Delivery device and medical instrument system

Abstract

The embodiment of the present application discloses a delivery device and a medical instrument system comprising the delivery device, the delivery device comprising an outer sheath member and an inner sheath member. The outer sheath member comprises an outer sheath handle and an outer sheath tube assembly arranged at least partially distally to the outer sheath handle, both the outer sheath handle and the outer sheath tube assembly form a cavity between a proximal end and a distal end, and the two cavities are communicated; the outer sheath handle is used for being operated by an operator to drive the outer sheath tube assembly to move, and the distal end of the outer sheath tube assembly is used for being detachably connected with an implantable device; the inner sheath member comprises an inner sheath handle and an inner sheath tube assembly arranged at least partially distally to the inner sheath handle, the inner sheath tube assembly is arranged in the two cavities, and the distal end of the inner sheath tube assembly is used for being detachably connected with the implantable device; at least part of the inner sheath handle is exposed to the outer sheath handle, and the inner sheath handle is used for being operated by the operator to drive the inner sheath tube assembly to move.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and more specifically, to a delivery device and a medical device system. Background Technology

[0002] Percutaneous interventional therapy is a rapidly developing treatment method in recent years, and its application areas are becoming increasingly wide. Transcatheter interventional therapy, in particular, allows for the placement of instruments and / or drugs into sites such as the heart, arteries, and veins.

[0003] Some implantable devices in related technologies have two connectors spaced apart axially. After the implantable device is released into the patient's body, the sheath of the delivery device needs to be detached from the two connectors sequentially. However, in the delivery devices of related technologies, each sheath requires a separate control component to drive its different movement modes during the delivery and release of the implantable device. This results in a complex overall structure and cumbersome assembly process for delivery devices with multiple connectors, thus increasing costs. Furthermore, it makes the operation of the delivery device cumbersome and inconvenient for doctors. Summary of the Invention

[0004] This invention provides a conveying device that simplifies the handle structure and facilitates operation, thereby solving the problems existing in related technologies.

[0005] The delivery device of this invention includes an outer sheath component and an inner sheath component. The outer sheath component includes an outer sheath handle and an outer sheath tube assembly at least partially disposed distal to the outer sheath handle. Both the outer sheath handle and the outer sheath tube assembly form a cavity between their proximal and distal ends, and the two cavities are connected. The outer sheath handle is operated by an operator to move the outer sheath tube assembly, and the distal end of the outer sheath tube assembly is detachably connected to an implantable device. The inner sheath component includes an inner sheath handle and an inner sheath tube assembly at least partially disposed distal to the inner sheath handle. The inner sheath tube assembly passes through the two cavities, and the distal end of the inner sheath tube assembly is detachably connected to the implantable device. At least a portion of the inner sheath handle is exposed outside the outer sheath handle, and the inner sheath handle is operated by an operator to move the inner sheath tube assembly.

[0006] The medical device system of this invention includes an implantable device and the aforementioned delivery device. The implantable device includes a first connector and a second connector spaced apart from each other. The distal end of the outer sheath assembly is detachably connected to the first connector, and the distal end of the inner sheath assembly is detachably connected to the second connector. The delivery device is used to deliver and release the implantable device into the patient's body.

[0007] One embodiment of the above invention has at least the following advantages or beneficial effects:

[0008] The conveying device of this invention includes an outer sheath component and an inner sheath component. The outer sheath component includes an outer sheath handle and an outer sheath tube assembly connected to the outer sheath handle. The inner sheath component includes an inner sheath handle and an inner sheath tube assembly connected to the inner sheath handle. The outer sheath handle can be operated by the operator to drive the outer sheath tube assembly to achieve different movement modes. At least a portion of the inner sheath handle is exposed outside the outer sheath handle, and the inner sheath handle can be operated by the operator to drive the inner sheath tube assembly to achieve different movement modes. Thus, the operator can directly and independently operate either the inner sheath handle or the outer sheath handle, thereby driving the inner and outer sheath tube assemblies to achieve different movement modes, which simplifies the internal drive structure of the conveying device and facilitates operator operation. Attached Figure Description

[0009] Figure 1 The diagram shown is a schematic diagram of a medical device system according to an embodiment of the present invention.

[0010] Figure 2 The diagram shown is a schematic representation of an implantable device according to an embodiment of the present invention.

[0011] Figure 3 The diagram shown is a schematic diagram of a conveying device according to an embodiment of the present invention.

[0012] Figure 4 The diagram shown is a schematic representation of the outer sheath component according to an embodiment of the present invention.

[0013] Figure 5 The diagram shown is a schematic representation of the inner sheath component according to an embodiment of the present invention.

[0014] Figure 6 The diagram shown is a partial cross-sectional view of the conveying device according to an embodiment of the present invention.

[0015] Figure 7 The diagram shown is a schematic representation of the locking member according to an embodiment of the present invention.

[0016] Figure 8 The diagram shown is a cross-sectional view of the locking member according to an embodiment of the present invention.

[0017] Figure 9 The diagram shown is a partial cross-sectional view of the outer sheath component according to an embodiment of the present invention.

[0018] Figure 10 The diagram shown is a schematic diagram of the first liquid injection connector according to an embodiment of the present invention.

[0019] Figure 11 The diagram shown is an exploded view of the first injection connector according to an embodiment of the present invention.

[0020] Figure 12 The diagram shown is a cross-sectional view of the first injection connector according to an embodiment of the present invention.

[0021] Figure 13 The diagram shown is a schematic diagram of the second seat body according to an embodiment of the present invention.

[0022] Figure 14 The diagram shows a connection tube of an embodiment of the present invention with an outer sheath connector and a first injection connector at both ends.

[0023] Figure 15 The diagram shows a partial cross-sectional view of the inner sheath component according to an embodiment of the present invention.

[0024] Figure 16 What is shown is Figure 9 A magnified view of a portion of point A in the middle.

[0025] The reference numerals in the attached figures are explained as follows:

[0026] 10. Conveying device; 100. Outer sheath component; 200. Inner sheath component; 1. Outer sheath handle; 11. Outer handle housing; 111. Outer sheath interface; 112. First opening; 12. First injection connector; 13. First conductive connector; 14. Valve body; 141. Receiving channel; 142. Fluid channel; 143. First seat; 144. Second seat; 145. Channel section; 146. Connecting section; 147. Receiving groove; 1471. Abutment surface; 148. Guide groove; 149. Clearance space; 15. Opening and closing assembly; 15a. Gasket; 151. Cutout; 16. Outer sheath connector; 161. Main channel; 162. Branch channel; 163. Main pipe; 164. Branch pipe; 165. Seal; 166. Opening; 167. End; 168. Intermediate component; 169. Base; 17. Connecting pipe; 18. Positioning structure; 181. Positioning post; 182. Positioning frame; 183. Positioning cavity; 2. Outer sheath assembly; 21. Outer sheath hose; 22. Outer conductive head; 4. Inner sheath handle; 41. Inner handle housing; 411. Inner sheath interface; 412. Second opening; 42. Second injection connector; 421. First channel; 422. Second channel; 43. Second conductive connector; 44. Three-way valve; 45. Guide wire port; 5. Inner sheath assembly; 51. Inner sheath hose; 52. Inner conductive head; 53. Guide sleeve; 54. Reinforcing tube; 6. Locking component; 61. First locking tube; 611. Limiting part; 62. Second locking tube; 621. First tube section; 622. Second tube section; 63. Extrusion part; 631. First sliding surface; 64. Clamping part; 641. Second sliding surface; 642. Gripper; 65. Knob; 7. Loader; 8. Implantable device; 81. Sealing plate; 82. Anchoring plate; 821. Electrode; 83. First connector; 84. Second connector; 85. First fixing part; 86. Second fixing part; 87. Third fixing part; 88. Expandable body. Detailed Implementation

[0027] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided so that the invention will be thorough and complete, and the concept of the exemplary embodiments will be fully conveyed to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore their detailed description will be omitted.

