Tissue biopsy device and method of forming same

Abstract

Various embodiments can relate to a tissue biopsy instrument in accordance with various embodiments. The tissue biopsy instrument can include a hollow tube having a distal end portion and a proximal end portion. The tissue biopsy instrument can also include a cutting device held within the distal end portion of the hollow tube.

Description

Technical Field

[0001] Various embodiments of this disclosure may relate to a tissue biopsy instrument. Various embodiments of this disclosure may relate to a method of forming a tissue biopsy instrument. Background Technology

[0002] A tissue biopsy involves extracting a sample of tissue from a patient to determine the presence or extent of a disease, such as cancer. Typically, a core of tissue is extracted to aid in histological diagnosis. To obtain a core, two things are required: (1) the core needs to be removed from the patient; and (2) the end of the core needs to be cut and extracted.

[0003] Currently, the most commonly used technique is "core-cut." In core-cut biopsy, a long hollow tube is used to obtain sample tissue, with a stylet located inside the tube. The stylet has a recess on its side near the tip. A spring-loaded mechanism is used to perform the two-step procedure. This mechanism can be disposable or reusable (e.g., the Magnum Reusable Core Biopsy Instrument). During the procedure, when the operator presses the start button, there are two actions (often referred to as "throw-out"). First, the stylet extends beyond the distal end of the hollow tube into the tissue or tumor of interest, exposing the recess. Next, the hollow tube moves distally to remove the tissue and surround the removed tissue between the recess and the hollow tube. Such a process can be difficult to control and can often be uncomfortable and / or painful for the patient. Furthermore, it may damage adjacent critical structures. Additionally, the operation can be noisy due to the need for a spring mechanism to achieve the throw-out. Moreover, the length of the collected sample may be limited by the length of the recess. In addition, samples obtained from dense tumors may be inconsistent.

[0004] Another existing technique for obtaining a core biopsy is vacuum-assisted core biopsy. A vacuum is used to hold the tissue within the recess of a needle. A rotary cutter located within the needle itself is then used to cut and extract the biopsy sample. Vacuum-assisted core biopsy entered the market in 1995 and was introduced to Singapore in 1999 for applications such as breast biopsies. However, instruments using vacuum-assisted core biopsies are typically bulky. Summary of the Invention

[0005] Various embodiments may relate to a tissue biopsy instrument. The tissue biopsy instrument may include a hollow tube having a distal portion and a proximal portion. The tissue biopsy instrument may also include a cutting device held or fixed within the distal portion of the hollow tube.

[0006] Various embodiments may relate to a method of forming a tissue biopsy instrument. The method may include providing or forming a hollow tube having a distal portion and a proximal portion. The method may also include forming or attaching a cutting device to the hollow tube, such that the cutting device is held or secured within the distal portion of the hollow tube.

[0007] Brief description of the attached figures

[0008] In the accompanying drawings, the same reference numerals in different views generally refer to the same parts. The drawings are not necessarily drawn to scale; instead, the emphasis is generally placed on illustrating the principles of various embodiments. In the following description, various embodiments of the invention are described with reference to the following drawings.

[0009] Figure 1 This is a schematic diagram of a part of a tissue biopsy instrument according to various embodiments.

[0010] Figure 2A This is a schematic diagram of a part of a tissue biopsy instrument with a needle core according to various embodiments.

[0011] Figure 2B yes Figure 2A The diagram shows a cross-sectional schematic of a tissue biopsy instrument having a handle according to various embodiments.

[0012] Figure 2C Schematic diagrams according to various other embodiments are shown, in which the handle is removed from the hollow tube and an external vacuum source / pump is installed in the proximal portion of the hollow tube to generate suction or vacuum to retrieve tissue samples from within the hollow tube.

[0013] Figure 2D A schematic diagram illustrating the use of tissue biopsy instruments according to various embodiments for breast biopsy is shown.

[0014] Figure 2E A schematic diagram is shown of a tissue biopsy instrument according to various embodiments being rotated to cut the distal end of a tissue core.

[0015] Figure 3A A cross-sectional view of a tissue biopsy instrument according to various embodiments is shown.

[0016] Figure 3B A cross-sectional view of another tissue biopsy instrument according to various embodiments is shown.

