CN117159229A

CN117159229A - Interventional system convenient to rotate

Info

Publication number: CN117159229A
Application number: CN202311153273.5A
Authority: CN
Inventors: 曾小桐; 章懿; 杨雅珂; 倪雨菲
Original assignee: Hangzhou Qiming Medical Devices Co ltd
Current assignee: Hangzhou Qiming Medical Devices Co ltd
Priority date: 2023-05-24
Filing date: 2023-05-30
Publication date: 2023-12-05
Also published as: CN116350398A; CN116327447A; CN117224286A; CN117547382A; CN116350398B; CN117547382B; CN116327447B

Abstract

The application discloses an intervention system convenient to rotate, which comprises an intervention conveying system and an artificial implant loaded on the intervention conveying system; the artificial implant is an aortic valve and is provided with a first mark; the interventional delivery system includes a catheter assembly for delivering an artificial implant, and a control handle for controlling the catheter assembly, the catheter assembly comprising: an outer sheath for receiving an artificial implant therein; an inner shaft which is rotatably arranged in the outer sheath tube in a penetrating way and is in sliding fit along the axial direction relative to the outer sheath tube; a balloon body deformable under the action of a fluid, the aortic valve being radially compressed and disposed on the outer periphery of the balloon body; the interventional delivery system is configured with a third identifier, and the rotational amplitude between the inner shaft and the outer sheath is adjusted by the first identifier and the third identifier to match the deviation information when the artificial implant is loaded in the interventional delivery system. The intervention system convenient to rotate can improve the positioning accuracy and is convenient to operate.

Description

Interventional system convenient to rotate

The application relates to a divisional application, the application number of the original application is 202310621086.9, the application date is 2023, 05 and 30 days, and the name of the interventional system is convenient for rotation.

Technical Field

The application relates to the technical field of medical instruments, in particular to an intervention system convenient to rotate.

Background

Transcatheter aortic valve implantation (Transcatheter Aortic Valve Implantation, TAVI), or transcatheter aortic valve replacement (Transcatheter Aortic Valve Replacement, TAVR); the artificial heart valve is delivered to the aortic valve area to be opened through the femoral artery to be sent into the interventional catheter, thereby completing the implantation of the artificial valve and recovering the valve function. This procedure does not require chest opening, and thus is less invasive and faster in post-operative recovery, requiring experienced cardiovascular medicine and surgeon practice.

Referring to fig. 1-2 c, taking the aortic valve 100 as an example, the aortic valve 100 of the human body is composed of three valve leaflets 110, and a commissure 120 is formed between adjacent valve leaflets 110, which are respectively a commissure 120a, a commissure 120b, and a commissure 120c. Behind each leaflet 110, the aortic wall bulges outward, forming the aortic sinus. Two of the three aortic sinuses emit coronary arteries and are therefore designated left coronary sinus (LCC) and right coronary sinus (RCC), the other being the non-coronary sinus (NCC). The two coronary arteries are the left coronary artery 130 and the right coronary artery 140, wherein the left coronary artery 130 is abbreviated as LCA and the right coronary artery 140 is abbreviated as RCA.

The prosthetic aortic heart valve also typically has three leaflets 220 and corresponding commissures, each in one-to-one correspondence with the commissures 120 of the aortic valve 100. During surgery, it is desirable that the commissures of the implanted prosthetic heart valve be aligned with the commissures 120 of the native aortic valve, avoiding the prosthetic leaflets 220 from blocking coronary blood flow.

In the prior art, in order to facilitate the in-vivo delivery of the prosthetic heart valve, the prosthetic heart valve needs to be pressed and held to a smaller diameter in vitro, then the prosthetic heart valve is delivered to a proper position in the body by a delivery system, and then the prosthetic heart valve is expanded and released. To achieve positioning, visualization may be provided at certain locations of the prosthetic heart valve, such as at the commissures 120, and the circumferential position of the prosthetic heart valve may be adjusted during implantation by rotating the prosthetic heart valve (e.g., rotating the delivery system to rotate the valve together), such that the commissures of the prosthetic heart valve align with the commissures 120 of the native valve.

However, this way of aligning by rotating the prosthetic heart valve has the following problems:

the sheath tube of the common conveying system is longer, the blood vessel of the human body is often more tortuous, the force of the rotary conveying system at the handle can not be well transmitted to the far-end artificial heart valve, and the rotation at the handle can not mean that the artificial heart valve can also rotate by corresponding degrees, besides the reason that the sheath tube is too long, the rotary effect is poor and the control is not easy because the rotary effect is influenced by the anti-kink degree of the sheath tube and the like.

Disclosure of Invention

The invention provides an intervention system convenient to rotate, which solves the problems that a prosthetic heart valve is easy to deviate and has poor positioning effect in the prior art.

An interventional system for facilitating rotation, comprising an interventional delivery system and an artificial implant loaded into the interventional delivery system;

the artificial implant is an aortic valve and comprises a bracket and a plurality of valve leaflets connected to the bracket, wherein a connecting part is formed between the adjacent valve leaflets, and the aortic valve is provided with a first mark;

the interventional delivery system includes a catheter assembly for delivering the prosthetic implant, and a control handle for controlling the catheter assembly, the catheter assembly comprising:

an outer sheath for receiving the artificial implant therein;

an inner shaft rotatably penetrating the outer sheath tube and axially slidably engaged with the outer sheath tube;

an adapter secured to the inner shaft for releasably connecting the artificial implant;

the interventional delivery system is configured with a third marker, and when the artificial implant is loaded in the interventional delivery system, the rotation amplitude between the inner shaft and the outer sheath tube is adjusted through the first marker and the third marker to match deviation information, wherein the deviation information is obtained by comparing position information of each valve sinus in a primary aortic valve with reference information.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

The application also provides an intervention system which is convenient to rotate, comprising an intervention conveying system and an artificial implant loaded on the intervention conveying system;

an outer sheath for receiving the artificial implant therein;

an inner shaft penetrating the outer sheath tube and axially sliding and matching with the outer sheath tube;

an adapter rotatably mounted to the inner shaft for releasably coupling the artificial implant,

a locking structure acting between the inner shaft and the adapter to maintain the relative circumferential positions of the two;

The interventional delivery system is configured with a third identifier, and when the artificial implant is loaded in the interventional delivery system, the rotation amplitude between the adapter and the inner shaft is adjusted through the first identifier and the third identifier so as to match deviation information, wherein the deviation information is obtained by comparing position information of each valve sinus in a primary aortic valve with reference information.

Optionally, the support adopts memory material and releases through the mode of self-expanding, the adapter is the installation head, the installation head with be equipped with circumference and the axial limit structure of mutually supporting between the support of aortic valve, limit structure includes:

the connecting lug is fixedly connected to the bracket;

and the positioning part is arranged at the periphery of the mounting head and is matched with the positioning groove and/or the positioning raised head of the connecting lug.

Optionally, the connection ear is used as the first identifier.

Optionally, the adapter is a balloon deformable under the action of fluid, and the aortic valve is radially compressed and arranged on the periphery of the balloon.

Optionally, a stop is further provided inside or outside the balloon body, the stop limiting the axial relative position of the aortic valve and the balloon body.

Optionally, the third mark is configured on the stop piece.

Optionally, the interventional delivery system further comprises:

an adjustment wire for releasably securing the artificial implant to the balloon, one end of the adjustment wire being capable of remaining secured to the balloon and the other end being capable of passing through the artificial implant and having a locking hole;

the locking wire is provided with opposite locking states and unlocking states, the proximal end of the locking wire is connected to the control handle, the distal end of the locking wire penetrates into each locking hole in the locking state to limit the artificial implant, and the locking wire is separated from each locking hole in the unlocking state to release the artificial implant.

Optionally, at least one axial end of the bracket is provided with an eyelet structure for the adjusting wire to pass through, and the eyelet structure is used as the first mark; the adjustment line and/or the lock line serves as the third identifier. Optionally, the first identifier and the third identifier are respectively configured independently, and are respectively an identifier or a part where the shape recognition can be performed.

