Cold therapy biopsy device

Abstract

Certain aspects of the present disclosure provide for a biopsy device. The biopsy device includes a probe defining a sample notch for collecting a tissue sample and a coolant chamber. The coolant chamber positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source. The coolant chamber and the sample notch being fluidically isolated from one another during collection of the tissue sample.

Description

COLD THERAPY BIOPSY DEVICETECHNICAL FIELD

[0001] The present disclosure relates to biopsy devices and methods, and more specifically, to biopsy devices and methods for cooling a targeted biopsy site.BACKGROUND

[0002] A biopsy procedure may be performed on a subject to aid in the examination of tissues in a region of interest, such as to determine whether the tissue contains cancerous cells. Biopsy techniques for the evaluation of breast tissue, for example, may involve the insertion of a biopsy probe into the breast tissue region of interest to capture one or more tissue samples from a target site in the region of interest. The tissue samples may be severed from the surrounding tissue region. There may be bleeding, swelling, and irritation at target site after removal of the tissue and / or biopsy device. Generally, techniques for reducing bleeding, swelling, and irritation at the target site are provided at the surface level, for example, pressure via a bandage or cooling via a cold pack. These techniques may have reduced efficacy within the region of interest and target site.

[0003] Therefore, there is need for improved biopsy devices and techniques for reducing bleeding, swelling, and irritation of a target site following a biopsy procedure.SUMMARY

[0004] In one embodiment, a biopsy device includes a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch. The sample notch is configured to be fluidically coupled to a coolant source. The coolant chamber and the sample notch are fluidically isolated from one another during collection of the tissue sample.

[0005] In another embodiment, a method of performing a biopsy procedure includes advancing a biopsy device to a targeted biopsy site. The biopsy device includes a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source, the coolant chamber and the tissue sample being fluidically isolated from one another during collection of the tissue sample; and a cutter cannula. The method further includes collecting the tissue sample within the sample notch by actuating the cutter cannula and cooling the targeted biopsy site by circulating coolant fluid from the coolant source through the coolant chamber.

[0006] In another embodiment, a biopsy device includes a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch. The sample notch and the tissue sample are fluidically isolated from one another during collection of the tissue sample; and a coolant source fluidically is coupled to the coolant chamber.

[0007] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0009] FIG. 1 schematically depicts a biopsy device, according to one or more embodiments shown and described herein;

[0010] FIG. 2 schematically depicts a block representation of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0011] FIG. 3 schematically depicts a cross-sectional view of a probe of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0012] FIG. 4 schematically depicts an enlarged portion of an embodiment of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0013] FIGS. 5A schematically depicts an enlarged portion of an embodiment of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0014] FIG. 5B schematically depicts an enlarged portion of an embodiment of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0015] FIG. 5C schematically depicts the valve depicted in FIGS. 5A-5B, according to one or more embodiments shown and described herein;

[0016] FIG. 6A schematically depicts a cross-sectional view of an embodiment of biopsy device depicted in FIG. 1, according to one or more embodiments shown and described herein;

[0017] FIG. 6B schematically depicts a side view of the embodiment depicted in FIG. 6A, according to one or more embodiments shown and described herein; and

[0018] FIG. 7 schematically depicts an example method for performing a biopsy procedure, according to one or more embodiments shown and described herein.

[0019] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the disclosure, and such exemplifications are not to be construed as limiting the scope of the application in any manner.DETAILED DESCRIPTION

[0020] Embodiments described herein are directed to biopsy devices, systems, and methods for cooling a targeted biopsy site. For example, the biopsy devices and methods may be used to cool a targeted biopsy site, for example, following collection of a tissue sample. Specifically, embodiments described herein include a biopsy device including a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch. The coolant chamber is fluidically coupled to, or is configured to be fluidically coupled to, a coolant source. The coolant chamber and the sample notch are fluidically isolated from one another during collection of the tissue sample. Accordingly, a single device may provide for both biopsy of tissue and subsequent cooling, thereby improving and simplifying procedures. In addition, separation of the coolant chamber from the sample notch may ensure samples are kept isolated for cooling fluid. These and additional embodiments and benefits will be described in greater detail herein.

[0021] As used herein, the term “proximal” means closer to the direction of an origin of an element, such as a biopsy device. The origin of a biopsy device may be a handle, or other user- manipulated portion of the biopsy device. The term “distal” means further from the origin, or handle, of the biopsy device. Put another way, the term “distal” means closer to or in a direction of a tip of a biopsy device, which is separated from a handle of the biopsy device by the length of the probe of the biopsy device.

[0022] The terms “coupled,” “fixed,” “attached to,” and the like refer to both direct coupling, fixing, and attaching, as well as indirect coupling, fixing, or attaching through one or more intermediate components or features, unless otherwise specified herein.