[0017] Figure 4A This is a schematic cross-sectional view of a portion of a hollow tube with a pointed tip, according to various embodiments.

[0018] Figure 4B This is a schematic cross-sectional view of a portion of another hollow tube according to various embodiments, the hollow tube having two tips such that the two tips form a "V" shape.

[0019] Figure 4C This is a schematic cross-sectional view of a portion of another hollow tube according to various embodiments, the hollow tube having a first tip and a second tip, the height of the second tip being greater than the height of the first tip.

[0020] Figure 4D This is a schematic cross-sectional view of a portion of another hollow tube according to various embodiments, the hollow tube having a flat cut edge at its distal end.

[0021] Figure 5A This is a schematic cross-sectional view of a portion of a needle core according to various embodiments, the needle core having a pointed portion on one side of the distal end of the needle core.

[0022] Figure 5B This is a schematic cross-sectional view of a portion of another needle core according to various embodiments, the needle core having a pointed portion at the center of the distal end of the needle core.

[0023] Figure 5C It should be like Figure 5A The needle shown is fully inserted into something similar to Figure 4A The diagram shows a cross-sectional view of a portion of a tissue biopsy instrument according to various embodiments, within the hollow tube of the hollow tube shown.

[0024] Figure 5D It should be like Figure 5B The needle shown is fully inserted into something similar to Figure 4B The diagram shows a cross-sectional view of a portion of a tissue biopsy instrument according to various embodiments, within the hollow tube of the hollow tube shown.

[0025] Figure 6 This is a schematic cross-sectional view of a tissue biopsy instrument according to various embodiments.

[0026] Figure 7 This is a schematic cross-sectional view of another tissue biopsy instrument according to various embodiments.

[0027] Figure 8 A schematic diagram illustrating a method for forming a tissue biopsy instrument according to various embodiments is shown.

[0028] illustrate

[0029] The following detailed description is taken with reference to the accompanying drawings, which illustrate specific details and embodiments in which the invention can be practiced. These embodiments have been described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized, and changes may be made to the structure, logic, and electrical aspects, without departing from the scope of the invention. Because some embodiments can be combined with one or more other embodiments to form new embodiments, the various embodiments are not necessarily mutually exclusive.

[0030] Features described in the context of one embodiment may be adapted accordingly to the same or similar features in other embodiments. Features described in the context of one embodiment may be adapted accordingly to other embodiments, even if not explicitly described in those other embodiments. Furthermore, additions, combinations, and / or alternatives described with respect to features in the context of one embodiment may be adapted accordingly to the same or similar features in other embodiments.

[0031] In the context of various embodiments, the articles “a,” “an,” and “the” used with respect to features or elements include references to one or more features or elements.

[0032] In the context of various embodiments, the terms “about” or “approximately” applied to numerical values ​​include exact values ​​and reasonable variations, such as within 10% of a specified value.

[0033] As used herein, the term “and / or” includes any and all combinations of one or more of the relevant listed items.

[0034] The word "includes" is intended to include, but is not limited to, anything that follows the word "includes". Therefore, using the term "includes" means that the listed elements are required or mandatory, but other elements are optional and may or may not be present.

[0035] The phrase “composed of” is intended to include and be limited to anything that follows the phrase “composed of.” Therefore, the phrase “composed of” implies that the listed elements are required or mandatory, and that no other elements exist.

[0036] The embodiments described in the context of one of the instruments are similarly applicable to other instruments. Similarly, the embodiments described in the context of a method are similarly applicable to instruments, and vice versa.

[0037] Various embodiments can address one or more problems faced by conventional tissue biopsy devices.

[0038] Figure 1 This is a schematic diagram of a portion of a tissue biopsy instrument according to various embodiments. The tissue biopsy instrument may include a hollow tube 102 (or cannula) having a distal portion and a proximal portion. The tissue biopsy instrument may also include a cutting device 104, which is fixed, held, or suspended within the distal portion of the hollow tube 102.

[0039] In other words, the tissue biopsy instrument can be a hollow tube 102 with a cutting device 104 at one end.

[0040] To avoid any doubt, Figure 1 The purpose of this study is to illustrate the features of tissue biopsy instruments according to various embodiments, and is not intended to limit, for example, the size, shape, orientation, etc. of the individual components. For example, although Figure 1 A horizontally extending cutting device 104 is shown, but various other embodiments may involve a cutting device along any other direction or any other angle (e.g., vertical). Figure 1 Curve indication in Figure 1 Only a portion of the tissue biopsy instrument is shown, and the tissue biopsy instrument extends beyond the curve.

