106 are arranged in a longitudinal row. Each aperture 106 forms a transverse opening that penetrates the body 101 to the central longitudinal conduit 102.

[0032] In various aspects, the central longitudinal conduit 102 is fluidly coupled by a fluid line or conduit 111 to a pressure generating device, such as a pump 110. For example, the pump 110 may be configured to pump fluid through the central longitudinal conduit 102 into the aperture 106 at the distal notch 104. As will be described in more detail herein, pushing or pumping fluid through the aperture 106 can facilitate the removal of tissue samples from the inner stylet 100 into an extraction conduit 130 (Figs. 2-4) coupled to the inner stylet 100.

[0033] In various examples, a biopsy needle assembly 150 included in a biopsy assembly 180 (Figs. 5-7) includes an inner stylet 100 and a cutting cannula 160 (Fig. 7A) disposed movably relative to the inner stylet 100. The biopsy assembly 180 may further include a carrier 120 configured to house the biopsy needle assembly 150, i.e., the cutting cannula 160 and the inner stylet 100 therein. Referring primarily to Figs. 2-4, the carrier 120 includes a housing 122 configured to slidably house the biopsy needle assembly 150. The housing 122 includes a proximal end 124 and a distal end 126. Between the proximal end 124 and the distal end 126, the housing 122 forms a trough sized and dimensioned to house the biopsy needle assembly 150. The tubular passage defined by the distal end 126 is sized and dimensioned to house the distal end of the needle assembly passing therethrough. The biopsy needle assembly 150 is slidably disposed within the distal end 126 and is configured to project distally through the tubular passage in various examples, as will be described in more detail herein. The proximal portion of the needle assembly is configured to be positioned within the trough formed by the housing 122.

[0034] Carrier 120 further includes an extraction conduit 130 that extends along housing 122. The distal portion of extraction conduit 130 forms a receiving portion 132 configured to receive a tissue sample from the needle assembly, and more particularly from distal notch 104 in inner stylet 100. Receiving portion 132 transitions to a connection portion 134 that extends proximally to tissue sample storage volume 136. Tissue sample storage volume 136 is fluidly coupled to extraction conduit 130 and to a vacuum source 140 by a vacuum conduit 141. When sufficient vacuum pressure is generated, the tissue sample pushed from inner stylet 100 into receiving portion 132 can be drawn proximally along extraction conduit 130 and into tissue sample storage volume 136.

[0035] Referring primarily to FIGS. 3 and 4, tissue sample storage volume 136 can be segmented, or compartmentalized, into individual storage compartments 138 located therearound. Carrier 120 further includes a motor 139 operably configured to rotate tissue sample storage volume 136. In various examples, by being rotatable by motor 139 relative to the proximal ends of housing 122 and extraction conduit 130, one of storage compartments 138 can be fluidly coupled to extraction conduit 130. Storage compartment 138 can define an individual sealed compartment sized to receive, hold, and store a tissue sample therein. In various examples, each compartment 138 can receive different tissue samples from different areas within the patient's suspected tissue and its surrounding area.

[0036] Referring mainly to FIGS. 5 - 7 herein, a biopsy assembly 180 is shown. The biopsy assembly 180 includes a needle assembly that includes an inner stylet 100 and a cutting cannula 160, and further includes a carrier 120. The needle assembly is held within the housing 122 of the carrier 120 and is movable relative to the housing 122 between a retracted or home position (FIG. 5) and an extended position (FIG. 6). In the extended position (FIG. 6), the needle assembly is configured to pierce and excise a tissue sample. For example, the cutting cannula 160 can be moved distally relative to the distal notch 104 in the inner stylet 100 to excise the tissue sample. Thereafter, the cutting cannula 160 can be moved proximally to release the excised tissue sample from the distal notch 104. Before releasing the excised tissue sample, the biopsy needle assembly 150 can be retracted from the tissue and returned to the retracted position (FIG. 5). The tissue sample can remain in the biopsy needle assembly 150 until the biopsy needle assembly 150 is returned to the retracted position. In the retracted position, the distal notch 104 can be exposed by moving the cutting cannula 160 coaxially relative to the inner stylet 100.

[0037] When the pump 110 (FIG. 1C) is actuated, the tissue sample is moved from the distal notch 104 and pushed into the receiving portion 132 of the extraction conduit 130. For example, by pumping air from the pump 110 (FIG. 1C) through the aperture 106, an air pump can be generated at the distal notch 104 to push the tissue sample into the receiving portion 132.

