Driving assembly, control device, conveying system and intervention system

Abstract

The utility model relates to the technical field of medical instruments, and discloses a driving assembly, a control device, a conveying system and an intervention system. The driving assembly comprises a sleeve, a driving handle and a driving rod. The sleeve is provided with a first internal space; the driving handle is connected to the near end of the sleeve and provided with a second inner space communicated with the first inner space, and a first driving structure is arranged in the second inner space. The main body of the driving rod penetrates through the first internal space and the second internal space; an extension part is arranged at the far end of the main body and extends out of the far end of the sleeve; a second driving structure is arranged at the near end of the main body. The second driving structure is located in the second internal space and is matched and connected with the first driving structure; and the extension part is used for limiting relative rotation between the driving rod and the sleeve. According to the driving assembly, the control device can have better stability when controlling the interventional substance, and the operation difficulty is reduced.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and further to a drive assembly, a control device, a delivery system and an interventional system. Background Art

[0002] Medical devices play an important role in the diagnosis and treatment of diseases. For example, in interventional medical technology, operators can use the guidance of medical imaging equipment (such as angiography, fluoroscopy, computed tomography (CT), magnetic resonance imaging (MR), ultrasound, etc.) to deliver interventional substances to the target location using a delivery system, and manipulate the interventional substances to achieve diagnosis or treatment of the disease. The delivery system plays an important role in manipulating interventional substances. When facing the complex environment in the body, continuously improving the stability of the delivery system in manipulating interventional substances is of great significance to interventional medical technology. Utility Model Content

[0003] In view of this, the present application provides a driving assembly, a control device, a delivery system and an intervention system to improve the control stability of the intervention substance.

[0004] In a first aspect, a drive assembly is provided, which includes a sleeve, a drive handle and a drive rod. The sleeve has a first internal space; the drive handle is connected to the proximal end of the sleeve and has a second internal space, the second internal space is connected to the first internal space, and a first drive structure is arranged in the second internal space; the drive rod includes a main body, which is arranged in the first internal space and the second internal space; an extension portion is arranged at the distal end of the main body, and the sleeve extends from the distal end of the sleeve; a second drive structure is arranged at the proximal end of the main body, and is located in the second internal space. The second drive structure is matched and connected with the first drive structure; and the extension portion is used to limit the relative rotation between the drive rod and the sleeve.

[0005] The above drive assembly is provided with an extension at the distal end of the drive rod, a second drive structure is provided at the proximal end of the drive rod, and a first drive structure is provided in the internal space of the drive handle; through the matching connection of the first drive structure and the second drive structure, the length of the extension extending out of the sleeve can be controlled during installation, so that the drive rod has a certain extension amount; the setting of the extension portion provides an additional length for the delivery rod, and the setting of the proximal end of the drive rod makes the additional length (i.e., the extension amount of the drive rod) adjustable. In this way, the drive assembly can provide an additional length setting for the manipulation of the interventional material to prevent the delivery rod from retracting to the proximal end, which may cause the distal end of the delivery rod to accidentally detach from the interventional material and lose control of the interventional material; it can also have more flexible applicability. When facing different interventional materials, a suitable additional length can be set, which is conducive to the promotion and application of transcatheter interventional technology. In addition, the setting of the proximal and distal ends of the drive rod can make the drive of the delivery rod by the drive rod more stable, reduce the difficulty of operation, and reduce the failure of surgery caused by operating errors, thereby reducing damage to patients and reducing patient discomfort.

[0006] In one implementation, the driving handle is used to receive the driving force, and the driving force drives the sleeve to rotate, and the rotation of the sleeve is transmitted to the second driving structure through the extension part through the main body; the second driving structure drives the first driving structure to rotate; or, the rotation of the second driving structure is converted into an axial displacement relative to the first driving structure, changing the length of the extension part extending out of the sleeve. In the above driving process, the driving component can provide a rotational force or an axial driving force for the delivery rod, so that the distal end of the delivery rod produces an axial displacement, and the axial displacement is used to control the state of the interventional material.

[0007] In one implementation, the outer contour of the extension is non-circular, and the inner contour of the distal end of the sleeve matches the outer contour of the extension. Thus, when the drive handle is rotated, the outer wall of the extension can quickly abut against the inner wall of the sleeve, limiting the relative rotation between each other, so that the driving force received by the drive handle can be transmitted to the drive rod through the sleeve. This implementation makes the drive assembly simple in structure, low in cost, and has less restriction on the axial movement of the drive rod.

[0008] In one implementation, the outer profile of the extension portion includes an arc-shaped edge, so that the friction force of the axial movement between the extension portion and the sleeve can be reduced, making the axial movement between the drive rod and the sleeve smoother.

[0009] In one implementation, the driving assembly further includes a first elastic element, which is sleeved on the main body of the driving rod and is located in the first internal space; the first elastic element is in a compressed state. In this way, when the driving assembly drives the delivery rod, the elastic element can apply elastic force to both ends to resist the retraction tendency of the delivery rod when it is bent, further reducing the occurrence of the distal end of the delivery rod accidentally detaching from the interventional material, and further improving the stability of the manipulation of the interventional material.

[0010] In one implementation, a first limiting structure and a second limiting structure are provided in the first internal space, the first limiting structure is used to limit the distal displacement of the first elastic element, and the second limiting structure is used to limit the proximal displacement of the first elastic element. The two ends of the first elastic element abut between the proximal end of the extension portion and the second limiting structure, or abut between the first limiting structure and the second limiting structure. In this way, the elastic element remains in a compressed state during the driving process of the drive assembly, providing elastic force to resist the retraction tendency of the delivery rod when it is bent; in addition, the elastic element can be prevented from detaching from the sleeve, thereby improving the stability of the drive assembly.

[0011] In one implementation, the sleeve includes a first section and a second section, the proximal end of the first section is connected to the drive handle, the distal end of the first section is connected to the proximal end of the second section, the extension portion extends out of the sleeve from the distal end of the second section; and the first elastic element is confined within the first section.

[0012] In one implementation, the first limiting structure includes an inner wall of the second section, and the inner wall of the second section extends into the sleeve to form a space for the extension portion to pass through, and the size of the space is smaller than the cross-sectional size of the first elastic element. In this way, the inner wall structure of the sleeve can be used to achieve the distal limit of the elastic element, which has a simple structure and low cost. In addition, the inner wall setting of the second section can simultaneously meet the requirements of limiting the distal end of the elastic element and limiting the relative rotation between the drive rod and the sleeve with a simple structure, which is conducive to reducing the cost of the drive assembly, and is simple to assemble, which is more conducive to clinical application.

[0013] The second limiting structure includes a limiting nut, and the inner wall of the first section has a mounting section for mounting the limiting nut. The mounting section has an internal thread, and the limiting nut has an external thread, and the internal thread matches the external thread; the limiting nut has a through hole, the size of which is larger than the cross-sectional size of the main body of the driving rod, and is used for the main body of the driving rod to pass through, and the size of the through hole is smaller than the cross-sectional size of the first elastic element. In this way, the assembly of the driving component can be facilitated, such as the installation of the elastic element; for another example, the installation of the second limiting structure can be facilitated by the setting of the mounting section, and the position of the second limiting structure in the first internal space can be adjusted during installation, thereby adjusting the compression degree and elastic force of the elastic element, and having better installation flexibility.

[0014] In one implementation, the second drive structure includes a drive nut having an external thread, and the inner wall of the first drive structure has an internal thread that matches the external thread of the drive nut. The drive structure can be adjusted by the thread, which can achieve fine-tuning of the axial displacement of the drive rod, which is more conducive to the operator to accurately control the state of the interventional material; on the other hand, the thread has a certain self-locking effect, so that the drive rod can be maintained in the current position when not affected by external forces, so that both ends of the drive rod have a certain force to maintain the stability of the drive rod, thereby reducing the difficulty of operation; in addition, the above drive structure is simple, low-cost, and easy to install.

[0015] In one implementation, a third limiting structure is provided on the outer wall of the sleeve, which is used to limit the axial movement of the sleeve toward the proximal end when the driving assembly drives the delivery rod.

[0016] In a second aspect, a manipulation device is provided, comprising a housing and any one of the drive assemblies provided in the first aspect above. A channel is provided in the housing, the channel is used to accommodate the proximal end of the delivery rod; the drive assembly is used to drive the delivery rod. The housing has a first mounting position, the drive assembly is installed in the first mounting position, the drive handle of the drive assembly extends out of the housing, is used to receive the driving force, and the extension of the drive rod of the drive assembly extends into the channel of the delivery rod, connecting the proximal end of the delivery rod.

[0017] The above control device is equivalent to setting an extra length for the delivery rod through the setting of the drive assembly, and the extension of the drive rod is adjustable to prevent the delivery rod from retracting to the proximal end, which may cause the distal end of the delivery rod to accidentally detach from the interventional material and lose control of the interventional material. The drive rod drives the delivery rod more stably, reduces the difficulty of operation, and is more conducive to the promotion and application of transcatheter interventional technology; and reduces surgical failures caused by operational errors, thereby reducing damage to patients and reducing patient discomfort.