[0041] In various embodiments, the tissue biopsy instrument may be a tissue biopsy device or part of a tissue biopsy device capable of performing core taking, cutting, and extraction steps.

[0042] During the procedure, the operator (e.g., a surgeon, radiologist, or any other suitable person) may “twist” or rotate the hollow tube 102, that is, around a central axis parallel to the longitudinal length of the hollow tube 102 (e.g., Figure 1 (As shown) The hollow tube 102 is "twisted" or rotated. By rotating the hollow tube 102, the cutting device 104 can cut or remove tissue samples ("twisting cutting" technique). Therefore, various embodiments may eliminate the need for the spring mechanism present in conventional core needle biopsy instruments to remove tissue samples. Various embodiments may allow the operator to use the "twisting cutting" technique as described above, which is easier to control compared to conventional core needle biopsy instruments. Furthermore, since various embodiments do not involve releasing the spring mechanism to achieve ejection, the operation can be performed in a quieter and more controlled manner. Additionally, various embodiments may involve smoother insertion and retrieval of tissue samples from the patient. Various embodiments may reduce patient trauma and / or pain. The patient can be a human. Alternatively, the patient can be an animal, such as a dog. The recess of the needle core in conventional core needle biopsy instruments is typically 1.9 cm long, thus limiting the volume of sample that can be retrieved. Various embodiments are not limited to such a size and may be able to collect larger volume samples by using the entire length of the hollow tube 102. Compared to conventional core biopsy instruments and vacuum-assisted core biopsy instruments, it may have no dead zone length or a smaller dead zone length. The hollow tube 102 may include openings at both ends of the tube 102, and a space extending between the openings at both ends. The hollow tube 102 may, for example, have no other openings or recesses on its sides.

[0043] In various embodiments, the cutting device 104 may be a wire. For example, the wire may have a thickness selected from about 0.01 mm to about 0.2 mm, such as about 0.1 mm. In various other embodiments, the cutting device 104 may be a blade. The blade may have a sharp edge (i.e., a cutting edge) facing away from the proximal portion of the tissue biopsy instrument. In various embodiments, the blade may have a single cutting edge extending along the length of the blade. The cutting device 104 (e.g., wire or blade) needs to be robust (i.e., withstand insertion, advancement, and cutting of tissue without deforming or breaking). The cutting device 104 may be fixed to the hollow tube 102 and may not move relative to the hollow tube.

[0044] In various embodiments, the cutting device 104 may include any suitable material. For example, the cutting device 104 may include a material selected from the group consisting of hardened steel, tempered steel, stainless steel, carbon steel, titanium, ceramic, platinum, and obsidian.

[0045] In various embodiments, the hollow tube 102 may comprise any suitable material. For example, the hollow tube may comprise a material selected from the group consisting of hardened steel, tempered steel, stainless steel, carbon steel, and titanium.

[0046] In various embodiments, the hollow tube 102 may have any value selected from the range of 8 to 20. The hollow tube may have an inner diameter selected from the range of about 0.603 mm (20) to about 3.429 mm (8). The hollow tube may have an outer diameter selected from the range of 0.9081 mm (20) to about 4.191 mm (8). The hollow tube 102 may have a longitudinal length selected from the range of about 8 cm to about 20 cm, for example, selected from about 10 cm to about 15 cm.

[0047] In various embodiments, the cutting device 104 may extend from a first portion of the inner wall of the hollow tube 102 or be suspended to a second portion of the inner wall of the hollow tube 102. The cutting device 104 may extend through the internal space of the tube 102. The cutting device 104 may extend along the diameter of the hollow tube 102 (i.e., the inner diameter defined by the inner wall). In various other embodiments, the cutting device 104 may extend from a portion of the inner wall, having a free end protruding into the space defined by the hollow tube 102. In other words, the cutting device 104 may be held at only one end and may have a free end extending into the space surrounded by the hollow tube. For example, the cutting device may extend to 50% or 75% of the inner diameter of the hollow tube 102. The cutting device 104 may be fixed to the hollow tube 102 and cannot move relative to the hollow tube 102. When the cutting device 104 extends from a first portion of the inner wall of the hollow tube 102 to a second portion of the inner wall of the hollow tube 102, the hollow tube 102 may need to be rotated 180 degrees or more to cut the distal end of the tissue core. In contrast, when the cutting device 104 is held or fixed at only one end, the hollow tube 102 may need to be rotated 360 degrees or more to make the cut.

