Biopsy device and method

Abstract

Biopsy devices and methods are disclosed. A biopsy device may include a needle assembly and a carrier. The needle assembly may include a cutting cannula and a needle tubing core. The needle wick may include a body forming a longitudinal conduit. The needle wick may further include a notch in the body and a bore along the notch. The carrier may include a housing configured to slidably receive a needle tubing core, wherein the housing includes a proximal end and a distal end. The carrier also includes an extraction catheter extending from the proximal end to the distal end, and a storage container fluidly coupled to the extraction catheter and the vacuum source. Upon activation of the pump, the tissue sample is pushed from the notch to the extraction conduit, and upon activation of the vacuum source, the tissue sample is extracted along the extraction conduit to the storage container.

Description

[0001] Cross-references

[0002] This application claims priority to U.S. Provisional Application No. 63 / 367,787, filed on July 6, 2022, which is hereby incorporated by reference in its entirety for all purposes. Background Art

[0003] Biopsy needles and related devices may be used to collect and / or harvest tissue. Summary of the invention

[0004] In one general aspect, the present disclosure provides a biopsy assembly, including a needle assembly, the needle assembly including a cutting sleeve and a needle core. The needle core includes a body forming a longitudinal conduit, wherein the longitudinal conduit is coupled to a pump fluid. The needle core also includes a notch in the body and a hole along the notch. The hole forms a transverse opening through the body to the longitudinal conduit. The biopsy assembly also includes a carrier, the carrier includes a shell configured to slidably receive the needle core, wherein the shell includes a proximal end and a distal end. The carrier also includes an extraction conduit extending from the proximal end to the distal end, and a storage container coupled to the extraction conduit and a vacuum source fluid. The cutting sleeve can be moved distally relative to the notch to remove a tissue sample, wherein the cutting sleeve can be moved proximally to release the tissue sample. After the pump is activated, the tissue sample is pushed from the notch to the extraction conduit, and after the vacuum source is activated, the tissue sample is extracted along the extraction conduit to the storage container.

[0005] In another aspect, the present disclosure provides a biopsy assembly including a needle assembly including an inner core including a hollow body forming a longitudinal conduit, a solid distal end face, a lateral recess, and a through hole defined through the hollow body along the lateral recess. The needle assembly also includes a cutting cannula slidably disposed around the inner core. The biopsy assembly also includes a carrier including a housing configured to slidably receive the needle assembly, wherein the housing includes a proximal end and a distal end. The carrier also includes an extraction conduit extending from the proximal end to the distal end, and a storage container coupled to a vacuum source fluid.

[0006] 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, wherein the biopsy needle comprises a notch configured to receive a tissue sample, retracting the cutting cannula proximally through the notch to release the tissue sample, and pumping a fluid through the biopsy needle into a hole defined along the notch to expel the tissue sample from the notch into an extraction conduit. The method also comprises generating a vacuum in the extraction conduit to draw the tissue sample into a storage container fluidly coupled to the extraction conduit. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The novel features of the various aspects are set forth with particularity in the appended claims. However, the described aspects, both as to the organization and method of operation, may be best understood by reference to the following description taken in conjunction with the accompanying drawings, wherein

[0008] Figure 1A is a plan view of a distal portion of a needle stylet according to various aspects of the present disclosure.

[0009] Figure 1B According to various aspects of the present disclosure Figure 1A Elevation view of the distal portion of the needle stylet.

[0010] Figure 1C According to various aspects of the present disclosure Figure 1A The plane 1C in the Figure 1A A cross-sectional elevation view of the distal portion of the needle tube core.

[0011] Figure 2 is a perspective view of a carrier according to various aspects of the present disclosure, the carrier comprising a housing, an extraction conduit, a motor, and a tissue storage container, wherein the tissue storage container is fluidly coupled to a vacuum tube.

[0012] Figure 3 According to various aspects of the present disclosure Figure 2 A perspective view of a carrier showing the tissue storage container as transparent for illustrative purposes.

[0013] Figure 4 According to various aspects of the present disclosure Figure 2 Elevation view of the carrier.

