Plug-in part guiding device

Abstract

The present application can provide a kind of insertion component leading-out device, with: main body (2);Perforating component (3) for forming perforation hole (H1), the perforation hole (H1) is in first direction (D1) and the wall of organization (T) is perforated;And connector (4) is structured to connect the perforating component (3) and insertion component (I), the perforating component (3) has front end (31) and perforating shaft portion (32), the maximum size of perforating shaft portion (32) is less than the outer diameter of insertion component (I), the main body (2) has the leading-out hole (24) extending along first direction (D1), the perforating component (3) is structured to, in the same axis with the axis of leading-out hole (24), be guided to first direction (D1) and second direction (D2), leading-out hole (24) has the size that connector (4) and insertion component (I) can be inserted, by being set as above insertion component leading-out device, can accurately and easily lead out insertion component in the wall of organization of organism to outside.

Description

Technical Field

[0001] This invention relates to a device for discharging insert components. Background Technology

[0002] When treating organisms including human bodies, there are cases where a linear insertion member extends from one side of the organism's wall-like tissue to the other. For example, Patent Document 1 discloses a skin button for arranging a drive line. To supply power to a visually enhanced artificial heart (VAD) implanted in the human body, a drive line is arranged at a predetermined angle relative to the wall-like tissue of the human body via a skin button, with the drive line penetrating the skin, fascia, muscle layer, peritoneum, or other wall-like tissues. The skin button has a connecting portion for the drive line to pass through and a flange portion provided around the connecting portion. The skin button is fixed to the skin of the human body with the flange portion positioned between the epidermis and dermis of the skin.

[0003] When pulling the aforementioned drive wire from the abdominal cavity to the outside, a tunneling device can be used to form an insertion hole in the wall-like tissue of the human body for the drive wire to pass through. In this case, after inserting the drive wire through the insertion hole formed by the tunneling device, the drive wire is then inserted into a skin button, which is then positioned on the skin of the human body, allowing the skin button to be fixed to the skin.

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: Japanese Patent Application Publication No. 2020-81537 Summary of the Invention

[0007] The problem that the invention aims to solve

[0008] However, during the procedure of creating the insertion hole using a tunneling device, the position and angle of the insertion hole sometimes deviate from the ideal position and angle that should be formed. Thus, if the drive wire is inserted into an insertion hole that has deviated in position and angle, the position and angle of the drive wire within the insertion hole will also deviate. Therefore, if the drive wire is inserted into a skin button that is fixed to the skin, the skin button may float or sink relative to the skin, potentially hindering the initial treatment of the tissue due to stretching and compressive loads on the skin tissue.

[0009] Therefore, the object of the present invention is to provide an insertion component export device that can accurately and easily export an insertion component inserted into a wall-like tissue of a living organism.

[0010] Technical solutions for solving the problem

[0011] The insertion component export device of the present invention is a device for inserting a linear insertion component into a wall-like tissue of an organism. The device comprises: a main body capable of being disposed on one side of the wall-like tissue in the thickness direction; a perforating component movable relative to the main body for forming a perforation hole, the perforation hole perforating the wall-like tissue in a first direction from one side to the other; and a connector having a first connecting portion and a second connecting portion, the first connecting portion being capable of connecting to the perforation component at one end, and the second connecting portion being capable of connecting to the insertion component at the other end, the connector being configured to connect the perforation component and the insertion component, the perforation component having a front end portion and a perforation shaft portion, the perforation shaft portion being disposed on one side of the wall-like tissue in the thickness direction; and a connector having a first connecting portion and a second connecting portion, the first connecting portion being capable of connecting to the perforation component at one end, the second connecting portion being capable of connecting to the insertion component at the other end, the connector being configured to connect the perforation component and the insertion component, the perforation component having a front end portion and a perforation shaft portion, the perforation shaft portion being disposed on one side of the wall-like tissue in the thickness direction; and a connector having a first connecting portion and a second connecting portion, the first connecting portion being capable of connecting to the perforation component at one end portion, the second connecting portion being capable of connecting to the insertion component ... The perforated component is adjacent to the front end in the longitudinal direction to form a portion inserted into the wall-like tissue. The maximum radial dimension of the perforated shaft portion in the insertion component is smaller than the outer diameter of the insertion component. The main body has a discharge hole with an internal space extending along the first direction. The perforated component is configured such that, inside the discharge hole, on an axis coaxial with the axis of the discharge hole, it is guided in the first direction and a second direction opposite to the first direction. The discharge hole has a size such that when the perforated component is connected to a connector connected to the insertion component on the other side of the wall-like tissue, the connector and the insertion component can be inserted through when the perforated component is moved in the second direction.

[0012] Invention Effects

[0013] According to the insertion component export device of the present invention, an insertion component inserted into a wall-like tissue of a living organism can be accurately and easily exported from the body. Attached Figure Description

[0014] Figure 1 This diagram shows the state in which an insertion component, which is inserted into an insertion hole formed in a wall-like tissue, is fixed to the wall-like tissue by a fixing device.

[0015] Figure 2 This is an exploded view of a plug-in component delivery device according to one embodiment of the present invention.

[0016] Figure 3 It means assembly Figure 2 The diagram shows a partial cross-sectional view of the insertion component leading out of the device, and the state before the perforating component perforates the wall-like tissue.

[0017] Figure 4 This indicates that the perforated component is from Figure 3 The diagram shows a partial cross-sectional view of a state in which the perforated component has perforated the wall-like tissue as it moves in the first direction.

[0018] Figure 5 This is a top view showing the state in which the guide component is assembled on the main body of the insertion component outlet device.

[0019] Figure 6 This is a front view showing the state in which the guide component is assembled on the main body of the insertion component outlet device.

[0020] Figure 7 It is a diagram showing the state before the connection of the perforated parts, connectors, and plug-in parts.

[0021] Figure 8 It is a diagram showing the state after connecting the perforated parts, connectors, and plug-in parts.

[0022] Figure 9 It is a schematic diagram showing the main body of the insertion component outlet device disposed in the wall-like tissue, and the state before the perforating component perforates the wall-like tissue.

[0023] Figure 10 This indicates that the perforated component is from Figure 9 The diagram shown is a schematic representation of the state after the wall-like tissue has been perforated.

[0024] Figure 11 It means from Figure 10 The diagram shown illustrates the state after the perforated component, connector, and insertion component are connected.

[0025] Figure 12 This indicates that the connector comes from Figure 11 The diagram shows a schematic representation of a state in which the tissue partially penetrates the wall-like structure and causes the perforations to expand locally.

[0026] Figure 13 This indicates that the plug-in component is from Figure 12 The diagram shown is a schematic representation of the state after the tissue has been extended to one side of the wall-like structure.

[0027] Figure 14 It means from Figure 13 The diagram shows a schematic representation of the state in which the main body is removed from the wall-like tissue and fixed to the wall-like tissue by a fixing device with a through-hole component.

[0028] Figure 15 This is a reference diagram showing a fastening device in which a through-hole is formed at an angle offset relative to an ideal through-hole extending parallel to the communication path of the fastening device.

[0029] Figure 16 It means in Figure 15 The reference diagram shows the state in which the skin floats up in the fixation device shown.

[0030] Figure 17 This is a diagram illustrating the insertion component delivery device according to the second embodiment of the present invention. Detailed Implementation

[0031] The following description, with reference to the accompanying drawings, describes an embodiment of the insertion member delivery device of the present invention. It should be noted that, in this specification, "perpendicular to A" and similar expressions do not only refer to a direction that is completely perpendicular to A, but also include a direction that is substantially perpendicular to A. Similarly, in this specification, "parallel to B" and similar expressions do not only refer to a direction that is completely parallel to B, but also include a direction that is substantially parallel to B. Furthermore, in this specification, "C-shape" and similar expressions do not only refer to a perfect C-shape, but also include a shape that is visually reminiscent of a C-shape (approximately C-shaped).

[0032] The insertion component export device 1 in this embodiment is used to export the linear insertion component I (refer to...) Figure 1 T-shaped tissue inserted into the wall of an organism (see reference) Figures 9-13 Details will be discussed later, such as... Figures 9-13 As shown, the insertion component outlet device 1 forms a perforation H1 (refer to) on one side Ta of the wall thickness direction TD of the biological wall-like tissue T towards the other side Tb. Figure 4 Afterwards, as the insertion component I moves from the other side (Tb) of the wall-like tissue T to the other side (Ta), the perforation hole H1 is enlarged by the connector 4 described later, forming an insertion hole H2 larger than the perforation hole H1 (see reference). Figure 1 and Figure 13 Thus, the insertion component I is inserted into the insertion hole H2 of the wall-like tissue T, and the insertion component I is led out from the wall-like tissue T.

