CN216439373U

CN216439373U - Positioning device capable of being adjusted in rotating mode

Info

Publication number: CN216439373U
Application number: CN202121309927.5U
Authority: CN
Inventors: 吕世文; 郑玲和; 凌正青
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2021-06-10
Filing date: 2021-06-10
Publication date: 2022-05-06
Anticipated expiration: 2031-06-10

Abstract

The application relates to the field of medical equipment, especially, relate to a but rotational adjustment's positioner, include: a fixing member; a generally lengthwise extending coupling mechanism rotatably coupled distal to the mount; at least one steering wire; wherein, the fixed part is provided with a guide channel; one end of the control wire is connected to the connecting mechanism, and the other end of the control wire passes through the corresponding guide channel and is connected to the control mechanism; and wherein manipulation of the steering wire by the steering mechanism causes rotation of the attachment mechanism relative to the mount, thereby effecting adjustment of the circumferential position of the attachment mechanism and the component associated therewith. Through dragging the contained angle that the adjustable link of control line and guide channel become on the cross section of mounting, the overwhelming majority of pulling force all concentrates on between guide channel and the link, and the loss is minimum, and very timely to the feedback of adjusting, and the precision is high.

Description

Positioning device capable of being adjusted in rotating mode

Technical Field

The application relates to the field of medical equipment, in particular to a positioning device capable of being rotationally adjusted.

Background

Aortic Stenosis (AS) is one of the common valvular diseases, with a 4.6% incidence rate in people over 75 years of age in the united states, and the third most common cardiovascular disease in the united states following coronary heart disease and hypertension. Surgical aortic valve replacement has long been the only accepted treatment for long term efficacy. Nevertheless, based on high risk assessment of surgery and concern for postoperative complications, there are 1/3-2/3 patients who abandon surgical treatment and therefore have an average annual mortality rate of 50-60% once symptomatic. Due to continuous innovation of heart intervention means and medical instruments, medical catheter treatment, especially Percutaneous Aortic Valve Replacement (PAVR) gradually becomes a mainstream operation mode, and clinical tests prove that the medical catheter treatment is simple, convenient and feasible, and brings good news to patients who cannot receive surgical treatment.

The main options for percutaneous aortic valve replacement currently available are three surgical approaches, namely the anterior (transfemoral and interatrial puncture), the reverse (retrograde entry into the aortic arch via the femoral artery) and the non-extracorporeal direct access valve replacement (transapical), the second of which is the most convenient and rapid technique and is widely used. The existing stent positioning devices in the market represent an Edwards balloon-expanded SAPIEN (save artificial artery and advanced artery) valve stent positioning device and a Corevalve self-expanding ReValling valve stent positioning device, and research and development personnel continuously provide technical schemes and instrument innovations so as to improve the survival rate of patients and improve the living condition of the patients.

Nevertheless, PAVR still has many defects and technical problems in many aspects such as selection of target population, long-term curative effect and postoperative complications, etc. which are not solved or overcome. Researches show that the improvement of the valve stent positioning device and the operation technology plays a vital role in inhibiting complications such as aortic perforation, paravalvular leakage, thrombus, cerebral apoplexy and the like. For example, in patent cn201110092241.x, edward life sciences provides a heart valve positioning device (10) in which a prosthetic valve (16) is mounted on a valve catheter (23) inside a delivery sleeve (24). A step balloon (18) extends from the delivery cannula and provides a tapered surface for facilitating advancement through a body vessel. The stage balloon also facilitates passage through the leaflets of the native valve. After the prosthetic valve is positioned within the native valve, the delivery sleeve is retracted to expose the prosthetic valve. In one embodiment, the delivery sleeve is retracted by using a lead screw (500) that effects relative movement between the valve catheter and the delivery sleeve. The prosthetic valve is preferably self-expanding. If desired, the stage balloon can be expanded to securely seat the prosthetic valve at the native valve site. The prosthetic valve is preferably connected to the valve catheter by a plurality of flexible extension arms (80) that enable the prosthetic valve to be collapsed after initial deployment of the prosthetic valve so that the prosthetic valve can be repositioned if desired. The technical scheme in the prior art has the defects that when the artificial valve is released to enter the heart to be positioned, the circumferential position of the artificial valve needs to be adjusted, so that the positioning of the artificial valve can be more accurate, and the scheme in the prior art does not have a design which can adjust the circumferential position of the artificial valve, so that the positioning position of the valve cannot be adjusted when the valve is positioned, the artificial valve needs to be positioned in the heart at one step, the fault tolerance rate is very low, and the risk coefficient of the operation is greatly improved.

As described above, the conventional aortic valve replacement surgery and device have no design that can adjust the circumferential position of the valve prosthesis after releasing the positioning member in the heart, and thus it cannot be ensured that the positioning member can enter the sinus more precisely during positioning, thereby reducing the surgical risk.

Accordingly, there is a pressing need in the art for a positioning system for an implant device, such as a valve, that is simpler to operate, more accurate in positioning, less prone to surgical complications, and shorter in surgical time.

Disclosure of Invention

The present application has been made in view of the above and other more general considerations.

It is an object of the present application to overcome the deficiencies of the prior art by providing a new type of rotatably adjustable positioning device for patients suffering from cardiovascular diseases such as aortic stenosis and requiring interventional treatment.