[0014] Figure 5 According to various aspects of the present disclosure, Figure 2 1 and a plan view of a biopsy device with a carrier and a needle assembly located within a housing of the carrier, wherein the needle assembly includes the needle stylet and cutting cannula of FIG. 1 , and wherein the needle assembly is in a retracted position relative to the housing.

[0015] Figure 6 According to various aspects of the present disclosure Figure 5 A plan view of a biopsy device with the needle assembly in an extended position relative to the housing of the carrier.

[0016] Figure 7 According to various aspects of the present disclosure Figure 5 An elevation view of the distal end portion of a biopsy device depicting the needle assembly in Figure 5 The retracted position and Figure 6 a position intermediate between the extended positions.

[0017] Fig. 7A According to various aspects of the present disclosure Figure 7Detailed view of the distal portion of the biopsy device, which is shown partially transparent for illustrative purposes and further depicts further relative retraction of the cutting cannula.

[0018] The accompanying drawings are not intended to be drawn to scale. Throughout these several views, corresponding reference numerals indicate corresponding parts. For clarity, not every component is labeled in every figure. The examples listed herein illustrate certain embodiments of the present invention in one form, and such examples should not be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION

[0019] A biopsy is a procedure that generally involves removing a tissue sample from the body and examining it. For example, tissue samples can be examined for a variety of diseases. One type of biopsy is a needle biopsy, which involves inserting a needle into a patient's body (e.g., through the skin) to collect tissue from a suspicious area. Needle biopsy techniques include the core needle biopsy (CNB) technique and the vacuum-assisted biopsy (VAB) technique.

[0020] CNB can use a thinner needle than VAB and thus be less invasive and / or cause less bleeding and / or discomfort. For example, the needle for CNB is typically an 18- to 14-gauge needle, while the needle for VAB is typically a 14- to 7-gauge needle (e.g., an outer diameter between 2.1 and 4.6 mm). Thus, in some cases, CNB can result in fewer surgical complications than VAB. For example, larger diameter needles can be associated with a higher risk of bleeding, especially with VAB relative to CNB. In the article “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, World Journal of Surgical Oncology, 2011; Vol. 9, pp. 87–101, which is incorporated herein by reference in its entirety, the authors found that for benign tumors, VAB using an 8-gauge needle was associated with a higher risk of postoperative bleeding than CNB using a 14-gauge needle; however, for malignant lesions, there was no difference between the two techniques.

[0021] The use of a VAB device in conjunction with a vacuum system allows for a larger tissue sample to be obtained from each insertion. However, some studies have shown that the differences between CNB and VAB techniques are not statistically significant. Although VAB using, for example, a 14-gauge automatic gun can yield more tissue in a shorter amount of time than CNB, results suggest that the use of VAB techniques is generally not necessary for diagnosis. In some cases, the use of VAB techniques may increase confidence in ruling out malignancy; however, a second biopsy is generally recommended regardless of the biopsy method.

[0022] A VAB device may include a coaxial gun in which a tissue sample is returned through a cannula and recovered outside the body (e.g., Tru-CoreTMII automated biopsy device) or stored in a small rear container (e.g. and the Mammotome RevolveTM biopsy device). Coaxial systems may be able to extract smaller lesions (e.g., 10 mm vs. 19 mm), and the procedure may be faster.

[0023] Mechanisms to generate vacuum pressure for VAB can be expensive and may require high pressures to remove obstructions / debris from the various lumens and ports in these systems.

[0024] In addition to sample size, the consistency of the lesion is also important in the biopsy procedure. For example, it is usually best to obtain a tissue sample that is neither broken nor fragmented.

[0025] CNB and VAB devices and techniques are further described in the following articles: R. Plantade and I. Thomassin-Naggara, "MRI Vacuum-Assisted Breast Biopsies," Diagnostic and Interventional Imaging, Vol. 95, 9th edition, September 2014, pp. 779-801; L. Philpotts, R. Hooley, and C. Lee, "Comparison of Automated Versus Vacuum-Assisted Biopsy Methods for Sonographically Guided Core Biopsy of the Breast," American Journal of Roentgenology, Vol. 180, 2nd edition, February 2003, pp. 347-51; and S. Nakano, Y. Imawari, A. Mibu, M. Otsuka, and T. Oinuma, The British Journal of Neurosurgery, Vol. 180, 2nd edition, February 2003, pp. 347-51. The article “Differentiating Vacuum-Assisted Breast Biopsy from Core Needle Biopsy: Is It Necessary?” published in Journal of Radiology, December 2018, Vol. 91, 20180250, is incorporated herein by reference in its entirety.