Optionally, at least one of the first and third markers is circumferentially distributed and spans at least 60 degrees.

Optionally, the third mark has a reference bit and mark distribution areas located at two circumferential sides of the reference bit, and the circumferential span of the mark distribution areas is at least 120 degrees.

Optionally, the first identifier is specifically at least one of the following ways:

a1, the combination part of the valve leaflet and the bracket comprises a fixed edge of the valve leaflet, and the midpoint part of the fixed edge is used as the first mark;

a2, in the multiple valve leaflets, the splicing parts of two adjacent valve leaflets on the support are connecting parts, and the connecting parts are used as the first marks;

a3, carrying an identification symbol on the periphery of the aortic valve, wherein the identification symbol is used as the first identification;

the third identifier is specifically at least one of the following modes:

b1, in the catheter assembly, the periphery of one pipe fitting is provided with an identification symbol, and the identification symbol is used as the third identification;

b2, the surface of the control handle is provided with an identification symbol, and the identification symbol is used as the third identification;

b3, at least one part of the control handle is circumferentially fixed with the control handle as a whole and has an identifiable shape difference with the peripheral area, and the part is used as the third mark.

Optionally, the control handle has a first posture under the operating condition, and under the first posture, the third sign is vertical upwards relative to the circumference position of intervention conveying system.

Optionally, a driving mechanism is configured in the control handle to drive the inner shaft to rotate relative to the outer sheath tube.

Optionally, the locking structure is a lock nut in threaded fit with the inner shaft, and the lock nut is axially abutted to the mounting head for positioning.

Optionally, the artificial implant is preloaded in the outer sheath in a compressed state; the control handle comprises a first handle and a second handle which are in running fit, the proximal end of the outer sheath tube is connected to the first handle, the proximal end of the inner shaft is connected to the second handle, and a mark is arranged between the first handle and the second handle and used for identifying the rotation range of the artificial implant along with the inner shaft in the body.

Optionally, the artificial implant is preloaded in the outer sheath in a compressed state; the control handle drives the inner shaft to rotate through self rotation, and the self rotation angle of the control handle is used for identifying the rotation amplitude of the artificial implant along with the inner shaft in vivo, and the self rotation angle of the control handle is identified as at least one of the following modes:

c1, the periphery of the control handle is provided with a rotation angle identification symbol;

c2, an identification ring is arranged on the outer periphery of the control handle in a rotating way, and visual, audible or tactile prompts are provided when the identification ring rotates;

C3, setting up the stabilizer, control handle rotate the location install in the stabilizer, the stabilizer with be equipped with between the control handle mutually support in order to instruct control handle rotation range's sign.

The intervention system convenient to rotate has at least one of the following technical effects:

1. positioning accuracy is improved, and operation is convenient;

2. the relative posture of the artificial implant is adjusted in advance before the artificial implant is implanted into the body, so that personalized customization is realized, and the inconvenience of in-vivo rotation adjustment is reduced;

3. in vivo adjustments may also be made for deflection caused during implantation.

Drawings

FIG. 1 is a schematic illustration of the structure of an aortic valve in a heart;

FIG. 2a is a schematic view of an aortic arch according to one embodiment of the present application;

FIG. 2b is a cross-sectional view of the aortic valve of FIG. 2 a;

FIG. 2c is a schematic illustration of the structure of an artificial aortic valve;

FIG. 3a is a schematic view of the structure after release of the artificial implant;

FIG. 3b is a schematic diagram of an interventional delivery system;

FIG. 3c is a flow chart of a method of deploying an artificial implant to an interventional delivery system in accordance with one embodiment of the present application;

FIG. 4a is a schematic diagram of an aortic valve acquired using an MSCT or other equivalent imaging system;

Fig. 4b is a schematic structural diagram of the to-be-evaluated image in a normal state, wherein the to-be-evaluated image is additionally distributed around the central point of the aortic valve by taking the clock time as a circumferential scale;

fig. 4c is a schematic structural diagram of an image to be evaluated in a normal state in another embodiment, wherein the image to be evaluated is additionally distributed around the central point of the aortic valve with the clock time as a circumferential scale;

fig. 4d is a schematic structural diagram of distribution of aortic valve center points added to the image to be evaluated under normal condition with the angle as circumferential scale;

fig. 4e is a schematic structural diagram of the image to be evaluated in a normal state in another embodiment, wherein the image to be evaluated is additionally distributed around the central point of the aortic valve with an angle as a circumferential scale;

FIG. 5a is a schematic diagram illustrating the structure of the image to be evaluated in FIG. 4b deflected to the left by an angle α;

FIG. 5b is a schematic diagram illustrating the structure of the evaluation image to be evaluated in FIG. 4b deflected right by an angle β;

FIG. 6a is a view of a grasper for use with a balloon-expandable artificial implant according to one embodiment of the present application;

FIG. 6b is a press grip for use with an artificial implant using a self-expanding approach;

FIG. 6c is a schematic illustration of the structure of an artificial implant mounted to the mechanical channel of the crimping apparatus and beginning crimping;

FIG. 7a is a schematic illustration of a configuration of an artificial implant without an intervening delivery system;

FIG. 7b is an enlarged view of A1 of FIG. 7 a;

FIG. 7c is a schematic view of the structure of FIG. 7a before being pressed and held;

FIG. 7d is an enlarged view of A2 of FIG. 7 c;

FIG. 7e is a schematic view of the structure of an artificial implant with a bracket for crimping;

FIG. 8 is a schematic diagram of an interventional delivery system according to an embodiment of the present application;

FIG. 9 is a schematic diagram of an interventional system for facilitating rotation according to an embodiment of the present application;

FIG. 10a is a schematic view of a support frame according to an embodiment;

FIG. 10b is a schematic view of the structure of an embodiment of an artificial implant;

FIG. 10c is a schematic view of a frame according to an embodiment;

FIG. 11a is a schematic view of a structure in which identification lines are continuously distributed in a catheter assembly;

FIG. 11b is a schematic illustration of the identification line being distributed in segments over the catheter assembly;

FIG. 11c is a schematic view of a structure in which the identification lines are continuously distributed on the control handle;

FIG. 11d is a schematic illustration of the continuous distribution of identification lines to the catheter assembly and control handle;

FIG. 12a is a schematic view of the structure of the prosthetic implant in the balloon periphery in an expanded state;

FIG. 12b is a schematic view of an artificial implant disposed around the balloon body and having one end of the adjustment wire with a locking hole passing through the locking hole;

FIG. 12c is a schematic view of the structure of the lockwire limit adjuster wire out of the lockwire hole;

FIG. 13 is a schematic view of the artificial implant loaded into an interventional system;

FIG. 14a is a schematic view of a third marker distributed about the distal end of an outer sheath in an interventional system that facilitates rotation in accordance with one embodiment of the present application;

FIG. 14b is a schematic diagram of a third mark configured on a control handle according to one embodiment of the present application;

FIG. 14c is a schematic view of another embodiment of a rotatable insertion system according to the present application, wherein a stopper is disposed inside a balloon;

FIG. 14d is a schematic diagram of another embodiment of a rotational intervention system according to the present application;

FIG. 14e is a schematic view of a configuration in which the mounting head is capable of rotational adjustment with the inner shaft;

FIG. 14f is a schematic view of the lock nut positioned against the mounting head;

FIG. 14g is a schematic diagram of an interventional delivery system according to another embodiment of the present application;

FIG. 15a is a schematic diagram of an interventional delivery system according to an embodiment of the present application;

FIG. 15b is a schematic diagram of an interventional delivery system according to another embodiment of the present application;

FIG. 15c is a schematic diagram of an interventional delivery system according to another embodiment of the present application;

FIG. 15d is a schematic diagram of an interventional delivery system according to another embodiment of the present application;

FIG. 15e is a schematic diagram of an interventional delivery system according to another embodiment of the present application;

FIG. 15f is a schematic view of another embodiment of an interventional delivery system including a stabilizer;

FIG. 16a is a schematic view of an interventional delivery system according to another embodiment of the present application including an interceptor;

FIG. 16b is a schematic view of the deflection device being inserted into the aortic arch and releasing the screen;

FIG. 16c is a cross-sectional view of the delivery tube secured to the outside of the outer sheath and the deflector received within the delivery tube;

FIG. 17a is a cross-sectional view of the deflection device received within the outer sheath with the connecting shaft and inner shaft being movable distally relative to the outer sheath;

FIG. 17b is a cross-sectional view of the deflection device received within the outer sheath, with the outer sheath being capable of proximal movement relative to the inner shaft;

FIG. 17c is a schematic diagram of the structure of FIG. 17 b;

FIG. 17d is a cross-sectional view of the deflector device received within the delivery tube and being exposed and releasable to the delivery tube;

fig. 17e is a schematic diagram of the structure of fig. 17 d.