According to another aspect of the present application, there is provided a rotationally adjustable positioning device comprising: a fixing member; a generally lengthwise extending coupling mechanism rotatably coupled distal to the mount; and at least one steering wire; wherein, the fixed part is provided with a guide channel; one end of the control wire is connected to the connecting mechanism, and the other end of the control wire passes through the corresponding guide channel and is connected to the control mechanism; and wherein the adjustment of the circumferential position of the connection means and the component associated therewith is effected by operating the steering wire by means of the steering means to rotate the connection means relative to the mount.

According to an embodiment, the shape of the fixing is selected from one of the following: umbrella-shaped, cylindrical, truncated conical, prismatic and sleeve.

According to an embodiment, the positioning of the guide channel is selected from at least one of: the guide channel is positioned in the fixing piece; and the guide channel is arranged on the periphery of the fixing piece.

According to an embodiment, the guide channel is a substantially axially extending through-hole, channel, slot or rail provided in the fixture.

According to one embodiment, the fixing member includes an inner sleeve and an outer sleeve fitted around the outer periphery of the inner sleeve; wherein the guide channel is disposed in at least one of the inner sleeve and the outer sleeve and extends substantially axially; alternatively, the guide channel is formed by a gap between the inner sleeve and the outer sleeve.

According to an embodiment, the at least one steering wire comprises a first steering wire and a second steering wire.

According to one embodiment, the first steering wire and the second steering wire share a guide channel; alternatively, the first steering wire and the second steering wire are arranged to pass through two guide passages independent of each other, respectively.

According to an embodiment, at the periphery of the connection mechanism, one of the following is provided: first and second circumferentially arranged and spaced apart connections; and a single connecting portion protruding outwardly from an outer circumference of the connecting mechanism.

According to one embodiment, the first and second attachment portions are posts, pegs, hooks or bosses protruding outwardly from the outer periphery of the attachment mechanism, one end of the first and second steering wires being attached to the respective first and second attachment portions in a tying, tying or other fixed manner; and wherein the first and second connection portions are symmetrically arranged at both sides of the guide passage.

According to one embodiment, the steering mechanism is provided with a winding rod, the first steering wire being wound on one side of the winding rod in a clockwise or counterclockwise direction through the guide channel, and the second steering wire being wound on the other side of the winding rod in an opposite counterclockwise or clockwise direction through the guide channel.

According to one embodiment, a first winding site in the form of a perforation is provided on one side of the winding rod and a second winding site in the form of a perforation is provided on the other side of the winding rod.

According to one embodiment, the steering mechanism further comprises a hollow outer housing, and a control knob for rotating the cord reel; and one end of the wire winding rod is operatively connected with the control knob; and the other end of the spool rod is located within the hollow interior of the outer housing.

According to one embodiment, the second steering wire is in a slack state when the steering mechanism is operated to place the first steering wire in tension; and, when the manipulation mechanism is operated to place the second manipulation wire in a tensioned state, the first manipulation wire is placed in a relaxed state.

According to one embodiment, a variable range of the rotatably adjustable angle of the connecting portion is preset between-60 ︒ and 60 ︒.

According to one embodiment, on a cross section perpendicular to the axial direction of the connecting mechanism, an included angle formed by two connecting lines between the center of each of the first connecting portion and the second connecting portion and the center of the connecting mechanism is alpha, and the variable range of the included angle alpha is determined by the variable range of the angle of the connecting portion which can be rotatably adjusted; and the steering wires from the connecting part to the corresponding guide channel form an included angle beta with the central line of the respective guide channel in a tensioning state, wherein the included angle alpha is changed along with the change of the included angle beta.

According to one embodiment, the included angle α is in the range of 0 ︒ < α ≦ 180 ︒, e.g., 120 ︒ ≦ a ≦ 150 ︒.

According to an embodiment, the angle β is in the range 0 ︒ < β < 90 ︒, e.g. 30 ︒ < β < 75 ︒.

According to an embodiment, the connection mechanism comprises: a connection device having a generally cylindrical body; a rotation device mounted at the proximal end of the connection device; and a restraining wire; wherein one end of the restraining wire is fixed to the rotating means and the other end of the restraining wire extends through the connecting means to be detachably connected to the implanted prosthesis at the distal end of the connecting means.

According to one embodiment, the implant prosthesis is a prosthetic heart valve prosthesis comprising a stent body and a positioning member assembled together.

According to one embodiment, the prosthetic heart valve prosthesis is an aortic valve prosthesis and the number of positioning members is 3.

According to one embodiment, the positioning device further comprises an inner core tube and a middle sheath tube; the connecting device is sleeved on the periphery of the inner core pipe, the rotating device is sleeved on the periphery of the middle layer sheath pipe, and the middle layer sheath pipe can axially move relative to the inner core pipe.

According to another aspect of the present application, there is also provided a rotatably adjustable positioning device, comprising: the connecting mechanism, the fixing piece and the control wire; the fixed piece is provided with a guide channel; one end of the control wire is connected with the connecting mechanism, and the other end of the control wire penetrates through the guide channel; and, manipulating the steering wire causes the attachment mechanism to rotate circumferentially relative to the fixed member.

According to an embodiment, the number of the guide channels is 2, and the 2 guide channels are independent from each other, so that the situation that the control wire is wound is avoided.