[0048] Although Figure 1 The illustration shows the inner wall of tube 102 defining a circular internal space (spanning the transverse section of tube 102), but it is contemplated that in various other embodiments, the inner wall of tube 102 may define an internal space of any other suitable shape. A first portion and a second portion of the inner wall may be opposing portions of the inner wall. In various embodiments, the cutting device 104 may be welded, attached, or joined to the hollow tube 102 by any suitable fixing method. In various embodiments, the cutting device 104 and the hollow tube 102 may form an integral structure, wherein the cutting device 104 extends from a first portion of the inner wall of the hollow tube 102 to a second portion of the inner wall of the hollow tube 102, or extends only from a portion of the inner wall into the space defined by the hollow tube 102.

[0049] As described above, the cutting device 104 can be held within the distal portion of the hollow tube 102. In various embodiments, the distal portion can refer to the farthest part of the hollow tube 102, for example, it can be 5%, 10%, 20%, or 30% of the farthest part of the hollow tube 102.

[0050] In various embodiments, the distal portion of the hollow tube 102 may include a tip. This tip can be used to insert into the patient's body during surgery. In various other embodiments, the distal portion of the hollow tube 102 may have two tips, such that the two tips form a "V" shape. In still various other embodiments, the distal portion of the hollow tube 102 may be flat, but has a cut end.

[0051] In various embodiments, the tissue biopsy instrument may include a needle core located within a hollow tube 102. The needle core may be slidably movable along the longitudinal length of the hollow tube 102. The needle core may have a longitudinal length selected from the range of about 8 cm to about 20 cm, for example, from about 10 cm to about 15 cm. The needle core may include a material selected from the group consisting of hardened steel, tempered steel, stainless steel, carbon steel, and titanium. The needle core may have one or more grooves. The one or more grooves may extend from the distal end of the needle core (partially towards the opposite proximal end of the needle core) parallel to or along the longitudinal length of the needle core. The one or more grooves may be used to accommodate a cutting device 104.

[0052] In various embodiments, the tissue biopsy instrument may also include a handle for holding or configured to hold the proximal portion of the hollow tube. In various embodiments, the handle, along with the hollow tube 102 and the cutting device 104, may be discarded after each surgical procedure.

[0053] In various other embodiments, the handle may be reusable, while the hollow tube 104 with the cutting device 104 may form a disposable portion. The handle may include a cover made of any suitable material, such as a suitable polymer or metal like stainless steel. The tissue biopsy instrument or handle may include a coupling mechanism, such as a connector, configured to retain the hollow tube 102. The connector may be disposable. The connector may include a transparent or translucent material, such as a plastic material. By having a transparent or translucent material, the operator can see whether the hollow tube 102 is filled with the excised tissue sample, thus helping the operator determine whether to withdraw the tissue biopsy instrument. Before or during surgery (i.e., after a new or unused sterile hollow tube 102 with the cutting device 104 has been used to insert into the patient), the distal portion of the hollow tube 104 may be inserted into or attached to the handle via the coupling mechanism or connector. When the hollow tube 102 is inserted into or attached to the coupling mechanism or connector, the coupling mechanism or connector may already be inserted into or attached to the handle. After the surgery, the hollow tube 104 with the cutting device 104 can be detached or removed from the coupling mechanism / connector and discarded, while the handle can be reused for future surgeries. The coupling mechanism or connector can also be discarded. For example, the coupling mechanism can be a clamping mechanism for holding the needle, a bolt and engagement mechanism (e.g., where the outer surface of the proximal portion of the hollow tube 102 has threads for groove engagement with the mating surface of the handle), a magnetic coupling mechanism (where the hollow tube 102 is coupled to the handle via a magnetic or electromagnetic field), or any other suitable coupling means.

