A rotatable and adjustable positioning device

Abstract

The present application relates to the field of medical devices, and more particularly to a rotatably adjustable positioning device, comprising: a fixing member; a connecting mechanism rotatably connected to a distal side of the fixing member and extending substantially longitudinally; at least one control wire; wherein the fixing member is provided with a guide channel; one end of the control wire is connected to the connecting mechanism, and the other end passes through a corresponding guide channel and is connected to a control mechanism; and wherein the control mechanism operates the control wire to rotate the connecting mechanism relative to the fixing member, thereby adjusting the circumferential position of the connecting mechanism and components associated therewith. By pulling the control wire, the angle between the connecting end and the guide channel on the cross section of the fixing member can be adjusted, and most of the pulling force is concentrated between the guide channel and the connecting end, resulting in minimal loss, and very timely feedback on the adjustment with high accuracy.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a rotatably adjustable positioning device. Background Art

[0002] Aortic stenosis (AS) is a common valvular disease, with an incidence of 4.6% in the US population over 75 years old. It is the third most common cardiovascular disease in the country, after coronary artery disease and hypertension. For a long time, surgical aortic valve replacement has been the only recognized long-term treatment. Despite this, due to concerns about the high risk of surgery and postoperative complications, one-third to two-thirds of patients still forgo surgical treatment. As a result, once symptoms develop, the average annual mortality rate reaches 50%-60%. Due to continuous innovations in cardiac interventional techniques and medical devices, catheter-based treatment, particularly percutaneous aortic valve replacement (PAVR), has gradually become a mainstream procedure. Clinical trials have proven its simplicity and feasibility, bringing hope to many patients who are unable to undergo surgical treatment.

[0003] Currently, percutaneous aortic valve replacement (PAV) offers three primary surgical approaches: antegrade (via femoral vein and transseptal puncture), retrograde (via femoral artery retrograde access to the aortic arch), and direct off-pump valve replacement (transapical). The latter approach is the most convenient and widely adopted. Marketed stent positioning devices include the Edwards balloon-expandable SAPIEN valve stent positioning device and the Corevalve self-expanding ReValving valve stent positioning device. Researchers are continuously providing technical solutions and device innovations to increase patient survival rates and improve their lives.

[0004] Despite this, PAVR still has many defects and technical difficulties that have not been solved or overcome in terms of target population selection, long-term efficacy and post-operative complications. Studies have shown that improvements in valve stent positioning devices and operating techniques play a vital role in suppressing complications such as aortic perforation, paravalvular leakage, thrombosis and stroke. For example, in patent CN201110092241.X, Edwards Life Sciences provides a heart valve positioning device (10), in which an artificial valve (16) is mounted on a valve catheter (23) inside a delivery sheath (24). A stage balloon (18) extends from the delivery sheath and provides a tapered surface for facilitating advancement through human vessels. The stage balloon also helps pass through the leaflets of the native valve. After the artificial valve is positioned in the native valve, the delivery sheath is retracted to expose the artificial valve. In one embodiment, the delivery sheath is retracted by utilizing a screw (500) that achieves relative movement between the valve catheter and the delivery sheath. The artificial valve is preferably self-expanding. If necessary, the stage balloon can be expanded to firmly place the artificial valve at the site of the native valve. The artificial valve is preferably connected to the valve catheter by a plurality of flexible extension arms (80), which enable the artificial valve to shrink after the initial expansion of the artificial valve, so that the artificial valve can be repositioned if necessary. The defect of the technical solution of the prior art is that when the artificial valve is released into the heart for positioning, the artificial valve needs to be adjusted in the circumferential position so that the positioning of the artificial valve can be more accurate. However, there is no design in the solution of the prior art that can adjust the circumferential position of the artificial valve, which makes it impossible to adjust the positioning position of the valve during positioning, so that the artificial valve must be positioned in the heart in one step, and the error tolerance rate is very low, which greatly increases the risk factor of the operation.

[0005] As mentioned above, existing aortic valve replacement surgeries and devices do not have a design that allows the valve prosthesis to be circumferentially adjusted after the positioning member is released within the heart. Therefore, it is impossible to ensure that the positioning member can be positioned more accurately into the sinus during positioning to reduce the surgical risk.

[0006] Therefore, there is an urgent need in the art for a positioning system for implantable devices such as valves that is simpler to operate, more accurately positioned, has fewer surgical complications, and shortens the operation time. Summary of the Invention

[0007] This application is proposed in view of the above and other more concepts.

[0008] One of the purposes of the present application is to overcome the deficiencies of the prior art and to provide a novel rotatably adjustable positioning device for patients with cardiovascular diseases such as aortic stenosis who require interventional treatment.

[0009] According to another aspect of the present application, a rotatably adjustable positioning device is provided, comprising: a fixing member; a connecting mechanism rotatably connected to a distal side of the fixing member and extending generally longitudinally; and at least one steering wire; wherein the fixing member is provided with a guide channel; one end of the steering wire is connected to the connecting mechanism, and the other end is connected to the steering mechanism through a corresponding guide channel; and wherein the steering wire is operated by the steering mechanism to rotate the connecting mechanism relative to the fixing member, thereby achieving adjustment of the circumferential position of the connecting mechanism and the components associated therewith.

