Medical device for taking tissue samples

Abstract

A medical device (1) for collecting tissue (T) includes a long body (2) having an engagement part (21) that engages with tissue (T), a cylindrical body (3) that accommodates the tissue (T) engaged with the engagement part (21) by drawing the long body (2) inside, and a cutting body (4) having a cutting part (41) that cuts the tissue (T) that has been drawn in.

Description

Technical Field

[0001] The present invention relates to a medical device for collecting tissues. In a bowl It relates thereto.

Background Art

[0002] In recent years, attempts have been made to transplant various cells for the repair of damaged tissues and the like. For example, for the repair of myocardial tissue damaged by ischemic heart diseases such as angina pectoris and myocardial infarction, the use of fetal cardiomyocytes, skeletal myoblasts, mesenchymal stem cells, cardiac stem cells, ES cells, iPS cells, etc. has been attempted (Haraguchi et al., Stem Cells Transl Med. 2012 Feb;1(2):136-141).

[0003] As part of such attempts, cell constructs formed using scaffolds and sheet-like cell cultures in which cells are formed into sheets have been developed (Sawa et al., Surg Today. 2012 Jan;42(2):181-4). The sheet-like cell culture is obtained by culturing and processing cells using human tissues or the like as raw materials. In order to produce a sheet-like cell culture, it is necessary to secure the amount of tissue required for production, so the human body is incised with a scalpel or the like to collect the tissue.

[0004] Japanese Patent Application Laid-Open No. 2012-235878 discloses a biopsy device including a tubular sheath and a core shaft constituting a needle body having a spiral groove at the tip. This device attempts to capture tissue in the spiral groove by inserting and removing the core shaft into and out of the sheath.

[0005] Japanese Patent Application Laid-Open No. 2015-85141 discloses a puncture needle including a sheath member, a needle tube, and a needle member provided with a rotary blade, and scales are provided on the outer peripheries of the needle member operation part and the needle tube operation part. This puncture needle attempts to adjust the protruding length of the needle member by means of the scale.

Summary of the Invention

[0006] The inventors of the present invention faced the challenge that conventional biopsy devices, which collect small amounts of tissue by moving a needle-like body, cannot secure the required amount of tissue. Therefore, the objective of the present invention is to solve such problems and provide a medical device that can quantitatively collect tissue with a simple mechanism and simple operation.

[0007] In order to solve the above problems, the inventors of this invention diligently conducted research and for the first time discovered that tissue could be quantitatively collected by a simple operation of drawing the tissue into a tubular body and cutting it. Based on this finding, they continued their research and, as a result, completed the present invention.

[0008] In other words, the present invention relates to the following: [1] A medical device for taking tissue, comprising: a long body having an engaging portion for engaging with tissue; a cylindrical body for containing the tissue engaged with the engaging portion by drawing the long body inside it; and a cutting body having a cutting portion for cutting the drawn-in tissue. [2] The medical device according to [1], wherein the engaging portion is hook-shaped. [3] The medical device according to [1] or [2], wherein the cutting portion is in the shape of a snare loop. [4] A medical device according to any one of [1] to [3], wherein the elongated body and the cutting body are connected, and cutting by the cutting body occurs in conjunction with the operation of pulling the elongated body into the cylindrical body.

[0009] [5] A medical device according to any one of [1] to [4], further comprising a sliding body that slides so as to fold back the outer and inner surfaces of the cylindrical body. 。

[0010] According to the present invention, tissue can be quantitatively collected with a simple mechanism and simple operation, offering significant advantages in terms of operability and manufacturing costs. [Brief explanation of the drawing]

[0011] [Figure 1] Figure 1A is a conceptual diagram showing a medical device according to the first embodiment of the present invention, and Figure 1B is an explanatory diagram showing a method for collecting tissue using the medical device shown in Figure 1A. [Figure 2] Figure 2A is a conceptual diagram showing a medical device according to a second embodiment of the present invention, and Figure 2B is an explanatory diagram showing a method for collecting tissue using the medical device shown in Figure 2A. [Figure 3] Figure 3A is a perspective view of a medical device according to a second embodiment of the present invention, and Figure 3B is a cross-sectional view of the medical device shown in Figure 3A. [Modes for carrying out the invention]

