Apparatus and method for fine needle core biopsy of soft tissue and fixation of specimen - Patent Application 20070123333

Abstract

The device may include: a collection tube having an inner surface defining an interior space, the collection tube having a first end and a second end defining a luer; a tissue collection chamber contained within the interior space of the collection tube; a closure cap having a first end configured to receive one end of the tissue collection chamber and connect to the first end of the collection tube, the closure cap having a second end configured to selectively receive one of a working element, a vacuum source, and a fluid source of the biopsy device; and a tubular mesh screen disposed within the tissue collection chamber and facing the inner surface, the tubular mesh screen having an open end closest to the closure cap and a closed end furthest from the closure cap.

Description

[Technical field]

[0001] The embodiments relate to medical devices and methods, and more particularly to handheld or mounted devices for single or multiple soft tissue biopsies or material retrievals in a single insertion, and corresponding methods for sampling and preserving material, such as soft tissue samples. The embodiments further relate to an improvement over currently used fine needle aspiration systems, specifically by providing devices and methods for minimally invasive and more reliable vacuum assisted fine needle core biopsy and tissue preservation. Summary of the Invention

[0002] The embodiments relate to various medical devices and methods used in aspiration and soft tissue biopsy procedures, as well as structures and functions for storing acquired tissue samples for later pathological analysis. According to one embodiment, a soft tissue aspiration and / or core biopsy device may be configured to remove liquid, semi-solid, single or multiple biopsy samples in a single insertion through the skin (percutaneous procedure) in any soft tissue area of ​​the body. The embodiments may include structures and functions for different stages of a multi-stage biopsy procedure that may be performed manually or with the device attached to a stereotactic table stage or a magnetic resonance imaging (MRI) table. The soft tissue biopsy device embodiments, along with its associated sub-components described herein, provide the possibility to retrieve solid, continuous and / or fragmented soft tissue, as well as liquid and semi-solid tissue for analysis, diagnosis and treatment, and may provide improved functionality and performance with respect to the device and method for performing fine needle aspiration and fine needle core biopsy sampling. Embodiments may be configured to be portable, disposable or reusable and may be electrically, mechanically and / or manually powered and operated, for example. [Brief description of the drawings]

[0003] [Figure 1]FIG. 1 is a side perspective view of a combination soft tissue biopsy and tissue specimen fixation device, according to one embodiment.

[0004] [Diagram 2] FIG. 2 is a side view of a closure cap having an open central lumen according to one embodiment.

[0005] [Diagram 3] FIG. 2 is a side view of a tissue collection chamber or tissue collection chamber according to one embodiment.

[0006] [Figure 4] FIG. 1 is a side view of a tissue sample fixation device according to one embodiment.

[0007] [Diagram 5] FIG. 1 is a side view of a self-contained, battery-powered vacuum and liquid collection device that may be used with a tissue collection device, according to one embodiment.

[0008] [Figure 6] FIG. 1 is a side view of a combination soft tissue biopsy device with a self-contained vacuum and liquid collection device installed according to one embodiment.

[0009] [Figure 7] 1 is a close-up view of a distal end of a biopsy device according to one embodiment.

[0010] [Figure 8] 1A-1C are diagrams of a soft tissue device having an alternative needle tip according to one embodiment.

[0011] [Figure 9] FIG. 1 is a side view of a tissue collection needle assembly according to one embodiment.

[0012] [Figure 10] FIG. 1 is a diagram of a motorized rotor and control mechanism for a soft tissue biopsy device according to one embodiment.

[0013] [Figure 11] FIG. 1 is a diagram of a motorized rotor and control mechanism installed in a soft tissue biopsy device, according to one embodiment.

[0014] [Figure 12] 13 is a flow chart of a method for entering a tissue collection chamber and securing remaining tissue with a soft tissue biopsy device according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The following provides a detailed description of the structure and operation of the embodiments illustrated in the accompanying drawings. The following description is merely illustrative of the embodiments described and illustrated herein. Thus, the embodiments are not limited to these implementations and may be realized by other implementations.