[0023] The singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise.

[0024] The term “at least one of’ in the context of, e.g., “at least one of A, B, and C” refers only A, only B, only C, or any combination of A, B, and C.

[0025] As used in this application, stating that any part is in any way on (e.g., positioned on, located on, disposed on, or formed on, etc.) another part, indicates that the referenced part is either in contact with the other part, or that the referenced part is above the other part with one or more intermediate part(s) located therebetween.

[0026] As used herein, connection references (e.g., attached, coupled, connected, and joined) may include intermediate members between the elements referenced by the connection reference and / or relative movement between those elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and / or in fixed relation to each other. As used herein, stating that any part is in “contact” with another part is defined to mean that there is no intermediate part between the two parts.

[0027] Unless specifically stated otherwise, descriptors such as “first,” “second,” “third,” etc., are used herein without imputing or otherwise indicating any meaning of priority, physical order, arrangement in a list, and / or ordering in any way, but are merely used as labels and / or arbitrary names to distinguish elements for ease of understanding the disclosed examples. In some examples, the descriptor “first” may be used to refer to an element in the detailed description, while the same element may be referred to in a claim with a different descriptor such as “second” or “third.” In such instances, it should be understood that such descriptors are used merely for identifying those elements distinctly that might, for example, otherwise share a same name.

[0028] Approximating language, as used herein throughout the specification and claims, is applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about”, “approximately”, and “substantially”, are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value, or the precision of the methods or machines for constructing or manufacturing the components and / or systems. For example, the approximating language may refer to being within a ten percent margin.

[0029] Here and throughout the specification and claims, range limitations are combined and interchanged, such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise. For example, all ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other.

[0030] Referring to FIG. 1 , an embodiment of a biopsy device 100 is schematically depicted. The biopsy device 100 includes a probe 104. The biopsy device 100 may further include a cutter cannula 102 and a handle 120. The biopsy device 100 may include a greater or fewer number of components than depicted without departing from the scope of the present disclosure.

[0031] In embodiments, the probe 104 is coaxially arranged within the cutter cannula 102. As will be described in greater detail herein, the cutter cannula 102 may have a sharpened distal edge operable to cut a tissue sample from a target location. That is, the cutter cannula 102 may slide along the probe 104 to dissect a sample of tissue. In embodiments, the cutter cannula 102 may be formed of any suitable material such as stainless steel, titanium, etc. In some embodiments, the cutter cannula 102 may be coated with one or more coatings to assist in preventing tissue from sticking to the cutter cannula 102, such as polyetrafluoroethylene (PTFE) or the like, during a cooling procedure. Such coatings may apply to an inside or outside surface of the cutter cannula 102. The cutter cannula 102 may have a rotational cutting motion and / or a longitudinal cutting motion, for example, to sever a tissue sample.

[0032] The handle 120 may be coupled to a proximal end of the probe 104 and the cutter cannula 102. For example, the probe 104 and / or the cutter cannula 102 may be moveably coupled to the handle 120, for example, via any number of motors, gearing, actuators, control circuits, or the like. In embodiments, the handle 120 may be configured and ergonomically designed to be grasped by a user, for example, performing a biopsy procedure. The handle 120 may include control input devices (e.g., buttons, toggles, switches, etc.) for providing user control over various functions of the biopsy device 100. For example, control input devices may include devices to operate a cutting operation, piercing operation, cooling operation, etc. For example, there may be a firing button 128 configured to fire the probe 104 into a region of interest, a sample sequence button 130 configured to collect a tissue sample by actuating the cutter cannula 102 distally, a cooling sequence button 132 configured to control cooling of the biopsy device 100 such as by instigating circulation of a coolant fluid, adjusting circulation of the coolant fluid, and / or ceasing circulation of the coolant fluid within the biopsy device 100. Other inputs are contemplated and possible.

[0033] In embodiments, the handle 120 may include visual indicators (e.g., light indicators, display screens, etc.) providing visual feedback of the status of one or more conditions, operations, and / or positions of components of the biopsy device 100. The visual indicators may include, for example, a battery indicator 122 configured to indicate a battery level of the biopsy device 100. The visual indicators may include, for example, an error light 124 configured to indicate an operation error of the biopsy device 100 (e.g., failed operation, incomplete cut, blockage, etc.). The visual indicators may include, for example, a mode indicator 126 to indicate a mode of the biopsy device 100 (e.g., a piercing mode, cutting mode, cooling mode, etc.).