According to an embodiment, part of the guide channel is arranged inside the fixing member, while part of the guide channel is arranged at the outer circumference of the fixing member.

According to one embodiment, the guide channel may be an axially arranged through hole in the fixation member.

According to one embodiment, the through hole is provided in a rounded configuration to avoid cutting the steering wires.

According to one embodiment, the fixing element is provided with a guide track at its periphery, and the guide channel is provided in the guide track.

According to one embodiment, when the positioning device is used in an aortic replacement procedure, the prosthetic heart valve prosthesis comprises a stent body and a positioning member, and the prosthetic heart valve prosthesis is pre-positioned by first releasing the positioning member so that the positioning member is positioned to the sinus floor of the aorta, and then releasing the stent body.

According to one embodiment, the implanted prosthesis is a vascular stent or a valve clip.

According to one embodiment, when the implanted prosthesis is to be delivered into the body in a circumferentially adjustable angle, the steering mechanism is operable such that the steering wire drives the connection mechanism and further drives the implanted prosthesis to rotate circumferentially.

According to one embodiment, the positioning means comprise a restraining wire, the connecting means comprise a connecting hole, the implant is provided with a removal hole, the removal hole is arranged to penetrate through the connecting hole during preassembly, one end of the restraining wire penetrates through the removal hole to complete the connection, and the other end of the restraining wire extends to the outside of the body.

According to an embodiment, the steering wires are selected from one of the following: a wire, a rope, a cable, a strand, a wire, a flexible band, and any combination thereof.

According to another aspect of the present application, there is also provided a rotatably adjustable positioning device, comprising: a fixing member; a generally lengthwise extending coupling mechanism rotatably coupled distal to the fixture, the coupling mechanism having first and second circumferentially arranged and spaced apart coupling portions disposed about an outer periphery thereof; the first control wire and the second control wire are provided with guide channels, and the first control wire and the second control wire share one guide channel or respectively pass through two independent guide channels; wherein one end of the first and second steering wires are connected to the first and second connecting portions, respectively, and the other ends thereof are connected to corresponding portions on the steering mechanism through corresponding guide channels; wherein when the operating mechanism is operated to place the first operating wire in a tensioned state, the second operating wire is in a relaxed state; when the actuation means are operated to put the second actuation wire in tension, the first actuation wire is in a relaxed state, so that the connection means can be rotated relative to the fixing element in two rotational directions opposite to each other, thereby enabling an adjustment of the circumferential position of the connection means and the component associated therewith.

According to another aspect of the present application, there is also provided a rotatably adjustable positioning apparatus, comprising: a fixing member; a generally lengthwise extending coupling mechanism rotatably coupled distal to the fixture, a single connection point being provided on the coupling mechanism; a single control wire, wherein the fixed member is provided with a single guide channel; one end of the control wire is connected with an elastic reset mechanism wound at a single connecting point of the connecting mechanism, and the other end of the control wire is connected to the control mechanism through a guide channel; the connecting mechanism rotates relative to the fixing piece by operating the control wire to be tensioned through the control mechanism, and after the control wire is loosened, the elastic force resetting mechanism enables the connecting mechanism to reversely rotate.

Compared with the prior art, the technical scheme of the application has the advantages that at least the following steps are included:

in the prior art, the end of a tube is usually controlled and rotated, force is transmitted to the other end of the tube through rotation to achieve the purpose of adjusting the angle, the tube can generate torsional force in the rotating process, so that the adjustment is not accurate enough, particularly, when the length of the tube is longer or the tube faces a complex distorted blood vessel form, the adjustment precision is sharply reduced, the problem of adjustment delay or even incapability exists, and when the adjustment is performed in a blood vessel access way, due to the fact that the blood vessel has a plurality of distortions in a certain degree, the difficulty and timeliness of the adjustment are further increased, and the positioning operation of an operation is not facilitated. According to one concept of the application, the included angle formed by the connecting end and the guide channel on the cross section of the fixing piece can be adjusted by pulling the control wire, most of the pulling force is concentrated between the guide channel and the connecting end, the loss is extremely small, and the adjustment is timely and accurate in feedback.

According to one concept of the application, the steering wires comprise a first steering wire and a second steering wire, the first steering wire can be made to drive the connecting mechanism to rotate in a clockwise direction by steering the steering mechanism clockwise, and the second steering wire can be made to drive the connecting mechanism to rotate in an anticlockwise direction when steering the steering mechanism anticlockwise.

According to one concept of the present application, one end of the first operating wire is connected to the first winding portion, and the other end portion of the first operating wire is wound on the winding bar in a clockwise direction. One end of the second operating wire is connected to the second winding portion, and the other end portion of the second operating wire is wound on the winding bar in a counterclockwise direction. The arrangement of the concept can satisfy the adjustment of the implanted prosthesis in the circumferential direction and the angle, and simultaneously, the design and the assembly of the concept are simple, the cost is low, and the design is more favorable for low-cost and high-reliability industrial mass production.

According to the above concepts of the technical solution of the present application, as well as other concepts, a number of technical problems and drawbacks existing in the prior art can be solved, for example, the circumferential position of the valve prosthesis can not be precisely adjusted after the positioning member is released, the positioning of the positioning member into the sinus is not precise enough, the unlimited release of the valve prosthesis may cause the stent to deviate or even deviate from the expected position when released in the heart, and so on.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

FIG. 1a is a schematic view of a coupling mechanism, a mount, and a steering wire according to one embodiment of the present application.