[0016] According to embodiments, the soft tissue biopsy device or combined soft tissue biopsy and tissue specimen fixation device 10 may be configured to collect and remove tissue or other material from the body, and the working element may have a diameter range of, for example, about 22 gauge to 8 gauge, or other suitable diameter. As used herein, the term "working element" or "working element 13" refers to the distal end of the biopsy device 10 that penetrates an open cavity, such as a natural body cavity or airway, or tissue to remove target tissue and tissue fragments, as well as other solids and liquids. According to various embodiments herein, such working element 13 may be of rigid or flexible construction. In various implementations, the working element may include a coring biopsy device, a mechanically interlocking cutting device, a lateral cutting device configured to cut invaginated tissue, a morcellation biopsy device, or any device configured to cut, scrape, tear, nibble, and / or aspirate tissue or cells or fluids from the body. Cryogenic and RF-based biopsy devices may also be used as "working elements." According to embodiments, a simple device 11 (which may be considered a subset of device 10) for fixing tissue collected with a biopsy device (either biopsy device 10 described herein or another device that includes compatible elements for collecting and transporting tissue, similar to those described for biopsy devices 10 or 11 herein) when the tissue is still contained within a tissue collection chamber in a collection tube, such as a hypodermic syringe barrel, may advantageously allow the tissue to be immersed in a formalin-containing solution and immediately fixed after biopsy material collection according to embodiments and methods herein.

[0017] 1 illustrates one embodiment of a combination biopsy and soft tissue sample fixation device 10 that, according to an embodiment, includes various components such as a closure cap 12, a tissue collection chamber 14, a standard syringe barrel 16 with a male Luer connection, a common Luer adapter 15, and a distal working element 13, such as a hypodermic needle or other working element. Components that perform the biopsy, material retrieval, or that make up the combination biopsy and tissue fixation device 10 are discussed further below.

[0018] FIG. 2 is a side view of a closure cap 12 having an open central lumen, indicated by dashed lines, according to one embodiment. Such closure caps 12 may be of various sizes and may be made of injection molded plastic, such as polycarbonate or other polymers, or machined from billet stock. The closure cap may include one or more sealing "O" rings 22 along its periphery configured to seal against the inner wall of a standard syringe barrel 16, as shown in FIG. 1, and may be of various sizes to accommodate corresponding compatible closure caps 12. According to an embodiment, the closure cap 12 may also include a standard luer connection 32, male or female (female shown in FIG. 2), at its outer or distal end, and may also include slotted wings 42 configured to fit over wings on the proximal end of the standard syringe barrel 16 to secure it to the syringe barrel 16. According to the embodiments and methods described herein, the luer connector 32 at the distal end of the closure cap 12 may be connected to either a working element 13, such as a hypodermic needle or other working element as described herein, a vacuum source, or a fluid source, such as a flask of formalin or other solution, having a compatible luer connector that can be connected to the distal luer connector 32 of the closure cap 12. According to embodiments, the closure cap 12 is configured to take the place of a plunger of a standard syringe, providing novel features and advantages for fine needle aspiration or soft tissue biopsy compared to a standard complete syringe with a plunger and needle tip.

[0019] 3 is a side view of a tissue collection chamber or tissue collection chamber 14 according to one embodiment. Such tissue collection chamber element 14 may, according to one embodiment, have a clamshell structure characterized by a longitudinally disposed body having a fine screen mesh 24 integrated therein as or on the periphery. According to one embodiment, the fine mesh screen 24 may be closed at a proximal end 34 and open at a distal end for receiving tissue and fluids through an extension 44. According to one embodiment, such tissue collection chambers 14 may be made in a variety of sizes to fit within standard syringe barrels of various sizes, thereby receiving collected tissue and fluids at the distal end and then allowing the integrated fine screen mesh 24 to accommodate solid tissue segments and fragments in the central lumen while allowing liquids to be drawn through the mesh screen and expelled from the syringe barrel in which the tissue collection chamber is located.

