Operating device and implant placement device

Abstract

This operating device (14) and implant indwelling tool (10) comprise an outer cylinder (28) in which a lumen (28b) that penetrates the interior in the axial direction is formed, a shaft (62) disposed in the lumen (28b), and a gripping mechanism (22) that is provided to the outer cylinder (28) and the shaft (62) and that grips a filamentous implant (110) so as to be capable of switching between a fixed state in which detachment is impossible and a release state in which detachment is possible. The gripping mechanism (22) has a first insertion hole (34) that radially penetrates a side portion of the outer cylinder (28), a second insertion hole (66) that is provided in the shaft (62) at a portion corresponding to the first insertion hole (34) and that radially penetrates a side portion of the shaft (62), and a turning mechanism (77) for rotating the shaft (62) relative to the outer cylinder (28).

Description

[Technical Field]

[0001] The present invention relates to an operating device and an implant placement tool for placing an implant in the body. [Background technology]

[0002] Various treatment methods have been proposed for placing implants in biological tissue. For example, Japanese Patent Application Laid-Open No. 2020-127607 describes a device that promotes the regeneration of damaged tissue by implanting porous collagen fibers with countless pores inside into the damaged area. Summary of the Invention

[0003] To reliably place a filamentous implant in biological tissue, it is desirable to reliably hold and release one end of the implant. Therefore, a suturing device for introducing suture thread, such as that shown in U.S. Patent No. 9,301,748, can be used. This device has a structure in which tweezers-like gripping members are opened and closed with a wire.

[0004] However, the device described in U.S. Pat. No. 9,301,748 requires the tip to be widely spread radially when the gripping members are released, and may not function reliably inside biological tissue that is under pressure.

[0005] Therefore, an object of one embodiment is to provide an operating device and an implant placement tool that can reliably place an implant in the body.

[0006] One aspect of the following disclosure is an operating device comprising: an outer tube having an inner cavity formed therein that penetrates in the axial direction; a shaft disposed in the inner cavity; and a gripping mechanism provided on the outer tube and the shaft that grips a filamentous implant in a switchable manner between a non-detachable fixed state and a detachable released state, wherein the gripping mechanism has: a first insertion hole that penetrates radially through a side of the outer tube; a second insertion hole that is provided in the shaft at a portion corresponding to the first insertion hole and that penetrates radially through a side of the shaft; and a rotation mechanism that rotates the shaft relative to the outer tube, and grips the implant by inserting it into the first insertion hole and the second insertion hole.

[0007] Another aspect is an implant retention device comprising the operating device of the above aspect and a puncture needle having an outer needle that can insert the outer tube of the operating device while holding the implant.

[0008] According to the operating device and implant placement tool of the above aspect, the implant can be placed reliably in the body. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of an implant retention device according to an embodiment in a separated state. [Figure 2] FIG. 2 is a perspective view showing components of the operating device of FIG. 1. [Figure 3] 3A is an enlarged perspective view of the tip portion of the outer cylinder shown in FIG. 2, and FIG. 3B is a side view of the tip portion of FIG. 3A. [Figure 4] 4A is a perspective view of the outer cylindrical hub of FIG. 2, and FIG. 4B is a cross-sectional view of the outer cylindrical hub taken along line IVB-IVB of FIG. 4A. [Figure 5] 5A is an enlarged perspective view of the tip portion of the shaft of FIG. 2, and FIG. 5B is a side view of the tip portion of FIG. 5A. [Figure 6] FIG. 3 is a perspective view of the shaft hub of FIG. 2. [Figure 7] FIG. 10 is an enlarged cross-sectional view of the vicinity of the operating portion of the shaft hub in the released state. [Figure 8]FIG. 3 is an exploded perspective view showing a rotation mechanism of the shaft hub of FIG. 2. [Figure 9] 9A is a cross-sectional view showing a state in which the operating portion of the shaft hub is pulled out from the rotating shaft portion, and FIG. 9B is a cross-sectional view showing a state in which the operating portion of the shaft hub is pushed into the rotating shaft portion. [Figure 10] 2 is a perspective cross-sectional view of an outer cylinder hub and a shaft hub of the operating device of FIG. 1. [Figure 11] 2 is a cutaway perspective view showing the internal structure of the outer cylindrical hub of FIG. 1. FIG. [Figure 12] 2 is a cross-sectional view showing an upper portion of the outer cylindrical hub of FIG. 1 cut away. [Figure 13] FIG. 2 is a perspective view showing components that constitute the puncture needle of FIG. [Figure 14] 14A is a perspective view of the outer cylinder and the shaft in the released state, and FIG. 14B is a cross-sectional view showing the operation of the shaft hub when the released state of FIG. 14A is achieved. [Figure 15] 15A is a perspective view of the outer cylinder and the shaft in a fixed state, and FIG. 15B is a cross-sectional view showing the operation of the shaft hub when the fixed state of FIG. 15A is achieved. [Figure 16] FIG. 10 is an explanatory diagram showing a state in which a puncture needle has punctured the skin of a living body. [Figure 17] FIG. 10 is an explanatory view showing the operation after the inner needle assembly has been pulled out from the puncture needle. [Figure 18] FIG. 10 is an explanatory view showing the operation of inserting the operating device into the outer needle assembly. [Figure 19] 19A is a top view showing the operation of pressing the outer cylindrical hub of the operation device against the skin, and FIG. 19B is a side view of FIG. 19A. [Figure 20] FIG. 20A is a top view showing the positional relationship between the locking projection and the outer needle hub, and FIG. 20B is a side view of FIG. 20A. [Figure 21] FIG. 21A is a top view showing the positional relationship between the lock protrusion and the outer needle hub when the tip of the operating device is protruded from the outer needle, and FIG. 21B is a side view of FIG. 21A. [Figure 22]FIG. 22A is a cross-sectional view showing an operation for releasing the operating device, and FIG. 22B is a perspective view showing the released state of the outer cylinder and shaft of the operating device. [Figure 23] 10 is an explanatory diagram showing the operation of withdrawing the outer needle assembly and the operating device from the skin, leaving the implanted body behind. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0010] Preferred embodiments of the operating device and implant placement device will be described in detail below with reference to the accompanying drawings. In the following description, the side closest to the user when handling the device will be referred to as the "proximal end" and the side of the needle tip away from the user will be referred to as the "distal end."