[0012] In this invention, "tissue" refers to biological tissue containing cells used to prepare a sheet-like cell culture. Non-limiting examples of cells include myoblasts (e.g., skeletal myoblasts), mesenchymal stem cells (e.g., those derived from bone marrow, adipose tissue, peripheral blood, skin, hair follicles, muscle tissue, endometrium, placenta, umbilical cord blood, etc.), cardiomyocytes, fibroblasts, cardiac stem cells, embryonic stem cells, iPS cells, synovial cells, chondrocytes, epithelial cells (e.g., oral mucosal epithelial cells, retinal pigment epithelial cells, nasal mucosal epithelial cells, etc.), endothelial cells (e.g., vascular endothelial cells, etc.), hepatocytes (e.g., hepatocytes), pancreatic cells (e.g., islet cells, etc.), renal cells, adrenal cells, periodontal ligament cells, gingival cells, periosteal cells, skin cells, etc. Non-limiting examples of iPS cell-derived adherent cells include iPS cell-derived cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, renal cells, adrenal cells, periodontal ligament cells, gingival cells, periosteal cells, skin cells, synovial cells, chondrocytes, etc. Typically, the living tissue is muscle tissue, and the cells are adherent cells, preferably skeletal myoblasts.

[0013] In this invention, "medical device" refers to machinery, instruments, etc., intended for use in the diagnosis, treatment, or prevention of diseases in humans or animals, or for affecting the structure or function of the human or animal body.

[0014] In the present invention, "long body" refers to a long member having an engaging portion at its tip that engages with tissue. Examples of engagement include hooking, and examples of the engaging portion include a hook shape. A hook shape refers to a rod-shaped body with its tip bent into a hook shape, allowing for easy and effective hooking onto muscle fibers such as muscle tissue.

[0015] In this invention, "tubular body" refers to a long, pipe-shaped member capable of housing a long body inside. The tubular body can accommodate tissue engaged in the engagement portion by drawing the long body inside. In this invention, the tubular body has an inner surface on the inside and an outer surface on the outside. The recessed inner part of the tubular body is sometimes called the inner surface, concave surface, interior, or lumen, while the protruding outer part of the tubular body is sometimes called the outer surface, convex surface, or exterior. The tubular body can have any shape as long as it can house the long body and tissue inside, and its cross-section can be freely designed to be circular, square, polygonal, etc. The tubular body may have tapered portions or steps in the axial direction, or may have gradually different inner and outer diameters. The volume of the tubular body can be 2 to 10 ml, more preferably 4 to 5 ml.

[0016] The cylindrical body is not particularly limited as long as it has sufficient rigidity to protect the tissue from external forces, and any commercially available cylindrical body can be used. Examples of materials for the cylindrical body include, but are not limited to, polyethylene, polypropylene, fluororesin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyetheretherketone, glass, and metals (e.g., iron, stainless steel, aluminum, titanium).

[0017] In this invention, "cutting body" refers to a long member having a cutting section at its tip for cutting tissue. An example of a cutting section is a snare loop. A snare loop is a structure in which both ends of a looped wire are housed in a sheath so as to be able to move forward and backward, and the loop can be enlarged by advancing the looped portion from the tip of the sheath, and conversely, the loop can be made smaller by retracting it into the sheath. In other words, the cutting section has a structure that allows it to cut tissue like a lasso by enlarging the wire loop to hook onto the base of the tissue and then reducing (constricting) the loop. The cutting body can employ methods such as constricting the loop to constrict the tissue, then passing a high-frequency current through the wire to cauterize and cut the tissue, or constricting the tissue with the wire without passing a high-frequency current through the wire.

[0018] In this invention, "sliding body" refers to a strip-shaped body that can slide along the surface of a cylindrical body. In one embodiment, the strip-shaped body has a cylindrical shape that can slide along the surface shape of the cylindrical body. The sliding body slides along the long axis of the cylindrical body and moves from the inner surface to the outer surface and from the outer surface to the inner surface by folding back at the tip of the cylindrical body. That is, by moving from the outer surface of the cylindrical body to the inner surface by folding back at the tip, the sliding body slides along the cylindrical body like a conveyor belt, and can draw tissue that comes into contact with the sliding body into the interior of the cylindrical body.