[0054] In various embodiments, the tissue biopsy instrument can be configured for manual operation. During operation, the operator can manually “twist” or rotate the hollow tube 102, i.e., “twist” or rotate the hollow tube 102 about a central axis, such that the cutting device 104 can cut or remove the tissue sample. In various other embodiments, the tissue biopsy instrument can be electrically or battery-powered. In various embodiments, the handle can include a rotating mechanism configured (when powered) to rotate the hollow tube 102 about a central axis passing through the hollow tube 102. In one implementation, the handle can also include a compartment configured to hold electrical energy (e.g., a battery) for driving the rotating mechanism. In another implementation, the handle can include a power cord to be plugged into an external power source (e.g., a wall socket) that can provide the electrical energy required to drive the rotating mechanism.

[0055] In various embodiments, the tissue biopsy instrument may not require vacuum assistance. In various embodiments, the cutting device 104 can capture a tissue sample within the hollow tube 102. The hollow tube 102 with the captured tissue sample can then be withdrawn from the patient to retrieve the tissue sample. The tissue biopsy instrument may not include a vacuum pump or source. After the hollow tube 102 with the captured tissue sample has been withdrawn, the tissue sample can be pushed out of the hollow tube 102 using an external device (e.g., a wire pusher). The tissue sample can be retrieved by pushing the hollow tube 102. Alternatively, an external device, including a vacuum pump or source, can be attached to the hollow tube 102 to retrieve the tissue sample. In various other embodiments, the tissue biopsy instrument can be a vacuum-assisted device. The handle may include a vacuum pump or source connected to the hollow tube 102. In the current context, a vacuum pump or source can refer to a component or device that generates a full vacuum or partial vacuum or suction force. The generated vacuum or suction force enables the retrieval of the tissue sample. In various embodiments, a rotating mechanism can be configured to generate a vacuum or suction force. In other words, in various embodiments, the rotating mechanism can also act as a vacuum source (in addition to its ability to push the hollow tube 102). In addition to the function of rotation, a single mechanism or device can cause rotational movement of the hollow tube 102 and provide suction force. In various other embodiments, the rotation mechanism and the vacuum pump or source can be separate / independent of each other. The vacuum pump or source can be powered by electrical energy or by an external power source via a power cord. The vacuum pump or source can be configured to (when powered) generate a vacuum or partial vacuum to "suction" (i.e., move by suction force) the excised tissue sample along the hollow tube. A battery or external power source can provide electrical energy to drive the vacuum pump or source. In various embodiments, the tissue biopsy instrument or handle can include a tissue collector for collecting the excised tissue.

[0056] Figure 2A This is a schematic diagram of a part of a tissue biopsy instrument with a needle core according to various embodiments. Figure 2A Curve indication in Figure 2A Only a portion of the tissue biopsy instrument is shown, and the tissue biopsy instrument extends beyond the curve. The tissue biopsy instrument may include a hollow tube 202 with a cutting device 204. The tissue biopsy instrument may include a needle core 206 within the hollow tube 202. As shown by the shaded line, the needle core 206 may be solid and have a groove 207 extending from its distal end parallel to or along the longitudinal length of the needle core 206. In various embodiments, the needle core 206 may be used to prevent tissue from entering the hollow tube 202 when the hollow tube 202 is advanced into a human or animal body (e.g., when the hollow tube 202 is inserted or introduced into a patient and reaches a tumor during insertion). The groove 207 may be used to receive the cutting device 204 when the needle core 206 is fully inserted into the hollow tube 202 during the advancement of the hollow tube 202 into a human or animal body. The groove 207 may extend along the entire diameter of the needle core 206. In embodiments where the cutting device 204 extends only partially from the inner wall of the hollow tube 202 (i.e., the cutting device 204 has a free end protruding into the space within the hollow tube 202), the groove 207 may also extend only partially along the diameter of the needle core 206 to accommodate the cutting device 204.

[0057] Figure 2B yes Figure 2A The diagram shows a cross-sectional schematic of a tissue biopsy instrument having a handle 208 according to various embodiments. The needle core 206 can be removed from the hollow tube 202 before the handle 208 is attached to the hollow tube 202.

