CN115715714A - Positioning device of artificial valve, artificial valve system, using method and simulation intervention method and device - Google Patents

Abstract

The application discloses positioner, prosthetic valve system, application method and simulation intervention method and device of prosthetic valve, wherein the positioner of prosthetic valve is used for fixing a position prosthetic valve with the mode of components of a whole that can function independently, positioner is the tubular structure, and the district is placed for prosthetic valve to the inside of tubular structure, has relative inflow side and outflow side in the axial of tubular structure, positioner includes: a plurality of supporting units arranged at intervals along the circumferential direction; the supporting legs are correspondingly arranged between two adjacent supporting units in the circumferential direction, at least two fixed ends are arranged on each supporting leg, the two fixed ends are respectively connected with the two adjacent supporting units, and each supporting leg extends to the inflow side by the two fixed ends of the supporting leg and is intersected. This application passes through positioner assistance-localization real-time artificial valve, can effectively improve artificial valve's support location and implant the effect.

Description

Positioning device of artificial valve, artificial valve system, using method and simulation intervention method and device

Technical Field

The present application relates to the field of medical devices, and more particularly, to a positioning device for a prosthetic valve, a prosthetic valve system, a method of use, and a method and device for simulated intervention.

Background

With the aging population, the incidence of valvular Heart disease has increased significantly, primarily due to the development of lesions in the Native Heart Valve (Native Valve) of patients. Such as native heart valve narrowing, native valve leakage, and regurgitation. At present, the experimental and clinical results show that the medicament for treating the pathological changes of the autologous heart valves has poor treatment effect and good operation effect. Surgery is primarily directed to replacement of the valve. When replacing the valve, the native valve may be excised and replaced with a biological or mechanical valve. Mechanical valves require lifelong administration of anticoagulant drugs to prevent clot formation, and the clicking of the valve is usually heard through the chest. Biological tissue valves generally do not require such drugs. Tissue valves may utilize porcine or bovine valves and are typically attached to a synthetic annulus, which is secured to the patient's heart valve annulus.

There is still room for improvement in stent positioning and implantation in prior art prosthetic valves. Especially in cases of aortic insufficiency, there is a risk of slipping down after implantation of the existing prosthetic aortic valve on the market.

Disclosure of Invention

In order to solve the above technical problem, the present application discloses a positioning device for a prosthetic valve, for positioning the prosthetic valve in a split manner, the positioning device is a cylindrical structure, the inside of the cylindrical structure is a prosthetic valve placing area, and the cylindrical structure has opposite inflow side and outflow side in the axial direction, the positioning device includes:

a plurality of bearing units arranged at intervals along the circumferential direction;

the supporting legs are correspondingly arranged between two adjacent supporting units in the circumferential direction, at least two fixed ends are arranged on each supporting leg, the two fixed ends are respectively connected with the two adjacent supporting units, and each supporting leg extends to the inflow side by the two fixed ends of the supporting leg and is intersected.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, there is a tendency for eversion between the outflow sides of the individual support units for supporting the prosthetic valve.

Optionally, the supporting units include two groups configured independently, the positioning device has a compressed state for intervention transportation and a release state for presetting, the positioning device in the compressed state is a strip, and the two groups of supporting units are located at two ends of the positioning device in the length direction respectively.

Optionally, one end of the supporting leg connected between the two sets of supporting units facing the outflow side is an open port, and two sides of the open port are turned and flattened relative to the release state in the compression state.

Optionally, in the two groups of supporting units, the number of the supporting units in each group is the same; or one set may be one carrier unit and the other set may be two carrier units.

Optionally, all the bearing units and all the supporting legs integrally form three U-shaped units which are sequentially connected end to end, and the three U-shaped units are enclosed to form the cylindrical structure.

Optionally, the supporting unit is V-shaped, a vertex of the V-shape points to the outflow side, and two sides of the V-shape are respectively connected to fixing ends of different supporting legs.

Optionally, in the same group of support units, a pulling strip is arranged between two adjacent support units.

Optionally, the pulling strip is V-shaped, the apex of the V-shape pointing to the inflow side or the outflow side, and the two sides of the V-shape are connected to the support units on the respective sides.

Optionally, the pulling strip is connected to the inflow side of the respective bearing unit.

Optionally, a transition rod extending to the outflow side is arranged between the two adjacent supporting units, and a connecting lug is arranged on the transition rod.

Optionally, the transition bar between the two support units is generally V-shaped, the vertex of the V-shape being provided with said engaging lug.

Optionally, the transition bar is connected to the outflow side of the respective racking unit.

Optionally, in the circumferential direction of the positioning device, central angles corresponding to distribution areas of all the connecting lugs are acute angles.

Optionally, the engaging lug is located between two adjacent support units or aligned with one of the support units in the circumferential direction of the positioning device.

Optionally, only one of the engaging lugs in the positioning device is configured.

Optionally, there are a plurality of engaging lugs in the positioning device, and the engaging lugs are released asynchronously, and the circumferential positions of the engaging lugs are different, or the axial positions of the opening and closing structures on the conveying system are different.

Optionally, the shape of the connecting lug is T-shaped, L-shaped, C-shaped or annular.

Optionally, the engaging lug is aligned with the apex circumferential position of the V-shape in the pulling strip.

Optionally, the transition rod is connected with the traction bar through a reinforcing rod.