[0020] FIG. 4 is a side view of the biopsy device 10 shown in FIG. 1 according to one embodiment, but with the working element 13 removed. FIG. 4 shows a simple tissue sample fixation device 11 as a subset of device 10, which according to one embodiment includes a standard syringe barrel 16 with a tissue collection chamber or tissue collection chamber 14 located inside the syringe barrel, and a sealing cap 12 shown in place of the syringe plunger. In this case, the tissue collection chamber 14, according to one embodiment, is located inside the syringe barrel 16 with the proximal or closed end 34 of the tissue collection chamber closest to the luer connection or distal end of the syringe barrel 16 itself. The sealing cap 12 may be placed at the distal or outer open end of the tissue collection chamber 14, with the tissue collection chamber being held in the open central lumen of the sealing cap 12. The closure cap 12 may then be positioned at the proximal end of the syringe barrel 16 to mate and seal against the inner surface of the syringe barrel 16 to enclose the tissue collection chamber within the syringe barrel, according to one embodiment. The open end 44 of the tissue collection chamber 14 may fit snugly into the interior opening of the open end of the closure cap 12 to receive and collect a sample taken by a working element 13 attached to the closure cap 12 during a biopsy procedure. The combination of the syringe barrel 16, tissue collection chamber 14 and closure cap 12 is thus configured as a closed tissue and liquid containment or strainer system, with both ends of such device 11 open. According to one embodiment, both open ends of such device 11 may be configured with luer connectors 32 (one at each end of the specimen fixation device 11) for easy connection of accessories such as a formalin flush system that can flush formalin into a specimen captured in the tissue collection chamber 14 and drain out the other side of the device 11. According to one embodiment, once a simple biopsy device 10 has been used to obtain a liquid or solid or fragmented tissue sample from a target site, the working element 13 (whatever form it may take) can be removed and the biopsy device 10 becomes a tissue fixation device 11.As previously mentioned, and according to one embodiment, if a different biopsy device than device 10 is used for tissue sampling, and such alternative biopsy device is fitted with a tissue collection chamber similar to that described herein, and further uses a standard syringe as a tissue collection tube, then closure cap 12 may be secured to the tissue collection tube with the enclosed tissue collection chamber for immediate fixation of the contained tissue specimen with a formalin flush. According to yet another embodiment, closure cap 12 and syringe barrel 16 may be used as fixation device 11 with a simple fine mesh screen first inserted into the luer end of syringe barrel 16. Thus, a tissue sample obtained from any biopsy device may be placed into a syringe barrel 16 with a fine mesh screen, a sealing cap 12 may be attached to the syringe barrel 16, appropriate luer tubes may be placed on either end of the fixation device 11, a formalin solution may then be run through the fixation device 11 to preserve the tissue sample, and finally, luer caps may be placed on each end of the fixation device 11 for transporting the device containing the tissue sample to a pathology laboratory for tissue analysis.

[0021] According to one embodiment, a working element 13, such as a needle, may be placed at either end of the device 10 to obtain a tissue or liquid sample. If the working element 13 is placed at the luer connection 32 of the syringe barrel 16, the tissue collection chamber 14, when placed in the syringe barrel, may simply be rotated so that its open end 44, along with the connected needle working element, is at the luer end 32 of the syringe barrel to receive tissue samples aspirated into the device 10 when used for soft tissue biopsy. This arrangement may appear to be the inverse of the arrangement described in FIG. 4 above. In such an embodiment, the closure cap 12 is placed at the closed end 34 of the tissue collection chamber 14 to seal the tissue collection chamber within the syringe barrel 16. In such a case, according to an embodiment, the closure cap 12 of the device 10 represents the proximal end of the device 10, and thus the luer connection 32 of the closure cap 12 may be connected to an appropriate external vacuum and liquid containment source.