[0026] VAB may provide certain advantages, such as obtaining larger and / or more complete tissue samples, faster acquisition time, and / or the ability to store multiple tissue samples in a back container. However, existing VAB techniques use larger diameter needles and cannulas to excise and extract tissue samples, which may be less preferred in certain circumstances than CNB techniques that use smaller diameter needles and cannulas. For example, larger diameter needles result in larger incisions and may increase the risk of one or more complications in certain circumstances.

[0027] As further described herein, a smaller diameter biopsy needle can be used in conjunction with an extraction feature that removes a tissue sample to a rear tissue sample storage volume along a separate extraction conduit. For example, the extraction conduit can be separate and distinct from the biopsy needle and can extend from a distal notch in the biopsy needle to a rear tissue sample storage volume. In some cases, the biopsy needle can include a feature to facilitate the discharge of excised and harvested tissue from a distal notch in the biopsy needle. For example, the distal notch in the biopsy needle can be coupled to a rear tissue sample storage volume outside the needle through an extraction conduit. Suction can facilitate the discharge of the tissue sample from the notch into the extraction conduit. In this case, the tissue sample is not extracted through the cutting cannula and needle core therein, and therefore, a thinner needle similar in size to the core biopsy needle can be used to excise the tissue sample. Therefore, bleeding and / or discomfort caused by the biopsy needle and associated incisions can be reduced. Additionally or alternatively, by using an extraction conduit with a larger diameter than a conventional VAB cannula, debris accumulation that may clog and / or at least partially block the vacuum port can be minimized.

[0028] In various aspects of the present disclosure, the smaller diameter biopsy needle can be the size of the biopsy needle used in the CNB procedure (e.g., 14 to 18 gauge) or smaller in diameter. For example, a biopsy device according to various aspects of the present disclosure can use a core biopsy needle that is coupled to a rear container having multiple compartments and designed to store multiple tissue samples. Additionally or alternatively, as further described herein, the core biopsy needle can include features that allow for the removal of tissue samples effectively, efficiently, and in a shorter cycle time than the prior art.

[0029] In various aspects of the present disclosure, the biopsy device also includes a biopsy needle carrier, a tissue sample storage volume, an extraction conduit including a receiving portion and a connecting portion, and a vacuum source or vacuum pressure generating device. The biopsy device can be used with both a manual biopsy needle device and an automatic biopsy needle device (e.g., an automatic biopsy gun). In various cases, the tissue collection / cutting process using the biopsy device disclosed herein is the same as the collection / cutting process of a conventional core biopsy needle; however, the extraction technique to remove the tissue sample from the needle to the tissue sample storage volume is different.

[0030] Main references Figures 1A to 1C , showing a biopsy needle assembly 150 ( Figures 5 to 7 ) is provided with an inner core 100. The inner core 100 is similar in many respects to the inner core of a needle used for CNB techniques. For example, the size of the inner core 100 can be designed to fit a 14-gauge or smaller cutting cannula. The inner core 100 includes a body 101 that defines a central longitudinal conduit 102 extending therethrough.

[0031] The central longitudinal conduit 102 extends from the proximal end of the inner core 100 to its distal end. The distal end of the inner core 100 forms a face or edge 108 that is configured to mate with a cutting cannula 160 (see Fig. 7A ) together with the inner core 100 to pierce the tissue. The distal end of the inner core 100 is solid. In other words, the edge 108 defines a solid surface for piercing the tissue.

[0032] Unlike conventional biopsy needles, the inner core 100 further includes a distal notch 104 defined in the body 101 and an array of holes 106 along the distal notch 104. The holes 106 are arranged in longitudinal rows. Each hole 106 forms a transverse opening through the body 101 to the central longitudinal conduit 102.

[0033] In various aspects, central longitudinal conduit 102 is fluidly coupled to a pressure generating device, such as a pump 110, via a fluid line or conduit 111. For example, pump 110 can be configured to pump fluid through central longitudinal conduit 102 and into aperture 106 in distal recess 104. As further described herein, pushing or pumping fluid through aperture 106 can facilitate removal of a tissue sample from inner core 100 and into extraction conduit 130 ( Figures 2 to 4 ).

