Conveying device and artificial valve

By in series with the bracket in the conveying device, the anchor is arranged asynchronously and coaxially, and by using the coordination of the limiting member and the propeller, the controllable release and positioning of the anchor is achieved, and the increase in the diameter of the conveying system in the prior art is solved. Problem, improving the convenience and anchoring stability of artificial valves through blood vessels, reducing the risk of vascular complications.

CN119174661APending Publication Date: 2024-12-24SHANGHAI HEALING MEDICAL DEVICES CO LTD
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Patent Information

Application Number
CN202310753333.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-06-21
Publication Date
2024-12-24

AI Technical Summary

Technical Problem

When existing aortic valve regurgitation indication products lack calcification anchoring zones, the anchoring structure leads to an increase in the diameter of the delivery system, making it difficult to access through the vascular system, increasing the risk of vascular complications and reducing the safety of device use.

Method used

Design a conveying device, by connecting the anchor with the bracket asynchronously and coaxially, using the push component to drive the anchor to move the anchor in the direction of the bracket, realize the concentric sleeve of the anchor, reduce the diameter of the conveying system, and pass the limiting member. The cooperation with the propeller realizes controllable release and positioning of the anchor, and the protective sleeve prevents the anchor from contacting the airbag member directly.

Benefits of technology

The compression diameter of the artificial valve is minimized, the process of passing through blood vessels is simplified, the stability and safety of the anchors are improved, the risk of vascular complications is reduced, and the safety of the device is enhanced.

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Abstract

The invention provides a conveying device and an artificial valve, the conveying device is used for conveying the artificial valve, the artificial valve comprises an anchoring part and a support, the conveying device comprises a conveying part and a pushing assembly, the anchoring part and the support are suitable for being placed on the conveying part, and the anchoring part and the support are connected in series, asynchronously and coaxially arranged; the pushing assembly is arranged on the conveying piece in a sleeving mode, the pushing assembly is connected with the anchoring piece, and the pushing assembly is configured to drive the anchoring piece to move towards the support under the action of external force till the anchoring piece is arranged on the peripheral side of the support in a sleeving mode, so that coaxial and concentric sleeving is achieved; the total compression diameter of the artificial valve can be minimized, the diameter of a conveying system is reduced, the valve can pass through a blood vessel more smoothly, the anchoring piece and the support can be sequentially connected in series along the axis and are asynchronously and coaxially arranged, the outer diameter of overall loading is reduced, and conduction block is reduced.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a delivery device and an artificial valve. Background Art

[0002] The artificial valve is generally installed in a compressed state in the loading section and advanced through the patient's circulatory system until the artificial valve reaches the implantation site. Then, the artificial valve expands to its functional size at the site of the defective natural valve. The artificial valve can have a self-expanding stent or a balloon-expandable stent. The actual shape and configuration of any particular transcatheter artificial valve depends to some extent on the problem and characteristics of the valve being repaired (i.e., the aortic valve, mitral valve, tricuspid valve or pulmonary valve).

[0003] In the existing treatment plan, the artificial valve relies on radial support force to abut against the calcified part of the human aortic valve, and then expands from the central axis to the surrounding area, anchored at the native valve leaflets, replaces the native valve work, and restores normal blood flow at the aortic valve. However, for mildly calcified aortic valve stenosis or simple aortic valve regurgitation symptoms, there are fewer or no calcified parts at the aortic valve, the leaflets are relatively soft, and lack anchoring areas, which cannot provide sufficient support for the artificial aortic valve. The anchoring strength of existing artificial valves is difficult to meet expectations. After the artificial aortic valve is implanted, it cannot be firmly anchored at the native leaflets and is prone to falling off.

[0004] The above problems are common situations encountered in the off-label treatment of aortic regurgitation. Currently, all products for aortic regurgitation indications contain a special anchoring structure, which provides radial centripetal force and works together with the radial centrifugal force of the valve body to clamp the native valve leaflets and achieve an anchoring effect. Therefore, compared with stenosis indications, regurgitation indication devices are able to anchor the valve in the absence of a calcified anchoring area. However, the introduction of the anchoring structure may cause the diameter of the entire delivery system to increase. Cases with a smaller vascular access diameter cannot use devices with a delivery system that is too large in diameter. Even if the delivery system can be punctured into the patient's circulatory system, the larger diameter will make it more difficult for the valve to pass through the vascular access, which will correspondingly increase vascular complications and reduce the safety of device use. Summary of the invention

[0005] Therefore, the technical problem to be solved by the present invention is that all products for aortic regurgitation indication in the prior art contain a special anchoring structure, which provides radial centripetal force, and works together with the radial centrifugal force of the valve body to clamp the native valve leaflets and achieve an anchoring effect. Therefore, compared with stenosis indications, regurgitation indication devices are able to anchor the valve in the absence of a calcified anchoring area. However, the introduction of the anchoring structure may cause the diameter of the entire delivery system to increase. Cases with a smaller vascular access diameter cannot use devices with a delivery system that is too large in diameter. Even if the delivery system can be punctured into the patient's circulatory system, the larger diameter will increase the difficulty of the valve passing through the vascular access, which will correspondingly increase vascular complications and reduce the safety of device use.