[0022] FIG. 5 is a side view of a self-contained, battery-powered vacuum and liquid collection device 50 that may be used with the tissue collection device 10 described herein, according to one embodiment. Such a vacuum and liquid collection device 50 may provide a vacuum source and liquid containment source for the biopsy device 10, allowing fluids collected during the biopsy procedure to be contained in the vacuum device and stored for subsequent cellular analysis, if desired. An example of such a self-contained vacuum and liquid collection device 50 is described in U.S. Pat. No. 11,234,684, which is incorporated herein by reference in its entirety. However, it should be noted that other vacuum devices may be used with the embodiments described herein. Indeed, according to other embodiments, any vacuum source, whether a separate vacuum pump, wall suction, or other vacuum and liquid containment systems used in conjunction with conventional biopsy procedures, may be used with the device 10 by simply connecting it to the luer connection 32 of the syringe barrel of the device 10. According to another embodiment, such an external vacuum / liquid collection system could include a separate complete syringe that fits into the Luer connection 32 of the syringe barrel of the device 10 using an appropriate Luer adapter 15 .

[0023] FIG. 6 is a side view of a biopsy device 10 incorporating a self-contained vacuum and liquid collection system as an element of the device 10. According to one embodiment, in this view, an assembly of a syringe barrel 16, tissue collection chamber 14, and closure cap 12 with a distal luer connector 32 is connected to a hypodermic needle, and an additional self-contained vacuum and liquid collection device 50 is disposed on the syringe barrel 16. According to an embodiment, the self-contained vacuum and liquid connection device 50 may be configured to mate with the luer end 32 of the syringe barrel 16, thereby providing a vacuum in the central lumen of the device 10. According to other embodiments, different luer connectors or adapters 15 may be fitted to either end of the device 10 to add additional functionality, such as external valves to control the flow of various substances into or out of the device 10 or device 11 at various stages of using such devices. According to another embodiment, device 10, in either configuration, may have a long flexible tube as or as part of working element 13, depending on the method, for example for purposes of aspirating and collecting liquids and semi-solids from deep lung regions for cellular and tissue analysis.

[0024] As shown, one embodiment of the material delivery or removal device 10 of the present invention may be implemented in a handheld configuration including an ergonomically comfortable assembly unit, as shown in Figure 6. The working element 13 may extend from the device 10 such that the device 10 may be easily grasped, oriented, and manipulated in one hand while the other hand is free to hold a guided probe, such as an ultrasound transducer. Furthermore, if the hand holding the device 10 can be rotated or turned in a partial rotation with a vibrating motion, the working element 13 may be more efficient in collecting and cutting target tissue during a biopsy procedure, depending on the method.

[0025] However, it should be understood that embodiments of device 10 may be readily configured to accommodate any number of guidance devices, such as a stereotactic imaging table or other guidance modalities such as MRI. The entire device 10 may be configured to be disposable or may be configured to be reusable in whole or in part.

[0026] 7 is a close-up view of the distal end of biopsy device 10 according to one embodiment. In this view, closure cap 12 can be seen placed over the proximal wing end of a standard syringe barrel 16, with working element 13 (in this case a standard Luer hypodermic needle) attached to Luer connector 32 of closure cap 12. According to an embodiment, this attachment of working element 13 to closure cap 12 can be in the form of any of a number of standard Luer connectors 15 (shown in FIG. 1), including a rotating Luer connector adapter.

[0027] 8 is a diagram of a soft tissue device shown with an alternative standard Luer needle tip as working element 13, according to an embodiment. According to an embodiment, such a needle tip may be a Chiba or Francine type hypodermic needle or other configurations as described below in FIG.