[0010] According to one embodiment, the shape of the fixing element is selected from one of the following: an umbrella shape, a cylinder, a truncated cone, a prism and a sleeve.

[0011] According to an embodiment, the positioning of the guide channel is selected from at least one of the following: the guide channel is located in the fixing element; and the guide channel is provided on the periphery of the fixing element.

[0012] According to an embodiment, the guide channel is a substantially axially extending through-hole, channel, slot or rail provided in the fixture.

[0013] According to one embodiment, the fixing member includes an inner sleeve and an outer sleeve sleeved on the outer circumference of the inner sleeve; wherein the guide channel is provided in at least one of the inner sleeve and the outer sleeve and extends substantially axially; or, the guide channel is formed by the gap between the inner sleeve and the outer sleeve.

[0014] According to one embodiment, the at least one steering wire includes a first steering wire and a second steering wire.

[0015] According to one embodiment, the first steering wire and the second steering wire share a guiding channel; or, the first steering wire and the second steering wire are configured to pass through two independent guiding channels respectively.

[0016] According to one embodiment, one of the following is provided on the periphery of the connection mechanism: first and second connection portions arranged and spaced apart in the circumferential direction; and a single connection portion protruding outward from the periphery of the connection mechanism.

[0017] According to one embodiment, the first connecting part and the second connecting part are small columns, short piles, hooks or bosses protruding outward from the periphery of the connecting mechanism, and one end of the first control line and the second control line are connected to the corresponding first connecting part and the second connecting part by tying, tying, binding or other fixed methods; and wherein the first connecting part and the second connecting part are symmetrically arranged on both sides of the guide channel.

[0018] According to one embodiment, the control mechanism is provided with a winding rod, the first control line passes through the guide channel and is wound around one side of the winding rod in a clockwise or counterclockwise direction, and the second control line passes through the guide channel and is wound around the other side of the winding rod in the opposite counterclockwise or clockwise direction.

[0019] According to one embodiment, a first winding location in the form of a perforation is provided on one side of the winding rod, and a second winding location in the form of a perforation is provided on the other side of the winding rod.

[0020] According to one embodiment, the control mechanism further comprises a hollow outer shell, and a control knob for rotating the winding rod; one end of the winding rod is operably connected to the control knob; and the other end of the winding rod is located in the hollow interior of the outer shell.

[0021] According to one embodiment, when the manipulation mechanism is operated to put the first manipulation wire in a tensioned state, the second manipulation wire is in a relaxed state; and when the manipulation mechanism is operated to put the second manipulation wire in a tensioned state, the first manipulation wire is in a relaxed state.

[0022] According to one embodiment, the variable range of the rotatable adjustable angle of the connecting portion is preset to be between -60° and 60°.

[0023] According to one embodiment, on a cross section of the connecting mechanism perpendicular to the axial direction, the angle formed by two connecting lines between the centers of each of the first connecting part and the second connecting part and the center of the connecting mechanism is α, and the variable range of the angle α is determined by the variable range of the angle of rotation adjustment of the connecting part; and, the angle formed between the steering line from the connecting part to the corresponding guide channel and the center line of the respective guide channel in a tensioned state is β, wherein the angle α changes with the change of the angle β.

[0024] According to one embodiment, the angle α is within the range of 0°<α≤180°, for example, 120°≤α≤150°.

[0025] According to one embodiment, the angle β is in the range of 0︒<β<90︒, for example, 30︒<β<75︒.

[0026] According to one embodiment, the connecting mechanism includes: a connecting device having a generally cylindrical body; a rotating device installed at the proximal end of the connecting device; and a limiting wire; wherein one end of the limiting wire is fixed to the rotating device, and the other end of the limiting wire extends through the connecting device and is detachably connected to the implant prosthesis located at the distal end of the connecting device.

[0027] According to one embodiment, the implanted prosthesis is an artificial heart valve prosthesis, which includes a stent body and a positioning element assembled together.

[0028] According to one embodiment, the artificial heart valve prosthesis is an aortic valve prosthesis, and the number of the positioning elements is three.

[0029] According to one embodiment, the positioning device further includes an inner core tube and a middle sheath tube; wherein the connecting device is sleeved on the outer circumference of the inner core tube, the rotating device is sleeved on the outer circumference of the middle sheath tube, and the middle sheath tube is axially movable relative to the inner core tube.

[0030] According to another aspect of the present application, a rotatably adjustable positioning device is also provided, comprising: a connecting mechanism, a fixing member and a steering wire; a guide channel is provided on the fixing member; one end of the steering wire is connected to the connecting mechanism, and the other end passes through the guide channel; and, manipulating the steering wire can cause the connecting mechanism to rotate circumferentially relative to the fixing member.

[0031] According to one embodiment, two guide channels are provided, and the two guide channels are independent of each other to avoid entanglement of the steering wires.

[0032] According to one embodiment, part of the guide channel is provided inside the fixing element, while part of the guide channel is provided on the periphery of the fixing element.

[0033] According to one embodiment, the guide channel may be a through hole axially arranged on the fixing member.

[0034] According to one embodiment, the through hole is configured as a rounded structure to avoid cutting the steering wire.

[0035] According to one embodiment, a guide rail is provided on the periphery of the fixing member, and the guide channel is provided in the guide rail.