[0028] like Figure 1 As shown, Figure 1The diagram shown is a schematic representation of a medical device system according to an embodiment of the present invention. The medical device system of this embodiment includes a delivery device 10, an implantable device 8, and a loader 7. The delivery device 10 is used to deliver and implant the implantable device 8 into the patient's body via interventional therapy. The loader 7 is sleeved around the delivery device 10 and is used to load the implantable device 8 onto the delivery device 10.

[0029] It is understood that the terms "comprising" and "having," and any variations thereof, in the embodiments of this invention are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the steps or units listed, but may optionally include steps or units not listed, or may optionally include other steps or components inherent to such processes, methods, products, or devices.

[0030] The implantable device 8 can be a cardiac occluder, a vascular occluder, a vascular filter, or the like. This invention uses a left atrial appendage occluder as an example for illustration; however, it is understood that the implantable device 8 can also be other types of implantable devices.

[0031] like Figure 2 As shown, Figure 2 The diagram shown is a schematic representation of an implantable device 8 according to an embodiment of the present invention. As an example, the implantable device 8 is a left atrial appendage occluder, including an expandable body 88 and a first connector 83 and a second connector 84 disposed on the expandable body 88. The first connector 83 and the second connector 84 are spaced apart in the axial direction of the implantable device 8 and are used for connection to a delivery device 10. For example, the first connector 83 is detachably connected to the distal end of the outer sheath assembly 2 of the delivery device 10, and the second connector 84 is detachably connected to the distal end of the inner sheath assembly 5 of the delivery device 10, as will be described in detail later.

[0032] The expandable body 88 includes a sealing disc 81 and an anchoring disc 82, which are spaced apart in the axial direction of the implantable device 8, with the sealing disc 81 located near the proximal end of the anchoring disc 82. A first connector 83 is located near a second connector 84; specifically, the first connector 83 is located on the sealing disc 81, and the second connector 84 is located on the anchoring disc 82.

[0033] It should be noted that, in the embodiments of the present invention, the terms "distal," "distal," "proximal," and "proximal" are defined by their distance from the operator operating the delivery device 10 along the delivery path during the surgical procedure. Specifically, the end / side of a component closer to the operator along the delivery path is called the "proximal" / "proximal," and the end further away from the operator along the delivery path is called the "distal" / "distal."

[0034] As an example, the implantable device 8 is released into the left atrial appendage orifice, and after the first connector 83 and the second connector 84 are respectively detached from the delivery device 10, the distal end of the delivery device 10 is withdrawn from the body. For example, both the first connector 83 and the second connector 84 can be circumferentially detachable from the delivery device 10; for instance, the first connector 83 is threadedly connected to the delivery device 10, and the second connector 84 is threadedly connected to the delivery device 10.

[0035] Of course, in some embodiments, the first connector 83 and the second connector 84 can also be connected to the conveying device 10 in a plug-and-play manner. In some embodiments, the first connector 83 is indirectly connected to the distal end of the outer sheath assembly 2, and / or the second connector 84 is indirectly connected to the distal end of the inner sheath assembly 5.

[0036] In this embodiment, both the sealing disk 81 and the anchoring disk 82 can be made of conductive material. The sealing disk 81 adopts a conductive skeleton, and the first connector 83 is electrically connected to the skeleton of the sealing disk 81. The anchoring disk 82 is provided with electrodes 821 for conducting electricity, and the second connector 84 is electrically connected to the electrodes 821 of the anchoring disk 82. Both the first connector 83 and the second connector 84 are also used for transmitting electrical energy.

[0037] As an example, such as Figure 2 As shown, a plurality of fasteners are provided between the first connector 83 and the second connector 84, namely a first fastener 85, a second fastener 86, and a third fastener 87. These fasteners are used to connect the sealing disc 81 and the anchoring disc 82 and also serve as insulation.

[0038] Specifically, the sealing disc 81 is mesh-like and can be manufactured by weaving or cutting processes. A first connector 83 is connected to the proximal end of the sealing disc 81, and preferably also serves to gather the proximal ends of the braided filaments in the sealing disc 81. A first fixing member 85 is disposed at the distal end of the sealing disc 81, and preferably, the first fixing member 85 also serves to gather the distal ends of the braided filaments in the sealing disc 81. The first fixing member 85 can be made of a conductive material or an insulating material.

[0039] The anchoring disc 82 can be made by weaving or cutting. The ends of the anchoring disc 82 are gathered together and pressed between the second fixing member 86 and the third fixing member 87. Both the second fixing member 86 and the third fixing member 87 can be made of insulating material. The second connecting member 84 is located at the distal end of the third fixing member 87, thereby ensuring insulation between the sealing disc 81 and the anchoring disc 82, as well as insulation between the anchoring disc 82 and the second connecting member 84.

[0040] It is understandable that the above description is based solely on... Figure 2 To illustrate expandable body 88 as an example, Figure 2The expandable body 88 includes a sealing disc 81 and an anchoring disc 82, forming a double-disc structure. In other embodiments, the expandable body 88 may have other structural forms, such as a single-disc structure, a three-disc structure, or a structure with more than one disc. For example, the expandable body 88 may be a single-disc structure in the shape of a plunger.

[0041] The above description is only based on Figure 2 This example illustrates how insulation is achieved between the sealing disc 81 and the anchoring disc 82. Of course, in other embodiments, insulation is achieved between the first connector 83 and the second connector 84 in other ways.

[0042] like Figure 3 As shown, Figure 3 The diagram shown illustrates a delivery device 10 according to an embodiment of the present invention. The delivery device 10 of this embodiment includes an outer sheath member 100 and an inner sheath member 200, the inner sheath member 200 being movably disposed within the outer sheath member 100. The distal end of the outer sheath member 100 is detachably connected to a first connector 83 of the implantable device 8. The distal end of the inner sheath member 200 is detachably connected to a second connector 84 of the implantable device 8.

[0043] In one embodiment, the distal end of the outer sheath member 100 can be connected to the first connector 83 via a plug-in connection or a circumferential rotational connection. When it is a circumferential rotational connection, it can be a threaded connection. The distal end of the inner sheath member 200 can be connected to the second connector 84 via a plug-in connection or a circumferential rotational connection. When it is a circumferential rotational connection, it can be a threaded connection.

[0044] like Figure 4 As shown, Figure 4 The diagram shown is a schematic representation of an outer sheath component 100 according to an embodiment of the present invention. The outer sheath component 100 includes an outer sheath handle 1 and an outer sheath tube assembly 2. At least a portion of the outer sheath tube assembly 2 is disposed distal to the outer sheath handle 1. Both the outer sheath handle 1 and the outer sheath tube assembly 2 form a cavity between their proximal and distal ends, and the two cavities are connected. The outer sheath handle 1 is operated by an operator to move the outer sheath tube assembly 2, for example, to induce circumferential rotation and / or axial movement in the outer sheath tube assembly 2. The outer sheath tube assembly 2 includes an outer sheath flexible tube 21 and an external conductive head 22. The external conductive head 22 is disposed at the distal end of the outer sheath flexible tube 21 and is used to connect to a first connector 83. The connection between the external conductive head 22 and the first connector 83 can be a plug-in connection or a circumferential rotational connection. When the operator operates the outer sheath handle 1, the outer sheath tube assembly 2 can be moved synchronously.

[0045] like Figure 5 As shown, Figure 5The diagram shows a schematic of the inner sheath component 200 according to an embodiment of the present invention. The inner sheath component 200 includes an inner sheath handle 4 and an inner sheath tube assembly 5. At least a portion of the inner sheath tube assembly 5 is disposed distal to the inner sheath handle 4, and the inner sheath tube assembly 5 passes through the two cavities of the outer sheath component 100. The inner sheath handle 4 is operated by an operator to drive the inner sheath tube assembly 5 to move synchronously, for example, to drive the inner sheath tube assembly 5 to produce circumferential rotation and / or axial movement. The inner sheath tube assembly 5 includes an inner sheath flexible tube 51 and an inner conductive head 52. The inner conductive head 52 is disposed at the distal end of the inner sheath flexible tube 51 for connection to a second connector 84. The connection between the inner conductive head 52 and the second connector 84 can be a plug-in connection or a circumferential rotational connection. When the operator operates the inner sheath handle 4, the inner sheath tube assembly 5 can be moved.