[0028] FIG. 9 is a side view of a tissue collection needle assembly or working element 13 according to one embodiment. In this case, the working element 13 may be comprised in part of a monolithic structure formed from two or more laser cut and welded stainless steel hypotubes according to one embodiment. According to an embodiment, such a working element 13 may include a single inner tube disposed at least in part within a coaxially disposed outer tube. According to one embodiment, such stainless steel inner hypotube may be cut (e.g., by a laser) to define a monolithic distal assembly that defines one or more working elements, such as a beak 33, a living hinge that attaches the beak to the generally tubular body of the device, or a living hinge that spans uniformly between the beak and the generally tubular body of the device. According to one embodiment, the cuts in the hypotube may define one or more tendons configured to actuate the beak 33. The cuts in the hypotube may also define one or more tendon actuation tabs that can actuate (e.g., open and close) the beak via the tendons to limit movement of the beak. The tendon actuator tabs may be located anywhere along the length of the hypotube. According to one embodiment, the coaxially disposed outer tube 43 may include one or more coatings. According to one embodiment, the outer tube 43 may be comprised of stainless steel hypodermic tubing ("hypotube"). The device may be made of materials other than stainless steel, such as plastic or other suitable materials, and may incorporate features of the beak, tendons, and, according to embodiments, tendon actuation tabs or inner tube actuator elements. Such working elements 13 according to one embodiment are described and may be found in U.S. Patent Nos. 10,555,751; 9,808,226; 10,076,315 and 9,456,807, which are incorporated herein by reference.As noted elsewhere in this disclosure, the working elements may include configurations other than those described in these patent numbers and described herein, as the devices according to the embodiments described herein are not concerned with the type of working element used to separate and collect tissue from the body.

[0029] A working element 13 as described in the above cited US patent may include three hypotubes (elements 33, 43 and 53 shown in this figure) that are laser cut to a specific pattern and welded together to form the assembled working element 13. As described in the referenced patent, such a working element 13 may further include an innermost short beak element including a pair of beaks 33 attached to tendons that are used to actuate opening and closing movement of the pair of beaks by axial movement of the tendons relative to the main body of the beak element, a coaxially surrounding inner tube laser welded to the base of the beak element, and an outermost coaxial tube welded to the base of the tendon. According to an embodiment, such a structure allows the beak of the beak element to be opened and closed by relative axial movement of the inner tube and the outermost tube. According to the method, such a working element 13 is mounted in the closure cap 12 of the device 10, with the inner tube 53 of the working element extending from the distal end of the closure cap 12 through the open end 44 of the device 10 to the tissue collection chamber 14, and allows the device 10 to collect tissue by inserting the working element into tissue, rotating or partially rotating and vibrating the open beak of the beak element of the working element 13, and then simply grasping the outer tube of the working element and pulling proximally to close the beak and sever the extracted tissue sample. According to an embodiment, the tissue sample thus extracted may be transferred proximally along the length of the working element 13 to the tissue collection chamber 14 of the device 10. The clasp element 23 of such a working element 13 allows for synchronous rotation of the entire working element, while allowing the outer tube of the working element to move axially relative to the inner tube to open and close the beak, which rotates and moves through the soft tissue to be sampled in the biopsy procedure to effectively coring.

[0030] 10 is a diagram of a motorized, motorized rotator and control mechanism 60 for a soft tissue biopsy device 10, according to one embodiment. Such a rotator mechanism 60 may be configured to be placed over the syringe barrel 16 of the device 10, similar to the placement of element 50 over the device 10 previously described in FIGS. 5 and 6. In this case, the rotator mechanism 60 placed over the syringe barrel 16 (the position of the syringe barrel 16 within the rotator mechanism 60 is indicated in this figure by a short dashed line) may, according to an embodiment, include an internal, electric motorized driven roller 64 and an opposing passive roller 65 that grips the outer circumference of the syringe barrel 16 of the device 10, thereby allowing rotation of the entire device 10 within the rotator mechanism 60. The rotor mechanism 60 may serve as a simple handle for an operator of the device 10, and in this view can be seen, according to the method, to include a small battery-powered electric motor 66 for driving the drive roller 64; a battery 67, and a motor switch 68 that allows the operator to turn the rotation on and off as required. According to one embodiment, in front of the switch 68 is a simple spring-loaded sliding fork arm element 62 that extends forward of the working element as described in the following paragraphs, which may allow the operator to selectively close the beak 33 of the working element 13 by pulling the sliding fork arm 62 proximally, or open the beak 33 by resiliently returning to a forward position as a result of the sliding fork arm element 62 being spring-loaded to return to the initial position of the rotor mechanism 60.