[0011] As shown in Fig. 1, the implant retention device 10 according to this embodiment includes a puncture needle 12 and an operating device 14. The puncture needle 12 has an outer needle 16 and an inner needle 18, and the inner needle 18 has a sharp tip 18a. The puncture needle 12 is used by inserting the outer needle 16 and the inner needle 18 through the skin 112 (see Fig. 16) into a target site inside biological tissue 116. After the puncture needle 12 has inserted into the target site, the operating device 14 is inserted into the outer needle 16. The operating device 14 includes a gripping mechanism 22 that holds a fibrous implant 110 (see Fig. 17, etc.) at the tip 14a. The operating device 14 is inserted into the outer needle 16 of the puncture needle 12 with the implant 110 (see Fig. 14A) held at the tip 14a, and delivers the implant 110 to the target site.

[0012] 2, the operating device 14 includes an outer cylinder assembly 24 and a shaft assembly 26. The operating device 14 is assembled by placing the shaft assembly 26 inside the outer cylinder assembly 24.

[0013] The outer cylinder assembly 24 comprises a long outer cylinder 28 and an outer cylinder hub 30 joined to the base end side of the outer cylinder 28. The outer cylinder 28 is a cylindrical member made of a metal such as stainless steel or a hard resin, and has an inner cavity 28b formed therein so as to pass through in the axial direction. The diameter of the outer cylinder 28 is formed to have an outer diameter dimension that allows it to be inserted into the outer needle 16 of the puncture needle 12 shown in FIG. 1. The inner cavity 28b of the outer cylinder 28 opens to the base end side and communicates with the hollow portion 30a of the outer cylinder hub 30.

[0014] 3A, an end face 32 that is approximately perpendicular to the axial direction of the outer tube 28 is formed at the tip end 28a of the outer tube 28. A pair of first insertion holes 34 that constitute part of the gripping mechanism 22 are formed on the outer periphery closer to the base end than the end face 32. The first insertion holes 34 are positioned opposite each other across the central axis of the outer tube 28. The first insertion holes 34 hold the implant 110 so that it penetrates the outer tube 28 in the radial direction.

[0015] The first insertion hole 34 has a circumferential dimension A that is larger than the diameter of the embedding body 110. The first insertion hole 34 also extends long in the axial direction, and the axial dimension B is larger than the circumferential dimension A. The first insertion hole 34 is formed in a groove shape that opens at the end face 32. The first insertion hole 34 does not have to open at the end face 32, but opening at the end face 32 is preferable because it makes it easier to position the thin embedding body 110.

[0016] As shown in FIG. 4A, the outer tube hub 30 is joined to the base end of the outer tube 28. The outer tube hub 30 is formed of a hard resin material such as polycarbonate resin. A connecting portion 38 that holds the outer tube 28 is provided on the tip side of the outer tube hub 30. The connecting portion 38 is formed in a shape that tapers toward the tip side, and its interior is joined in close contact with the outer periphery of the outer tube 28. A rectangular tube portion 40 with a rectangular cross section is formed on the base end side of the connecting portion 38.