[0034] FIG. 2 schematically depicts the biopsy device 100 as a simplified block diagram for clarity. FIG. 3 schematically depicts a cross section of the probe 104. Collectively referring to FIGS. 2 and 3, the probe 104 may be an elongated tube or stylet. The probe 104 may be formed of any suitable material such as stainless steel, titanium, etc. In embodiments, the probe 104 may be coated with a nonstick coating such as PTFE or the like to prevent sticking of tissue during cooling, for example, during a cooling procedure. The probe 104 may define a sample notch 112 and a coolant chamber 110 positioned adjacent to the sample notch 112. Distal to the sample notch 112 and the coolant chamber 110 may be a piercing tip 106 forming a distal end of probe 104. The piercing tip 106 may be a sharp piercing tip to assist in traversing tissue to a target location. The sample notch 112 may be an elongated opening formed within a sidewall of the probe 104 so as to be a radial opening into a sample lumen 108 of the probe 104. The sample notch 112 may include cutting edges around the perimeter of the opening formed by the sample notch 112. In embodiments, the probe 104 may be coupled to any number of motors, gearing, actuators, control circuits, or the like such that the probe 104 is moveable relative to the handle 120 such as in a firing or piercing operation. For example, the probe 104 may be advanced relative to the handle 120 to pierce a target tissue 140 and embedded within the target tissue 140 to a target location, such as depicted in FIG. 2. In some embodiments, the probe 104 may instead be inserted manually or via a secondary driver device.

[0035] Upon insertion into the target tissue 140 and advancement to the target location, the biopsy device 100 may be controlled (such as via the one or more control input devices) to take a tissue sample. During such procedure, the cutter cannula 102 may be withdrawn from the sample notch 112, allowing tissue to enter the sample notch 112. The cutter cannula 102 may be driven distally to cut the tissue that has interested the sample notch 112 from the surrounding target tissue 140. As noted herein above, cutting the tissue sample may cause localized bleeding, swelling, anddiscomfort. Traditionally, after tissue collection localized compression and cooling may be applied to the external tissue (e.g., the skin above the target location), which may have limited efficacy in providing relief.

[0036] In embodiments, the coolant chamber 110 may provide direct relief via the probe 104 to cool the biopsy site of target tissue 140, thereby improving the comfort of the subject and promoting healing. For example, the coolant chamber 110 is configured to hold or have circulated there through coolant fluid, for example, liquid nitrogen, argon, carbon dioxide, or the like, which will cool the probe 104 and, in embodiments, the cutter cannula 102. In embodiments, cooling may be caused by a user, such by pushing the cooling sequence button (e.g., cooling sequence button 132 described above). In some embodiments, cooling may be automatically caused via logic executed by a control circuit after tissue sample collection to cool the biopsy site. In embodiments, the coolant chamber 110 may be selectively fluidically coupled to a coolant source 114 such as via a pump (which may be within or outside of the handle 120), which may be selectively operated to circulate coolant fluid through the coolant chamber 110. In embodiments, the coolant chamber 110 is closed off or fluidically isolated from the sample notch 112 during collection of the tissue sample. In some embodiments, during a cooling cycle, the coolant chamber 110 is closed off or fluidically isolated from the sample notch 112, thereby preventing coolant from egressing, or flowing out the sample notch 112. In any case, after sample collection, coolant may be circulated into the coolant chamber 110 within the probe 104, thereby cooling the probe 104 and, in embodiments, the cutter cannula 102. A user, if desired, may also concurrently apply pressure externally to aid in healing as well.

[0037] In embodiments, it is contemplated that cooling may be provided while the tissue sample is positioned within the sample notch 112. However, in some embodiments, it may be desirable to transport the tissue sample from the sample notch 112 prior to providing cooling, such as to protect the tissue sample from the cooler temperatures.

[0038] For example, in embodiments, the probe 104 further includes a first valve 116, a distal valve, located adjacent to the sample notch 112. The first valve 116 may form a distal end of the coolant chamber 110 and is between the sample notch 112 and the coolant chamber 110. When the first valve 116 is positioned in an opened position, the sample notch 112 and the coolant chamber 110 may be in fluid communication, such as to allow proximal passage of tissue sample through the coolant chamber 110. Where the first valve 116 is positioned in a closed position, the sample notch 112 and the coolant chamber 110 may be fluidically isolated, such as during acooling procedure. In embodiments, the first valve 116 is configured to move between the opened position and the closed position under vacuum pressure (e.g., negative pressure), such as vacuum pressure from a vacuum source 136. In embodiments, the first valve 116 is a one-way valve. For example, the first valve 116 may allow proximal passage, such as of tissue sample, but prevent distal passage, such as of coolant fluid within the coolant chamber 110.

[0039] In embodiments and with specific reference to FIG. 2, a second valve 118, or proximal valve, may form a proximal end of the coolant chamber 110. In embodiments, when the second valve 118 is positioned in an opened position, coolant fluid may flow from the coolant source 114 to the coolant chamber 110 via the second valve 118. Further, in embodiments, when the second valve 118 is positioned in an opened position, the tissue sample may be transported through the second valve 118, such as for sample collection. When the second valve 118 is positioned in a closed position, fluid may not flow between the coolant source 114 and the coolant chamber 110 via the second valve 118. In embodiments, the coolant fluid may be liquid nitrogen, argon, carbon dioxide, or the like.