[0033] In this specification, "organism" refers to the body of animals other than humans. "Wall-like tissue" refers to tissue that can pass through the perforated component 3 described later (see reference 3). Figure 2 This refers to any wall, membrane, or other tissue of a living organism that is perforated and has a predetermined thickness capable of penetration. Specifically, wall-like tissue refers to various tissues within a living organism, such as skin (epidermis, dermis, subcutaneous tissue), muscle layers, tissues constituting various organs, and layers composed of these tissues. In this embodiment, the wall-like tissue T of the insertion / penetration component I is tissue including skin and muscle layers. Furthermore, in this embodiment, one side (Ta) of the wall-like tissue T is the lateral side of the body, and the other side (Tb) is the medial side. Moreover, either side of the wall-like tissue can be any side of the wall-like tissue, and can be appropriately changed depending on the purpose of the insertion / penetration component dispensing device.

[0034] In this embodiment, the insertion component delivery device 1 is used to insert into the fixation device F (refer to) fixed to the wall-shaped tissue T. Figure 1 The insertion component I is led out of the body. More specifically, the insertion component leading out device 1 is used to insert the drive wire (insertion component I) used in implanted medical devices (e.g., VAD, artificial lungs, and other artificial organs) through the wall-like tissue T of the abdomen, i.e., the skin and muscle layer, and lead the drive wire out of the body. Figure 1 As shown, the drive line that is led out of the body is fixed to a designated position on the abdomen via a fixing device F.

[0035] The insertion component I has a predetermined length and is a component that penetrates the wall-like tissue T of a living organism. Furthermore, the term "linear" in "linear insertion component I" means that, whether hollow or solid, the insertion component I extends to a predetermined length. In this embodiment, the insertion component I is a medical strip component configured to extend from one side Ta of the wall-like tissue T of the living organism to the other side Tb. More specifically, the insertion component I is a drive line for an artificial organ (artificial assistive heart). One end of the insertion component I is connected to an artificial organ (not shown) positioned within the body, and the other end is connected to a device (power supply, etc.) positioned externally. Furthermore, as described later, the insertion component I is inserted through the wall-like tissue T of the living organism and led out from inside the body before being connected to the externally positioned device.

[0036] like Figure 2 and Figure 4 As shown, the insertion member I has a connecting portion Ia located at the other end of the insertion member I for connecting to a device disposed externally, and a insertion member body Ib. The connecting portion Ia can, for example, be a generally cylindrical plug (male plug) for connecting to a power connection portion (female plug) of a device disposed externally, such as a power supply, but the shape and structure of the connecting portion Ia are not particularly limited. Furthermore, in this embodiment, as... Figure 2 and Figure 4 As shown, the outer diameter of the connecting portion Ia is larger than the outer diameter of the insertion component body Ib. However, the outer diameter of the connecting portion Ia can be smaller than or the same as the outer diameter of the insertion component body Ib. In this embodiment, the insertion component body Ib has a specified flexibility and rigidity. The insertion component body Ib has a specified elasticity that allows it to recover its original shape if subjected to bending deformation.

[0037] The internal structure of the insertion component I is not particularly limited; in this embodiment, for example... Figure 1As shown, the insertion component I includes: a cooling water circulation passage Ic, which circulates cooling water between the artificial organ inside the body and a pressure pump outside the body; and a power cable Id, which connects the artificial organ inside the body and a power source outside the body. Furthermore, the insertion component I can be configured to have only a power cable, only a cooling water circulation passage, include components with other functions, or be a hollow component without internal components. When used as a hollow component connecting the inside and outside of the body, the insertion component I can also be used to deliver therapeutic drugs from outside the body to a treatment site inside the body.

[0038] When the insertion component I is inserted into the wall-like tissue T via the insertion component delivery device 1, for example, as Figure 1 As shown, the insertion component I is inserted into the fixing device F, and the fixing device F is fixed to the wall-like tissue T. Thus, the insertion component I is fixed in a predetermined position while inserted into the wall-like tissue T via the fixing device F. Furthermore, in this embodiment, after the insertion component I is inserted into the wall-like tissue T via the insertion component delivery device 1 (see...), Figure 13 Remove the insertion component exit device 1, and fix the fixing device F, which is a component different from the insertion component exit device 1, to the wall-shaped tissue T (see reference). Figure 1 and Figure 14 However, if the insertion component outlet device 1 has the functions required to serve as a fixation device F, it can also be used directly as a fixation device without removing the insertion component outlet device 1 from the wall-like tissue T.

[0039] As for the fixing device F, a well-known fixing device, such as a so-called skin button, can be used, therefore detailed description is omitted. As an example, such as... Figure 1 As shown, the fixation device F includes: a fixing part F1, fixed to a wall-like tissue T; a connecting part F2, having a connecting passage F21 for insertion of the insertion component I; and a chuck component F3, which liquid-tightly fixes the insertion component I. To facilitate anchoring of a portion of the wall-like tissue T (skin), it is preferable to perform surface treatment on at least a portion of the fixation device F. Furthermore, the material of the fixation device F is preferably formed of a biocompatible material. Examples of biocompatible materials include titanium and titanium alloys among metallic materials, and high-strength polytetrafluoroethylene (PTFE) and polyetheretherketone (PEEK) based on compression molding among resin materials. The material used in the fixation device F is appropriately selected according to the location or application of the fixation device F.

[0040] The cut wall-shaped tissue T (skin tissue) is guided and fixed in the fixing part F1 of the fixing device F. In this embodiment, the fixing part F1 is provided such that its end on the side of the wall-shaped tissue T in the connecting part F2 extends radially outward relative to the connecting part F2. In this embodiment, the fixing part F1 is formed as a flange surrounding the periphery of the connecting part F2.

[0041] In this embodiment, the connecting portion F2 connects the inside of the organism to the outside of the organism. The connecting portion F2 is the part through which the insertion component I is inserted, and it is configured to be generally cylindrical. The chuck component F3 is a component disposed between the inner wall of the connecting passage F21 of the connecting portion F2 and the outer surface of the insertion component I, and it secures the insertion component I tightly and fluid-tightly. If the fixing device F with the insertion component I inserted is fixed to the wall-like tissue T, the cells proliferate and the fixing device F is fixed to the wall-like tissue T.

[0042] Next, the structure of the insertion component delivery device 1 of this embodiment will be described.

[0043] like Figures 2-4 As shown, the insertion component delivery device 1 includes: a main body 2, which can be disposed on one Ta side of the wall thickness direction TD of the wall-shaped tissue T; and a perforating component 3, which can be moved relative to the main body 2 to form a perforation hole H1, the perforation hole H1 perforating the wall-shaped tissue T in a first direction D1 from one Ta side to the other Tb side (see reference). Figure 4 ); and connector 4 (refer to) Figure 2 and Figure 4 The connector 4 includes a first connecting portion 41 and a second connecting portion 42. The first connecting portion 41 can be connected to the perforated component 3 at one end 4a (see reference). Figure 7 and Figure 8 The second connecting part 42 can be connected to the insertion part I at the other end 4b (see reference). Figure 7 and Figure 8 The connector 4 is configured to connect the through-hole component 3 and the insertion component I. Additionally, in this embodiment, as... Figures 2-4 As shown, the insertion component outlet device 1 also includes a guide component 5.

[0044] In this specification, "wall thickness direction TD" refers to the thickness direction of the wall-shaped tissue T, that is, the direction connecting the surface of the wall-shaped tissue T on one side (Ta) and the surface of the other side (Tb). In this embodiment, the wall thickness direction TD is also the direction that approaches or moves away from the surface (outer or inner side) of the wall-shaped tissue T (the direction perpendicular to the surface). Furthermore, in this specification, when describing the various components of the insertion member discharging device 1, the direction parallel to the wall thickness direction TD when the insertion member discharging device 1 is positioned in the wall-shaped tissue T is sometimes also referred to as the wall thickness direction TD. In addition, the first direction D1 refers to the direction in which the perforating member 3 moves from one side (Ta) toward the other side (Tb) when it perforates the wall-shaped tissue T. The "first direction D1 from one side (Ta) toward the other side (Tb)" can be inclined relative to the wall thickness direction TD or parallel to the wall thickness direction TD. In this embodiment, the angle θ formed by the first direction D1 (axis X of the perforated component 3) and the surface of the wall-like tissue T opposite to the main body 2 (in the case of surface curvature, the surface that contacts the portion forming the perforation hole H1) (refer to...) Figure 4 For example, the angle can be set to 10–80°, preferably 20–70°, and more preferably 30–60°. The second direction D2 is the direction opposite to the first direction D1, and refers to the direction of movement when the perforating member 3 is pulled out after perforating the wall-shaped tissue T. In addition, in this specification, the direction including both the first direction D1 and the second direction D2 is referred to as the X-axis direction (the X-axis direction of the perforating member 3).