[0019] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. Figure 1A is a conceptual diagram showing a medical device according to the first embodiment of the present invention, and Figure 2A is a conceptual diagram showing a medical device according to the second embodiment of the present invention. In addition, the sizes of the components in the figures of this application have been exaggerated as appropriate for the sake of clarity, and the sizes of the components shown in the figures do not represent their actual dimensions.

[0020] (First embodiment) First, a first embodiment of the present invention will be described. As shown in FIG. 1A, the medical device 1 according to the first embodiment of the present invention includes an elongated body 2, a cylindrical body 3, and a cutting body 4. The elongated body 2 has an engaging portion 21 and a main body portion 22 that indicates the engaging portion 21. The main body portion 22 is an elongated rod-shaped member. The proximal end of the main body portion 22 is gripped by the user and receives the operating force of the user. The elongated body 2 has a hook-shaped engaging portion 21 that engages with the tissue T at the tip of the main body portion 22. The engaging portion 21 has a rod-shaped body bent in a hook shape. The base of the engaging portion 21 is joined to the tip of the main body portion 22. The engaging portion 21 may be curved, for example, in a C shape, a J shape, an L shape, or a U shape.

[0021] The cylindrical body 3 is a pipe-shaped member. The cylindrical body 3 has an inner surface 3a on the inside, an outer surface 3b on the outside, and a tip portion 3c. The cylindrical body 3 has an inner diameter that can accommodate the elongated body 2 therein. The inner diameter of the cylindrical body 3 has a dimension that can accommodate the sheath 42 described later together with the elongated body 2. The cylindrical body 3 has a length that can accommodate most of the elongated body 2 except for the proximal end. The inner part of the cylindrical body 3 has a predetermined volume. The volume of the cylindrical body 3 is, for example, 2 to 10 mm. More preferably, it can be 4 to 5 mm. The volume of the cylindrical body 3 is substantially equal to the maximum value of the amount of tissue T accommodated inside the cylindrical body 3. The cutting body 4 is an elongated member having a cutting portion 41 that can cut the tissue T at its tip, a sheath 42, and a wire 43.

[0022] The cutting portion 41 is located at the tip of the wire 43. The wire 43 has a loop-shaped portion 43a formed at its tip in a snare loop shape. That is, the wire 43 has a loop-shaped portion 43a formed in a loop shape at its tip. Both ends of the loop-shaped portion 43a of the wire 43 are accommodated in the sheath 42 so as to be able to advance and retreat. When the loop-shaped portion 43a advances from the tip of the sheath 42, its inner diameter increases. Conversely, when the loop-shaped portion 43a retreats into the sheath 42, its inner diameter decreases. The proximal end side of the wire 43 extends from the proximal end side of the sheath 42. The proximal end side of the wire 43 is gripped by the user and an operating force is input. The advancement and retreat of the loop-shaped portion 43a are performed through the operation of the proximal end side of the wire 43. The wire 43 can use, for example, a metal wire.

[0023] In the initial state before use, the loop-shaped portion 43a is expanded to a diameter larger than that of the cylindrical body 3, and as shown in the figure, it is attached so as to be wound obliquely around the outer surface 3b of the cylindrical body 3. The tip of the sheath 42 is disposed at the same axial position as the tip portion 3c of the cylindrical body 3. When the wire 43 is drawn in, the cutting portion 41 cuts the tissue T at the position of the tip portion 3c of the cylindrical body 3.

[0024] In this embodiment, the sheath 42 is disposed inside the cylindrical body 3. Accordingly, the cutting body 4 is disposed inside the cylindrical body 3. However, this embodiment is not limited thereto, and the cutting body 4 can also be disposed outside the cylindrical body 3 together with the sheath 42 (see FIG. 2A). In the embodiment of FIG. 1A, the cylindrical body 3 can have a structure having a main lumen for accommodating the elongated body 2 and a sub-lumen for accommodating the cutting body 4 (as the inner lumen of the sheath 42).

[0025] As shown in FIG. 1A, when using the medical device 1 of the present invention, first, the skin portion S covering the tissue T is incised, and the hook-shaped engaging portion 21 is engaged (hooked) with the tissue T. The hook-shaped engaging portion 21 has a shape bent in a hook shape, and for example, can be hooked on muscle fibers such as muscle tissue by a simple operation. At this time, by advancing the cutting portion 41 from the sheath 42, the loop-shaped portion 43a is expanded to a size larger than the diameter of the cylindrical body 3. The engaging portion 21 passes through the inside of the loop-shaped portion 43a and engages with the tissue T.