Reference numerals in the drawings are described as follows:

1000. an interventional system;

100. an aortic valve; 101. pulmonary valve; 102. a mitral valve; 103. aortic arch; 110. valve leaves; 120. linking; 120a, commissures; 120b commissures; 120c commissure; 130. a left coronary artery; 140. a right coronary artery;

200. An artificial implant; 210. a bracket; 220. valve leaves; 230. a commissure; 230a, a commissure; 230b, a commissure; 230c, a commissure; 240. an eyelet; 251. a fixed edge; 260. a connecting lug;

300. a press grip; 310. a housing; 311. a mechanical channel; 320. a force application block; 330. a second identifier; 340. a bracket;

400. an interventional delivery system; 401. a marking line; 410. a catheter assembly; 420. a balloon body; 421. an adjustment line; 422. a lock hole; 423. locking wires; 424. a stopper; 430. an outer sheath; 431. a delivery tube; 440. an inner shaft; 450. a mounting head; 451. a positioning part; 460. a control handle; 461. a first handle; 462. a second handle; 470. an offset device; 480. a lock nut; 482. an identification ring; 483. a stabilizer;

500. a deflection device; 510. a pull wire; 520. a mesh enclosure; 521. a support frame; 522. a filter screen; 530. a connecting shaft; 524. a handle.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

In the present disclosure, the terms "comprises" and "comprising," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a system, article, or apparatus that comprises a list of elements is not necessarily limited to those elements expressly listed but may include other elements not expressly listed or inherent to such article or apparatus.

Referring to fig. 1 and 3a, in order to solve the problem of alignment of the existing artificial heart valve, the present application provides an artificial implant 200, which can be placed not only on the aortic valve 100 but also on the mitral valve 102, the pulmonary valve 101, etc. after being adaptively adjusted according to the needs, the following embodiment is an example of placing the artificial implant 200 on the aortic valve 100, and the artificial implant 200 has a commissure 230 corresponding to the commissure 120 of the aortic valve 100, respectively a commissure 230a, a commissure 230b, and a commissure 230c, as in the existing artificial aortic heart valve.

Referring to fig. 3 b-3 c, the present application provides a method of deploying an artificial implant 200 to an interventional delivery system 400, wherein the artificial implant 200 is an artificial aortic valve comprising:

s100, obtaining an image to be evaluated, wherein the image to be evaluated at least comprises position information of each valve sinus in a native aortic valve;

in step S100, there are various ways to obtain the image to be evaluated, and there are differences in the relations among the left coronary sinus (LCC), the right coronary sinus (RCC) and the non-coronary sinus (NCC) between the different evaluation images, for example, the cross-sectional structure of the native aortic valve is a horizontal mirror image of the image obtained in the multi-slice computed tomography (MSCT) or any other equivalent imaging system. For ease of understanding, the following examples obtain evaluation images in the manner of multi-slice computed tomography (MSCT). In this embodiment, an image to be evaluated may be obtained in advance for the current patient, for example, the image to be evaluated may be an image perpendicular to the plane of the native aortic valve annulus, and the position information of each sinus of the aortic valve may be determined in the image.

S200, comparing the position information with the reference information to obtain deviation information;

in this embodiment, reference information may be predetermined, and the reference information may be obtained by analyzing a reference image. The reference image may be an image of a specified group, for example, a group older than 65 years old, for example, a group … … suffering from heart valve disease, and an image of a majority of people perpendicular to the plane of the native aortic valve annulus may be selected, and the position information of each valve sinus is determined according to the image, and the position information is used as the reference information. The specific method can refer to the prior art, and will not be described in detail.

Since there is a difference in the positions of the valve sinuses in the native aortic valve of each individual, it is necessary to previously measure a deviation between actual valve sinus position information of the current patient and reference information in order to achieve accurate positioning of the artificial implant 200, so that the deviation information is obtained in advance.

S300, determining a first relative position between the artificial implant 200 and the interventional delivery system 400 according to the deviation information;

in step S300, the foregoing deviation information may be used in advance to implement adjustment before the intervention, and specifically, the intervention operator may determine the first relative position between the present artificial implant 200 and the intervention delivery system 400 according to the deviation information, and the position information of the artificial implant 200 assembled according to the first relative position may match the position information in the native aortic valve after the intervention, for example, may be that the commissure 230 of the artificial implant 200 corresponds to the commissure 120 in the native aortic valve one-to-one.

S400, loading the artificial implant 200 to the interventional delivery system 400 according to the first relative position.

In this embodiment, when the artificial implant 200 is installed in the interventional delivery system 400, an interventional operator can adjust the circumferential position of the artificial implant 200 in advance according to deviation information, and after the artificial implant 200 is released, the safety hidden trouble caused by the leaflet of the artificial implant 200 shielding the coronary sinus is avoided.

By adopting the method, the artificial implant can be loaded in an adaptive manner in vitro according to the position information of each valve sinus in the native aortic valve of the patient in advance, so that when the artificial implant is delivered and released in vivo, the joint of the artificial implant can be just aligned with the joint of the native aortic valve, thereby improving the hemodynamics and reducing the risk. And the operation of rotating the artificial implant in the body is not needed, so that the risk of thrombus falling caused by rotation can be prevented.

Referring to fig. 4a to 5b, the images to be evaluated are schematic diagrams, wherein the viewing angle of the images to be evaluated is perpendicular to the plane of the annulus where the aortic valve is located, so that the information position deviation of each valve sinus caused by the angle problem is avoided. The position information at least can determine the actual rotation angle of the right coronary sinus relative to the central point of the aortic valve in the image to be evaluated; the reference information can at least determine a reference rotation angle of the right coronary sinus relative to the aortic valve center point; the deviation information is the deviation of the actual rotation angle from the reference rotation angle. The rotation angle is the direction of the right coronary sinus relative to the central point of the aortic valve, specifically, the positioning line can be determined first, in an ideal state, a horizontal line is firstly made as a reference line (L2 in the figure), then a central line is made at the midpoint of the right coronary sinus (RCC) (the central line is L1 in the figure, and the central line can be opposite to the commissure 120b opposite to the right coronary sinus RCC), the central point of the aortic valve is the intersection point of L1 and L2, the included angle between L1 and L2 is the so-called rotation angle, and as can be seen in the figure, the included angle between L1 and L2 is approximately equal to 90 degrees, which is the actual situation of most individuals.

The coronary sinus has an angle deviation relative to an ideal state, the angle between the central line (L1) and the reference line (L2) is greater than or less than 90 degrees, in order to facilitate reading of a specific angle, in comparison, a circumferential scale distributed around the center of an aortic valve is added to an image to be evaluated (a circle containing all valve sinuses is made on a band evaluation image with the center point of the aortic valve as the center, the circumferential scale is arranged on the circle), the circumferential scale can be fully circumferential or only half circumferential, of course, the circumferential scale has various expression modes, for example, the clock moment is taken as an example, the angle between every two adjacent big lattice values is 30 degrees, the angle between every two adjacent big lattices is 6 degrees, an operator can read according to the specific scale with a distance, and in the same way, the angle between every two adjacent big lattices and the small lattice can also be directly read in an angle mode, for example, in fig. 4d and 4e, the angle between every two adjacent big lattices is 10 degrees, and the angle between adjacent big lattices and the small lattice is 5 degrees.