Optionally, both ends of the stiffener are connected to the middle portions of the traction bar and the transition bar, respectively.

The prosthetic valves of the present application are used, for example, in the heart or peripheral sites, i.e., prosthetic heart valves.

The application also discloses a prosthetic valve system which comprises a prosthetic valve capable of being nested inside and outside and the positioning device in the scheme.

For example, the outflow side of the prosthetic valve has a radially enlarged structure, the positioning device is on the outside, and the plurality of bearing units are positioned against the enlarged structure.

Optionally, the prosthetic valve is a prosthetic aortic valve.

Use of a prosthetic valve system as described herein, comprising:

providing a first delivery system and a second delivery system for loading the positioning device and the prosthetic valve, respectively, in a compressed state;

delivering the positioning device with a first delivery system and pre-releasing such that the prosthetic valve placement region is expanded, at least a portion of the positioning device remaining coupled to the first delivery system after pre-releasing;

adjusting the positioning device through a first conveying system until the supporting legs reach the expected positions;

completely releasing the artificial valve into the artificial valve placing area by using a second conveying system, and enabling the positioning device and the artificial valve to be mutually acted and positioned;

and recovering the conveying systems, wherein the first conveying system is completely released after being decoupled with the positioning device, and then the first conveying system is recovered.

The first delivery system and the second delivery system constitute a prosthetic valve intervention system, and the application also equivalently provides an operation method of the prosthetic valve intervention system.

Optionally, the delivery system comprises a plurality of tubes which are slidably nested inside and outside and have a spatial upper axis, and after half-release, the positioning device is eccentrically arranged with respect to the axis of the first delivery system.

Optionally, the delivery system is accessed at the aortic valve via the aorta.

Optionally, the first delivery system has opposite distal and proximal ends and comprises, in order from inside to outside, actively nested:

the distal end of the core tube is fixed with a guide part, and the inside of the core tube is used as a guide wire channel;

the far end of the middle tube is fixed with a mounting head, and the periphery of the mounting head is provided with a positioning structure matched with the connecting lug of the positioning device;

the far end of the second release pipe wraps the near end of the positioning device under the loading state of the positioning device, and the positioning device is bound to the mounting head;

the positioning device is in a loading state, and the distal end of the first release pipe wraps the whole positioning device.

Optionally, the first delivery system has opposite distal and proximal ends and comprises:

the distal end of the core tube is fixed with a guide part, and the inside of the core tube is used as a guide wire channel;

the distal end of the second release pipe is provided with a branch structure, the tail end of each branch is provided with a lantern ring, and the lantern ring is aligned and overlapped with the proximal end of the positioning device when the positioning device is in a loading state;

the locking rod is movably arranged between the core pipe and the second release pipe in a penetrating mode, and the far end of the locking rod penetrates through the overlapped part of the lantern ring and the positioning device when the positioning device is in a loading state;

the positioning device comprises a first release pipe, and the distal end of the first release pipe wraps the whole positioning device in a loading state.

The application also discloses a simulated intervention method of the prosthetic valve system, comprising:

providing a first conveying system, a second conveying system and an in-vitro organ for simulation, wherein the first conveying system and the second conveying system are respectively used for loading a positioning device and a prosthetic valve in a compressed state;

delivering the positioning device with a first delivery system and pre-releasing such that the prosthetic valve placement area expands, at least a portion of the positioning device remaining coupled to the first delivery system after pre-releasing;

adjusting the positioning device through a first conveying system until the supporting legs reach the expected positions;

completely releasing the artificial valve into the artificial valve placing area by using the second conveying system, and enabling the positioning device and the artificial valve to be positioned in an interaction way;

and recovering the conveying systems, wherein the first conveying system is completely released after being decoupled with the positioning device, and then the first conveying system is recovered.

The application also discloses a simulated intervention device of the artificial valve system, which comprises a first conveying system, a second conveying system, the artificial valve, the positioning device in the technical scheme and an external organ for simulation.

This application passes through positioner assistance-localization real-time artificial valve, can effectively improve artificial valve's support location and implant the effect.

Specific advantageous technical effects will be further explained in conjunction with specific structures or steps in the detailed description.

Drawings

FIG. 1a is a schematic view of an embodiment of a positioning device;

FIG. 1b is a schematic view of a portion of the holding unit of the positioning apparatus of FIG. 1 a;

FIG. 2 is a schematic diagram illustrating the movement trend of the positioning device in FIG. 1a when the positioning device enters a compression state;

FIG. 3 is a schematic structural view of the outflow side portion of the positioning device of FIG. 1 a;

FIG. 4 is a schematic view of the positioning device shown in FIG. 1a from another perspective;

FIG. 5 is a schematic view of another embodiment of a positioning device;

FIG. 6 is a schematic structural view of the outflow side portion of the positioning device of FIG. 5;

FIG. 7 is a schematic view of another perspective of the positioning device of FIG. 5;

FIG. 8 is a schematic view of another perspective of the positioning device of FIG. 5;

FIG. 9 is a schematic view of the positioning device of FIG. 5 in a compressed state;

FIG. 10 is another perspective view of the positioning device of FIG. 9 in a compressed state;

FIG. 11 is a schematic view of an embodiment of a positioning device in conjunction with a conveyor system;

FIG. 12 is a schematic view of the positioning device of FIG. 11 entering a released state from a compressed state;

FIG. 13 is a schematic view of a conveyor system of the positioning device in one embodiment;

