Interventional medical device delivery device and delivery assembly

Abstract

The utility model discloses a kind of interventional medical instrument conveyer and conveying assembly, comprising: outer sheath, sheath core subassembly, handle main body and sheath tube retreat structure;Sheath tube retreat structure is located in handle main body, and sheath tube retreat structure includes: rotor, slider, limiting structure and outer sheath connecting piece;Thread is provided on rotor, rotor can be operated relative to handle main body rotation, sliding portion is provided on slider, and sliding portion is engaged with the thread of rotor, slider moves by the rotation of rotor drive, limiting structure is used to limit the rotary motion of slider relative to rotor;The proximal end of outer sheath is fixedly connected with outer sheath connecting piece, and the distal end of outer sheath connecting piece is connected with slider, and outer sheath connecting piece is retreated by slider push;Sheath core subassembly includes sheath core and middle layer pipe, and middle layer pipe is fixedly sleeved outside sheath core, and outer sheath is movably sleeved outside middle layer pipe, and the proximal end of sheath core extends out of middle layer pipe and is fixed, and through channel is provided on middle layer pipe, and guiding passage is used for the release of medical instrument to pass through.The utility model solves the problem that conveying device will have greater frictional resistance when loading and releasing medical instrument, leading to loading and releasing more difficult, and it is difficult to accurately control sheath tube retreat distance when releasing.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to an implantable medical device delivery device and delivery assembly. Background Technology

[0002] Interventional therapy is a new technology that has been applied in clinical practice in recent years. It involves pre-loading an implantable medical device into a delivery system, then introducing it into the human body, and releasing the medical device to the lesion site under the monitoring of a fluoroscopic device to achieve the therapeutic purpose. For example, in the treatment of cardiovascular diseases, a stent is delivered to the lesion through a delivery system, and then the stent is released to expand and support the blood vessel wall.

[0003] For implantable medical devices that require pre-loading onto a delivery system, during loading, the device is first secured to the sheath core via a release mechanism to position the device axially. The distal end of the release mechanism extends from the outer sheath to the delivery system's handle. The loading component is inserted into the outer sheath and connected to the device. By pulling the loading component backward, the device, release mechanism, and sheath core are loaded as a whole into the outer sheath, where the support is compressed under its radial constraint. During release, the outer sheath is retracted, and the release mechanism on the handle is operated to release the constraint on the device.

[0004] During loading, the loading component experiences significant frictional resistance, making loading difficult. Additionally, before release, the support is compressed by the radial constraint of the outer sheath, resulting in considerable friction between the support and the outer sheath. During release, the outer sheath needs to be pulled backward to overcome this friction and detach the support. When directly pulling the outer sheath backward, the frictional resistance makes the retraction release operation difficult and precise control of the retraction distance challenging. Furthermore, after loading is complete, the release component also experiences significant frictional resistance, making retraction difficult as well. Utility Model Content

[0005] The main objective of this invention is to provide an implantable medical device delivery device to solve the problem that in related technologies, the delivery device experiences significant frictional resistance during loading and releasing of medical devices, making loading and releasing difficult and making it difficult to accurately control the retraction distance of the outer sheath during release.

[0006] To achieve the above objectives, this utility model provides an implantable medical device delivery device, comprising: an outer sheath, a sheath core assembly, a handle body, and a sheath retraction structure; wherein, the sheath retraction structure is located inside the handle body and includes: a rotor, a slider, a limiting structure, and an outer sheath connector; the rotor is threaded and operably rotatable relative to the handle body; the slider is provided with a sliding part that engages with the rotor's thread, driving the slider to move through the rotor's rotation; the limiting structure restricts the slider's rotational movement relative to the rotor; the proximal end of the outer sheath is fixedly connected to the outer sheath connector, and the distal end of the outer sheath connector is connected to the slider, pushing the outer sheath connector backward through the slider to retract the outer sheath; the sheath core assembly includes a sheath core and a middle layer tube, the middle layer tube being sleeved and fixed outside the sheath core, and the outer sheath being movably sleeved outside the middle layer tube; the proximal end of the sheath core extends out of and is fixed to the middle layer tube, and the middle layer tube is provided with a through guide channel for the release component of the medical device to pass through.

[0007] Optionally, the handle body is provided with a loading and release channel, the distal end of the sheath core extends into a middle tube and forms a loading space for loading medical devices between it and the outer sheath tube, and the two ends of the guide channel are respectively connected to the loading and release channel and the loading space.

[0008] Optionally, the guide channel includes a groove provided on the inner side wall of the intermediate layer tube; or, the guide channel includes a groove provided on the outer side wall of the intermediate layer tube; or, the guide channel includes a through hole provided in the wall of the intermediate layer tube.

[0009] Optionally, the sheath core assembly also includes a sleeve embedded in a guide channel for guiding the release and loading components through.

[0010] Optionally, multiple bushings are provided, and the multiple bushings are distributed at intervals within the guide channel; at least one of the multiple bushings is located at one end of the guide channel near the loading space, and at least one of the multiple bushings is located at one end of the guide channel near the loading release channel.

[0011] Optionally, the inner wall of the rotor is provided with threads, and the slider is disposed inside the rotor; the limiting structure includes a first limiting part and a second limiting part; the first limiting part is disposed between the slider and the second end of the outer sheath tube connector, and is used to limit the rotation of the slider relative to the outer sheath tube connector; the second limiting part is used to limit the rotational movement of the outer sheath tube connector relative to the rotor.

[0012] Optionally, the second end of the outer sheath connector is axially mated with the slider so that the slider can push the outer sheath connector backward, while the outer sheath connector can be retracted independently and separated from the slider.

[0013] Optionally, the first limiting part includes a first locking part and a second locking part. The first locking part is disposed on the slider, and the second locking part is disposed at the second end of the outer sheath connector. The first locking part and the second locking part engage to limit the rotational movement of the slider relative to the rotor.

[0014] Optionally, the outer sheath connector includes a sheath joint and a connecting rod. The connecting rod is fixedly connected to the sheath joint. The first end of the connecting rod is used to fixally connect the outer sheath, and the second end of the connecting rod is used to connect to the slider. A first limiting part is provided between the second end of the connecting rod and the slider.

[0015] Optionally, the second limiting part includes a limiting tube for fixing inside the handle body. A third locking part is provided on the limiting tube along the axial direction, and a fourth locking part is provided on the outer sheath tube connector. The fourth locking part engages with the third locking part and can move relative to each other along the axial direction, so as to limit the rotation of the outer sheath tube connector while allowing the outer sheath tube connector to move axially relative to the handle.

[0016] Optionally, the first snap-fit ​​portion is a first snap-fit ​​groove located near the end of the slider, and the second snap-fit ​​portion is a second snap-fit ​​protrusion. The second snap-fit ​​protrusion and the first snap-fit ​​groove are inserted and engaged along the axial direction of the rotor. The distance between the sidewall of the first snap-fit ​​groove and the axis of the slider is less than or equal to the inner radius of the slider.

[0017] Optionally, it also includes a retainer connected to the outer sheath connector and rotatable about the axis of the outer sheath connector; a first state limiting structure disposed on the retainer, which can be in a first state and a second state as the retainer rotates; and a second state limiting structure disposed on the limiting tube, in which the first state limiting structure and the second state limiting structure abut against each other in the retraction direction of the outer sheath connector in the first state, and in the second state, the first state limiting structure and the second state limiting structure are completely offset in the circumferential direction.

[0018] Optionally, the first state limiting structure is located on the inner wall of the fixer, the limiting tube is sleeved inside the fixer, and the fixer and the outer sheath tube connector can move linearly along the axial direction relative to the limiting tube; the second state limiting structure is located on the outer wall of the limiting tube.

[0019] Optionally, it also includes a retainer, which is connected to the outer sheath connector and can rotate about the axis of the outer sheath connector; the retainer is provided with an unlock button, which can be toggled to rotate the retainer; the handle body is provided with a connecting blocking groove and a retraction groove, the retraction groove is arranged along the axial direction of the handle body, the blocking groove is arranged along the circumference of the handle body, and the unlock button can rotate from the blocking groove into the retraction groove and slide within the retraction groove.

[0020] Optionally, it also includes a locking structure, which is located between the outer sheath connector and the retainer, and is used to lock the rotation angle of the retainer.

[0021] Optionally, it also includes a connector body, the distal end of which is provided with a first connecting part, which is connected to the proximal end of the handle body; the connector body is provided with a first channel, a second channel and a third channel that are interconnected, the two ends of the first channel are open structures, and the second channel and the third channel are located on the side of the first channel; the proximal end of the sheath core passes through the first channel and is fixed, the second channel is used for the release part of the delivery device to pass through, and the third channel is used for injecting liquid into the distal end of the delivery device.

[0022] Optionally, two or more second channels are provided, with different second channels used to pass through different release elements.

[0023] Optionally, it also includes a rigid sleeve, which is sleeved on the outside of the sheath core. The distal end of the rigid sleeve passes through the outer sheath tube connector, and the proximal end of the rigid sleeve is fixed in the first channel. The outer sheath tube connector can move along the axial direction of the rigid sleeve. There is a movable space between the rigid sleeve and the sheath core sub-assembly, and the guide channel, the second channel, and the third channel are connected to the movable space.

[0024] Optionally, it also includes a second seal fixed to the proximal end of the outer sheath connector and slidably sleeved on the rigid sleeve to seal the liquid flow channel between the sheath core assembly and the outer sheath connector during movement of the outer sheath connector.

[0025] Optionally, the first channel includes a distal channel, a mid-channel, and a proximal channel; wherein, the diameter of the distal channel is larger than the diameter of the mid-channel, the proximal end of the rigid sleeve is fixed in the distal channel and abuts against the inner end face of the distal channel; the proximal end of the sheath core extends out of the distal channel and is fixed after passing through the mid-channel and the proximal channel; the entrance of the second channel is located in the mid-channel and close to the distal channel, and the entrance of the third channel is located in the mid-channel and close to the proximal channel.

[0026] Optionally, it also includes a guidewire connector and a release connector, the guidewire connector being connected to the first channel and used to guide the guidewire into the sheath core of the sheath core assembly;

[0027] The guide wire connector is provided with a second connecting part, which is used to fix and connect to the proximal end of the handle body;

[0028] A first sealing element is provided inside the end of the first channel, and the first sealing element is sealed and sleeved on the sheath core and abuts against the end face of the guide wire connector;

[0029] The release element connector is detachably fixed to the connector body via a quick-release structure and corresponds to the second channel. The release element connector is used to fix the release element extending from the distal end of the second channel.

[0030] Optionally, the handle body also includes a first housing and a second housing, which are fastened together and fixed. A third connecting part, a fourth connecting part, and a fifth connecting part are provided between the first housing and the second housing. The distal end of the connector body is located between the first housing and the second housing and is fixed by the cooperation of the third connecting part and the first connecting part. The distal end of the guide wire connector is located between the first housing and the second housing and is fixed by the cooperation of the fourth connecting part and the second connecting part. The limiting tube is located between the first housing and the second housing and is fixed by the fifth connecting part.

[0031] According to another aspect of the present invention, a conveying assembly is provided, including the above-described conveyor and a release member;

[0032] The release element is inserted into the second channel, the active space, and the guide channel. The distal end of the release element extends into the loading space and constrains the medical device onto the sheath core. The proximal end of the release element extends out of the second channel and is fixed by the release element connecting connector.

[0033] Optionally, it also includes a fixing member, which is fixed to the sheath core and located in the loading space; the distal end of the release member passing through the fixing member has a bend, which hooks onto the fixing member to fix the position of the release member relative to the fixing member, and the bend can deform under the backward traction force of the release member to detach from the fixing member and release the restriction on the medical device; or, the distal end of the release member is fixedly connected to the fixing member, and the portion of the release member used to restrict the medical device is provided with a breakable part, which is configured to break when the backward traction force on the release member exceeds a preset value; or, the distal end of the release member is used to pass through the fixing member or between the fixing member and the sheath core, the fixing member includes a deformable part, which applies pressure to the release member through deformation to fix the release member and the fixing member to restrict the position of the medical device on the sheath core.

[0034] In this embodiment of the invention, an outer sheath, a sheath core assembly, a handle body, and a sheath retraction structure are provided. The sheath retraction structure is located within the handle body and includes a rotor, a slider, a limiting structure, and an outer sheath connector. The rotor has threads and can be operably rotated relative to the handle body. The slider has a sliding part that engages with the rotor's threads, driving the slider to move via the rotor's rotation. The limiting structure restricts the slider's rotational movement relative to the rotor. The proximal end of the outer sheath is fixedly connected to the outer sheath connector, and the distal end of the outer sheath connector is connected to the slider. The slider pushes the outer sheath connector backward, thus retracting the outer sheath. The sheath core assembly includes a sheath core and a middle layer tube. The middle layer tube is sleeved and fixed outside the sheath core, and the outer sheath is movably sleeved outside the middle layer tube. The proximal end of the sheath core extends out of and is fixed to the middle layer tube. The middle layer tube has a through guide channel for the release element of the medical device to pass through.

[0035] On the one hand, because the rotor is rotated during the retraction of the outer sheath tube, the screw of the rotor drives the slider to move linearly, and the slider pushes the outer sheath tube connector to move linearly, it is more labor-saving than directly pulling the outer sheath tube connector in the same environment of frictional resistance, making it easier for the operator to perform the retraction of the outer sheath tube and reducing the difficulty of operation.

[0036] On the other hand, due to the use of a threaded drive, the retraction distance can be controlled more easily, improving the accuracy of retraction. The retraction rhythm is controllable and orderly, allowing for simultaneous release and adjustment of the position of the medical device within the body. This reduces the need for deliberate force during release, which distracts attention from the simultaneous observation required, thus improving safety.

[0037] On the other hand, by setting the guide channel on the middle tube, sufficient movement space can still be provided for the release component and the loading component even when the outer contour size of the outer sheath tube is small. This can reduce the friction force on the loading component during the movement of the loading component, thereby reducing the loading resistance. It can also reduce the friction force on the release component during the movement of the release component, thereby reducing the release resistance.