[0036] According to one embodiment, when the positioning device is used for aortic replacement surgery, the artificial heart valve prosthesis includes a stent body and a positioning member. The artificial heart valve prosthesis is pre-positioned by first releasing the positioning member so that the positioning member is positioned at the bottom of the aortic sinus, and then releasing the stent body.

[0037] According to one embodiment, the implanted prosthesis is a vascular stent or a valve clip.

[0038] According to one embodiment, when the implant prosthesis is delivered into the human body and needs to be adjusted circumferentially, the control mechanism can be operated so that the control wire drives the connecting mechanism and further drives the implant prosthesis to rotate circumferentially.

[0039] According to one embodiment, the positioning device includes a limiting wire, the connecting device includes a connecting hole, and the implant prosthesis is provided with a disassembly hole. During pre-installation, the disassembly hole passes through the connecting hole, and one end of the limiting wire passes through the disassembly hole to complete the connection, wherein the other end of the limiting wire extends to the outside of the body for operation.

[0040] According to an embodiment, the steering line is selected from one of the following: a thread, a rope, a cable, a twisted wire, a strand, a metal wire, a flexible ribbon, and any combination thereof.

[0041] According to another aspect of the present application, a rotatably adjustable positioning device is also provided, comprising: a fixing member; a connecting mechanism rotatably connected to the distal side of the fixing member and extending generally longitudinally, wherein a first connecting portion and a second connecting portion are circumferentially arranged and spaced apart on the periphery of the connecting mechanism; a first manipulation line and a second manipulation line, wherein the fixing member is provided with a guide channel, and the first manipulation line and the second manipulation line share a guide channel, or respectively pass through two independent guide channels; wherein one end of the first manipulation line and the second manipulation line are respectively connected to the first connecting portion and the second connecting portion, and their other ends pass through the corresponding guide channels and are connected to the corresponding parts on the manipulation mechanism; wherein, when the manipulation mechanism is operated to put the first manipulation line in a tensioned state, the second manipulation line is in a relaxed state; when the manipulation mechanism is operated to put the second manipulation line in a tensioned state, the first manipulation line is in a relaxed state, so that the connecting mechanism can rotate in two opposite rotational directions relative to the fixing member, thereby realizing the adjustment of the circumferential position of the connecting mechanism and the components associated therewith.

[0042] According to another aspect of the present application, a rotatably adjustable positioning device is also provided, comprising: a fixing member; a connecting mechanism rotatably connected to a substantially longitudinally extending distal end of the fixing member, the connecting mechanism being provided with a single connection point; a single operating wire, wherein the fixing member is provided with a single guide channel; wherein one end of the operating wire is connected to an elastic reset mechanism arranged around a single connection point of the connecting mechanism, and the other end is connected to the operating mechanism through the guide channel; and the operating mechanism operates the operating wire to tighten so as to rotate the connecting mechanism relative to the fixing member, and after the operating wire is released, the elastic reset mechanism causes the connecting mechanism to rotate in the opposite direction.

[0043] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0044] In the prior art, the angle is usually adjusted by controlling and rotating the end of the tube, and the force is transferred to the other end of the tube through rotation. However, the tube will generate a torsional force during the rotation, resulting in inaccurate adjustment. Especially when the tube is longer or faces a complex and twisted vascular morphology, the accuracy of the adjustment will drop sharply, and there will be problems of adjustment delay or even inability to adjust. When adjusting during vascular access, the blood vessels themselves have a certain degree of multiple twists, which further increases the difficulty and timeliness of adjustment, and is not conducive to surgical positioning operations. According to one concept of the present application, the angle formed by the connecting end and the guide channel on the cross section of the fixing part can be adjusted by pulling the control line. The vast majority of the pulling force is concentrated between the guide channel and the connecting end, with minimal loss, and the feedback on the adjustment is very timely and accurate.

[0045] According to one concept of the present application, the control line includes a first control line and a second control line. By operating the control mechanism clockwise, the first control line can drive the connecting mechanism to rotate in a clockwise direction, and when operating the control mechanism counterclockwise, the second control line can drive the connecting mechanism to rotate in a counterclockwise direction. The structure according to this concept is simple, the adjustment is very convenient, and the assembly requirements for the positioning device are low.

[0046] According to one concept of the present application, one end of a first steering wire is connected to a first winding portion, and the other end portion of the first steering wire is wound around a winding rod in a clockwise direction. One end of a second steering wire is connected to a second winding portion, and the other end portion of the second steering wire is wound around a winding rod in a counterclockwise direction. This configuration can meet the requirements for adjusting the implant prosthesis in the circumferential direction and at an angle. At the same time, this design and assembly are simple and low-cost, making it more conducive to mass industrial production with low cost and high reliability.

[0047] According to the above concepts of the technical solution of the present application, as well as other concepts, many technical problems and defects existing in the prior art can be solved. For example, the circumferential position of the valve prosthesis can no longer be accurately adjusted after the positioning member is released, so that the positioning member is not accurately positioned into the sinus. Unrestricted release of the valve prosthesis may cause the stent to deviate or even move out of the expected position when released in the heart, etc.

[0048] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0050] Figure 1a Schematic diagram of a connecting mechanism, a fixing member and a control line according to an embodiment of the present application.