[0046] Please continue reading. Figure 3 At least a portion of the inner sheath handle 4 is exposed outside the outer sheath handle 1. By operating the inner sheath handle 4, the inner sheath member 200 can be moved relative to the outer sheath member 100 in the circumferential and / or axial directions to disengage the inner sheath member 200 from the second connector 84 of the implantable device 8.

[0047] In this embodiment, the inner sheath handle 4 and the outer sheath handle 1 are spaced apart axially. In other words, the inner sheath handle 4 is completely exposed outside the outer sheath handle 1. By spaced apart axially, the inner sheath handle 4 and the outer sheath handle 1 do not overlap radially, thereby reducing the radial dimension of the outer sheath handle 1. Furthermore, the complete exposure of the inner sheath handle 4 to the outer sheath handle 1 makes it easier for the operator to manipulate the inner sheath handle 4, for example, to achieve axial movement and / or circumferential rotation.

[0048] The outer sheath handle 1 and the inner sheath handle 4 are arranged sequentially along the axial direction for operation. The operator can hold the outer sheath handle 1 with one hand and the inner sheath handle 4 with the other hand. The operator can operate the inner sheath handle 4 to produce axial or circumferential relative movement with respect to the outer sheath handle 1, so as to control the corresponding relative movement between the inner sheath assembly 5 and the outer sheath assembly 2.

[0049] Of course, in some embodiments, the distal end of the inner sheath handle 4 may be concealed within the outer sheath handle 1, while the proximal end of the inner sheath handle 4 is exposed within the outer sheath handle 1. The operator can manipulate the proximal end of the inner sheath handle 4 to drive the inner sheath member 200 to move axially and / or circumferentially.

[0050] The inner sheath handle 4 is positioned proximal to the delivery device 10. Driven by the inner sheath handle 4, the inner sheath assembly 5 can move proximally from the cavity of the outer sheath member 100 until it is completely detached from the outer sheath member 100. In other words, the inner sheath member 200 can move axially with unlimited length relative to the outer sheath member 100, allowing it to completely detach from the outer sheath member 100. This design facilitates the subsequent rotational release of the outer sheath member 100 from the implantable device 8, avoiding the resistance that the outer sheath handle 1 needs to overcome from the proximal inner sheath handle 4 and the inner sheath assembly 5 during this process.

[0051] Specifically, when disengaging the inner sheath component 200, the outer sheath component 100, and the implantable device 8, the following method can be used: After the inner conductive head 52 of the inner sheath component 200 is disengaged from the second connector 84, the inner sheath component 200 is directly withdrawn from the patient's body, i.e., the inner sheath component 200 and the outer sheath component 100 are completely detached. Then, the outer conductive head 22 of the outer sheath component 100 is disengaged from the first connector 83. During the disengagement process of the outer sheath component 100 from the first connector 83, since the inner sheath component 200 and the outer sheath component 100 are completely detached, the inner sheath component 200 will not affect the rotational movement of the outer sheath component 100 during the rotational disengagement process, making the rotational disengagement of the outer sheath component 100 more convenient.

[0052] Of course, the advantage that the inner sheath member 200 can be completely detached from the outer sheath member 100 also applies to the plug-in connection between the outer sheath member 100 and the first connector 83.

[0053] In other embodiments, the inner sheath member 200, the outer sheath member 100, and the implantable device 8 can be disengaged by the following method: the inner conductive head 52 of the inner sheath member 200 is first disengaged from the second connector 84, and then the inner sheath member 200 is moved proximally until it is inside the outer sheath member 100. Next, the outer conductive head 22 of the outer sheath member 100 is disengaged from the first connector 83, and finally, the inner sheath member 200 and the outer sheath member 100 are withdrawn together from the patient's body.

[0054] The conveying device 10 of this embodiment includes an outer sheath component 100 and an inner sheath component 200. The outer sheath component 100 includes an outer sheath handle 1 and an outer sheath tube assembly 2 connected to the outer sheath handle 1. The inner sheath component 200 includes an inner sheath handle 4 and an inner sheath tube assembly 5 connected to the inner sheath handle 4. The outer sheath handle 1 can be operated by an operator to drive the outer sheath tube assembly 2 to move, and the inner sheath handle 4 can be operated by an operator to drive the inner sheath tube assembly 5 to move. By designing that at least part of the inner sheath handle 4 is exposed outside the outer sheath handle 1, the operator can directly operate the inner sheath handle 4 to independently control the movement of the inner sheath tube assembly 5, thereby simplifying the handle structure and facilitating operator operation.

[0055] like Figures 6 to 8 As shown, Figure 6 The diagram shown is a partial cross-sectional view of the conveying device 10 according to an embodiment of the present invention. Figure 7 The diagram shown is a schematic diagram of the locking member 6 according to an embodiment of the present invention. Figure 8 The diagram shows a cross-sectional view of the locking member 6 according to an embodiment of the present invention. The conveying device 10 also includes the locking member 6, which is connected between the outer sheath handle 1 and the inner sheath assembly 5. The locking member 6 is capable of switching between a locked state and an unlocked state. In the unlocked state, the outer sheath assembly 100 and the inner sheath assembly 200 can move relative to each other. In the locked state, the locking member 6 deforms and clamps the inner sheath assembly 5, thereby preventing relative movement between the inner sheath assembly 200 and the outer sheath assembly 100.

[0056] When the locking member 6 is in the locked state, it can prevent the inner sheath member 200 and the outer sheath member 100 from moving relative to each other. During the delivery and release of the implantable device 8, it can prevent the operator from accidentally operating the inner sheath member 200.

[0057] It is understood that preventing relative movement between the inner sheath member 200 and the outer sheath member 100 includes both circumferential and axial movements.

[0058] In one embodiment, a portion of the locking member 6 is disposed in the cavity of the outer sheath handle 1, and the inner sheath assembly 5 passes through the locking member 6.

[0059] like Figure 7 and Figure 8As shown, the locking member 6 includes a first locking tube 61, a second locking tube 62, a pressing member 63, and a clamping member 64. The first locking tube 61 is axially movably disposed within the cavity of the outer sheath handle 1, and the inner sheath tube assembly 5 passes through the first locking tube 61. The second locking tube 62 is axially fixed and circumferentially rotatably connected to the outer sheath handle 1. The second locking tube 62 is used to drive the first locking tube 61 to move relative to the second locking tube 62 along the axial direction of the first locking tube 61. As an example, the outer periphery of the second locking tube 62 may be provided with two first limiting portions spaced apart axially, and the inner wall of the cavity of the outer sheath handle 1 is provided with two second limiting portions spaced apart axially. The two second limiting portions respectively stop the two first limiting portions, so that the two second limiting portions restrict the axial displacement of the second locking tube 62.

[0060] The squeezing member 63 is disposed on the first locking tube 61, the second locking tube 62, or the outer sheath handle 1. The clamping member 64 is disposed on the first locking tube 61 and / or the second locking tube 62. During the process of the second locking tube 62 rotating and causing the first locking tube 61 to move relative to the second locking tube 62 along the axial direction of the first locking tube 61, the clamping member 64 is deformed by the squeezing member 63 at least in the radial direction to clamp the inner sheath assembly 5.