Considering that the actual circumferential position is to be compared with the reference information, the circumferential scale further comprises a first scale for indicating the reference rotation angle, the specific position of the first scale can be set according to the requirement, the application does not need to do special requirements, for example, the first scale can be indicated as '12' in the figure, the second scale (namely, the angle between the 'L2' and the position at which the L1 is actually pointed) is obtained for the actual rotation angle, and likewise, when the angle is adopted for reading, the first scale can be indicated as '90 DEG', the specific position can be flexibly set according to the actual requirement, and the deviation of the second scale and the first scale is deviation information.

Referring to fig. 5a, the native aortic valve is deflected entirely to the left, with L1 pointing 11, at which point the angle α between 11 and the first degree (pointing 12) is 30 degrees, i.e. the deviation information is 30 degrees, and likewise, as in fig. 5b, the native aortic valve is deflected entirely to the right, at which point the angle β between L1 and the first degree is 36 degrees, i.e. the deviation information is 36 °. The artificial implant 200 may thus be subjected to an adaptive angular rotation based on the actual deflection information such that a first relative position between the artificial implant 200 and the interventional delivery system 400 is determined.

In order to facilitate loading and adjusting the circumferential position of the artificial implant 200, the application also provides a loading instrument with a second mark, the artificial implant 200 is provided with a first mark, the artificial implant 200 is registered to the loading instrument during loading, and the circumferential relative positions of the first mark and the second mark are adjusted until the circumferential relative positions are matched with deviation information in the registration process; the loading instrument is then used to load the prosthetic implant 200 into the interventional delivery system 400.

If no information deviation exists, the original positions of the first mark and the second mark in the circumferential direction are relatively fixed, and when deviation information exists between the actual position information of each valve sinus in the primary aortic valve and the reference information, the first mark and the second mark relatively rotate on the basis of the original positions until the deviation information is matched. The loading instrument is capable of compressing the prosthetic implant 200 such that the circumferential relative position between the first and second markers remains constant throughout the compression process to load the prosthetic implant 200 in this position on the interventional delivery system 400.

Further, the interventional delivery system 400 is provided with a third identifier, and the matching relationship between the interventional delivery system 400 and the loading instrument is determined according to the third identifier and the second identifier. So that the circumferential relative positions of the first and third markers are compatible with the deviation information, the loading instrument and the second marker can be used as intermediate references in the assembly process, and the circumferential relationship between the artificial implant 200 and the interventional delivery system 400 still needs to be concerned during the final interventional procedure.

The loading instrument may be used with existing auxiliary tools to radially compress the artificial implant 200, to cooperatively couple the compressed artificial implant 200 with the interventional delivery system 400, and to remove the loading instrument after assembly.

Referring to fig. 6 a-7 e, in one embodiment the loading instrument may be a grasper 300, the grasper 300 comprising:

the plurality of force application blocks 320, each force application block 320 is movably connected with each other and surrounds and defines the mechanical channel 311, and the plurality of force application blocks 320 can be relatively gathered and separated and correspondingly retract and release the mechanical channel 311;

the plurality of force application blocks 320 adopt a direct driving mode or are integrally sleeved with a shell 310 with a avoidance mechanical channel 311, and the shell 310 is provided with a driving mechanism linked with the force application blocks 320;

The second flag 330 is disposed on the housing 310 or the force application block 320 around the mechanical channel 311.

Wherein the second marks 330 are specifically distributed in the circumferential scale (1-12 similar to a clock is used to express the circumferential position in the figure).

To facilitate delivery in the body, the prosthetic implant 200 is radially compressed using the grasper 300 prior to surgery to achieve a smaller radial dimension, compressed, loaded into the interventional delivery system 400, delivered to the treatment site in the body in a compressed state, and finally expanded to a functional dimension at the desired location.

When the artificial implant 200 is not inserted into the mechanical channel 311, the plurality of force applying blocks 320 are in a relatively separated state. After the artificial implant 200 enters the mechanical channel 311, the force application blocks 320 gradually switch from separation to gathering, and in the process, the force application blocks 320 shrink the mechanical channel, the inner wall of the mechanical channel 311 presses the artificial implant 200, and the inner wall of the mechanical channel 311 uniformly reduces the size of the artificial implant 200.

The press grip 300 has opposite front and back sides (see fig. 6c, front side X1 and back side X2), a bottom side (e.g., F in fig. 6 a) that mates with the support table, and a top side opposite the bottom side. Wherein both ends of the mechanical path 311 are opened to the front and rear surfaces of the press grip 300, respectively.

In order to reduce the deviation of the loading of the artificial implant 200 with respect to the interventional delivery system 400, the circumferential positions of the interventional delivery system 400 and the loading instrument remain unchanged throughout the compression process, preferably in the present application the third marking of the interventional delivery system 400 is always aligned with the first scale of the loading instrument in a compressed state.

Further, of course, the artificial implant 200 may be pressed and held singly or compressed a plurality of times as required by the driving force of the press and holder 300. During crimping loading of the prosthetic implant 200 into the interventional delivery system 400 using the crimping apparatus 300, there may be circumferential torsion of the interventional delivery system 400, or uneven deformation of the prosthetic implant 200 itself, etc., all of which may cause assembly misalignment. For example, it is actually desirable to maintain the circumferential angle between the first marking (p in fig. 7b and 7 d) of the prosthetic implant 200 and the marking (12 o 'clock) in the grasper 300 at W2, but after the grasper is completed (the application block 320 is in relative separation), the first marking is at an angle W1 to the 12 o' clock. It is therefore necessary to rotate the entire interventional delivery system 400 clockwise by an adaptive angle to compensate for the assembly offset caused by the crimping process.

To compensate for this assembly offset, of course, a bracket 340 may be provided on the crimping apparatus 300, the bracket 340 being on one axial side of the mechanical channel 311 to support the implant 200 or the interventional delivery system 400 during assembly such that the implant 200 will always tend to the axis of the mechanical channel 311 as it deforms and contracts, thereby reducing the assembly offset.

When no assembly instrument is used or the second marker is not provided, the artificial implant 200 is provided with the first marker, the interventional delivery system 400 is provided with the third marker, and the circumferential relative positions of the first marker and the third marker only need to be adjusted until the circumferential relative positions are matched with deviation information during loading.

Referring to fig. 8, the interventional delivery system 400 includes a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, at least one of the control handle 460 and the catheter assembly 410 bearing a third identification. To configure the actual view during surgery, the control handle 460 has a first posture in the working state, the first posture mainly refers to the circumferential posture of the control handle 460 when the surgery is performed, for example, the control handle 460 is provided with a window or an operating knob, the window or the operating knob faces right above when in use, and when the catheter assembly 410 is loaded, the distal end part of the catheter assembly is in the first posture at the control handle 460, and the control handle 460 can be just in the first posture to avoid torsional stress. The distal end portion of the catheter assembly 410 may be used to attach or receive the artificial implant 200, in this state, in cooperation with the loading instrument, and the intended in-vivo posture of the artificial implant 200 may be known only by the control handle 460 outside the body at the time of the operation.

Based on the above, the assembly offset of angle W1 from angle W2 may be calibrated after assembly is complete, e.g., the prosthetic implant 200 is of radially deformable structure and has opposite expanded and compressed states;

in an expanded state or a partially expanded state (partial expansion being understood to mean that at least a portion in the axial direction does not reach the desired maximum radial dimension), registering the artificial implant 200 to a loading instrument in accordance with the relative position, and using the loading instrument to apply a driving force to the artificial implant 200 to switch the artificial implant 200 to a compressed state for loading in the interventional delivery system 400;

torsional stresses may exist between the artificial implant 200 and the interventional delivery system 400 while the loading instrument is maintained in a driving force, and the torsional stresses should be released and then calibrated, for example, the driving force of the loading instrument may be released, leaving the artificial implant 200, the catheter assembly 410, and the control handle 460 in a relaxed state in the circumferential direction.