[0051] Figure 1b for Figure 1a Another view of the embodiment shown after being rotated circumferentially by a certain angle.

[0052] Figure 2a -2d is a schematic diagram of different forms of guide channels and their relationship with the steering wires and connecting parts.

[0053] Figure 3a -3b is a schematic diagram of an implant prosthesis positioning device according to an embodiment of the present application.

[0054] Figure 4a -4d is a structural diagram of a control mechanism according to an example of the present application.

[0055] Figure 5a -5g is a schematic diagram of an implant prosthesis positioning device according to another embodiment of the present application.

[0056] Figure 6a -6c is a schematic diagram of another example of the fixing member of the present application.

[0057] Figure 7a -7c is a structural diagram of another embodiment of the present application.

[0058] Figure 8a -8c is a structural diagram of another embodiment of the present application.

[0059] The features indicated by the numbers in the accompanying drawings are as follows:

[0060] 1-connecting mechanism, 11-first connecting part, 12-second connecting part, 13-connecting device, 131-through hole, 14-rotating device, 15-limiting wire, 2-fixing part, 21-guide channel, 22-inner sleeve, 23-outer sleeve, 3-steering wire, 31-first steering wire, 32-second steering wire, 33-elastic recovery mechanism, 4-implanted prosthesis, 41-stent body, 42-positioning part, 5-steering mechanism, 51-outer shell, 52-winding rod, 521-first winding part, 522-second winding part, 53-control knob, 6-inner core tube, 7-middle sheath tube. DETAILED DESCRIPTION

[0061] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0062] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or executed in various ways. Each example is provided in an explanation of the disclosed embodiments, not in a limiting manner. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, a feature illustrated or described as part of one embodiment may be used in conjunction with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0063] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0064] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0065] In the present application, the term “proximal end” or “proximal side” refers to an end or side closer to a surgical operator, and “distal end” or “distal side” refers to an end or side farther from a surgical operator.

[0066] In the prior art, the angle is usually adjusted by controlling and rotating the end of the tube, and then transferring force to the other end of the tube through rotation. The tube generates a torsional force during rotation, resulting in inaccurate adjustment. Especially when the tube is long or faces a complex and twisted blood vessel, the accuracy of adjustment is drastically reduced, and there may even be problems with delayed adjustment or inability to adjust. Moreover, when performing tube adjustment during vascular access, the blood vessels themselves have a certain degree of multiple twists, which further increases the difficulty and delay of adjustment, making it difficult to perform positioning operations.

[0067] One purpose of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems.

[0068] Example 1

[0069] like Figure 1a 1b shows a rotatably adjustable positioning device for aortic valve surgery according to an embodiment of the present application, comprising a fixing member 2, a connecting mechanism 1 rotatably connected to the distal side of the fixing member 2 and extending substantially longitudinally, and a control line 3 in a flexible form such as a thread, rope, cable, twisted wire, strand, wire, flexible belt, etc. The fixing member 2, which may be substantially in the shape of an umbrella, is provided with a guide channel 21, which may be in the form of a through hole, a channel, etc. Figure 2a As shown. Figure 1a As shown in FIG1b, one end of the steering wire 3 is connected to the connecting mechanism 1, for example, bolted, tied or wrapped around the connecting end 16 of the connecting mechanism 1, while the other end thereof extends through the guide channel 21 of the fixing member 2 and is operably connected to the steering mechanism 5. A connecting portion may be provided at the connecting end 16, for example, a small column or short pile, for example, which protrudes radially, in order to facilitate bolting, tying or wrapping the steering wire 3. The figure shows two such connecting portions in the form of small columns or short piles arranged circumferentially along the main body of the connecting mechanism 1, which will be described in detail below. In this way, for example, by pulling the steering wire 3, the connecting mechanism 1 can be moved circumferentially relative to the fixing member 2, for example, rotated. In this embodiment, by pulling the steering wire 3, the angle α formed by the connecting end 16 and the guide channel 21 on the cross section of the connecting mechanism 1 perpendicular to the axial direction can be adjusted (such as Figure 2d As shown in FIG. 1 , the pulling force is mostly concentrated on the control line 3 between the guide channel 21 and the connection end 16 . Therefore, the loss of the control line 3 and the entire device is minimal, and the feedback of the pulling adjustment action is very timely and highly accurate.

[0070] In this embodiment, as one of the preferred examples, the guide channel 21 can be set as a through hole or channel passing through the main body of the fixing member 2, which generally extends along the preset direction of the pulling control line 3, such as Figure 2a As shown, it extends substantially axially, for example.

[0071] As another example, the guide channel 21 may be provided on the periphery of the fixing member 2 having a generally cylindrical body, such as Figure 2b As shown, this is in the form of an axially extending passageway passing between two circumferentially spaced radially projecting bosses of the generally cylindrical body of the fixture 2 .

[0072] As another example, the guide channel 21 is in the form of Figure 2a The guide channel and Figure 2b The combination of guide channels shown, wherein each accommodates a portion of the steering wire 3 so that it is guided and pulled during operation. In this example, the number of guide channels 21 can be two, and the two guide channels 21 are independent of each other to avoid the entanglement of the steering wire 3 during operation.