[0018] In one implementation, a second mounting position is provided in the housing, and the second mounting position intersects with the first mounting position. The control device further includes a locking assembly installed at the second mounting position. The locking assembly has a locked state and an unlocked state, respectively used to lock or unlock the axial movement of the drive assembly relative to the housing toward the proximal end.

[0019] The design of the above locking assembly can ensure that when the control device controls the delivery rod to control the state of the interventional substance, the drive assembly as a whole will not move toward the proximal end. Only the drive assembly can be controlled to achieve the control of the axial micro-displacement of the delivery rod. The delivery rod is not easy to separate from the interventional substance, which effectively reduces the risk of accidental separation of the interventional substance and the delivery system. After completing the implantation control of the interventional substance, the operator only needs to press the push rod of the locking assembly to release the locking state, and then pull the drive handle of the drive assembly toward the proximal end to drive the delivery rod to quickly separate from the interventional substance. The operation is convenient and quick.

[0020] In one implementation, the locking assembly includes a locking element, a push rod and a second elastic element. The locking element has an opening, the sleeve of the driving assembly passes through the opening, and the outer wall of the sleeve is provided with a third limiting structure, and the first side of the opening is used to limit the movement of the third limiting structure to the proximal end. One end of the push rod is connected to one side of the locking element, and the other end extends out of the housing from the second mounting position. One end of the second elastic element abuts or is connected to the inner wall of the second mounting position, and the other end abuts or is connected to the other side of the locking element. Wherein, when the locking assembly is in a locked state, the second elastic element is in a first compressed state, the locking element is located in a first position, so that the third limiting structure is located on the first side of the opening; the push rod is used to overcome the elastic force of the second elastic element under the action of an external force, and push the locking element in the direction of the second elastic element, so that the third limiting structure is away from the first side of the opening, and the locking assembly enters an unlocked state, and the second elastic element is in a second compressed state. The design of the locking assembly is conducive to the operator's single-handed operation, and can prevent misunderstanding of locking caused by accidentally touching the push rod.

[0021] In one implementation, the cross-sectional shape of the opening includes an ellipse or a racetrack shape, so that the friction force of the axial movement between the locking element and the sleeve can be reduced, so that the sleeve can pass through the opening of the locking element more smoothly in the unlocked state.

[0022] In one implementation, the control device further includes a mounting assembly for mounting the drive assembly at the first mounting position.

[0023] In one implementation, the mounting assembly includes a mounting rail and a mounting element; the mounting rail is arranged at a first mounting position and extends axially in the opposite direction of the channel; the mounting element is arranged on the sleeve of the driving assembly, and the mounting element matches the mounting rail and can move axially relative to the mounting rail.

[0024] In a third aspect, a delivery system is provided for delivering an interventional substance, the delivery system comprising a catheter, a delivery rod, and any one of the manipulation devices of the second aspect. The distal end of the catheter is used for detachably connecting the interventional substance; the delivery rod is inserted into the catheter; and the manipulation device is used for manipulating the interventional substance through the delivery rod.

[0025] In a fourth aspect, an intervention system is provided, comprising an intervention substance and any one of the delivery systems of the third aspect, for delivering the intervention substance. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The following is a brief introduction to the drawings used in describing the embodiments of the present application:

[0027] Figure 1 A schematic diagram of an application scenario of transcatheter interventional therapy provided in an embodiment of the present application;

[0028] Figure 2A schematic diagram of the structure of an intervention system provided in an embodiment of the present application;

[0029] Figure 3 A schematic diagram of the structure of a control device provided in an embodiment of the present application;

[0030] Figure 4 A schematic diagram of the structure of a drive assembly provided in an embodiment of the present application;

[0031] Figure 5 A schematic diagram of the remote end of a drive assembly provided in an embodiment of the present application;

[0032] Figure 6 A schematic diagram of the structure of another driving assembly provided in an embodiment of the present application;

[0033] Figure 7 A side view of a drive assembly provided in an embodiment of the present application;

[0034] Figure 8 A partial structural schematic diagram of a control device provided in an embodiment of the present application;

[0035] Fig. 9 A schematic diagram of the structure of an installation assembly provided in an embodiment of the present application;

[0036] Fig.10 A partial schematic diagram of an interventional system provided in an embodiment of the present application;

[0037] Figure 11-13 A schematic diagram of different states of an intervening substance provided in an embodiment of the present application;

[0038] Fig.14 A cross-sectional view of the distal end of a delivery rod provided in an embodiment of the present application within an intervention substance;

[0039] Figure 15-18 A schematic diagram of an implantation process of an interventional substance provided in an embodiment of the present application. DETAILED DESCRIPTION

[0040] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. The accompanying drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other accompanying drawings and other embodiments can be obtained based on these accompanying drawings without creative work. Adjustments and improvements made without departing from the concept of the present application are all within the scope of protection of the present application.

[0041] In order to simplify the drawings, the drawings in the embodiments of the present application only schematically show the parts related to the embodiments of the application, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, only some structures or components are schematically depicted in the drawings, and there may be more or fewer similar structures or components in reality.

[0042] In this application, unless otherwise clearly specified and limited, ordinal numbers, such as "first", "second", etc., are only used to distinguish and describe related objects, and cannot be understood as indicating or implying the relative importance or order between related objects; in addition, they do not represent the number of related objects. "And / or" is used to describe the relationship between related objects, which represents any combination relationship between related objects, for example, "a and / or b" includes: "a alone", "b alone", or "a and b".

[0043] The terms “install”, “set” and “connect” should be understood in a broad sense. For example, “install” can be directly installed or installed through other components; “set” can be directly set or set through other components; “connect” can be directly connected or connected through other components.

[0044] In the embodiments shown in the drawings, directional indications (such as up, down, left, right, front, and back, etc.) are not absolute but relative when describing the structure and movement of each component, and are not used to limit the direction of the product in actual use.

[0045] In the embodiments of the present application, "proximal end" and "distal end" are used to describe the position or direction of the associated (or described) object (referred to as associated object) relative to the operator from the perspective of the operator (for example, a doctor or operator). For example, the "proximal end" refers to the end close to the operator during the normal operation of the medical device by the operator; the "distal end" refers to the end away from the operator during the normal operation of the medical device by the operator, or the end that first enters the patient's body. For example, the "proximal end" of A refers to the end of A close to the operator; the "distal end" of A refers to the end of A away from the operator. Alternatively, the "proximal end" of A refers to the end of A away from the patient (or the affected area, or the target intervention location); the "distal end" of A refers to the end of A close to the patient (or the affected area, or the target intervention location).

[0046] Transcatheter interventional therapy can introduce interventional substances such as materials, medical devices, or drugs into the body through a catheter to perform minimally invasive diagnosis and / or treatment of diseases. Transcatheter interventional therapy can achieve better treatment effects through smaller wounds and is more conducive to postoperative recovery, so it is increasingly used in clinical practice. For example, transcatheter interventional therapy can be used for intravascular specimen collection or angiography and other diagnoses; for example, it can be used for drug infusion, embolization, vascular dilatation and shaping, intravascular stent placement, vascular filter placement, intravascular foreign body or thrombus removal, or intravascular plaque grinding and other treatments; for example, it can be used to implant medical devices into the heart and other organs for the treatment of heart disease.

[0047] For example, for heart disease treatment, please refer to Figure 1 , which is a schematic diagram of an application scenario of transcatheter interventional treatment provided in an embodiment of the present application. Figure 1 The structure of the heart is shown, as Figure 1 As shown, the heart is a hollow muscular organ with four chambers, namely the left atrium (LA) 11, the right atrium (RA) 21, the left ventricle (LV) 12, and the right ventricle (RV) 22. There is an atrioventricular valve (hereinafter referred to as the valve) between the atrium and the ventricle. When the ventricle relaxes, the valve opens and blood flows from the atrium to the ventricle; when the ventricle contracts, the valve closes to prevent blood from flowing back from the ventricle to the atrium. The valve between the left atrium 11 and the left ventricle 12 is the mitral valve (MV) 13, and the valve between the right atrium 21 and the right ventricle 22 is the tricuspid valve (TV) 23; the mitral valve 13 has two leaflets, which are perpendicular to the ventricular cavity and connected to the left ventricular wall through chordae tendineae 14 and papillary muscles 15; the tricuspid valve 23 has three leaflets, which are perpendicular to the ventricular cavity and connected to the right ventricular wall through chordae tendineae 24 and papillary muscles 25. The large blood vessels connected to the heart mainly include the aorta 31, the pulmonary artery 32, the superior vena cava 41 and the inferior vena cava 42. The heart and the large blood vessels work together to achieve blood circulation.