[0031] FIG. 11 is a diagram of a motorized rotor and control mechanism 60 mounted on a soft tissue biopsy device 10 according to one embodiment. In this figure, the device 10 with the assembled components is mounted inside the rotor and control mechanism 60 so that the entire device 10 including the working element 13 can be rotated. FIG. 11 shows the working element of FIG. 9. According to one embodiment, as shown, the inner tube 53 is inserted through the distal end of the closure cap 12 into the tissue collection chamber 14 located within the syringe barrel 16. As also shown, the clasp 23 of the working element 13 is exposed outside the open end of the closure cap 12, allowing relative axial movement between the inner tube 53 and the outer tube 43 of the working element 13 to open and close the beak 33. According to the method, this relative movement is induced by pulling the exposed distal clasp 23 towards the exposed proximal clasp 23, which causes the beak 33 to close and penetrate the tissue, separating the extracted tissue specimen. Moving the distal clasp element 23 back to its forward position reopens the beak 33 and allows the device 10 to enter extraction mode. Thus, the motorized rotator and control mechanism 60 mounted over the syringe barrel 16 shown in FIG. 11 operates to rotate the entire device 10, which necessarily extends to the working element 13 with the beak 33. A swivel-type luer adapter 15 is connected to the proximal end of the device 10 at the luer connection 32 of the syringe barrel 16, which is itself connected to flexible tubing that leads to a source of vacuum and liquid collection, thereby allowing vacuum-assisted transfer of the extracted tissue from the working element 13 to the tissue collection chamber 14 of the device 10. As described above in the description of FIG. 10, in accordance with an embodiment, rotation of the device 10 is guided and controlled by a motorized rotor and control mechanism 60, with a sliding fork arm 62 positioned over the distal clasp 23 of the working element 13, allowing operator-controlled motorized rotation and allowing the beak 33 to be opened and closed by simply pulling the sliding fork arm 62 proximally, or returned to its normal forward or distal position to open the beak at any point during the biopsy procedure.

[0032] FIG. 12 is a flow chart of a method of entering and securing remaining tissue with a soft tissue biopsy device in a tissue collection chamber, according to one embodiment. As shown in FIG. 12, according to one embodiment, the method of performing a biopsy or resection procedure may be preceded by, for example, imaging the tissue of the organ or structure of interest and identifying a target lesion or tissue to perform the biopsy or resection on. The skin may then be cleaned using sterile techniques, the patient may be draped, and anesthesia may be administered. The distal tip or working element 13 of the device 10 may then be introduced through the skin incision. Tissue penetration at the target site may be performed with the working element 13 in a predetermined configuration (e.g., an open or closed configuration; i.e., one or more beaks 33 of FIG. 9 described above may be open or closed (if used)), which may be selected by the operator. In one embodiment, device 10 may be suctioned through a central lumen such that the proximal force generated by such suction tends to draw the extracted tissue into said central lumen and facilitate collection of the tissue at the proximal end of device 10 in tissue collection chamber 14 after beak 33 closes to sever the tissue (or tissue collected by other means).

[0033] As shown in FIG. 1, a vacuum may be used to aspirate tissue and fluids through a connection at the proximal end of the device 10. Fluid flow containing material from the tissue site may be collected by aspiration and discarded or stored for later cellular analysis. Fixation of the collected tissue specimen contained in the tissue collection chamber within the syringe body may be accomplished by simply removing the working element 13 from the distal end of the device and attaching compatible luer connection tubing to both ends of the device, after which the sample contained within the device 10, specifically within the specimen collection chamber 14, is flushed with formalin solution to fix the tissue sample. Luer caps installed at both ends of the device 10 operate to keep the tissue submerged in the formalin solution for later transport to a pathology laboratory for examination. Thus, a method according to one embodiment may include using a biopsy device to remove a piece of tissue from an incision in the body, as shown at B121 in FIG. 12. As shown in block B122, the excised tissue fragments and fluids from the body may be drawn into a tissue collection chamber contained within a collection tube connected to the biopsy device, the tissue collection chamber having a tubular mesh open at one end and closed at the other end. Block B123 calls for drawing fluids from the tissue collection chamber through the tubular mesh to retain the excised tissue fragments within the tubular mesh. The biopsy device may then be disconnected from the tissue collection chamber, as shown in B124. A fixative fluid may be flowed into the tissue collection chamber to fix the tissue fragments retained within the tubular mesh, as shown in B125. The collection tube may be capped with the retained and fixed tissue fragments within it, as shown in B126. Alternatively, the tissue collection chamber may be removed from the collection tube, leaving the removed tissue collection chamber capped with the retained and fixed tissue fragments within it.