[0038] Furthermore, the guide channels on the middle tube allow both the release and loading components to move via these channels, eliminating the need for significant bending into the gap between the middle and outer sheath tubes. This reduces or eliminates resistance from the ends of the middle tube to the release and loading components during movement, further reducing loading and releasing resistance and improving the smoothness of their movement. Additionally, the guide channels constrain the circumferential position of the release components, preventing entanglement between multiple components and avoiding increased pulling resistance or even failure to pull. Moreover, the ability for the release and loading components to move within different channels also prevents interference between them during loading. Attached Figure Description

[0039] The accompanying drawings, which form part of this utility model, are used to provide a further understanding of the utility model, making other features, objects, and advantages of the utility model more apparent. The illustrative embodiments of the utility model and their descriptions are used to explain the utility model and do not constitute an undue limitation of the utility model. In the drawings:

[0040] Figure 1 This is a partial cross-sectional view of the conveyor according to an embodiment of the present invention;

[0041] Figure 2 This is a structural schematic diagram of the sheath core assembly according to an embodiment of the present utility model;

[0042] Figure 3 This is a schematic diagram of the structure after the sleeve is configured according to an embodiment of this utility model;

[0043] Figure 4 This is a schematic diagram of the structure after the sleeve is configured according to another embodiment of the present invention;

[0044] Figure 5 This is a schematic diagram of the cross-sectional structure of the middle layer tube according to an embodiment of the present invention;

[0045] Figure 6 This is a schematic diagram of the cross-sectional structure of the middle layer tube according to another embodiment of the present invention;

[0046] Figure 7 This is a schematic diagram of the cross-sectional structure of the middle layer tube according to another embodiment of the present invention;

[0047] Figure 8 This is a schematic diagram of the sheath retraction structure according to an embodiment of the present utility model;

[0048] Figure 9 This is a schematic diagram showing that the rotor is a split structure according to an embodiment of this utility model;

[0049] Figure 10 This is a schematic diagram of an integral rotor structure according to an embodiment of the present utility model;

[0050] Figure 11 yes Figure 1 The diagram shows the exploded structure of the conveyor.

[0051] Figure 12 yes Figure 11 The diagram shows the assembly structure of the conveyor.

[0052] Figure 13 This is a schematic diagram of the sheath retraction structure according to another embodiment of the present invention;

[0053] Figure 14 yes Figure 13 A schematic diagram of the assembly of the inner and outer sheath connectors and the slider;

[0054] Figure 15 This is a cross-sectional view of the conveyor according to another embodiment of the present invention;

[0055] Figure 16 This is a structural schematic diagram according to one embodiment of the present utility model;

[0056] Figure 17 This is a cross-sectional structural schematic diagram of the first state limiting structure in a first state according to an embodiment of the present invention;

[0057] Figure 18 This is a cross-sectional structural schematic diagram of the first state limiting structure in the second state according to an embodiment of the present invention;

[0058] Figure 19 Based on this utility model Figure 12 A schematic diagram of the cross-sectional structure in the embodiment shown;

[0059] Figure 20 This is a schematic diagram of the locking structure in this utility model;

[0060] Figure 21 This is a cross-sectional view of the locking structure in this utility model;

[0061] Figure 22 This is an exploded structural diagram of the fixator and sheath joint in this utility model;

[0062] Figure 23 This is a schematic diagram of the assembly structure of the fixator and the sheath connector in this utility model;

[0063] Figure 24 This is a cross-sectional view of the conveyor after the connector is installed according to one embodiment of the present invention;

[0064] Figure 25 This is an exploded structural diagram of the conveyor according to one embodiment of the present invention;

[0065] Figure 26 This is a structural schematic diagram of the assembly of the connector body and the outer sheath tube connector according to one embodiment of the present utility model;

[0066] Figure 27 This is a schematic diagram of the connector structure according to one embodiment of the present invention;

[0067] Figure 28 This is a schematic diagram of the conveyor according to one embodiment of the present invention;

[0068] Figure 29 This is a schematic diagram of the structure in which the distal end of the release member is in a locked state according to one embodiment of the present invention;

[0069] Figure 30 This is a schematic diagram of the structure of the release member in a state of being ready to be released according to one embodiment of the present invention;

[0070] Figure 31 This is a schematic diagram of the structure in which the distal end of the release member is in a locked state according to another embodiment of the present invention;

[0071] Figure 32 yes Figure 31 A magnified structural diagram of part A in the middle;

[0072] Figure 33 This is a schematic diagram of the structure in which the distal end of the release member is in a locked state according to another embodiment of the present invention;

[0073] Figure 34 This is a structural schematic diagram of the wire fixing component according to one embodiment of the present utility model;

[0074] Figure 35 This is a structural schematic diagram of the wire fixing member according to another embodiment of the present utility model. Detailed Implementation

[0075] It should be noted that, where there is no conflict, the embodiments and features in the embodiments of this utility model can be combined with each other. The present utility model will now be described in detail with reference to the accompanying drawings and embodiments.

[0076] To solve related technical problems, such as Figure 1 , Figure 2 and Figure 8As shown, this utility model embodiment provides an implantable medical device delivery device, including: an outer sheath 200, a sheath core assembly 3, a handle body 1, and a sheath retraction structure; wherein, the sheath retraction structure is disposed inside the handle body 1, and the sheath retraction structure includes: a rotor 12, a slider 13, a limiting structure, and an outer sheath connector 14; the rotor 12 is provided with threads, and the rotor 12 is operably rotatable relative to the handle body 1; the slider 13 is provided with a sliding part 130, which engages with the threads of the rotor 12, and the rotation of the rotor 12 drives the slider 13 to move; the limiting structure is used to limit the slider. 13 rotates relative to rotor 12; the proximal end of outer sheath 200 is fixedly connected to outer sheath connector 14, and the distal end of outer sheath connector 14 is connected to slider 13. The slider 13 pushes outer sheath connector 14 backward to push outer sheath 200 backward; sheath core assembly 3 includes sheath core 30 and middle layer tube 31. Middle layer tube 31 is sleeved and fixed outside sheath core 30. Outer sheath 200 is movably sleeved outside middle layer tube 31. The proximal end of sheath core 30 extends out of middle layer tube 31 and is fixed. A through guide channel 32 is provided on middle layer tube 31. The guide channel 32 is used for the release element of medical device to pass through.

[0077] A medical device delivery system is used to deliver implantable medical devices to the lesion site within the human body and to release the implantable medical device. Taking a stent as an example of an implantable medical device, the delivery system mainly includes a handle body 11, an outer sheath 200 connected to the handle body 11, a sheath core assembly 3, and a sheath retraction structure. The sheath retraction structure is located within the handle body 1, and the outer sheath 200 is fixedly connected to the sheath retraction structure, which drives the outer sheath 200 to retract. The sheath core assembly 3 passes through the outer sheath 200, and the stent can be mounted between the distal end of the sheath core assembly 3 and the distal end of the outer sheath 200, with the outer sheath 200 providing radial constraint on the stent.

[0078] During bracket loading, a loading component can be connected to the proximal end of the bracket. The loading component extends out after passing through the outer sheath 200 and the handle body 1. By pulling the loading component backward, the bracket is pulled between the outer sheath 200 and the sheath core assembly 3. After the bracket is loaded, its axial position needs to be constrained. Therefore, a release component needs to be connected to the bracket. The release component passes through at least a portion of the bracket and is fixedly connected to the fixing structure on the sheath core assembly 3, thereby fixing the relative position of the bracket and the sheath core assembly 3. The proximal end of the release component extends to the handle body 1.

[0079] like Figure 29As shown, in some embodiments, the conveyor is used in conjunction with the fixing member 600 and the guide member 700. The fixing member 600 and the guide member 700 are sleeved and fixed to the distal end of the sheath core 30, and the guide member 700 is located at the proximal end of the fixing member 600. A lead wire groove is provided on the guide member 700, and the distal end of the release member 6 can pass through the lead wire groove and then be constrained to the bracket, and then fixedly connected to the fixing member 600, thereby constraining the axial position of the bracket on the sheath core 30. Various fixing methods can be used between the release member 6 and the fixing member 600, which will not be described in detail in this embodiment. In addition, the release member 6 can constrain the position of the bracket by passing through the bracket.

[0080] After the stent is delivered to the lesion site, the sheath retraction mechanism on the handle body 1 is operated first to retract the outer sheath 200, exposing the stent. The stent expands under the action of the expansion force. Then, the release member 6 is operated on the handle body 1 to separate the distal end of the release member 6 from the stent, thereby completely separating the stent from the sheath core assembly 3. This completes the stent delivery and release. After release, the sheath core assembly 3 and the outer sheath 200 are simultaneously withdrawn. In the embodiment that uses the fixing member 600 and the guide member 700, the release member 6 separates from the fixing member 600 after being subjected to a pulling force towards the proximal end, and retracts to separate from the stent, thereby releasing the constraint on the stent.

[0081] like Figure 2 As shown, the sheath core assembly 3 in this embodiment includes a sheath core 30 and a middle layer tube 31. The middle layer tube 31 is sleeved and fixed outside the sheath core 30. The distal end of the sheath core 30 extends out of the middle layer tube 31 and forms a loading space between it and the outer sheath tube 200. The loading space is used to load and accommodate the stent. The proximal end of the sheath core 30 extends out of the middle layer tube 31 and is fixed after passing through the handle body 1. A guide channel 32 is provided on the middle layer tube 31 for the loading component and release component 6 of the medical device to pass through. Specifically, when loading the stent, the loading component can be connected to the stent through the guide channel 32 on the middle layer tube 31. During loading, pulling the loading component backward allows it to move along the guide channel 32. The release component 6 can also be connected to the stent through the guide channel 32, thereby constraining the position of the stent on the sheath core 30. During release, pulling the release component 6 backward allows it to move along the guide channel 32. Of course, when the number of guide channels 32 is limited, the loading component may not choose to move through the guide channels 32, but instead move through the gap between the middle tube 31 and the outer sheath tube 200. In this case, the loading component can be made of wire, thread, etc. with a smaller diameter.

[0082] In this embodiment, by providing a guide channel 32 on the middle tube 31, the release component 6 has an independent moving space, avoiding the problem of easy entanglement and twisting of the release component 6 and the loading component in the gap between the middle tube 31 and the outer sheath tube.

[0083] In some embodiments, the number of guide channels 32 corresponds to the number of release members 6. In embodiments where the fixing member 600 and the guide member 700 are used, the position and number of lead slots on the guide member 700 correspond to the position and number of guide channels 32 on the middle layer tube 31, such that the distal end of each release member 6 can enter the corresponding lead slot on the guide member 700 after extending out of the middle layer tube 31 along the corresponding guide channel 32. When a channel is provided in the fixing member 600 for the release member 6 to pass through, the number and position of the channels on the fixing member 600 also correspond to the number of guide channels 32, such that the distal end of each release member 6 can enter the corresponding channel on the fixing member 600 after extending out of the guide member 700.

[0084] In some embodiments, the release element 6 is provided in two or more, so two or more guide channels 32 can be provided in the middle tube 31, and the lead groove on the guide 700 and the channel on the fixing element 600 also need to be provided in two or more.

[0085] When a larger outer sheath cannot be used for surgery, such as in the TIPS procedure, where only a 10Fr outer sheath can pass through, a guide channel 32 is opened on the middle tube 31 to provide space for the release element 6 and the loading element to move. This reduces loading and release resistance without increasing the size of the outer sheath.

[0086] The implantable medical device mentioned in this embodiment can be a stent or a balloon; the release element 6 can be a wire or rod, such as an elastic metal wire, which can be made of nickel-titanium alloy or stainless steel; the loading element can be a filamentous drawstring made of metal or polymer material, and the distal end of the drawstring can pass through the stent and then return through the guide channel 32. Of course, the drawstring can also be inserted through the guide channel 32, pass through the stent, and return through the gap between the middle layer tube 31 and the outer sheath tube 200.

[0087] Furthermore, in related technologies, the release element 6 is disposed in the gap between the middle tube 31 and the outer sheath tube. At the distal end of the middle tube 31, due to the certain wall thickness of the middle tube 31, the release element 6 needs to bend to fit against the surface of the sheath core 30. When the release element 6 moves, it bends at the end of the middle tube 31 and rubs against the end face of the middle tube 31, increasing the moving resistance of the release element 6. Similarly, the loading element also has corresponding problems.

[0088] Therefore, by providing a guide channel 32 inside the wall of the middle tube 31, whether the guide channel 32 is located inside the wall of the middle tube 31 or is opened on the inner wall of the middle tube 31, the distance between the release member 6, the loading member and the sheath core 30 will be reduced, the degree of bending of the release member 6 at the end of the middle tube 31 will be reduced, the friction between the release member 6 and the end face of the middle tube 31 will be reduced, and thus the loading resistance will be reduced.

[0089] In this embodiment, the sheath retraction structure is adapted to be installed on the handle body 1 of the implantable medical device delivery device, and is used to control the retraction of the outer sheath 200 when the stent is released. Figure 1 and Figure 8 As shown, the sheath retraction structure mainly includes a rotor 12, a slider 13, a limiting structure, and an outer sheath connector 14. The outer sheath connector 14 can be installed inside the handle body 1 of the conveyor. The first end (i.e., the distal end) of the outer sheath connector 14 can be fixedly connected to the first end (i.e., the proximal end) of the outer sheath 200, thereby driving the outer sheath 200 to move. The rotor 12 can be installed inside the handle body 1 and can be operated to rotate in a specific direction, such as clockwise or counterclockwise. A thread is provided on the rotor 12, which can be located on the outer wall or the inner wall of the rotor 12. When the thread is located on the inner wall of the rotor 12, the rotor 12 should be a hollow structure. A sliding part 130 is provided on the slider 13, which can engage with the thread on the rotor 12. The sliding part 130 can be a thread on the slider 13, allowing the slider 13 to be threadedly connected to the rotor 12. The sliding part 130 can be a columnar protrusion or a short thread provided on the slider 13. After the columnar protrusion engages in the thread of the rotor 12, the columnar protrusion or the short thread can move linearly along a specific trajectory during the rotation of the rotor 12.

[0090] In this embodiment, the slider 13 moves linearly by rotating the rotor 12. Therefore, after the sliding part 130 on the slider 13 engages with the thread on the rotor 12, it is necessary to further restrict the rotational movement of the slider 13 so that during the rotation of the rotor 12, the slider 13 can only move linearly along the axial direction and cannot rotate with the rotor 12. For this purpose, a limiting structure is provided in this embodiment to restrict the rotational movement of the slider 13 relative to the rotor 12.

[0091] Depending on the function of the limiting structure, when the slider 13 is installed on the outer wall of the rotor 12, the limiting structure can be a groove, slide rail, guide rod on the handle body 1, a sliding protrusion, sliding hole, etc. on the slider 13. When the sliding hole is installed on the inner wall of the rotor 12, the slider 13 is not easy to cooperate with the structure on the handle body 1. In this case, the limiting structure can be arranged between the outer sheath tube connector 14 and the slider 13. This will not be described in detail in this embodiment.

[0092] Under the rotation of rotor 12, slider 13 can move linearly along the axial direction, and then pushes outer sheath connector 14 to move linearly, thereby causing outer sheath 200 to retract. Various connection relationships can be adopted between slider 13 and outer sheath connector 14. For example, slider 13 and the second end (i.e., the distal end) of outer sheath connector 14 can abut against each other, or slider 13 and the second end of outer sheath connector 14 can be axially inserted, or slider 13 and the second end of outer sheath connector 14 can be fixed, etc. In this embodiment, the connection relationship between the two is not limited, as long as it satisfies the requirement that the thrust of slider 13 is applied to outer sheath connector 14.