The current circumferential relative position between the artificial implant 200 and the loading instrument is a second relative position, which is adjusted to the first relative position to adjust the circumferential relative position between the artificial implant 200 and the catheter assembly 410, i.e., to perform pre-interventional calibration.

An embodiment of the present application provides a method of delivering an artificial implant 200, comprising:

the method according to the above embodiments of the present application loads the artificial implant 200 on the interventional delivery system 400;

maintaining the circumferential relative positional relationship between the artificial implant 200 and the interventional delivery system 400 and delivering the artificial implant 200 to a predetermined location;

releasing the artificial implant 200.

During delivery and release, it is desirable to maintain the circumferential relationship between the artificial implant 200 and the control handle 460, or even if the artificial implant 200 is rotated about its own axis to change the circumferential relationship, the amount of change may be known at least by a flag provided on the control handle to match the deviation information, and similarly during release, it is desirable to maintain the control handle 460 in the first position, or even if the control handle 460 is changed in position, the amount of change may be known at least to match the deviation information.

Referring to fig. 9-10 c, considering the pre-calibration of the implant 200 prior to intervention, the present application provides an interventional system 1000 that facilitates rotation, including an interventional delivery system 400 and the implant 200 loaded in the interventional delivery system 400, wherein the implant 200 in fig. 9 is merely illustrative of the location of the interventional delivery system 400, and is generally surrounded by an external tube after loading.

The artificial implant 200 is an aortic valve, comprising a stent 210 and a plurality of leaflets 220 connected to the stent 210, in particular, the number of the leaflets 220 is 3, and the aortic valve is provided with a first mark; the interventional delivery system 400 is provided with a third identifier for adjusting the circumferential relative position between the first identifier and the third identifier based on deviation information matching the deviation information when loading the prosthetic implant 200 in the interventional delivery system 400, the obtaining of the deviation information being obtainable based on the above method, e.g. the deviation information being the position information of each valve sinus in the native aortic valve compared to the reference information.

The interventional delivery system 400 includes a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, the interventional delivery system 400 having opposite distal and proximal ends, the control handle 460 being located proximally, the catheter assembly 410 being located distally, reference being made to the X-direction and the Y-direction in fig. 9 for ease of understanding, wherein the X-direction is the distal end and the Y-direction is the proximal end.

At least one of the control handle 460 and the catheter assembly 410 carries a third identifier; the first mark and the third mark are respectively independent configurations, and are respectively the mark symbol or the part where the shape recognition can be carried out. The identification symbol can be printed, etched and the like on the basis of the original component, and the component for shape recognition can be characterized in that a specific position of a certain component is provided with a bulge, a corner, a cavity and the like, so that the circumferential position of the component is conveniently used as a reference or used for recognizing change.

At least one of the first indicia and the third indicia are circumferentially distributed and span at least 60 degrees. The circumferential positions of the interventional delivery system 400 and the artificial implant 200 can be accurately measured within a variation range of at least 60 degrees, and of course, the circumferential directions 360 can be distributed, and the distribution accuracy, i.e., the corresponding angular resolution, can be 1-5 degrees.

For example, the third mark has a reference bit and mark distribution areas located on both sides of the reference bit in the circumferential direction, the mark distribution areas having a circumferential span of at least 120 degrees; even when the deviation information is 0, the first mark and the connecting portion 230 are not required to be aligned strictly, and may be aligned with each other or have a predetermined angle. The deviation information may be scaled as long as the predetermined angle is known or measurable.

For example, the third mark position is distributed on the scale of the periphery of the catheter assembly 410, the split position of two adjacent valve leaflets on the bracket 210 is a commissure part 230, when the deviation information is 0, the commissure part 230 is used as a first mark to be aligned with the third mark reference position, for example, an eyelet 240 which is offset from the commissure part 230 by 60 degrees in the circumferential direction is further arranged on the bracket 210, and if the eyelet 240 is used as the first mark, the eyelet 240 is understood to have a preset included angle of 60 degrees with the third mark reference position, but the circumferential registration process and the identification are not affected.

Further, the first identifier is specifically at least one of the following ways:

a1, the bracket 210 is of a radially deformable tubular structure and is provided with an axial direction, at least one axial end of the bracket 210 is provided with a grid node or a cell 240 structure, and the grid node or the cell 240 structure at the end is used as a first mark;

a2, the combination part of the valve leaflet 220 and the bracket 210 comprises a fixed edge 251 of the valve leaflet 220, and the midpoint part of the fixed edge 251 is used as a first mark;

a3, the bracket 210 is provided with an axial positioning structure matched with the interventional delivery system 400, and the axial positioning structure is used as a first mark;

a4, in the multiple valve leaflets 220, the splicing parts of two adjacent valve leaflets 220 on the support are the connecting parts 230, and the connecting parts 230 are used as first marks;

a5, the periphery of the aortic valve is provided with an identification symbol which is used as a first identification.

Referring to fig. 11 a-11 d, the control handle 460 has a first position in the operational state in which the third marker is vertically upward relative to the circumferential position of the interventional delivery system. Wherein the third identifier is specifically at least one of the following modes:

b1, in the catheter assembly 410, the periphery of one pipe fitting is provided with an identification symbol, and the identification symbol is used as a third identification;

b2, the outer surface of the control handle is provided with an identification symbol which is used as a third identification;

b3, at least one part of the control handle is circumferentially fixed with the control handle as a whole and has an identifiable shape difference from the peripheral area, and the part is used as a third mark.

The identification symbols b1 and b2 may be various, such as an identification line 401, where the identification line 401 is continuously or stepwise arranged on the catheter assembly 410 and/or the control handle 460 from the distal end to the proximal end.

The artificial implant 200 may be released by balloon or self-expanding, and the manner of the artificial implant 200 and the catheter assembly 410, as well as the stent material of the artificial implant 200, may be adjusted accordingly.

Referring to fig. 12a to 13, when the ball-expanding method is employed, the catheter assembly 410 includes:

an outer sheath 430 for receiving the artificial implant 200 therein, the outer surface of the outer sheath 430 from the proximal end to the distal end having a marking symbol as a third marking;

an inner shaft 440 penetrating the outer sheath 430 and slidably engaged with the outer sheath 430 in the axial direction;

balloon 420 is connected to a distal end portion of inner shaft 440, and artificial implant 200 is radially compressed and disposed on an outer periphery of balloon 420.

During release, the outer sheath 430 slides proximally to expose the artificial implant 200, and then fluid is injected into the balloon body 420 through the control handle 460 to inflate, so as to drive the artificial implant 200 to expand radially for release.

To maintain the axial positional relationship between the prosthetic implant 200 and the balloon 420 during delivery and release, the interventional delivery system 400 further includes:

an adjustment wire 421 for releasably securing the artificial implant 200 to the balloon 420, one end of the adjustment wire 421 being capable of remaining secured to the balloon 420, the other end being capable of passing through the artificial implant 200 and having a locking hole 422;

the locking wire 423 has opposite locking states in which the locking wire 423 penetrates into each locking hole 422 to restrict the artificial implant 200, and unlocking states in which the locking wire 423 is separated from each locking hole 422 to release the artificial implant 200.

For ease of description, the prosthetic implant 200 has a distal end and a proximal end.

Balloon 420 is made of an elastic material and is disposed at a distal end of interventional delivery system 400, capable of bending and allowing prosthetic implant 200 disposed thereon to reach a lesion site. Balloon 420 may also be inflated/deflated to expand itself, driving implant 200 to an inflated state, and balloon 420 to a deflated state after deflation/inflation.