[0034] According to other embodiments, the method may include connecting a sealing cap between the collection tube and the biopsy device. The flushing step may include leaving a volume of fixative fluid in the collection tube and in the received tissue collection chamber. The method may further include sending the capped collection tube and / or tissue collection chamber with the tissue fragments retained and fixed to a pathology laboratory for tissue analysis. One or both of the drawing steps may include connecting a vacuum source to the tissue collection device.

[0035] It should be understood that the above description is merely one exemplary methodology, and that one or more of the above steps may be omitted, or other fixations may be added, depending on the target site within the body or the methodology of other operators. Depending on the procedure, the order of some steps may be changed.

[0036] In certain clinical situations, it may be desirable to inject a solvent into a particular area (e.g., simply water or saline, or may be mixed with a drug such as a local anesthetic or hemorrhage suppressant) to allow cells, tissues, and thick viscous liquids or semi-solids to be saturated with such solvent and facilitate transport. In such situations, it may be desirable to simultaneously inject and aspirate fluid for this purpose. In conjunction with the working elements of the device embodiments described herein, a closed-chamber syringe may be equipped with appropriate valve and tubing elements to create a single plunger action to perform both functions simultaneously. This may also be accomplished using, for example, a two plunger, single syringe device.

[0037] The described embodiments may be formed of or include one or more biocompatible materials, such as, for example, stainless steel or other biocompatible alloys, and may be made of, include, or be coated with polymeric and / or biopolymeric materials as necessary to optimize function. For example, the cutting elements (such as components of the working element 13) may include or be made of hardened alloys or carbon fibers or other polymers or plastics, and may be further coated with one or more materials that are slippery so that consistency and friction are optimized for passage through various biological tissues. Some of the components may have intentionally different surface treatments relative to adjacent components, which may be inferred here with respect to the transport tube and storage components (not shown). The various internal or external components may be made of suitable commercially available materials, such as polymers such as nylon, moldable plastics, etc. The handle may be configured to easily fit into one of a number of existing guide platforms (such as a stereotactic table stage). The materials used in the present device for delivering or removing a substance may also be carefully selected from a ferromagnetic point of view, so that the device for delivering or removing a substance of the present invention maintains compatibility with magnetic resonance imaging (MRI) devices commonly used in procedures for delivering or removing a substance. The vacuum / delivery assembly components may include a readily available reed valve for switching between aspirating and discharging a substance, such as a fluid that may be aspirated by the vacuum component, in addition to a commercially available vacuum pump, a syringe, and a tube for connecting to the device for delivering or removing a substance of the present invention. Fluids collected in this manner by embodiments of the device may then be discharged into an additional external and portable liquid storage container connected to the tube of the device for safe storage and cell analysis in a laboratory.

[0038] Although specific embodiments of the present disclosure have been described, these embodiments are presented as examples only and are not intended to limit the scope of the present disclosure. Indeed, the novel methods, devices, and systems described herein may be embodied in a wide variety of other forms. Furthermore, various omissions, substitutions, and modifications may be made in the form of the novel methods and systems described herein without departing from the spirit of the present disclosure. The appended claims and their equivalents are intended to cover such forms or modifications, and are intended to fall within the scope and spirit of the present disclosure. For example, those skilled in the art will recognize that in various embodiments, the actual physical and logical structures may differ from those illustrated. In some embodiments, certain steps described in the examples above may be omitted and other steps may be added. Also, the features and attributes of the specific embodiments disclosed above may be combined in various ways to form additional embodiments, all of which are within the scope of the present disclosure. Although the present disclosure provides certain preferred embodiments and applications, other embodiments apparent to those skilled in the art are within the scope of the present disclosure, including embodiments that do not provide all of the features and advantages described herein. Accordingly, the scope of the present disclosure is intended to be defined solely by reference to the appended claims.