[0093] In this embodiment, during retraction, the rotor 12 is rotated in a directional manner. During the rotation of the rotor 12, the rotational movement of the slider 13 is restricted by a limiting structure, causing the slider 13, which meshes with the threads on the rotor 12, to move linearly along the axial direction of the rotor 12. Since the slider 13 is connected to the outer sheath connector 14, and the outer sheath connector 14 is connected to the outer sheath 200, the backward linear movement of the slider 13 can push the outer sheath connector 14 and the outer sheath 200 backward. Because the rotor 12 rotates during the retraction of the outer sheath 200, the threads of the rotor 12 drive the slider 13 to move linearly, and the slider 13 pushes the outer sheath connector 14 linearly. Under the same frictional resistance, this method is more labor-saving than directly pulling the outer sheath connector 14, making it easier for the operator to retract the outer sheath 200 and reducing the operational difficulty. This solves the problem in related technologies where the release of medical devices within the delivery device is difficult due to high release resistance.

[0094] Furthermore, due to the use of a threaded drive, the retraction distance can be controlled more easily, improving the accuracy of retraction. The retraction rhythm is controllable and orderly, allowing for simultaneous release and adjustment of the medical device's position within the body. This reduces the need for deliberate force during release, which can distract from the need for simultaneous observation and improves safety.

[0095] In one embodiment, when the outer wall of the rotor 12 is threaded and the slider 13 is located on the outside of the rotor 12, although the outer sheath 200 can be retracted in a relatively effortless manner, the inner diameter of the slider 13 will be larger than the outer diameter of the rotor 12, resulting in a less efficient effort-saving effect. Therefore, as... Figure 1 and Figure 8 As shown, in this embodiment, the slider 13 is disposed inside the rotor 12. Specifically, a thread is provided on the inner wall of the rotor 12, and the slider 13 is disposed inside the rotor 12. With this arrangement, the outer diameter of the rotor 12 is larger than the outer diameter of the slider 13, which can further reduce the effort when the rotor 12 rotates through the lever effect.

[0096] It is understandable that the smaller the thread pitch on the inner wall of rotor 12, the less effort is required, and correspondingly, the more rotations of rotor 12 are needed to achieve the same drive stroke. Conversely, the larger the thread pitch on the inner wall of rotor 12, the more effort is required, and correspondingly, the fewer rotations of rotor 12 are needed to achieve the same drive stroke. The thread pitch can be set according to the actual situation.

[0097] In one embodiment, the handle body 1 is provided with a loading and release channel. The distal end of the sheath core 30 extends into a middle tube 31, forming a loading space for loading medical devices between it and the outer sheath tube 200. The two ends of the guide channel 32 are respectively connected to the loading and release channel and the loading space. Specifically, the proximal end of the loading component passing through the guide channel 32 can be led out through the loading and release channel, thereby facilitating the operation of the loading component. Similarly, the proximal end of the release component passing through the guide channel 32 can also be led out through the loading and release channel.

[0098] Furthermore, the circumferential positions of the release element 6 and the loading element can be constrained by the guide channel 32. When multiple release elements 6 and multiple guide channels 32 are arranged, the multiple release elements 6 are arranged circumferentially one by one in the guide channel. Through the constraint of the guide channel 32, the problem of entanglement between the release elements 6 can be avoided, which would lead to increased pulling resistance or even inability to pull the release elements 6.

[0099] Furthermore, regarding the loading component, taking the loading component as a pull cable as an example, after connecting to the bracket, the loading component needs to return to the handle. Therefore, it is necessary to construct an entry channel and a return channel for the loading component. When there are enough guide channels 32, one guide channel 32 can be used as the entry channel, another guide channel 32 as the return channel, and the remaining guide channels 32 as channels for the release component 6. At this time, by constraining the circumferential positions of different release components through different guide channels 32, the circumferential positions of the two parts of the loading component are also constrained, which can prevent entanglement between release components 6, between release components 6 and the loading component, and between the two parts of the loading component.

[0100] In one implementation, such as Figure 5 As shown, the guide channel 32 includes a groove on the inner wall of the middle tube 31. The groove extends axially along the middle tube 31, connecting the loading space with the loading release channel. This allows the release member 6 to be confined within the groove, enabling it to move within the groove to pull the support and release the support. Furthermore, by creating the groove on the inner wall of the middle tube 31 as the guide channel 32, the release member 6, which is attached to the sheath core 30, will not be excessively bent when entering the guide channel 32, resulting in smoother movement of the release member 6.

[0101] In some other embodiments, the guide channel 32 includes a groove provided on the outer wall of the middle tube 31, the groove extending axially along the middle tube 31 and communicating with the loading space and the loading release channel, which can satisfy the requirement to confine the release member 6 within the groove, so that the release member 6 can move within the groove to pull the bracket and release the bracket.

[0102] In other embodiments, the guide channel 32 can also be a through hole disposed within the wall of the middle layer tube 31, extending axially along the middle layer tube 31, as long as it can connect the loading release channel with the loading space. However, in this embodiment, the release member 6 attached to the sheath core 30 will still bend slightly when entering the guide channel 32, resulting in additional resistance during movement; the same applies to the loading member. Furthermore, opening a hole within the wall of the middle layer tube 31 is more difficult to process than slotting within the wall; therefore, the preferred method in this invention is as follows. Figure 5 As shown, a groove is made on the inner wall of the middle layer tube 31 as a guide channel 32.

[0103] In the above embodiments, when the guide channel 32 is set as a through hole in the wall of the middle layer tube 31, the wall thickness of the middle layer tube 31 needs to meet the requirements of the opening, and the thickness on both sides of the hole needs to meet the standard. For example, if the thinnest part of the wall thickness of the middle layer tube 31 needs to be 0.2mm, then the thickness on both sides of the hole needs to reach 0.2mm, and the overall diameter of the middle layer tube 31 will be larger. However, when the guide channel 32 is set on the inner or outer wall of the middle layer tube 31, only the thickness on one side of the guide channel 32 needs to meet the standard, and the wall thickness requirement of the middle layer tube 31 is lower. This can reduce the overall outer diameter of the middle layer tube 31 and meet the needs of smaller-sized interventions.

[0104] Furthermore, when the guide channel 32 is located on the outer wall of the middle layer tube 31, since the outer sheath tube is also sleeved on the outside of the middle layer tube 31, the release member 6 will be located between the outer sheath tube and the middle layer tube 31. When the outer sheath tube or the release member 6 is retracted, friction will occur between the outer sheath tube and the release member 6, affecting the retraction operation. Therefore, in this utility model, it is preferable to set the guide channel 32 on the inner wall of the middle layer tube 31.

[0105] In this embodiment, the contour of the guide channel 32 is adapted to the outer contour of the corresponding release member 6 and loading member, so as to constrain the circumferential position of the release member 6 and loading member in the guide channel 32. This can, to a certain extent, prevent the release member 6 and loading member from being squeezed out of the guide channel 32 during the movement of the release member 6 and loading member and entering the inner wall of the middle tube 31 and the sheath core 30, which would lead to an increase in movement resistance.

[0106] Additionally, it should be noted that when the contour of the guide channel 32 matches the outer contour of the corresponding release member 6 and loading member, at least two guide channels 32 need to be provided on the middle layer tube 31, one guide channel 32 for the release member 6 channel and the other guide channel 32 for the loading member channel. Specifically, taking the cross-section of the release member 6 as a circle as an example, the cross-section of the guide channel 32 can be set as a semicircle, a 3 / 4 circle, or a U-shape, etc., and no limitation is made here in this embodiment.

[0107] In one implementation, such as Figure 6 and Figure 7 As shown, there are two or more guide channels 32, which are distributed circumferentially along the middle layer tube 31. When there are two guide channels 32, the release component 6 and the loading component can be moved in different guide channels 32. In this case, the far end of the loading component passes through the support and then returns along the same path. That is, the two loading components are located in the same guide channel 32, and the loading component and the release component 6 do not interfere with or affect each other.

[0108] When there are three guide channels 32, two release members 6 and one loading member can be set at the same time. The loading member still passes through the support at its far end and then returns along the same path. The two release members 6 are set in different guide channels 32, and the two release members 6 and one loading member are set in different guide channels 32 respectively. As an alternative implementation, one release member 6 and one loading member can be set. The far end of the loading member passes through the support and returns through another guide channel 32. That is, the two loading members are located in different guide channels 32, which can avoid phenomena such as entanglement of the loading members.

[0109] When the number of guide channels 32 is four, it can be two release components 6 and two loading components, or two release components and one loading component, or three release components and one loading component, which can be selected according to actual needs.

[0110] Furthermore, two or more guide channels 32 are arranged symmetrically. Taking two guide channels 32 as an example, for instance... Figure 6 As shown, the two guide channels 32 are arranged vertically, so that the release component 6 and the loading component are located in independent guide channels 32; for example, when there are four guide channels 32, the arrangement of the four guide channels 32 is as follows. Figure 7 As shown, the two release members 6 can be respectively positioned within two symmetrical guide channels 32, either vertically or horizontally, resulting in more stable constraint on the support. Simultaneously, the loading members located within the other two symmetrical guide channels 32 ensure even force distribution when the support moves towards the loading space. In other embodiments, the guide channels 32 can be configured with three, five, six, etc., allowing for the installation of multiple release members 6 and loading members; this application does not impose any limitations on this.

[0111] In the above embodiments, as a preferred embodiment, the guide channel 32 is a groove provided on the inner side wall of the middle layer tube 31. The groove extends along the axial direction of the middle layer tube 31, connecting the loading space with the loading release channel, and the release member 6 can be loaded into the guide channel 32.

[0112] Because a groove is made on the inner wall of the middle tube 31, when the middle tube 31 is sleeved on the sheath core 30, the release member 6 and the loading member located in the guide channel 32 may be squeezed into the gap between the groove and the sheath core 30 under the action of tension when they move. This may cause the release member 6 and the loading member to deviate from the guide channel 32, or even become entangled on the sheath core 30 and twisted, affecting the movement of the release member 6 and the loading member.

[0113] Therefore, in the embodiments of this application, as Figure 3 As shown, the conveyor also includes a sleeve 24, which is embedded in the guide channel 32. The sleeve 24 is used to guide the release component 6 and the loading component through. Embedding the sleeve 24 in the guide channel 32 ensures that the release component 6 and the loading component are always kept within the corresponding guide channel 32, preventing the release component 6 and the loading component from being squeezed into the gap between the middle tube 31 and the sheath core 30, which would affect the loading and release of the support.

[0114] In this embodiment, as Figure 3 As shown, the length of the sleeve 24 is adapted to the length of the guide channel 32, so that the release component 6 and the loading component can be guided by the sleeve 24 in the distance from the loading release channel to the loading space, ensuring that the movement path of the release component 6 and the loading component is along the axial direction of the middle tube 31.

[0115] In some other embodiments, such as Figure 4 As shown, multiple sleeves 24 can be configured, with the sleeves 24 spaced apart within the guide channel 32. The sleeves 24 are sufficient to guide the release member 6 and the loading member to extend along the axial direction of the middle tube 31. The multiple sleeves 24 are fixedly disposed within the guide channel 32. Using multiple spaced-apart sleeves 24, compared to using a single continuous sleeve 24, reduces the material usage of the sleeves 24, thereby lowering production costs.

[0116] Furthermore, at least one of the plurality of sleeves 24 is disposed at one end of the guide channel 32 near the loading space, and at least one of the plurality of sleeves 24 is disposed at one end of the guide channel 32 near the loading release channel, wherein, as Figure 4 As shown, two sleeves 24 need to be installed at both ends of the guide channel 32 to guide the release component 6 and the loading component from the loading release channel and the loading space into the guide channel 32.

[0117] In this embodiment, only two sleeves 24 can be provided. The two sleeves 24 are located at both ends of the guide channel 32. Since the release member 6 is a relatively long member, as long as it passes through both ends of the guide channel 32 and through the sleeves 24, the part of the release member 6 located in the middle of the guide channel 32 is also located in the guide channel 32. As long as the release member 6 passes through the sleeves 24 at both ends of the guide channel 32, the position of the release member 6 in the guide channel 32 can also be guaranteed.

[0118] In some other embodiments, when two grooves are provided on the inner sidewall of the middle tube 31, it can be used in conjunction with the sleeve 24, such as the sleeve 24 whose length matches the groove, so that the release member 6 and the loading member are always restricted by the sleeve 24.

[0119] In one embodiment, such as Figure 8 and Figure 9 As shown, when the slider 13 is disposed inside the rotor 12, the limiting structure includes a first limiting part 16 and a second limiting part; the first limiting part 16 is disposed between the slider 13 and the second end of the outer sheath tube connector 14, and is used to limit the rotation of the slider 13 relative to the outer sheath tube connector 14; the second limiting part is used to limit the rotational movement of the outer sheath tube connector 14 relative to the rotor 12.

[0120] In this embodiment, the first limiting part 16 is located between the second end of the outer sheath tube connector 14 and the slider 13. At this time, the slider 13 and the second end of the outer sheath tube connector 14 are no longer simply abutting each other; they need to have a radial insertion-fitting relationship. Firstly, the first limiting part 16 prevents the slider 13 from rotating relative to the outer sheath tube connector 14. Secondly, it is necessary to prevent the outer sheath tube connector 14 from rotating relative to the rotor 12, thereby limiting the slider 13's rotation relative to the rotor 12. Therefore, this embodiment also includes a second limiting part, which restricts the rotational movement of the outer sheath tube connector 14 relative to the rotor 12. The second limiting part can be provided on the outer sheath tube connector 14 and the handle body, and they cooperate to restrict the rotation of the outer sheath tube connector 14. For example, the second limiting part can be a groove, protrusion, etc., on the outer sheath tube connector 14, and a corresponding groove and protrusion can be provided on the handle body.

[0121] Controlling the retraction of the outer sheath 200 by rotating the rotor 12 is more labor-saving than directly pulling the outer sheath 200 back. In TIPS surgery, generally only two centimeters of stent need to be released before the outer sheath 200 can be directly pulled back to save operation time. This is because the inner diameter of the shunt channel is smaller than the outer diameter of the released stent, and the stent experiences additional resistance from the liver parenchyma, resisting the pulling force of the sheath retraction and preventing displacement. Therefore, the retraction structure in this embodiment needs to accommodate both the rotor 12 rotation retraction method and the direct retraction of the outer sheath 200.

[0122] Specifically, in this embodiment, the second end of the outer sheath connector 14 is not fixedly connected to the slider 13, but is axially aligned, so that the slider 13 can push the outer sheath connector 14 backward, and the outer sheath connector 14 can be retracted independently and separated from the slider 13. Based on this, to limit the relative rotation of the slider 13 and the outer sheath connector 14 by the first limiting part 16, such as... Figure 9 As shown, the first limiting part 16 can be a groove extending radially on the slider 13 and a protrusion extending radially at the second end of the outer sheath tube connector 14. Of course, the groove and the protrusion can be interchanged, and this embodiment does not impose any restrictions. The groove and the protrusion are engaged through axial linear movement, which can both limit the relative rotation of the slider 13 and the outer sheath tube connector 14 and separate them through axial movement, so that the outer sheath tube connector 14 can be pulled back directly.

[0123] In one embodiment, the sliding part 130 includes threads on the slider 13, which is threadedly connected to the rotor 12. With this configuration, the pitch distribution of each thread segment on the rotor 12 is consistent, and the rotational motion of the rotor 12 can stably drive the slider 13 to move linearly.