FIG. 14 is a distal end view of the delivery system of FIG. 13;

FIG. 15 is a schematic view of the delivery system release positioning device of FIG. 13;

FIG. 16a is a schematic view of a prosthetic valve and positioning device in accordance with an embodiment;

FIG. 16b is a view from another perspective of the prosthetic valve and positioning device of FIG. 16 a;

FIG. 17 is a schematic view of the interventional path of the prosthetic valve and/or the positioning device;

FIG. 18a is a schematic distal end view of the first delivery system in accordance with one embodiment;

FIG. 18b is a schematic view of the partial release positioning apparatus of the first delivery system of FIG. 18 a;

FIGS. 19a to 20 are schematic views illustrating different states of the prosthetic valve access system according to the first embodiment;

FIGS. 21a to 22d are schematic views showing different states of a prosthetic valve access system in a second embodiment;

FIGS. 23 to 24d are schematic views illustrating different states of the prosthetic valve access system according to the first embodiment;

fig. 25 to 38 are schematic diagrams illustrating specific steps of an operation method of the prosthetic valve intervention system, respectively.

The reference numbers in the figures are as follows:

10. a positioning device; 11. an inflow side; 12. an outflow side; 14. a prosthetic valve placement area;

20. a holding unit;

30. supporting legs; 31. a fixed end; 34. opening the opening;

40. pulling the strip; 43. connecting lugs;

45. a transition rod;

46. a reinforcing rod;

50. a prosthetic valve; 51. an expanded structure;

91. a first conveying system; 911. a guide wire; 912. a first release tube; 913. a second release tube; 9131. a branched structure; 9132. a collar; 914. a guide section; 915. a core tube; 916. an intermediate pipe; 917. a mounting head; 9171. a positioning structure; 918. a lock lever; 92. a second conveying system; 921. a guidewire.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to the protection scope of the present 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 a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components 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 in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The outflow side 12 and the inflow side 11 are in opposite directions in this context, so that each component is provided with a corresponding outflow side 12 and inflow side 11, and in the context of this non-explicit emphasis, the expressions in the following with respect to both the outflow side 12 and the inflow side 11 refer to the corresponding component in the portion of the corresponding direction, but not limited to the end of the direction.

Referring to fig. 1a to 10, the present application discloses a positioning device 10 for a prosthetic valve, which is used to position a prosthetic valve 50 in a split manner, and has a cylindrical structure, the inside of the cylindrical structure is a prosthetic valve placing area 14, and the cylindrical structure has an inflow side 11 and an outflow side 12 opposite to each other in the axial direction of the cylindrical structure, and the positioning device includes:

a plurality of the holding units 20 arranged at intervals in a circumferential direction;

the supporting legs 30 are correspondingly arranged between two adjacent supporting units 20 in the circumferential direction, each supporting leg 30 is provided with at least two fixed ends 31, the two fixed ends 31 are respectively connected with the two adjacent supporting units 20, and each supporting leg 30 extends from the two fixed ends 31 of the supporting leg to the inflow side 11 to intersect.

The positioning device realizes the matching of the positioning device and the corresponding physiological structure through the supporting legs 30, and realizes the positioning of the artificial valve 50 through the bearing unit 20, thereby realizing the auxiliary positioning of the positioning device on the artificial valve 50, and effectively improving the support positioning and implantation effects of the artificial valve 50. The support feet 30 are frame structures (e.g., in the form of a grid or U-shape hereinafter) made of resilient members. The frame structure of the elastic member serves to support the foot 30 and spatially determine the relative position of the bolster unit 20 and the positioning structure with respect to the sinus. Therefore, the elastic member of the support leg 30 may be made of the same material as the elastic member of the holder unit 20, or may be made of a different material. However, from the mechanical structure, both need to satisfy a certain strength to realize the support on the spatial structure.

In the specific arrangement of the positioning device, reference may be made to the embodiment shown in fig. 1a to 4 and the embodiment shown in fig. 5 to 10.

The positioning device is mainly used for realizing the auxiliary fixation of the artificial valve 50. Wherein the supporting units 20 are used for being matched with the artificial valve 50, the supporting feet 30 are generally abutted against the sinus to realize the matching with the corresponding physiological structure, and the pulling strips 40 are used for limiting the relative position of each supporting unit 20. The three parts form a cylindrical structure and are mutually matched in mechanical relation so as to realize a preset function. The design principle, operation process and structural effect of each part will be explained in detail below. From whole effect, this application passes through positioner assistance-localization real-time artificial valve 50, can effectively improve artificial valve 50's support location and implantation effect.