FIG. 1b is another view of the embodiment of FIG. 1a rotated circumferentially by a certain angle.

Fig. 2a-2d are schematic views of different types of guide channels and their relationship to steering wires and connections.

Figures 3a-3b are schematic views of an implanted prosthetic positioning device according to one embodiment of the present application.

Fig. 4a-4d are schematic structural views of a steering mechanism according to an example of the present application.

Figures 5a-5g are schematic views of an implanted prosthetic positioning device according to another embodiment of the present application.

Fig. 6a-6c are schematic views of another example of a fastener of the present application.

Fig. 7a-7c are schematic structural views of another embodiment of the present application.

Fig. 8a-8c are schematic structural views of another embodiment of the present application.

The figures in the drawings refer to the following features:

1-connection means, 11-first connection means, 12-second connection means, 13-connection means, 131-through hole, 14-rotation means, 15-restriction wire, 2-fixation means, 21-guide channel, 22-inner sleeve, 23-outer sleeve, 3-control wire, 31-first control wire, 32-second control wire, 33-elastic recovery means, 4-implant prosthesis, 41-stent body, 42-positioning means, 5-control means, 51-outer shell, 52-winding rod, 521-first winding position, 522-second winding position, 53-control knob, 6-inner core tube, 7-middle sheath tube.

Detailed Description

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the application.

In this application, the term "proximal" or "proximal" refers to the end or side closer to the operator, and "distal" or "distal" refers to the end or side farther from the operator.

In the prior art, the purpose of adjusting the angle is usually achieved by controlling and rotating the end of the tube, and transmitting force to the other end of the tube by rotation. The tube generates torsion force during the rotation process, which causes the adjustment of the tube to be not accurate enough, especially when the length of the tube is long or faces the blood vessel with complex twisted shape, the adjustment accuracy of the tube can be reduced sharply, and even the problem of delayed or unable adjustment exists. Moreover, when the adjustment of the tube is performed in the vascular access, the difficulty and untimely nature of the adjustment are further increased due to the fact that the vessel itself has a plurality of twists to a certain extent, which is not favorable for the positioning operation of the operation.

One of the objects of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

Example one

As shown in fig. 1a and 1b, a rotationally adjustable positioning device useful in aortic valve surgery according to an embodiment of the present application is illustrated, comprising a fixture 2, a substantially longitudinally extending attachment mechanism 1 rotatably attached distal to the fixture 2, and a steering wire 3 in a flexible form, such as a wire, rope, cable, strand, wire, flexible band, or the like. On the fixing element 2, which may be for example substantially umbrella-shaped, a guide channel 21 is provided, which may be for example in the form of a through hole, channel or the like, as shown in fig. 2 a. As shown in fig. 1a and 1b, one end of the steering wire 3 is connected to the connection means 1, e.g. by a bolt, tie or wrap at the connection end 16 of the connection means 1, while its other end extends through the guide channel 21 of the fixation member 2 to be operatively connected to the steering means 5. In the region of the connecting end 16, there may be provided a connecting portion, for example a radially projecting post or peg, for example to facilitate bolting, tying or winding of the steering wires 3, two such connecting portions in the form of posts or pegs arranged circumferentially along the body of the connection 1 being shown in the drawings, as will be described in more detail below. In this way, the connecting means 1 can be moved, for example rotated, in the circumferential direction relative to the holder 2, for example by pulling the actuation cable 3. In this embodiment, the angle α (fig. 2 d) between the connection end 16 and the guide channel 21 in a cross-section of the connection device 1 perpendicular to the axial direction can be adjusted by pulling the actuating wire 3. The pulling force is mostly concentrated in the steering wire 3 between the guide channel 21 and the connection end 16, so that the loss of the steering wire 3 and the whole device is very small, the feedback of the pulling adjustment action is very timely, and the precision is high.

In the present embodiment, as one of preferred examples, the guide channel 21 may be provided as a through hole or a channel through the body of the holder 2, which extends substantially in the preset direction of pulling the manipulation wire 3, as shown in fig. 2a, which extends, for example, substantially axially.

As another example, the guide channel 21 may be provided at the outer periphery of the fixing 2 having a generally cylindrical body, as shown in fig. 2b, in the form of an axially extending channel passing between two radially protruding bosses circumferentially spaced apart of the generally cylindrical body of the fixing 2.

As another example, the guide channel 21 is in the form of a combination of the guide channel shown in fig. 2a and the guide channel shown in fig. 2b, each accommodating a portion of the steering wire 3 in order to be guided and pulled during operation. In this example, the number of the guide channels 21 may be 2, and the 2 guide channels 21 are independent from each other to avoid the twisting of the steering wire 3 during operation.

In this embodiment, the positioning device may further comprise an implant prosthesis 4 and a steering mechanism 5. The implant prosthesis 4 may be attached to the distal or distal end of the attachment mechanism 1 and may rotate therewith. The other end of the steering wire 3, i.e. the end designed to be connected to the steering mechanism 5, extends through a guide channel 21 to be connected to the steering mechanism 5 (as shown in fig. 4a-4d, for example). In this way, the operator, e.g. a surgeon, can manipulate the steering mechanism 5 to facilitate winding (tensioning) and releasing (slackening) the steering wire 3, thereby steering the attachment mechanism 1 connected to the steering wire 3 to rotate circumferentially relative to the fixation member 2.