[0048] For example, transcatheter interventional therapy can be applied to structural heart diseases, such as diseases caused by abnormal cardiac structure or abnormal large blood vessel structure. For example, valve diseases or defect diseases. For example, valve diseases include blood regurgitation caused by valve lesions between the atria and ventricles (such as mitral regurgitation or tricuspid regurgitation), aortic stenosis, aortic regurgitation, pulmonary stenosis, or pulmonary regurgitation. Defect diseases include, for example, ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus. For valve diseases such as mitral regurgitation or tricuspid regurgitation, transcatheter interventional therapy technology can be used to deliver implantable medical devices such as valve clips to the lesion site to perform edge-to-edge repair of the mitral valve or tricuspid valve. For defect diseases such as ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus, transcatheter interventional treatment can be used. Medical devices such as occluders are implanted and delivered to the lesion site via catheter to block defects in the left or right ventricles, or between the left and right atria, or to block the passage between the aorta and the pulmonary artery.

[0049] Due to the complex internal environment of the organism, such as factors such as heart beating during surgery, the operator's operation requirements are high when manipulating the interventional material, and there may be problems such as insufficient control stability, thereby affecting the effect of interventional treatment. The embodiment of the present application provides a drive component that can be used in a control device of a delivery system, which is used to perform distal driving when the proximal end controls the distal interventional material. When facing a complex internal environment of the organism, the control device has more stable controllability, which can reduce the operation requirements for the operator, and reduce the damage to the patient during the operation or relieve the patient's discomfort.

[0050] The following is a description with reference to the accompanying drawings:

[0051] Please refer to Figure 2 , which is a schematic diagram of the structure of an intervention system provided in an embodiment of the present application. Figure 2 As shown, the intervention system 200 includes a delivery system 201 and an intervention substance 202. The delivery system 201 is used to deliver the intervention substance 202; the intervention substance includes, for example, an implantable medical device. The delivery system 201 includes, for example, a catheter 210 and a control mechanism 220. The catheter 210 is used to provide a delivery channel for the intervention substance 202, and the control mechanism 220 is used to control the distal movement of the catheter 210; the control mechanism 220 can also be used to control the intervention substance 202, for example, to control the connection and detachment of the intervention substance 202 with the distal end of the catheter 210, and for example, to control the state of the intervention substance 202. By controlling the state of the distal end of the intervention substance 202 through the control mechanism 220, the intervention substance 202 can adapt to the distal environment to change its state, which is conducive to the control of the implantation process of the intervention substance, so that the intervention substance can be more accurately implanted into the lesion position.

[0052] The catheter 210 may adopt a multi-layer catheter structure, which includes, for example, at least two layers of catheters, wherein the outer layer of the catheter provides an operation channel for other catheters, and the other catheters are used to deliver the interventional material 202. The control mechanism 220 includes, for example, a plurality of control devices for controlling the distal end movement of the catheter 210. For example, Figure 2 As shown, the delivery system 201 includes, for example, a three-layer catheter structure and a control device corresponding to the three-layer catheter. For example, the catheter 210 includes a guide catheter 211, a control catheter 212, and an inner layer catheter 213; the control mechanism 220 includes a control device 221, a control device 222, and a control device 223, which are respectively used to control the distal movement of the guide catheter 211, the control catheter 212, and the inner layer catheter 213. The control mechanism 220 may also include a loader 224, including a base 2241 and a loading catheter 2242. When in use, the loading catheter 2242 penetrates the proximal end of the control device 221, becomes a channel for the control catheter 212, the inner layer catheter 213, and the interventional material 202 to enter the guide catheter 211, and the interventional material 202 is loaded into the guide catheter 211 through the control device 221.

[0053] The interventional substance 202 is detachably connected to the distal end of the inner layer catheter 213, and the manipulation device 223 can control the connection or detachment of the interventional substance 202 and the inner layer catheter 213 through the delivery rod. For example, the delivery system 201 delivers the interventional substance 202 to the lesion site, and uses the manipulation device 223 to manipulate the interventional substance 202, and implants the interventional substance into the lesion site in a target form to achieve the treatment of the disease. Then the manipulation device 223 is used to control the interventional substance 202 to be detached from the distal end of the inner layer catheter 213 and remain in the biological body. For example, a driving component 2231 can be set on the manipulation device 223 (only the driving handle part of the driving component is shown in the figure, and the other parts of the driving component can be located in the housing of the manipulation device 223), which is used to drive the delivery rod, and the connection and detachment of the interventional substance 202 and the distal end of the inner layer catheter 213 are controlled by the delivery rod, and the state of the interventional substance 202 is controlled by the delivery rod.

[0054] The above description of the delivery system is only an example. The present application does not limit the shape and number of the catheters of the delivery system, nor does it limit the shape and number of the control devices included in the control mechanism. Delivery systems with different structures can be set according to different interventional materials.

[0055] Please refer to Figure 3, which is a schematic diagram of the structure of a manipulation device provided in an embodiment of the present application. The manipulation device 300 can be used to manipulate the interventional material through the delivery rod, for example, to control the connection or detachment of the interventional material at the distal end by driving the delivery rod; and / or, to control the state of the interventional material at the distal end by driving the delivery rod. For example, the manipulation device can be Figure 2 A control device 223 of the interventional system is shown.

[0056] like Figure 3 As shown, the manipulation device 300 includes a housing 310 and a drive assembly 320. A channel 311 of a delivery rod is provided in the housing 310, and the channel 311 is used to accommodate the proximal end of the delivery rod. The drive assembly 320 is used to drive the delivery rod so that the delivery rod moves (including rotation or axial displacement). In some embodiments of the present application, a first mounting position L1 is provided in the housing 310, and the drive assembly 320 is installed in the first mounting position L1. The drive handle 322 of the drive assembly 320 extends out of the housing 310 for receiving a driving force, and the extension 3232 of the drive rod of the drive assembly 320 extends into the channel 311 of the delivery rod to connect the proximal end of the delivery rod. In this way, the drive assembly 320 can drive the delivery rod to move by the drive rod. The movement of the delivery rod can be used to control the state of the interventional material; and / or, the movement of the delivery rod can be used to control the connection or detachment of the interventional material with the distal end of the inner layer catheter.

[0057] In some embodiments of the present application, the driving component is designed to increase the stability of the connection of the interventional material during the driving of the delivery rod. When facing a complex in vivo environment of a biological body, the interventional material can be manipulated more stably and the difficulty of operation can be reduced, thereby reducing damage to the patient during the operation or alleviating the patient's discomfort.

[0058] Please refer to Figure 4 , which is a schematic diagram of the structure of a driving component provided in an embodiment of the present application. Figure 3 and Figure 4As shown, the drive assembly 320 includes a sleeve 321, a drive handle 322, and a drive rod 323. The sleeve 321 has a first internal space S1; the drive handle 322 is connected to the proximal end of the sleeve 321 and has a second internal space S2. The second internal space S2 is connected to the first internal space S1, or the first internal space S1 has an opening facing the second internal space S2; and a first drive structure 324 is arranged in the second internal space S2. The drive rod 323 includes a main body 3231, which is arranged in the first internal space S1 and the second internal space S2; an extension portion 3232 is arranged at the distal end of the main body 3231, and the sleeve 321 is extended from the distal end of the sleeve 321; a second drive structure 3233 is arranged at the proximal end of the main body 3231, and is located in the second internal space S2. The second drive structure 3233 is matched and connected with the first drive structure 324; the extension portion 3232 is used to limit the relative rotation between the drive rod 323 and the sleeve 321.

[0059] The delivery system faces a complex biological environment. When delivering interventional materials, it may take more than one turn to reach the target position. The turn will cause a length change in the delivery path in the delivery system. For example, on the delivery rod, it may appear to be retracted toward the proximal end. Although the retracted length appears to be a trace amount, the manipulation of the interventional material is very important. Improper manipulation may cause the interventional material to detach from the distal end of the inner catheter, thereby causing surgical failure, or causing harm to the patient, or causing discomfort to the patient. The above drive assembly is provided with an extension portion at the distal end of the drive rod, a second drive structure is provided at the proximal end of the drive rod, and a first drive structure is provided in the internal space of the drive handle; through the matching connection of the first drive structure and the second drive structure, the length of the extension portion extending out of the sleeve can be controlled during installation, so that the drive rod has a certain extension amount; the setting of the extension portion provides additional length for the delivery rod, and the setting of the proximal end of the drive rod makes the additional length (i.e., the extension amount of the drive rod) adjustable. In this way, the drive assembly can not only provide an extra length setting for the manipulation of the interventional material, so as to prevent the delivery rod from retracting to the proximal end, which may cause the distal end of the delivery rod to accidentally detach from the interventional material and lose control of the interventional material; it can also have more flexible applicability. When facing different interventional materials, a suitable extra length can be set, which is conducive to the promotion and application of transcatheter interventional technology. In addition, the setting of the proximal and distal ends of the drive rod can make the drive of the delivery rod by the drive rod more stable, reduce the difficulty of operation, and reduce the failure of the operation caused by operating errors, thereby reducing the harm to the patient and reducing the patient's discomfort.