In particular, this section will focus on the details of the placement of the holding unit 20. In both embodiments, the outflow side 12 of each support unit 20 has a tendency to evert between them for supporting the prosthetic valve 50. Referring specifically to figure 1b, the support unit 20 may be everted by stretching itself, or in other embodiments, the support unit 20 may be everted by deforming itself, the force source of the deformation may be the pre-shape of the support unit 20, the interaction of the prosthetic valve 50, the force of the instruments, etc. The tendency of each support unit 20 to evert may be uniform or may be different. The engagement of the retainer unit 20 with the prosthetic valve 50 is primarily represented by the radial closeness and axial counterbalance of the cylindrical structure. However, a complex situation may occur between the two types of fitting, for example, when the fitting surfaces of the holder unit 20 and the prosthetic valve 50 are inclined relative to the central axis of the cylindrical structure, the two directions of fitting may be represented by the interaction between the two on the inclined surfaces of the fitting. The supporting unit 20 has a polygonal structure as a whole and extends to fit the outer peripheral surface of the prosthetic valve 50. The polygonal structure can increase the bearing area and improve the matching effect with the artificial valve 50 under the condition of certain materials and weight. It should be noted that the fitting of the prosthetic valve 50 to the positioning device is not only achieved by the supporting unit 20, but the prosthetic valve 50 may interact with the supporting legs 30, the pulling strips 40, etc. of the supporting unit 20. Referring to fig. 16a and 16b, the retainer unit 20 plays a major role in the actual mating process because it most closely interacts with the enlarged structure 51 of the prosthetic valve 50.

In the embodiment shown in fig. 1a to 10, the supporting unit 20 includes two sets of relatively independent positioning devices, the positioning device has a compressed state (refer to fig. 9) for interventional delivery and a releasing state (refer to fig. 1a and 5) for presetting, the positioning device in the compressed state is in a strip shape, and the two sets of supporting units 20 are respectively arranged at two ends of the positioning device in the length direction. In fig. 2 and 8, the support foot 30 connected between the two sets of support units 20 is open at the end facing the outflow side 12, and the two sides of the open 34 in the compressed state are folded flat against the released state. I.e., as shown in the figures, different sets of the supporting units 20 are located away from each other. In the two sets of the holder units 20, the number of the holder units 20 in each set is the same; or with reference to the figures, one set of one carrier unit 20 and the other set of two carrier units 20. In a particular preference, there are three support units 20 and three support feet 30. The racking unit 20 and the support foot 30 are spaced apart. All the supporting units 20 and all the supporting legs 30 form three U-shaped units connected end to end in sequence on the whole, and form a cylindrical structure by surrounding. In a specific form of the supporting unit 20, the supporting unit 20 is in a V shape, the vertex of the V shape points to the outflow side 12, and two sides of the V shape are respectively connected to the fixing ends 31 of different supporting legs 30. I.e., spaced between the support unit 20 and the support feet 30 as described above.

As will be understood from the above, the positioning device interacts with the prosthetic valve 50 through the support unit 20, and the working state of the support unit 20 directly affects the positioning effect. Corresponding connections between the support units 20 can be provided to adjust the position of the support units 20. In particular, this section will focus on the details of the arrangement of the connections between the individual support units 20. Referring to fig. 1a through 10, in each embodiment, a plurality of support units 20 in the same set, with a plurality of pulling straps 40 between adjacent support units 20. I.e., no pulling straps 40 are provided between the different sets of support units 20, i.e., independently as described above. The pulling strips 40 are primarily used to limit the relative positions of the individual support units 20. It is therefore understood in principle that the pulling strips 40 need to be structurally strong enough to exert a certain force on the racking unit 20. From this point of view, the rigid arrangement is the most straightforward design direction. However, in the field of interventional instruments, different requirements are required, for example, the volume of the positioning device is reduced to facilitate the interventional delivery process, and the spatial state of the positioning device is expanded to facilitate the cooperation with the prosthetic valve 50. Thus, referring to one embodiment, the pulling straps 40 are flexible structures. The flexible structure is understood to mean that the pulling straps 40 have some ability to deform, but provide some restraint to the support elements 20 during deformation, at least limiting the maximum distance each support element 20 can be moved away from relative to the support element.

In the form of the pulling strip 40, and as shown in the drawings, the pulling strip 40 is V-shaped with the apex of the V pointing towards the inflow side 11 or the outflow side 12 and the sides of the V attached to the respective side of the racking unit 20. The pulling strips 40 are attached to the inflow side 11 of the respective supporting unit 20. The V-shaped structure can be obtained by removing materials from the middle of the large-volume elastic rod and also can be obtained by connecting the long-strip-shaped elastic rods with each other, and the specific connection mode can be a bolt connection mode, a welding mode, an adhesion mode and the like. The V-shaped configuration allows for structural optimization of the force capacity of the tension straps 40, thereby improving the control of the tension straps 40 over the support unit 20.

As can be seen from a comparison of fig. 1a to 4 and 5 to 10, the significant difference between the two embodiments is the connection between the transition bar 45 (which can be understood as the connection ear 43 from another perspective) and the pulling strip 40.

In the embodiment shown in fig. 1a to 4, the pulling strips 40 are V-shaped with the apex of the V facing the outflow side 12. Referring to fig. 3, the transition bar 45 is connected to the draw bar 40 by a stiffener 46. Further, both ends of the reinforcing bar 46 are connected to the middle portions of the pulling strip 40 and the transition bar 45, respectively. The reinforcing rods 46 and the connecting lugs 43 may be aligned as shown in the drawings or may be offset.

In the embodiment shown in fig. 5-10, the pulling strip 40 is V-shaped with the apex of the V facing the inflow side 11. Referring to fig. 6, the V-shaped apex of the pulling strip 40 is set free. In the radial dimension of the positioning device, the V-shaped apex of the pulling strip 40 is set back compared to the engaging lug 43. When the positioning device is in a compressed state, the pulling strip 40 is located within the support foot 30, and the apex of the V-shape is aligned with or offset from the attachment lug 43.