[0045] like Figure 3 and Figure 4 As shown, the main body 2 is disposed on one side (Ta) of the wall thickness direction (TD) of the wall-shaped tissue T. In this embodiment, the main body 2 is fixed to the skin of the wall-shaped tissue T. The shape and structure of the main body 2 are not particularly limited as long as it can be disposed on one side (Ta) of the wall thickness direction (TD) of the wall-shaped tissue T and has the outlet hole 24 described later. In this embodiment, the main body 2 has a main body portion 21, a flange portion 22, and a holding portion 23.

[0046] The main body 21 is the portion where the outlet hole 24, described later, is provided, and it forms the base portion that occupies most of the main body 2. In this embodiment, as... Figures 3-6 As shown, the main body 21 is formed as a column extending along the wall thickness direction TD. An outlet hole 24 is provided through the main body 21. In this embodiment, the flange 22 extends outward perpendicularly to the wall thickness direction TD from the outer periphery of one end of the main body 21 (the end on the wall-shaped tissue T side) (see reference). Figure 5 and Figure 6The flange portion 22 is preferably of a shape and size corresponding to the fixing portion F1 of the fixing device F. The holding portion 23 is the part held by the surgeon when using the insertion component export device 1, such as when moving the main body 2, when making a puncture using the puncture component 3, or when exporting the insertion component I.

[0047] Furthermore, the method for fixing the wall-like tissue T to the main body 2 is not particularly limited. In this embodiment, the skin (wall-like tissue T) of a size corresponding to the main body 21 is removed, and the skin corresponding to the flange 22 is incised so that the flange 22 is inserted under the skin. Thus, as Figure 3 As shown, the main body 2 is fixed to the wall-like tissue T with the flange 22 inserted into the skin and the main body 21 exposed from the skin. In this embodiment, the portion of the main body 2 disposed in the wall-like tissue T has a shape corresponding to the aforementioned fixing device F. After the main body 2 is removed from the wall-like tissue T, the fixing device F can be fixed to the wall-like tissue T in the same state (e.g., position and orientation) as the main body 2. In this case, the fixing operation of the fixing device F to the wall-like tissue T can be easily performed. Furthermore, when the connecting passage F21 of the fixing device F and the outlet hole 24 of the main body 2 extend with the same size, the same position, and the same angle, as described later, when the insertion member I is inserted into the connecting passage F21 of the fixing device F, the fixing device F is less likely to be subjected to a force from the direction of displacement of the insertion member I relative to the desired position of the fixing device F. In this case, as described later, the floating or sinking of the fixing device F relative to the wall-like tissue T can be suppressed.

[0048] Furthermore, other fixation methods, such as medical straps, can be used to fix the main body 2 to the wall-like tissue T, as long as it is difficult for the main body 2 to shift position relative to the wall-like tissue T. Additionally, the main body 2 can be temporarily fixed to the wall-like tissue T only during surgery, or it can be fixed to the wall-like tissue T for a long period or permanently as required by the patient's treatment. Furthermore, the material constituting the main body 2 is not particularly limited; for example, biocompatible metals or resins can be used.

[0049] As mentioned above, such as Figures 2-4 As shown, the main body 2 has an outlet hole 24, which has an internal space extending along the first direction D1. Further details will be described later. The outlet hole 24 has a size such that when the perforated component 3 is moved in the second direction D2 while connected to the connector 4 connected to the insertion component I on the other side Tb of the wall-like tissue T (see reference...), the perforated component 3 is in a state where it is connected to the connector 4 connected to the insertion component I. Figure 12 and Figure 13 The connector 4 and the insertion part I can be inserted to a certain size. Additionally, in this embodiment, as... Figure 3 and Figure 4As shown, the outlet hole 24 is configured to pass through when the perforating member 3 perforates the wall-shaped tissue T. Furthermore, in this embodiment, at least a portion of the guide member 5 is inserted into the outlet hole 24.

[0050] The outlet hole 24 extends along the first direction D1 (axis X direction), defining the insertion angle of the insertion member I when it is inserted into the outlet hole 24. Furthermore, in this embodiment, as described later, the through-hole member 3 is configured as follows... Figure 3 and Figure 4 As shown, inside the outlet hole 24, the perforated part is guided in the first direction D1 and the second direction D2 on the same axis as the outlet hole 24 (axis X). In this case, as will be described later, the axis of the perforation hole H1 of the wall-shaped tissue T formed by the perforating member 3 coincides with the axis of the insertion member I, which is inserted into the outlet hole 24 (or the communication passage F21 of the fixing device F) after the wall-shaped tissue T is perforated. Thus, the portion of the insertion member I that penetrates the wall-shaped tissue T and the portion of the insertion member I that penetrates the outlet hole 24 (or the communication passage F21 of the fixing device F) of the body 2 are arranged on the same axis. Therefore, as will be described later, the body 2 is subjected to a force from the portion of the insertion member I that penetrates the outlet hole 24 (or the communication passage F21 of the fixing device F), which suppresses floating or sinking relative to the desired position. Furthermore, "guided by the interior of the outlet hole 24" means that the perforated part 3 is guided directly or indirectly by the outlet hole 24. In this embodiment, the perforated member 3 is indirectly guided from the inside of the outlet hole 24 via the guide hole 51 of the guide member 5. Furthermore, as described later in the embodiment (see...), Figure 17 In this way, the perforated component 3 can also be directly guided from the inside of the outlet hole 24. Furthermore, "on the same axis" means that the perforated component 3 and the outlet hole 24 extend substantially on a common axis. In this embodiment, the extending direction of the axis of the perforated component 3 and the extending direction of the axis of the outlet hole 24 are substantially on the same straight line. Additionally, the perforated component 3 and the outlet hole 24 can be slightly bent as long as they extend substantially on a common axis.

[0051] The extension angle of the outlet hole 24 is not particularly limited. As mentioned above, the angle θ formed by the axis (axis X) of the outlet hole 24 and the surface on one side Ta of the wall-like tissue T (in the case of surface curvature, the surface that contacts the part forming the perforation hole H1) is (refer to) Figure 4 For example, the angle can be set to 10 to 80°, preferably 20 to 70°, and more preferably 30 to 60°. The angle of the outlet hole 24 can be set to an angle corresponding to the angle of the connecting passage F21 of the fixing device F (for example, the angle difference with the axis of the connecting passage F21 is 10° or less, preferably 5° or less) or the same angle.

[0052] In this embodiment, the outlet hole 24 extends linearly along the X-axis for a predetermined length. The cross-sectional shape of the outlet hole 24 is not particularly limited as long as it allows the connector 4 and the insertion member I to pass through. In this embodiment, the cross-section of the outlet hole 24 perpendicular to the first direction D1 is circular. Furthermore, the size of the outlet hole 24 is not particularly limited as long as it allows the perforated member 3 to pass through in a perforated wall-like structure T and allows the connector 4 and the insertion member I to pass through. In this embodiment, the inner diameter of the outlet hole 24 has an inner diameter corresponding to the portion of the connector 4 and the insertion member I with the largest outer diameter (for example, an inner diameter that is 100-110% of the outer diameter of the portion of the connector 4 and the insertion member I with the largest outer diameter, preferably 100-105%, more preferably 100-103%).

[0053] like Figures 2-4 As shown, the outlet hole 24 has a first opening 24a facing the wall-like tissue T and a second opening 24b that is an opening on the side opposite to the first opening 24a. An internal space of the outlet hole 24 is formed between the first opening 24a and the second opening 24b. The first opening 24a faces the wall-like tissue T and opens on the lower surface of the main body 21. The second opening 24b opens on the side of the main body 21.

[0054] like Figures 2-4As shown, the inner surface of the outlet hole 24 on the second direction D2 side has a engaged portion 24c that engages with the engaging portion E of the guide member 5, which will be described later. As described later, the engaged portion 24c of the outlet hole 24 engages with the engaging portion E of the guide member 5, thereby preventing the guide portion 52 of the guide member 5 from disengaging from the outlet hole 24. The structure of the engaged portion is not particularly limited as long as it can engage with the engaging portion in a manner that prevents the guide portion 52 from disengaging from the outlet hole 24. In this embodiment, the engaged portion 24c is an internal thread that engages with the engaging portion E, which is provided as an external thread. However, the engaged portion can also be provided as an engaging claw, an engaging recess, an engaging protrusion, etc., depending on the structure of the engaging portion. Furthermore, the inner diameter of the engaged portion 24c (the smallest part of the inner diameter of the engaged portion 24c) is larger than the outer diameter of the connector 4 and the insertion member I, so that the connector 4 and the insertion member I can extend from the second opening 24b of the outlet hole 24 in the second direction D2. In the case where the engaging portion 24c is configured as an external thread as in this embodiment, as described later, it is desirable to release the engagement between the engaging portion E and the engaged portion 24c before one end 4a of the connector 4 is inserted through the wall-like tissue T (before one end 4a enters the wall-like tissue T). That is, the positions of the engaging portion E, the engaged portion 24c, and one end 4a of the connector 4 are set such that when the engagement between the engaging portion E and the engaged portion 24c is released, one end 4a of the connector 4 is located closer to the interior of the wall-like tissue T. As a result, when one end 4a of the connector 4 passes through the wall-like tissue T, rotation of the connector 4 following the rotation of the guide member 5 (rotation when the engagement between the engaging portion E and the engaged portion 24c is released) can be prevented. Therefore, the release of the engagement between the through shaft portion 32 and the connector 4 due to rotation when the connector 4 is inserted into the tissue T is suppressed.