Claims

1. 1. An apparatus comprising: a collection tube having an interior surface defining an interior space, the collection tube having a first end and a second end defining a luer; a tissue collection chamber contained within the interior space of the collection tube; a closure cap having a first end configured to receive one end of the tissue collection chamber and connect to the first end of the collection tube, the closure cap having a second end configured to selectively receive one of a working element of a biopsy device, a vacuum source, and a fluid source; a tubular mesh screen disposed within the tissue collection chamber and facing the inner surface, the tubular mesh screen having an open end closest to the closure cap and a closed end furthest from the closure cap; 13. An apparatus comprising:

2. The device of claim 1 , wherein the collection tube comprises a syringe barrel.

3. The device of claim 1 , wherein the collection tube has a clamshell structure and is configured to be open along a longitudinal axis.

4. The device of claim 1 , wherein the collection tube has at least one wing extending away from a body of the collection tube at the first end of the collection tube.

5. The device of claim 4 , wherein the closure cap has at least one wing configured to fit over the at least one wing of the collection tube.

6. The device of claim 1 , wherein the closure cap comprises an O-ring configured to seal the first end of the closure cap to the first end of the collection tube.

7. The device of claim 1 , wherein the second end of the closure cap comprises a luer configured to selectively couple to the working element of a biopsy device, the vacuum source of the working element, and the fluid source.

8. 10. The device of claim 1, wherein the fluid is a fixation fluid, and the device is configured to be removed from the biopsy device and at least partially filled with the fixation fluid to preserve tissue collected by the biopsy device until examination.

9. 10. The apparatus of claim 9, further comprising a first luer cap disposed on the first end of the collection tube and a second luer cap disposed on the second end of the collection tube.

10. The device of claim 1 , configured for handheld operation.

11. The apparatus of claim 1 , configured for attachment to a stereotactic imaging stage.

12. The device of claim 1 , further comprising a motorized rotor and control mechanism mounted to the device and configured to rotate the working element of the biopsy device.

13. 1. A method comprising: Providing a biopsy device containing the excised tissue fragment and fluid; drawing the excised tissue fragments and the fluid into a tissue collection chamber contained within a collection tube coupled to the biopsy device, the tissue collection chamber including a tubular mesh open at one end and closed at the other end; withdrawing the fluid from the tissue collecting chamber through the tubular mesh and retaining the excised fragment of tissue within the tubular mesh; removing the biopsy device from the tissue collection chamber; flowing a fixation fluid through the tissue collection chamber to fix the tissue fragments retained within the tubular mesh; and Capping at least one of the collection tube and the tissue collection chamber with the retained and fixed tissue fragment therein. A method comprising:

14. The method of claim 13 , further comprising connecting a sealing cap between the collection tube and the biopsy device.

15. 14. The method of claim 13, wherein pouring comprises leaving a certain amount of the fixative fluid within the collection tube and contained tissue collection chamber.

16. 14. The method of claim 13, further comprising sending at least one of the capped collection tube and the tissue collection chamber with the tissue section retained and secured thereto to a pathology laboratory for tissue analysis.

17. The method of claim 13 , wherein drawing comprises coupling a vacuum source to the tissue collection device.

18. 14. The method of claim 13, wherein a collection tube and the tissue collection chamber are configured to be at least partially filled with the fixative fluid to preserve tissue collected by the biopsy device until the collected and preserved tissue is to be examined.

19. 14. The method of claim 13, further comprising attaching a first luer cap to the first end of the collection tube and attaching a second luer cap to the second end of the collection tube.

20. The method of claim 13 , wherein the collection tube is configured for handheld operation.

21. The method of claim 13 , wherein the collection tube is configured to be attached to a stereotactic imaging stage.

22. The method of claim 13, further comprising fixing a motorized rotor and control mechanism attached to the collection tube to rotate a working element of the biopsy device.

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