In the direction from the inflow side 11 to the outflow side 12, the pulling strips 40 have a decreasing distance from the center axis of the tubular structure. The gradual decrease in the distancing tendency enables the pulling strip 40 to better conform to the outer peripheral surface of the prosthetic valve 50. In a certain sense, the pulling strip 40 with the gradually decreasing trend away can form a surrounding space, so that the secondary positioning of the artificial valve 50 is realized, and the function of the positioning device is cooperatively realized.

In view of the overall configuration of the positioning device, the outflow side 12 of the cylindrical structure tends to expand in diameter as compared to its own axis, and the tendency to expand in diameter gradually increases and then decreases in the direction from the inflow side 11 to the outflow side 12.

The gradually decreasing trend of expanding after gradually increasing can adapt to the peripheral shape and the changing trend of the existing artificial valve 50, thereby reducing the cost of technology upgrading. Meanwhile, the final gradually-reduced expanding trend can better realize the attachment with the outer peripheral surface of the artificial valve 50 and can avoid the invasion of surrounding tissues, thereby facilitating the implementation of the interventional process.

Specifically, the above-described expansion tendency is achieved by changing the direction in which the pulling strip 40 extends. As a result of the resulting variation, the direction of extension of the ends of the outflow side 12 of the tubular structure is parallel to the central axis of the tubular structure or converge towards each other at a distance, in reference to an embodiment.

Independently of the pulling straps 40, in the embodiment shown in fig. 3 and 6, a transition bar 45 is provided between two adjacent support units 20, extending towards the outflow side 12, and the transition bar 45 is provided with an engaging lug 43. The engaging lug 43 extends from the transition rod 45 towards the outflow side. The engaging ears 43 are adapted to interact with the delivery device. In the particular relationship of the transition bar 45, and as shown with reference to the figures, the transition bar 45 between the two support units 20 is generally V-shaped with the connecting ears 43 at the apex. The transition bar 45 is connected to the outflow side 12 of the respective racking unit 20. It will be appreciated that the transition between the transition rod 45, the racking unit 20 and the attachment ears 43 should be smooth to avoid interference with the positioning device during the intervention.

The effect of delivering and releasing the positioning device during the intervention is directly related to the placement of the engaging ears 43. Specifically, this section will focus on analyzing the details of the arrangement of the engaging lug 43. From the design principle, the central angle corresponding to the distribution area of all the connecting lugs 43 is an acute angle in the circumferential direction of the positioning device. In particular, in the figures, only one engaging lug 43 is provided in the positioning device. That is, the width of the engaging lug 43 in the circumferential direction of the positioning device is acute with respect to the central angle of the central axis of the positioning device. In other embodiments, where the engaging lugs 43 are arranged in a plurality, the circumferential distance between two engaging lugs 43 with the farthest circumferential distance is acute corresponding to the central angle of the central axis of the positioning device. The advantage of this arrangement is that the circumferential positions of the positioning device are arranged differently in relation to the coupling of the delivery device during delivery and release of the positioning device, thereby providing a structural basis for the intended technical effect. The set technical effects include, but are not limited to:

conveying the specific state of the positioning device;

staged release of the positioning device;

adjusting the state of the positioning device in the releasing process;

reversible operation of the release process of the positioning device; and so on.

Based on this design, the above setting mode can also be adjusted as follows: the connecting lugs 43 in the positioning device are multiple and are released asynchronously; or alternatively

There are a plurality of engaging lugs 43 in the positioning device, and the axial position arrangement of each engaging lug 43 and the conveying system is different.

In the specific arrangement of the engaging ears 43, as shown in fig. 1a to 10, the engaging ears 43 are located between two adjacent support units 20 or aligned with one support unit 20 in the circumferential direction of the positioning device. The engaging ears 43 are aligned with the apex circumferential location of the V-shape in the pulling strip 40. Further, the shape of the engaging lug 43 is T-shaped, L-shaped, C-shaped, or annular.

The positioning device of the present application can be applied to a plurality of locations, and similarly, the prosthetic valve 50 that is cooperated with the positioning device of the present application can also be applied to a plurality of locations. For example, referring to fig. 16a and 16b, the artificial valve 50 is a prosthetic aortic heart valve, and correspondingly, the positioning device is also configured as a positioning device for the prosthetic aortic heart valve.

Referring to fig. 18a to 38, the present application further discloses a method of operating a prosthetic valve access system, comprising:

providing a first delivery system 91 and a second delivery system 92 for loading the positioning device and the prosthetic valve 50, respectively, in a compressed state;

delivering the positioning device 10 with the first delivery system 91 and pre-releasing such that the prosthetic valve placement region 14 is expanded, at least a portion of the positioning device 10 remaining coupled to the first delivery system 91 after pre-releasing;

adjusting the positioning device by the first conveying system 91 until the supporting foot 30 reaches the desired position;

fully releasing the prosthetic valve 50 into the prosthetic valve placement region 14 using the second delivery system 92 to allow the positioning device 10 and the prosthetic valve 50 to be positioned in interaction;

the respective transport systems are recovered, wherein the first transport system 91 is first decoupled from the positioning device 10 to completely release the positioning device 10, and then the first transport system 91 is recovered.

The first delivery system, the second delivery system, the positioning device and the prosthetic valve 50 may be arranged as described above, for example, as shown in fig. 11-16 b, or may be arranged differently.