According to one example, the steering mechanism 5 may comprise an outer housing 51, a wire winding rod 52 and a control knob 53 assembled together, as shown in fig. 4a-4 d. One end of the winding rod 52 is fixedly connected to the control knob 53, and the other end of the winding rod 52 protrudes and is disposed inside the hollow outer housing 51. The steering wire 3 may be wound around the wire winding rod 52. For example, the winding rod 52 may be provided with a first winding portion 521 and a second winding portion 522, for example, in the form of perforations, as shown in fig. 4 d. The first control wire 31 is fixed to the first winding portion 521 by, for example, tying, binding, adhering, etc., and is wound around the winding bar 52 in a clockwise or counterclockwise direction (e.g., several turns may be wound around the first winding portion 521). The second steering wire 32 is also secured to the second winding location 522, such as by tying, binding, adhering, etc., and is wound around the winding rod 52 in a direction opposite to the winding direction of the first steering wire 31, i.e., counterclockwise or clockwise (which may include several turns around the second winding location 522, for example).

When the control knob 53 is turned clockwise, the first steering wire 31 is in a tensioned (wound) state and further drives the link mechanism 1 connected thereto, for example, to rotate clockwise, while the second steering wire 32 is in a relaxed (released) state.

When the control knob 53 is turned counterclockwise, the second manipulation wire 32 is in a tensioned (wound) state and further drives the link mechanism 1 connected thereto to rotate counterclockwise, for example, while the first manipulation wire 31 is in a relaxed (released) state.

According to one example, the coupling mechanism 1 may comprise a coupling device 13 having, for example, a generally cylindrical body, a rotation device 14 mounted at a proximal end of the coupling device 13, and a restraining wire 15. One end of the restraining wire 15 is fixed to the rotating means 14, for example bolted or tied to the rotating means 14; the other end of the restraining wire 15 is removably connected to the implanted prosthesis 4 at the distal end of the attachment means 13 through a through hole 131 in the attachment means 13, as shown in figures 3a-3 b.

The implant prosthesis 4 may be a prosthetic heart valve prosthesis, and the prosthetic heart valve prosthesis may include a stent body 41 and a positioning member 42 assembled together, as shown in fig. 3a and 5 b.

According to one example, the pre-positioning of the prosthetic heart valve prosthesis may be accomplished by first releasing the positioning member 42 to position it to the sinus floor, and then releasing the stent body 41 during a subsequent surgical procedure.

In operation, when the implanted prosthesis 4 needs to be circumferentially angled during delivery into the heart of a human body, the surgeon can operate the control knob 53 of the steering mechanism 5 to drive the steering wire 3 wound on the winding rod 52, as shown in fig. 4a-4d, so that the steering wire 3 drives the connecting mechanism 1 connected thereto to rotate clockwise or counterclockwise relative to the fixing member 2, and the rotation further drives the implanted prosthesis 4 connected to the connecting mechanism 1 to rotate circumferentially, as described in detail below.

In a surgical operation, the coupling mechanism 1 is provided with a first coupling part 11 and a second coupling part 12, for example in the form of a peg, a pillar, at the coupling end 16, as shown in fig. 3 a. The steering wires 3 are connected to the first connection portion 11 and the second connection portion 12, for example, in a bolted or tied manner. When the first steering wire 31 pulls the first coupling portion 11 to rotate circumferentially, the implant prosthesis 4 coupled to the coupling mechanism 1 may rotate circumferentially in a clockwise direction, for example. When the second steering wire 32 pulls the second connecting portion 12 to rotate circumferentially, the implant prosthesis 4 connected to the connecting mechanism 1 may rotate circumferentially in a counterclockwise direction, for example.

On a cross section perpendicular to the axial direction of the connecting mechanism 1, an included angle formed by two connecting lines between the center of each of the first connecting portion 11 and the second connecting portion 12 and the center of the connecting mechanism 1 is α, and a variable range of the included angle α is determined by a variable range of the rotatably adjustable angle of the connecting portion 11.

According to one example, the included angle α is in the range of 0 ︒ < α ≦ 180 ︒, e.g., 120 ︒ ≦ a ≦ 150 ︒.

Since the aortic sinuses have 3 sinus bottoms and are uniformly distributed on the circumference, the angle between adjacent sinus bottoms and the connecting line of the aortic valve center is about 120 ︒. The positioning elements 42 of the implanted prosthesis 4 are provided in a number of 3 matching the sinus floor of the aortic sinus. As described above, the surgeon manipulates the steering mechanism 5 to conveniently and precisely drive the implanted prosthesis 4 in either a clockwise or counterclockwise rotation, for example, to position the positioning member 42 to the corresponding sinus floor. The maximum rotational angle of the securing member 42 in either the counterclockwise or clockwise direction as delivered into the heart is about 60 ︒, so that one preferred value of the included angle α is about 120 ︒.