[0055] like Figures 2-4 As shown, a main body side abutment surface 25 is provided on the second direction D2 side of the outlet hole 24. This main body side abutment surface 25 abuts against the stop surface 54 of the guide member 5, thereby restricting the movement of the guide member 5 relative to the main body 2 in the first direction D1. In this embodiment, the main body side abutment surface 25 is formed by the periphery of the second opening 24b of the outlet hole 24, which is a surface extending perpendicularly to the axis X direction.

[0056] In this embodiment, such as Figures 2-6As shown, the insertion component outlet device 1 includes a guide member 5, which can be at least partially inserted into the outlet hole 24 and has a guide hole 51 that guides the through-hole component 3 along the same axis (axis X) as the axis of the outlet hole 24. The guide member 5 is partially inserted into the outlet hole 24 of the main body 2 from the second opening 24b side and is installed in a manner that allows it to be detached from the main body 2. The guide member 5 guides the through-hole component 3 in the first direction D1 (along axis X) through the guide hole 51. The shape and structure of the guide member 5 are not particularly limited as long as it can be at least partially inserted into the outlet hole 24 and has a guide hole 51 that guides the through-hole component 3 along the same axis as the axis of the outlet hole 24. Furthermore, as described later, in the insertion component outlet device 1, the guide member 5 can be omitted (see reference 1) because it is configured to make the through-hole component 3 have part of the function of the guide member 5 (e.g., the function of the guide part 52). Figure 17 ).

[0057] The guide hole 51 guides the perforated component 3 on the same axis as the outlet hole 24, thereby defining the perforation direction based on the perforated component 3. Figure 3 and Figure 4 As shown, the perforated component 3 is guided by the guide hole 51 in a manner that it moves along the axis X in the first direction D1. The perforated component 3 is able to form a perforated hole H1 in the wall-like tissue T along the axis X, which is the same axis as the axis of the outlet hole 24. The axes of the perforated hole H1 and the axis of the outlet hole 24 are both arranged on the same axis (axis X) along the first direction D1. Thus, as described above, when the insertion component I is inserted into the outlet hole 24 (or the communication passage F21 of the fixing device F), the portion of the insertion component I that passes through the insertion hole H2 that penetrates the wall-like tissue T is arranged on the same axis as the portion of the insertion component I that passes through the outlet hole 24 (or the communication passage F21 of the fixing device F) that passes through the main body 2.

[0058] A guide hole 51 is provided through the guide member 5 in the X-axis direction, having an opening on the first direction D1 side and an opening on the second direction D2 side. The shape of the guide hole 51 is not particularly limited, as long as it can guide the perforated member 3 on the same axis as the outlet hole 24. In this embodiment, the guide hole 51 is an opening with a circular cross-section, configured to guide the perforated member 3 with a circular cross-section. The size of the guide hole 51 is formed to correspond to the size of the perforated member 3, so that the perforated member 3 can move stably in the first direction D1 when passing through the guide hole 51, provided that the perforated member 3 does not become loose relative to the guide hole 51 and disengage from the predetermined perforation position towards the skin, or that the insertion member 3 does not experience excessive force during insertion and removal relative to the guide hole 51.

[0059] In this embodiment, such as Figures 2-6 As shown, the guide member 5 includes: a cylindrical guide portion 52 inserted into the outlet hole 24; and an extension portion 53 disposed on the second direction D2 side of the guide portion 52, extending radially outward relative to the outer periphery of the guide portion 52. Furthermore, in this embodiment, the guide member 5 has a cylindrical portion 55 with a diameter larger than that of the guide portion 52 between the guide portion 52 and the extension portion 53 in the first direction D1, and this cylindrical portion 55 has the aforementioned stop surface 54.

[0060] The guide portion 52 is the part inserted into the outlet hole 24. In this embodiment, the guide portion 52 is guided within the outlet hole 24 such that the guide hole 51 of the guide member 5 and the axis of the outlet hole 24 are arranged on the same axis when inserted into the outlet hole 24. In this case, the guide portion 52 is guided within the outlet hole 24, thereby the guide member 5 is stably held relative to the body 2, and the perforating member 3 is stably guided in the first direction D1 by the guide hole 51 of the guide member 5. In addition, the guide portion 52 is guided by the outlet hole 24 so that after the perforation of the wall-shaped tissue T is completed by the perforating member 3 and the perforating member 3 is connected to the connector 4 and the insertion member I, the perforating member 3 and the guide member 5 can move in the second direction D2 along the axis (axis X) of the outlet hole 24. Thus, as will be described later, when the connector 4 and the insertion member I are inserted from the other side Tb of the wall-shaped tissue T to the other side Ta (see reference 1), Figure 12 and Figure 13 The first opening 24a facing the outlet hole 24 is precisely guided along the axis X, and the insertion component I is inserted into the outlet hole 24 at the desired angle through the wall-like tissue T.

[0061] In this embodiment, the guide portion 52 has a shape and size corresponding to the outlet hole 24, arranged to stably guide and be disposed within the outlet hole 24. In this embodiment, the guide portion 52 is formed in a cylindrical shape, and the outlet hole 24 has a cylindrical internal space. Furthermore, the guide portion 52 may have a gap with the inner surface of the outlet hole 24, provided that it does not produce unnecessary wobbling when disposed within the outlet hole 24. The inner diameter of the outlet hole 24 may, for example, be 100-110% of the outer diameter of the guide portion 52, preferably 100-105%, and more preferably 100-103%.

[0062] The length of the guide portion 52 in the X-axis direction is not particularly limited. In this embodiment, it is preferable that the length of the guide portion 52 (and the outlet hole 24) be set in such a way that a perforation hole H1 is formed by the perforation member 3, and the connector 4 is connected to the perforation member 3 from the other side Tb of the wall-like tissue T (see reference). Figure 11During the period from when the perforated part 3 and the connector 4 move in the second direction D2 and one end 4a of the connector 4 reaches the first opening 24a of the outlet hole 24, the guide part 52 is guided by the outlet hole 24. In this case, from the time the connector 4 connects to the perforated part 3 until it enters the outlet hole 24, the connector 4 and the insertion part I move along the axis X on the same axis as the axis of the outlet hole 24. Therefore, the connector 4 and the insertion part I can reliably move into the outlet hole 24. After the connector 4 enters the first opening 24a of the outlet hole 24, the connector 4 is guided within the outlet hole 24. Therefore, even after the guide part 52 disengages from the outlet hole 24 in the second direction D2, and the guide part 5 and the perforated part 3 move in an inclined manner relative to the axis of the outlet hole 24, the connector 4 and the insertion part I also move along the axis X within the outlet hole 24. Therefore, the connector 4 and the insertion part I can be stably exited.

[0063] like Figures 2-4 As shown, the guide member 5 has a locking portion E, which engages with the main body 2 to prevent the guide portion 52 of the guide member 5 from disengaging from the outlet hole 24. By providing the locking portion E, when the perforating member 3 is used to perforate the wall-like tissue T, even if a force in the second direction D2 is applied to the guide member 5, it is possible to prevent the guide member 5 from disengaging from the outlet hole 24. Therefore, the perforating member 3 can be stably moved in the first direction D1 (see reference). Figure 9 as well as Figure 10 The engaging portion E engages with the main body 2 in a manner that restricts the movement of the guide member 5 in the second direction D2 relative to the main body 2. Preferably, the engaging portion E is configured to restrict the movement of the guide member 5 relative to the main body 2 in both the first direction D1 and the second direction D2. In this embodiment, the engaging portion E is an external thread provided at the end of the guide portion 52 on the second direction D2 side, which engages with the internal thread provided in the engaged portion 24c of the main body 2. However, the shape and structure of the engaging portion are not particularly limited as long as they can engage with the main body 2 and prevent the guide portion 52 of the guide member 5 from disengaging from the outlet hole 24. For example, the engaging portion may also be an engaging claw, engaging recess, engaging protrusion, etc., having a structure corresponding to the structure of the engaged portion of the main body 2 and engaging with the engaged portion in the axial X direction.