[0017] The rectangular tube portion 40 is a cylindrical portion whose cross section perpendicular to the axial direction is rectangular, and is elongated in the axial direction and thin in the vertical direction. The rectangular tube portion 40 has a flat top surface 40a at its upper end, side surfaces 40b and 40c on both sides, and a flat bottom surface 40d at its lower end. Near the base end of the top surface 40a, first graduations 42a and second graduations 42b are formed as grooves extending in the width direction. Locking protrusions 44 are formed on the side surfaces 40b and 40c.

[0018] As shown in FIG. 4B , a first hollow portion 46 is formed inside the rectangular tube portion 40. The first hollow portion 46 is formed to extend in the axial direction of the rectangular tube portion 40. A thick-walled portion 38a of the connecting portion 38 is formed on the tip side of the first hollow portion 46. An axial hole 38b is formed inside the thick-walled portion 38a and penetrates in the axial direction. The outer tube 28 is inserted into and joined to the tip of the axial hole 38b, and the tip of the axial hole 38b communicates with the inner cavity 28b of the outer tube 28. A tip wall 46b is formed as a wall portion at the tip of the first hollow portion 46 (the base end of the thick-walled portion 38a). The axial hole 38b opens at the tip wall 46b and communicates with the first hollow portion 46. A rotating shaft portion 68 (described below) of the shaft assembly 26 is rotatably housed in the axial hole 38b and the first hollow portion 46.

[0019] 4A, a joint portion 50a for attaching a molded body 50b is formed at the base end of the rectangular tube portion 40. The joint portion 50a is formed like a wall rising upward from the base end of the rectangular tube portion 40. The joint portion 50a constitutes a part of the tip side of the grip portion 50.

[0020] The gripping portion 50 is provided on the base end side of the rectangular tube portion 40. As shown in Fig. 4B, the gripping portion 50 is composed of a joint portion 50a and a molded body 50b connected to the base end side of the joint portion 50a. The molded body 50b is made of the same resin material as the rectangular tube portion 40, and is joined to the base end side of the joint portion 50a by a method such as adhesive bonding, welding, or crimping.

[0021] 4A, gripping portion 50 includes a main body portion 53, a pair of support plates 54, a pair of gripping rings 56, and a storage portion 61. Main body portion 53 is a tubular member formed in a box shape, and is formed to have a larger vertical dimension than square tube portion 40.

[0022] As shown in FIG. 4B, a second hollow portion 58 and a base end wall 58a are formed inside the main body portion 53. The tip side of the second hollow portion 58 communicates with the first hollow portion 46 of the rectangular tube portion 40. The base end wall 58a is provided on the base end side of the second hollow portion 58. The base end wall 58a is provided on the base end side of the second hollow portion 58 and separates the base end side of the second hollow portion 58. An axial hole 58b through which the pivot shaft portion 68 (see FIG. 2) is inserted is formed in the base end wall 58a.

[0023] As shown in FIG. 4A, the accommodation portion 61 is formed on the base end side of the main body portion 53. The accommodation portion 61 is a cylindrical portion formed in an oval (non-circular) shape that is long in the vertical direction. As shown in FIG. 4B, an accommodation hole 61a is formed inside the accommodation portion 61. The accommodation hole 61a extends in the axial direction and opens on the base end side. The accommodation hole 61a accommodates an operating portion 70 (described below) of the shaft assembly 26 so that it can slide in the axial direction. An engagement hole 59 is formed at the upper end of the accommodation portion 61. The engagement hole 59 passes through the upper end wall of the accommodation portion 61 and communicates with the accommodation hole 61a.

[0024] 4A, the support plate 54 is a plate-like member extending in the width direction from the lower end of the main body portion 53. The support plate 54 is formed in a trapezoidal shape in a plan view, and a pair of support plates 54 is provided on one side portion 52a and the other side portion 52b of the main body portion 53. The support plate 54 is formed in a flat plate shape parallel to the bottom surface 40d of the rectangular tube portion 40.

[0025] The grip ring 56 is a cylindrical member extending widthwise from near the upper end of the main body 53. A pair of grip rings 56 are provided on one side 52a and the other side 52b of the main body 53. The grip ring 56 is trapezoidal in plan view, and has a finger hole 60 formed therein that penetrates in the vertical direction. The shape of the outer periphery of the grip ring 56 in top view is the same as the shape of the support plate 54.

[0026] The finger holes 60 of the grip ring 56 are formed in a trapezoidal shape with an axial dimension that narrows as it extends outward in the width direction. By adjusting the widthwise position at which the user inserts their finger into the finger holes 60 according to the thickness of their finger, the user can position their finger on the grip ring 56 without creating any play in the axial direction, allowing for accurate operation.