[0073] In this embodiment, the positioning device may further include an implant prosthesis 4 and a control mechanism 5. The implant prosthesis 4 may be connected to the distal end or distal side of the connection mechanism 1 and may rotate therewith. The other end of the control wire 3, i.e., the end designed to be connected to the control mechanism 5, extends through the guide channel 21 and connects to the control mechanism 5 (e.g., Figure 4a Thus, an operator, such as a surgeon, can manipulate the manipulation mechanism 5 to facilitate winding (tensioning) and releasing (relaxing) the manipulation wire 3, thereby manipulating the connection mechanism 1 connected to the manipulation wire 3 to rotate circumferentially relative to the fixing member 2.

[0074] According to one example, the control mechanism 5 may include an outer housing 51, a winding rod 52 and a control knob 53 assembled together. Figure 4a -4d. 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 arranged inside the hollow outer shell 51. The control line 3 can be wound on the winding rod 52. For example, the winding rod 52 can be provided with a first winding portion 521 and a second winding portion 522, such as a perforated form. Figure 4d The first control cable 31 is secured to the first winding portion 521 by, for example, tying, binding, or adhering, and is wound around the winding rod 52 in a clockwise or counterclockwise direction (for example, it may be wound several turns around the first winding portion 521). The second control cable 32 is similarly secured to the second winding portion 522 by, for example, tying, binding, or adhering, and is wound around the winding rod 52 in a direction opposite to the winding direction of the first control cable 31, i.e., counterclockwise or clockwise (for example, it may be wound several turns around the second winding portion 522).

[0075] When the control knob 53 is rotated clockwise, the first control wire 31 is in a tensioned (wound) state and further drives the connecting mechanism 1 connected thereto to rotate, for example, clockwise, while the second control wire 32 is in a relaxed (released) state.

[0076] When the control knob 53 is rotated counterclockwise, the second control wire 32 is in a tensioned (wound) state and further drives the connecting mechanism 1 connected thereto to rotate, for example, counterclockwise, while the first control wire 31 is in a relaxed (released) state.

[0077] According to one example, the connection mechanism 1 may include a connection device 13 having a generally cylindrical body, a rotation device 14 mounted at the proximal end of the connection device 13, and a restriction wire 15. One end of the restriction wire 15 is fixed to the rotation device 14, for example, bolted or tied to the rotation device 14; the other end of the restriction wire 15 passes through a through hole 131 on the connection device 13 and is detachably connected to the implant prosthesis 4 at the distal end of the connection device 13, as shown in FIG. Figure 3a -3b.

[0078] The implanted prosthesis 4 may be an artificial heart valve prosthesis, and the artificial heart valve prosthesis may include a stent body 41 and a positioning member 42 assembled together, such as Figure 3a and 5b.

[0079] According to one example, the pre-positioning of the artificial heart valve prosthesis can be completed by first releasing the positioning member 42 to position it at the bottom of the aortic sinus, and then releasing the stent body 41 in a subsequent surgical procedure.

[0080] During the operation, when the implant prosthesis 4 needs to be adjusted circumferentially during the process of being delivered into the human heart, the surgeon can operate the control knob 53 of the control mechanism 5 to drive the control wire 3 wound on the winding rod 52, such as Figure 4a -4d, the manipulation 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 implant prosthesis 4 connected to the connecting mechanism 1 to rotate circumferentially, as described in detail below.

[0081] During the surgical operation, the connecting mechanism 1 is provided with a first connecting portion 11 and a second connecting portion 12 at the connecting end 16, for example in the form of a short pile or a small column. Figure 3a As shown. The control wire 3 is connected to the first connecting portion 11 and the second connecting portion 12, for example, by means of a bolt or tie. When the first control wire 31 pulls the first connecting portion 11 to rotate circumferentially, the implant 4 connected to the connecting mechanism 1 can rotate circumferentially, for example, in a clockwise direction. When the second control wire 32 pulls the second connecting portion 12 to rotate circumferentially, the implant 4 connected to the connecting mechanism 1 can rotate circumferentially, for example, in a counterclockwise direction.

[0082] On a cross section of the connecting mechanism 1 perpendicular to the axial direction, the angle formed by the two lines connecting the centers of the first connecting part 11 and the second connecting part 12 and the center of the connecting mechanism 1 is α, and the variable range of the angle α is determined by the variable range of the rotatable adjustable angle of the connecting part 11.

[0083] According to an example, the angle α is within the range of 0︒<α≤180︒, for example, 120︒≤a≤150︒.

[0084] Because the aortic sinus has three sinus floors, evenly distributed around the circumference, the angle between adjacent sinus floors and the line connecting the aortic valve center is approximately 120°. The implant prosthesis 4 is provided with three positioning members 42, matching the number of the aortic sinus floors. As described above, the surgeon manipulates the control mechanism 5 to conveniently and precisely rotate the implant prosthesis 4 clockwise or counterclockwise, for example, to position the positioning members 42 at the corresponding sinus floors. The maximum counterclockwise or clockwise rotation angle of the positioning members 42 during delivery into the heart is approximately 60°, so a preferred value for the angle α is approximately 120°.

[0085] According to one example, when viewed in a cross section perpendicular to the axial direction of the fixing member 2, the first connecting portion 11 and the second connecting portion 12 are arranged symmetrically about the center of the guide channel 21. This arrangement ensures that the implant prosthesis 4 can be conveniently and accurately adjusted to the ideal implant position as needed, whether in the counterclockwise or clockwise direction.