[0038] When the vacuum source 140 (FIGS. 2 - 4) is actuated, the tissue sample is drawn proximally along the connection portion 134 of the extraction conduit 130 to the tissue sample storage volume 136. In various examples, one end of the tissue sample storage volume 136 can be fluidly connected to the connection portion 134 of the extraction conduit 130, and the opposite end can be fluidly connected to the vacuum source 140 (FIGS. 2 - 4).

[0039] Each tissue sample is stored in compartment 138 of tissue sample storage volume 136. After the tissue is stored in one of the storage sections, motor 139 rotates tissue sample storage volume 136 such that an empty compartment 138 faces vacuum source 140 and connection 132. Vacuum source 140 and other control and supply devices can be integrated into housing 122 of carrier 120, or connection elements from tissue sample storage volume 136 to vacuum source 140 can be directly integrated into housing 122.

[0040] In various examples, one or more sterilized components are used for each patient. In some examples, certain components of biopsy assembly 180 can be made sterilized components, and other components can be merely disinfected each time they are used. For example, sterilized biopsy needle assembly 150 can be used for each patient. In certain examples, carrier 120 can also be a sterilized component used for each patient. It can be beneficial to separate sterilized parts from other parts that are merely disinfected and rigidly connected to the system. For example, biopsy needle assembly 150 can be an independent component that can be easily inserted into and removed from biopsy assembly 180. Further, carrier 120 can be an independent component that can be easily inserted into and removed from biopsy assembly 180. In various examples, the needle assembly, carrier, extraction conduit, and drive elements can be sterilized components that are easily insertable and removable, including their connection elements.

[0041] Various aspects of the subject matter described herein are set forth in the examples numbered below.

[0042] Example 1 - A biopsy assembly comprising a needle assembly having a cutting cannula and a needle stylet. The needle stylet includes a body forming a longitudinal conduit, and the longitudinal conduit is fluidly coupled to a pump. The needle stylet further includes a notch provided in the body and an aperture along the notch. The aperture forms an opening that extends transversely through the body to the longitudinal conduit. The biopsy assembly further includes a carrier configured to slidably receive the needle stylet, and the housing has a proximal end and a distal end. The carrier further includes an extraction conduit extending from the proximal end to the distal end and a storage container fluidly coupled to the extraction conduit and a vacuum source. The cutting cannula is movable distally relative to the notch to excise a tissue sample and movable proximally to release the tissue sample. When the pump is activated, the tissue sample is moved from the notch to the extraction conduit, and when the vacuum source is activated, the tissue sample is extracted along the extraction conduit into the storage container.

[0043] Example 2 - The biopsy assembly of Example 1, wherein the diameter of the needle stylet is a first diameter, the diameter of the extraction conduit is a second diameter, and the second diameter is greater than the first diameter.

[0044] Example 3 - The biopsy assembly of Example 1 or Example 2, wherein the needle stylet is between 14 gauge and 18 gauge.

[0045] Example 4 - The biopsy assembly of Example 1, Example 2, or Example 3, wherein the extraction conduit is greater than 14 gauge.

[0046] Example 5 - The biopsy assembly of Example 1, Example 2, Example 3, or Example 4, wherein the carrier further includes a motor operably configured to rotate the storage container.

[0047] Example 6 - The biopsy assembly of Example 1, Example 2, Example 3, Example 4, or Example 5, wherein the storage container includes a plurality of individual compartments and is rotatable relative to the proximal end of the extraction conduit such that one of the individual compartments is fluidly coupled to the extraction conduit.

[0048] Example 7 - A biopsy assembly according to Example 1, Example 2, Example 3, Example 4, Example 5, or Example 6, further comprising a pump operably configured to selectively pump fluid along a longitudinal conduit to an aperture through a needle stylet.

[0049] Example 8 - A biopsy assembly according to Example 1, Example 2, Example 3, Example 4, Example 5, Example 6, or Example 7, wherein the needle stylet comprises a solid distal face.

[0050] Example 9 - A biopsy assembly according to Example 1, Example 2, Example 3, Example 4, Example 5, Example 6, Example 7, or Example 8, further comprising a vacuum source operably configured to selectively generate a vacuum force in an extraction conduit.

[0051] Example 10 - A biopsy assembly comprising a needle assembly comprising a hollow body forming a longitudinal conduit, a solid distal face, a lateral notch, and a through - hole defined to penetrate the hollow body along the lateral notch. The needle assembly further comprises a cutting cannula slidably positioned around the inner stylet. The biopsy assembly further comprises a carrier comprising a housing configured to slidably receive the needle assembly, the housing having a proximal end and a distal end. The carrier further comprises an extraction conduit extending from the proximal end towards the distal end and a storage container fluidly coupled to a vacuum source.