[0027] Next, the shaft assembly 26 will be described. As shown in Fig. 2, the shaft assembly 26 has a shaft 62 and a shaft hub 64 joined to the base end of the shaft 62. Of these, the shaft 62 is formed in a cylindrical shape with an outer diameter that allows it to be inserted into the inner cavity 28b of the outer cylinder 28. The shaft 62 is made of a metal such as stainless steel. Note that the shape of the shaft 62 is not limited to a cylindrical shape, and it may also be a hollow cylindrical shape.

[0028] As shown in FIGS. 5A and 5B, a second insertion hole 66 is formed in the tip end 62a of the shaft 62. The second insertion hole 66 is formed so as to penetrate the side of the shaft 62 in the radial direction. The second insertion hole 66 extends long in the axial direction, opens at the tip end of the shaft 62, and is formed as a U-shaped notched groove in side view. The second insertion hole 66 is formed in a portion of the shaft 62 that is inside (corresponding portion of) the first insertion hole 34. The width (circumferential dimension C) of the second insertion hole 66 is larger than the diameter of the embedding body 110. Furthermore, the length (axial dimension D) of the second insertion hole 66 is formed so as to be larger than the width.

[0029] As shown in FIG. 6 , a shaft hub 64 is provided at the base end of the shaft 62. The shaft hub 64 is joined to the shaft 62 and includes a cylindrical rotating shaft 68 that is elongated in the axial direction, and an operating unit 70 provided on the base end side of the rotating shaft 68. The rotating shaft 68 is a member made of a resin material such as polycarbonate resin, and is joined to the base end of the shaft 62. The rotating shaft 68 is joined so as to rotate integrally with the shaft 62. A first blade 72 and a second blade 74 are formed on the outer periphery of the rotating shaft 68 and protrude radially outward.

[0030] The first blade portion 72 is a protrusion provided near the base end of the rotating shaft portion 68. The first blade portion 72 is composed of a pair of blade-shaped protrusions 72a that face each other across the center of the rotating shaft portion 68. The second blade portion 74 is a protrusion provided near the tip end of the rotating shaft portion 68, and is composed of a pair of blade-shaped protrusions 74a that are positioned opposite each other.

[0031] As shown in Fig. 8, a sliding portion 76 that protrudes radially outward is provided at the base end of the rotating shaft portion 68. The sliding portion 76 is formed with a constant protruding height around the entire circumference of the rotating shaft portion 68. As shown in Fig. 7, an outer peripheral surface 76a of the sliding portion 76 abuts and slides against a rotating shaft portion accommodating hole 78 of the operating unit 70, which will be described later. As shown in Fig. 8, a screw groove 76b is formed by cutting out the sliding portion 76 in part of the circumferential direction of the sliding portion 76. The screw groove 76b is formed at a slight incline with respect to the axial direction. A pair of screw grooves 76b is provided at opposing positions in the circumferential direction of the rotating shaft portion 68.

[0032] As shown in Figure 6, the operating unit 70 has a shaft accommodating portion 80 with a rotating shaft accommodating hole 78 formed therein. The shaft accommodating portion 80 is formed in a cylindrical shape that is coaxial with the central axis of the rotating shaft accommodating hole 78. A connecting portion 82 is formed at the top of the shaft accommodating portion 80 and is integrally connected to the shaft accommodating portion 80. The upper end of the connecting portion 82 is formed in a cylindrical shape. In the operating unit 70, the shaft accommodating portion 80 and the connecting portion 82 slide along the accommodating hole 61a of the outer cylindrical hub 30 (see Figure 4B).

[0033] As shown in FIG. 8 , a distal end scale mark 85a, a proximal end scale mark 85b, and an engagement protrusion 88 are formed on the upper end of the connecting portion 82. The distal end scale mark 85a and the proximal end scale mark 85b are groove-like structures extending in the width direction and spaced apart in the axial direction. The distal end scale mark 85a indicates that the gripping mechanism 22 is in the released state and is located at a position that coincides with the proximal end of the main body 53 when the operating unit 70 is pulled out to the proximal end. The engagement protrusion 88 is located between the distal end scale mark 85a and the proximal end scale mark 85b. The engagement protrusion 88 is located at a position that engages with the engagement hole 59 when the operating unit 70 is pushed in, thereby maintaining the gripping mechanism 22 in the released state. The proximal end scale mark 85b is located at a position that coincides with the proximal end of the storage portion 61 when the engagement protrusion 88 is engaged with the engagement hole 59.

[0034] An operation ring 84 is formed at the base end of the connecting portion 82. The operation ring 84 is formed in an oval shape in a plan view. A finger hole 86 is formed to penetrate the operation ring 84 in the vertical direction. The finger hole 86 is a portion where the user mainly places their thumb, and is formed with a larger diameter than the finger hole 60 of the outer cylindrical hub 30. Because the finger hole 86 is formed in an oval shape, the user can adjust their finger in the width direction according to their finger size, allowing them to place their finger without any gaps in the axial direction.