[0060] In the above drive assembly 320, the drive handle 322 is connected to the proximal end of the sleeve 321. When the operator rotates the drive handle 322, the drive handle 322 can drive the sleeve 321 to rotate together; that is, the drive handle 322 receives the driving force and transmits the driving force to the sleeve 321. Since the relative rotation between the sleeve 321 and the driving rod 323 is limited by the extension portion 3232, the sleeve 321 can drive the driving rod 323 to rotate; that is, the sleeve 321 can further transmit the driving force to the driving rod 323; the rotation of the driving rod 323 can drive the second driving structure 3233 at the proximal end to rotate. In some embodiments of the present application, the second driving structure 3233 can drive the first driving structure 324 to rotate; the overall rotation of the driving rod can drive the delivery rod to rotate, thereby controlling the state of the interventional material. In other embodiments of the present application, the rotation of the second driving structure 3233 is converted into axial movement relative to the first driving structure 324, changing the length of the extension portion 3232 extending out of the sleeve 321, and the axial movement of the driving rod can drive the delivery rod to produce axial displacement, thereby controlling the state of the interventional material.

[0061] In one application, the operator rotates the driving handle 322 so that the driving handle 322 receives the driving force, and drives the sleeve 321 to rotate under the action of the driving force. The rotation of the sleeve 321 is transmitted to the second driving structure 3233 through the extension portion 3232 and the main body 3231, and the second driving structure 3233 drives the first driving structure 324 to rotate. In the driving process, the rotation of the driving rod 323 can generate a driving force for the delivery rod at the proximal end of the delivery rod, and the driving force is transmitted by the delivery rod and converted into an axial displacement at the distal end of the delivery rod, and the state of the intervention material is controlled by the axial displacement. For example, a transmission member is provided in the main body of the intervention material, and the transmission member has an external thread and is matched and connected with the internal thread of the main body of the intervention material; the rotation of the delivery rod provides a driving force to the transmission member at the distal end, and the main body of the intervention material is attached to the inner layer catheter. The transmission member generates an axial displacement relative to the main body of the intervention material under the action of the driving force, and the axial displacement can change the state of the intervention material. The valve clip will be described as an example later.

[0062] When the above driving assembly is used to drive the delivery rod, the driving handle 322 can be rotated in the first direction to make the driving rod rotate in the first direction, thereby driving the delivery rod to rotate in the first direction, and the rotation in the first direction drives the transmission member inside the interventional material to produce an axial displacement toward the distal end at the distal end; the driving handle 322 can be rotated in the second direction (opposite to the first direction) to make the driving rod rotate in the second direction, thereby driving the delivery rod to rotate in the second direction, and the rotation in the second direction drives the transmission member inside the interventional material to produce an axial displacement toward the proximal end at the distal end. Different axial displacements can drive the interventional material to produce different state changes to suit the implantation operation of the interventional material.

[0063] In another application, the operator rotates the driving handle 322 so that the driving handle 322 receives the driving force, and the sleeve 321 is driven to rotate under the action of the driving force. The rotation of the sleeve 321 is transmitted to the second driving structure 3233 through the extension portion 3232 and the main body 3231. The rotation of the second driving structure 3233 causes an axial displacement between the second driving structure 3233 and the first driving structure 324. The axial displacement can change the length of the driving rod 323 extending into the second internal space S2, so that the length of the driving rod 323 (or the extension portion 3232) extending out of the sleeve 321 can be adjusted by the rotation of the driving handle 322. The change in the length of the driving rod 323 (or the extension portion 3232) extending out of the sleeve 321 can be used to drive the delivery rod to generate an axial displacement, and the axial displacement can change the state of the interventional material, which will be described later using the valve clip as an example.

[0064] When the above driving assembly is used to drive the delivery rod, the driving handle 322 can be rotated in the first direction to shorten the length of the driving rod 323 extending into the second internal space S2, thereby pushing the extension portion 3232 to move distally, and driving the delivery rod to move distally through the extension portion 3232, thereby generating an axial displacement toward the distal end at the distal end of the delivery rod; the driving handle 322 can be rotated in the second direction (opposite to the first direction) to lengthen the length of the driving rod 323 extending into the second internal space S2, thereby driving the extension portion 3232 to move proximally, and driving the delivery rod to move proximally through the extension portion 3232, thereby generating an axial displacement toward the proximal end at the distal end of the delivery rod. Different axial displacements can drive the interventional material to produce different state changes to suit the implantation operation of the interventional material.

[0065] In some embodiments of the present application, the extension 3232 is designed to limit the relative rotation between the drive rod 323 and the sleeve 321. For example, the outer contour of the extension 3232 is non-circular, and the inner contour of the distal end of the sleeve 321 matches the outer contour of the extension 3232, that is, the inner contour of the distal end of the sleeve 321 is also non-circular. In this way, when the drive handle 322 is rotated, the outer wall of the extension 3232 can quickly abut against the inner wall of the sleeve 321 to limit the relative rotation between each other, so that the driving force received by the drive handle 322 can be transmitted to the drive rod 323 through the sleeve 321. This implementation makes the drive assembly 320 simple in structure and low in cost, and has less restriction on the axial movement of the drive rod 323.

[0066] In some other embodiments of the present application, a limiting structure may also be provided on the outer wall of the extension portion 3232 and / or the inner wall of the sleeve 321, and the limiting structure is used to limit the relative rotation between the extension portion 3232 and the sleeve 321, and provide the degree of freedom of axial movement between the extension portion 3232 and the sleeve 321. For example, the limiting structure may include a matching groove body and a protruding structure, the protruding structure is located in the groove body, and the groove body provides an axial track for the protruding structure. When the driving handle 322 drives the sleeve 321 to rotate, the protruding structure is restricted in the groove body, and the relative rotation between the sleeve 321 and the extension portion 3232 is restricted, but the protruding structure can move axially along the groove body, so that the sleeve 321 and the extension portion 3232 generate an axial displacement. The protruding structure may be located on the inner wall of the sleeve 321, and the groove body may be located on the outer wall of the extension portion 3232; or, the groove body may be located on the inner wall of the sleeve 321, and the protruding structure may be located on the outer wall of the extension portion 3232. The above restriction structures are only examples, and other restriction structures may also be used to implement the invention, and the present application is not limited thereto.

[0067] The present application does not limit the specific shape of the outer contour of the extension portion 3232 or the inner contour of the distal end of the sleeve 321, which may be a regular shape or an irregular shape, for example, it may be an ellipse, a rectangle, a triangle, or other polygons; for example, it may be a runway shape, including two parallel sides, and symmetrical arcuate edges connected between the two sides. In some embodiments of the present application, the outer contour of the extension portion 3232 or the inner contour of the distal end of the sleeve 321 includes an arcuate edge, such as an ellipse or a runway shape, which can reduce the friction of the axial movement between the extension portion 3232 and the sleeve 321, making the axial movement between the drive rod 323 and the sleeve 321 smoother. For example, please refer to Figure 5 , which is a schematic diagram of the far end of a drive assembly provided in an embodiment of the present application. Figure 5 As shown, the outer contour of the extension portion 3232 is in a racetrack shape, and the inner contour of the distal end of the sleeve 321 matches it and is also in a racetrack shape.

[0068] In some embodiments of the present application, the drive assembly 320 may further include an elastic element to enable the drive rod 323 to resist the retraction tendency of the delivery rod when it is bent, further improving the stability of the manipulation of the interventional material. For example, please refer to Figure 6 , which is a schematic diagram of the structure of another driving component provided in an embodiment of the present application. Figure 6As shown, the driving assembly 320' also includes an elastic element 325 (in order to distinguish the description, it can be called a first elastic element); the elastic element 325 is sleeved on the main body 3231 of the driving rod 323 and is located in the first internal space S1 of the sleeve 321. The elastic element 325 is in a compressed state to apply elastic force to both ends to resist the retraction tendency of the delivery rod when it is bent. In this way, when the driving assembly drives the delivery rod, the elastic element can resist the retraction tendency of the delivery rod when it is bent, further reducing the occurrence of the accidental separation of the distal end of the delivery rod from the interventional material, and further improving the stability of the manipulation of the interventional material.