[0061] In this embodiment, the clamping member 64 is disposed at the proximal end of the first locking tube 61, and the pressing member 63 is disposed at the second locking tube 62. When the second locking tube 62 rotates, it can drive the first locking tube 61 to move relative to the second locking tube 62 along the axial direction of the first locking tube 61 and toward the proximal end, so that the clamping member 64 gradually approaches the pressing member 63. When the clamping member 64 and the pressing member 63 come into contact, the clamping member 64 is deformed by the pressing member 63 at least radially, thereby clamping the inner sheath assembly 5. Further, the clamping member 64 and the first locking tube 61 are integrally formed, and the pressing member 63 and the second locking tube 62 are integrally formed. It is understood that in modified embodiments, the clamping member 64 and the first locking tube 61 may not be integrally formed, for example, they may be detachably connected; the pressing member 63 and the second locking tube 62 may not be integrally formed, for example, they may be detachably connected.

[0062] Of course, in some embodiments, when the clamping member 64 is disposed on the first locking tube 61, the pressing member 63 may also be disposed on the outer sheath handle 1. For example, the clamping member 64 is disposed at the distal end of the first locking tube 61, and the pressing member 63 protrudes from the inner wall surface of the cavity of the outer sheath handle 1. When the second locking tube 62 rotates, it can drive the first locking tube 61 to move relative to the second locking tube 62 along the axial direction of the first locking tube 61 and toward the distal end, so that the clamping member 64 gradually approaches the pressing member 63 until the clamping member 64 and the pressing member 63 contact each other, at least radially, the clamping member 64 is deformed by the pressing member 63 and clamps the inner sheath assembly 5.

[0063] Furthermore, in some embodiments, the clamping member 64 may be disposed in the second locking tube 62, and the pressing member 63 may be disposed in the first locking tube 61. The first locking tube 61 is sleeved on the outer periphery of the second locking tube 62. When the second locking tube 62 rotates, it can drive the first locking tube 61 to move axially, ultimately achieving that the clamping member 64 is deformed by the pressing member 63 at least in the radial direction, thereby clamping the inner sheath assembly 5.

[0064] It is understandable that when the clamping member 64 is disposed in the second locking tube 62, the squeezing member 63 may be disposed at the distal end of the first locking tube 61.

[0065] Of course, in some embodiments, the clamping member 64 is detachably connected between the first locking tube 61 and the second locking tube 62, both of which are integrally formed with a pressing member 63. The first locking tube 61 and the second locking tube 62 are screwed together. A portion of the clamping member 64 extends into the first locking tube 61, and a portion of the clamping member 64 extends into the second locking tube 62. The clamping member 64 has a through-hole extending through its proximal and distal ends, through which the inner sheath assembly 5 passes. When the first locking tube 61 moves proximally relative to the second locking tube 62 along the axial direction of the first locking tube 61, the clamping member 64 is jointly pressed by the pressing member 63 on the first locking tube 61 and the second locking tube 62, causing the clamping member 64 to deform at least radially under the pressure of the pressing member 63, thereby clamping the inner sheath assembly 5.

[0066] Understandably, the clamping member 64 can be made of an elastic material. Furthermore, the clamping member 64 is an elastic member that deforms radially when compressed in the radial direction; this elastic member is made of, for example, rubber, but is not limited to, it. The clamping member 64 can also be made of copper, which improves its wear resistance.

[0067] It should be noted that the clamping member 64 can be integrally disposed on the first locking tube 61, and the clamping member 64 can be integrally disposed on the second locking tube 62. For example, the clamping member 64 can be integrally disposed on the proximal end of the first locking tube 61, and the clamping member 64 can be integrally disposed on the distal end of the second locking tube 62.

[0068] The extrusion member 63 can be integrally mounted on the first locking tube 61, the extrusion member 63 can be integrally mounted on the second locking tube 62, and the extrusion member 63 can also be integrally mounted on the outer sheath handle 1.

[0069] Of course, the clamping member 64 can also be detachably connected to the first locking tube 61 or the second locking tube 62. The pressing member 63 can also be detachably connected to the first locking tube 61, the second locking tube 62 or the outer sheath handle 1.

[0070] The first locking tube 61 and the second locking tube 62 can be threaded together. The first locking tube 61 has external threads, and the second locking tube 62 has internal threads. The second locking tube 62 is sleeved on the outer periphery of the first locking tube 61 and is threaded together. In some embodiments, the first locking tube 61 has internal threads, and the second locking tube 62 has external threads. The first locking tube 61 is sleeved on the outer periphery of the second locking tube 62 and is threaded together. In some embodiments, the first locking tube 61 and the second locking tube 62 are slidably connected to a guide rail via an inclined guide groove.

[0071] Please continue reading. Figures 6 to 8 The second locking tube 62 includes a first tube section 621, and the first locking tube 61 passes through the first tube section 621. The inner wall surface of the first tube section 621 may have internal threads, and the outer periphery of the first locking tube 61 has external threads. The first locking tube 61 passes through the first tube section 621 and is threadedly connected to the first tube section 621.

[0072] The extrusion member 63 is disposed at the proximal end of the first tube segment 621 and extends obliquely toward the axial direction of the second locking tube 62, that is, the proximal end of the extrusion member 63 extends into the interior space of the second locking tube 62. Since the extrusion member 63 extends obliquely into the interior of the second locking tube 62, when the first locking tube 61 moves axially toward its proximal end, the clamping member 64 is compressed by the extrusion member 63 and deforms at least radially, thereby clamping the inner sheath assembly 5.

[0073] The inner wall surface of the extruder 63 has a first sliding surface 631. The radial dimension of the proximal end of the first sliding surface 631 is smaller than that of its distal end, that is, the proximal portion of the first sliding surface 631 is tapered, for sliding engagement with the proximal end of the clamping member 64, and for extruding the clamping member 64 at least radially.

[0074] In this embodiment, the radial dimension of the first sliding surface 631 gradually decreases from the distal end to the proximal end, enabling the clamping member 64 to achieve a better sliding fit with the first sliding surface 631. During the sliding fit between the clamping member 64 and the pressing member 63, the clamping member 64 deforms at least in the radial direction. The design of the gradually decreasing radial dimension of the first sliding surface 631 is more conducive to the radial deformation of the clamping member 64.

[0075] The proximal end of the clamping member 64 has a second sliding surface 641 for sliding engagement with a first sliding surface 631, such that the first sliding surface 631 can compress the second sliding surface 641 at least in the radial direction, so as to deform the clamping member 64 and clamp the inner sheath assembly 5.

[0076] It is understandable that the first sliding surface 631 and the second sliding surface 641 can be planar or curved. For example, the first sliding surface 631 and the second sliding surface 641 can both be planar, both can both be curved, or one can be planar and the other can be curved.

[0077] In this embodiment, both the first sliding surface 631 and the second sliding surface 641 are conical surfaces.

[0078] In some embodiments, in the locked state, the first sliding surface 631 and the second sliding surface 641 are disengaged from each other, and the second sliding surface 641 moves to the proximal end of the first sliding surface 631. In some embodiments, in the locked state, the first sliding surface 631 and the second sliding surface 641 abut against each other.

[0079] The second locking tube 62 also includes a second tube segment 622, which is disposed near the proximal end of the extruder 63. That is, from distal to proximal, the second locking tube 62 sequentially includes a first tube segment 621, the extruder 63, and the second tube segment 622. The locking member 6 also includes a knob 65, which is fixedly connected to the second locking tube 62 and exposed on the outer sheath handle 1. The knob 65, exposed on the outer sheath handle 1, is used to receive circumferential rotation by the operator.

[0080] Please continue reading. Figure 7 and Figure 8 The first locking tube 61 has a clamping member 64 at its proximal end and a limiting part 611 at its distal end. The limiting part 611 is cylindrical, facilitating the insertion of the inner sheath assembly 5. The limiting part 611 is rectangular in cross-section perpendicular to the axial direction, including a top wall and a bottom wall opposite to each other, and two opposite side walls connecting the top and bottom walls. These two side walls are used to limit the movement of the outer sheath handle 1, allowing the first locking tube 61 to move only along its axial direction and preventing circumferential rotation. In other embodiments, the top and bottom walls are used to limit the movement of the first locking tube 61 to the outer sheath handle 1, allowing the first locking tube 61 to move only along its axial direction and preventing circumferential rotation.