[0124] In another embodiment, the sliding part 130 includes a protrusion provided on the slider 13, which engages with the thread of the rotor 12.

[0125] Specifically, in this embodiment, the sliding part 130 is no longer a thread provided on the outer wall of the slider 13, but one or more protrusions. When there are multiple protrusions, the multiple protrusions are distributed at intervals, and the distribution pattern is still in the form of a spiral.

[0126] The retraction of the outer sheath 200 can be divided into two stages: the first stage is from the support being completely wrapped to partial release, and the second stage is from partial release to complete release. The first stage has the greatest resistance, so the focus is on saving effort; the second stage has less resistance, so the focus is on saving time. When the slider 13 is threadedly connected to the rotor 12, the number of rotations of the rotor 12 and the linear travel of the slider 13 are linearly related throughout the retraction phase, which cannot match the different stages' requirements for saving effort and time.

[0127] Therefore, in this embodiment, the thread distribution on the rotor 12 is adjusted. Specifically, the thread on the rotor 12 includes at least a first thread segment and a second thread segment. The first thread segment and the second thread segment are distributed along the retraction direction of the slider 13, and the pitch of the first thread segment is smaller than the pitch of the second thread segment.

[0128] With this configuration, the first threaded section has a smaller pitch, and the second threaded section has a larger pitch. When controlling the linear movement of the slider 13 via the first threaded section, less effort is required. When controlling the linear movement of the slider 13 via the second threaded section, the slider 13 travels a greater distance with the same number of rotations, thus saving more time. Because the threads on the rotor 12 are configured this way, the slider 13 cannot be threadedly connected to the rotor 12. Therefore, the sliding portion 130 on the slider 13 is a protrusion, preferably cylindrical, to reduce sliding friction resistance within the threads.

[0129] In one embodiment of the first limiting part 16, such as Figures 9 to 12 As shown, the first limiting part 16 includes a first locking part 160 and a second locking part 161. The first locking part 160 is disposed on the slider 13, and the second locking part 161 is disposed on the second end of the outer sheath connector 14. The first locking part 160 and the second locking part 161 engage to limit the rotational movement of the slider 13 relative to the rotor 12.

[0130] Specifically, such as Figure 9 As shown, the first engaging portion 160 is a first engaging groove 1600 located near the end of the slider 13, and the second engaging portion 161 is a second engaging protrusion 1610. The second engaging protrusion 1610 and the first engaging groove 1600 are inserted into each other along the axial direction of the rotor 12, and the far end of the first engaging groove 1600 is closed, so that thrust can be transmitted to the second engaging protrusion 1610.

[0131] Of course, the far end of the first snap-fit ​​slot 1600 may not be closed, but its opening width should be smaller than the width of the second snap-fit ​​protrusion 1610 so as to be able to transmit thrust.

[0132] In this embodiment, the first snap-fit ​​groove 1600 extends radially along the slider 13, and the second snap-fit ​​protrusion 1610 also extends radially along the outer sheath connector 14. The two can be engaged and disengaged through axial linear movement. The first snap-fit ​​groove 1600 can be configured as multiple and distributed circumferentially along the slider 13, and the corresponding second snap-fit ​​protrusion 1610 can also be configured as multiple and distributed circumferentially along the outer sheath connector 14.

[0133] In one embodiment of the outer sheath connector 14, such as Figure 8 As shown, the outer sheath connector 14 includes a sheath joint 141 and a connecting rod 140. The connecting rod 140 is fixedly connected to the sheath joint 141. The connecting rod 140 is used to fixally connect the outer sheath 200. The distal end of the connecting rod 140 is used to connect to the slider 13. A first limiting part 16 is provided between the distal end of the connecting rod 140 and the slider 13.

[0134] Specifically, in this embodiment, the sheath connector 141 and the connecting rod 140 are concentrically arranged and fixedly connected. The connecting rod 140 is a hollow rod-shaped structure, and the sheath connector 141 has a channel corresponding to the connecting rod 140. The outer sheath 200 can be inserted and fixed inside the connecting rod 140, and the sheath core assembly 3, which passes through the outer sheath 200, can extend through the sheath structure and towards the proximal end. The distal end of the connecting rod 140 is connected to the slider 13, and the first limiting part 16 is disposed here.

[0135] As described above, the second limiting part is used to cooperate with the handle to limit the rotation of the outer sheath connector 14 relative to the rotor 12. In one embodiment, such as Figure 8 and Figure 11 As shown, the second limiting part includes a limiting tube 15, which is used to fix it inside the handle body 1. A third locking part 150 is provided on the limiting tube 15 along the axial direction. The outer sheath tube connector 14 is provided with a fourth locking part 17. The fourth locking part 17 and the third locking part 150 are engaged and can move relative to each other along the axial direction, so as to restrict the rotation of the outer sheath tube connector 14 while the outer sheath tube connector 14 can move axially relative to the handle.

[0136] Specifically, in this embodiment, the limiting tube 15 can be clamped and fixed inside the handle body 1, and the retraction direction of the outer sheath tube connector 14 coincides with the axial direction of the limiting tube 15. During the retraction process, the outer sheath tube connector 14 can move linearly backward relative to the limiting tube 15. A part of the outer sheath tube connector 14 can be sleeved on the outside of the limiting tube 15, for example, the sheath tube joint 141 of the outer sheath tube connector 14 can be sleeved on the outside of the limiting tube 15. A third locking part 150 is provided axially on the limiting tube 15, and a fourth locking part 17 is provided axially on the outer sheath tube connector 14. When the limiting tube 15 and the outer sheath tube connector 14 satisfy the sleeve relationship, the third locking part 150 and the fourth locking part 17 satisfy the radial locking relationship. The cooperation of the third locking part 150 and the fourth locking part 17 restricts the rotation of the outer sheath tube connector 14 relative to the limiting tube 15, that is, restricts its rotation relative to the rotor 12.

[0137] In addition, the limiting tube 15 also serves as a guide structure for the retraction of the outer sheath tube connector 14, which can guide the retraction of the outer sheath tube connector 14 and prevent it from getting stuck.

[0138] In one implementation, such as Figure 11 As shown, the limiting tube 15 can pass through the sheath joint 141 in the outer sheath connector 14 and be sleeved on the outside of the connecting rod 140.

[0139] In one implementation, such as Figure 11 As shown, the third snap-fit ​​portion 150 is a third snap-fit ​​groove provided on the limiting tube 15, and the third snap-fit ​​groove extends along the axial direction of the limiting tube 15. The fourth snap-fit ​​portion 17 is a fourth snap-fit ​​protrusion 170.

[0140] Specifically, the third locking groove is an elongated groove, the length of which needs to meet the retraction stroke of the outer sheath tube connector 14. The third locking groove can be located on both sides of the limiting tube 15. The fourth locking protrusion 170 is located on the outer wall of the outer sheath tube connector 14 and extends radially, preferably located on the connecting rod 140 of the outer sheath tube connector 14. The fourth locking protrusion 170 and the third locking groove can engage and move relative to each other in the axial direction. The second locking protrusion 1610 and the fourth locking protrusion 170 on the connecting rod 140 can be independent protrusion structures at both ends of the connecting rod 140, or they can be... Figure 10 The image shows two elongated protrusions on the connecting rod 140, or as shown... Figure 11 and Figure 12 As shown, the small protrusion at the distal end of the connecting rod 140 has two parts, one before and one after. For ease of mold opening during production, the two protrusions on the connecting rod 140 are preferred.

[0141] like Figure 11 and Figure 12 As shown, when the limiting tube 15 passes through the sheath joint 141 in the outer sheath connector 14 and is sleeved on the outside of the connecting rod 140, the second locking protrusion 1610 and the fourth locking protrusion 170 are preferably provided in the front and rear parts of the small protrusion at the far end of the connecting rod 140.

[0142] When the first locking groove 1600 is a groove located on the inner wall of the slider 13 and closed at its distal end, after the outer sheath tube 200 is retracted by pushing the outer sheath tube connector 14 through the slider 13, the position of the slider 13 on the rotor 12 is close to the proximal end of the rotor 12. At this time, if it is necessary to return the outer sheath tube connector 14 to its initial position, the slider 13 needs to be moved forward. When the first limiting part 16 is located between the slider 13 and the outer sheath tube connector 14, if it is necessary to control the slider 13 to move forward by rotating the rotor 12, the first limiting part 16 and the rotor 12 rotation must always be kept in check, that is, the connection between the slider 13 and the connecting rod 140 on the outer sheath tube connector 14 must be maintained, which is difficult to operate and takes a long time.

[0143] Therefore, in order to achieve rapid retraction of the outer sheath connector 14, such as Figure 9As shown, in this embodiment, the distance between the sidewall of the first locking groove 1600 and the axis of the slider 13 is less than or equal to the inner radius of the slider 13. With this setting, the distance from the outermost edge of the second locking protrusion 1610 to the center of the connecting rod 140 is also less than or equal to the inner radius of the slider 13. After the first locking groove 1600 and the second locking protrusion 1610 cooperate, they can transmit thrust and, when the outer sheath connector 14 retracts, rotate the slider 13 (i.e., rotate the rotor 12) so that the second locking protrusion 1610 is completely misaligned with the first locking groove 1600. Then, the second locking protrusion 1610 can directly enter the slider 13, realizing the rapid retraction of the outer sheath connector 14.

[0144] like Figure 9 As shown, in order to facilitate the formation of the first snap-fit ​​groove 1600, a boss 1601 is provided on the inner side of the slider 13 in this embodiment, and the first snap-fit ​​groove 1600 is provided on the boss 1601.

[0145] In one embodiment of rotor 12, such as Figure 9 As shown, the rotor 12 includes a first rotating body 121 and a second rotating body 122 arranged opposite to each other. The first rotating body 121 and the second rotating body 122 are detachably fixedly connected, and the first rotating body 121 and the second rotating body 122 are provided with matching threads. Specifically, the cross-sections of the first rotating body 121 and the second rotating body 122 can be semicircular, and they form a cylindrical rotor 12 after being joined together. To facilitate connection, protrusions and grooves can be respectively provided on the end faces of the first rotating body 121 and the second rotating body 122 to ensure the accuracy of the connection.

[0146] Based on this, in order to prevent the slider 13 from detaching from the rotor 12 during movement, the first rotating body 121 and the second rotating body 122 are provided with first limiting end faces 126 at both ends, and the slider 13 is restricted from detaching by the first limiting end faces 126.

[0147] In another embodiment of rotor 12, such as Figure 10 As shown, rotor 12 is a one-piece structure.

[0148] Based on this, in order to facilitate the installation of the slider 13 and prevent the slider 13 from detaching from the rotor 12 during movement, a loading inlet 125 is provided at one end of the rotor 12, and a second limiting end face 124 is provided at the other end of the rotor 12. The slider 13 is loaded into the rotor 12 through the loading inlet 125. An end cover 123 is detachably provided on the loading inlet 125. The end cover 123 and the second limiting end face 124 are used to restrict the slider 13 from detaching.

[0149] In one embodiment, such as Figure 13As shown, the rotor 12 is installed inside the handle body 1 and can rotate, the slider 13 is located inside the rotor 12, and the outer sheath connector 14 is located inside the handle body 1 and connected to the slider 13.

[0150] In this embodiment, the handle body 1 may include a first housing 100 and a second housing 101 that can be fastened together, and the rotor 12 may be installed between the first housing 100 and the second housing 101. In one embodiment, to facilitate the rotation of the rotor 12, bearings may be fitted and fixed at both ends of the rotor 12, and the bearings are pressed and fixed between the first housing 100 and the second housing 101, thereby positioning the rotor 12. To facilitate the rotation of the rotor 12, at least a portion of the rotor 12 is exposed on the handle, or a rotatable rotating sleeve may be provided on the handle, and the rotating sleeve is fitted and fixed on the rotor 12. Taking the limiting tube 15 as an example, the second limiting part may have a corresponding connecting plate 18 provided on the inner side of the first housing 100 and the second housing 101. After the first housing 100 and the second housing 101 are fastened together, the limiting tube 15 can be pressed and fixed by the connecting plate 18. Of course, the limiting tube 15 may also be fixed in the handle in other ways, which is not limited in this embodiment. In one embodiment, the distal end of the limiting tube 15 can be inserted into the rotor 12 to support the rotor 12, and the rotor 12 can rotate on the limiting tube 15.

[0151] The process of withdrawing the outer sheath usually involves applying a backward pushing or pulling force to the outer sheath connector. During the operation, it is necessary to avoid instrument failure caused by the outer sheath connector being withdrawn due to misoperation before the stent reaches the lesion. It is also necessary to avoid instrument failure caused by the outer sheath being withdrawn due to vibration during transportation.

[0152] Therefore, in one embodiment, such as Figure 16 As shown, the conveyor also includes a retainer 19, which is connected to the outer sheath connector 14 and can rotate about the axis of the outer sheath connector 14.

[0153] The first state limiting structure 190 is disposed on the fixer 19. As the fixer 19 rotates, the first state limiting structure 190 can be in a first state and a second state.

[0154] In the first state, the first state limiting structure 190 and the second state limiting structure 151 abut against each other in the retraction direction of the outer sheath connector 14. In the second state, the first state limiting structure 190 and the second state limiting structure 151 are completely offset in the circumferential direction.

[0155] In this embodiment, the distal end of the outer sheath connector 14 can be fixedly connected to the outer sheath. The outer sheath connector 14 has a channel through which the sheath core assembly can pass. The retainer 19 is connected to the outer sheath connector 14, and the connection between the retainer 19 and the outer sheath connector 14 satisfies the following conditions: the retainer 19 can rotate relative to the outer sheath connector 14, while the retainer 19 and the outer sheath connector 14 are not separated. For example, the retainer 19 and the outer sheath connector 14 can be connected by a bearing or by a corresponding slide rail, etc., but this embodiment does not impose any limitations.

[0156] The first-state limiting structure 190 is disposed on the fixture 19. During the rotation of the fixture 19, the first-state limiting structure 190 has a first state and a second state. For example, as Figure 17 As shown, when the retainer 19 is in the initial position, the first-state limiting structure 190 is in the first state. Figure 18 As shown, when the retainer 19 rotates by a set angle, the first-state limiting structure 190 is in the second state. In essence, in this embodiment, the first state and the second state refer to different circumferential positions of the first-state limiting structure 190.

[0157] like Figure 16 and Figure 17 As shown, the second state limiting structure 151 is used to cooperate with the first state limiting structure 190. When the first state limiting structure 190 is in the first state, the first state limiting structure 190 and the second state limiting structure 151 abut against each other in the retraction direction of the outer sheath connector 14, thereby limiting the retraction movement of the outer sheath connector 14. Figure 18 As shown, when the first state restriction structure 190 is in the second state, the first state restriction structure 190 and the second state restriction structure 151 are completely misaligned in the circumferential direction, and the outer sheath tube connector 14 can be freely retracted at this time.