[0069] In some embodiments of the present application, the extension positions of the proximal and distal extensions of the elastic element 325 can also be limited in the sleeve 321. For example, a first limiting structure 326 and a second limiting structure 327 are provided in the first internal space S1. The first limiting structure 326 is used to limit the distal displacement of the elastic element 325, and the second limiting structure 327 is used to limit the proximal displacement of the elastic element 325. Both ends of the elastic element 325 abut between the proximal end of the extension portion 3232 and the second limiting structure 327, or abut between the first limiting structure 326 and the second limiting structure 327. For example, when the distance that the extension portion 3232 extends toward the distal end is small, the proximal end of the extension portion 3232 is closer to the distal end of the elastic element 325 relative to the first limiting structure 326, and then both ends of the elastic element 325 abut between the proximal end of the extension portion 3232 and the second limiting structure 327; as the distance that the extension portion 3232 extends toward the distal end increases, the first limiting structure 326 can replace the extension portion 3232, and the distal end of the elastic element 325 can extend as far as the first limiting structure 326, so that the elastic element 325 remains in a compressed state during the driving process of the drive assembly 320', providing elastic force to resist the retraction tendency of the delivery rod when bending; in addition, the elastic element 325 can be prevented from detaching from the sleeve 321, thereby improving the stability of the drive assembly.

[0070] In some embodiments of the present application, the sleeve 321 may include a first section P1 and a second section P2, the proximal end of the first section P1 is connected to the driving handle 322, the distal end of the first section P1 is connected to the proximal end of the second section P2, the extension portion 3232 extends out of the sleeve 321 from the distal end of the second section P2; and the elastic element 325 is confined in the first section.

[0071] Alternatively, if Figure 6As shown, the first limiting structure 326 includes the inner wall of the second section P2, and the inner wall of the second section P2 extends into the sleeve 321 to form a space for the extension portion 3232 to pass through, and the size of the space is smaller than the cross-sectional size of the elastic element 325. In this way, the inner wall structure of the sleeve 321 can be used to achieve the distal end limiting of the elastic element 325, which has a simple structure and low cost. In addition, the inner wall setting of the second section P2 can simultaneously meet the requirements of limiting the distal end of the elastic element 325 and limiting the relative rotation between the drive rod 323 and the sleeve 321 with a simple structure, which is conducive to reducing the cost of the drive assembly, and is simple to assemble, which is more conducive to clinical application.

[0072] Alternatively, if Figure 6 As shown, the second limiting structure 327 includes a limiting nut, and the inner wall of the first section P1 has a mounting section P11 for mounting the limiting nut. The mounting section P11 has an internal thread, and the limiting nut has an external thread, and the internal thread matches the external thread. Further, the limiting nut has a through hole H, the size of the through hole H is larger than the cross-sectional size of the main body 3231 of the driving rod 323, and is used for the main body 3231 of the driving rod 323 to pass through, and the size of the through hole H is smaller than the cross-sectional size of the elastic element 325; in this way, there is no obvious contact between the main body 3231 of the driving rod 323 and the elastic element 325 and the limiting nut, and they can move freely axially relative to each other. This structure can facilitate the assembly of the drive assembly, for example, facilitating the installation of the elastic element; for example, by setting the mounting section P11, the installation of the second limiting structure 327 can be facilitated, and during installation, the position of the second limiting structure 327 in the first internal space S1 can be adjusted, thereby adjusting the compression degree and elastic force of the elastic element 325, and having better installation flexibility.

[0073] The present application does not limit the length of the installation segment P11. For example, the interior of the first segment P1 can form the installation segment P11 in whole or in part. The present application does not limit the starting and ending positions of the installation segment P11. For example, it can extend a preset distance from the proximal end of the first segment P1 to the distal end. For another example, the starting position of the installation segment P11 may not be located at the proximal end of the first segment P1. For example, the installation segment P11 begins to form after a distance from the proximal end of the first segment P1. The present application does not limit the ending position of the installation segment P11. The ending position can be set to the distal end or middle position of the first segment P1, or any other position. The longer the setting of the installation segment P11 is, the more optional installation positions are provided for the second limiting structure 327. During actual installation, the installation position can be selected according to the situation of the elastic element 325, so that the elastic element 325 is in a compressed state, providing a certain elastic force to resist the retraction tendency of the delivery rod.

[0074] Please continue to refer to Figure 4 and Figure 6In some embodiments of the present application, the second driving structure 3233 includes, for example, a driving nut having an external thread, and the inner wall of the first driving structure 324 has an internal thread that matches the external thread of the driving nut. The driving structure can be adjusted by threads, which can achieve fine-tuning of the axial displacement of the driving rod, which is more conducive to the operator to accurately control the state of the interventional material; on the other hand, the threads have a certain self-locking effect, so that the driving rod can be maintained in the current position when not affected by external forces, so that both ends of the driving rod have a certain force to maintain the stability of the driving rod, thereby reducing the difficulty of operation; in addition, the above driving structure is simple, low-cost, and easy to install.

[0075] In the drawings of the above embodiments, the extension portion 3232 is an extension rod, and the proximal end of the extension portion 3232 is fixedly connected to the distal end of the main body 3231 of the driving rod 323 through the end. However, the present application is not limited thereto, and in other embodiments, the extension portion 3232 may also be a sleeve rod sleeved on the main body 3231 of the driving rod 323, and the distal end of the main body 3231 may be located inside the sleeve rod or extend out of the sleeve rod.

[0076] In the drawings of the above embodiments, the second driving structure 3233 is a driving nut, and the proximal end of the main body 3231 of the driving rod 323 is connected to the driving nut. However, the present application is not limited thereto. In other embodiments, the proximal end of the main body 3231 of the driving rod 323 may pass through the second driving structure 3233 and pass out from the proximal end of the second driving structure 3233. The present application does not limit the structure or form of the second driving structure 3233 and the first driving structure 324.

[0077] Please continue to refer to Figure 4 and Figure 6 In some embodiments of the present application, the outer wall of the sleeve 321 is provided with a third limiting structure 328, which is used to limit the axial movement of the sleeve 321 toward the proximal end when the driving assembly 320 / 320' drives the delivery rod. For example, when the driving assembly is installed in the control device, the third limiting structure can cooperate with other components of the control device (such as the locking component) to achieve the axial movement restriction of the sleeve of the driving assembly toward the proximal end. For example, please refer to Figure 7 , which is a side view of a drive assembly provided in an embodiment of the present application. Figure 7 As shown, the third limiting structure 328 includes, for example, a limiting ring 328' sleeved on the sleeve 321. The above is only an example, and the embodiment of the present application does not limit the implementation of the third limiting structure, and other limiting methods can also be used, as long as they can cooperate with other components on the control device to limit the axial movement of the sleeve toward the proximal end when the driving component drives the delivery rod.

[0078] Optionally, the sleeve 321 also includes a base 3211, and there is a preset distance between the base 3211 and the third limiting structure 328, so that a clamping space C is formed between the base 3211 and the third limiting structure 328. When the drive assembly is installed on the control device, the clamping space C can be used to limit the axial movement of the sleeve to the distal end and the proximal end. For example, the cross-sections of the base 3211 and the third limiting structure 328 are both annular structures to form an annular groove therebetween. The outer diameters of the cross-sections of the base 3211 and the third limiting structure 328 are the same or different. The present application does not limit the size of the preset distance, and it can be set according to actual conditions, for example, the specifications of the element clamped in the clamping space.

[0079] The control device will be further described below with reference to the accompanying drawings.

[0080] Please refer to Figure 3 and Figure 8 ,in Figure 8 This is a partial structural diagram of a control device provided in an embodiment of the present application. Figure 3 and Figure 8 As shown, the control device 300 includes a housing 310 and a drive assembly 320 / 320'. A channel 311 is provided in the housing 310, and the channel 311 is used to accommodate the proximal end of the delivery rod. The drive assembly 320 / 320' is used to drive the delivery rod and has the structure provided by any of the above embodiments. The housing 310 has a first mounting position L1, the drive assembly 320 / 320' is installed in the first mounting position L1, and the drive handle 322 of the drive assembly 320 / 320' extends out of the housing 310 to receive the driving force. The extension 3232 of the drive rod 323 of the drive assembly 320 / 320' extends into the channel 311 to connect the proximal end of the delivery rod. The distal end of the extension 3232 can be fixedly connected to the proximal end of the delivery rod, and the connection method includes, for example, but is not limited to: welding (for example, using laser, or brazing, etc.), bonding, integrated processing, or using plastic pipe welding, etc.

[0081] The above control device is equivalent to setting an extra length for the delivery rod through the setting of the drive component, and the extra length of the drive rod is adjustable to prevent the delivery rod from retracting to the proximal end, which may cause the distal end of the delivery rod to accidentally detach from the interventional material and lose control of the interventional material; and it has more flexible applicability. When facing different interventional materials, a suitable extra length can be set, which is conducive to the promotion and application of transcatheter interventional technology. In addition, the setting of the proximal and distal ends of the drive rod can make the drive of the delivery rod by the drive rod more stable, reduce the difficulty of operation, and reduce the failure of surgery due to operational errors, thereby reducing damage to patients and reducing patient discomfort.