[0081] A clamping member 64 is disposed at the proximal end of the first locking tube 61, and includes a plurality of circumferentially spaced jaws 642, with a gap between adjacent jaws 642 in the circumferential direction. Under the compression action of the pressing member 63, the proximal ends of the plurality of jaws 642 deform and move closer together, thereby clamping the inner sheath assembly 5. The aforementioned second sliding surface 641 is provided on the outer side of the proximal end of the jaws 642.

[0082] like Figure 4 and Figure 9 As shown, Figure 9The diagram shows a partial cross-sectional view of the outer sheath component 100 according to an embodiment of the present invention. The outer sheath handle 1 includes an outer handle housing 11 and a first injection connector 12. The outer handle housing 11 forms a cavity within the outer sheath handle 1. The first injection connector 12 is disposed within the cavity of the outer sheath handle 1 and communicates with the proximal end of the outer sheath assembly 2. The outer handle housing 11 includes an outer sheath interface portion 111, which has a first opening 112. The cavity in the outer sheath handle 1 extends to the outer sheath interface portion 111 and extends through the first opening 112. The first injection connector 12 is disposed within the outer sheath interface portion 111 and is exposed on the surface of the outer handle housing 11 through the first opening 112. It is used to connect to a first injection device (not shown in the diagram). The first injection device provides liquid to the outer sheath assembly 2 through the first injection connector 12. It is understood that the liquid provided by the first injection device includes, but is not limited to, physiological saline, contrast agents, or other drugs.

[0083] The outer sheath handle 1 also includes a first conductive connector 13, which is disposed within the cavity of the outer sheath handle 1, specifically within the outer sheath interface portion 111, and is electrically connected to the outer sheath tube assembly 2. The first conductive connector 13 is exposed on the surface of the outer sheath handle 1 through a first opening 112 for connection to a first external power source (not shown in the figure). The first external power source provides electrical energy to the outer sheath tube assembly 2 through the first conductive connector 13. It is understood that the electrical energy provided by the first external power source can be transmitted to the first connector 83 of the implantable device 8.

[0084] The outer sheath interface portion 111 protrudes from the outer wall of the outer handle housing 11. The first opening 112 is located at the end of the outer sheath interface portion 111 away from the outer handle housing 11. The protruding direction of the outer sheath interface portion 111 is inclined relative to the axis of the outer handle housing 11. The first opening 112 faces the proximal end of the outer handle housing 11.

[0085] The outer sheath interface portion 111 protrudes from the outer wall of the outer handle housing 11, which can alleviate the problem of insufficient cavity volume in the outer sheath handle 1. Furthermore, the outer sheath interface portion 111 is inclined relative to the axis of the outer handle housing 11, and the first opening 112 faces the proximal end of the outer handle housing 11, thus facilitating the operator to insert the first injection device. Figures 10 to 12 As shown, Figure 10 The diagram shown is a schematic diagram of the first liquid injection connector 12 according to an embodiment of the present invention. Figure 11 The diagram shown is an exploded view of the first liquid injection connector 12 according to an embodiment of the present invention. Figure 12The diagram shows a cross-sectional view of the first injection connector 12 according to an embodiment of the present invention. The first injection connector 12 of this embodiment includes a valve body 14 and an opening / closing assembly 15. The valve body 14 forms a receiving channel 141 and a fluid channel 142. The receiving channel 141 communicates with a first opening 112 for receiving the injection end of a first injection device. The fluid channel 142 communicates with an outer sheath assembly 2. The opening / closing assembly 15 has a cut 151 that penetrates two opposite sides in the thickness direction of the opening / closing assembly 15. The opening / closing assembly 15 is located between the receiving channel 141 and the fluid channel 142. The injection end of the first injection device is used to enter the fluid channel 142 through the cut 151 along the receiving channel 141 and inject liquid into the fluid channel 142. The liquid flows through the fluid channel 142 into the inner cavity of the outer sheath assembly 2.

[0086] It is understood that the first injection connector 12 of this embodiment is disposed in the cavity of the outer sheath handle 1. The receiving channel 141 of the first injection connector 12 can receive the injection end of the first injection device. The injection end can pass through the cut 151 along the receiving channel 141 and enter the fluid channel 142, thereby allowing the liquid from the first injection device to pass through the cut 151 along the receiving channel 141 and enter the fluid channel 142, and finally enter the inner cavity of the outer sheath assembly 2. Compared with the method of supplying liquid to the outer sheath assembly 2 using an external three-way valve in related technologies, the first injection connector 12 of this embodiment is integrated into the outer sheath handle 1, which improves the integration of the outer sheath handle 1 on the one hand, and facilitates the circumferential rotation of the outer sheath component 100 on the other hand.

[0087] The opening and closing assembly 15 includes a resilient gasket 15a with a notch 151. In one embodiment, the notch 151 can be cross-shaped. When the injection end of the first injection device is inserted into the notch 151, the notch 151 is opened, allowing liquid flowing from the injection end to flow out through the fluid channel 142 from the first injection connector 12. The notch 151 is in a closed state in its natural state, and the receiving channel 141 and the fluid channel 142 are isolated by the gasket 15a.

[0088] When the incision 151 is opened, the first injection connector 12 can receive the liquid from the first injection device. When the incision 151 is closed, the receiving channel 141 and the fluid channel 142 are isolated by the gasket 15a to ensure the sealing of the outer sheath component 100 and prevent outside air from entering the outer sheath assembly 2 through the first injection connector 12.

[0089] The valve body 14 includes a first seat 143 and a second seat 144, which are detachably connected. The first seat 143 has a receiving channel 141, and the second seat 144 includes a channel portion 145 and a connecting portion 146 connected to each other. The connecting portion 146 is detachably connected to the first seat 143, and the channel portion 145 and the connecting portion 146 form a fluid channel 142. The opening and closing assembly 15 is sandwiched between the first seat 143 and the second seat 144.

[0090] In one embodiment, the connecting portion 146 and the first seat 143 can be connected by threads, for example, the outer periphery of the connecting portion 146 has external threads, and the inner wall of the first seat 143 has external threads. Of course, the connecting portion 146 can also be sleeved on the outer periphery of the first seat 143.

[0091] The threaded connection between the connecting part 146 and the first seat 143 facilitates the disassembly and assembly of the first seat 143 and the second seat 144, thereby simplifying the assembly and replacement of the gasket 15a. In other embodiments, the connection between the connecting part 146 and the first seat 143 is not limited to a threaded connection; for example, it may be connected by at least one method such as snap-fit ​​or adhesive bonding.

[0092] The connecting portion 146 forms a recessed receiving groove 147 opposite to the receiving channel 141, extending away from the receiving channel 141. The opening and closing assembly 15 covers the opening of the receiving groove 147. The receiving groove 147 is used to receive the injection end of the first injection device, and the bottom surface of the receiving groove 147 forms an abutment surface 1471 for abutting the injection end. The receiving channel 141 is a constant-diameter channel, and the fluid channel 142 is a constant-diameter channel. A constant-diameter channel has the same radial dimension at different axial positions. The injection end of the first injection device can abut against the abutment surface 1471 via the receiving channel 141 and the fluid channel 142.

[0093] After the injection end of the first injection device is inserted into the first injection connector 12, the injection end passes through the cut 151 and can abut against the contact surface 1471 of the receiving groove 147. When the injection end abuts against the contact surface 1471, the operator knows that the injection end has been inserted in place, which improves the operator's operating feel.