[0040] In embodiments, the coolant fluid 138 from the coolant source 114 may be circulated within the coolant chamber 110, such as to cool (e.g., reduce the temperature of) the probe 104. Cooling of the probe 104 may induce cooling of a cooling zone 142 of the region of interest. Such cooling may beneficially reduce bleeding, swelling, and / or irritation of the region of interest following collection of the tissue sample. In embodiments, coolant fluid may be circulated for a time period, for example, a time period of less than 1 minute, less than 2 minutes, less than 3 minutes, less than 4 minutes, less than 5 minutes, greater than 1 second, greater than 30 seconds, greater than 1 minute, etc. In embodiments, the biopsy device 100 may be removed based on the time period of the cooling procedure.

[0041] Accordingly, a tissue sample severed by the cutter cannula 102 at the sample notch 112 of the probe 104 may be transported by vacuum applied by the vacuum source 136 through the coolant chamber 110 in a proximal direction, through the first valve 116 and the second valve 118. After the tissue sample is transported proximally, a cooling procedure may circulate coolant fluid 138 through the coolant chamber 110 via the second valve 118 in an opened position. The first valve 116 forms the distal end of coolant chamber 110, such as to retain the coolant fluid 138 within the coolant chamber 110. Beneficially, movement between an opened position and a closed position of the second valve 118 allows transitioning between a sample collection procedure and a coolant procedure.

[0042] Biopsy device 100 may further include a temperature sensor 134 (e.g., a thermocouple or the like) configured to detect a temperature of the biopsy device 100. That is the temperature sensor 134 may output a signal, such as to a control circuit, indicative of a temperature of the probe 104 or surrounding tissue. In embodiments, a thermocouple is coupled to the probe and outputs a signal indicative of a temperature of the probe. In embodiments, the control circuit may control the flow of coolant fluid based on feedback from the temperature sensor. For instance, it may be desirable that cooling of the biopsy device 100 and / or surrounding tissue be between about 8°C to about -30°C. For example, the temperature may be from about -30°C to about 8°C, from about -20°C to about 8°C, from about -10°C to about 8°C, from about 0°C to about 8°C, from about -30°C to about 0°C, from about -30°C to about 10°C, from about -30°C to about 20°C, from about -30°C to about 30°C, from about 0°C to about 10°C, from about 0°C to about 20°C, from about 0°C to about 30 °C, etc.

[0043] In embodiments, the biopsy device may be removed based on the temperature of the biopsy device. For example, the temperature may be from about -30 °C to about 8 °C, from about -20°C to about 8°C, from about -10°C to about 8°C, from about 0°C to about 8°C, from about -30°C to about 0°C, from about -30°C to about 10°C, from about -30°C to about 20°C, from about -30°C to about 30°C, from about 0°C to about 10°C, from about 0°C to about 20°C, from about 0°C to about 30 °C, etc.

[0044] In some embodiments, cooling may only be applied for short period of time to prevent overcooling or frostbite. Accordingly, in embodiments, the coolant fluid 138 within coolant chamber 110 may be adjusted based on the detected temperature of biopsy device 100. In embodiments, biopsy device 100 may be removed from the region of interest based on the detected temperature of biopsy device 100. In some embodiments, visual temperature feedback such as via a display may be used to provide information as to cooling temperatures.

[0045] FIG. 4 schematically depicts a portion of an embodiment of a biopsy device 400, for example, for use as part of the biopsy device 100.

[0046] A probe 404 includes a piercing tip 406 forming a distal end of the probe 404. The probe 404 further includes a sample notch 412 to facilitate the reception of a tissue sample into a sample lumen 408, via collection by a cutter cannula 402. A valve 416, which may be an embodiment of the first valve 116 described with respect to FIG. 2, forms a proximal end of the sample lumen 408 within the probe 404. The valve 416 separates the sample notch 412 and aproximal portion of probe 404, for example, a distal end of a coolant chamber, such as coolant chamber 110 as described with respect to FIG. 2.

[0047] In the depicted embodiment, the valve 416 is a petal valve. The valve 416 may be positioned in an opened position (not depicted), allowing proximal passage of a tissue sample through the valve 416. When the valve 416 is in the opened position, a tissue sample severed by the cutter cannula 402 at the sample notch 412 of the probe 404 may be transported by vacuum applied by a vacuum source (not depicted) through the valve 416 in a proximal direction.

[0048] The valve 416 may be positioned in a closed position (as depicted), restricting passage through the valve 416. When in the closed position, the valve 416 may fluidically isolate the sample lumen 408 and the sample notch 412 from the proximal portion of the probe 404. The valve 416 may transition between an opened position and a closed position under vacuum pressure (e.g., negative pressure), such as from vacuum source 136 described herein.