[0064] The engaging part E engages with the engaged part 24c in a manner that allows for disengagement. Therefore, after the perforation of the wall-shaped tissue T using the perforating member 3 is completed, the connector 4 and the insertion member I can be led out to the outlet hole 24 by removing the guide member 5 from the main body 2 (see reference). Figures 11-13 ).

[0065] like Figures 2-6As shown, the protrusion 53 is provided on the second direction D2 side of the guide portion 52, extending radially outward relative to the outer periphery of the guide portion 52. The protrusion 53 improves the operability when perforating the wall-shaped tissue T through the perforating member 3. Specifically, a finger can be hooked onto the surface of the protrusion 53 on the first direction D1 side, and the perforating member 3 can be pressed into the first direction D1. In other words, the perforating member 3 acts as a plunger of a syringe, and the protrusion 53 functions like the flange of a syringe barrel. Therefore, it is easy to apply force to the perforating member 3, and perforation of the wall-shaped tissue T by the perforating member 3 becomes easier. In addition, the protrusion 53 also improves the operability when attaching and detaching the guide portion 52 relative to the main body 2. Specifically, when engaging and disengaging the engagement between the engagement portion E, which is a threaded structure, and the engaged portion 24c, the guide portion 5 can be easily rotated about the axis X by holding the protrusion 53 and rotating it. Therefore, it is easy to attach and detach the guide portion 5 from the main body 2.

[0066] Furthermore, in this embodiment, such as Figure 5 and Figure 6 As shown, the protrusion 53 is provided on the second direction D2 side of the cylindrical portion 55 of the guide member 5, and is configured to extend circumferentially relative to the cylindrical portion 55. However, the shape of the protrusion 53 is not particularly limited, and it may be configured to protrude only from a portion in the circumferential direction.

[0067] The perforating component 3 is movable relative to the main body 2 and is a component that forms a perforation hole H1 in the wall-like tissue T. In this embodiment, the front end portion 31 of the perforating component 3 is formed in the shape of a needle, but it does not necessarily have to be needle-shaped as long as it can form a perforation hole H1 in the wall-like tissue T.

[0068] In this embodiment, when the perforating component 3 perforates the wall-shaped tissue T, such as Figure 3 , Figure 4 , Figure 9 as well as Figure 10 As shown, by moving relative to the main body 2 and the guide member 5 in the first direction D1, the first opening 24a of the outlet hole 24 protrudes along the axis X in the first direction D1. Thus, a perforation hole H1 is formed in the wall-like tissue T. Furthermore, after the perforation member 3 forms the perforation hole H1, as... Figures 11-13 As shown, the insertion component I is indirectly connected to the connector 4. When the perforated component 3 moves in the second direction D2 and is pulled out from the wall-shaped tissue T in the second direction D2, the insertion component I is led out from the other side Tb side of the wall-shaped tissue T to the other side Ta side.

[0069] like Figures 2-4As shown, the perforated component 3 has a front end portion 31 and a perforated shaft portion 32, which is adjacent to the front end portion 31 in the length direction of the perforated component 3 and becomes a portion for insertion into the wall-shaped tissue T. In addition, the perforated component 3 has a connecting portion C for connection with the connector 4.

[0070] The front end portion 31 is the portion of the perforated member 3 located at the end in the first direction D1 along its length. By moving the perforated member 3 in the first direction D1, the front end portion 31 perforates the wall-like tissue T, forming a perforation hole H1 that extends from one side Ta of the wall-like tissue T to the other side Tb. In this embodiment, the front end portion 31 is formed into a pointed needle shape towards its tip, but as long as the perforation hole H1 can be formed in the wall-like tissue T, it does not need to be pointed like a cylinder, and the tip of the front end portion 31 does not need to be sharp.

[0071] The perforated shaft portion 32 is adjacent to the front end portion 31 along the length direction (axial X direction) of the perforated member 3 and is inserted into the wall-like tissue T. The perforated shaft portion 32 has a length along the axial X direction capable of penetrating the wall-like tissue T, and at least a portion of the perforated shaft portion 32 is inserted into the wall-like tissue T. The shape of the perforated shaft portion 32 is not particularly limited as long as it can perforate the wall-like tissue T. In this embodiment, the cross-section of the perforated shaft portion 32 perpendicular to the length direction is formed as a circle.

[0072] The maximum dimension of the perforated shaft portion 32 in the radial direction (perpendicular to the length direction of the insertion member I) is smaller than the outer diameter of the insertion member I. In this embodiment, the perforated shaft portion 32 is formed as a cylinder having the same outer diameter in the length direction, such as... Figures 2-4As shown, the outer diameter of the perforating shaft portion 32 is configured to be smaller than the outer diameter of the insertion member I. By making the maximum size of the perforating shaft portion 32 smaller than the outer diameter of the insertion member I, compared to the case where a perforating hole is opened in the wall-like tissue T using a perforating shaft portion with the same outer diameter as the insertion member I, a perforating hole H1 can be formed with less force. Here, "maximum size of the perforating shaft portion 32" refers to the maximum size of the portion of the perforating shaft portion 32 that enters the wall-like tissue T. In addition, "outer diameter of the insertion member I" refers to the outer diameter of the insertion member I when the outer diameter of the insertion member I including the connecting portion Ia is the same in the length direction of the insertion member I; when the outer diameter of the insertion member I including the connecting portion Ia varies locally in the length direction, it refers to the portion of the insertion member I that has the largest outer diameter extending from the other side Tb of the wall-like tissue T to the other side Ta (for example, when the outer diameter of the connecting portion Ia is the largest, the outer diameter of the connecting portion Ia becomes the largest outer diameter). Furthermore, the maximum size of the perforated shaft portion 32 of the perforated component 3 is not particularly limited. The diameter of the perforated shaft portion 32 of the perforated component 3 can be any size that is desired for perforating the wall-like tissue T without causing damage, and can exert the force required to pull out the connector 4 and the insertion component I when connected to the connector 4. For example, it can be set to 5 to 70% of the outer diameter of the insertion component I, preferably 20 to 60%, and more preferably 35 to 50%.

[0073] In addition, in this embodiment, such as Figures 2-4 As shown, the perforating member 3 has a stop 33 that limits the amount of protrusion of the perforating member 3 from the body 2 within a predetermined range. When the wall-like tissue T is perforated by the perforating member 3 from one side Ta to the other Tb, the stop 33 limits the amount of protrusion of the perforating member 3 from the body 2 (the first opening 24a of the outlet hole 24) (refer to...) Figure 4 The perforation is limited to a specified range. Therefore, for example, when a wall-like tissue T is pierced from outside the body towards the inside by the perforating member 3, the position reached by the tip 31 of the perforating member 3 can be easily controlled. Thus, the risk of damage to other organs or tissues due to increased protrusion of the perforating member 3 can be reduced. Furthermore, the "specified range" can be, for example, set as the extent to which the tip of the perforating member 3 does not reach internal organs or other tissues other than the target of perforation when it enters the wall-like tissue T; this specified range can be appropriately varied depending on the target of perforation (the perforation site, physique, age, sex, etc. of the organism).

[0074] In this embodiment, the stop portion 33 abuts against the abutting portion 53a provided on the guide member 5, thereby limiting the protrusion of the perforated member 3 from the main body 2 within a predetermined range. In this embodiment, the stop portion 33 extends relative to the perforated shaft portion 32 in a direction perpendicular to the axis X direction. More specifically, the extended stop portion 33 is configured to abut against the abutting portion 53a of the peripheral portion (in this embodiment, the end face of the protruding portion 53 on the second direction D2 side) of the opening of the guide hole 51 of the guide member 5.

[0075] Furthermore, the shape of the stop portion is not particularly limited as long as it can limit the protrusion of the perforated member 3 from the main body 2 within a specified range; it can be disc-shaped or rectangular plate-shaped. In this embodiment, the stop portion 33 is provided at the end of the perforated member 3 on the second direction D2 side, but it can also be provided at a location other than the end of the perforated member 3 (e.g., the position between the end of the perforated member 3 on the second direction D2 side and the center of the perforated shaft portion 32, etc.).

[0076] Furthermore, in this embodiment, the stop portion 33 and the guide member 5 engage with each other in the X-axis direction. Therefore, after the perforating member 3 forms a perforation H1 in the wall-shaped tissue T, when the perforating member 3 is pulled out of the wall-shaped tissue T, as... Figure 12 and Figure 13 As shown, by moving the guide component 5 relative to the main body 2 in the second direction D2, the perforation component 3 can also move in the second direction D2 simultaneously. Furthermore, at this time, the connector 4 and the insertion component I are extended from the other side (Tb) of the wall-like tissue T to the other side (Ta). Therefore, the guide component 5 can be removed from the main body 2, the perforation component 3 can be pulled out from the wall-like tissue T, and the insertion component I can be extended simultaneously, improving operability and helping to shorten the operation time.