[0094] like Figure 12 and Figure 13 As shown, Figure 13The diagram shown is a schematic representation of the second seat 144 according to an embodiment of the present invention. The abutment surface 1471 has a guide groove 148 recessed in the direction away from the opening / closing assembly 15, and the guide groove 148 communicates with the fluid channel 142. When the injection end of the first injection device abuts against the abutment surface 1471 of the receiving groove 147, liquid can flow into the fluid channel 142 through the guide groove 148. The design of the guide groove 148 facilitates liquid flow and prevents the abutment surface 1471 from obstructing the flow of liquid into the fluid channel 142.

[0095] In one embodiment, the shape of the guide groove 148 can be "+", but is not limited thereto.

[0096] like Figure 6 , Figure 9 and Figure 14 As shown, where Figure 14 The diagram shows a schematic of the connecting tube 17 of this embodiment of the invention, with its two ends connected to the outer sheath connector 16 and the first injection connector 12, respectively. The outer sheath handle 1 also includes the outer sheath connector 16 and the connecting tube 17. The outer sheath connector 16 is disposed in the cavity of the outer handle housing 11 and is generally tubular in shape. The outer sheath connector 16 has a main channel 161 and a branch channel 162 that are interconnected. The proximal end of the outer sheath tube assembly 2 is connected to the distal end of the outer sheath connector 16 and communicates with the main channel 161. The inner sheath tube assembly 5 passes through both ends of the main channel 161. One end of the connecting tube 17 communicates with the fluid channel 142, and the other end communicates with the branch channel 162.

[0097] The outer sheath connector 16 includes an end 167, an intermediate part 168, and a base 169. From the distal end to the proximal end, the end 167, the intermediate part 168, and the base 169 are detachably connected in sequence, such as the end 167 being threaded to one end of the intermediate part 168, and the other end of the intermediate part 168 being threaded to the base 169.

[0098] The proximal end of the outer sheath hose 21 is fixedly connected to the outer sheath connector 16. As an example, the proximal end of the outer sheath hose 21 is fixed between the end 167 and the intermediate member 168. Specifically, during the assembly of the outer sheath hose 21, the end 167, and the intermediate member 168, the proximal end of the outer sheath hose 21 is inserted into the perforation at the proximal end of the end 167, and the proximal end of the outer sheath hose 21 is flared to deform it into a conical shape, which is adapted to the shape of the perforation wall at the proximal end of the end 167. Then, the intermediate member 168 is assembled with the end 167, so that the conical proximal end of the outer sheath hose 21 is clamped between the perforation wall of the end 167 and the distal end of the intermediate member 168.

[0099] The outer sheath connector 16 also includes a resilient seal 165 disposed at the proximal end of the outer sheath connector 16, for example, sandwiched between the proximal end of the intermediate member 168 and the base 169. The seal 165 is provided with an axially oriented opening 166 for the inner sheath assembly 5 to pass through, for example, for the reinforcing tube 54 and the inner sheath hose 51 to pass through.

[0100] As an example, the outer sheath connector 16 is used to connect the first injection connector 12 and the outer sheath assembly 2, and also seals the proximal end of the outer sheath assembly 2 by providing a seal 165.

[0101] In this embodiment, the end 167 and the intermediate component 168 are designed as detachable separate structures to facilitate the assembly of the proximal end of the outer sheath hose 21. The intermediate component 168 and the base 169 are designed as detachable separate structures to facilitate the assembly of the seal 165.

[0102] The outer sheath connector 16 includes a main pipe 163 and a branch pipe 164. The main pipe 163 forms a main channel 161, and the distal end of the main pipe 163 is connected to the proximal end of the outer sheath hose 21. The inner sheath assembly 5 passes through the main pipe 163. The branch pipe 164 forms a branch channel 162 and is connected to the main pipe 163. The axis of the branch pipe 164 is inclined to the axis of the main pipe 163, and the end of the branch pipe 164 away from the main pipe 163 extends towards the proximal end of the main pipe 163.

[0103] By setting the axis of the branch pipe 164 at an inclination to the axis of the main pipe 163, and extending the branch pipe 164 to the proximal end of the main pipe 163, the design of connecting the two ends of the connecting pipe 17 to the channel portion 145 of the first liquid injection joint 12 respectively, it is beneficial to increase the distance between the two ends of the connecting pipe 17 and reduce the curvature and length of the connecting pipe 17.

[0104] The liquid supplied by the first injection device flows sequentially through the first injection connector 12, connecting pipe 17, branch pipe 164, main pipe 163, and the proximal end of the outer sheath assembly 2, until the distal end of the outer sheath assembly 2.

[0105] In this embodiment, the main pipe 163 of the outer sheath connector 16 can be formed by the end 167, the intermediate part 168 and the base 169, and the branch pipe 164 can be formed in the intermediate part 168.

[0106] Please continue reading. Figure 10 , Figure 12 and Figure 14The axis of the fluid channel 142 and the axis of the receiving channel 141 are offset from each other, so that the outer wall of the channel portion 145 forms a recessed clearance space 149 in the direction of the axis of the fluid channel 142 relative to the outer wall of the connecting portion 146. The outer sheath connector 16 and / or the outer sheath tube assembly 2 pass through the clearance space 149 to avoid interference between the channel portion 145 and the outer sheath connector 16 and / or the outer sheath tube assembly 2.

[0107] In this embodiment, by designing the axis of the fluid channel 142 and the axis of the receiving channel 141 to be offset from each other, on the one hand, the outer walls of the channel portion 145 and the connecting portion 146 together form a relatively large clearance space 149, which is used for the outer sheath connector 16 and / or the outer sheath tube assembly 2 to pass through. This can further improve the integration of the outer sheath handle 1, effectively utilize the volume inside the outer handle housing 11, and reduce the size of the outer sheath handle 1. On the other hand, the channel portion 145 of the first injection connector 12 is far away from the branch pipe 164 of the outer sheath connector 16, thereby allowing adjustment of the curvature and length of the connecting pipe 17.

[0108] like Figure 14 As shown, the outer sheath handle 1 also includes a positioning structure 18, which is disposed on the inner wall of the cavity of the outer sheath handle 1 and located at the proximal end of the outer sheath handle 1, for positioning the connecting tube 17 on the proximal side of the outer sheath handle 1.

[0109] In one embodiment, the positioning structure 18 may include a positioning post 181 and a positioning frame 182. The positioning frame 182 is closer to the proximal end than the positioning post 181. A section of the connecting tube 17 (its middle portion in the figure) is positioned between the positioning post 181 and the positioning frame 182.

[0110] It should be noted that the positioning frame 182 extends from the inner wall of the outer handle housing 11 into the interior of the outer handle housing 11, forming a positioning cavity 183. This positioning cavity 183 is square-shaped and is used to restrict the circumferential movement of the limiting portion 611 (specifically, its two side walls) of the first locking tube 61. Specifically, the limiting portion 611 of the first locking tube 61 is disposed in the positioning cavity 183, and the limiting portion 611 can only move axially relative to the positioning frame 182, but cannot rotate circumferentially.

[0111] like Figure 5 and Figure 15 As shown, Figure 15The diagram shows a partial cross-sectional view of the inner sheath component 200 according to an embodiment of the present invention. The inner sheath handle 4 includes an inner handle housing 41 and a second injection connector 42. The second injection connector 42 is disposed within the inner handle housing 41 and communicates with the proximal end of the inner sheath assembly 5. The inner handle housing 41 includes an inner sheath interface portion 411, which has a second opening 412. The second injection connector 42 is exposed on the surface of the inner handle housing 41 through the second opening 412 and is used to connect to a second injection device (not shown in the figure). The second injection device is used to supply liquid to the inner sheath assembly 5. The liquid supplied by the second injection device includes, but is not limited to, physiological saline, contrast agent, or other drugs.

[0112] In one embodiment, the second injection device can be connected to the second injection connector 42 via a three-way valve 44.

[0113] The inner sheath handle 4 also includes a tubular guide wire port 45, which communicates with the inner cavity of the inner sheath assembly 5. One end of the guide wire port 45 is exposed on the surface of the inner sheath handle 4, through which a guide wire can pass through the guide wire port 45 and enter the inner cavity of the inner sheath assembly 5.