For example, with reference to the embodiment shown in fig. 18a to 20, which disclose the arrangement and operation method of a prosthetic valve intervention system, the first delivery system 91 in fig. 18a realizes the loading of the positioning device 10 through the first release tube 912; in FIG. 18b, the first release tube 912 is moved away from the guide 914 to initiate release of the positioning device 10; in fig. 19a the positioning device 10 is half released and the engaging lug 43 is connected to the first transport system 91, which connection is held in the drawing by a second release tube 913.

In this embodiment, in order to cooperate with the release process of the positioning device 10, a structural modification of the first delivery system 91 is also provided, the first delivery system 91 having opposite distal and proximal ends and comprising, in order from inside to outside, movably nested:

a core tube 915, a guide part 914 is fixed at the far end, and the inside of the core tube 915 is used as a guide wire channel;

a middle tube 916, a distal end of which is fixed with a mounting head 917, an outer periphery of the mounting head 917 having a positioning structure 9171, for example, a slot matching with the shape of the connecting lug 43, or a positioning column capable of passing through the connecting lug 43, which is matched with the connecting lug 43 of the positioning device 10;

a second release tube 913, the distal end of the second release tube 913 covering the engaging ears 43 to constrain the positioning device 10 to the mounting head 917 when the positioning device 10 is in the loaded state (compressed state), the second release tube 913 being proximally retracted to expose the engaging ears 43, i.e., to completely release the positioning device 10;

the first release tube 912, the positioning device 10 in the loaded state (compressed state), the distal end of the first release tube 912 wrapping the entire positioning device 10, and the first release tube 912 being retracted proximally to expose the positioning device 10 (except for the engaging lug 43), i.e., to release the positioning device 10.

To control the movement of the tubes, the proximal ends of the tubes extend and are connected to a control handle, which carries the tubes by means of corresponding drive structures.

In fig. 19b, the second delivery system 92 carrying the prosthetic valve 50 enters the prosthetic valve placement region 14; in fig. 19c, the guide portion 914 of the first delivery system 91 is retracted to avoid the release process of the prosthetic valve 50; in FIG. 19d, the prosthetic valve 50 (shown in phantom) is initially released and interacts with the positioning device 10; in FIG. 19e, the second release tube 913 is moved to fully release the positioning device 10, but the second delivery system 92 and the prosthetic valve 50 are not shown for clarity; the prosthetic valve 50 is fully released and interfits with the positioning device 10 in fig. 20.

For another example, referring to fig. 18a to 18b, fig. 21a to 22d illustrate an embodiment of a prosthetic valve access system, which is configured and operated in accordance with the present invention, and in order to cooperate with the release process of the positioning device 10, a structural modification of the first delivery system 91 is also provided, wherein the first delivery system 91 has a distal end and a proximal end, and comprises:

a core tube 915, a guide part 914 is fixed at the far end, and the inside of the core tube 915 is used as a guide wire channel;

a second release tube 913 having a branched structure 9131 at a distal end thereof and a loop 9132 at a distal end of each branch, wherein the loops 9132 are aligned and overlapped with the engaging ears 43 (loop structure) of the positioning device 10 when the positioning device 10 is in the loaded state (compressed state);

the lock rod 918 is movably arranged between the core tube 915 and the second release tube 913 in a penetrating manner, and when the positioning device 10 is in a loading state (a compression state), the distal end of the lock rod 918 penetrates through the overlapped part of the lantern ring 9132 and the connecting lug 43 to realize the interlocking of the lantern ring 9132 and the connecting lug 43;

the first release tube 912, the positioning device 10 in the loaded state (compressed state), the distal end of the first release tube 912 wrapping the entire positioning device 10, the first release tube 912 being retracted proximally to expose the positioning device 10, the positioning device 10 being fully expandable as viewed in its radial dimension, but the locking rod 918 still passing through the overlapping portion of the collar 9132 and the engaging lug 43, the positioning device 10 and the first delivery system 91 being still coupled until the locking rod 918 is retracted to unlock the collar 9132 and the engaging lug 43, and the positioning device 10 being fully released.

To control the movement of the tubes, the proximal ends of the tubes extend and are connected to a control handle, which carries the tubes by means of corresponding drive structures.

Some steps in the release process are consistent with fig. 18a to 18b and will not be described again.

The main difference is that in fig. 21a the positioning device 10 is half released and the engaging lug 43 is connected to the first conveying system 91; in fig. 22a, the second delivery system 92 carrying the prosthetic valve 50 enters the prosthetic valve placement region 14 and the guide 914 of the first delivery system 91 is retracted to avoid the release process of the prosthetic valve 50; in fig. 22b, the prosthetic valve 50 is initially released and interacts with the positioning device 10; in fig. 22c, the first conveyor system 91 is retracted to provide more room for adjustment; the prosthetic valve 50 is fully released and interfits with the positioning device 10 in fig. 22 d.

For another example, referring to fig. 18a to 18b, and fig. 23 to 24d, the embodiments of the first delivery system 91 may refer to fig. 18a to 20, and some steps in the release process are consistent with fig. 18a to 18b, and are not repeated herein.

The main difference is that in fig. 23 the positioning device 10 is half released and the engaging lug 43 is connected to the first delivery system 91; in fig. 24a, the second delivery system 92 carrying the prosthetic valve 50 enters the prosthetic valve placement region 14; in fig. 24b, the guide portion 914 of the first delivery system 91 is retracted to avoid the release process of the prosthetic valve 50, and the prosthetic valve 50 is initially released and interacts with the positioning device 10; in FIG. 24c, the first delivery system 91 fully releases the positioning device 10, and the prosthetic valve 50 is not shown for clarity; the prosthetic valve 50 is fully released and interfits with the positioning device 10 in fig. 24 d.