[0086] According to one example, the positioning device may further include an inner core tube 6 and a middle sheath tube 7. Figure 3b As shown, the connecting device 13 is sleeved on the outer circumference of the inner core tube 6, and the rotating device 14 is sleeved on the outer circumference of the middle sheath tube 7, and the middle sheath tube 7 can move axially relative to the inner core tube 6. The middle sheath tube 7 can be assembled and disassembled with the connecting device 13 by axially moving the middle sheath tube 7 toward the proximal end relative to the inner core tube 6.

[0087] The operation process of the positioning device includes the following steps.

[0088] 1) Operate the positioning device to enter the heart through the vascular approach, and then release the positioning member 42 on the implant prosthesis 4 to the desired position in the heart, such as Figure 5a and 5b.

[0089] 2) Observe the current position of the positioning member 42 relative to the aortic sinus. If the position does not reach the ideal expected position, the surgeon can operate the control mechanism 5 to pull the corresponding control wire 3, so that the control wire 3 drives the rotating device 14 of the connecting mechanism 1 connected thereto to rotate. The rotation of the rotating device 14 in turn drives the limiting wire 15 connected to the rotating device 14 to rotate. The limiting wire 15 in turn drives the connecting device 13 connected thereto and the implanted prosthesis 4 to rotate together, thereby adjusting the position of the positioning member 42 of the implanted prosthesis 4, thereby finally positioning the positioning member 42 to the ideal expected position of the sinus floor, such as Figure 5c shown.

[0090] 3) When the positioning member 42 reaches the desired position at the sinus floor, Figure 5d As shown, the stent body 41 is further released into place. Afterwards, the positioning device is removed and the implantation operation is completed. Figure 5e -5g shown.

[0091] Example 2

[0092] The second embodiment is substantially the same as the first embodiment, except that it has a fixing member with a different structure.

[0093] like Figure 6a As shown, a rotatably adjustable positioning device that can be used for aortic valve surgery is illustrated, including a fixing member 2, a connecting mechanism 1 that is rotatably connected to the distal side of the fixing member 2 and extends generally longitudinally, and a flexible steering line 3 such as a silk thread, rope, cable, strand, wire, etc.

[0094] In the second embodiment, the fixing member 2 includes an inner sleeve 22 and an outer sleeve 23 which is sleeved on the outer periphery of the inner sleeve 22. A guide channel 21 in the form of a through hole, channel or groove extending substantially axially is provided in the fixing member 2. Figure 6b As shown, the guide channel 21 can be an axially extending groove provided at the inner sleeve 22 and located between the inner sleeve 22 and the outer sleeve 23, so as to facilitate the passage of the control line 3 therethrough. Figure 6c As shown, the guide channel 21 can be an axially extending groove provided at the outer sleeve 23 and located between the inner sleeve 22 and the outer sleeve 23, so as to facilitate the passage of the control line 3 therethrough.

[0095] Generally similar to the embodiment, one end of the control wire 3 is connected to the connecting mechanism 1, for example, by being bolted, tied, or wrapped around the connecting end 16 of the connecting mechanism 1, and the other end extends through the guide channel 21 in the fixing member 2 and is operably connected to the control mechanism 5. Thus, by manipulating the fixing member 5, the control wire 3 can be pulled, thereby causing the rotating device 14 of the connecting mechanism 1 connected thereto to rotate circumferentially relative to the fixing member 2. The rotating device 14, in turn, drives the restraining wire 15 connected thereto to rotate. The restraining wire 15, in turn, drives the connected connecting mechanism 13 and the implant 4 to rotate together, thereby adjusting the position of the positioning member 42 of the implant 4, thereby ultimately positioning the positioning member 42 to the desired desired position at the sinus floor.

[0096] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0097] Example 3

[0098] The third embodiment is substantially the same as the first embodiment, except that this embodiment adopts a single connecting portion 11 , a single steering wire 3 and two guide channels 21 .

[0099] like Figure 7a As shown, a rotatably adjustable positioning device that can be used for aortic valve surgery is illustrated, including a fixing member 2, a connecting mechanism 1 that is rotatably connected to the distal side of the fixing member 2 and extends generally longitudinally, and a flexible steering line 3 such as a silk thread, rope, cable, strand, wire, etc.

[0100] In the third embodiment, the guide channel 21 can be configured as a through hole or channel passing through the main body of the fixing member 2, which generally extends along the preset direction of the pulling control line 3, such as Figure 7a As shown, it extends substantially axially, for example.

[0101] In the third embodiment, the number of guide channels 21 may be two, and the two guide channels 21 are independent of each other to avoid entanglement of the control wire 3 during operation (in the present embodiment, there is also a preset angle between the two guide channels).

[0102] In the third embodiment, the variable range of the rotatable angle of the connecting portion 11 is preset to be between -60° and 60°.

[0103] In the third embodiment, the control wire 3 from the connection portion 11 to the corresponding guide channel 21 forms an angle β with the center line of the respective guide channel 21 in a tensioned state, and the angle β is within the range of 0︒<β<90︒, for example, 30︒<β<75︒.