[0049] In embodiments, when the valve 416 is in the close position, a cooling procedure may provide for coolant fluid from the coolant source to be circulated within a coolant chamber, as described herein, such as to cool the probe 404. Cooling of the probe 404 may induce cooling of a cooling zone of the region of interest. Such cooling may beneficially reduce bleeding, swelling, and / or irritation of the region of interest following collection of a tissue sample.

[0050] FIGS. 5A - 5C schematically depict a portion of an embodiment of a probe 504, for example, for use within biopsy device 100.

[0051] The probe 504 includes a sample lumen 508 and a coolant chamber 510 positioned adjacent within the probe 504. A valve 516 is positioned between the sample lumen 508 and the coolant chamber 510, forming a proximal end of the sample lumen 508 and a distal end of the coolant chamber 510. The valve 516 may be an embodiment of the first valve 116 described with respect to FIG. 2. The valve 516 is a ball valve with an aperture 515 formed therein. The aperture 515 may allow fluid communication through the valve 516 as depicted in FIG. 5C.

[0052] The valve 516 includes a control tab 522 fitting within a control notch 520. In FIG. 5Asthe valve 516 is positioned in a closed position with the aperture 515 perpendicular to the sample lumen 508 and the coolant chamber 510, thereby fluidically isolating the sample lumen 508 and the coolant chamber 510. In the closed position, the control tab 522 is in a first position within the control notch 520. The valve 516 may be in a closed position during a coolingprocedure, described herein, such as to fluidically isolate the coolant chamber 510 during the cooling procedure.

[0053] In FIG. 5B, the valve 516 is positioned in an opened position with the aperture 515 coaxial with the sample lumen 508 and the coolant chamber 510, thereby allowing proximal passage, for example, of a tissue sample, through the valve 516. In the opened position, the control tab 522 is in a second position within the control notch 520. The valve 516 may be in an opened position during a sample collection procedure, for example, allowing transportation of a tissue sample proximally through the coolant chamber 510.

[0054] In embodiments, the control tab 522 may actuate within the control notch 520, thereby actuating the valve 516 from the closed position to the opened position, and / or vice versa. The valve 516 may be controlled in conjunction with actuation of a cutter cannula, such as the cutter cannula 102 depicted in FIG. 2. For example, the cutter cannula 102 may actuate to cut a tissue sample from the target tissue 140 and the control tab 522 positions within the control notch 520 to the second position, rotating the valve 516 to the opened position, whereby the aperture 515 is coaxial with the sample lumen 508 and the coolant chamber 510. As another example, the cutter cannula 102 may actuate following a cut of the tissue sample, and the control tab 522 positions within the control notch 520 to the first position, rotating the valve 516 to the closed position, whereby the aperture 515 is perpendicular with the sample lumen 508 and the coolant chamber 510. A cooling procedure, described herein, may beneficially circulate coolant fluid through the coolant chamber 510 as to cool the probe 504. In the closed position, the valve 516 fluidically isolates the coolant chamber 510 and the sample lumen 508.

[0055] FIGS. 6A-6B schematically depicts another embodiment of a probe 604, for example, for use within the biopsy device 100 depicted in FIG. 1 or FIG. 2. FIG. 6 A depicts a longitudinal cross section of the probe 604. In the depicted embodiment, the probe 604 may be an elongated tube or stylet. The probe 604 may define a first sample notch 612A and a second sample notch 612B. Distal to the first sample notch 612A and the second sample notch 612B may be a piercing tip 606 forming a distal end of the probe 604. The piercing tip 606 may be a sharp piercing tip to assist in traversing tissue to a target location. The first sample notch 612A and the second sample notch 612B may be a notch formed within a sidewall of the probe 604 so as to be a radial opening into a sample lumen 608 of the probe 604. In embodiments, the probe 604 may be coupled to any number of motors, gearing, actuators, control circuits, or the like such that the probe 604 is moveable relative to a handle (not depicted) such as in a firing or piercing operation. For example,the probe 604 may be advanced relative to the handle to pierce target tissue and imbed itself within the target tissue to a target location. In some embodiments, the probe 604 may instead be inserted manually or via a secondary driver device.

[0056] In embodiments, the probe 604 is coaxially arranged within the cutter cannula 602. The cutter cannula 602 may have a sharpened distal edge operable to cut a tissue sample from a target location. That is, the cutter cannula 602 may slide along the probe 604 to dissect a sample of tissue. In embodiments, the cutter cannula 602 may be formed of any suitable material such as stainless steel, titanium, etc. In some embodiments, the cutter cannula 602 may be coated with one or more coatings to assist in preventing tissue from sticking to the cutter cannula 602, such as polyetrafluoroethylene (PTFE) or the like. Such coatings may apply to an inside or outside surface of the cutter cannula 602. The cutter cannula 602 may have a rotational cutting motion and / or a longitudinal cutting motion, for example, to sever a tissue sample.