[0034] In various embodiments, biopsy assembly 180 ( Figures 5 to 7 ) includes a biopsy needle assembly 150, which includes an inner tube core 100 and a cutting sleeve 160 (movably arranged relative to the inner tube core 100) Fig. 7A ). The biopsy assembly 180 may further include a carrier 120 configured to receive the biopsy needle assembly 150, namely the cutting cannula 160 and the inner tube core 100 therein. Figures 2 to 4 , carrier 120 includes a housing 122 configured to slidably receive a biopsy needle assembly 150. Housing 122 includes a proximal end 124 and a distal end 126. Between proximal end 124 and distal end 126, housing 122 forms a slot sized and dimensioned to receive biopsy needle assembly 150. Distal end 126 defines a tubular passage sized and dimensioned to receive the distal end of a needle assembly therethrough. Biopsy needle assembly 150 is slidably disposed within distal end 126 and is configured to protrude distally through the tubular passage in various circumstances, as further described herein. The proximal portion of the needle assembly is configured to be placed in the slot formed by housing 122.

[0035] The carrier 120 also includes an extraction conduit 130 extending along the housing 122. The distal portion of the extraction conduit 130 forms a receiving portion 132 that is configured to receive a tissue sample from the needle assembly, and more specifically, from the distal notch 104 in the inner core 100. The receiving portion 132 transitions to a connecting portion 134 that extends proximally to a tissue sample storage volume 136. The tissue sample storage volume 136 is fluidly coupled to the extraction conduit 130 and the vacuum source 140 via a vacuum conduit 141. Upon generation of sufficient vacuum pressure, a tissue sample pushed from the inner core 100 into the receiving portion 132 can be pulled proximally along the extraction conduit 130 into the tissue sample storage volume 136.

[0036] Main references Figure 3 and Figure 4 , the tissue sample storage volume 136 can be segmented or divided into discrete storage compartments 138 arranged around the perimeter of the tissue sample storage volume 136. The carrier 120 also includes a motor 139 that is operably configured to rotate the tissue sample storage volume 136. In various cases, the tissue sample storage volume 136 can be rotated by the motor 139 relative to the housing 122 and the proximal end of the extraction conduit 130 to fluidly couple one of the storage compartments 138 with the extraction conduit 130. The storage compartments 138 can define discrete sealed compartments that are sized to receive, hold, and store tissue samples therein. In various cases, each compartment 138 can accommodate a different tissue sample from a different area within the patient's suspicious tissue or its margins.

[0037] Now the main reference Figures 5 to 7 , a biopsy assembly 180 is shown. The biopsy assembly 180 includes a needle assembly including an inner tubular core 100 and a cutting cannula 160, and also includes a carrier 120. The needle assembly is retained within a housing 122 of the carrier 120 and can be in a retracted or home position ( Figure 5 ) and extended position ( Figure 6 ). In the extended position ( Figure 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 core 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. Prior to releasing the excised tissue sample, the biopsy needle assembly 150 can be retracted from the tissue and returned to the retracted position ( Figure 5 ). The tissue sample can be retained in the biopsy needle assembly 150 until the biopsy needle assembly 150 is returned to the retracted position. In the retracted position, the cutting sleeve 160 can be moved coaxially relative to the inner tube core 100 to expose and expose the distal notch 104.

[0038] When starting pump 110 ( Figure 1C ), the tissue sample is pushed or urged from the distal notch 104 into the receiving portion 132 of the extraction conduit 130. For example, air can be drawn from the pump 110 ( Figure 1C ) is pumped to create an air pump in the distal recess 104 and push the tissue sample into the receiving portion 132.

[0039] When starting the vacuum source 140 ( Figures 2 to 4 ), 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 embodiments, the tissue sample storage volume 136 may be fluidly connected to the connection portion 134 of the extraction conduit 130 at one end and fluidly connected to the vacuum source 140 ( Figures 2 to 4 ).