[0077] The connecting part C is the portion that connects to the connector 4. The position of the connecting part C is not particularly limited, as long as it is positioned on the other side (Tb) of the wall-shaped tissue T, after the perforating member 3 has pierced it, to allow connection with the connector 4. In this embodiment, as... Figures 2-4 As shown, the connecting portion C is positioned adjacent to the front end portion 31 in the second direction D2. The shape and structure of the connecting portion C are not particularly limited, as long as they can be connected to the connector 4 to allow the insertion member I to be led out from the wall-like tissue T. In this embodiment, the connecting portion C is an external thread located on the outer periphery of the through-hole shaft portion 32 that engages with the internal thread of the first connecting portion 41 of the connector 4. However, the connecting portion C may also be a locking claw, locking recess, locking protrusion, etc., having a structure corresponding to the structure of the first connecting portion 41 of the connector 4 and engaging with the first connecting portion 41 in the axial X direction.

[0078] Connector 4 connects the through-hole component 3 to the insertion component I. In this embodiment, as... Figure 11 As shown, with the perforating component 3 perforating the wall-shaped tissue T, the connector 4 connects to the perforating component 3 and the insertion component I on the other side (Tb) of the wall-shaped tissue T. As will be described later, the perforating component 3 and the insertion component I connected via the connector 4 on the other side (Tb) of the wall-shaped tissue T are as follows... Figure 12 and Figure 13 As shown, the perforated component 3 moves in the second direction D2 to become an integral part, and moves through the perforation hole H1 (insertion hole H2) toward one side Ta of the wall-like tissue T. Thus, the insertion component I is led out toward one side Ta of the wall-like tissue T.

[0079] like Figure 7 and Figure 8 As shown, connector 4 includes: a first connecting portion 41, which can be connected to the through member 3 at one end 4a; and a second connecting portion 42, which can be connected to the insertion member I at the other end 4b. The overall shape of the connector is not particularly limited as long as it can connect the through member 3 and the insertion member I. In this embodiment, connector 4 is generally cylindrical in shape.

[0080] The first connecting part 41 is the part that connects to the perforated part 3. For example... Figure 7 and Figure 8 As shown, in this embodiment, the first connecting portion 41 has an internal thread that engages with the connecting portion C of the through-hole member 3, which is composed of an external thread. More specifically, the first connecting portion 41 has an internal thread on one end 4a of the connector 4, and this internal thread is provided on the inner surface of the cylindrical hollow portion 41a disposed along the axis of the connector 4. Figure 8 As shown, the cylindrical hollow portion 41a of the first connecting portion 41 is formed to accommodate not only the connecting portion C of the perforated component 3, but also the front end portion 31 of the perforated component 3.

[0081] The structure of the first connecting part 41 is not particularly limited as long as it is configured such that the connection between the perforated part 3 and the connector 4 is not released when the perforated part 3 moves in the second direction D2 while the perforated part 3, connector 4, and insertion part I are connected. For example, the first connecting part can be other mechanical connection structures such as locking claws, or it can be configured to be connected by magnetic force.

[0082] The second connecting portion 42 is the part that connects to the insertion member I. In this embodiment, the second connecting portion 42 can connect to the connecting portion Ia provided at the end of the insertion member I. More specifically, a male plug (connecting portion Ia) is provided at the end of the drive line of the insertion member I and is inserted into the drive portion (power supply) of the drive line, and the second connecting portion 42 is configured to fit into the male plug (connecting portion Ia). For example, a locking protrusion (not shown) is provided on the outer periphery of the male plug that serves as the connecting portion Ia, and the second connecting portion 42 can be composed of a cylindrical hollow portion 42a with a locking recess (not shown) on its inner surface for engaging with the locking protrusion of the connecting portion Ia.

[0083] The structure of the second connecting part 42 is not particularly limited as long as it is configured such that the connection between the connector 4 and the plugging part I is not released when the perforated part 3 moves in the second direction D2 while the perforated part 3, connector 4, and plugging part I are connected. For example, the second connecting part can be other mechanical connection structures such as screws or locking claws, or it can be configured to be connected by magnetic force. In addition, in this embodiment, the second connecting part 42 is configured to connect the connector 4, which is separated from the plugging part I, to the end of the plugging part I, but the connector can also be pre-connected to the plugging part I.

[0084] Furthermore, in this embodiment, the connector 4 has a widened portion 43 on one end 4a side, but the widened portion 43 will be described later.

[0085] As described above, in the insertion component delivery device 1 of this embodiment, such as Figure 3 and Figure 4 As shown, the perforated component 3 is configured to be guided in the first direction D1 and the second direction D2 on the same axis (axis X) as the axis of the outlet hole 24 inside the outlet hole 24. Furthermore, the outlet hole 24 has a size such that when the perforated component 3 is connected to the connector 4 connected to the insertion component I on the other side Tb of the wall-like tissue T, the connector 4 and the insertion component I can pass through each other. Thus, the portion of the insertion component I that passes through the insertion hole H2 penetrating the wall-like tissue T and the portion of the insertion component I that passes through the outlet hole 24 of the body 2 are arranged on the same axis. Therefore, the body 2 is prevented from floating or sinking relative to the desired position due to force exerted on the portion of the insertion component I that passes through the outlet hole 24.

[0086] Furthermore, after the perforation of the wall-shaped tissue T is completed through the perforation component 3 and the perforation component 3 is connected to the connector 4 and the insertion component I (see reference...) Figure 11 ), perforated component 3, such as Figure 12 and Figure 13As shown, the connector 4 and the insertion member I are guided by the outlet hole 24 in a second direction D2 along the axis (axis X). Thus, when the connector 4 and the insertion member I are inserted from the wall-like tissue T from one side (Tb) to the other side (Ta), the first opening 24a facing the outlet hole 24 is accurately guided along the axis X, and the insertion member I penetrates the wall-like tissue T at the desired angle and is inserted into the outlet hole 24. As described above, the insertion member outlet device 1 of this embodiment can accurately and easily outlet the insertion member I from the wall-like tissue T.

[0087] The effects described above will be explained in more detail below.

[0088] As described above, the perforated component 3 is guided inside the outlet hole 24 on the same axis as the axis of the outlet hole 24, thereby... Figure 4 As shown, the perforation hole H1 formed by the perforating component 3 is a through hole with the same axis as the outlet hole 24. Therefore, it is difficult for the angle of extension of the perforation hole H1 formed through the wall-like tissue T to deviate from the angle of the axis of the outlet hole 24 on one side Ta of the wall-like tissue T. Therefore, as Figure 13 As shown, when the insertion component I is extended from the other side Tb of the wall-like tissue T to the other side Ta, the insertion hole H2 in the insertion component I passes through the wall-like tissue T (refer to...). Figure 13 Both portion P1 of the insertion member 1 and portion P2 passing through the outlet hole 24 (or the connecting passage F21 of the fixing device F) are straight along the axis X. Therefore, it is possible to prevent the body 2 and the fixing device F from floating or sinking relative to the surface of the wall-like tissue T, which would result from the portion P1 passing through the insertion hole H2 through the wall-like tissue T and the portion P2 passing through the outlet hole 24 extending at different angles. In particular, when piercing the perforation hole H1 at a predetermined angle relative to the wall-like tissue of the human body, especially when the predetermined angle is an angle of inclination relative to the wall-like tissue of the human body, and particularly when the angle of inclination is 30 to 60 degrees, when the cutting area is enlarged by the arc-shaped guide member at the front end of a conventional tunneling device and the wall-like tissue T is inserted, the guide member slides on the skin surface, making the piercing operation difficult. By using the insertion member outlet device 1 of this embodiment, the piercing member 3 does not slide on the skin surface, and the piercing operation becomes easier due to the above-mentioned effects. Therefore, when the fixed equipment F is used as a skin button, the drive line can be output at an angle, and the drive line will not become an obstacle under the clothing compared to the case of outputting it vertically relative to the skin.

[0089] The following will explain this in more detail. Unlike the insertion member delivery device 1 of this embodiment, when a perforation hole for the insertion member I to pass through is formed by a perforation member such as a tunneling device, it is necessary to press the perforation member from one side of the wall-like tissue T to the other side, or from the other side to one side. However, deviations are easily generated relative to the ideal position and angle of the perforation. The state in which the angle of the perforation deviates from the ideal angle is as follows: Figure 15 As shown in the reference example. Figure 15 In this diagram, H10 represents a perforated hole with an ideal angle, and H20 represents a perforated hole whose actual angle deviates from the ideal angle. Furthermore, the perforated hole with an ideal angle, H10, is a perforated hole whose axis is on the same axis as the axis X of the connecting passage F21 of the fixing device F.