[0057] Positioned adjacent to the first sample notch 612A and the second sample notch 612B is a coolant chamber 610, depicted in FIG. 6 A, as a first portion of the coolant chamber 610A and a second portion of the coolant chamber 610B. As depicted in FIG. 6B, coolant chamber 610 may be positioned concentrically to the cutter cannula 602, and coaxially with the probe 604. The coolant chamber 610 (or 610A and 610B) are fluidically isolated from the first and second sample notches 612A and 612B.

[0058] In embodiments, coolant fluid from a coolant source may be circulated within the coolant chamber 610, such as to cool (e.g., reduce the temperature of) probe 604. Beneficially, the coolant chamber 610 covers the probe 104 such as to provide an increased surface area of cooling. In embodiments, the coolant fluid comprises at least one of: liquid nitrogen; argon; or carbon dioxide. Cooling of the probe 604 may induce cooling of a cooling zone of the region of interest. Such cooling may beneficially reduce bleeding, swelling, and / or irritation of the region of interest following collection of tissue sample. Further, in embodiments a cooling procedure, as described herein, may occur simultaneously to collection of the tissue sample. In some embodiments, a cooling procedure may occur following collection of the tissue sample.

[0059] FIG. 7 depicts an example method 700 of performing a biopsy procedure with a biopsy device, for example, biopsy device 100. Aspects of the method 700 may be performed with according to one or more embodiments described herein.

[0060] Initially, the method 700 begins at block 702 with advancing a biopsy device to a targeted biopsy site. With reference to FIGS. 1-2 and 6A-6B, the biopsy device comprises a probe, for example, the probe 104 defining a sample notch 112 for collecting a tissue sample and a coolant chamber 110 or the coolant chamber 610 (in FIG. 6B) positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source, such as coolant source 114. The coolant chamber and the tissue sample may be fluidically isolated from one another during collection of the tissue sample. The biopsy device further comprises a cutter cannula positioned concentrically within the probe, wherein the coolant chamber is positioned concentrically about the cutter cannula, such as cutter cannula 102 or cutter cannula 602 (in FIG. 6A-6B).

[0061] The method 700 proceeds to block 704 with collecting the tissue sample within the sample notch, e.g., sample notch 112, by actuating the cutter cannula, e.g., cutter cannula 102 or cutter cannula 602 (in FIG. 6A-6B).

[0062] In embodiments, the probe further comprises a valve positioned between the sample notch and the coolant chamber. For example, the first valve 116, the valve 416 in FIG. 4, or the valve 516 in FIGS. 5A-5C. The valve may be a one-way valve, and the method 700 further comprises positioning the valve in the opened position, for example, the first valve 116, the valve 416 in FIG. 4, or the valve 516 in FIG. 5B; and passing the tissue sample proximally through the coolant chamber. In embodiments, the valve is configured to move under vacuum pressure, for example, provided by vacuum source 136 in FIG. 2.

[0063] In embodiments, the method 700 further comprises moving the tissue sample from the sample notch, e.g., sample notch 112 in FIG. 2, and through the coolant chamber, e.g., coolant chamber 110, via a vacuum, for example, vacuum source 136 in FIG. 2. For example, a tissue sample severed by cutter cannula 102 at sample notch 112 of probe 104 may be transported by vacuum applied by vacuum source 136 through coolant chamber 110.

[0064] The method 700 then proceeds to block 706 with cooling the targeted biopsy site by circulating coolant fluid from the coolant source through the coolant chamber, for example, coolant chamber 110, or coolant chamber 610 in FIGS. 6A-6B. In embodiments, the coolant fluid comprises at least one of: liquid nitrogen; argon; or carbon dioxide. In embodiments, the method 700 further comprises positioning the valve in a closed position, for example, valve 516 in FIG. 5A, whereby the sample notch and the coolant chamber are fluidically isolated during circulating the coolant fluid.

[0065] In embodiments, coolant fluid may be circulated for a time period, for example, a time period of less than 1 minute, less than 2 minutes, less than 3 minutes, less than 4 minutes, less than 5 minutes, greater than 1 second, greater than 30 seconds, greater than 1 minute, etc.