[0035] As shown in Fig. 7, the rotating shaft accommodating hole 78 inside the shaft accommodating portion 80 is formed to extend in the axial direction. The rotating shaft accommodating hole 78 accommodates the sliding portion 76 at the base end of the rotating shaft 68 so that it can slide in the axial direction. As shown in Figs. 7 and 8, a pair of screw threads 78b are provided on the inner circumferential surface 78a of the rotating shaft accommodating hole 78 and protrude inward. The screw threads 78b are provided at a position that engages with the screw groove 76b, and extend while rotating in the axial direction.

[0036] As shown in FIGS. 9A and 9B, when the screw thread 78b engages with the screw groove 76b and slides in the axial direction, a rotational displacement is generated in the rotation shaft 68. That is, the rotation mechanism 77 of this embodiment is configured by a screw structure having the screw thread 78b and the screw groove 76b. As shown in FIG. 9A, when the user pulls the operating unit 70 out of the rotation shaft 68, a counterclockwise rotational movement is generated as viewed from the base end side (user side). Also, as shown in FIG. 9B, when the user pushes the operating unit 70 toward the rotation shaft 68, a clockwise rotational movement is generated as viewed from the base end side. The rotation direction is not limited to the above example and may be reversed.

[0037] As shown in FIG. 10 , the shaft hub 64 is mounted inside the outer cylindrical hub 30. The rotating shaft portion 68 of the shaft hub 64 passes through the shaft hole 58b in FIG. 4B and is accommodated in the shaft hole 38b, the first cavity 46, and the second cavity 58 of the outer cylindrical hub 30. The operating portion 70 of the shaft hub 64 is accommodated in the accommodation portion 61 of the grip portion 50 of the outer cylindrical hub 30 so as to be slidable in the axial direction. Because the operating portion 70 and the accommodation hole 61a of the accommodation portion 61 are formed in a non-circular shape, the operating portion 70 is displaced in the axial direction without rotating. Meanwhile, the rotating shaft portion 68 is accommodated in the outer cylindrical hub 30 so as to be rotatable.

[0038] As shown in FIG. 11 , a pair of rotation restricting protrusions 92 serving as a rotation restricting portion 90 is formed on the base end wall 58a of the outer cylindrical hub 30. The pair of rotation restricting protrusions 92 are spaced a predetermined angle apart in the circumferential direction of the pivot shaft 68, and the first wing portion 72 is disposed between the pair of rotation restricting protrusions 92. The rotation restricting protrusions 92 abut against the first wing portions 72, thereby restricting the rotation angle range of the pivot shaft 68 to a range between a released state and a locked state. The rotation restricting portion 90 includes the first wing portions 72 and the rotation restricting protrusions 92. The first wing portions 72 abut against the base end wall 58a, thereby preventing the pivot shaft 68 from moving toward the base end.

[0039] 12, the second blade portion 74 abuts against the tip wall 46b of the outer cylindrical hub 30 from the base end side, preventing the rotation shaft portion 68 from moving toward the tip side. In other words, the tip wall 46b, the base end wall 58a, the first blade portion 72, and the second blade portion 74 prevent the rotation shaft portion 68 from displacing in the axial direction relative to the outer cylindrical hub 30.

[0040] Next, the puncture needle 12 of the implant indwelling device 10 will be described. As shown in FIG. 13, the puncture needle 12 comprises an outer needle assembly 94 and an inner needle assembly 96. The inner needle assembly 96 is detachably attached to the outer needle assembly 94 from the proximal end side of the outer needle assembly 94. The outer needle assembly 94 comprises a cylindrical outer needle 16 having a blunt tip 16a, and an outer needle hub 100 provided at the proximal end of the outer needle 16. An axially extending lumen 16b is formed through the interior of the outer needle 16. A hollow portion 100a is formed in the outer needle hub 100. The hollow portion 100a opens at a guide groove 100b at the upper end. In addition, engagement holes 100c are formed on both sides of the proximal end side of the outer needle hub 100.

[0041] The inner needle assembly 96 comprises an inner needle 18 having a sharp tip 18a, and an inner needle hub 104 provided on the proximal end side of the inner needle 18. The inner needle 18 is arranged axially slidably within the lumen 16b of the outer needle 16. When the inner needle hub 104 is pushed forward in the axial direction, the sharp tip 18a of the inner needle 18 protrudes from the tip 16a of the outer needle 16. The inner needle assembly 96 can be pulled out from the proximal end side of the outer needle assembly 94. The puncture needle 12 is used by puncturing the skin 112 of a patient (living body) to a target site in living tissue, with the inner needle assembly 96 attached to the outer needle assembly 94.