[0052] Example 11 - A method for performing a biopsy, the method comprising advancing a biopsy needle and a cutting cannula into tissue, the biopsy needle having a notch configured to receive a tissue sample; retracting the cutting cannula proximally past the notch to release the tissue sample; pumping fluid through the biopsy needle into an aperture defined along the notch to discharge the tissue sample from the notch into an extraction conduit; and pulling the tissue sample into a storage container fluidly coupled to the extraction conduit by generating a vacuum in the extraction conduit.

[0053] In various examples, the biopsy devices and methods disclosed herein may be used in connection with magnetic resonance imaging (MRI) technology. For example, the biopsy assembly may extend into the field of view imaged by an MRI device to facilitate placement of a biopsy needle into a patient's tissue. In certain examples, the biopsy assembly, and / or a robotic arm supporting the biopsy assembly, may extend through a central bore in the MRI device. Exemplary systems and components are described in further detail in International Patent Application No. PCT / US2021 / 014628, entitled MRI-Guided Robotic System and Method for Biopsy, published July 29, 2021, the entire contents of which are incorporated herein by reference.

[0054] Although several forms have been shown and described, it is not the applicant's intention to limit and confine the scope of the appended claims to such details. Many changes, variations, modifications, substitutions, combinations, and equivalents thereof to those forms may be made and contemplated by those skilled in the art without departing from the scope of the present disclosure. Further, the structure of each element related to the forms described can alternatively be described as a means for providing the function performed by the element. Additionally, where a particular material is disclosed for a particular component, other materials may be used. Accordingly, it is understood that the foregoing description and the appended claims are intended to cover all such changes, combinations, and variations as fall within the scope of the disclosed forms. The appended claims are intended to cover all such changes, variations, modifications, substitutions, alterations, and equivalents.

[0055] Those skilled in the art will generally recognize that the terms used herein, and particularly in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "comprising" should be construed as "including but not limited to", the term "comprising" should be construed as "including at least ~", the term "including" should be construed as "including but not limited to", etc.). When a specific number is intended for an element of a claim being modified, such intent is explicitly stated in the claim, and when such a statement does not exist, those skilled in the art will further understand that such intent does not exist. For example, for purposes of illustration, the following appended claims may include the use of the modifying expressions "at least one" and "one or more" to modify elements of the claims. However, even when the same claim includes a modifying expression such as "one or more" or "at least one" and an expression corresponding to the English indefinite article "a" or "an", the use of such an expression should not be construed to limit any particular claim including an element thus modified to a claim including only one such element (e.g., an expression corresponding to the English "a (indefinite article)" and / or "an (indefinite article)" should typically be construed to mean "at least one" or "one or more"). The same holds true for the use of definite articles used to modify elements of the claims.

[0056] In addition, even if a specific number of elements of a claimed element are explicitly recited, one of ordinary skill in the art would recognize that such elements are typically meant to be present at least in the recited number (e.g., a bare recitation of "two elements" without other modifying language typically means at least two elements or two or more elements). Further, in instances where conventional expressions similar to "at least one of A, B, and C" are used, such a configuration is generally assumed to be intended based on how one of ordinary skill in the art would understand such a conventional expression (e.g., a system including "at least one of A, B, and C" includes, but is not limited to, a system including only A, only B, only C, a combination of A and B, a combination of A and C, a combination of B and C, and / or a combination of A, B, and C). In instances where conventional expressions similar to "at least one of A, B, or C" are used, such a configuration is generally assumed to be intended based on how one of ordinary skill in the art would understand such a conventional expression (e.g., a system including "at least one of A, B, or C" includes, but is not limited to, a system including only A, only B, only C, a combination of A and B, a combination of A and C, a combination of B and C, and / or a combination of A, B, and C). Typically, one of ordinary skill in the art further understands that disjunctive phrases and / or expressions presenting two or more alternative terms, whether included in the description, claims, or drawings, are to be understood as encompassing one, any, or both of such terms, unless the context dictates otherwise. For example, the expression "A or B" is typically understood to include the possibilities of "A" or "B" or "A and B".

[0057] In connection with the appended claims, one of ordinary skill in the art will understand that the acts described therein can generally be performed in any order. Further, although various operation flow diagrams are presented in a certain order, it must be understood that the various operations can be performed in other orders than the order shown, or can be performed simultaneously. Examples of such alternative orders can include, unless the context otherwise specifies, overlapping, alternating, interrupted, rearranged, progressive, preliminary, supplementary, simultaneous, reversed, or other variant orders. Further, terms such as "in response to," "associated with," or other past-tense adjectives generally are not intended to exclude such variants unless the context otherwise specifies.