In any embodiment, the transport system employs a plurality of tubes slidably nested inside and outside and having a spatial axis, as will be appreciated from the figures. The difference is that in the embodiment shown in fig. 23 to 24d, after half-release, the positioning device 10 is arranged eccentrically with respect to the axis of the first transport system 91. The eccentric arrangement of the axis of the positioning device 10 can be achieved by the above structural optimization of the positioning device 10 and the conveying system, and the specific structural description is referred to above and will not be repeated herein.

The operation method of the intervention system for artificial valve in the present application can be applied to the intervention process of multiple physiological structures, and the process shown in the figure is exemplarily that the delivery system enters the aortic valve through the aorta. The artificial valve 50 is an artificial aortic heart valve, and correspondingly, the positioning device is also correspondingly set as a positioning device of the artificial aortic heart valve. Specific interventional paths for the prosthetic valve interventional system one or more of the available interventional paths may be selected, such as the femoral artery, the ascending aorta, the carotid artery, the brachiocephalic trunk a, left common carotid artery B, left subclavian artery C, etc., as shown in fig. 17.

The implementation steps are specifically explained below with reference to fig. 25 to 38:

in fig. 25, the conveying system specifically includes a first conveying system 91 and a second conveying system 92, and adopts a double-entry path arrangement;

in fig. 26, the guidewire 911 of the first delivery system 91 is accessed;

in fig. 27, a first conveyor system 91 enters with the positioning device 10;

in fig. 28, the first conveyor system 91 is turned to the tight curve side;

in fig. 29, the positioning device 10 is partially released (preferably two thirds of the release process, i.e. the above-mentioned partially coupled state), and the positioning device 10 can be rotated and aligned;

in fig. 30, the positioning device 10 is released and fully opened, with at least a portion of the positioning device 10 still locked to the first delivery system 91, and the positioning device 10 is aligned to the annulus/sinus or other desired location;

in fig. 31, the guide 914 of the first conveyance system 91 is withdrawn;

in fig. 32, the guidewire 911 of the first delivery system 91 is withdrawn and the first delivery system 91 is pulled back as a whole to bring the sheath of the first delivery system 91 into close proximity with the minor major minor curve;

in fig. 33, the guidewire 921 of the second delivery system 92 enters through the center of the positioning device 10 to the ventricle;

in fig. 34, a second conveyor system 92 is entering;

in FIG. 35, the stent portion of the prosthetic valve 50 is released (preferably about two-thirds of the release process) and clamped to the positioning device 10;

in FIG. 36, the positioning device 10 is fully released and the first delivery system 91 is withdrawn;

in fig. 37, the prosthetic valve 50 is fully released;

in fig. 38, the second delivery system 92 is withdrawn.

The application also discloses a simulated intervention method of the artificial valve, which comprises the following steps:

providing a first delivery system 91, a second delivery system 92 and an extracorporeal organ for simulation, wherein the first delivery system 91 and the second delivery system 92 are respectively used for loading the positioning device 10 and the artificial valve 50 in a compressed state;

delivering the positioning device with the first delivery system and pre-releasing such that the prosthetic valve placement region 14 is expanded, at least a portion of the positioning device remaining coupled to the first delivery system after pre-releasing;

adjusting the positioning device by the first conveying system until the supporting legs 30 reach the desired position;

completely releasing the prosthetic valve 50 into the prosthetic valve placement region 14 using the second delivery system, such that the positioning device and the prosthetic valve 50 are positioned in interaction;

and recovering the conveying systems, wherein the first conveying system is firstly decoupled from the positioning device, then the positioning device is completely released, and then the first conveying system is recovered.

The application also discloses a simulated intervention device of the artificial valve, which comprises a first conveying system, a second conveying system, the artificial valve 50, a positioning device according to the technical scheme and an external organ for simulation.

The details of the simulated intervention method of the prosthetic valve and the specific implementation of the device are described in the above description of the operation method of the prosthetic valve intervention system, and are not described herein again.

Of course, when the in vitro organ for simulation in the above embodiment is a real in vivo environment, it can also be regarded as providing an intervention method of the artificial valve, and the specific steps are the same as above.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several implementation modes of the present application, and the description thereof is specific and detailed, but not construed as limiting the scope of the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, and these are all within the scope of protection of the present application.

Claims (27)

1. The positioner of artificial valve for with the mode location artificial valve of components of a whole that can function independently, positioner is the tubular structure, and the inside of tubular structure is artificial valve and places the district, has relative inflow side and outflow side in the axial of tubular structure, its characterized in that, positioner includes:

a plurality of bearing units arranged at intervals along the circumferential direction;

the supporting device comprises a plurality of supporting legs, wherein a supporting leg is correspondingly arranged between two adjacent supporting units in the circumferential direction, at least two fixed ends are arranged on each supporting leg, the two fixed ends are respectively connected with the two adjacent supporting units, and each supporting leg extends from the two fixed ends of the supporting leg to the inflow side to intersect.

2. The prosthetic valve positioning device of claim 1, wherein each of the support units has a tendency to evert between the outflow sides for supporting the prosthetic valve.