[0026] Next, as shown in Figure 1B, the elongated body 2 is pulled (triggered) to the base end of the cylindrical body 3, and the tissue T engaged with the engaging portion 21 is housed inside the cylindrical body 3. At this time, the tissue T passes through the inside of the expanded loop-shaped portion 43a (cut portion 41) and reaches the base end of the cylindrical body 3, becoming stretched from the tip to the base end of the cylindrical body 3. That is, near the tip of the cylindrical body 3, two muscle fibers are arranged in parallel in the axial direction of the cylindrical body 3, and near the base end of the cylindrical body 3, the muscle fibers hooked onto the engaging portion 21 are positioned to fold back. Then, near the tip of the cylindrical body 3, the expanded cut portion 41 is positioned to surround the base of the stretched tissue T.

[0027] Then, by retracting the cutting portion 41 into the sheath 42 and reducing the size of the loop-shaped portion 43a, the base of the stretched tissue T is cut near the tip portion 3c of the cylindrical body 3, and the tissue T can be collected while contained within the cylindrical body 3. The amount of tissue T collected depends on the distance the long body 2 is pulled into the base end of the cylindrical body 3, so the tissue T can be collected quantitatively. In one embodiment, when cutting the tissue T, a high-frequency current is passed through the wire 43 to constrict and cauterize the tissue T, so that the tissue T remaining in the living body is not left in a cut state, and the junction surfaces of the cut muscle fibers can be joined (adhered).

[0028] In another embodiment, when cutting tissue T, the base of tissue T is ligated, and without passing a high-frequency current through the wire 43, the loop-shaped portion 43a is constricted to completely cut off the tissue T. This allows the muscle fibers to remain ligated on the living body side, thus preventing the dispersal of muscle fibers and other tissues, and also enabling hemostasis. When using tissue T contained in the cylindrical body 3, the long body 2 is pushed out toward the tip of the cylindrical body 3 to release the tissue T engaged with the engaging portion 21.

[0029] In one embodiment, the medical device 1 can be configured such that cutting by the cutting body 4 occurs in conjunction with the operation of pulling the elongated body 2 into the base end of the cylindrical body 3. This can be achieved, for example, by connecting the wire 43 of the elongated body 2 and the cutting body 4 at their base ends, and in conjunction with the operation of pulling the elongated body 2 into the base end of the cylindrical body 3, the connected wire 43 is pulled into the sheath 42, and cutting occurs as the loop-shaped portion 43a (cutting portion 41) of the cutting body 4 becomes smaller.

[0030] (Second embodiment) Figure 2A shows a medical device 1A according to a second embodiment of the present invention. In this embodiment, the medical device 1A further includes a sliding body 5 that can slide along the inner surface 3a and outer surface 3b of a cylindrical body 3. The sliding body 5 is a flexible cylindrical sheet-like member. The sliding body 5 may be made of a flexible resin sheet, elastomer sheet, woven fabric sheet, or nonwoven fabric sheet. In the initial state, the outer end 52 of the sliding body 5 is located on the outer surface 3b, and the inner end 51 of the sliding body 5 is located on the inner surface 3a. The inner end 51 is joined to the elongated body 2. The sliding body 5 can be slid so as to fold back the outer surface 3b and inner surface 3a of the cylindrical body 3 by pulling the inner end 51 or the outer end 52. The sliding body 5 deforms along the shape of the outer surface 3b and the inner surface 3a of the cylindrical body 3. The tip 3c of the cylindrical body 3 is the portion to which the sliding body 5 is folded back. In order to ensure smooth sliding of the sliding body 5 and reduce wear of the sliding body 5, it is desirable that the tip portion 3c has an R-shaped cross-section (is chamfered).

[0031] The sliding body 5 has a cylindrical shape that allows it to slide along the surface shape of the cylindrical body 3. For example, by passing it from the base end side (upper side in Figure 2A) of the cylindrical body 3 to the outside, pulling it towards the tip (downward side in Figure 2A), folding it inward at the tip portion 3c of the cylindrical body 3, and pulling the folded portion towards the base end, it can cover the inner and outer surfaces of the cylindrical body 3. Then, by pulling the inner end portion 51 of the sliding body 5 towards the base end of the cylindrical body 3, the sliding body 5 can be slid from the outer surface to the inner surface of the cylindrical body 3 in a manner similar to a conveyor belt.