[0158] The second state limiting structure 151, acting as a fixing member, can be mounted on the handle body. For example, a protrusion on the handle body corresponding to the first state limiting structure 190 can serve as the second state limiting structure 151, while a protrusion on the fixing member 19 can serve as the first state limiting structure 190. The two restrict the backward movement of the outer sheath connector 14 by their front and rear end faces abutting against each other. One of the protrusions can have a through groove, and the other protrusion can rotate into and out of the through groove. The cooperation of the two restricts the backward movement of the outer sheath connector 14. The second state limiting structure 151 can also be mounted on other fixed components. In this embodiment, its mounting position and specific structure are not limited, as long as they can satisfy the above functions.

[0159] In this embodiment, after loading is completed, the retainer 19 is rotated to place the first state limiting structure 190 in the first state. In the first state, the first state limiting structure 190 and the second state limiting structure 151 abut against each other in the retraction direction of the outer sheath connector 14, preventing the outer sheath connector 14 from retracting axially. This achieves the technical effect of limiting the axial position of the outer sheath connector 14, avoiding accidental pulling of the outer sheath connector 14 during surgery, or the outer sheath being pulled back due to transportation vibration. When the set position is reached, the retainer 19 can be rotated to place the second state limiting structure 151 in the second state. In the second state, the first state limiting structure 190 and the second state limiting structure 151 are completely misaligned in the circumferential direction, allowing the outer sheath connector 14 to retract axially, thereby enabling the release operation of the medical device.

[0160] As a preferred implementation method, such as Figure 16 As shown, the second state limiting structure 151 is provided on the limiting tube 15.

[0161] Specifically, in this embodiment, the limiting tube 15 can be fixed inside the handle body and axially connected to the outer sheath tube connector 14. During the retraction process, the outer sheath tube connector 14 can move linearly along the axial direction of the limiting tube 15. Therefore, the limiting tube 15 can guide the linear movement of the outer sheath tube connector 14, improving the accuracy of the movement. In addition, after setting the limiting tube 15, the second state limiting structure 151 can be set on the limiting tube 15, which can simplify the structure of the handle body. When the first state limiting structure 190 is in the second state, the outer sheath tube connector 14 can move axially along the limiting tube 15. At this time, the second state limiting structure 151 can pass through the outer sheath tube connector 14.

[0162] In one implementation, such as Figure 16 As shown, the first state limiting structure 190 is provided on the inner wall of the fixer 19, the limiting tube 15 is sleeved in the fixer 19, and the fixer 19 and the outer sheath tube connector 14 can move linearly along the axial direction relative to the limiting tube 15; the second state limiting structure 151 is provided on the outer wall of the limiting tube 15.

[0163] Specifically, in this embodiment, the limiting tube 15 is a hollow tubular structure. The retainer 19 can be connected to the rear end of the outer sheath tube connector 14. After the limiting tube 15 is fixed inside the handle body, it can be sleeved inside the retainer 19, so that the limiting tube 15 can dock with the outer sheath tube connector 14. The outer sheath tube connector 14 and the retainer 19 are provided with channels for the limiting tube 15 to pass through. Therefore, a second state limiting structure 151 can be provided on the outer wall of the limiting tube 15, and a first state limiting structure 190 can be provided on the inner wall of the retainer 19.

[0164] To improve the stability of the first-state limiting structure 190 and the second-state limiting structure 151 when they abut against each other in the retraction direction of the outer sheath connector 14, in this embodiment, two or more first-state limiting structures 190 are provided and distributed circumferentially at intervals along the retainer 19, and two or more second-state limiting structures 151 are provided and distributed circumferentially at intervals along the limiting tube 15. In a preferred embodiment, two of each of the first-state limiting structures 190 and the second-state limiting structure 151 are provided and symmetrically distributed along the axial direction.

[0165] In one specific implementation, such as Figures 16 to 18 As shown, the first state limiting structure 190 includes a first stop, and the second state limiting structure 151 includes a second stop. In this embodiment, the retraction movement of the outer sheath tube connector 14 is limited by the abutting of the end faces of the first and second stops. The circumferential misalignment of the first and second stops allows the outer sheath tube connector 14 to retract freely. Its structure is simple and easy to use.

[0166] Since the outer sheath connector 14 retracts along the limiting tube 15, an arc-shaped groove is provided at the end of the first stop facing the limiting tube 15 in this embodiment. The arc-shaped groove fits against the surface of the limiting tube 15. During the retraction movement of the outer sheath connector 14, the arc-shaped groove of the first stop can always fit against the surface of the limiting tube 15 and slide backward along the surface of the limiting tube 15, thereby improving the movement accuracy of the outer sheath connector 14.

[0167] In another embodiment, such as Figure 11 and Figure 12 As shown, the conveyor also includes a retainer 19, which is connected to the outer sheath connector 14 and can rotate about the axis of the outer sheath connector 14.

[0168] The fastener 19 is provided with an unlock button 22, which can be turned to rotate the fastener 19.

[0169] The handle body 1 is provided with a connecting blocking groove 102 and a retraction groove 103. The retraction groove 103 is arranged along the axial direction of the handle body 1, and the blocking groove 102 is arranged along the circumferential direction of the handle body 1. The unlocking button 22 can rotate from the blocking groove 102 into the retraction groove 103 and slide within the retraction groove 103.

[0170] In this embodiment, the outer sheath connector 14 and the retainer 19 are installed inside the handle body 1. The distal end of the outer sheath connector 14 is used to connect and fix the outer sheath, and the retainer 19 can be connected to the proximal end of the outer sheath connector 14. A channel for the sheath core assembly 3 to pass through is formed within the outer sheath connector 14 and the retainer 19. The process of the outer sheath 200 retracting is essentially a process of the outer sheath connector 14 and the retainer 19 moving linearly backward along the axial direction within the handle body 1. Therefore, a channel that allows the linear movement of the outer sheath connector 14 and the retainer 19 needs to be formed within the handle body 1. The connection relationship between the retainer 19 and the outer sheath connector 14 satisfies the following: the retainer 19 can rotate relative to the outer sheath connector 14, while the retainer 19 and the outer sheath connector 14 are not separated. For example, the retainer 19 and the outer sheath connector 14 can be connected by bearings or by corresponding slide rails, etc., which is not limited in this embodiment.

[0171] To restrict the retraction of the outer sheath connector 14 during delivery and to release this restriction upon reaching the lesion location, an unlocking button 22 is provided on the fixator 19 in this embodiment. The unlocking button 22 protrudes from the outer wall of the fixator 19, allowing the operator to rotate the fixator 19 by pressing the unlocking button 22, thereby changing the position of the unlocking button 22. Simultaneously, a blocking groove 102 and a retraction groove 103 are provided on the handle body 1. The blocking groove 102 is circumferentially located on the handle body 1, while the retraction groove 103 is axially located on the handle body 1, i.e., along the retraction direction of the outer sheath. The blocking groove 102 and the retraction groove 103 communicate. When the unlocking button 22 is located within the blocking groove 102, the wall of the blocking groove 102 can limit the unlocking button 22, thereby restricting its linear axial movement and consequently limiting the axial movement of the fixator 19 and the outer sheath connector 14. After reaching the lesion location, the unlock button 22 can be pressed to rotate the fixator 19 relative to the outer sheath connector 14, causing the unlock button 22 to disengage from the blocking groove 102 and move into the retraction groove 103. At this time, the unlock button 22 can move axially to the distal end in the retraction groove 103, thereby allowing the fixator 19 and the outer sheath connector 14 to retract relative to the handle body 1, realizing the retraction operation of the outer sheath.

[0172] This invention achieves the technical effect of restricting the axial position of the outer sheath connector 14, preventing improper movement of the outer sheath connector 14 during transport by the delivery device or placement of the stent, which would cause the outer sheath to be pulled back, and releasing the restriction on the outer sheath connector 14 after reaching the lesion, allowing the outer sheath connector 14 to retract freely. This solves the problem in related technologies where the outer sheath connector 14 is easily retracted due to misoperation during transport by the delivery device or placement of the stent.

[0173] In one embodiment of the handle body 1, such as Figure 11 As shown, the handle body 1 includes a first housing 100 and a second housing 101. The first housing 100 and the second housing 101 are arranged opposite to each other and fastened together. The blocking groove 102 and the retraction groove 103 are both provided on the first housing 100.

[0174] In this embodiment, the handle body 1 mainly includes a first housing 100 and a second housing 101. After the first housing 100 and the second housing 101 are fastened together, a channel for the movement of the outer sheath connector 14 and the retainer 19 can be formed between the first housing 100 and the second housing 101. At the same time, a blocking groove 102 and a retraction groove 103 can be selectively provided on the wall of the first housing 100. The specific structure of the first housing 100 and the second housing 101 is not limited in this embodiment and can be designed according to actual needs.

[0175] In one embodiment of the unlock button 22, such as Figure 11 and Figure 19 As shown, the unlock button 22 includes a pressing part 220 and a connecting part 221. The connecting part 221 is fixedly connected to the outer wall of the retainer 19. The pressing part 220 protrudes from the handle body 1. The connecting part 221 is slidably connected to the blocking groove 102 and the retraction groove 103.

[0176] To facilitate direct retraction of the outer sheath, in this embodiment, the pressing part 220 of the unlock button 22 protrudes from the handle body 1, allowing operation of the pressing part 220 from the outside of the handle body 1 to perform the retraction operation of the outer sheath. Furthermore, the blocking groove 102 and the retraction groove 103 on the handle body 1 are slidably connected to the connecting part 221 in the unlock button 22. To reduce the impact of the retraction groove 103 on the structural strength of the handle body 1, the width of the retraction groove 103 can be appropriately reduced, and the corresponding connecting part 221 in the unlock button 22 can be set to a corresponding width. That is, the connecting part 221 can be set to a flat structure, while the pressing part 220 protrudes from the handle body 1, thus allowing for any easily operable structure.

[0177] To further improve the smoothness of the retreat movement, such as Figure 19 As shown, guide grooves 2210 are provided on both sides of the connecting part 221, and the side walls 1031 of the retraction groove 103 extend into the guide grooves 2210 and are slidably connected to the guide grooves 2210.

[0178] To further reduce the frictional resistance between the guide groove 2210 and the side wall 1031 of the retraction groove 103 during the retraction sliding process, such as Figure 19As shown, in this embodiment, a first guide slope 1030 is provided on the outer side of the sidewall 1031, and a second guide slope 2211 that fits into the first guide slope 1030 is provided in the guide groove 2210. The first guide slope 1030 and the second guide slope 2211 cooperate to guide the movement of the connecting part 221.

[0179] Specifically, in one embodiment, the two sidewalls 1031 of the retraction groove 103 are tapered structures, with a first guide slope 1030 formed on the outer side, and a second guide slope 2211 provided within the guide groove 2210 of the connecting portion 221. After installation, the second guide slope 2211 fits against the first guide slope 1030, thereby reducing the contact area between the guide groove 2210 and the two sidewalls 1031 of the retraction groove 103 while achieving guidance, reducing frictional resistance, and improving the smoothness of the retraction movement. Based on this, the length of the first guide slope 1030 or the second guide slope 2211 can be reduced according to actual conditions, thereby further reducing frictional resistance. However, the contact between the first guide slope 1030 and the second guide slope 2211 should be maintained to improve the precise guidance of the movement.

[0180] To further improve the smoothness and stability of the unlock button 22, a support protrusion 2212 is also provided on the connecting part 221 in this embodiment. The support protrusion 2212 is opposite to the second guide slope 2211 and abuts against the inner side surface of the side wall 1031. The surface of the support protrusion 2212 that abuts against the side wall 1031 is set as a protruding arc-shaped surface, and the surface of the side wall 1031 that abuts against the support protrusion 2212 is set as a plane.

[0181] Specifically, in this embodiment, the support protrusion 2212 is located inside the handle body 1, the guide groove 2210 is located between the support protrusion 2212 and the second guide slope 2211, and the two side walls 1031 of the retraction groove 103 extend into the guide groove 2210. The outer side surface of the side wall 1031 (i.e. the first guide slope 1030) is opposite to the second guide slope 2211, and the inner side surface of the side wall 1031 is opposite to the support protrusion 2212. By abutting the support protrusion 2212 against the inner side surface of the side wall 1031, and cooperating with the first guide slope 1030 and the second guide slope 2211, the unlock button 22 is supported, thereby improving the movement stability of the unlock button 22.

[0182] Based on this, in order to further reduce the frictional force of motion, the surface of the support protrusion 2212 that abuts against the side wall 1031 is set as a convex arc surface, and the surface of the side wall 1031 that abuts against the support protrusion 2212 is set as a plane, so that the support protrusion 2212 and the inner surface of the side wall 1031 are in line contact, reducing the contact area.

[0183] In the above embodiment, the retraction movement of the outer sheath connector 14 is restricted or permitted by rotating the retainer 19. To avoid accidental rotation of the retainer 19, such as... Figure 20 As shown, this embodiment also includes a locking structure 21, which is disposed between the outer sheath tube connector 14 and the retainer 19. The locking structure 21 is used to lock the rotation angle of the retainer 19.

[0184] Specifically, the locking structure 21 can lock the retainer 19 at a set rotation angle, for example, locking the retainer 19 in its initial position. At this time, the first state limiting structure 190 on the retainer 19 is in the first state, which can restrict the retraction movement of the outer sheath connector 14. When it is necessary to allow the outer sheath connector 14 to retract, the retainer 19 needs to be unlocked so that the retainer 19 can rotate, and the first state limiting structure 190 is in the second state. For ease of operation, it is preferable that the locking structure 21 provides a certain resistance to the rotation of the retainer 19, and the operator needs to overcome this resistance to operate the retainer 19 to rotate.

[0185] In one implementation, such as Figure 20 and Figure 21 As shown, the locking structure 21 includes a spring top ball 210 and a positioning groove 211. The spring top ball 210 is located on the rear end face of the outer sheath tube connector 14, and the positioning groove 211 is located on the front end face of the retainer 19.

[0186] In the first embodiment described above, when the first state limiting structure 190 is in the first state, the spring top ball 210 is engaged in the positioning groove 211, thereby limiting the rotation of the retainer 19. When unlocking is required, the retainer 19 can be rotated, and under the action of external force, the spring top ball 210 compresses the spring and disengages from the positioning groove 211, at which time the retainer 19 can rotate freely.

[0187] It is understandable that the spring top ball 210 can also be located on the front end face of the retainer 19, and the positioning groove 211 can be located on the rear end face of the outer sheath tube connector 14.

[0188] Of course, the appropriate locking structure 21 can also be selected according to actual needs. The specific description of the locking structure 21 in this embodiment is not restrictive.

[0189] Since the first state limiting structure 190 has a first state and a second state, meaning the first state limiting structure 190 needs to be in two rotation angles, in this embodiment, at least two positioning grooves 211 are provided and distributed along the circumference of the retainer 19. One positioning groove 211 is used to cooperate with the spring top ball 210 to limit the first state limiting structure 190 in the first state, and the other positioning groove 211 is used to cooperate with the spring top ball 210 to limit the first state limiting structure 190 in the second state.