[0042] The implant retainer 10 and operating device 14 of this embodiment are configured as described above, and their operation will be described below together with the method of use.

[0043] First, the operation of attaching the implant 110 to the operating device 14 will be described. The user grasps the operating device 14 by inserting their index and middle fingers into the finger holes 60 of the outer tube hub 30 of the operating device 14 shown in FIG. 1 and their thumb into the finger hole 86 of the shaft hub 64. In the initial state of the operating device 14, as shown in FIG. 14B, the operating portion 70 of the shaft hub 64 is pulled out toward the base end, and the engagement protrusion 88 is located toward the base end of the outer tube hub 30. At this time, the tip graduation mark 85a overlaps with the base end of the housing portion 61 of the outer tube hub 30. In this state, as shown in FIG. 14A, the second insertion hole 66 of the shaft 62 and the first insertion hole 34 of the outer tube 28 are aligned in the circumferential direction, resulting in a released state. The user can visually confirm the released state from the position of the tip graduation mark 85a shown in FIG. 8.

[0044] Next, as shown in FIG. 14A, the user grasps the thread-like implant 110 with tweezers or the like, and places the implant 110 so that it passes through the first insertion hole 34 and the second insertion hole 66.

[0045] Next, as shown in Figure 15B, the user pushes the operating unit 70 toward the outer tube hub 30. This operation causes the engagement protrusion 88 of the operating unit 70 to engage with and stop in the engagement hole 59 of the outer tube hub 30. When the operating unit 70 is displaced toward the tip side, the sliding portion 76 of the turning shaft 68 slides in the axial direction inside the turning shaft accommodating hole 78. Then, the screw groove 76b and the screw thread 78b that constitute the turning mechanism 77 shown in Figure 7 convert the axial displacement of the operating unit 70 into rotational displacement of the turning shaft 68 (see Figure 7), causing the turning shaft 68 to turn.

[0046] As the pivot shaft 68 rotates, as shown in FIG. 15A, the first insertion hole 34 and the second insertion hole 66 are shifted in the circumferential direction, and the implant 110 is sandwiched and fixed between the shaft 62 and the outer tube 28, making the implant 110 in a fixed state where it cannot be removed. As shown in FIG. 15B, the operating device 14 is maintained in a fixed state by the engagement of the engagement protrusion 88 of the operating part 70 with the engagement hole 59 of the outer tube hub 30. In this state, the base end graduation line 85b and the base end of the accommodation part 61 are aligned. With the above operations, the attachment of the implant 110 to the operating device 14 is completed.

[0047] 16, the user inserts the puncture needle 12 into the target site of the patient (living body). After inserting the puncture needle 12, the user pulls out the inner needle assembly 96 from the outer needle assembly 94, leaving the outer needle assembly 94 of the puncture needle 12 in place.

[0048] Next, as shown in FIGS. 17 and 18 , the user inserts the operating device 14 holding the implant 110 from the proximal end of the outer needle hub 100 of the outer needle assembly 94. The user then inserts the outer tube 28 of the operating device 14 into the lumen 16b of the outer needle 16 of the outer needle assembly 94 and moves the implant 110 into the living body through the lumen 16b. Because the implant 110 is protected by the outer needle 16, it is not subjected to resistance as it advances through the living body. This allows the implant 110 to be delivered without breaking, even if the target site is deep within the living tissue 116. As shown in FIGS. 19A and 19B , when the sheath hub 30 of the operating device 14 is advanced, the locking protrusion 44 abuts against the proximal end of the outer needle hub 100, stopping the operating device 14. In this state, the gripping mechanism 22 of the operating device 14 is housed inside the outer needle 16. As shown in FIGS. 20A and 20B, the first scale line 42a of the outer cylinder hub 30 overlaps with the base end of the outer needle hub 100, allowing the user to visually recognize the position of the tip 14a of the operating device 14.

[0049] Next, the user performs an operation to project the gripping mechanism 22 of the operating device 14 beyond the tip 16a of the outer needle 16. Here, in order to prevent the implant 110 from shifting from its placement position and to prevent a frictional load from acting on the implant 110, the operating device 14 is fixed to the biological tissue 116 and the outer needle assembly 94 is moved toward the proximal end. That is, as shown in Figures 19A and 19B, in order to fix the operating device 14 to the biological tissue 116, the user presses the gripping portion 50 of the outer cylinder hub 30 with their fingers toward the skin 112. This brings the support plate 54 of the gripping portion 50 into surface contact with the skin 112, and the gripping portion 50 is reliably fixed in a stable state.