[0040] Each tissue sample is stored in a compartment 138 of the tissue sample storage volume 136. After the tissue is stored in one of the storage portions, the motor 139 is configured to rotate the tissue sample storage volume 136 so that the empty compartment 138 faces the vacuum source 140 and the connecting portion 132. The vacuum source 140 and other control and supply devices can be integrated into the housing 122 of the carrier 120, and the connecting elements from the tissue sample storage volume 136 to the vacuum source 140 can be directly integrated into the housing 122.

[0041] In various cases, one or more sterile components are used for each patient. In some cases, some components of biopsy assembly 180 can be sterile components, and other components can only be sterilized between use. For example, sterile biopsy needle assembly 150 can be used for each patient. In some cases, carrier 120 can also be a sterile component for each patient. It is advantageous to separate sterile components from other components that are only sterilized and firmly connected to system. For example, biopsy needle assembly 150 can be an independent component that is easy to insert into biopsy assembly 180 and remove from biopsy assembly 180. In addition, carrier 120 can be an independent component that is easy to insert into biopsy assembly 180 and remove from biopsy assembly 180. In various cases, needle assembly, carrier, extraction conduit and drive element (including its connecting element) can be easy to insert and removable sterile components.

[0042] The following numbered examples list various aspects of the topics described in this article.

[0043] Example 1 - A biopsy assembly includes a needle assembly including a cutting cannula and a needle core. The needle core includes a body forming a longitudinal conduit, wherein the longitudinal conduit is coupled to a pump fluid. The needle core also includes a notch in the body and a hole along the notch. The hole forms a transverse opening through the body to the longitudinal conduit. The biopsy assembly also includes a carrier, which includes a housing configured to slidably receive the needle core, wherein the housing includes a proximal end and a distal end. The carrier also includes an extraction conduit extending from the proximal end to the distal end, and a storage container coupled to the extraction conduit and a vacuum source fluid. The cutting cannula can be moved distally relative to the notch to remove a tissue sample, wherein the cutting cannula can be moved proximally to release the tissue sample. After the pump is activated, the tissue sample is advanced from the notch to the extraction conduit, and after the vacuum source is activated, the tissue sample is extracted along the extraction conduit to the storage container.

[0044] Example 2 - The biopsy assembly of Example 1, wherein the needle stylet comprises a first diameter, wherein the extraction catheter comprises a second diameter, and wherein the second diameter is greater than the first diameter.

[0045] Example 3 - The biopsy assembly of Example 1 or 2, wherein the needle stylet is between 14 gauge and 18 gauge.

[0046] Example 4 - The biopsy assembly of Example 1, 2, or 3, wherein the extraction catheter is larger than 14 gauge.

[0047] Example 5 - The biopsy assembly of Example 1, 2, 3 or 4, wherein the carrier further comprises a motor operably configured to rotate the storage container.

[0048] Example 6 - The biopsy assembly of Example 1, 2, 3, 4, or 5, wherein the storage container comprises a plurality of discrete compartments, and wherein the storage container is rotatable relative to the proximal end of the extraction catheter to fluidly couple one of the discrete compartments with the extraction catheter.

[0049] Example 7 - The biopsy assembly of Examples 1, 2, 3, 4, 5, or 6, further comprising a pump operably configured to selectively pump fluid along the longitudinal conduit through the needle stylet to the aperture.

[0050] Example 8 - The biopsy assembly of Examples 1, 2, 3, 4, 5, 6, or 7, wherein the needle stylet comprises a solid distal face.

[0051] Example 9 - The biopsy assembly of Examples 1, 2, 3, 4, 5, 6, 7, or 8, further comprising a vacuum source operably configured to selectively generate a vacuum force in the extraction conduit.

[0052] Example 10 - A biopsy assembly, comprising a needle assembly, comprising an inner core, the inner core comprising a hollow body forming a longitudinal conduit, a solid distal face, a lateral recess, and a through hole defined through the hollow body along the lateral recess. The needle assembly also includes a cutting cannula slidably disposed around the inner core. The biopsy assembly also includes a carrier, the carrier including a housing configured to slidably receive the needle assembly, wherein the housing includes a proximal end and a distal end. The carrier also includes an extraction conduit extending from the proximal end to the distal end, and a storage container coupled to a vacuum source fluid.