[0058] In various embodiments, a coupling mechanism or connector 212 as described above may be present. The coupling mechanism or connector 212 may be used to attach or secure the hollow needle 202 to the handle 208. In various embodiments, the handle 208 may include a rotation mechanism 214 and / or a vacuum pump / source 216. As described above, the rotation mechanism 214 may be configured to rotate the hollow tube 202 about a central axis passing through the hollow tube 202, while the vacuum pump / source 216 may be configured to generate a vacuum or partial vacuum to “suction” the excised tissue sample along the hollow tube. In various embodiments, as described above, the rotation mechanism 214 and the vacuum pump / source 216 may be combined instead of as described above. Figure 2B As shown, they are separated. In other words, the rotating mechanism 214 can act as a vacuum pump / source 216. The handle 208 may also include an electrical power source 218 (e.g., a battery) to provide power to the rotating mechanism 214 and / or the vacuum pump / source 216. In various embodiments, the handle 208 may be without the rotating mechanism 214 and / or the vacuum pump / source 216. For example, the "torsion cut" can be performed manually, retrieval can be done using a "wire push," and / or an external vacuum source / pump can be used as described above. Figure 2CSchematic diagrams according to various other embodiments are shown, in which the handle is removed from the hollow tube 202 and an external vacuum source / pump is attached to the proximal portion of the hollow tube 202 to generate suction or vacuum to retrieve tissue samples within the hollow tube 202. After the tissue biopsy instrument has been withdrawn from the patient, the tissue sample trapped within the hollow tube 202 can be retrieved by attaching an external vacuum source / pump to the proximal portion of the hollow tube 202 and using the external vacuum source / pump to aspirate or move the tissue sample from the hollow tube 202.

[0059] Figure 2D A schematic diagram of a tissue biopsy instrument according to various embodiments is shown for use in a breast biopsy. First, the tumor can be located using an ultrasound probe and punctured. The operator then inserts a hollow tube 202 (with a needle core 206 fully inserted into the hollow tube 202) into the puncture site in the skin and advances the hollow tube through the soft fat layer and hard breast layer to reach the tumor. As the hollow tube 202 is advanced through the soft fat layer and hard breast layer, the needle core 206 prevents cells or tissue from entering the hollow tube 202. After advancement through the soft fat layer and hard breast layer, before the handle 208 is attached to the hollow tube 202 via a disposable sterile connector 212 (as shown in the diagram), Figure 2B As shown), remove the needle core 206 from the hollow tube 202 (as shown). Figure 2D (As shown).

[0060] Figure 2E A schematic diagram is shown illustrating a tissue biopsy instrument according to various embodiments being rotated to cut the distal end of a tissue core. As the hollow tube 202 rotates, the cutting device 204 can sever the distal end of the tissue core. The tissue core can then be captured within the hollow tube 202 by the cutting device 204. The tissue sample, along with the captured tissue core, can then be removed from the patient.

[0061] To avoid any doubt, Figures 2A-2E The purpose of this study is to illustrate the features of tissue biopsy instruments according to various embodiments, and is not intended to limit, for example, the size, shape, orientation, etc. of the individual components.

[0062] Figure 3A A transverse cross-sectional view of a tissue biopsy instrument according to various embodiments is shown, while Figure 3B A cross-sectional view of another tissue biopsy instrument according to various embodiments is shown. Figure 3A The tissue biopsy instrument shown has a hollow tube 302a and a cutting device 304a that extends along the inner diameter of the hollow tube 302a from a portion of the inner wall of the hollow tube 302a to an opposite portion of the inner wall of the hollow tube 302a. Figure 3BThe tissue biopsy instrument shown has a hollow tube 302b and a cutting device 304b, which extends partially from a portion of the inner wall of the hollow tube 302b along only the inner diameter of the hollow tube 302b. Figure 3B As shown, one end of the cutting device 304b can be engaged, fixed, or attached to the hollow tube 302b, while the opposite end of the cutting device 304b can be free, i.e., not attached to the hollow tube 302b. As described above, although Figures 3A-3B The diagram shows a transverse cross-section of the cutting devices 304a, 304b extending horizontally through the hollow tubes 302a, 302b, but various embodiments may involve instruments having cutting devices extending at any suitable angle or direction.