[0104] In the third embodiment, Figure 7b As shown, the steering wire 3 is a single wire that is cooperatively connected to the connecting portion 11. The connection method can be tying, tying, binding, or other fixed methods. One end of the steering wire 3 passes through the first guide channel 211, and the other end of the steering wire 3 passes through the second guide channel 212. At the same time, both ends of the steering wire 3 are operably connected to the steering mechanism 5. In this way, by manipulating the steering mechanism 5, the steering wire 3 can be pulled, thereby causing the rotating device 14 of the connecting mechanism 1 connected thereto to rotate circumferentially relative to the fixing member 2. The rotating device 14 in turn drives the limiting wire 15 connected to the rotating device 14 to rotate. The limiting wire 15 in turn drives the connecting device 13 connected thereto and the implanted prosthesis 4 to rotate together, thereby adjusting the position of the positioning member 42 of the implanted prosthesis 4, thereby ultimately positioning the positioning member 42 to the ideal expected position at the sinus floor.

[0105] In this regard, the relevant structure and concept of the third embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0106] Example 4

[0107] The fourth embodiment is substantially the same as the fourth embodiment, except that this embodiment adopts a single connecting portion 11 , a single guiding channel 21 and a single control wire 3 , and the control wire 3 includes an elastic reset mechanism.

[0108] like Figure 8a As shown, a rotatable and adjustable positioning device that can be used for aortic valve surgery is shown, including a fixing member 2; a connecting mechanism 1 that is rotatably connected to the distal end of the fixing member 2 and extends generally longitudinally, and a single connecting portion 11 is provided on the connecting mechanism 1; a single steering wire 3, wherein the fixing member 2 is provided with a single guide channel 21; wherein one end of the steering wire 3 is connected to an elastic reset mechanism 33 arranged around the single connecting portion 11, and the other end is connected to the steering mechanism 5 through the guide channel 21; and wherein the steering wire 3 is tightened by the steering mechanism 5 to rotate the connecting mechanism 1 relative to the fixing member 2, and after the steering wire 3 is loosened, the elastic reset mechanism 33 causes the connecting mechanism 1 to rotate in the opposite direction.

[0109] In the fourth embodiment, the elastic force restoring mechanism 33 can be configured as a spring or other components with elastic force restoring function.

[0110] In the fourth embodiment, the guide channel 21 can be configured as a through hole or channel passing through the main body of the fixing member 2, which generally extends along the preset direction of the pulling control line 3, such as Figure 7a As shown, it extends substantially axially, for example.

[0111] In the fourth embodiment, Figure 8b and Figure 8c As shown, the control wire 3 is a single wire that is coupled to the connecting portion 11. This connection can be achieved by tying, tying, binding, or other fixed methods. One end of the control wire 3 is connected to the connecting portion 11, and the elastic return mechanism 33 of the control wire 3 is wound around the connecting mechanism 1. The other end of the control wire 3 passes through the guide channel 21 and is operably connected to the control mechanism 5. Thus, by manipulating the control mechanism 5, the control wire 3 can be pulled, causing the rotating device 14 of the connecting mechanism 1 to rotate circumferentially relative to the fixed member 2. The rotating device 14, in turn, drives the restraining wire 15 connected to the rotating device 14 to rotate. The restraining wire 15, in turn, drives the connected connecting device 13 and the implant 4 to rotate together, thereby adjusting the position of the positioning member 42 of the implant 4. Furthermore, when the rotation angle needs to be adjusted in the opposite direction, the control wire 3 can be simply released. Due to the elastic restoring force of the elastic return mechanism 33 of the control wire 3, the control wire 3 can be rotated in the opposite direction to adjust a certain angle, thereby ultimately positioning the positioning member 42 at the desired desired position at the sinus floor.

[0112] In this regard, the relevant structure and concept of the fourth embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0113] The foregoing description of several embodiments of the present application has been presented for illustrative purposes. It is not intended to be exhaustive or to limit the present application to the precise configurations, configurations, and / or steps disclosed, and it is apparent that many modifications and variations are possible in light of the above teachings. It is intended that the scope of the invention and all equivalents thereof be defined by the appended claims.

Claims

1. A rotatable positioning device, characterized in that: include: fixings; a generally longitudinally extending connection mechanism rotatably connected distally to the fixing member; and at least one steering wire; wherein the fixing piece is provided with a guide channel; one end of the steering wire is connected to the connecting mechanism, and the other end passes through the corresponding guide channel to be connected to the steering mechanism; and wherein the steering wire is operated by the steering mechanism to rotate the connecting mechanism relative to the fixing piece, thereby adjusting the circumferential position of the connecting mechanism and the components associated therewith; the connecting mechanism comprises: a connecting device having a generally cylindrical body; a rotating device installed at the proximal end of the connecting device; and a limiting wire; wherein one end of the limiting wire is fixed to the rotating device, and the other end of the limiting wire extends through the connecting device and is detachably connected to the implant prosthesis located at the distal end of the connecting device; the shape of the fixing piece is selected from one of the following: umbrella-shaped, cylindrical, truncated cone, prism.

2. The positioning device according to claim 1, wherein: The positioning of the guide channel is selected from at least one of the following: the guide channel is located in the fixing member; and the guide channel is provided on the periphery of the fixing member.