[0082] When the rotation of the second drive structure 3233 is converted into an axial displacement relative to the first drive structure 324, the first drive structure 324 can be fixedly installed relative to the housing 310. For example, when the drive assembly 320 / 320' is installed on the housing 310, the first drive structure 324 can be connected to the components on the housing 310 to fix the first drive structure 324 to the housing 310. For example, a mounting member 350 is arranged outside the sleeve 321, and a mounting position L3 is arranged in the housing 310. The mounting member 350 can be installed in the mounting position L3, and the proximal end of the mounting member 350 can extend into the driving handle 322 to engage with the first drive structure 324. For example, the engagement of the mounting member 350 with the first drive structure 324 can be achieved by rotating the driving handle 322, and the engagement can be released by rotating the driving handle 322. For example, the engagement of the mounting member 350 with the first drive structure 324 can be released by pulling the driving handle 322 toward the proximal end. The above installation methods are only examples, and the present application is not limited thereto. When the driving assembly 320 / 320 ′ is installed on the housing, the first driving structure 324 may also be fixedly connected to the housing by other methods.

[0083] In some embodiments of the present application, Figure 3 and Figure 8 As shown, the housing 310 further includes a second installation position L2, which intersects with the first installation position L1. The control device 300 may further include a locking assembly 330, which is installed at the second installation position L2. The locking assembly 330 has a locked state (eg, Figure 8 as shown) and unlocked state (as shown Figure 3 ), respectively used to lock or unlock the axial movement of the drive assembly 320 / 320' toward the proximal end relative to the housing 310. When the locking assembly 330 is in the locked state, the axial movement of the sleeve 321 toward the proximal end relative to the housing 310 is locked; when the locking assembly 330 is in the unlocked state, the axial movement of the sleeve 321 toward the proximal end relative to the housing 310 is unlocked.

[0084] When the locking assembly 330 is in a locked state, the driving handle 322 can be rotated to drive the delivery rod to rotate or move axially, and the rotation or axial movement of the delivery rod can drive the state change of the interventional material, so that the interventional material changes state according to the environment during the implantation process. When the locking assembly 330 is in an unlocked state, the driving handle 322 can be pulled toward the proximal end, so that the driving handle 322 drives the sleeve 321 and the driving rod 323, and then drives the delivery rod to move toward the proximal end, so that the interventional material is quickly detached from the inner catheter and implanted into the body of the organism.

[0085] In the locked state, the driving handle 322 drives the delivery rod at a first magnitude, at which time the axial movement distance for manipulating the state of the interventional material is small, for example, the range can be 0.5-3.5 mm. In the unlocked state, the driving handle 322 drives the delivery rod at a second magnitude, which is greater than the first magnitude, at which time the axial movement distance for manipulating the removal of the inner layer catheter by the interventional material is large.

[0086] In this way, during the implantation of the interventional material, the axial position of the sleeve 321 of the drive assembly 320 / 320' can be locked by the locking assembly 330 to prevent the drive assembly 320 from generating axial displacement during the rotation of the drive handle 322, thereby affecting the stable drive of the delivery rod, and the drive rod 323 can stably drive the delivery rod, further reducing the risk of accidental separation of the interventional material from the distal end of the delivery system. After the implantation of the interventional material is completed, the axial displacement of the drive assembly 320 / 320' can be unlocked, and the drive handle 322 can be pulled to move the entire drive assembly toward the proximal end, thereby driving the delivery rod to move rapidly toward the proximal end, so that the delivery rod can quickly withdraw from the interventional material, thereby achieving rapid removal of the interventional material; the operation is convenient and fast, especially in complex procedures, which can effectively speed up the surgical process and improve the surgical effect, and has high clinical significance.

[0087] In some embodiments of this application, please continue to refer to Figure 3 and Figure 8 The locking assembly 330 includes a locking element 331, a push rod 332, and an elastic element 333 (to distinguish the description, it can be called a second elastic element). The locking element 331 has an opening 3311, and the sleeve 321 of the driving assembly 320 / 320' passes through the opening 3311. The outer wall of the sleeve 321 is provided with a third limiting structure 328, and the first side 3312 of the opening 3311 is used to limit the movement of the third limiting structure 328 toward the proximal end. One end of the push rod 332 is connected to one side of the locking element 331, and the other end extends out of the housing 310 from the second mounting position L2. One end of the second mounting position L2 passes through the side wall of the housing 310 and forms a through hole in the side wall of the housing 310. One end of the push rod 332 can be movably penetrated in the second mounting position L2 through the through hole, and the other end extends out of the second mounting position L2 to serve as the operating end O of the locking assembly 330. One end of the elastic element 333 abuts against or is connected to the inner wall of the second installation position L2 , and the other end abuts against or is connected to the other side of the locking element 331 .

[0088] like Figure 8As shown, when the locking assembly 330 is in the locked state, the elastic element 333 is in the first compressed state, and the locking element 331 is in the first position, so that the third limiting structure 328 is located at the first side 3312 of the opening 3311. The push rod 332 is used to overcome the elastic force of the elastic element 333 under the action of an external force, and push the locking element 331 in the direction of the elastic element 333, so that the third limiting structure 328 is away from the first side 3312 of the opening 3311, and the locking assembly 330 enters the unlocked state (as shown in FIG. Figure 3 As shown), the elastic element 333 is in a second compressed state.

[0089] The structure of the above locking assembly is conducive to the one-handed operation of the operator. In addition, when the push rod 332 is not subjected to external force, under the elastic force of the elastic element 333, the third limiting structure 328 can be located at the first side 3312 of the opening 3311, that is, the locking assembly 330 can limit the movement of the driving assembly 320 / 320' toward the proximal end relative to the housing 310. The elastic force of the elastic element 333 on the locking element 331 can prevent the mis-locking caused by the accidental touch of the push rod 332. Only when the operator applies a thrust to the push rod 332 that overcomes the elastic force of the elastic element 333, can the third limiting structure change its position and break away from the restriction of the first side 3312 of the opening 3311, so that the locking assembly 330 enters the unlocked state.

[0090] Through the design of the locking assembly in the above embodiment, when the control device controls the delivery rod to control the state of the interventional substance, the drive assembly as a whole will not move toward the proximal end, and the drive assembly can only be controlled to achieve the control of the rotational displacement or axial micro-displacement of the delivery rod. The delivery rod is not easy to separate from the interventional substance, which effectively reduces the risk of accidental separation of the interventional substance and the delivery system. After completing the implantation control of the interventional substance, the operator only needs to press the push rod of the locking assembly to release the locking state, and then pull the drive handle of the drive assembly toward the proximal end to drive the delivery rod to quickly separate from the interventional substance, which is convenient and quick to operate.

[0091] Furthermore, the design of the base 3211 of the sleeve 321 of the drive assembly 320 / 320' allows the base 3211 to be snapped onto the proximal end of the housing 310, and when the locking assembly 330 is in the locked state, the sleeve 321 is restricted from axially moving toward the distal end relative to the housing 310.

[0092] In some embodiments of the present application, the cross-sectional shape of the opening 3311 on the locking element 331 is similar to the design of the inner contour of the distal end of the sleeve 321, for example, including an arc-shaped edge, so that the friction force of the axial movement between the locking element 331 and the sleeve 321 can be reduced, so that the sleeve 321 can pass through the opening 3311 of the locking element 331 more smoothly in the unlocked state. For example, the cross-sectional shape of the opening 3311 includes an ellipse or a racetrack shape.

[0093] For example, the long diameter of the opening 3311 extends along the axial direction of the push rod 332, providing a movable space for the movement of the locking element 331. The axial direction of the push rod 131 can be, for example, perpendicular to the sleeve 321 of the drive assembly 320 / 320'. The maximum size of the opening 3311 is larger than the cross-sectional size of the third limiting structure 328, for example, the short diameter of the opening 3311 is larger than the cross-sectional size of the third limiting structure 328, and when the third limiting structure 328 leaves the first position, the third limiting structure 328 can pass through the opening 3311 on the locking element 331, so that the drive assembly 320 / 320' moves toward the proximal end. For example, the long diameter of the opening 3311 is, for example, 1.5-2.5 times the outer diameter of the third limiting structure 328, and the short diameter of the opening 3311 is, for example, 1.2-1.8 times the outer diameter of the third limiting structure 328.

[0094] The shape of the above opening 3311 is only an example. In some other embodiments of the present application, the cross section of the opening 3311 on the locking element 331 can also be set to other shapes, which can be regular or irregular, as long as the size of the opening 3311 allows the third limiting structure to pass through the opening when leaving the first position. For example, the cross section of the opening 3311 is rectangular; the long side of the opening 3311 extends along the axial direction of the push rod 332; the short side of the opening 3311 is larger than the cross-sectional size of the third limiting structure 328. When the third limiting structure 328 leaves the first position, the third limiting structure 328 can pass through the opening 3311 on the locking element 331, so that the drive assembly 320 / 320' moves toward the proximal end.