[0053] Example 11 - A method for performing a biopsy, the method comprising advancing a biopsy needle and a cutting cannula into tissue, wherein the biopsy needle includes a notch configured to receive a tissue sample, retracting the cutting cannula proximally through the notch to release the tissue sample, and pumping a fluid through the biopsy needle into a hole defined along the notch to expel the tissue sample from the notch into an extraction conduit. The method also includes generating a vacuum in the extraction conduit to draw the tissue sample into a storage container fluidly coupled to the extraction conduit.

[0054] In various cases, the biopsy devices and methods disclosed herein can be used in combination with magnetic resonance imaging (MRI) technology. For example, the biopsy assembly can extend into the field of view of the MRI device imaging to facilitate the placement of the biopsy needle relative to the patient's tissue. In some cases, the biopsy assembly and / or the robotic arm supporting the biopsy assembly can extend through the central hole in the MRI device. Exemplary systems and components are further described in International Application No. PCT / US2021 / 014628, entitled MRI-GUIDED ROBOTIC SYSTEMS AND METHODS FOR BIOPSY, which was published on July 29, 2021, and is incorporated herein by reference in its entirety.

[0055] Although several forms have been illustrated and described, the applicant has no intention of limiting or restricting the scope of the appended claims to these details. Without departing from the scope of the present disclosure, it will be apparent to those skilled in the art that many modifications, variations, changes, substitutions, combinations and equivalents to these forms may be realized and will occur. In addition, the structure of each element associated with the described form may alternatively be described as a means for providing the function performed by the element. In addition, in the case of materials for certain components being disclosed, other materials may be used. Therefore, it should be understood that the foregoing description and the appended claims are intended to cover all such modifications, combinations and variations within the scope of the disclosed forms. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications and equivalents.

[0056] Those skilled in the art will recognize that, in general, the terms used herein, and especially in the appended claims (e.g., the bodies of the appended claims), are generally intended to be “open-ended” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “comprising” should be interpreted as “including but not limited to,” etc.). Those skilled in the art will further understand that if a specific number of an introduced claim recitation is intended, such intent will be explicitly recited in the claim, and in the absence of such recitation, no such intent is present. For example, as an aid to understanding, the following appended claims are The use of the introductory phrases "at least one" and "one or more" may be included to introduce claim recitations. However, the use of such phrases should not be interpreted as implying that a claim recitation introduced by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations.

[0057] Furthermore, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should generally be interpreted to mean at least the recited number (e.g., a mere recitation of "two recitations" without other modifiers generally means at least two recitations, or two or more recitations). Furthermore, where a convention similar to "at least one of A, B, and C, etc." is used, generally such construction is intended in the sense that those skilled in the art will understand the convention (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Where a convention similar to "at least one of A, B, or C, etc." is used, generally such construction is intended in the sense that those skilled in the art will understand the convention (e.g., "a system having at least one of A, B, or C" would include, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will further understand that, whether in the specification, claims or drawings, disjunctive words and / or phrases generally indicating two or more optional terms should be understood to include the possibility of one, any or both of these terms, unless the context dictates otherwise. For example, the phrase "A or B" will generally be understood to include the possibility of "A" or "B" or "A and B".

[0058] With respect to the appended claims, it will be appreciated by those skilled in the art that the operations described therein may generally be performed in any order. In addition, although various operational flow charts are presented in (one or more) sequences, it will be understood that the various operations may be performed in other orders than the order shown, or may be performed simultaneously. Examples of such alternating orderings may include overlapping, interleaving, interrupting, reordering, increasing, preparatory, supplementing, simultaneous, reverse or other variations of ordering, unless the context otherwise dictates. In addition, terms such as "responsive to," "related to," or other past tense adjectives are generally not intended to exclude such variations, unless the context otherwise dictates.

[0059] It is worth noting that any reference to "one aspect," "an aspect," "an example," "an example," etc. means that a particular feature, structure, or characteristic described in conjunction with that aspect is included in at least one aspect. Thus, the appearance of the phrases "in one aspect," "in an aspect," "in an example," and "in an example" in various places throughout the specification are not necessarily all referring to the same aspect. Furthermore, in one or more aspects, the particular features, structures, or characteristics may be combined in any suitable manner.