[0050] The user then grasps the outer needle hub 100 and slides it toward the base end toward the outer cylinder hub 30. This causes the locking projection 44 to engage with the engagement hole 100c of the outer needle hub 100, as shown in Figures 21A and 21B. The locking projection 44 fixes the gripping mechanism 22 of the operating device 14 in a state in which it protrudes from the tip 16a of the outer needle 16. In this state, as shown in Figure 21A, the second graduation line 42b coincides with the base end of the outer needle hub 100, and the user can therefore visually confirm the protrusion of the gripping mechanism 22 at the position of the second graduation line 42b.

[0051] Next, the user performs an operation to pull out the operation unit 70 toward the base end, as shown in Fig. 22A, in order to switch the fixed state of the gripping mechanism 22 of the operating device 14 to a released state. When the operation unit 70 is pulled out toward the base end, the shaft 62 rotates together with the rotating shaft portion 68, and as shown in Fig. 22B, the circumferential positions of the first insertion hole 34 of the outer cylinder 28 and the second insertion hole 66 of the shaft 62 coincide with each other. This causes the gripping mechanism 22 of the operating device 14 to enter a released state in which the implant 110 can be removed.

[0052] The gripping mechanism 22 of the operating device 14 of this embodiment can switch between the fixed state and the released state simply by rotating the shaft 62 inside the outer tube 28 without the shaft 62 protruding outward from the outer tube 28. Therefore, the gripping mechanism 22 of this embodiment is less likely to be hindered in its release operation even when pressure is applied within the biological tissue 116, and the implant 110 can be reliably released even deep within the biological tissue 116.

[0053] 23, the user pulls out the operating device 14 together with the outer needle assembly 94 from the skin 112 of the living body. The implant 110 is separated from the gripping mechanism 22 due to friction with the living tissue 116 and is left in the living tissue 116.

[0054] The operating device 14 and implant placement device 10 of this embodiment have the following advantages.

[0055] The operating device 14 of this embodiment comprises an outer tube 28 having an inner cavity 28b formed therein that penetrates axially, a shaft 62 arranged in the inner cavity 28b, and a gripping mechanism 22 provided on the outer tube 28 and the shaft 62 that grips a thread-like implant 110 in a switchable manner between a non-detachable fixed state and a detachable released state, the gripping mechanism 22 having a first insertion hole 34 that penetrates radially through the side of the outer tube 28, a second insertion hole 66 that is provided in the shaft 62 at a portion corresponding to the first insertion hole 34 and that penetrates radially through the side of the shaft 62, and a rotation mechanism 77 that rotates the shaft 62 relative to the outer tube 28, and grips the implant 110 by inserting it through the first insertion hole 34 and the second insertion hole 66.

[0056] According to the above-described operating device 14, the shaft 62 does not protrude outward from the outer tube 28, and the implant 110 can be released simply by rotating inside the outer tube 28. Therefore, the implant 110 can be reliably released even inside the biological tissue 116 where pressure is applied, and the implant 110 can be reliably placed inside the biological tissue 116.

[0057] In the above-described operating device 14, the first insertion hole 34 and the second insertion hole 66 may be formed in a groove shape that opens at the tip. With this configuration, the implant 110 can be placed in the first insertion hole 34 and the second insertion hole 66 by sliding the side portion of the implant 110 from the tip side toward the base end side. There is no need to pass the tip of the soft implant 110 through the first insertion hole 34 and the second insertion hole 66, making it easier to attach the implant 110.

[0058] In the above-described operating device 14, the circumferential dimensions of the first insertion hole 34 and the second insertion hole 66 may be larger than the diameter of the embedding body 110, and the axial dimensions of the first insertion hole 34 and the second insertion hole 66 may be larger than the circumferential dimensions. With this configuration, the embedding body 110 can be easily attached to the first insertion hole 34 and the second insertion hole 66. Furthermore, because the first insertion hole 34 and the second insertion hole 66 extend long in the axial direction, slight misalignment of the axial positions of the outer tube 28 and the shaft 62 does not impede operation.

[0059] In the above-described operating device 14, in the fixed state, the first insertion hole 34 and the second insertion hole 66 are misaligned in the circumferential direction, and the implant 110 is sandwiched between the shaft 62 and the outer cylinder 28. With this configuration, the implant 110 can be reliably fixed in the gripping mechanism 22.

[0060] In the above-described operating device 14, in the released state, the circumferential positions of the first insertion hole 34 and the second insertion hole 66 are aligned. With this configuration, the implant 110 can be released without the outer tube 28 protruding outward, so that the release operation can be performed reliably even inside the biological tissue 116.