[0095] In some embodiments of the present application, a limiting structure (for distinction, it can be referred to as a fourth limiting structure) is provided on the first side of the opening 3311, and the fourth limiting structure can cooperate with the third limiting structure 328 to limit the axial movement of the sleeve 321 toward the proximal end. For example, the fourth limiting structure is, for example, a protruding structure, which can be engaged in the clamping space C. When the push rod 332 pushes the locking element 331 to move further toward the elastic element 333, the protruding structure can leave the clamping space C, unlocking the restriction on the third limiting structure 328.

[0096] exist Figure 3 and Figure 8In the example shown, the locking element 331 can be divided into a left half and a right half according to the orientation from the proximal end to the distal end, wherein the left half is the locking side and the right half is the unlocking side. The fourth limiting structure can be arranged on the inner wall of the locking side, and can be arranged along the shape of the inner wall of the locking side by way of example. In the locked state, the elastic element 333 is in a first compressed state, has an outward elastic force, and the locking side of the locking element 331 is close to the sleeve 321. Under the restriction of the fourth limiting structure on the inner wall of the locking side, the third limiting structure 328 on the sleeve 321 cannot pass through the locking element 331, and the axial movement of the sleeve 321 is locked. The operating end O of the push rod 332 is pressed to overcome the elastic force of the elastic element 333, so that it is further compressed, and the unlocking side is close to the sleeve 321, so that the locking assembly 330 is in the unlocked state, and the third limiting structure on the sleeve 321 can pass through the locking element 331. The above is only an example. In some other embodiments, the unlocking side may also be located at other positions of the locking element 331, such as the middle position of the opening 3311, or any position between the middle and the right side of the opening 3311, etc. It can also be located at a position between the middle and the left side of the opening 3311, as long as the position can make the third limiting structure no longer restricted; the present application is not limited to this.

[0097] In some embodiments of the present application, the control device 300 may further include an installation component 360 for installing the drive component 320 / 320' at the first installation position L1. In this way, the drive component 320 / 320' can be installed at a preset position of the housing 310 of the control device 300 through the installation component 360 to achieve connection with other components (e.g., the locking component 330) in the housing at a preset position.

[0098] Combined with reference Fig. 9 , which is a schematic diagram of the structure of an installation component provided in an embodiment of the present application. Figure 3 , Figure 7-Figure 9 As shown, the mounting assembly 360 includes a mounting track 361 and a mounting element 362; the mounting track 361 is disposed at the first mounting position L1; the mounting element 362 is disposed on the sleeve 321 of the driving assembly 320 / 320', and the mounting element 362 matches the mounting track 361 and can move axially relative to the mounting track 361. The mounting track 361 can extend along the axial direction of the channel 311, and the extension direction is the opposite direction of the channel 311.

[0099] In the above installation structure, the drive assembly 320 / 320' can be installed at a preset installation position (first installation position L1) in the shell 310 of the control device 300 through the cooperation between the installation element 362 and the installation track 361; in addition, the installation track 361 can also guide the axial movement of the drive assembly 320 / 320', thereby improving the installation efficiency, and the installation is simple and not easy to be misplaced.

[0100] In some embodiments of the present application, both ends or one end of the mounting rail 361 in the axial direction are open structures to facilitate the installation of the mounting element 362 .

[0101] The present application does not limit the number of mounting elements 362, which may be one, two, or more. Figure 7 As shown, there are two mounting elements 362, which are symmetrically arranged on both sides of the sleeve 321. In this way, the two sides of the drive assembly 320 / 320' are symmetrical, and it is not necessary to distinguish which mounting element is suitable for inserting into the mounting track during installation, and one of the mounting elements 362 can be used as a handle to facilitate the installation of the drive assembly 320 / 320'.

[0102] In some embodiments of the present application, the mounting assembly 360 further includes a mounting ring 363, which is sleeved on the distal end of the sleeve 321, and the mounting element 362 is disposed on the mounting ring 363, and is connected to the sleeve 321 of the drive assembly 320 through the mounting ring 363. The mounting method of the mounting element on the sleeve is only an example, and the present application does not limit the setting method of the mounting element on the sleeve, for example, it can be set by clamping, welding, interference fit, etc.

[0103] The embodiment of the present application does not limit the composition of the elastic element. For example, the elastic element 325 may be a spring, a spring sheet, or other elastic element. Similarly, the elastic element 333 may be a spring, a spring sheet, or other elastic element.

[0104] The control device or driving assembly provided in the above embodiments of the present application can be used to control the intervention material to improve the stability of the control of the intervention material. The following takes the intervention material as a valve clip as an example, and describes the control of the intervention material by the above driving assembly or control device in combination with the accompanying drawings.

[0105] Please refer to Figure 10-Figure 17 , Fig.10 A partial schematic diagram of an interventional system provided in an embodiment of the present application; Figure 11-13 A schematic diagram of different states of an intervening substance provided in an embodiment of the present application; Fig.14 A cross-sectional view of the distal end of a delivery rod provided in an embodiment of the present application within an intervention substance; Figure 15-18 This is a schematic diagram of an implantation process of an interventional substance provided in an embodiment of the present application. In this example, the interventional substance is a valve clip 400 .

[0106] The valve clipper 400 includes a main body 410, a clamping member 420 (also referred to as a clamping arm) and a catch member 430 (also referred to as a catch arm). The clamping member 420 and the catch member 430 can both open and close relative to the main body 410, and their opening and closing movements can be independent of each other. The proximal end of the main body 410 can be detachably connected to the distal end of the inner layer catheter 213 through the clutch device 215. The distal end of the delivery rod 214 extends from the distal end of the inner layer catheter 213 and is inserted into the matching member 2151 of the clutch device 215, so that the clasping member 2152 of the clutch device 215 is clasped together, and the valve clipper 400 is clamped to the distal end of the inner layer catheter 213. When the distal end of the delivery rod 214 is pulled out of the matching member 2151, the clasping member 2152 opens, and the valve clipper 400 is detached from the distal end of the inner layer catheter 213. A transmission member 440 may be provided in the main body 410, and the distal end of the delivery rod 214 may be inserted into the transmission member 440. The axial movement of the transmission member 440 is used to drive the opening and closing movement of the clamping member 420, so that the state of the interventional substance can be changed. The distal cross-section of the delivery rod 214 may be set to be non-circular. When the delivery rod 214 rotates, it quickly abuts against the inner wall of the transmission member 440, so that the transmission member 440 is axially displaced relative to the main body 410. In some embodiments of the present application, the rotation of the delivery rod 214 can be converted into the axial movement of the transmission member 440; for example, the transmission member 440 is provided with an external thread 441, and the main body 410 is provided with an internal thread 411. The rotation of the delivery rod 241 can cause the transmission member 440 to be axially displaced relative to the main body 410. In some embodiments of the present application, the axial displacement of the delivery rod 214 can cause the transmission member 440 to generate an axial displacement relative to the main body 410; the force that the delivery rod 214 bears when generating the axial displacement also includes a rotational force. In this case, there may also be a driving method in which the rotation of the delivery rod 214 is transmitted to the transmission member 440 through a non-circular cross-section, so that the transmission member 440 generates an axial displacement. In this case, the transmission member 440 may or may not be provided with an external thread, and the main body 410 may or may not be provided with an internal thread. The transmission member 440 may include a segmented structure, so that the further transmission of the rotational tendency can be reduced or prevented, so that a section of the transmission member 440 connected to the clamping member 420 (for example Fig.14 The lower half shown in FIG. 4A ) has only axial movement as much as possible, so that the movement of the clamp 420 tends to change continuously and stably, and during operation, the valve clamp 400 has a more stable state.

[0107] The valve clip 400 has a closed state (eg Fig.11 , Fig.15 and Fig.18 ) and the open state (as shown Fig.12 , Fig.13 , Fig.16 and Fig.17As shown); Optionally, the open state may also include an inverted state. The following description is made taking mitral valve repair as an example. Figure 10-13 The valve clip 400 in the figure is not covered with a film to better show its structure; Figure 15-18 The valve clip 400 in FIG. 4 has a covering to better show its status during the repair process. The repair of other valve structures (such as the tricuspid valve) is similar.

[0108] During the implantation process, the guide catheter 211 is equipped with a dilator and enters the right atrium along the guide wire through the femoral vein. The distal end of the guide catheter 211 passes through the atrial septum and enters the left atrium. The dilator is then withdrawn, and the control catheter 212 is equipped with the inner layer catheter 213 and the valve clip 400 and enters the left atrium along the inner cavity of the guide catheter 211. Fig.11 and Fig.15 As shown, the valve clip 400 is connected to the distal end of the inner layer catheter 213; during the process of conveying the valve clip 400, the valve clip 400 is in a closed state. At this time, the valve clip 400 enters the patient's body with the minimum radial dimension, which can effectively reduce the damage of the valve clip 400 to the patient and relieve the patient's discomfort.