The outer sheath 430 is hollow and tubular and slidably mounted on the interventional delivery system 400 and axially slides along the balloon 420 to change the constraint on the implant 200, and is capable of constraining the implant 200 inside the outer sheath 430 when the outer sheath 430 is positioned around the balloon 420, limiting the expansion of the implant 200, and exposing the implant 200 to allow the implant 200 to expand when the outer sheath 430 slides against the balloon 420 and completely exits the expansion path of the implant 200.

The adjustment wire 421 is used to limit the misalignment between the artificial implant 200 and the balloon 420 (especially in the axial direction of the balloon 420) during operation, and the misalignment between the two may affect the three-dimensional shape of the artificial implant 200 after entering the inflated state, and even may have a safety hazard, and the adjustment wire 421 may be used to releasably fix the artificial implant 200 to the balloon 420 without affecting the release of the artificial implant 200 on the premise of avoiding the axial misalignment as much as possible.

In this embodiment, the first symbol is a eyelet 240 structure on the bracket 210 for threading an adjustment wire 421. The eyelet 240 structure can be in fixed engagement with the interventional delivery system 400 and can also serve as a first marker, avoiding the problem of failure to accurately identify the first marker after compression. In the locked state, the eyelet 240 is engaged with the locking wire 423 after passing through the end of the corresponding adjusting wire 421 having the locking hole 422.

After one end of the adjusting wire 421 with the lock hole 422 passes through the eyelet 240 structure, the eyelet 240 structure is restricted by the lock wire 423 to be separated from the eyelet 240 structure, so that the adjusting wire 421 and the artificial implant 200 cannot be separated, mainly in that when the artificial implant 200 slides on the balloon body 420, the artificial implant is finally restricted from further sliding at the lock hole 422. Limiting axial sliding movement of the prosthetic implant 200 relative to the balloon 420 in the compressed/expanded state. Of course, the eyelet 240 may be disposed through the lock hole 422, and the lock wire 423 may limit the eyelet 240 from being separated from the adjustment wire 421.

Referring to fig. 14 a-14 c, one embodiment of the present application provides a rotational-facilitated interventional system 1000, comprising an interventional delivery system 400 and an artificial implant 200 loaded into the interventional delivery system 400;

the artificial implant 200 is an aortic valve, comprising a stent 210 and a plurality of valve leaflets 220 connected to the stent 210, wherein a commissure 230 is formed between adjacent valve leaflets 220, and the aortic valve is provided with a first mark;

the interventional delivery system 400 includes a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 including:

an outer sheath 430 for receiving the artificial implant 200 therein;

An inner shaft 440 rotatably penetrating the outer sheath 430 and slidably engaged with the outer sheath in an axial direction;

an adapter secured to the inner shaft 440 for releasably connecting the artificial implant 200;

the interventional delivery system 400 is configured with a third marker, and when the prosthetic implant 200 is loaded in the interventional delivery system 400, the rotational amplitude between the inner shaft 440 and the outer sheath 430 is adjusted by the first and third markers to match deviation information, which is obtained by comparing position information of each valve sinus in the native aortic valve with reference information.

When the stent 210 adopts the memory material and releases in a self-expanding manner, the adapter is the mounting head 450, and a circumferential and axial limit structure matched with each other is arranged between the mounting head 450 and the stent 210 of the aortic valve, and the limit structure comprises:

a connecting lug 260 fixedly connected to the bracket 210;

the positioning portion 451 is provided with a positioning groove and/or a positioning projection on the outer periphery of the mounting head 450 and engaged with the connecting lug 260. In this embodiment, the connection ear 260 serves as a first indicator.

The positioning portion 451 is matched with the connection lug 260, that is, as an axial positioning structure, the shape of the connection lug 260 is not strictly limited, for example, the connection lug 260 is located at the proximal end of the artificial implant 200, generally, a T-shaped, L-shaped, annular or the like can be adopted, the positioning portion 451 can adopt a positioning groove for receiving the T-shaped, L-shaped or a positioning protrusion clamped into the annular or the like, the positioning portion is at least partially radially opened, the connection lug 260 is abutted against the mounting head 450 via the opening portion during loading, and is axially limited after being abutted against each other, and the shape of the connection lug 260 itself can adopt the prior art, so that the application also provides an improvement scheme.

In some embodiments, the artificial implant 200 may be further connected to the mounting head 450 by a wire control manner, the structural gap or the eyelet portion of the artificial implant 200 itself may be used as the connection lug 260, one end of the pulling wire is controlled by the control handle 460, and the other end of the pulling wire is locked to the mounting head 450 after passing through the connection lug 260, and when released, the pulling wire is unlocked, and the pulling wire is pulled away from the connection lug 260, so as to allow the artificial implant to be separated from the mounting head.

After loading and during delivery, the outer sheath 430 wraps around the prosthetic implant 200 and the mating portion with the mounting head 450, preventing removal of the attachment tabs 260, and upon release, the outer sheath 430 moves and exposes the attachment tabs 260, allowing the attachment tabs to move radially outward (with at least a component of the radially outward movement) to release the axial restraint from the positioning portion 451.

The positioning portion 451 and the artificial implant 200 are also circumferentially limited to each other after being loaded, for example, the connecting lugs 260 are limited to the positioning grooves and cannot rotate, or are bound to the mounting head 450 by a pulling wire, and when circumferential registration is performed according to deviation information, the circumferential positional relationship between the mounting head 450 and the outer sheath 430 or the control handle 460 may be referred to.

When the stent 210 is released by balloon expansion, the adapter is a balloon 420 that can be deformed by fluid, and the aortic valve is radially compressed and disposed on the outer periphery of the balloon 420. Wherein, the balloon 420 is also provided with a stopper 424 on the inside or outside, the stopper 424 limiting the axial relative position of the aortic valve and the balloon 420. Of course, the stop member 424 can also compensate the height difference between the balloon body 420 and the stent 210, so as to avoid the potential safety hazard that the end of the stent 210 may stab the vessel wall, the stop member 424 may adopt a hollowed-out net cage structure or a plurality of arms arranged at intervals in the circumferential direction so as to support the inner wall of the balloon body 420, and the third mark may be configured on the stop member 424.

In one embodiment, the interventional delivery system 400 further comprises:

an adjustment wire 421 for releasably securing the artificial implant 200 to the balloon body 420, one end of the adjustment wire 421 being capable of remaining secured to the balloon body 420, the other end being capable of passing through the artificial implant 200 and having a locking hole 422;

the locking wire 423 has opposite locking states and unlocking states, the proximal end of the locking wire 423 is connected to the control handle 460, and the distal end of the locking wire 423 penetrates into each locking hole 422 in the locking state to restrict the artificial implant 200, and is disengaged from each locking hole 422 in the unlocking state to release the artificial implant 200. Wherein, at least one axial end of the bracket 210 is provided with an eyelet 240 structure for the adjusting wire 421 to pass through, and the eyelet 240 structure is used as a first mark; the adjustment line 421 and/or the lock line 423 serve as a third indicator. Of course, the first identifier may also adopt the structure described above.

In this embodiment, the rotation of the inner shaft 440 can be used to drive the artificial implant 200 to change the circumferential relative position of the interventional delivery system 400, if there is a definite circumferential assembly relationship between the artificial implant 200 and the mounting head 450 (i.e., the inner shaft 440) and the two are moved in a circumferential synchronous manner, the first marker can be disposed on the artificial implant 200, the mounting head 450 or the inner shaft 440, and the third marker can be disposed on the control handle 460 or distributed around the distal end of the sheath 430.

To facilitate locking and control the magnitude of rotation of the inner shaft 440, a drive mechanism is disposed within the control handle 460 to rotate the inner shaft 440 relative to the outer sheath 430. The driving mechanism can be arranged according to requirements, for example, screw driving can be adopted, and particularly, self-locking after rotation is realized through the shape and the material of the screw.