[0066] In embodiments, the biopsy device further comprises a thermocouple configured to detect a temperature of the biopsy device, for example, the temperature sensor 134 in FIG. 2, and the method 700 further comprises detecting the temperature of the biopsy device, and adjusting the coolant fluid within the coolant chamber in response to the detected temperature. In embodiments, a thermocouple is coupled to the probe and outputs a signal indicative of a temperature of the probe. For example, the temperature may be from about -30°C to about 8°C, from about -20°C to about 8°C, from about -10°C to about 8°C, from about 0°C to about 8°C, from about -30°C to about 0°C, from about -30°C to about 10°C, from about -30°C to about 20°C, from about -30°C to about 30°C, from about 0°C to about 10°C, from about 0°C to about 20°C, from about 0°C to about 30°C, etc.

[0067] In embodiments, the biopsy device further comprises a thermocouple configured to detect a temperature of the biopsy device for example, the temperature sensor 134 in FIG. 2, and the method 700 further comprises detecting the temperature of the biopsy device, and removing the biopsy device based on the temperature of the biopsy device. For example, the temperature may be from about -30°C to about 8°C, from about -20°C to about 8°C, from about -10°C to about 8°C, from about 0°C to about 8°C, from about -30°C to about 0°C, from about -30°C to about 10°C, from about -30°C to about 20°C, from about -30°C to about 30°C, from about 0°C to about 10°C, from about 0°C to about 20°C, from about 0°C to about 30°C, etc.

[0068] Embodiments can be described with reference to the following numerical clauses:

[0069] 1. A biopsy device, comprising: a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source, the coolant chamber and the sample notch being fluidically isolated from one another during collection of the tissue sample.

[0070] 2. The biopsy device of any preceding clause, further comprising a cutter cannula positioned concentrically within the probe, wherein the coolant chamber is positioned concentrically about the cutter cannula.

[0071] 3. The biopsy device of any preceding clause, further comprising a sample lumen within the probe, wherein the coolant chamber is positioned concentric to the sample lumen.

[0072] 4. The biopsy device of any preceding clause, wherein the probe further comprises a valve positioned between and fluidically isolating the sample notch from the coolant chamber during a cooling procedure.

[0073] 5. The biopsy device of clause 4, wherein the valve is a one-way valve, wherein in an opened position, the valve allows proximal passage of a sample through the coolant chamber.

[0074] 6. The biopsy device of clause 5, wherein the valve is configured to move to the opened position under vacuum pressure.

[0075] 7. The biopsy device of clause 4, wherein the valve is a petal valve, wherein in an opened position, the petal valve allows proximal passage of a sample through the coolant chamber.

[0076] 8. The biopsy device of clause 4, wherein the valve is a ball valve, wherein in an opened position the ball valve allows proximal passage of a sample through the coolant chamber.

[0077] 9. The biopsy device of any preceding clause, further comprising: a thermocouple coupled to the probe and outputting a signal indicative of a temperature of the probe.

[0078] 10. The biopsy device of any preceding clause, wherein the probe is coated in PTFE.

[0079] 11. The biopsy device of any preceding clause, further comprising a handle and the coolant source, wherein the coolant source is coupled to the handle.

[0080] 12. The biopsy device of any preceding clause, further comprising a proximal valve at a proximal end of the coolant chamber.

[0081] 13. A method of performing a biopsy procedure, the method comprising: advancing a biopsy device to a targeted biopsy site, the biopsy device comprising: a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source, the coolant chamber and the tissue sample being fluidically isolated from one another during collection of the tissue sample; and a cutter cannula; collecting the tissue sample within the sample notch by actuating the cutter cannula; and cooling the targeted biopsy site by circulating coolant fluid from the coolant source through the coolant chamber.

[0082] 14. The method of clause 13, further comprising moving the tissue sample from the sample notch and through the coolant chamber via a vacuum.

[0083] 15. The method of any one of clauses 13-14, wherein the coolant fluid comprises at least one of: liquid nitrogen; argon; or carbon dioxide.

[0084] 16. The method of any one of clauses 13-15, wherein: the biopsy device further comprises a thermocouple configured to detect a temperature of the biopsy device; and the method, further comprises: detecting the temperature of the biopsy device; and adjusting the coolant fluid within the coolant chamber in response to the detected temperature.

[0085] 17. The method of any one of clauses 13-15, wherein: the biopsy device further comprises a thermocouple configured to detect a temperature of the biopsy device; and the method, further comprises: detecting the temperature of the biopsy device; and removing the biopsy device based on the temperature of the biopsy device.

[0086] 18. A biopsy system comprising: a biopsy device comprising a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch, the sample notch and the tissue sample being fluidically isolated from one another during collection of the tissue sample; and a coolant source fluidically coupled to the coolant chamber.

[0087] 19. The biopsy system of any one of clause 18, further comprising a cutter cannula, wherein the probe is positioned within the cutter cannula.

[0088] 20. The biopsy system of any one of clauses 18-19, wherein the sample notch and the coolant chamber are fluidly connected through a first valve moveable between a closed position and an opened position.