According to an example, the first and

second connection portions

11 and 12 are arranged in left-right symmetry with respect to the center of the guide passage 21, as viewed in a cross section of the fixing member 2 perpendicular to the axial direction. By this arrangement it is ensured that the implanted prosthesis 4 can be adjusted easily and accurately to the desired implantation position in the circumferential direction, both in the counter-clockwise direction and in the clockwise direction, as required.

According to an example, the positioning device may further comprise an inner core tube 6 and a middle sheath tube 7, as shown in fig. 3 b. Wherein, the connecting device 13 is sleeved on the periphery of the inner core tube 6, the rotating device 14 is sleeved on the periphery of the middle layer sheath tube 7, and the middle layer sheath tube 7 can axially move relative to the inner core tube 6. The assembly and disassembly of the attachment means 13 to the implanted prosthesis 4 is achieved by proximal axial displacement of the middle sheath 7 relative to the inner core tube 6.

The operation process of the positioning device comprises the following steps.

1) The positioning device is manipulated through a transvascular approach into the heart and then the positioning member 42 on the implanted prosthesis 4 is released to the desired location within the heart, as shown in figures 5a and 5 b.

2) Observing the current position of the positioning member 42 relative to the aortic sinus, if the position does not reach the desired position, the surgeon can operate the control mechanism 5 to pull the corresponding control wire 3, so that the control wire 3 drives the rotation device 14 of the connection mechanism 1 connected thereto to rotate, the rotation of the rotation device 14 in turn drives the limiting wire 15 connected to the rotation device 14 to rotate, the limiting wire 15 in turn drives the connection device 13 connected thereto to rotate together with the implanted prosthesis 4, thereby achieving the adjustment of the position of the positioning member 42 of the implanted prosthesis 4, and finally achieving the positioning of the positioning member 42 to the desired position of the sinus floor, as shown in fig. 5 c.

3) When the retainer 42 reaches the desired location of the sinus floor, the stent body 41 is further released from its position as shown in fig. 5 d. Thereafter, the positioning device is removed and the implantation procedure is completed, as shown in figures 5e-5 g.

Example two

The second embodiment is substantially the same as the first embodiment except for having a differently configured fastener.

As shown in fig. 6a, a rotationally adjustable positioning device is illustrated which may be used in aortic valve surgery, comprising a fixture 2, a substantially longitudinally extending attachment mechanism 1 rotatably attached distally of the fixture 2, and a steering wire 3 in a flexible form, e.g. a wire, a rope, a cable, a strand, a wire, etc.

In the second embodiment, the fixing member 2 includes an inner sleeve 22 and an outer sleeve 23 fitted around the inner sleeve 22. A guide channel 21 in the form of a through-hole, channel or channel extending substantially axially is provided in the fixing element 2. As shown in fig. 6b, the guide channel 21 may be an axially extending channel provided at the inner sleeve 22 between the inner sleeve 22 and the outer sleeve 23 for facilitating passage of the steering wires 3 therethrough. As shown in fig. 6c, the guide channel 21 may be an axially extending channel provided at the outer sleeve 23 between the inner sleeve 22 and the outer sleeve 23 for facilitating passage of the steering wire 3 therethrough.

In a substantially similar manner to the first embodiment, the steering wire 3 is connected at one end to the attachment mechanism 1, for example by being bolted, tied or wound at the attachment end 16 of the attachment mechanism 1, and at the other end extends through a guide channel 21 in the fixing member 2 to be operatively connected to the steering mechanism 5. In this way, the actuating wire 3 can be pulled by actuating the actuating means 5, so that the rotating device 14 of the connecting means 1 connected thereto can be rotated in the circumferential direction relative to the fastening element 2. The rotation device 14 in turn causes the restraining wire 15 connected to the rotation device 14 to rotate, and the restraining wire 15 in turn causes the connecting device 13 connected thereto to rotate together with the implanted prosthesis 4, thereby achieving adjustment of the position of the positioning member 42 of the implanted prosthesis 4, and thus ultimately achieving positioning of the positioning member 42 to the desired location of the sinus floor.

In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

EXAMPLE III

The third embodiment is substantially the same as the first embodiment, except that it employs a single link 11, a single steering wire 3, and two guide channels 21.

As shown in fig. 7a, a rotationally adjustable positioning device is illustrated which may be used in aortic valve surgery, comprising a fixture 2, a substantially longitudinally extending attachment mechanism 1 rotatably attached distally of the fixture 2, and a steering wire 3 in a flexible form, e.g. a wire, a rope, a cable, a strand, a wire, etc.

In the third embodiment, the guide channel 21 may be provided as a through hole or a channel through the body of the fixing member 2, which extends substantially along the preset direction of pulling the manipulation wire 3, as shown in fig. 7a, which extends, for example, substantially axially.

In the third embodiment, the number of the guiding channels 21 may be 2, and the 2 guiding channels 21 are independent from each other, so as to avoid the winding of the steering wire 3 during the operation (in the third embodiment, there is a predetermined angle between the 2 guiding channels).

In the third embodiment, the variable range of the rotatably adjustable angle of the connecting portion 11 is preset between-60 ︒ and 60 ︒.

In the third embodiment, the steering wires 3 from the connecting portion 11 to the corresponding guide channel 21 form an angle β with the center line of the respective guide channel 21 in the tensioned state, and the angle β is in the range of 0 ︒ < β < 90 ︒, for example 30 ︒ < β < 75 ︒.