Referring to fig. 14 d-14 f, the present application also provides an interventional system 1000 for facilitating rotation, comprising an interventional delivery system 400 and an artificial implant 200 loaded into the interventional delivery system 400;

an outer sheath 430 for receiving the artificial implant 200 therein;

an adapter rotatably mounted to the inner shaft 440 for releasably coupling to the prosthetic implant 200,

a locking structure acting between the inner shaft 440 and the adapter, maintaining the relative circumferential positions of the two;

The interventional delivery system 400 is configured with a third marker, and when the prosthetic implant 200 is loaded in the interventional delivery system 400, the rotational amplitude between the adapter and the inner shaft 440 is adjusted by the first and third markers to match the deviation information, which is obtained by comparing the position information of each sinus in the native aortic valve with the reference information. The manner of release of the prosthetic implant 200 and the adapter in this embodiment may employ the above schemes. When the adapter is the mounting head 450, the artificial implant 200 is connected to the mounting head 450, and can rotate relative to the inner shaft 440 along with the mounting head 450, the first mark can be set on the artificial implant 200 or the mounting head 450, and a circumferential scale is provided on the outer periphery of the distal end of the outer sheath 430 as a third mark.

The locking structure may be locked after the mounting head 450 is rotated by a suitable angle, for example, may be a lock nut 480 that is threadedly engaged with the inner shaft 440, the lock nut 480 being axially positioned against the mounting head 450. Of course, the lock nut 480 may be provided with washers and spring washers in order to provide greater friction and tightening force. When the angle of the artificial implant 200 needs to be adjusted, the lock nut 480 is rotated back to the mounting head 450, so that the mounting head 450 can rotate relative to the inner shaft 440, circumferential adjustment is performed with circumferential graduations on the outer sheath 430 according to deviation information, and after the adjustment is completed, the lock nut 480 is rotated toward the mounting head 450 again until the lock nut is positioned against the mounting head 450.

Referring to fig. 14g, in another embodiment, an interventional delivery system 400 includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 including:

an outer sheath 430 for receiving the artificial implant 200 therein;

a mounting head 450 secured to the inner shaft 440 for releasably attaching the artificial implant 200, the mounting head 450 having a rotational locking structure that mates with the artificial implant 200 and that allows the artificial implant 200 to change and maintain a circumferential relative position to the mounting head 450, wherein changing the circumferential relative position is at least as wide as matching the deviation information.

In this embodiment, to facilitate angle calibration, the outer circumference of the mounting head 450 is provided with a circumferential scale as a third index, and the rotational locking structure tightens and secures the artificial implant 200 when the artificial implant 200 is rotated to an appropriate angle.

Upon self-expanding release, to facilitate control of the release process and retrieval procedure, the prosthetic implant 200 may be released in a wire-controlled manner and pre-connected to the interventional delivery system 400 by a pull wire 510. When pre-attached, i.e., pre-assembled, the artificial implant 200 may be compressed and wrapped around the outer sheath 430 as a whole, or the artificial implant 200 may be outside the outer sheath 430 or only partially received into the outer sheath 430, although the pull wire 510 has been threaded.

Referring to fig. 15a, the prosthetic implant 200 is preloaded on an interventional delivery system 400, the interventional delivery system 400 in one embodiment comprising a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 comprising:

an outer sheath 430 for receiving the artificial implant 200 therein during interventional delivery;

the inner shaft 440 is rotatably arranged in the outer sheath 430 in a penetrating manner and is in sliding fit with the outer sheath 430 along the axial direction, and the rotation amplitude between the inner shaft 440 and the outer sheath 430 at least can be matched with deviation information;

a mounting head 450 fixed to the inner shaft 440;

the artificial implant 200 is releasably connected between the pull wire 510 and the mounting head 450, and at least a portion of the pre-assembled artificial implant 200 is outside the outer sheath 430.

The circumferential positions of the artificial implant 200 and the mounting head 450 are relatively fixed, and at least a part of the pre-assembled artificial implant is positioned outside the outer sheath 430, so that the circumferential position adjustment of the artificial implant 200 can be realized by directly driving the control handle 460 to rotate the inner shaft, and a third mark can be configured on the outer periphery of the distal end of the outer sheath 430.

Referring to fig. 15b, the interventional delivery system 400 includes a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 including:

a mounting head 450 rotatably mounted to the inner shaft 440 for releasably coupling the artificial implant 200, the rotational amplitude between the mounting head 450 and the inner shaft 440 being at least capable of matching the deviation information;

a locking structure acting between the inner shaft 440 and the mounting head 450, maintaining the relative circumferential positions of the two;

The present embodiment adjusts the prosthetic implant 200 by rotating the mounting head 450 relative to the inner shaft 440, and may also utilize the locking arrangement described above in combination.

The above embodiments are pre-adjusted to match the deviation information during loading of the artificial implant 200, and the posture of the artificial implant 200 in the body and the registration with the native tissue can be observed in real time during operation in cooperation with the on-site imaging device.

In some cases, the circumferential posture of the artificial implant 200 still needs to be adjusted in vivo, and at this time, the artificial implant 200 is driven based on the overall rotation of the control handle 460 or the rotation of the inner shaft 440, so the following embodiments provide some specific solutions.

Referring to fig. 15c, the interventional delivery system 400 of the present embodiment includes a catheter assembly 410 for delivering an artificial implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 including:

an outer sheath 430 for receiving the artificial implant 200 therein;

a mounting head 450 fixed to the inner shaft 440;

the releasable connection between the artificial implant 200 and the mounting head 450, the artificial implant 200 being preloaded in a compressed state within the outer sheath 430;

when the inner shaft 440 is rotated for adjustment, the control handle 460 includes a first handle 461 and a second handle 462 (which may also be a driving member that rotates circumferentially, etc.) that are rotatably coupled to each other, the proximal end of the outer sheath 430 is connected to the first handle 461, the proximal end of the inner shaft 440 is connected to the second handle 462, and a marker is provided between the first handle 461 and the second handle 462 for identifying the rotational amplitude of the artificial implant 200 in the body along with the inner shaft 440.

Movement of the second handle 462 relative to the first handle 461 can drive rotation of the inner shaft 440 to adjust the pose of the prosthetic implant 200 in the body. A locking mechanism may be provided between the first handle 461 and the second handle 462 to maintain the relative circumferential position of the two.

If adjusted by rotating the control handle 460 itself, referring to fig. 15 d-15 f, the interventional delivery system 400 includes a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, the catheter assembly 410 comprising:

an outer sheath 430 for receiving the artificial implant 200 therein;

a mounting head 450 fixed to the inner shaft 440;

the releasable connection between the artificial implant 200 and the mounting head 450, the artificial implant 200 being preloaded in the outer sheath 430 in a compressed state;

the control handle 460 rotates the inner shaft 440 by rotating itself and the rotation angle of the control handle 460 itself is used to identify the rotation amplitude of the artificial implant 200 with the inner shaft 440 in the body. Wherein, the rotation angle of the recognition control handle 460 is at least one of the following ways:

c1, the periphery of the control handle 460 is provided with a rotation angle identification symbol;

c2, the outer circumference of the control handle 460 is provided with a marking ring 482 in a rotating way, and visual, audible or tactile prompts are provided when the marking ring 482 rotates;

c3, set up stabilizer 483, control handle 460 rotates the fixed position install in stabilizer 483, be equipped with the sign of mutually supporting in order to instruct control handle 460 rotation range between stabilizer 483 and the control handle 460.

Considering that the artificial implant 200 may contact with the vessel wall during circumferential rotation calibration after release, resulting in a risk of falling thrombus, the falling thrombus moves along the blood flow direction of the aorta, and may enter the left subclavian artery, the left common carotid artery and the ascending aorta on the aortic arch 103, which may cause safety problems, the following embodiments are further provided with an interception device.

Referring to fig. 16 a-16 c, the interventional delivery system 400 includes a catheter assembly 410 for delivering the prosthetic implant 200, and a control handle 460 for controlling the catheter assembly 410, the interventional delivery system 400 further including an interceptor device that, upon release in vivo, can filter and trap thrombus or drain thrombus to the inferior luminal artery, avoiding upward travel into the brain. The interception means may be a filter for catching thrombus or a deflector 500 for guiding the flow of thrombus.