[0090] like Figure 15 As shown, the insertion part I, which is inserted into the through hole H20 formed at an angle offset from the ideal angle, extends at different angles in the portion P10 passing through the through hole H20 and the portion P20 passing through the connecting passage F21 of the fixing device F, thus causing the insertion part I to undergo bending deformation. A restoring force, intended to straighten it, is applied to the bent insertion part I. Therefore, a force is applied from the insertion part I to the fixing device F. Figure 16 The force indicated by the middle arrow A is on one side of the fixing device F. Figure 16 The left-hand portion of the wall-like tissue T floats relative to the wall-like tissue T. Thus, if floating (or sinking) occurs between the wall-like tissue T and the fixation device F, tensile and compressive loads are applied to the wall-like tissue T, hindering the promotion of cell growth in the wall-like tissue T, and potentially delaying treatment. In contrast, in the insertion component delivery device 1 of this embodiment, as... Figure 13 and Figure 14 As shown, the portion P1 passing through the insertion hole H2 through the wall-like tissue T in the insertion component I and the portion P2 passing through the outlet hole 24 (the communication passage F21 of the fixation device F) are both straight along the axis X. Therefore, it is possible to suppress the floating or sinking of the wall-like tissue T relative to the body 2 (fixation device F) between the wall-like tissue T and the body 2 (fixation device F), and to prevent the promotion of cell growth of the wall-like tissue T from being hindered.

[0091] Furthermore, in this embodiment, the maximum dimension of the perforation shaft portion 32 of the perforation member 3 is smaller than the outer diameter of the insertion member I. Therefore, a perforation hole H1 can be easily formed in the wall-like tissue T. When a perforation member such as a tunneling device with the same outer diameter as the insertion member I is used to guide the insertion member I, a large force is required when perforating the wall-like tissue T. In contrast, in this embodiment, the perforation shaft portion 32 of the perforation member 3 is thinner than the outer diameter of the insertion member I, so a perforation hole H1 can be formed in the wall-like tissue T with a smaller force.

[0092] In addition, such as Figure 12 and Figure 13 As shown, the guide member 5 is configured to be pulled out of the outlet hole 24 together with the perforated member 3. In this case, when the guide member 5 is pulled out of the outlet hole 24, the perforated member 3 is also pulled out of the outlet hole 24 together with the guide member 5. Therefore, during the operation of pulling out the guide member 52 from the outlet hole 24 blocked by the guide portion 52 of the guide member 5, the movement of the perforated member 3 in the second direction D2 and the outlet operation of the connector 4 and the insertion member I are performed simultaneously. Therefore, the outlet of the insertion member I can be performed without complicated operations, improving workability.

[0093] In this embodiment, such as Figure 4 , Figure 11 as well as Figure 12 As shown, connector 4 has a widening portion 43, which is a portion whose radial width is widened when the perforating member 3 moves in the second direction D2 while connected to connector 4 connected to insertion member I on the other side Tb of the wall-like tissue T. Figure 11 and Figure 12 As shown, when the connector 4 moves in the second direction D2 through the through hole H1, the widening portion 43 enlarges the through hole H1 formed by the through member 3. Therefore, after the through hole H1 is formed by the through member 3, when the through member 3 moves in the second direction D2, the through hole H1 expands through the widening portion 43 of the connector 4, which also moves in the second direction D2. Thus, the insertion member I connected to the connector 4 on the first direction D1 side can pass through the through hole H2, which expands from the through hole H1 (see reference). Figure 13 Therefore, by utilizing the fine perforation member 3, perforation of the wall-shaped tissue T is facilitated, and by pulling the perforation member 3 out in the second direction D2, the perforation hole H1 is expanded by the connector 4, and the insertion member I is led out. Thus, the series of actions from perforation of the wall-shaped tissue T to the leading out of the insertion member I is very easy.

[0094] The shape of the widening portion 43 is not particularly limited, as long as it can widen the through hole H1 when the connector 4 moves in the second direction D2. In this embodiment, as... Figure 4 , Figure 11 as well as Figure 12As shown, the widening portion 43 has a tapered portion 43a, which is formed into a frustum-shaped cone as it widens from one end 4a of the connector 4 towards the other end 4b. The maximum outer diameter of the tapered portion 43a is configured to be equal to or larger than the outer diameter of the insertion member I. This allows for easier widening of the through hole H1 after the widening portion 43 of the connector 4 passes through, and the insertion hole H2 formed by the widened through hole H1 is equal to or larger than the outer diameter of the insertion member I. Thus, the insertion hole H2 is formed by the connector 4 leading forward to the insertion member I in the second direction D2. This allows the insertion member I to be pulled out from the wall-like tissue T without resistance. Furthermore, in this embodiment, the tapered portion 43a is formed by a smooth slope, but the tapered portion can also be configured to become a frustum-shaped cone by widening in a stepped manner.

[0095] Next, regarding the function and effect of the insertion component outlet device 1, refer to... Figures 9-13 The following description will be given more specifically as an example of the case where the insertion component (drive wire, hereinafter referred to as drive wire I) of the artificial heart is led out from inside the body to outside the body. Furthermore, the following description is merely an example, and the present invention is not limited to the following description.

[0096] First, an artificial assist heart (not shown) connected to drive line I is implanted into the patient's body. Next, in order to guide drive line I from inside the body to the outside, as... Figure 9 As shown, the insertion component export device 1 is positioned at a predetermined location on the wall-like tissue T, specifically at a predetermined location on the patient's abdomen. Furthermore, after exporting the drive line I, the insertion component export device 1 is ultimately replaced by a fixation device F.

[0097] The insertion and exit device 1 is positioned towards the abdomen by cutting the skin, which is part of the wall-like tissue T, allowing the flange portion 22 of the main body 2 to penetrate under the skin. The main body portion 21 and the flange portion 22 of the main body 2 have a fixing portion F1 and a communicating portion F2 with the fixing device F (see reference). Figure 1 The corresponding shape and size are determined through this setup process to ensure reliable installation of the fixing device F.

[0098] like Figure 9 As shown, with the main body 2 set in the wall-shaped tissue T, the guide portion 52 of the guide member 5 is inserted into the outlet hole 24 of the main body 2. The engaging portion E of the guide member 5, which is an external thread, engages with the engaged portion 24c of the main body 2, which is an internal thread. Therefore, the guide member 5 is fixed to the main body 2 while its movement in the X-axis direction is restricted. In addition, the perforated member 3 is inserted into the guide hole 51 of the guide member 5, and the front end portion 31 of the perforated member 3 does not protrude from the first opening 24a of the outlet hole 24 in the first direction D1.

[0099] If the main body 2-way wall-like tissue T is set up, then as Figure 10 As shown, a perforation hole H1 is formed in the wall-shaped tissue T by the perforating member 3. Specifically, with the holding part 23 of the main body 2 holding the main body 2 so that the main body 2 is not tilted, the perforating member 3 is pressed in the first direction D1. The perforating member 3 is guided by the guide hole 51 in a manner that moves on the same axis as the outlet hole 24, thus forming a perforation hole H1 extending on the same axis as the outlet hole 24 in the wall-shaped tissue T.

[0100] At this point, the surgeon's fingers hook onto the first direction D1 side of the protrusion 53 of the guide member 5, and the perforation member 3 is pressed into the first direction D1 by the other fingers of the same hand. Thus, the perforation member 3 can be pressed into the wall-like tissue T with a simple operation, similar to the operation of a syringe plunger. The perforation member 3 is thinner than the drive line I, allowing it to easily penetrate the skin and muscle layers.

[0101] Furthermore, if the perforating member 3 moves a predetermined amount in the first direction D1, the stop portion 33 of the perforating member 3 abuts against the contact portion 53a provided on the surface of the protruding portion 53 in the second direction D2, and the perforating member 3 stops. Therefore, it is possible to prevent the perforating member 3 from mistakenly perforating the wall-like tissue T too deeply. As a result, it is possible to prevent damage to other organs or tissues OR located in the body from the anterior end portion 31 of the perforating member 3.

[0102] When the perforated component 3 reaches the other side (in vivo) of the wall-like tissue T, such as Figure 11 As shown, the surgeon connects the perforated component 3 and the drive line I inside the patient's body via connector 4. Specifically, the first connecting portion 41 of connector 4, which is an internal thread, engages with the connecting portion C of perforated component 3, which is an external thread, thereby connecting perforated component 3 to connector 4. Furthermore, connector 4 and drive line I are connected by inserting a connecting portion Ia, which is a male plug at one end of drive line I, into a second connecting portion 42, which is a female plug at the other end 4b of connector 4. Thus, perforated component 3, connector 4, and drive line I are integrally connected in the X-axis direction.

[0103] If the perforated component 3 is connected to the drive line I via connector 4, then as Figure 12 As shown, the guide member 5 is removed from the main body 2. Specifically, by rotating the guide member 5 about axis X, the engagement between the engaging portion E of the guide member 5 and the engaged portion 24c of the main body 2 is released, allowing the guide portion 52 of the guide member 5 to be pulled out from the outlet hole 24. When the guide portion 52 of the guide member 5 is pulled out from the outlet hole 24, and the guide member 5 moves further in the second direction D2, the through-hole member 3, which is engaged in the X-axis direction at the location of the guide member 5 and the stop portion 33, also moves in the second direction D2. As a result, the connector 4 and the insertion member I also move in the second direction D2 through the through-hole member 3.