[0114] The second injection connector 42 includes a first channel 421 and a second channel 422 that are connected. The proximal end of the first channel 421 is connected to the guidewire port 45, and the distal end of the first channel 421 is connected to the inner cavity of the inner sheath assembly 5. The proximal end of the second channel 422 is connected to the three-way valve 44, and the distal end of the second channel 422 is connected to the first channel 421. The axes of the first channel 421 and the second channel 422 are inclined, and the proximal end of the second channel 422 extends towards the proximal end of the first channel 421.

[0115] The inner sheath handle 4 also includes a second conductive connector 43, which is disposed inside the inner handle housing 41 and electrically connected to the inner sheath assembly 5. The second conductive connector 43 is exposed on the surface of the inner sheath handle 4 through the second opening 412 for connection to a second external power source (not shown in the figure). The second external power source provides electrical energy to the inner sheath assembly 5 through the second conductive connector 43.

[0116] Please continue reading. Figure 5 , Figure 6 and Figure 15The inner sheath assembly 5 includes an inner sheath tube 51, a reinforcing tube 54, and a guide sleeve 53. The inner sheath tube 51 is inserted into the outer sheath component 100; specifically, the inner sheath tube 51 is inserted into the outer sheath assembly 2, the outer sheath connector 16, and the locking component 6. The distal end of the inner sheath tube 51 extends beyond the distal end of the outer sheath assembly 2 and is connected to the second connector 84 of the implantable device 8. The proximal end of the inner sheath tube 51 extends beyond the proximal end of the outer sheath handle 1 and is connected to the inner sheath handle 4. Simultaneously, the proximal end of the inner sheath tube 51 extends into the inner handle housing 41 and is connected to the second injection connector 42. The reinforcing tube 54 is sleeved around the outer periphery of the inner sheath tube 51 and is inserted into the outer sheath connector 16 of the outer sheath component 100. The distal end of the reinforcing tube 54 extends beyond the outer sheath handle 1 and is connected to the guide sleeve 53. The guide sleeve 53 is fitted into the locking member 6 of the outer sheath member 100. Specifically, the guide sleeve 53 is fitted into the first locking tube 61 and the second locking tube 62 of the locking member 6. When the locking member 6 is in the locked state, the clamping member 64 is used to clamp the outer periphery of the guide sleeve 53. The distal end of the guide sleeve 53 extends into the inner cavity of the outer sheath handle 1 and is fitted onto the proximal periphery of the reinforcing tube 54. The proximal end of the guide sleeve 53 extends out of the proximal end of the outer sheath handle 1 and is connected to the inner handle housing 41.

[0117] The guide sleeve 53 has a higher hardness than the inner sheath hose 51. Since the clamping member 64 clamps the harder guide sleeve 53 but not the softer inner sheath hose 51, the guide sleeve 53 can protect the inner sheath hose 51 and prevent it from being deformed, thus affecting the flow of the internal liquid.

[0118] In addition, the hardness of the reinforcing tube 54 is greater than that of the inner sheath hose 51, and the distal end of the guide sleeve 53 is sleeved on the proximal end of the reinforcing tube 54, which facilitates the transmission of torque on the inner sheath handle 4 side to the relatively less hard inner sheath hose 51.

[0119] Both the reinforcing tube 54 and the inner sheath hose 51 pass through the opening 166 of the sealing element 165 of the outer sheath joint 16. Since the reinforcing tube 54 is sleeved on the outer circumference of the inner sheath hose 51, the outer wall of the reinforcing tube 54 is in direct contact with the sealing element 165. The hardness of the reinforcing tube 54 is higher than that of the inner sheath hose 51, which strengthens the position where the reinforcing tube 54 connects to the outer sheath joint 16. The reinforcing tube 54 protects the inner sheath hose 51, preventing the sealing element 165 from compressing the inner sheath hose 51, damaging the structure of the inner sheath hose 51, and affecting the axial movement and circumferential rotation of the inner sheath hose 51.

[0120] It is understood that the various embodiments / implementations provided by the present invention can be combined with each other without causing contradictions, and will not be described one by one here.

[0121] In the embodiments of the invention, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance; the term "multiple" refers to two or more unless otherwise explicitly defined. The terms "install," "connect," "link," and "fix" should be interpreted broadly. For example, "connect" can be a fixed connection, a detachable connection, or an integral connection; "link" can be a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the invention according to the specific circumstances.

[0122] In the description of the embodiments of the invention, it should be understood that the terms "upper", "lower", "left", "right", "front", "rear", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of the invention and simplifying the description, and do not indicate or imply that the device or unit referred to must have a specific orientation or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of the invention.

[0123] In the description of this specification, the terms "one embodiment," "some embodiments," "specific embodiment," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0124] The above are merely preferred embodiments of the invention and are not intended to limit the scope of the invention. Those skilled in the art will recognize that various modifications and variations can be made to the invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the invention should be included within the protection scope of the invention.

Claims

1. A conveying device, characterized in that, include: An outer sheath component includes an outer sheath handle and an outer sheath tube assembly at least partially disposed distal to the outer sheath handle. Both the outer sheath handle and the outer sheath tube assembly form a cavity between their proximal and distal ends, and the two cavities are connected. The outer sheath handle is used by an operator to move the outer sheath tube assembly, and the distal end of the outer sheath tube assembly is used for detachable connection to an implantable device. The outer sheath handle includes an outer handle housing and a first injection connector. The first injection connector includes a valve body and an opening / closing assembly. The valve body includes a first seat and a second seat. The first seat forms a receiving channel for receiving an injection device. The second seat includes a channel portion and a connecting portion connected to each other. The connecting portion is detachably connected to the first seat. The channel portion and the connecting portion form a fluid channel communicating with the outer sheath assembly. The outer wall of the channel portion forms a recessed clearance space in the direction of the fluid channel axis relative to the outer wall of the connecting portion. The inner sheath component includes an inner sheath handle and an inner sheath tube assembly at least partially disposed distal to the inner sheath handle. The inner sheath tube assembly passes through the two cavities, and the distal end of the inner sheath tube assembly is used for detachable connection with the implantable device. At least a portion of the inner sheath handle is exposed outside the outer sheath handle. The inner sheath handle is used for operation by an operator to move the inner sheath tube assembly. The delivery device also includes a locking member connected between the outer sheath handle and the inner sheath assembly, and the locking member is capable of switching between a locked state and an unlocked state. In the unlocked state, the outer sheath member and the inner sheath member are capable of relative movement; In the locked state, the locking member deforms and clamps the inner sheath assembly, thereby preventing relative movement between the inner sheath assembly and the outer sheath assembly; Part of the locking member is disposed in the cavity of the outer sheath handle, and the inner sheath tube assembly passes through the locking member.

2. The conveying device according to claim 1, characterized in that, The inner sheath handle and the outer sheath handle are spaced apart axially.

3. The conveying device according to claim 1, characterized in that, The inner sheath handle is located at the proximal end of the delivery device, and the inner sheath assembly can move proximally from the two cavities of the outer sheath member until it is completely detached from the outer sheath member under the action of the inner sheath handle.

4. The conveying device according to claim 1, characterized in that, The outer sheath handle is capable of moving the outer sheath assembly axially or rotating it circumferentially relative to the inner sheath member; and / or The inner sheath handle can drive the inner sheath assembly to move axially or rotate circumferentially relative to the outer sheath member.

5. The conveying device according to any one of claims 1 to 4, characterized in that, The locking component includes: The first locking tube is axially movable within the cavity of the outer sheath handle, and the inner sheath tube assembly passes through the first locking tube. The second locking tube is fixed axially and rotatably connected to the outer sheath handle. The second locking tube is used to drive the first locking tube to move relative to the second locking tube along the axial direction of the first locking tube. An extrusion member is disposed on the first locking tube, the second locking tube, or the outer sheath handle; and A clamping member is disposed on the first locking tube and / or the second locking tube. During the process in which the second locking tube rotates and causes the first locking tube to move relative to the second locking tube along the axial direction of the first locking tube, the clamping member is deformed by the extrusion member at least in the radial direction to clamp the inner sheath tube assembly.