[0190] In the second embodiment described above, when the unlock button 22 is located within the blocking groove 102, the spring top ball 210 is engaged within the positioning groove 211, thereby restricting the rotation of the retainer 19. When unlocking is required, the retainer 19 can be rotated, and under the action of external force, the spring top ball 210 compresses the spring and disengages from the positioning groove 211, at which point the retainer 19 can rotate freely.

[0191] Since the unlock button can rotate from the blocking groove into the retraction groove and also from the retraction groove into the blocking groove, the unlock button needs to be at two rotation angles. Therefore, in this embodiment, at least two positioning grooves 211 are provided and distributed circumferentially along the retainer 19. One positioning groove 211 is used to cooperate with the spring ball 210 to position the unlock button in the blocking groove, and the other positioning groove 211 is used to cooperate with the spring ball 210 to position the unlock button in the retraction groove.

[0192] In one embodiment of the outer sheath connector 14, such as Figure 13 and Figure 14 As shown, the outer sheath connector 14 includes a sheath joint 141 and a connecting rod 140. The connecting rod 140 is used to insert and fix the outer sheath. The retainer 19 is connected to the sheath joint 141 and can rotate relative to the sheath joint 141.

[0193] Specifically, both the sheath connector 141 and the connecting rod 140 are hollow structures. The channel inside the connecting rod 140 allows the outer sheath to pass through and also allows the sheath core assembly inside the outer sheath to pass through. The corresponding channel inside the sheath connector 141 has the same function. The connecting rod 140 can be a slender rod-shaped structure to construct the corresponding channel. The sheath connector 141 can be a short and thick cylindrical structure to connect the retainer 19. In one embodiment, a rib is provided inside the sheath connector 141, and the connecting rod 140 is connected through the rib. A groove is provided on the limiting tube 15, and the rib can slide in the groove, so that the limiting tube 15 can pass through the interior of the sheath connector 141 and be sleeved on the connecting rod 140.

[0194] In one implementation, such as Figure 22 and Figure 23 As shown, to achieve the connection between the retainer 19 and the sheath connector 141, a connecting hook 1410 is provided on the rear end face of the sheath connector 141, and a connecting groove 195 is provided on the inner wall of the retainer 19. The connecting hook 1410 is hooked into the connecting groove 195 and can rotate within the connecting groove 195. In this embodiment, through the cooperation of the connecting groove 195 and the connecting hook 1410, the retainer 19 can both rotate relative to the sheath connector 141 and maintain its connection with the sheath connector 141.

[0195] Specifically, the inner wall of the retainer 19 is provided with an arc-shaped flange 191, and the flange 191 is provided with a notch 192, through which the hook can pass;

[0196] The retainer 19 is provided with an arc-shaped clip 193. A sealing head 194 is provided on the end of the arc-shaped clip 193 facing the sheath connector 141. The sealing head 194 is inserted and engaged with the notch 192 to seal the notch 192. The arc-shaped clip 193 is fixed to the inner wall of the retainer 19, and there is a gap between the front end of the arc-shaped clip 193 and the rear end of the flange 191 to form a connecting groove 195.

[0197] In this embodiment, an arc-shaped flange 191 is provided on the inner wall of the retainer 19. The number of notches 192 on the flange 191 corresponds to the number of connecting hooks 1410 on the sheath connector 141. The connecting hooks 1410 can pass through the notches 192 and be hooked onto the flange 191. Taking two symmetrical connecting hooks 1410 as an example, the flange 191 on the retainer 19 has two symmetrical notches 192, which divide the flange 191 into two segments. To limit the connecting hook 1410 to the flange 191, an arc-shaped retainer 193 is also provided inside the retainer 19. The arc-shaped retainer 193 can be installed on the inner wall of the retainer 19. The arc-shaped retainer 193 corresponds to the flange 191 in the axial direction, and the end face of the arc-shaped retainer 193 can fit against the end face of the connecting hook 1410. The arc-shaped retainer 193 and the flange 191 form a connecting groove 195, which limits the connecting hook 1410 within the connecting groove 195. To prevent the connecting hook 1410 from detaching through the notch 192, a sealing head 194 is provided on the arc-shaped retainer 193. After installation, the sealing head 194 is inserted into the notch 192. With this configuration, the retainer 19 can be rotated, and the connecting groove 195 rotates relative to the connecting hook 1410, while the connecting hook 1410 remains within the connecting groove 195.

[0198] To facilitate the positioning of the arc-shaped clip 193 and form a connecting groove 195 of suitable size, a limiting protrusion is provided on the flange 191 near the notch 192 in this embodiment. The limiting protrusion can abut against the end face of the arc-shaped clip 193, thereby positioning the arc-shaped clip 193. The arc-shaped clip 193 can be bonded and fixed to the inner wall of the retainer 19.

[0199] This delivery system requires a guide wire to guide its movement. Therefore, the guide wire is inserted into the delivery system, typically entering the sheath from the proximal end and exiting from the distal end. Since the system also involves the restraint and release of the implantable medical device, a release mechanism is also installed within the delivery system. This release mechanism remains fixed during the delivery of the implantable medical device. Upon reaching the lesion location, the release mechanism needs to be operated at the proximal end of the delivery system to release the implantable medical device located at the distal end of the system.

[0200] As can be seen, multiple operations need to be performed on the handpiece of the delivery device, including but not limited to retracting the outer sheath, guiding the guidewire, retracting the sheath core, and retracting the release element. Different operating areas overlap and interfere with each other during the operation, making it difficult to perform simultaneous operations. Furthermore, the operator needs to change the operating position multiple times during the operation, making the entire process quite inconvenient.

[0201] Based on this, such as Figures 24 to 28 As shown, the conveyor in this embodiment also includes a connector body 4, and a first connecting part 44 is provided at the distal end of the connector body 4. The first connecting part 44 is connected to the proximal end of the handle body 1.

[0202] The connector body 4 is provided with a first channel 41, a second channel 42 and a third channel 43 that are interconnected. The two ends of the first channel 41 are open structures, and the second channel 42 and the third channel 43 are located on the side of the first channel 41.

[0203] The proximal end of the sheath core 31 is fixed through the first channel 41, the second channel 42 is used for the release element 6 of the delivery device to pass through, and the third channel 43 is used for injecting liquid into the distal end of the delivery device.

[0204] In this embodiment, the connector is installed on the handle body 1 of the conveyor to create a channel for the release element 6 and a channel for the sheath core assembly 3, so as to facilitate the operation of the release element 6 and the insertion of the guide wire into the sheath core 31 of the sheath core assembly 3. Specifically, the connector is installed at the proximal end of the handle body 1 of the conveyor. The connector body 4 of the connector is provided with a first channel 41, a second channel 42 and a third channel 43 that are interconnected. The first channel 41 can mate with the proximal end of the sheath core assembly 3 and allow the sheath core assembly 3 to pass through. After the sheath core assembly 3 passes through the first channel 41, there is space between the sheath core assembly 3 and the first channel 41.

[0205] The second channel 42 is used for the passage of the release member 6 of the conveyor. Specifically, the distal end of the release member 6 needs to extend to the distal end of the sheath core 31 in the sheath core assembly 3 to constrain the bracket sleeved on the sheath core 31. The proximal end of the release member 6 disengages from the sheath core assembly 3 and enters the second channel 42. During the release of the bracket, the proximal end of the release member 6 needs to be manipulated to move it and release the distal bracket. During assembly, the distal end of the release member 6 passes through the second channel 42 into the space between the sheath core assembly 3 and the first channel 41 and extends toward the distal end of the conveyor to the location of the bracket.

[0206] The connector body 4 is also provided with a third channel 43, which is connected to the first channel 41. The third channel 43 is used to inject liquid into the distal end of the conveyor. After assembly, the third channel 43 is connected to the space between the sheath core assembly 3 and the wall of the first channel 41. This space is connected to the distal end of the conveyor, so the liquid injected into the third channel 43 can pass through this space and flow to the distal end of the conveyor.

[0207] In this embodiment, the first channel 41 can be arranged axially on the connector body 4, so that it is not easy to deform when the sheath core assembly 3 passes through. The second channel 42 and the third channel 43 are respectively located on both sides of the first channel 41. In some embodiments, the connector body 4 includes two arms, and the second channel 42 and the third channel 43 are respectively located in one arm.

[0208] like Figures 24 to 26 As shown, to facilitate the connection between the connector body 4 and the proximal end of the handle body 1, a first connecting portion 44 is provided at the first end (i.e., the distal end of the connector) of the connector body 4 in this embodiment. The first connecting portion 44 can cooperate with the proximal end of the handle body 1 to fix the connector body 4. In one embodiment, the first connecting portion 44 can be inserted into the proximal end of the handle body 1 and fixed by a snap-fit, etc. In another embodiment, the first connecting portion 44 can be snapped and fixed to the proximal end of the handle body 1. In this embodiment, the specific connection structure between the first connecting portion 44 and the proximal end of the handle body 1 is not limited and can be designed according to actual needs.

[0209] In this embodiment, by integrating the first channel 41, the second channel 42, and the third channel 43 into a single connector and installing the connector on the proximal end of the handle body 1, the operating area on the handle body 1 for controlling the retraction of the outer sheath 200 is separated from the operating area for controlling the release of the medical device by the release element 6, the operating area for operating the guidewire, and the area for injection. This avoids interference between the retraction of the outer sheath and other operations, facilitates coordination between multiple people operating simultaneously in front and behind positions, and improves space utilization in the operating room.

[0210] On the other hand, when the first channel 41, the second channel 42, and the third channel 43 are close to each other, the operating positions of the release element 6, the guidewire, and the injection position are also close to each other. During the operation, the operator does not need to change the operating position, which can further reduce the difficulty of operation. Moreover, after integrating the three channels into a connector body 4, only one installation position needs to be configured on the handle body 1 for installing the connector body 4. This reduces the number of installation positions on the handle body 1, thereby reducing the manufacturing cost of the handle body 1 and making it easier to install and disassemble. This solves the problems of inconvenient operation of the delivery device and the high manufacturing cost and complicated installation of the handle body 1 in the related technology.

[0211] In some embodiments, the second channel 42 is positioned close to the distal end of the first channel 41 to minimize the contact area of ​​the release member 6 within the first channel 41 and reduce friction. The third channel 43 is positioned close to the proximal end of the first channel 41 to facilitate the removal of internal air by means of liquid injection.

[0212] Depending on the requirements, two or more release members 6 can be provided to better constrain the stent to the distal end of the sheath core 31. In one embodiment, two release members 6 are provided, which can be located on a first side and a second side of the sheath core 31, respectively. One release member 6 is longer and can connect to the distal end of the stent, while the other release member 6 is shorter and can connect to the proximal end of the stent, thereby stably constraining the stent to the sheath core 31. Accordingly, as Figure 27 and Figure 28 As shown, in this embodiment, two second channels 42 need to be configured inside the connector body 4. The two second channels 42 are distributed circumferentially around the connector body 4, and each of the two second channels 42 leads to a release element 6, so that different release elements 6 can be operated in a certain order during the release process. Of course, there can be more release elements 6, and correspondingly, more second channels 42 need to be configured inside the connector body 4. In this embodiment, the specific number is not limited.

[0213] In one implementation, such as Figure 24 and Figure 26 As shown, the axis of the first channel 41 is coaxial with the axis of the proximal portion of the sheath core assembly 3. In the direction of movement of the release member 6, the axis of the second channel 42 forms an obtuse angle with the axis of the first channel 41. Specifically, taking a horizontally placed conveyor as an example, the axis of the first channel 41 is horizontal, which facilitates connection to the sheath core assembly 3 and also facilitates the entry of the guide wire into the sheath core assembly 3 and the movement of the guide wire. The second channel 42 is located to the side of the first channel 41 and is inclined. In the direction of movement of the release member 6, the second channel 42 forms an obtuse angle (i.e., the angle between the first channel 41 and the second channel 42 at the distal end is obtuse), thus making the bending angle of the release member 6 at the junction of the second channel 42 and the first channel 41 smaller, reducing the resistance encountered by the release member 6 during movement, and facilitating the pulling of the release member 6 during release. In some embodiments, this angle can be 120° to 160°.

[0214] Optionally, such as Figure 26As shown, the conveyor also includes a rigid sleeve 23, which is sleeved on the outside of the sheath core 31. The distal end of the rigid sleeve 23 passes through the outer sheath tube 200 connector 14, and the proximal end of the rigid sleeve 23 is fixed in the first channel 41. The outer sheath tube 200 connector 14 can move along the axial direction of the rigid sleeve 23.

[0215] There is a movable space between the rigid sleeve 23 and the sheath core 31 sub-assembly 3, and the guide channel, the second channel 42, and the third channel 43 are connected to the movable space.

[0216] With this configuration, the outer sheath connector 14 can retract along the rigid sleeve 23, thus improving the stability and accuracy of its retraction. Simultaneously, a channel can be formed between the rigid sleeve 23 and the sheath core 31. The distal end of this channel communicates with the internal space of the outer sheath connector 14 and the space between the outer sheath 200 and the middle tube 30. The proximal end of this channel communicates with the space between the sheath core 31 and the first channel 41, i.e., with the second channel 42 and the third channel 43. Therefore, the release member 6, inserted through the second channel 42, can extend distally through the channel within the rigid sleeve 23, and the liquid injected through the third channel 43 can also flow distally through the channel within the rigid sleeve 23.

[0217] Since liquid needs to be injected distally through the third channel 43, the liquid needs to flow through the internal space of the outer sheath connector 14. Therefore, it is necessary to prevent the liquid from leaking from the proximal end of the outer sheath connector 14. It is also necessary to prevent blood entering the outer sheath 200 during delivery from leaking from the proximal end of the outer sheath connector 14. In this embodiment, a second sealing element 9 is provided. The second sealing element 9 is fixed to the proximal end of the outer sheath connector 14 and slidably sleeved on the rigid sleeve 23. The gap between the proximal end of the outer sheath connector 14 and the rigid sleeve 23 is sealed by the second sealing element 9, thereby preventing the liquid inside the outer sheath connector 14 from flowing out. Simultaneously, since the outer sheath connector 14 needs to move along the rigid sleeve 23, the second sealing element 9 needs to be slidably sleeved on the rigid sleeve 23. Therefore, the second sealing element 9 achieves a dynamic sealing function in this embodiment.

[0218] In addition, based on the sealing concept, the rigid sleeve 23 in this embodiment can withstand greater compressive force without deformation, which can improve the sealing performance without affecting the movement of the outer sheath connector 14.

[0219] In one embodiment, for ease of sealing, such as Figure 26As shown, a sealing groove 10 is provided at the proximal end of the outer sheath connector 14, and a second sealing element 9 is disposed within the sealing groove 10. A sealing block 11 is also provided, which is slidably sleeved on the sheath core assembly 3 and fixed within the sealing groove 10 to press the second sealing element 9. The sealing block 11 and the sealing groove 10 can be interference-fitted to press and fix the second sealing element 9.