[0063] Figure 4A This is a schematic cross-sectional view of a portion of a hollow tube 402a with a pointed tip according to various embodiments. The hollow tube 402a may have a cut edge extending from the pointed tip at the distal end of the hollow tube 402a. Figure 4B This is a schematic cross-sectional view of a portion of another hollow tube 402b according to various embodiments, the hollow tube 402b having two tips such that the two tips form a "V" shape. The hollow tube 402b may have two cut edges extending from the tips at the distal end of the hollow tube 402b. Figure 4C This is a schematic cross-sectional view of a portion of another hollow tube 402c according to various embodiments, the hollow tube 402c having a first tip and a second tip, the second tip being higher than the first tip. The hollow tube 402c may have two cut edges extending from the tips at the distal end of the hollow tube 402c. The two tips may form an asymmetrical "V" shape. Figure 4D This is a schematic cross-sectional view of a portion of a hollow tube 402d according to various embodiments, the hollow tube 402d having a flat cut edge at its distal end. Figure 4A The curve shown in -D indicates Figure 4A -D only shows a portion of the corresponding tissue biopsy instrument. The cutting device is not shown. Figure 4A -D is shown.

[0064] Figure 5A This is a schematic cross-sectional view of a portion of a needle core 506a according to various embodiments, the needle core 506a having a pointed portion on one side of its distal end. The needle core 506a may have one or more grooves 507a extending from its distal end along its longitudinal length. The needle core 506a may also include a cut edge at its distal end, such as... Figure 5A As shown. Figure 5BThis is a schematic cross-sectional view of a portion of another needle core 506b according to various embodiments, the needle core 506b having a pointed portion at the center of its distal end. The needle core 506b may have one or more grooves 507b extending along the longitudinal length of the needle core 506b from its distal end (and from the pointed portion). The needle core 506b may also include a cut edge at its distal end, such as... Figure 5B As shown.

[0065] Figure 5C It should be like Figure 5A The needle core 506a shown is fully inserted into a similar... Figure 4A The diagram shows a cross-sectional view of a portion of a tissue biopsy instrument according to various embodiments, within the hollow tube 502a of the hollow tube 402a shown. Figure 5C As shown, the cutting device 504a can be fitted into one or more slots 507a of the needle core 506a. The distal end of the needle core 506a may not extend beyond the distal end of the hollow tube 502a. Thus, during the advancement of the tissue biopsy instrument through the subcutaneous tissue, when the needle core 506a is fully inserted into the hollow tube 502a, the cutting edge of the hollow tube 502a is used to cut the subcutaneous tissue. Figure 5D It should be like Figure 5B The needle core 506b shown is fully inserted into a similar position. Figure 4B The diagram shows a cross-sectional view of a portion of a tissue biopsy instrument according to various embodiments, within the hollow tube 502b of the hollow tube 402b shown. Figure 5D As shown, the cutting device 504b can be fitted into one or more slots 507b of the needle core 506b. The distal end of the needle core 506b can extend beyond the distal end of the hollow tube 502b. Thus, during the advancement of the tissue biopsy instrument through subcutaneous tissue, when the needle core 506b is fully inserted into the hollow tube 502b, the cutting edge of the needle core 506b is used to cut the subcutaneous tissue. Upon reaching the tumor, and before the distal end of the cutting device 506b is used to cut the tumor, the needle core 506b can be withdrawn from the hollow tube 502b, whose cutting edge can be used to penetrate the tumor. Figure 5A The curve shown in -D indicates Figure 5A -D only shows a portion of the corresponding needle core.

[0066] Figure 6 This is a schematic cross-sectional view of a tissue biopsy instrument according to various embodiments. The entire tissue biopsy instrument, including the hollow tube 602, the cutting device 604, and the handle 608, can be disposable. Figure 6The illustrated tissue biopsy instrument may not require a connector. In various embodiments, the hollow tube 602 and the handle 608 may form a single integral device. In various other embodiments, the hollow tube 602 may be directly attached to the handle 608. In various embodiments, the handle 608 may include a channel 609 extending from the rear of the handle 608, allowing a needle core to be inserted into the hollow tube 602 through the channel 609 of the handle 608.