6. The conveying device according to claim 5, characterized in that, The first locking tube and the second locking tube are threaded together.

7. The conveying device according to claim 5, characterized in that, The clamping member is disposed at the proximal end of the first locking tube; the squeezing member is disposed in the second locking tube.

8. The conveying device according to claim 7, characterized in that, The second locking tube includes a first tube segment, and the first locking tube passes through the first tube segment; The extrusion member is disposed at the proximal end of the first pipe section and extends obliquely toward the axis of the second locking pipe.

9. The conveying device according to claim 8, characterized in that, The inner wall surface of the extruder has a first sliding surface, the distal end of the first sliding surface having a smaller radial dimension than the proximal end, the first sliding surface being used to slide and engage with the proximal end of the clamping member, and to extrude the clamping member at least radially.

10. The conveying device according to claim 9, characterized in that, The clamping member includes a plurality of circumferentially spaced jaws, and the proximal end of each jaw is provided with a second sliding surface. The second sliding surface is used to slide and engage with the first sliding surface, such that the first sliding surface can compress the second sliding surface at least radially, so that the plurality of jaws deform at least at their proximal ends and move closer to each other, thereby clamping the inner sheath assembly.

11. The conveying device according to claim 8, characterized in that, The second locking tube further includes a second tube segment disposed at the proximal end of the extrusion member; the locking member further includes a knob fixedly connected to the second locking tube and exposed on the surface of the outer sheath handle.

12. The conveying device according to any one of claims 1 to 4, characterized in that, The inner sheath assembly includes a guide sleeve and an inner sheath hose. The proximal end of the guide sleeve is connected to the inner sheath handle. The guide sleeve is fitted around the inner sheath hose. The hardness of the guide sleeve is greater than that of the inner sheath hose. The locking member is used to clamp the outer periphery of the guide sleeve.

13. The conveying device according to claim 1, characterized in that, The outer handle housing surrounds the cavity of the outer sheath handle. The outer handle housing includes an outer sheath interface portion, which has a first opening. The cavity in the outer sheath handle extends to the outer sheath interface portion and passes through the first opening. The first injection connector is disposed at the outer sheath interface portion and is exposed on the surface of the outer handle housing through the first opening for connection with a first injection device. The first injection device is used to supply liquid to the outer sheath assembly through the first injection connector. The inner sheath handle includes an inner handle housing and a second injection connector. The second injection connector is disposed inside the inner handle housing and communicates with the proximal end of the inner sheath assembly. The inner handle housing includes an inner sheath interface portion with a second opening. The second injection connector is disposed in the inner sheath interface portion and exposed on the surface of the inner handle housing through the second opening for connection with a second injection device. The second injection device is used to supply liquid to the inner sheath assembly.

14. The conveying device according to claim 13, characterized in that, The outer sheath handle further includes a first conductive connector, which is disposed at the outer sheath interface and electrically connected to the outer sheath assembly. The first conductive connector is exposed on the outer sheath handle through the first opening for connection to a first external power source, which supplies electrical energy to the outer sheath assembly through the first conductive connector; and / or The inner sheath handle also includes a second conductive connector, which is disposed at the inner sheath interface and electrically connected to the inner sheath tube assembly. The second conductive connector is exposed in the inner sheath handle through the second opening and is used to connect to a second external power source. The second external power source provides electrical energy to the inner sheath tube assembly through the second conductive connector.

15. The conveying device according to claim 13, characterized in that, The outer sheath interface protrudes from the outer wall of the outer handle housing. The first opening is located at the end of the outer sheath interface away from the outer handle housing. The protruding direction of the outer sheath interface is inclined relative to the axis of the outer handle housing. The first opening faces the proximal end of the outer handle housing.

16. The conveying device according to any one of claims 13 to 15, characterized in that, The valve body forms a receiving channel and a fluid channel. The receiving channel is connected to the first opening and is used to receive the injection end of the first injection device. The fluid channel is connected to the outer sheath assembly. The opening and closing assembly has a slit that penetrates two opposite sides in the thickness direction of the opening and closing assembly. The opening and closing assembly is located between the receiving channel and the fluid channel. The injection end of the first injection device is used to pass through the slit along the receiving channel into the fluid channel and inject liquid into the fluid channel. The liquid flows through the fluid channel into the inner cavity of the outer sheath assembly.

17. The conveying device according to claim 16, characterized in that, The opening and closing assembly includes a resilient gasket with the cutout formed thereon; When the injection end of the first injection device is inserted into the incision, the incision opens, and the liquid flowing out of the injection end can flow out from the injection connector through the fluid channel; The cut is closed in its natural state, and the receiving channel and the fluid channel are isolated by the gasket.

18. The conveying device according to claim 16, characterized in that, The opening and closing assembly is sandwiched between the first base and the second base.

19. The conveying device according to claim 18, characterized in that, The connecting portion forms a recessed receiving groove in the direction away from the receiving channel, the opening and closing component covers the opening of the receiving groove, the receiving groove is used to receive the injection end of the first injection device, and the bottom surface of the receiving groove forms an abutment surface for abutting the injection end.

20. The conveying device according to claim 19, characterized in that, The contact surface is formed with a guide groove that is recessed away from the opening and closing component, and the guide groove is in communication with the fluid channel.

21. The conveying device according to claim 18, characterized in that, The outer sheath component includes an outer sheath connector for connecting the fluid channel of the first injection connector and the outer sheath assembly; the outer sheath connector and / or the outer sheath assembly pass through the clearance space.

22. The conveying device according to claim 21, characterized in that, The axis of the fluid channel and the axis of the receiving channel are offset from each other.

23. The conveying device according to claim 16, characterized in that, The outer sheath handle also includes: An outer sheath connector is disposed in the cavity of the outer handle housing and has a main channel and a branch channel that are interconnected. The proximal end of the outer sheath tube assembly is connected to the distal end of the outer sheath connector and communicates with the main channel. The inner sheath tube assembly passes through both ends of the main channel. A connecting pipe, one end of which is connected to the fluid channel and the other end of which is connected to the branch channel.

24. The conveying device according to claim 23, characterized in that, The outer sheath connector includes: A main conduit, forming the main channel; the distal end of the main conduit connects to the proximal end of the outer sheath assembly, and the inner sheath assembly passes through the main conduit; and A branch pipe forms the branch channel and is connected to the main pipe; the axis of the branch pipe is inclined relative to the axis of the main pipe, and the end of the branch pipe away from the main pipe extends towards the proximal end of the main pipe.

25. The conveying device according to claim 23, characterized in that, The inner sheath assembly includes: An inner sheath tube, the distal end of which is connected to the implantable device; A reinforcing tube is fitted around the outer periphery of the inner sheath hose; the hardness of the reinforcing tube is greater than the hardness of the inner sheath hose. The outer sheath connector is tubular, and an elastic seal is provided at the proximal end of the outer sheath connector. The seal has an opening in the axial direction for the reinforcing tube and the inner sheath hose to pass through.

26. The conveying device according to claim 23, characterized in that, The outer sheath handle also includes a positioning structure for positioning the connecting tube. The positioning structure is disposed on the inner wall of the cavity of the outer sheath handle and is located at the proximal end of the outer sheath handle.

27. A medical device system, characterized in that, include: An implantable device includes a first connector and a second connector spaced apart from each other; as well as The delivery device according to any one of claims 1 to 26, wherein the distal end of the outer sheath assembly is detachably connected to the first connector, and the distal end of the inner sheath assembly is detachably connected to the second connector; the delivery device is used to deliver and release the implantable device into the patient.

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