3. The device of claim 1, wherein the supporting units comprise two sets of supporting units configured independently, the positioning device has a compressed state for interventional delivery and a predetermined released state, the positioning device in the compressed state is in a strip shape, and the two sets of supporting units are respectively located at two ends of the positioning device in the length direction.

4. The positioning device for the artificial valve according to claim 3, wherein the supporting leg connected between the two sets of supporting units is an open port at one end facing the outflow side, and both sides of the open port in the compressed state are turned and flattened relative to the released state.

5. The positioning device for artificial valve according to claim 3, wherein the number of the supporting units in each of the two groups is the same; or one set is one supporting unit and the other set is two supporting units.

6. The positioning device for artificial valve according to claim 3, wherein all the supporting units and all the supporting legs integrally form three U-shaped units connected end to end in sequence and enclose the cylindrical structure.

7. The device as claimed in claim 6, wherein the supporting unit is V-shaped, the vertex of the V-shape is directed to the outflow side, and two sides of the V-shape are respectively connected to the fixing ends of different supporting feet.

8. The prosthetic valve positioning device of claim 3, wherein a pulling strip is disposed between two adjacent support units in the same set of support units.

9. The prosthetic valve positioning device of claim 3, wherein the pulling strip is V-shaped with the apex of the V pointing to either the inflow side or the outflow side, and the two sides of the V are connected to the respective side support units.

10. The prosthetic valve positioning device of claim 9, wherein the pulling string is attached to an inflow side of the respective support unit.

11. The positioning device for the artificial valve according to claim 8, wherein a transition rod extending to the outflow side is disposed between two adjacent supporting units, and the transition rod is provided with an engaging lug.

12. The prosthetic valve positioning device of claim 11, wherein the transition bar between the two retainer units is generally V-shaped with the apex of the V-shape being provided with the attachment ears.

13. The prosthetic valve positioning device of claim 11, wherein the transition bar is connected to an outflow side of the respective racking unit.

14. The positioning device for a prosthetic valve according to claim 11, wherein the central angle of the distribution area of all the connective ears is acute in the circumferential direction of the positioning device.

15. The prosthetic valve positioning device of claim 14, wherein the engaging ears are located between two adjacent retainer units or aligned with one of the retainer units in the circumferential direction of the positioning device.

16. The prosthetic valve positioning device of claim 14, wherein only one of the attachment ears in the positioning device is configured.

17. The positioning device for a prosthetic valve according to claim 14, wherein the positioning device has a plurality of engaging lugs which are not released synchronously, and the circumferential positions of the engaging lugs are different, and the axial positions of the opening and closing structures on the delivery system are different.

18. The prosthetic valve positioning device of claim 14, wherein the engaging ears are T-shaped, L-shaped, C-shaped, or ring-shaped.

19. The prosthetic valve positioning device of claim 11, wherein the attachment ears are aligned with the apex circumferential location of the V-shape in the pull strip.

20. The prosthetic valve positioning device of claim 11, wherein the transition rod and the pulling strip are connected by a reinforcing rod.

21. The prosthetic valve positioning device of claim 20, wherein the reinforcing rod is connected at both ends to the middle of the pull rod and the transition rod, respectively.

22. A prosthetic valve system comprising a prosthetic valve nestable inside and outside and the positioning device of any of claims 1 to 21.

23. The method of using a prosthetic valve access system of claim 22, comprising:

providing a first delivery system and a second delivery system for loading the positioning device and the prosthetic valve in a compressed state, respectively;

delivering the positioning device with a first delivery system and pre-releasing such that the prosthetic valve placement region is expanded, at least a portion of the positioning device remaining coupled to the first delivery system after pre-releasing;

adjusting the positioning device through a first conveying system until the supporting legs reach the expected positions;

completely releasing the artificial valve into the artificial valve placing area by using the second conveying system, and enabling the positioning device and the artificial valve to be positioned in an interaction way;

and recovering the conveying systems, wherein the first conveying system is firstly decoupled from the positioning device, then the positioning device is completely released, and then the first conveying system is recovered.

24. The method of claim 23, wherein the delivery system employs a plurality of tubes slidably nested inside and outside and having a spatial axis, and wherein the positioning device is eccentrically disposed relative to the axis of the first delivery system after half-release.

25. The method of claim 23, wherein the delivery system is advanced through the aorta to the aortic valve.

26. The method of claim 22, comprising:

providing a first conveying system, a second conveying system and an extracorporeal organ for simulation, wherein the first conveying system and the second conveying system are respectively used for loading a positioning device and a prosthetic valve in a compressed state;

delivering the positioning device with a first delivery system and pre-releasing such that the prosthetic valve placement region is expanded, at least a portion of the positioning device remaining coupled to the first delivery system after pre-releasing;

adjusting the positioning device through a first conveying system until the supporting legs reach the expected positions;

completely releasing the artificial valve into the artificial valve placing area by using a second conveying system, and enabling the positioning device and the artificial valve to be mutually acted and positioned;

and recovering the conveying systems, wherein the first conveying system is firstly decoupled from the positioning device, then the positioning device is completely released, and then the first conveying system is recovered.

27. Simulated intervention device for a prosthetic valve system, comprising a first delivery system, a second delivery system, a prosthetic valve, a positioning device according to claim 22, and an extracorporeal organ for simulation.

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