[0067] Figure 7 This is a schematic cross-sectional view of another tissue biopsy instrument according to various embodiments. The hollow tube 702 with cutting device 704 can be disposable, while the handle 708 can be reusable. The hollow tube 702 can be attached to or connected to the handle 708 using a disposable connector 712. The disposable connector 712 can include a transparent or translucent material, such as plastic. The connector 712 can be attached to the handle 708 before operation. The hollow tube 702 (with an inserted needle core) can be advanced through the tissue layer beneath the skin to reach the tumor. The needle core can then be withdrawn from the hollow tube 702, and the handle 708 can be coupled to or attached to the hollow tube 702 via the (sterile) connector 712. If reinsertion is required, the hollow tube 702 can be decoupled or detached from the (sterile) connector 712. The same (sterile) needle core can be reinserted into the same (sterile) hollow tube 702, and then the (sterile) hollow tube 702 (with the reinserted (sterile) needle core) can be advanced through the tissue layer beneath the skin, and the same handle 708 can be coupled or attached to the hollow tube 702 through the same (sterile) connector 712.

[0068] Various embodiments can be used for endoscopic biopsy. In various embodiments, the tissue biopsy device can be attached to the distal portion of a wire / cable extending along the length of the endoscope device.

[0069] Figure 8 A schematic diagram illustrating a method for forming a tissue biopsy instrument according to various embodiments is shown. The method may include, in step 802, providing or forming a hollow tube having a distal portion and a proximal portion. The method may further include, in step 804, forming a cutting device on the hollow tube or attaching a cutting device to the hollow tube such that the cutting device is fixed, held, or suspended within the distal portion of the hollow tube. The cutting device may be a wire or a blade.

[0070] In various embodiments, the method may include forming or providing a handle that holds or is configured to hold the proximal portion of a hollow tube. As described above, the handle may include a rotation mechanism, a compartment configured to hold electrical power, a coupling mechanism, and / or a vacuum source / pump. The method may include forming or providing a rotation mechanism, a compartment configured to hold electrical power, a coupling mechanism, and / or a vacuum source / pump.

[0071] In various embodiments, the method may include providing or forming a needle core within a hollow tube.

[0072] Various embodiments may include methods of operating tissue biopsy instruments as described herein. The method may include inserting a hollow tube with a cutting device into a patient, the cutting device being fixed or held within a distal portion of the hollow tube. The method may also include twisting or rotating the hollow tube to excise or remove a tissue sample from the patient, such as from a tumor within the patient.

Claims

1. A tissue biopsy instrument, comprising: A hollow tube, which has a distal section and a proximal section; as well as A cutting device, which is fixed inside the distal portion of the hollow tube.

2. The tissue biopsy instrument according to claim 1, in, The cutting device is a wire.

3. The tissue biopsy instrument according to claim 1, in, The cutting device is a blade.

4. The tissue biopsy instrument according to any one of claims 1 to 3, in, The cutting device comprises materials selected from the group consisting of hardened steel, tempered steel, stainless steel, carbon steel, titanium, ceramics, and obsidian.

5. The tissue biopsy instrument according to any one of claims 1 to 4, in, The cutting device extends from a first portion of the inner wall of the hollow tube to a second portion of the inner wall of the hollow tube.

6. The tissue biopsy instrument according to any one of claims 1 to 4, in, The cutting device extends from a portion of the inner wall and has a free end protruding into the space defined by the hollow tube.

7. The tissue biopsy instrument according to any one of claims 1 to 6, further comprising: A handle that holds the proximal portion of the hollow tube.

8. The tissue biopsy instrument according to claim 7, in, The handle includes a rotating mechanism configured to rotate the hollow tube about a central axis passing through the hollow tube when electrical power is supplied.

9. The tissue biopsy instrument according to claim 8, in, The handle also includes a compartment configured to retain electrical energy for driving the rotating mechanism.

10. The tissue biopsy instrument according to any one of claims 7 to 9, in, The handle includes a coupling mechanism configured to hold the hollow tube.

11. The tissue biopsy instrument according to any one of claims 7 to 10, in, The handle includes a vacuum pump, which is connected to the hollow tube.

12. The tissue biopsy instrument according to any one of claims 1 to 11, further comprising: The needle core is located inside the hollow tube.

13. The tissue biopsy instrument according to claim 12, in, The needle core has one or more grooves extending from the distal end of the needle core parallel to its longitudinal length.

14. A method for forming a tissue biopsy instrument, the method comprising: Provide hollow tubes with distal and proximal sections; as well as A cutting device is formed on the hollow tube or attached to the hollow tube such that the cutting device is fixed inside the distal portion of the hollow tube.

Images