[0061] The above-mentioned operating device 14 further includes an outer tube hub 30 joined to the base end of the outer tube 28, and a shaft hub 64 that supports the base end of the shaft 62 and is attached so as to be axially movable relative to the outer tube hub 30, and the shaft hub 64 includes a rotating shaft portion 68 joined to the base end of the shaft 62 and rotates integrally with the shaft 62, and an operating unit 70 having a rotating shaft portion accommodating hole 78 that accommodates the rotating shaft portion 68 so as to be slidable in the axial direction, and the rotating mechanism 77 is formed by the inner wall of the rotating shaft portion accommodating hole 78 and the outer periphery of the rotating shaft portion 68, and may include a screw mechanism that converts axial displacement of the operating unit 70 into rotational displacement of the rotating shaft portion 68.

[0062] According to the above configuration, by operating the shaft hub 64, a rotational displacement can be produced in the shaft 62, providing excellent operability.

[0063] The above-described operating device 14 may further include a rotation restricting unit 90 that restricts the rotation range of the rotating shaft unit 68. With this configuration, the rotation range of the rotating shaft unit 68 can be set within the range between the released state and the fixed state, and reliable operation is possible even when the gripping mechanism 22 is inserted inside a living body and cannot be seen.

[0064] In the above-described operating device 14, the rotation restricting portion 90 may have a rotation restricting protrusion 92 provided on the outer cylindrical hub 30 and a first blade portion 72 protruding outward from the rotating shaft portion 68. With this configuration, rotation can be restricted with a simple device configuration.

[0065] In the above-described operating device 14, the rotating shaft portion 68 has a second blade portion 74 protruding outward, and the outer tube hub 30 may have a wall portion (tip wall 46b) that abuts against the second blade portion 74 in the axial direction to prevent axial displacement of the rotating shaft portion 68 relative to the outer tube hub 30.

[0066] The implant retention device 10 of this embodiment includes the above-mentioned operating device 14 and a puncture needle 12 having an outer needle 16 into which the outer cylinder 28 of the operating device 14 can be inserted while grasping the implant 110. With this implant retention device 10, the implant 110 can be reliably placed inside the biological tissue 116.

[0067] Although the present invention has been described above by citing preferred embodiments, it goes without saying that the present invention is not limited to the above embodiments, and various modifications are possible within the scope of the present invention.

Claims

1. an outer cylinder having an inner cavity formed therein and passing through in the axial direction; a shaft disposed in the lumen; a gripping mechanism provided on the outer tube and the shaft, which grips the filamentous implant in a switchable manner between a fixed state that cannot be removed and a released state that can be removed; The gripping mechanism includes: a first insertion hole that penetrates a side portion of the outer cylinder in a radial direction; a second insertion hole provided in the shaft at a portion corresponding to the first insertion hole and penetrating a side portion of the shaft in the radial direction; a rotation mechanism that rotates the shaft relative to the outer cylinder; an outer cylinder hub joined to a base end of the outer cylinder; a shaft hub that supports a base end of the shaft and is attached so as to be axially movable relative to the outer cylinder hub, The shaft hub a rotation shaft portion joined to a base end portion of the shaft and rotating integrally with the shaft; an operating unit having a rotation shaft portion accommodating hole that accommodates the rotation shaft portion so as to be slidable in the axial direction, the rotation mechanism includes a screw mechanism formed by an inner wall of the rotation shaft accommodating hole and an outer periphery of the rotation shaft, and converts axial displacement of the operation unit into rotational displacement of the rotation shaft; An operating device that holds the implant by inserting it through the first insertion hole and the second insertion hole.

2. The operating device according to claim 1 , wherein the first insertion hole and the second insertion hole are formed in a groove shape and open at a tip end.

3. 3. An operating device as described in claim 1 or 2, wherein the circumferential dimensions of the first insertion hole and the second insertion hole are larger than the diameter of the embedded body, and the axial dimensions of the first insertion hole and the second insertion hole are larger than the circumferential dimensions.

4. An operating device as described in any one of claims 1 to 3, wherein in the fixed state, the circumferential positions of the first insertion hole and the second insertion hole are misaligned, and the embedded body is sandwiched between the shaft and the outer tube.

5. 5. The operating device according to claim 1, wherein in the released state, the first insertion hole and the second insertion hole are aligned in a circumferential direction.

6. 6. The operating device according to claim 1, further comprising a rotation restricting section that restricts a rotation range of the rotation shaft section.

7. 7. The operating device according to claim 6, wherein the rotation restricting portion has a rotation restricting protrusion provided on the outer cylindrical hub and a first blade portion protruding outward from the rotation shaft portion.

8. An operating device according to any one of claims 1 to 7, wherein the rotating shaft portion has a second blade portion protruding outward, and the outer tube hub has a wall portion that abuts against the second blade portion in the axial direction and prevents axial displacement of the rotating shaft portion relative to the outer tube hub.

9. An operation device according to any one of claims 1 to 8; a puncture needle having an outer needle that can be inserted into the outer cylinder of the operation device while holding the implant; An implant placement device comprising:

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