[0109] When the valve clip 400 is delivered to the target location (eg Fig.15 When the valve clip 400 is inserted into the main body 410 (as shown in FIG. 4 ), the driving handle 322 is rotated to drive the delivery rod 214 through the driving assembly, and the delivery rod 214 is inserted into the main body 410 (as shown in FIG. 4 ) of the valve clip 400. Fig.14 As shown), the delivery rod 214 drives the clamping member 420 to gradually open, so that the angle with the main body 410 gradually increases, and the Fig.12 and Fig.16 An open state is shown. For example, the valve clip 400 in the open state can be delivered to the left ventricle, or the valve clip 400 in the closed state can be delivered to the left ventricle, and then the clip 420 is controlled to open.

[0110] After the valve clip 400 is delivered to the left ventricle, the operator can adjust the position of the valve clip 400 through the image and determine whether the position and opening state of the valve clip 400 are suitable for capturing the valve leaflets. When the valve clip 400 is suitable for capturing the valve leaflets, the capture member 430 can be controlled to open by the capture member control handle 370, and move toward the clamping member 420 on the same side to capture the valve leaflets between the capture member 430 and the clamping member 420. The control device 223 can include two capture member control handles 370 to independently control the capture members 430 on both sides of the main body 410 to achieve independent capture of different valve leaflets.

[0111] After completing the leaflet capture (such as Fig.13 and Fig.17After that, the driving handle 322 is rotated to drive the delivery rod 214 through the driving assembly to control the clamping member 420 to close toward the main body 410. Since the capture member 430 is located between the clamping member 420 and the main body 410, the clamping member 420 can drive the capture member 430 to close, so that the valve clip 400 is restored to the closed state (as shown in FIG. Fig.18 Then, the push rod of the locking assembly is pressed to release the locking of the driving assembly; the driving handle is pulled toward the proximal end to drive the delivery rod 214 to leave the engaging member 2151 of the clutch device 215; so that the valve clip 400 is separated from the distal end of the inner layer catheter 213 (as shown in FIG. Fig.18 shown), and remain in the patient's body.

[0112] The angle between the clamps 420 facing the proximal end can be further increased, so that when the leaflet capture fails, the driving handle can be rotated to control the valve clip 400 to an inverted state through the delivery rod. In the inverted state, the angle between the clamps 420 facing the proximal end can be an obtuse angle, which is conducive to the valve clip 400 to retreat from the ventricle side to the atrial side and not entangle the tendons connecting the leaflets. In this way, it is convenient for the operator to control and reduce the damage to the patient's body tissue caused by the valve clip 400. Afterwards, the position and state of the valve clip 400 can be readjusted, and the above-mentioned leaflet capture and clamping steps are repeated until the leaflets are clamped in the opposite direction.

[0113] The driving assembly or control device of the above embodiments of the present application can control the valve clamp 400 to switch between the above states through the delivery rod 214, so that the valve clamp 400 maintains a stable connection with the distal end of the inner layer catheter 213 during the state conversion process, thereby improving the safety of the implantation of the valve clamp 400.

[0114] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0115] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. A drive assembly, characterized in that: include: a sleeve having a first interior space; A driving handle connected to the proximal end of the sleeve, having a second internal space, the second internal space is communicated with the first internal space, and a first driving structure is arranged in the second internal space; The driving rod comprises a main body, which is passed through the first internal space and the second internal space. An extension portion is provided at the distal end of the main body, and the sleeve is extended from the distal end of the sleeve. A second driving structure is provided at the proximal end of the main body, which is located in the second internal space, wherein the second driving structure is matched and connected with the first driving structure, and the extension portion is used to limit the relative rotation between the driving rod and the sleeve.

2. The drive assembly according to claim 1, characterized in that: The driving handle is used to receive a driving force, and drives the sleeve to rotate under the action of the driving force, and the rotation of the sleeve is transmitted to the second driving structure through the extension portion and the main body; Wherein, the second driving structure drives the first driving structure to rotate; or, the rotation of the second driving structure is converted into an axial displacement relative to the first driving structure, thereby changing the length of the extension portion extending out of the sleeve.

3. The drive assembly according to claim 1, characterized in that: The outer contour of the extension portion is non-circular, and the inner contour of the distal end of the sleeve matches the outer contour of the extension portion.

4. The drive assembly according to claim 3, characterized in that: The outer contour of the extension portion includes an arc-shaped edge.

5. The drive assembly according to claim 1, characterized in that: Also includes: The first elastic element is sleeved on the main body of the driving rod and is located in the first internal space, wherein the first elastic element is in a compressed state.

6. The drive assembly according to claim 5, characterized in that: A first limiting structure and a second limiting structure are provided in the first internal space, the first limiting structure is used to limit the distal displacement of the first elastic element, and the second limiting structure is used to limit the proximal displacement of the first elastic element; and Two ends of the first elastic element abut between the proximal end of the extending portion and the second limiting structure, or abut between the first limiting structure and the second limiting structure.

7. The drive assembly according to claim 6, characterized in that: The sleeve includes a first section and a second section, the proximal end of the first section is connected to the driving handle, the distal end of the first section is connected to the proximal end of the second section, the extension portion extends out of the sleeve from the distal end of the second section; and the first elastic element is confined within the first section.

8. The drive assembly according to claim 7, characterized in that: The first limiting structure includes an inner wall of the second section, the inner wall of the second section extends into the sleeve to form a space for the extension portion to pass through, and the size of the space is smaller than the cross-sectional size of the first elastic element.

9. The drive assembly according to claim 7, characterized in that: The second limiting structure includes a limiting nut, and the inner wall of the first section has a mounting section for mounting the limiting nut; Wherein, the installation section has an internal thread, the limiting nut has an external thread, and the internal thread matches the external thread; The limiting nut has a through hole, the size of which is larger than the cross-sectional size of the main body of the driving rod, for the main body of the driving rod to pass through, and the size of which is smaller than the cross-sectional size of the first elastic element.

10. The drive assembly according to claim 1, characterized in that The second driving structure comprises a driving nut having an external thread, and the inner wall of the first driving structure has an internal thread matching the external thread of the driving nut.

11. The drive assembly according to claim 1, characterized in that: The outer wall of the sleeve is provided with a third limiting structure, which is used to limit the axial movement of the sleeve toward the proximal end when the driving assembly drives the delivery rod.

12. A control device, characterized in that: include: a housing, wherein a channel is disposed in the housing, and the channel is used to accommodate the proximal end of the delivery rod; The drive assembly according to any one of claims 1 to 11, used to drive the delivery rod; Among them, there is a first installation position in the shell, the driving component is installed at the first installation position, the driving handle of the driving component extends out of the shell to receive the driving force, and the extension part of the driving rod of the driving component extends into the channel to connect the proximal end of the delivery rod.

13. The control device according to claim 12, characterized in that: The housing has a second installation position, the second installation position intersects with the first installation position, and the control device further includes: The locking assembly is installed at the second installation position and has a locked state and an unlocked state, and is used to lock or unlock the axial movement of the drive assembly relative to the shell toward the proximal end.

14. The control device according to claim 13, characterized in that: The locking assembly comprises: A locking element having an opening, wherein the sleeve of the drive assembly passes through the opening, the outer wall of the sleeve is provided with a third limiting structure, and the first side of the opening is used to limit the movement of the third limiting structure toward the proximal end; a push rod, one end of which is connected to one side of the locking element, and the other end of which extends out of the housing from the second mounting position; A second elastic element, one end of which abuts or is connected to the inner wall of the second mounting position, and the other end of which abuts or is connected to the other side of the locking element; Wherein, when the locking assembly is in the locking state, the second elastic element is in a first compressed state, and the locking element is located at a first position, so that the third limiting structure is located at a first side of the opening; The push rod is used to overcome the elastic force of the second elastic element under the action of external force, and push the locking element in the direction of the second elastic element, so that the third limiting structure is away from the first side of the opening, the locking assembly enters the unlocked state, and the second elastic element is in the second compressed state.

15. The control device according to claim 14, characterized in that: The cross-sectional shape of the opening includes an ellipse or a racetrack.

16. The control device according to claim 12, characterized in that: Also includes: The mounting assembly is used to mount the driving assembly at the first mounting position.

17. The control device according to claim 16, characterized in that: The installation assembly includes: A mounting rail, arranged at the first mounting position, extending in an axial direction of the channel in a direction opposite to the channel; The mounting element is arranged on the sleeve of the driving assembly, and the mounting element matches the mounting track and can move axially relative to the mounting track.

18. A delivery system for delivering an interventional substance, characterized in that: include: a catheter, wherein the distal end of the catheter is used for detachably connecting the intervention substance; A delivery rod, inserted into the catheter; The manipulation device according to any one of claims 12 to 17, used to manipulate the interventional substance via the delivery rod.

19. An interventional system, characterized in that: include: Intervention substances; The delivery system of claim 18, for delivering the intervention substance.

Images