In the third embodiment, as shown in fig. 7b, the steering wire 3 is a wire, the steering wire 3 is connected to the connecting portion 11 in a fitting manner, and the connecting manner can be a fastening, tying or other fixing manner, one end of the steering wire 3 passes through the first guiding channel 211, and the other end of the steering wire 3 passes through the second guiding channel 212; while both ends of the steering wire 3 are operatively connected to the steering mechanism 5. In this way, the actuating wire 3 can be pulled by actuating the actuating element 5, so that the rotating device 14 of the connecting element 1 connected thereto can be rotated in the circumferential direction relative to the fastening element 2. The rotation device 14 in turn causes the restraining wire 15 connected to the rotation device 14 to rotate, and the restraining wire 15 in turn causes the connecting device 13 connected thereto to rotate together with the implanted prosthesis 4, thereby achieving adjustment of the position of the positioning member 42 of the implanted prosthesis 4, and thus ultimately achieving positioning of the positioning member 42 to the desired location of the sinus floor.

In this regard, the related configuration and concept of the third embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

Example four

The fourth embodiment is substantially the same as the first embodiment, except that the embodiment employs a single link 11, a single guide channel 21, and a single steering wire 3, and the steering wire 3 includes a spring return mechanism.

As shown in fig. 8a, a rotationally adjustable positioning device is illustrated that can be used in aortic valve surgery, comprising a fixture 2; a substantially lengthways extending coupling mechanism 1 rotatably coupled distally of the fixture 2, a single coupling portion 11 being provided on the coupling mechanism 1; a single steering wire 3, wherein the fixed member 2 is provided with a single guide channel 21; wherein one end of the manipulation wire 3 is connected to an elastic force returning mechanism 33 wound at the single connection portion 11, and the other end is connected to the manipulation mechanism 5 through the guide passage 21; and, wherein, operate the tension of the said control wire 3 and make the said link mechanism 1 rotate relative to said stationary part 2 through the said control mechanism 5, after unclamping the said control wire 3, the said elasticity reset mechanism 33 makes the said link mechanism 1 rotate in the opposite direction.

In the fourth embodiment, the elastic force return mechanism 33 may be provided as a spring or other member with an elastic force return function.

In the fourth embodiment, the guide channel 21 may be provided as a through hole or a channel through the body of the holder 2, which extends substantially in the predetermined direction of pulling the manipulation wire 3, as shown in fig. 7a, which extends, for example, substantially axially.

In the fourth embodiment, as shown in fig. 8b and 8c, the steering wire 3 is a wire, the steering wire 3 is connected with the connecting part 11 in a matching way, the connecting way can be connected in a fastening way, a tying way or other fixing ways, one end of the steering wire 3 is connected with the connecting part 11, the elastic force resetting mechanism 33 of the steering wire 3 is wound on the connecting mechanism 1, and the other end of the steering wire 3 passes through the guide channel 21 and is operatively connected with the steering mechanism 5. In this way, the actuating wire 3 can be pulled by actuating the actuating element 5, so that the rotating device 14 of the connecting element 1 connected thereto can be rotated in the circumferential direction relative to the fastening element 2. The rotating device 14 rotates to drive the limiting wire 15 connected to the rotating device 14 to rotate, the limiting wire 15 rotates to drive the connecting device 13 connected with the limiting wire to rotate together with the implanted prosthesis 4, so as to realize the adjustment of the position of the positioning member 42 of the implanted prosthesis 4, meanwhile, when the rotation angle needs to be reversely adjusted, only the control wire 3 needs to be loosened, and the elastic restoring force of the elastic resetting mechanism 33 of the control wire 3 can be rotated in the reverse direction to adjust a certain angle, so that the positioning member 42 is finally positioned to the ideal expected position of the sinus floor.

In this regard, the relevant construction and concept of embodiment four is similar to embodiment one and therefore will not be repeated here.

The foregoing description of several embodiments of the application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, configurations and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention and all equivalents be defined by the following claims.

Claims

1. A rotationally adjustable positioning device, characterized in that: the method comprises the following steps:

a fixing member;

a generally lengthwise extending coupling mechanism rotatably coupled distal to the mount; and

at least one steering wire;

wherein, the fixing piece is provided with a guide channel;

one end of the control wire is connected to the connecting mechanism, and the other end of the control wire penetrates through the corresponding guide channel and is connected to the control mechanism; and

wherein the adjustment of the circumferential position of the connection means and the component associated therewith is achieved by the steering means operating the steering wire such that the connection means rotates relative to the fixture.

2. The positioning device of claim 1, wherein the shape of the fixture is selected from one of the following: umbrella-shaped, cylindrical, truncated conical, prismatic and sleeve.

3. The positioning device of claim 1, wherein the positioning of the guide channel is selected from at least one of:

the guide channel is positioned in the fixing piece; and

the guide channel is arranged on the periphery of the fixing piece.

4. The positioning device of claim 1, wherein the guide channel is a generally axially extending through-hole, channel, slot or rail provided in the fixture.

5. The positioning device as set forth in claim 4, wherein said fixing member includes an inner sleeve and an outer sleeve fitted around a periphery of said inner sleeve;

wherein the guide channel is disposed in at least one of the inner sleeve and the outer sleeve and extends generally axially; alternatively, the guide passage is formed by a gap between the inner sleeve and the outer sleeve.