[0104] When connector 4 moves in the second direction D2, as Figure 12 As shown, the tapered portion 43a located on one end 4a of the connector 4 radially pushes open the through hole H1. When the connector 4 moves further in the second direction D2, the through hole H1 expands through the tapered portion 43a of the connector 4 to a size that allows the drive line I to pass through, forming a through hole H2 (see reference). Figure 13 When connector 4 and drive line I pass through the through hole H2, as follows: Figure 13 As shown, the drive line I is led out of the body through the outlet hole 24 of the main body 2.

[0105] When the drive line I is led out of the body, disconnect the connector 4 from the drive line I, and remove the main body 2 from the wall-shaped tissue T, as follows. Figure 14 As shown, the fixing device F is fixed to the location where the main body 2 is located. The connecting passage F21 of the fixing device F is inclined at the same angle as the outlet hole 24 of the main body 2, and the connecting passage F21 and the insertion hole H2 of the fixing device F extend on the same axis. Specifically, as Figure 13 As shown, the drive line I extends in a straight line along the connecting passage F21 and the insertion hole H2. Therefore, the fixation device F is prevented from floating or sinking from the wall-like tissue T due to the fact that the portion P1 passing through the insertion hole H2 and the portion P2 passing through the connecting passage F21 of the drive line I extend at different angles.

[0106] <Second Implementation>

[0107] The second embodiment differs from the first embodiment in that it omits the guide member 5, and the perforating member 5 is directly guided to the outlet hole 24 of the main body 2. Furthermore, except for the absence of the guide member 5, it can be essentially configured to be the same structure as the first embodiment, and descriptions of the identical structure are omitted. The matters described in the first embodiment can be applied to the second embodiment.

[0108] In this embodiment, such as Figure 17 As shown, the perforating member 3 is provided with a guide portion 34 that is guided by the outlet hole 24. The outlet hole 24 has an inner diameter corresponding to the outer diameter of the guide portion 34 (for example, 100-110% of the maximum outer diameter of the guide portion 34, preferably 100-105%, more preferably 100-103%). The guide portion 34 is positioned so as not to protrude in the first direction D1 relative to the first opening 24a of the outlet hole 24 when passing through the perforated wall-shaped tissue T of the perforating member 3. In this embodiment, the guide portion 34 of the perforating member 3 has the same function as the guide portion 52 of the guide member 5 in the first embodiment.

[0109] Furthermore, in this embodiment, the main body 2 has an abutting portion 26 that abuts against the stop portion 33 of the perforated member 3. The abutting portion 26 is formed by the periphery of the opening on the second direction D2 side of the guide hole 24. The abutting portion 26 of the main body 2 has the same function as the abutting portion 53a of the guide member 3 in the first embodiment. In addition, in the second embodiment, the main body 2 has a flange portion 27, and the abutting portion 26 is provided on the end face of the flange portion 27 on the second direction D2 side.

[0110] The structure other than that described above is basically the same as that of the first embodiment. The insertion component outlet device 1 of the second embodiment can achieve the same effect as the insertion component outlet device 1 of the first embodiment.

[0111] Label Explanation

[0112] 1. Insertion component delivery device

[0113] 2. Main Body

[0114] 21 Main body

[0115] 22 Flange portion

[0116] 23 Control Department

[0117] 24 Outlet Holes

[0118] 24a First opening

[0119] 24b Second opening

[0120] 24c is stuck in the joint.

[0121] 25 Main body side contact surface

[0122] 26 abutment

[0123] 27. Flange portion

[0124] 3. Perforated components

[0125] 31. Front end of the perforated component

[0126] 32. Perforated shaft section

[0127] 33 Stop section

[0128] 34 Guiding Department

[0129] 4 connectors

[0130] 4a One end

[0131] 4b The other end

[0132] 41 First connecting part

[0133] 41a cylindrical hollow part

[0134] 42 Second connecting part

[0135] 42a cylindrical hollow part

[0136] 43. Widening section

[0137] 43a Conical part

[0138] 5. Guiding components

[0139] 51 Guide Hole

[0140] 52 Guidance Department

[0141] 53. Protruding part

[0142] 53a Abutment Section

[0143] 54 Stop surface

[0144] 55 cylindrical part

[0145] C Connection part

[0146] D1 First Direction

[0147] D2 Second Direction

[0148] E. Engaging part of the guide component

[0149] F Fixing device

[0150] F1 Fixing Part

[0151] F2 Connecting Part

[0152] F21 Connecting Path

[0153] F3 Chuck Components

[0154] H1 perforation hole

[0155] H10 Ideal angle perforation hole

[0156] H2 Through Hole

[0157] H20 produced a perforated hole that was offset from the ideal angle.

[0158] I. Connecting component (drive line)

[0159] Ia Connector

[0160] Ib Insertion Component Main Body

[0161] Ic Cooling water circulation path

[0162] Id power cable

[0163] OR other organizations

[0164] The part of the P1 insertion component that passes through the insertion hole

[0165] P10 passing through the perforation hole

[0166] P2 passes through the outlet hole (or connecting passage)

[0167] P20 The part that passes through the connecting path

[0168] T-wall-like tissue

[0169] One side of the wall-like tissue.

[0170] The other side of Tb wall-like tissue

[0171] TD (Transverse Dimension) refers to the wall thickness direction of wall-like tissues.

[0172] X-shaped perforated component shaft

[0173] θ is the angle between the first direction and one side of the wall-like tissue.

Claims

1. A device for inserting a thread-like insertion component into the wall-like tissue of an organism, wherein, The insertion component outlet device includes: The main body can be disposed on one side of the wall thickness direction of the wall-like tissue; A perforating component, movable relative to the body, is used to form a perforation hole that perforates the wall-like tissue in a first direction from one side to the other. and A connector includes a first connecting portion and a second connecting portion. The first connecting portion can be connected to the through-hole component at one end, and the second connecting portion can be connected to the through-hole component at the other end. The connector is configured to connect the through-hole component and the through-hole component. The perforating component has a front end portion and a perforating shaft portion, the perforating shaft portion being adjacent to the front end portion along the length direction of the perforating component to form a portion for insertion into the wall-like tissue. The maximum radial dimension of the perforated shaft portion in the insertion component is smaller than the outer diameter of the insertion component. The body has an outlet hole with an internal space extending along the first direction. The perforated component is configured such that, inside the outlet hole, it is guided in the first direction and a second direction opposite to the first direction on an axis coaxial with the outlet hole. The outlet hole has a size such that when the perforating member is moved in the second direction while connected to the connector connected to the insertion member on the other side of the wall-like tissue, the connector and the insertion member can be inserted.

2. The insertion component delivery device according to claim 1, wherein, The insertion component outlet device further includes a guide component, which is at least partially insertable into the outlet hole and has a guide hole that guides the through component on an axis coaxial with the outlet hole. The guide member is configured to be pulled out from the outlet hole together with the perforated member.

3. The insertion component delivery device according to claim 2, wherein, The guiding member includes: a cylindrical guiding portion inserted into the outlet hole; and an extension portion disposed on the second direction side of the guiding portion, extending radially outward relative to the outer periphery of the guiding portion. The guide member has a locking portion that engages with the main body to prevent the guide portion of the guide member from disengaging from the outlet hole.

4. The insertion component delivery device according to any one of claims 1 to 3, wherein, The perforated component has a stop portion that limits the amount of the perforated component protruding from the body within a specified range.

5. The insertion component delivery device according to any one of claims 1 to 3, wherein, The connector has a widening portion for expanding the perforation hole formed by the perforation of the perforation member when the perforation member is connected to the connector connected to the insertion member on the other side of the wall-like tissue and the perforation member moves in the second direction, the portion whose radial width is widened.

6. The insertion component delivery device according to claim 4, wherein, The connector has a widening portion for expanding the perforation hole formed by the perforation of the perforation member when the perforation member is connected to the connector connected to the insertion member on the other side of the wall-like tissue and the perforation member moves in the second direction, the portion whose radial width is widened.

7. The insertion component delivery device according to claim 5, wherein, The widening portion has a tapered portion formed as a frustum-shaped cone that widens as it approaches the other end of the connector, the maximum outer diameter of which is equal to or greater than the outer diameter of the insertion component.

8. The insertion component delivery device according to claim 6, wherein, The widening portion has a tapered portion formed as a frustum-shaped cone that widens as it approaches the other end of the connector, the maximum outer diameter of which is equal to or greater than the outer diameter of the insertion component.

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