[0032] In this embodiment, the sheath 42 is positioned on the outside of the cylindrical body 3. Since the sheath 42 and the wire 43 are spaced apart on the outside of the sliding body 5, they do not interfere with the operation of the sliding body 5.

[0033] In one embodiment, as shown in Figure 2B, the inner end 51 of the sliding body 5 can be fixed to the tip of the main body 22 of the elongated body 2, so that the inner end 51 of the sliding body 5 is retracted into the cylindrical body 3 in conjunction with the operation of retracting the elongated body 2 into the base end of the cylindrical body 3. With this configuration, by retracting the tissue T into the cylindrical body 3 while it is in contact with the sliding body 5, the tissue T can be housed in the cylindrical body 3 by being wrapped (clasped) by the sliding body 5. As a result, the load on the engaging portion 21 due to traction can be distributed to the sliding body 5, thereby preventing the tissue T from breaking.

[0034] (Third embodiment) In the second embodiment, the cut body 4 is positioned on the outside of the cylindrical body 3, but the embodiment is not limited to this configuration, and the cut body 4 can be positioned on either the inside or outside. As shown in Figures 3A and 3B, in the medical device 1B of this embodiment, the cut body 4 is positioned inside the sliding body 5. In the medical device 1B, the elongated body 2A has a pipe-like shape. The cut body 4 and the sheath 42 are housed inside the elongated body 2A. In this configuration, the sheath 42 is positioned to extend from the tip of the elongated body 2A by the length of the cylindrical body 3. The tip of the sheath 42 is positioned in the same axial direction as the tip portion 3c of the cylindrical body 3. The cut portion 41 is positioned to surround the root of the stretched tissue T. The elongated body 2A and the wire 43 of the cut body 4 are connected at the proximal end. When the long body 2A is pulled into the cylindrical body 3, the wire 43 is pulled into the sheath 42 in conjunction with the long body 2A. As a result, the inner diameter of the loop-shaped portion 43a is reduced, and the tissue T is cut by the cutting body 4.

[0035] The medical device of the present invention can be used sequentially, for example, by the following steps. (1) Provide medical devices (2) Engage the engaging part with the tissue (3) Retract the elongated body into the cylindrical body. (4) Cut the trapped tissue

[0036] In (3), by using the sliding body 5 connected to the long body 2, the traction of the tissue T by the engaging part 21 and the entrapment of the tissue T by the sliding body 5 can be performed simultaneously. In (4), the entrapped tissue T can be cut by passing a high-frequency current through the wire 43 to cauterize the tissue T, or by ligating the base of the tissue T and constricting it with the wire 43 without passing a high-frequency current through the wire 43.

Claims

1. A medical device for taking tissue samples, A long body having an engaging portion that engages with tissue, A cylindrical body that accommodates the tissue engaged in the engagement portion by drawing the elongated body inside it, A cutting body having a cutting section for cutting the drawn-in tissue, The cut portion includes a loop-shaped portion in which the wire is formed into a loop shape, A medical device in which the loop-shaped portion is expanded to a larger diameter than the cylindrical body in its initial state before use, and is attached so as to be wrapped around the outer surface of the cylindrical body.

2. The medical device according to claim 1, wherein the engaging portion is hook-shaped.

3. The medical device according to claim 1 or 2, wherein the cutting portion is in the shape of a snare loop.

4. A medical device for taking tissue samples, A long body having an engaging portion that engages with tissue, A cylindrical body that accommodates the tissue engaged in the engagement portion by drawing the elongated body inside it, A cutting body having a cutting section for cutting the drawn-in tissue, A medical device in which the long body and the cutting body are connected, and the cutting by the cutting body occurs in conjunction with the operation of pulling the long body into the cylindrical body.

5. A medical device for taking tissue samples, A long body having an engaging portion that engages with tissue, A cylindrical body that accommodates the tissue engaged in the engagement portion by drawing the elongated body inside it, A cutting body having a cutting section for cutting the drawn-in tissue, A medical device further comprising a sliding body that slides so as to fold back the outer and inner surfaces of the cylindrical body.

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