[0058] It is important to note that all references to "one aspect," "aspect," "example," "one example," etc. mean that the particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the use of the phrases "in one aspect," "in an aspect," "in an example," and "in one example" in various places throughout this specification are not necessarily all referring to the same aspect. Further, the particular features, structures, or characteristics can be combined in any suitable manner in one or more aspects.

[0059] Any patent application, patent, unpatented publication, or other disclosure document referred to herein and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated document is not inconsistent with this specification. Accordingly, to the extent necessary, the disclosure explicitly set forth herein prevails over any conflicting content incorporated herein by reference. Although it is referred to as being incorporated herein by reference, any document, or portion thereof, that conflicts with an existing provision, description, or other disclosure herein is incorporated only to the extent that no conflict arises between the incorporated document and the existing disclosure.

[0060] Any patent application, patent, unpatented publication, or other disclosure document referred to herein and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated document is not inconsistent with this specification. Accordingly, to the extent necessary, the disclosure explicitly set forth herein prevails over any conflicting content incorporated herein by reference. Although it is referred to as being incorporated herein by reference, any document, or portion thereof, that conflicts with an existing provision, description, or other disclosure herein is incorporated only to the extent that no conflict arises between the incorporated document and the existing disclosure.

[0061] In summary, many advantages resulting from using the concepts described herein are described. The foregoing description of one or more forms is presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more forms have been selected and described in order to illustrate the principles and practical applications thereof, to enable one of ordinary skill in the art to make and use various forms, and to include various changes as are suited to the particular use contemplated. The claims submitted herewith are intended to define the full scope.

Claims

1. A needle assembly comprising a cutting cannula and a needle stylet, wherein the needle stylet is A body forming a longitudinal conduit, wherein the longitudinal conduit is fluidly coupled to a pump, A notch provided in the body, An aperture along the notch, wherein the aperture forms an opening that penetrates the body laterally to the longitudinal conduit, and A needle assembly comprising, A carrier, and the said carrier is A housing configured to slidably accommodate the needle stylet, wherein the housing comprises a proximal end and a distal end, An extraction conduit extending from the proximal end toward the distal end, A storage container fluidly coupled to the extraction conduit and the vacuum source. Equipped with a carrier and Equipped with, The cutting cannula is movable distal to the notch in order to extract a tissue sample. The cutting cannula is movable proximally to release the tissue sample. When the pump is activated, the tissue sample is moved from the notch to the extraction conduit. When the vacuum source is activated, the tissue sample is extracted along the extraction conduit into the storage container. Biopsy assembly.

2. The diameter of the needle stylet is the first diameter, The diameter of the extraction conduit is the second diameter, The second diameter is larger than the first diameter. The biopsy assembly according to claim 1.

3. The needle stylet is 14 gauge to 18 gauge. The biopsy assembly according to claim 1.

4. The extraction conduit is larger than 14 gauge. The biopsy assembly according to claim 3.

5. The carrier further comprises a motor configured to operate to rotate the storage container. The biopsy assembly according to claim 1.

6. The storage container comprises a plurality of individual compartments, The storage container is rotatable with respect to the proximal end of the extraction conduit such that one of the individual compartments is fluidly coupled to the extraction conduit. The biopsy assembly according to claim 5.

7. The pump further comprises the pump configured to operate to selectively pump fluid along the longitudinal conduit through the needle stylet to the aperture, The biopsy assembly according to claim 1.

8. The aforementioned needle stylet has a solid distal face, The biopsy assembly according to claim 6.

9. The extraction conduit further comprises a vacuum source configured to operate in such a way as to selectively generate a vacuum force. The biopsy assembly according to claim 1.

10. A biopsy assembly, wherein the biopsy assembly is An inner stylet comprising a hollow body forming a longitudinal conduit, a solid distal face, a lateral notch, and a through hole defined to penetrate the hollow body along the lateral notch, A cutting cannula is slidably positioned around the inner stylet. A needle assembly comprising, A carrier, and the said carrier is A housing configured to slidably house the needle assembly, wherein the housing comprises a proximal end and a distal end, An extraction conduit extending from the proximal end toward the distal end, A storage container fluidly coupled to a vacuum source and Equipped with a carrier and A biopsy assembly comprising the above components.

11. A method for performing a biopsy, wherein the method is The procedure includes advancing a biopsy needle and a cutting cannula into the tissue, wherein the biopsy needle has a notch configured to accommodate a tissue sample. The above method further, By retracting the cutting cannula proximal to the notch, the tissue sample is released. The tissue sample is released from the notch into the extraction conduit by pressurizing the fluid through the biopsy needle into an aperture defined along the notch, By generating a vacuum in the extraction conduit, the tissue sample is drawn into a storage container fluidly coupled to the extraction conduit. Methods that include...

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