[0220] To facilitate the assembly of the rigid sleeve 23, such as Figure 26 As shown, in this embodiment, the first channel 41 includes a distal channel 410, a middle channel 411, and a proximal channel 412; wherein, the diameter of the distal channel 410 is larger than the diameter of the middle channel 411, the distal channel 410 is used to pass through the rigid sleeve 23 sleeved outside the sheath core assembly 3 in the conveyor, and the inner end face of the distal channel 410 is used to abut against the end face of the rigid sleeve 23;

[0221] The middle channel 411 and the proximal portion are used for the portion of the sheath core assembly 3 extending out of the rigid sleeve 23 to pass through. The entrance of the second channel 42 is located in the middle channel 411 and close to the distal channel 410. The entrance of the third channel 43 is located in the middle channel 411 and close to the proximal channel 412.

[0222] Specifically, the diameter of the distal channel 410 matches the diameter of the rigid sleeve 23, and the diameter of the intermediate channel 411 matches the diameter of the sheath core 31. During installation, the end face of the rigid sleeve 23 abuts against the end face of the distal channel 410, while the sheath core 31 enters the intermediate channel 411 and can extend into the proximal channel. The distal channel 410 allows for positioning of the relative positions of the connector body 4 and the rigid sleeve 23, facilitating the insertion of the release element 6 into the rigid sleeve 23 via the second channel 42.

[0223] To facilitate guidewire insertion, an additional guidewire connector 7 is required, such as... Figure 26 As shown, the guidewire connector 7 can be installed at the proximal end of the connector body 4 and corresponds to the first channel 41. To facilitate the connection between the guidewire connector 7 and the connector body 4, in this embodiment, the diameter of the proximal channel 412 is larger than the diameter of the middle channel 411, and the proximal channel 412 is used to connect the guidewire connector 7. The diameter of the proximal channel 412 matches the diameter of the distal end of the guidewire connector 7, and the distal end of the guidewire connector 7 can be inserted into the proximal channel 412. The sheath core 31 can be inserted into the guidewire connector 7 and fixed to facilitate the guidewire entering the sheath core 31.

[0224] In one implementation, such as Figure 25 and Figure 26 As shown, the guide wire connector 7 is detachably connected to the connector body 4 and corresponds to the first channel 41. The guide wire connector 7 is used to guide the wire into the sheath core 31.

[0225] Specifically, in this embodiment, the guidewire connector 7 can be connected to the proximal end of the first channel 41, specifically to the proximal channel 412 of the first channel 41. The sheath core 31 in the sheath core assembly 3 is mated to the guidewire connector 7, and the guidewire can enter the sheath core 31 through the guidewire connector 7.

[0226] In one embodiment, the guide wire connector 7 is a Luer connector, and the connector body 4 is a double Luer connector.

[0227] After configuring a third channel 43 on the connector body 4 for liquid injection, it is necessary to prevent liquid from flowing out from the proximal end of the connector body 4. Therefore, as follows... Figure 26 As shown, the connector in this embodiment also includes a first sealing element 8. The first sealing element 8 is disposed in the proximal channel 412 and abuts against the end face of the guide wire connector 7. The first sealing element 8 is used to seal the sheath core 31 of the sheath core assembly 3.

[0228] Specifically, the first sealing element 8 can be a sealing ring, which is fitted onto the sheath core 31. After the guide wire connector 7 is installed to the proximal end of the connector body 4, it presses the first sealing element 8 against the end face of the proximal channel 412, thereby sealing the proximal end of the first channel 41 through the first sealing element 8 and preventing the liquid injected through the third channel 43 from flowing out.

[0229] like Figure 26 As shown, to facilitate the fixing of the guide wire connector 7, a second connecting part 70 is provided on the guide wire connector 7 in this embodiment. The second connecting part 70 is used for fixed connection with the proximal end of the handle body 1. In one embodiment, the second connecting part 70 can also be a connecting groove. Correspondingly, a connecting plate corresponding to the connecting groove is provided on the handle body 1 of the conveyor. When the two shells of the handle body 1 are fastened together, the connecting plate is inserted into the connecting groove to fix the guide wire connector 7. In another embodiment, the second connecting part 70 can be inserted into the proximal end of the handle body 1 for fixation. For example, the second connecting part 70 can be set as a buckle, and a slot is provided at the proximal end of the handle body 1. The buckle can be inserted into the slot and fixed.

[0230] When releasing the bracket, the release component 6 needs to be pulled back. This process needs to be performed on the connector body 4. To facilitate pulling the release component 6, as follows: Figure 24 and Figure 26 As shown, the connector assembly in this embodiment also includes a release member connecting connector 5, which is detachably fixed to the connector body 4 and corresponds to the second channel 42. The release member connecting connector 5 is used to fix the release member 6 extending from the distal end of the second channel 42.

[0231] Specifically, after the bracket is loaded, the proximal end of the release element 6 can be fixed to the release element connecting joint 5 after passing through the second channel 42. The release element connecting joint 5 can then be fixed to the joint body 4, thereby fixing the release element 6. When it is necessary to release the bracket, the release element connecting joint 5 can be removed from the joint body 4. At this time, the release element connecting joint 5 can be held and pulled outward to pull the release element 6 to release the bracket.

[0232] In one embodiment, the release element connecting joint 5 and the joint body 4 are detachably connected via a quick-release structure. Specifically, the release element connecting joint 5 and the joint body 4 can be connected by threads or snap-fit, thereby facilitating installation and disassembly, and consequently, the loading and release of the bracket. The release element 6 and the release element connecting joint 5 can be bolted or welded together, etc., but this embodiment does not impose any limitations.

[0233] Optionally, such as Figure 25 As shown, the handle body 1 also includes a first housing 100 and a second housing 101, which are fastened together and fixed to each other. A third connecting part 102, a fourth connecting part 103 and a fifth connecting part 104 are provided between the first housing 100 and the second housing 101.

[0234] The distal end of the connector body 4 is located between the first housing 100 and the second housing 101, and is fixed by the cooperation of the third connecting part 102 and the first connecting part 44.

[0235] The distal end of the guide wire connector 7 is located between the first housing 100 and the second housing 101, and is fixed by the cooperation of the fourth connecting part 103 and the second connecting part 70.

[0236] The limiting tube 15 is located between the first housing 100 and the second housing 101 and is fixed by the fifth connecting part 104.

[0237] In one embodiment, the third connecting part 102, the fourth connecting part 103, and the fifth connecting part 104 are all connecting plates disposed between the first housing 100 and the second housing 101. The third connecting part 102, the fourth connecting part 103, and the fifth connecting part can be used to position and connect the connector body 4, the guide wire connector 7, and the limiting tube.

[0238] According to another aspect of the present invention, a conveying assembly is provided, including the above-described conveyor and release member 6;

[0239] Release element 6 is inserted into the second channel 42, the activity space, and the guide channel 32. The distal end of release element 6 extends to the loading space and secures the medical device to the sheath core 31 (e.g., Figure 29 As shown), the proximal end of the release member 6 extends into a second channel 42 and is secured by the release member 6 connecting connector 5.

[0240] Specifically, in this embodiment, the release element 6 can be a slender rod-shaped or filamentous structure. The sheath core assembly 3 can include a sheath core 31 and a middle layer tube 30 sleeved and fixed outside the sheath core 31. The distal end of the release element 6 is connected to a medical device sleeved on the sheath core 31, such as a stent, thereby constraining the medical device to the distal end of the sheath core 31. The proximal end of the release element 6 extends into the second channel 42 through a guide channel within the middle layer tube 30. The proximal end of the release element 6 needs to be fixed, so the proximal end of the release element 6 can further extend out of the second channel 42 and be fixedly connected to the release element 6 connecting connector 5. During release, the release element 6 connecting connector 5 is operated to separate from the connector body 4, thereby pulling the release element 6 to move, separating the distal end of the release element 6 from the medical device, and achieving precise release of the medical device.

[0241] The conveying assembly also includes a wire fastener 600, which is fixed to the sheath core and located in the loading space.

[0242] To facilitate the positioning of the distal restraint bracket and the release of the bracket, such as Figure 29 and Figure 30 As shown, in one embodiment, the distal end of the release member 6 passing through the fixing member 600 has a bend 4001. The bend 4001 is hooked onto the fixing member 600 so that the positions of the release member 6 and the fixing member 600 are relatively fixed, and the bend 4001 can deform under the rearward traction force of the release member 6 to detach from the fixing member 600 and release the restriction on the medical device.

[0243] The release component 6 in the release assembly provided in this application has a return bend 4001 at its distal end. Through the hooking of the return bend 4001, the release component 6 can be temporarily fixed in relative position with the fixing component 600. When the release component 6 is subjected to a rearward traction force, the return bend 4001 deforms and detaches from the fixing component 600, releasing the restriction on the interventional medical device. This structure is simple, easy to operate, and the unlocking process is easy, and can be completed without a complex structure.

[0244] Furthermore, such as Figure 29 and Figure 30 As shown, the bend 4001 includes a first section 40011 and a second section 40012. The first section 40011 is a bent section, and the second section 40012 is a straight section. The second section 40012 can be attached to the outer wall of the wire fastener 600, such as... Figure 29 As shown, the first segment 40011 of the curved section hooks onto the end of the wire fixing member 600, and the second segment 40012 of the straight section adheres to the outer wall of the wire fixing member 600. The first segment 40011 and the second segment 40012 together complete the hooking of the wire fixing member 600, so that the position of the release member 6 and the wire fixing member 600 is temporarily fixed relative to each other.

[0245] Specifically, the length of the second segment 40012 is greater than or equal to the length of the fixed wire member 600, which can increase the traction force required when the release member 6 retracts. At the same time, it can also increase the stability of the release member 6 hooking the fixed wire member 600, ensuring that the relative position of the release member 6 and the fixed wire member 600 remains unchanged during the retraction of the outer sheath tube 100.

[0246] In this embodiment, a bendable structure is provided on the side of the first segment 40011 away from the fixing member 600. The bendable structure not only makes it easier to bend the distal end of the release member 6 back, but also makes it easier for the bend 4001 to deform under the traction force during the release process, making the release process smoother. Specifically, the bendable structure includes a groove in the middle of the first segment 40011.

[0247] In this embodiment, a release member moving channel is provided inside the fixing member 600 for the distal end of the release member 6 to pass through. The release member 6 can be inserted into the release member moving channel. The release member moving channel is provided inside the fixing member 600 to accommodate the release member 6 and to prevent the release member 6 from being squeezed by the fixing member 600 onto the surface of the sheath core 30 and unable to move. Although the release member 6 can move inside the fixing member 600, the return bend 4001 hooks onto the fixing member 600 after the return bend, preventing the release member 6 from retracting. Only after the outer sheath tube 100 has retracted completely will the distal end of the release member 6 be freed from the restriction of the outer sheath tube 100. Under the action of the backward traction force, the return bend 4001 deforms and detaches from the fixing member 600, thus releasing the restriction on the medical device.

[0248] Furthermore, a receiving groove for accommodating the second segment 40012 is provided on the outer wall of the fixing member 600. Since the size of the outer sheath tube 100 is fixed, the second segment 40012 needs to be inserted between the fixing member 600 and the inner wall of the outer sheath tube 100. If it is directly stored, the friction may be too large, making storage difficult, or even the second segment 40012 cannot be stored due to the size. However, by providing a receiving groove on the outer wall of the fixing member 600, the second segment 40012 can be accommodated in the receiving groove. With this design, when the size between the inner wall of the outer sheath tube 100 and the fixing member 600 is fixed, the second segment 40012 can also be stored in the outer sheath tube 100.

[0249] In one embodiment, there are at least two release members 6, which can be distributed in the circumferential direction of the sheath core 30. Specifically, when there are two release members 6, the two release members can be of the same length and can be symmetrically distributed on both sides of the sheath core 30 to restrict two positions on the medical device located in the same circumferential direction, respectively, to ensure the restriction effect on the medical device, so that the medical device can release and expand after reaching the preset position.

[0250] Of course, the two release elements can also be of different lengths. The longer release element can restrict the distal portion of the medical device, while the shorter release element can restrict the proximal portion. During release, the release elements can be pulled back one by one as needed.

[0251] The number of release components 6 can also be more, such as three, four, five, etc. Multiple release components 6 can be evenly distributed on the circumference of the sheath core 30 or unevenly distributed on the circumference of the sheath core 30.

[0252] In this embodiment, two fixing members 600 are provided at the distal end of the sheath core 30. The two fixing members 600 are located at both ends of the medical device. The release member 6 passes through the two fixing members 600 and has a bend 4001 in the part passing through the fixing member 600 located at the distal end of the medical device. The fixing member 600 located at the proximal end of the medical device allows the release member 6 to move. The release member 6 is tightened at both ends of the medical device by the fixing members 600, so that the part of the release member 6 between the two fixing members 600 can restrict the medical device and prevent the medical device from self-expanding prematurely.

[0253] Furthermore, it also includes a guide 700, which is located at the distal end of the sheath core 30 and between the two wire fixing members 600. The release member 6 passes through the proximal wire fixing member 600, then through the guide 700, and finally through the portion of the distal wire fixing member 600 with a bend 4001. The guide 700 in the middle can guide the release member 6 through and its axial movement during retraction. Specifically, the guide 700 has a lead wire groove for the release member 6 to pass through. The guide 700 is installed at the distal end of the sheath core 30 and is located between the two wire fixing members 600. The lead wire groove can guide the distal end of the release member 6 through and guide the axial movement path of the distal end of the release member 6.

[0254] In this embodiment, the release element 6 can be a wire or rod, such as an elastic metal wire or a plastic metal wire, and can be made of nickel-titanium alloy or stainless steel.

[0255] In another embodiment, such as Figure 31 and Figure 32 As shown, the distal end of the release member 6 is fixedly connected to the fixing member 600. The part of the release member 6 used to restrict the medical device is provided with a breakable part 4002. The breakable part 4002 is configured to break when the backward traction force received by the release member 6 exceeds a preset value.

[0256] The release component 6 in the release assembly provided in this application has a fracturing part 4002 at its distal end. Before the fracturing part 4002 breaks, the distal end of the release component 6 is fixedly connected to the fixing part 600 to constrain the medical device. When the medical device needs to be released, the release component 6 is pulled back. When the force pulling the release component 6 exceeds a preset value, the fracturing part 4002 breaks, the distal end of the release component 6 is separated from the fixing part 600 and can be pulled back. After the release component 6 is pulled back, the constraint on the medical device is released, so that the medical device can fully expand and complete the implantation of the medical device.

[0257] In this embodiment, the easily breakable part 4002 is located between the fixing member 600 and the medical device. This design ensures that the part of the release member 6 near the fixing member 600 will not affect the expansion of the medical device after it breaks. If the easily breakable part 4002 is located at the position of the medical device, the part of the release member 6 that is fixedly connected to the fixing member 600 may block the medical device after it breaks, which may affect the expansion of the medical device.