[0060] Any patent application, patent, non-patent publication, or other public material referred to in this specification and / or listed in any Application Data Sheet is incorporated herein by reference to the extent that the incorporated material is not inconsistent with this document. Therefore, to the extent necessary, the disclosure explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof that is stated to be incorporated herein by reference but conflicts with existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public material.

[0061] Any patent application, patent, non-patent publication, or other public material referred to in this specification and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated material is not inconsistent with this document. Therefore, to the extent necessary, the disclosure explicitly set forth herein will supersede any conflicting material incorporated herein by reference. Any material, or portion thereof, that is allegedly incorporated herein by reference but conflicts with existing definitions, statements, or other public material set forth herein is incorporated only to the extent that there is no conflict between the incorporated material and the existing public material.

[0062] In summary, many benefits resulting from the adoption of the concepts described herein have been described. The above description of one or more forms has been given for purposes of illustration and description. It is not intended to be exhaustive or limited to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more forms are selected and described in order to illustrate the principles and practical applications, thereby enabling one of ordinary skill in the art to utilize various forms and make various modifications suitable for the intended specific use. The claims submitted herein are intended to define the entire scope.

Claims

1. A biopsy assembly, comprising: A needle assembly, the needle assembly comprising a cutting sleeve and a needle tube core, wherein the needle tube core comprises: a body forming a longitudinal conduit, wherein the longitudinal conduit is fluidly coupled to a pump; a recess in the body; and a hole along the notch, wherein the hole forms a transverse opening through the body to the longitudinal conduit; and A carrier, the carrier comprising: a housing configured to slidably receive the needle core, wherein the housing comprises a proximal end and a distal end; an extraction conduit extending from the proximal end to the distal end; and a storage container fluidly coupled to the extraction conduit and to a vacuum source; wherein the cutting cannula is movable distally relative to the notch to excise a tissue sample, wherein the cutting cannula is movable proximally to release the tissue sample, wherein upon activation of the pump, the tissue sample is advanced from the notch to the extraction conduit, and wherein upon activation of the vacuum source, the tissue sample is extracted along the extraction conduit to the storage container. 2 . The biopsy assembly of claim 1 , wherein the needle stylet comprises a first diameter, wherein the extraction conduit comprises a second diameter, and wherein the second diameter is greater than the first diameter.

3. The biopsy assembly of claim 1, wherein the needle stylet is between 14 gauge and 18 gauge.

4. The biopsy assembly of claim 3, wherein the extraction catheter is larger than 14 gauge.

5. The biopsy assembly of claim 1, wherein the carrier further comprises a motor operably configured to rotate the storage container.

6. The biopsy assembly of claim 5, wherein the storage container comprises a plurality of discrete compartments, and wherein the storage container is rotatable relative to the proximal end of the extraction catheter to fluidly couple one of the discrete compartments to the extraction catheter.

7. The biopsy assembly of claim 1, further comprising the pump operably configured to selectively pump fluid along the longitudinal conduit through the needle stylet to the aperture. The biopsy assembly of claim 6 , wherein the needle stylet comprises a solid distal end face.

9. The biopsy assembly of claim 1, further comprising the vacuum source operably configured to selectively generate a vacuum force in the extraction conduit.

10. A biopsy assembly comprising: Needle assembly, comprising: an inner core comprising a hollow body forming a longitudinal conduit, a solid distal end face, a lateral notch, and a through hole defined through the hollow body along the lateral notch; and a cutting sleeve slidably disposed around the inner core; and Vectors, including: a housing configured to slidably receive the needle assembly, wherein the housing includes a proximal end and a distal end; an extraction conduit extending from the proximal end to the distal end; and A storage container is fluidly coupled to the vacuum source.

11. A method for performing a biopsy, the method comprising: advancing a biopsy needle and a cutting cannula into tissue, wherein the biopsy needle includes a notch configured to receive a tissue sample; retracting the cutting cannula proximally through the notch to release the tissue sample; pumping a fluid through the biopsy needle into an aperture defined along the notch to expel the tissue sample from the notch into an extraction conduit; as well as A vacuum is created in the extraction conduit to draw the tissue sample into a storage container fluidly coupled to the extraction conduit.

12. A surgical apparatus and method as herein described and illustrated.

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