3. The positioning device according to claim 1, wherein: The guide channel is a substantially axially extending through-hole provided in the fixing member.

4. The positioning device according to claim 3, wherein: The fixing member includes an inner sleeve and an outer sleeve sleeved on the outer circumference of the inner sleeve; wherein the guide channel is provided in at least one of the inner sleeve and the outer sleeve and extends substantially axially; or, the guide channel is formed by a gap between the inner sleeve and the outer sleeve.

5. The positioning device according to claim 4, wherein: The at least one steering wire includes a first steering wire and a second steering wire.

6. The positioning device according to claim 5, wherein: The first steering wire and the second steering wire share one guiding channel; or, the first steering wire and the second steering wire are configured to pass through two independent guiding channels respectively.

7. The positioning device according to claim 6, wherein: One of the following is provided on the outer circumference of the connecting mechanism: a first connecting portion and a second connecting portion that are circumferentially arranged and spaced apart; and a single connecting portion that protrudes outward from the outer circumference of the connecting mechanism.

8. The positioning device according to claim 7, wherein: The first connecting part and the second connecting part are hooks or bosses protruding outward from the outer periphery of the connecting mechanism, and one end of the first steering line and the second steering line are respectively connected to the corresponding first connecting part and the second connecting part in a tied manner; and wherein the first connecting part and the second connecting part are symmetrically arranged on both sides of the guide channel.

9. The positioning device according to claim 8, wherein: The control mechanism is provided with a winding rod, the first control wire passes through the guide channel and is wound on one side of the winding rod in a clockwise or counterclockwise direction, and the second control wire passes through the guide channel and is wound on the other side of the winding rod in a counterclockwise or clockwise direction opposite to the winding direction of the first control wire.

10. The positioning device according to claim 9, wherein: A first winding location in the form of a perforation is provided on the one side of the winding rod, and a second winding location in the form of a perforation is provided on the other side of the winding rod.

11. The positioning device according to claim 10, wherein: The control mechanism further includes a hollow outer shell, and a control knob for rotating the winding rod; wherein one end of the winding rod is operably connected to the control knob; and the other end of the winding rod is located in the hollow interior of the outer shell.

12. The positioning device according to claim 11, wherein: When the manipulation mechanism is operated to put the first manipulation wire in a tensioned state, the second manipulation wire is in a relaxed state; and when the manipulation mechanism is operated to put the second manipulation wire in a tensioned state, the first manipulation wire is in a relaxed state.

13. The positioning device according to claim 12, wherein: The variable range of the rotatable angle of the connecting portion is preset to be between -60° and 60°.

14. The positioning device according to claim 1, wherein The positioning device further includes an inner core tube and a middle sheath tube; and wherein the connecting device is sleeved on the outer circumference of the inner core tube, the rotating device is sleeved on the outer circumference of the middle sheath tube, and the middle sheath tube is axially movable relative to the inner core tube.

15. The positioning device according to claim 1, wherein The control line is made of silk thread.

16. The positioning device according to claim 1, wherein The control line is a flexible belt.

17. A rotatable positioning device, characterized in that: include: a fixing member and a control mechanism; a connecting mechanism rotatably connected to a substantially longitudinally extending distal end of the fixing member, wherein a first connecting portion and a second connecting portion are provided on the outer periphery of the connecting mechanism and are circumferentially arranged and spaced apart; a first control wire and a second control wire, wherein the fixing member is provided with a guide channel, and the first and second control wires share the same guide channel, or respectively pass through two independent guide channels; wherein one end of the first and second control wires are respectively connected to the first and second connecting portions, and their other ends pass through the corresponding guide channels and are connected to corresponding parts of the control mechanism; wherein, when the control mechanism is operated to put the first control wire in a tensioned state, the second control wire is in a relaxed state; and when the control mechanism is operated to put the second control wire in a tensioned state, the first control wire is in a relaxed state, so that the connecting mechanism can rotate relative to the fixing member in two opposite rotational directions, thereby achieving adjustment of the circumferential position of the connecting mechanism and the components associated therewith; the connecting mechanism comprises: a connecting device having a substantially cylindrical body; A rotating device mounted at the proximal end of the connecting device; and a limiting wire; wherein one end of the limiting wire is fixed to the rotating device, and the other end of the limiting wire extends through the connecting device and is detachably connected to the implant prosthesis located at the distal end of the connecting device.

18. A rotatable positioning device, characterized in that: include: and a control mechanism; a connecting mechanism rotatably connected to a substantially longitudinally extending distal end of the fixing member, the connecting mechanism being provided with a single connection point; a single steering wire, wherein the fixing member is provided with a single guide channel; wherein one end of the steering wire is connected to an elastic reset mechanism arranged around the single connection point, and the other end passes through the guide channel and is connected to the control mechanism; and wherein the control mechanism operates the steering wire to tighten so as to rotate the connecting mechanism relative to the fixing member, and after loosening the steering wire, the elastic reset mechanism causes the connecting mechanism to rotate in the opposite direction; the connecting mechanism comprises: a connecting device having a substantially cylindrical body; a rotating device mounted at the proximal end of the connecting device; and a limiting wire; wherein one end of the limiting wire is fixed to the rotating device, and the other end of the limiting wire extends through the connecting device and is detachably connected to an implanted prosthesis located at the distal end of the connecting device.

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