Wherein, catheter assembly 410 comprises:

an outer sheath 430 for receiving the artificial implant 200 therein;

taking the deflection device 500 as an example, the deflection device 500 includes:

a mesh enclosure 520 having a deformable support frame 521 and a screen 522 mounted within the support frame 521;

A connection shaft 530 connected between the support frame 521 and the control handle 460. The connecting shaft 530 is configured independently or as the same component as the inner shaft 440.

The support frame 521 comprises a deformable annular frame to which the edges of the screen 522 are secured, with a shank 524, and is connected to a connecting shaft 530 by the shank 524.

When tubing is independently configured or a multi-lumen structure is utilized with respect to the delivery channel of both the deflection device 500 and the prosthetic implant 200, such as by independently configuring tubing, the interventional delivery system 400 further includes a delivery tube 431 secured outside of the outer sheath 430, the deflection device 500 being received within the delivery tube 431 and being exposed and releasable to the delivery tube 431 by actuation of the control handle 460; the prosthetic implant 200 is then positioned within the outer sheath 430.

For ease of understanding, the inner shaft 440, outer sheath 430, and connecting shaft 530, and delivery tube 431 are shown in solid lines and relatively movable in phantom in the cross-sectional views of the embodiments described below.

The inner shaft 440 is movable distally relative to the outer sheath 430 to expose and release the prosthetic implant 200 under the drive of the control handle 460 and the connecting shaft is movable distally relative to the delivery tube 431 to expose and release the mesh enclosure 520 under the drive of the control handle 460.

The released mesh cap 520 is disposed at the aortic arch, the mesh cap 522 can prevent thrombus from entering the artery above the aortic arch, the above-mentioned potential safety hazards are avoided, and the deflection device 500 is recovered after the release of the artificial implant 200 is completed.

The filter may be in a mesh-tube or dendritic structure capable of trapping thrombus, which is intercepted by the filter under the action of blood flow, and the filter carrying thrombus is recovered after the artificial implant 200 is released.

Referring to fig. 17a, in another embodiment, the outer sheath 430 is a multi-lumen tube, the inner shaft 440 extends through one lumen, and the deflection device 500 is received within the other lumen.

The release can be carried out by the following modes:

the inner shaft 440 can be moved distally relative to the outer sheath 430 under the drive of the control handle 460 to expose and release the prosthetic implant 200, and the connecting shaft 530 can be moved distally relative to the outer sheath 430 under the drive of the control handle 460 to expose and release the mesh enclosure 520; the release can be performed by the following ways:

referring to fig. 17 b-17 c, outer sheath 430 is capable of proximal movement relative to inner shaft 440 under the drive of control handle 460 to expose and release artificial implant 200 and mesh enclosure 520. Wherein, the side wall of the cavity for accommodating the deflection device 500 is opened in advance, the connecting shaft 530 is completely positioned in the cavity, and the net cover 520 connected with the connecting shaft 530 is positioned outside the cavity. When outer sheath 430 is moved proximally, artificial implant 200 and mesh enclosure 520 can be released smoothly. Of course, whether the connecting shaft 530 is movable distally relative to the outer sheath 430 upon actuation of the control handle 460 may be adaptively selected as desired.

Referring to fig. 17d to 17e, in another embodiment, the outer sheath 430 is a multi-lumen tube, the inner shaft 440 extends through one lumen, a delivery tube 431 is slidably disposed in the other lumen, and the deflecting device 500 is received in the delivery tube 431 and is exposed and released to the delivery tube 431 by actuation of the control handle 460. Wherein the length of the delivery tube 431 at the distal end is greater than the outer sheath 430, i.e., the delivery tube 431 is partially exposed to the outer sheath 430, and the mesh enclosure 520 is outside of the delivery tube 431. In this embodiment, to enable smooth release of the prosthetic implant 200, the outer sheath 430 can be moved proximally relative to the inner shaft 440 under the drive of the control handle 460 or the inner shaft 440 can be moved distally under the drive of the control handle 460.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.

Claims

1. An interventional system for facilitating rotation, comprising an interventional delivery system and an artificial implant loaded in said interventional delivery system;

an outer sheath for receiving the artificial implant therein;

a balloon body deformable under the action of a fluid, the aortic valve being radially compressed and disposed on the outer periphery of the balloon body;

2. The interventional system according to claim 1, wherein the balloon body is further provided with a stop inside or outside, the stop limiting an axial relative position of the aortic valve and the balloon body, the third marker being arranged at the stop.

3. The interventional system of claim 1, further comprising a loading instrument with a second marker, wherein said artificial implant is first registered to said loading instrument during loading, wherein a circumferential relative position of both said first marker and said second marker is adjusted during registration until said deviation information is accommodated;

and loading the artificial implant into an interventional delivery system by using the loading instrument.

4. The interventional system of claim 3, wherein said loading instrument is a grasper, said grasper comprising:

The force application blocks are movably connected with each other and surround and define a mechanical channel, and the force application blocks can be relatively gathered and separated and correspondingly retract and release the mechanical channel;

the force application blocks adopt a direct driving mode or are integrally sleeved with a shell for avoiding a mechanical channel, and the shell is provided with a driving mechanism linked with the force application blocks;

the second mark is arranged on the shell or the force application block around the mechanical channel.

5. The interventional system of claim 4, wherein said grasper is provided with a cradle for holding a manual implant or interventional delivery system, said cradle being on one axial side of said mechanical channel.

6. An interventional system for facilitating rotation, comprising an interventional delivery system and an artificial implant loaded in said interventional delivery system;

An outer sheath for receiving the artificial implant therein;

an adapter mounted to the inner shaft for releasably connecting the artificial implant;

the stent adopts memory material and releases through the mode of self-expanding, the adapter is the installation head, the installation head with be equipped with circumference and the axial limit structure of mutually supporting between the support of aortic valve, limit structure includes:

the connecting lug is fixedly connected to the bracket;

the positioning part is arranged at the periphery of the mounting head and is matched with the positioning groove and/or the positioning raised head of the connecting lug;

7. The interventional system of claim 6, wherein said artificial implant is releasably connected to said mounting head by a pull wire, said attachment ear being a structural gap or eyelet portion of said artificial implant itself, one end of said pull wire being controlled by said control handle and the other end being engaged with said attachment ear;

The artificial implant is preloaded in the outer sheath in a compressed state, or

At least a portion of the prosthetic implant after preassembly is external to the outer sheath.

8. The interventional system of claim 6, wherein the interventional system comprises,

the adapter is fixed to the inner shaft, or

The adapter is rotatably mounted to the inner shaft and the interventional system further includes a locking structure that acts between the inner shaft and the adapter to maintain the relative circumferential positions of the two.

9. The interventional system of claim 8, wherein said locking structure is a lock nut threadedly engaged with said inner shaft, said lock nut being axially positioned against said mounting head.

10. The interventional system of any one of claims 1-9, wherein at least one of the first marker and the third marker is circumferentially distributed and spans at least 60 degrees;

the third mark is provided with a reference bit and mark distribution areas positioned at two circumferential sides of the reference bit, and the circumferential span of the mark distribution areas is at least 120 degrees.

11. The interventional system of claim 10, wherein a third marker is distributed about the outer sheath distal end.

12. The interventional system of any one of claims 1-9, wherein the control handle rotates the inner shaft by rotating itself and the control handle rotates by itself by an angle that identifies the rotation of the artificial implant with the inner shaft in vivo by at least one of:

13. The interventional system according to any one of claims 1-9, wherein the control handle has a first position in an operational state in which the artificial implant is loaded and the third marker is vertically upwards relative to a circumferential position of the interventional delivery system.

14. The interventional system of any of claims 1-9, wherein when loading an artificial implant in the interventional delivery system, a driving force is applied to the artificial implant, the artificial implant is switched to a compressed state, and the driving force is released, such that the artificial implant, the catheter assembly, and the control handle are circumferentially relaxed and calibrated.