[0089] 21. The biopsy system of clause 20, wherein the first valve is a one-way valve, wherein in the opened position, the first valve is configured to allow substance to pass from the sample notch to the coolant chamber, and prevent egress from the coolant chamber to the sample notch.

[0090] 22. The biopsy system of any one of clauses 18-21, further comprising: a thermocouple coupled to the probe and outputting a signal indicative of a temperature of the probe.

[0091] 23. The biopsy system of any one of clauses 18-21, wherein the probe is coated inPTFE.

[0092] 24. The biopsy system of any one of clauses 18-21, wherein the coolant source is at least one of: liquid nitrogen; argon; or carbon dioxide.

[0093] 25. The biopsy system of any one of clauses 18-21, further comprising a proximal valve at a proximal end of the coolant chamber.

[0094] It is noted that the terms "substantially" and "about" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0095] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMS1. A biopsy device, comprising: a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source, the coolant chamber and the sample notch being fluidically isolated from one another during collection of the tissue sample.

2. The biopsy device of claim 1, further comprising a cutter cannula, wherein the probe is positioned within the cutter cannula.

3. The biopsy device of claim 1, further comprising a cutter cannula positioned concentrically within the probe, wherein the coolant chamber is positioned concentrically about the cutter cannula.

4. The biopsy device of claim 1, wherein the probe further comprises a valve positioned between and fluidically isolating the sample notch from the coolant chamber during a cooling procedure.

5. The biopsy device of claim 4, wherein the valve is a one-way valve, wherein in an opened position, the valve allows proximal passage of a sample through the coolant chamber.

6. The biopsy device of claim 5, wherein the valve is configured to move to the opened position under vacuum pressure.

7. The biopsy device of claim 4, wherein the valve is a petal valve, wherein in an opened position, the petal valve allows proximal passage of a sample through the coolant chamber.

8. The biopsy device of claim 4, wherein the valve is a ball valve, wherein in an opened position the ball valve allows proximal passage of a sample through the coolant chamber.

9. The biopsy device of claim 1, further comprising: a thermocouple coupled to the probe and outputting a signal indicative of a temperature of the probe.

10. The biopsy device of claim 1, wherein the probe is coated in PTFE.

11. The biopsy device of claim 1, further comprising a handle and the coolant source, wherein the coolant source is coupled to the handle.

12. The biopsy device of claim 1, further comprising a proximal valve at a proximal end of the coolant chamber.

13. A method of performing a biopsy procedure, the method comprising: advancing a biopsy device to a targeted biopsy site, the biopsy device comprising: a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch and configured to be fluidically coupled to a coolant source, the coolant chamber and the tissue sample being fluidically isolated from one another during collection of the tissue sample; and a cutter cannula; collecting the tissue sample within the sample notch by actuating the cutter cannula; and cooling the targeted biopsy site by circulating coolant fluid from the coolant source through the coolant chamber.

14. The method of Claim 13, further comprising moving the tissue sample from the sample notch and through the coolant chamber via a vacuum.

15. The method of Claim 13, wherein the coolant fluid comprises at least one of: liquid nitrogen;argon; or carbon dioxide.

16. The method of Claim 13, wherein: the biopsy device further comprises a thermocouple configured to detect a temperature of the biopsy device; and the method further comprises: detecting the temperature of the biopsy device; and adjusting the coolant fluid within the coolant chamber in response to the detected temperature.

17. The method of Claim 13, wherein: the biopsy device further comprises a thermocouple configured to detect a temperature of the biopsy device; and the method further comprises: detecting the temperature of the biopsy device; and removing the biopsy device based on the temperature of the biopsy device.

18. A biopsy system comprising: a biopsy device comprising a probe defining a sample notch for collecting a tissue sample and a coolant chamber positioned adjacent to the sample notch, the sample notch and the tissue sample being fluidically isolated from one another during collection of the tissue sample; and a coolant source fluidically coupled to the coolant chamber.

19. The biopsy system of claim 18, further comprising a cutter cannula positioned concentrically within the probe, wherein the coolant chamber is positioned concentrically about the cutter cannula. .

20. The biopsy system of claim 18, wherein the sample notch and the coolant chamber are fluidly connected through a first valve moveable between a closed position and an opened position.

21. The biopsy system of claim 20, wherein the first valve is a one-way valve, wherein in the opened position, the first valve is configured to allow substance to pass from the sample notch to the coolant chamber, and prevent egress from the coolant chamber to the sample notch.

22. The biopsy system of claim 18, further comprising: a thermocouple coupled to the probe and outputting a signal indicative of a temperature of the probe.

23. The biopsy system of claim 18, wherein the probe is coated in PTFE.

24. The biopsy system of claim 18, wherein the coolant source is at least one of: liquid nitrogen; argon; or carbon dioxide.

25. The biopsy system of claim 18, further comprising a proximal valve at a proximal end of the coolant chamber.

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