[0258] In this embodiment, as Figure 32 As shown, the release component 6 includes a first release section 4003 and a second release section 4004. A breakable portion 4002 is disposed between the first release section 4003 and the second release section 4004. The end of the first release section 4003 away from the second release section 4004 is fixedly connected to the wire fixing component 600. The diameters of the first release section 4003 and the second release section 4004 are both larger than the diameter of the breakable portion 4002. The diameters of the first release section 4003 and the second release section 4004 are both D0, and the diameter of the breakable portion 4002 is D1, where D0 > D1. By designing the diameter of the breakable portion 4002 to be smaller than the diameters of the left and right release sections, the breakable portion 4002 can break under a smaller backward traction force.

[0259] Specifically, the fractured portion 4002 is located between the fixing member 600 and the medical device. That is, after the fractured portion 4002 breaks, the first release section 4003 does not cover the medical device, and the first release section 4003 will not affect the expansion process of the medical device. Furthermore, the end of the first release section 4003 away from the second release section 4004 is used to pass through and fix between the fixing member 600 and the sheath core 30.

[0260] In this embodiment, the easily breakable part 4002 includes a groove provided on the release member 6. The groove is located between the first release section 4003 and the second release section 4004. The recessed part of the groove has a small diameter and is easy to break, so that the surgeon can more easily break it from the groove when applying a backward traction force to the release member 6.

[0261] Furthermore, the groove is an annular groove, which further facilitates the breakage of the easily fractured part 4002. In other embodiments, the groove may also be a longitudinal cross-section with two symmetrical V-shapes or arcs, resulting in fewer connecting portions in the middle of the easily fractured part 4002, allowing it to break under a smaller pullback force. In this embodiment, the release member 6 is configured to have at least two, with the at least two release members 6 spaced apart in the circumferential direction of the sheath core 30. In this embodiment, a lead wire groove is provided at the distal end of the sheath core 30. The lead wire groove is used to guide the release member 6 through and guide the release member 6 to move in the axial direction. By inserting the release member 6 into the lead wire groove, the radial movement of the release member 6 is restricted, allowing the release member 6 to move only axially.

[0262] Furthermore, a guide 700 is provided at the distal end of the sheath core 30. The guide 700 is located at the position of the medical device, and a lead wire groove is formed on the guide 700. In this embodiment, the release member 6 can be a wire or a rod, such as an elastic metal wire, a plastic metal wire, etc., and can be made of nickel-titanium alloy or stainless steel.

[0263] In yet another embodiment, such as Figures 33 to 35 As shown, the distal end of the release member 6 is used to pass through the fixing member 600 or between the fixing member 600 and the sheath core 30. The fixing member 600 includes a deformable part 6001. The deformable part 6001 applies pressure to the release member 6 by deformation, so that the release member 6 is fixed to the fixing member 600, thereby limiting the position of the medical device on the sheath core 30.

[0264] In this embodiment, the fixing member 600 includes a deformable part 6001. When the deformable part 6001 deforms, it can apply pressure to the release member 6 to fix the release member 6 to the fixing member 600, preventing the release member 6 and the medical device from moving backward with the outer sheath. When the outer sheath has finished retracting and the medical device needs to be released, the operator pulls the release member 6 backward to apply a backward traction force. As the backward traction force increases, the distal end of the release member 6 overcomes the pressure applied by the deformable part 6001, allowing the distal end of the release member 6 to detach from the fixing member 600 and retract to release the medical device, so that the medical device can fully expand to the preset position. The deformable part 6001 allows the release member 6 to be fixed relative to the fixed part 600, preventing the release member 6 and the medical device from moving backward with the outer sheath. When the release member 6 needs to be retracted, a backward traction force can be applied to make the release member 6 overcome the pressure applied by the deformable part 6001 and thus detach from the fixed part 600, thereby completing the retraction of the release member 6 and releasing the restriction on the medical device. This structure is simple and easy to operate, and facilitates the release of the constraint on the medical device.

[0265] In this embodiment, the deformable part 6001 applies pressure to the release member 6 through elastic deformation. The elastic deformation can generate elastic force, and under the action of the elastic force, pressure can be applied to the release member 6. When it is necessary for the release member 6 to release the constraint on the medical device, the release member 6 can be retracted as long as the applied retraction traction force exceeds the pressure applied by the elastic force.

[0266] Furthermore, at least a portion of the fixing member 600 is elastic, and the deformable portion 6001 is the elastic portion of the fixing member 600. The centripetal pressure applied by the member 6 can be released by the elastic expansion of the deformable portion 6001.

[0267] Specifically, the deformable part 6001 includes an annular elastic body, which is used to fit onto the distal end of the sheath core 30. The distal end of the release member 6 passes between the elastic body and the sheath core 30. The elastic body squeezes the release member 6 with elastic force to apply pressure to the release member 6, so that the release member 6 can be fixed with the fixing member 600. When it is necessary to release the medical device, the operator applies a backward traction force to the release member 6. Under the action of the backward traction force, the distal end of the release member 6 overcomes the pressure applied by the elastic body with elastic force and retracts until it is completely removed from the elastic body. The release member 6 can then move backward to release the constraint on the medical device.

[0268] In other embodiments, the deformable part 6001 can also apply pressure to the release member 6 through plastic deformation. The plastic deformation can be generated by external force. After the plastic deformation occurs, pressure is applied to the release member 6, so that the release member 6 can be fixed relative to the fixing member 600, preventing the release member 6 and the medical device from moving backward with the outer sheath. When it is necessary to release the medical device, the operator applies a backward traction force to the release member 6. Under the action of the backward traction force, the distal end of the release member 6 overcomes the pressure, so that the deformable part 6001 returns to the initial state until the distal end of the release member 6 can be separated from the deformable part 6001. After the retraction is completed, the constraint on the medical device is released.

[0269] Furthermore, when the deformable part 6001 is plastically deformable, the deformable part 6001 includes a plastic sidewall 60011 and a plastic channel 60012. The plastic sidewall 60011 is axially disposed on the fixed member 600, and the plastic channel 60012 is formed inside the plastic sidewall 60011. The distal end of the release member 6 passes through the plastic channel 60012, and pressure is applied to the release member 6 through the deformation of the plastic sidewall 60011 and the plastic channel 60012.

[0270] In this embodiment, as Figure 34 and Figure 35As shown, the plastic channel 60012 can be configured to communicate with the inner cavity of the wire fixing member 600, or it can be configured to be relatively independent from the inner cavity of the wire fixing member 600, which can be selected according to actual usage requirements. In this embodiment, the plastic channel 60012 matches the shape of the release member 6, so that when the plastic sidewall 60011 deforms, pressure can be applied to the release member 6. In this embodiment, the release member 6 can be a wire or a rod, such as an elastic metal wire, a plastic metal wire, etc., and can be made of nickel-titanium alloy or stainless steel.

Claims

1. An implantable medical device delivery system, characterized in that, include: The outer sheath, sheath core assembly, handle body, and sheath retraction structure; among which, The sheath retraction structure is located inside the handle body, and the sheath retraction structure includes: a rotor, a slider, a limiting structure, and an outer sheath connector; The rotor is provided with threads, and the rotor is operable to rotate relative to the handle body. The slider is provided with a sliding part, which engages with the threads of the rotor. The slider is driven to move by the rotation of the rotor. The limiting structure is used to limit the rotational movement of the slider relative to the rotor. The proximal end of the outer sheath is fixedly connected to the outer sheath connector, and the distal end of the outer sheath connector is connected to the slider. The slider pushes the outer sheath connector backward, thereby pushing the outer sheath backward. The sheath core assembly includes a middle tube and a sheath core. The middle tube is sleeved and fixed outside the sheath core, and the outer sheath tube is movably sleeved outside the middle tube. The proximal end of the sheath core extends out of the middle tube and is fixed relative to the handle body. A through guide channel is provided on the middle tube for the release element of the medical device to pass through.

2. The implantable medical device delivery device according to claim 1, characterized in that, The handle body is provided with a loading and release channel, the distal end of the sheath core extends out of the middle tube and forms a loading space for loading medical devices between it and the outer sheath tube, and the two ends of the guide channel are respectively connected to the loading and release channel and the loading space.

3. The implantable medical device delivery device according to claim 2, characterized in that, The guide channel includes a groove disposed on the inner sidewall of the middle layer tube; or, The guide channel includes a groove disposed on the outer wall of the middle layer tube; or, The guide channel includes a through hole disposed within the wall of the middle layer tube.

4. The implantable medical device delivery device according to claim 3, characterized in that, The sheath core assembly also includes a sleeve embedded in the guide channel, the sleeve being used to guide the release member and the loading member through.

5. The implantable medical device delivery device according to claim 1, characterized in that, The inner wall of the rotor is provided with threads, and the slider is disposed inside the rotor; The limiting structure includes a first limiting part and a second limiting part; The first limiting part is disposed between the slider and the second end of the outer sheath connector, and is used to limit the rotation of the slider relative to the outer sheath connector; The second limiting part is used to limit the rotational movement of the outer sheath connector relative to the rotor.

6. The implantable medical device delivery device according to claim 5, characterized in that, The second end of the outer sheath connector is axially aligned with the slider, so that the slider can push the outer sheath connector backward, and the outer sheath connector can be retracted independently and separated from the slider.

7. The implantable medical device delivery device according to claim 6, characterized in that, The outer sheath connector includes a sheath joint and a connecting rod. The connecting rod is fixedly connected to the sheath joint. The first end of the connecting rod is used to fixally connect the outer sheath, and the second end of the connecting rod is used to connect to the slider. The first limiting part is provided between the second end of the connecting rod and the slider.

8. The implantable medical device delivery device according to claim 7, characterized in that, The second limiting part includes a limiting tube for fixing inside the handle body. A third locking part is provided on the limiting tube along the axial direction. The outer sheath tube connector is provided with a fourth locking part. The fourth locking part engages with the third locking part and can move relative to each other along the axial direction, so as to restrict the rotation of the outer sheath tube connector while allowing the outer sheath tube connector to move axially relative to the handle.

9. The implantable medical device delivery device according to claim 5, characterized in that, The first limiting part includes a first locking part and a second locking part. The first locking part is disposed on the slider, and the second locking part is disposed at the second end of the outer sheath connector. The first locking part and the second locking part engage to restrict the rotational movement of the slider relative to the rotor. The first snap-fit ​​part is a first snap-fit ​​groove provided near the end of the slider, and the second snap-fit ​​part is a second snap-fit ​​protrusion. The second snap-fit ​​protrusion and the first snap-fit ​​groove are inserted and engaged along the axial direction of the rotor. The distance between the sidewall of the first snap-fit ​​groove and the axis of the slider is less than or equal to the inner radius of the slider.

10. The implantable medical device delivery device according to claim 8, characterized in that, It also includes a retainer, which is connected to the outer sheath connector and is rotatable about the axis of the outer sheath connector; and A first state limiting structure is disposed on the fixture, and as the fixture rotates, the first state limiting structure can be in a first state and a second state. A second-state limiting structure is disposed on the limiting tube. In the first state, the first-state limiting structure and the second-state limiting structure abut against each other in the retraction direction of the outer sheath tube connector. In the second state, the first-state limiting structure and the second-state limiting structure are completely offset in the circumferential direction; or The fixture is equipped with an unlock button, which can be turned to rotate the fixture. The handle body is provided with a connecting blocking groove and a retraction groove. The retraction groove is arranged along the axial direction of the handle body, and the blocking groove is arranged along the circumferential direction of the handle body. The unlock button can rotate from the blocking groove into the retraction groove and slide within the retraction groove.

11. The implantable medical device delivery device according to claim 10, characterized in that, It also includes a locking structure, which is disposed between the outer sheath connector and the retainer, and the locking structure is used to lock the rotation angle of the retainer.

12. The implantable medical device delivery device according to claim 8, characterized in that, It also includes a connector body, the distal end of which is provided with a first connecting part, the first connecting part being connected to the proximal end of the handle body; The connector body is provided with a first channel, a second channel and a third channel that are interconnected. The two ends of the first channel are open structures, and the second channel and the third channel are located on the side of the first channel. The proximal end of the sheath core passes through and is fixed in the first channel, the second channel is used for the release element of the delivery device to pass through, and the third channel is used for injecting liquid into the distal end of the delivery device.

13. The implantable medical device delivery device according to claim 12, characterized in that, It also includes a rigid sleeve, which is sleeved outside the sheath core. The distal end of the rigid sleeve passes through the outer sheath tube connector, and the proximal end of the rigid sleeve is fixed in the first channel. The outer sheath tube connector can move along the axial direction of the rigid sleeve. There is a movable space between the rigid sleeve and the sheath core assembly, and the guide channel, the second channel, and the third channel are connected to the movable space.

14. The implantable medical device delivery device according to claim 13, characterized in that, It also includes a second seal, which is fixed to the proximal end of the outer sheath connector and slidably sleeved on the rigid sleeve to seal the liquid flow channel between the sheath core assembly and the outer sheath connector during the movement of the outer sheath connector.

15. The implantable medical device delivery device according to claim 12, characterized in that, It also includes a guidewire connector and a release connector, the guidewire connector being connected to the first channel and used to guide the guidewire into the sheath core of the sheath core assembly; The guide wire connector is provided with a second connecting part, which is used to fix and connect to the proximal end of the handle body; A first sealing element is provided inside the end of the first channel, and the first sealing element is sealed and sleeved on the sheath core and abuts against the end face of the guide wire connector; The release element connector is detachably fixed to the connector body via a quick-release structure and corresponds to the second channel. The release element connector is used to fix the release element extending from the distal end of the second channel.

16. The implantable medical device delivery device according to claim 15, characterized in that, The handle body also includes a first housing and a second housing, which are fastened together and fixed to each other. A third connecting part, a fourth connecting part and a fifth connecting part are provided between the first housing and the second housing. The distal end of the connector body is located between the first housing and the second housing, and is fixed by the cooperation of the third connecting part and the first connecting part; The distal end of the guide wire connector is located between the first housing and the second housing, and is fixed by the cooperation of the fourth connecting part and the second connecting part; The limiting tube is located between the first housing and the second housing and is fixed by the fifth connecting part.

17. A conveying assembly, characterized in that, Includes the conveyor and release element as described in any one of claims 1 to 16; The release element is inserted into the second channel, the activity space, and the guide channel. The distal end of the release element extends into the loading space and constrains the medical device onto the sheath core. The proximal end of the release element extends out of the second channel and is fixed by the release element connecting connector.

18. The conveying assembly according to claim 17, characterized in that, It also includes a wire fixing component, which is fixed to the sheath core and located in the loading space; The distal end of the release member, passing through the fixing member, has a bend that hooks onto the fixing member, thereby fixing the relative positions of the release member and the fixing member. The bend is also capable of deforming under the rearward traction force of the release member to detach from the fixing member, thus releasing the restriction on the medical device; or... The distal end of the release member is fixedly connected to the fixing member. A fracture-prone portion is provided on the portion of the release member used to restrict the medical device. This fracture-prone portion is configured to break when the retraction force applied to the release member exceeds a preset value; or... The distal end of the release member is used to pass through the fixing member or between the fixing member and the sheath core. The fixing member includes a deformable part, which applies pressure to the release member by deformation, thereby fixing the release member to the fixing member and restricting the position of the medical device on the sheath core.

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