6. The positioning device of any of claims 1-5, wherein the at least one steering wire comprises a first steering wire and a second steering wire.

7. The positioning device of claim 6, wherein the first and second steering wires share one of the guide channels; alternatively, the first steering wire and the second steering wire are provided to pass through two guide passages independent of each other, respectively.

8. The positioning device according to claim 7, wherein one of the following is provided at an outer periphery of the connection mechanism:

first and second circumferentially arranged and spaced apart connections; and

a single connecting portion projecting outwardly from an outer periphery of the connecting mechanism.

9. The positioning device according to claim 8, wherein the first and second connecting portions are small posts, short pegs, hooks, or bosses protruding outwardly from the outer periphery of the connecting mechanism, and one ends of the first and second steering wires are each connected to the respective first and second connecting portions in a tethered, tied, or tied manner; and is

Wherein the first and second connection parts are symmetrically arranged at both sides of the guide passage.

10. The positioning device as set forth in claim 6, wherein the manipulation mechanism is provided with a wire winding rod, the first manipulation wire is wound on one side of the wire winding rod in a clockwise or counterclockwise direction through the guide channel, and the second manipulation wire is wound on the other side of the wire winding rod in a counterclockwise or clockwise direction opposite thereto through the guide channel.

11. The positioning device as set forth in claim 10, wherein a first winding portion in the form of a perforation is provided on said one side of said wire winding rod, and a second winding portion in the form of a perforation is provided on said other side of said wire winding rod.

12. The positioning device as set forth in claim 10 wherein said steering mechanism further includes a hollow outer housing and a control knob for rotating said wire take-up rod; and is

Wherein one end of the wire winding rod is operatively connected with the control knob; and the other end of the spool rod is located within the hollow interior of the outer housing.

13. The positioning device as set forth in claim 6 wherein said second steering wire is in a slack state when said first steering wire is in a tensioned state by operating said steering mechanism; and is

The first steering wire is in a slack state when the steering mechanism is operated to place the second steering wire in tension.

14. The positioning device as set forth in claim 8, wherein a variable range of the rotatably adjustable angle of the connection part is preset between-60 ︒ and 60 ︒.

15. The positioning device according to claim 8, wherein, in a cross section perpendicular to an axial direction of the connecting mechanism, an included angle formed by two connecting lines between respective centers of the first connecting portion and the second connecting portion and a center of the connecting mechanism is α, and a variable range of the included angle α is determined by a variable range of the rotatably adjustable angle of the connecting portions; and is

Wherein an included angle formed between the steering wires from the connecting portion to the corresponding guide channel in a tensioned state and a center line of the respective guide channel is β, wherein the included angle α varies with a variation of the included angle β.

16. The positioning device of claim 1, wherein the connection mechanism comprises:

a connection device having a generally cylindrical body;

a rotating means mounted at a proximal end of said connecting means; and

limiting the filaments;

wherein one end of the restraining wire is fixed to the rotating means and the other end of the restraining wire extends through the connecting means to be detachably connected to an implanted prosthesis located at the distal end of the connecting means.

17. The positioning device as set forth in claim 16,

wherein the positioning device further comprises an inner core tube and a middle layer sheath tube; and is

The connecting device is sleeved on the periphery of the inner core pipe, the rotating device is sleeved on the periphery of the middle layer sheath pipe, and the middle layer sheath pipe can axially move relative to the inner core pipe.

18. The positioning device of claim 1, wherein the steering wire is selected from one of the following: a wire, a rope, a cable, a strand, a wire, a flexible band, and any combination thereof.

19. A rotationally adjustable positioning device, characterized in that: the method comprises the following steps:

the fixed part and the control mechanism;

a generally lengthwise extending coupling mechanism rotatably coupled distal to the fixture, the coupling mechanism having first and second circumferentially arranged and spaced apart coupling portions disposed about an outer periphery thereof;

a first steering wire and a second steering wire,

the fixing piece is provided with a guide channel, and the first operating line and the second operating line share one guide channel or respectively pass through two independent guide channels;

wherein one end of the first and second steering wires are connected to the first and second connecting portions, respectively, and the other ends thereof are connected to corresponding portions on the steering mechanism through the corresponding guide channels;

wherein the second steering wire is in a slack state when the steering mechanism is operated to place the first steering wire in tension; when the actuation mechanism is operated to place the second actuation wire in tension, the first actuation wire is in a relaxed state such that the connection mechanism is rotatable relative to the mount in two rotational directions opposite to each other, thereby enabling adjustment of the circumferential position of the connection mechanism and the component associated therewith.

20. A rotationally adjustable positioning device, characterized in that: the method comprises the following steps:

the fixed part and the control mechanism;

a generally lengthwise extending attachment mechanism rotatably attached distal to the fixture, a single attachment point being provided on the attachment mechanism;

the control device is used for controlling the control wire,

wherein the fixing piece is provided with a single guide channel;

wherein one end of the control wire is connected with an elastic reset mechanism wound at the single connecting point, and the other end of the control wire passes through the guide channel and is connected to the control mechanism; and is

Wherein the connection mechanism is rotated relative to the fixing member by operating the manipulation wire to be tensioned by the manipulation mechanism, and the elastic force returning mechanism reversely rotates the connection mechanism after releasing the manipulation wire.