[0006] To this end, the present invention provides a delivery device for delivering an artificial valve, wherein the artificial valve comprises an anchor and a stent, and the device comprises:

[0007] A conveying member, on which an anchor member and a stent are placed, and the anchor member and the stent are asynchronously and coaxially arranged in series;

[0008] A pushing component is sleeved on the conveying member, the pushing component is connected to the anchoring member, and the pushing component is configured to drive the anchoring member to move toward the bracket under the action of an external force until the anchoring member and the bracket are coaxially and concentrically sleeved.

[0009] Optionally, the push component includes:

[0010] A limiting member, sleeved on the conveying member, and provided with a limiting portion;

[0011] The propulsion member is provided with a wrapping structure on one side close to the limiting member, and the wrapping structure is configured to wrap around the limiting portion so that a limiting space suitable for fixing the proximal end of the anchor member is formed between the wrapping structure and the limiting portion.

[0012] Optionally, the propulsion member is configured to move relative to the limiting member under the action of an external force, so that the wrapping structure is separated from the peripheral side of the limiting portion to release the anchoring member.

[0013] Optionally, the limiting portion is a plurality of through holes provided on the limiting member, and the fixing head on the anchoring member is arranged in the through holes.

[0014] Optionally, the limiting member is fixed or relatively fixed to the pushing member.

[0015] Optionally, the conveying device further comprises an airbag component, which is arranged at the distal end of the conveying component, and the stent is sleeved on the surface of the airbag component, and the airbag component is configured to be inflated to drive the stent to expand.

[0016] Optionally, the conveying device further comprises a protective sleeve which is sleeved on the conveying member, wherein the protective sleeve is arranged at the proximal end of the stent or covers the surface of the stent, and the anchoring member is configured to be pushed by the pushing assembly, passing through the surface of the protective sleeve to the surface of the stent.

[0017] Optionally, the conveying device also includes a protective cover fixed to the pushing assembly, the anchor member is sleeved on the surface of the protective cover, and the protective cover is configured to be driven by the pushing assembly and cover the surface of the airbag member until the anchor member is sleeved on the surface of the bracket.

[0018] Optionally, a limiting member in the pushing assembly is fixed to the protective sleeve;

[0019] Or the limiting member in the pushing assembly is relatively fixed to the protective cover to limit the movement range of the protective cover.

[0020] Optionally, the distal end of the protective sleeve protrudes beyond the proximal end thereof.

[0021] Optionally, the pushing component is sleeved on the surface of the protective sleeve.

[0022] An artificial valve comprises an anchor and a stent. The artificial valve is transported by the above-mentioned transport device. The anchor and the stent are sleeved on the surface of the transport member in the transport device.

[0023] Optionally, the anchoring member comprises:

[0024] The main body is annular and includes a plurality of connecting ribs;

[0025] A limiting protrusion is provided at the distal end of the body;

[0026] A developing member, arranged outside the connecting rib;

[0027] The delivery device is suitable for being connected to the body to limit the body to be in a compressed state, and the body is configured to enter a released state after being separated from the delivery device.

[0028] Optionally, the artificial valve further comprises a connecting wire, one end of which is slidably connected to the connecting rib, and the other end of which is connected to the stent.

[0029] Optionally, the connecting wire is connected to the middle portion of the stent, or the connecting wire is connected to the proximal portion of the stent.

[0030] Optionally, the connecting wire is braided from a single strand or multiple strands of silk thread, and a connecting ring is provided at one end of the connecting wire close to the anchor, or rings are provided at both ends of the connecting wire.

[0031] Optionally, the connecting wire outer sleeve is provided with a sleeve.

[0032] Optionally, a developing wire is provided on the connecting wire.

[0033] Optionally, the anchoring member further comprises:

[0034] A fixing head connected to the proximal end of the body, the fixing head being suitable for connecting to the conveying device;

[0035] An extension arm connected between the fixing head and the body;

[0036] A limiting track is arranged inside the connecting rib;

[0037] Wherein, the connecting wire is slidably connected to the limiting track.

[0038] The present invention provides a delivery device and an artificial valve, which have the following advantages:

[0039] 1. The present invention provides a conveying device for conveying an artificial valve, wherein the artificial valve includes an anchor and a stent. The device includes a conveying member and a pushing assembly, wherein the conveying member is suitable for placing the anchor and the stent, and the anchor and the stent are asynchronously coaxially arranged in series; a pushing assembly, which is sleeved on the conveying member, and the pushing assembly is connected to the anchor, and the pushing assembly is configured to drive the anchor to move toward the stent under the action of an external force until the anchor is sleeved on the periphery of the stent.

[0040] The delivery device of this structure is configured such that the anchor and the stent are asynchronously and coaxially arranged in series on the delivery member, and the pushing assembly on the delivery member is connected to the anchor to drive the anchor to move toward the stent until the anchor is sleeved around the stent. This can minimize the overall compressed diameter of the artificial valve and reduce the diameter of the delivery system, so that the valve can pass through the blood vessel more smoothly. At the same time, a pushing assembly is provided to connect the series-connected anchor and the stent to form a structure in which the anchor is located outside the stent. At this time, the anchor and the stent are concentrically sleeved to facilitate the anchoring of the artificial valve.

[0041] 2. The present invention provides a conveying device, wherein the pushing assembly comprises a limiter and a pusher, wherein the limiter is sleeved on the conveying member, and the limiter is provided with a limiter portion; the pusher is provided with a wrapping structure on one side close to the limiter, and the wrapping structure is configured to wrap around the limiter portion, so that a limit space suitable for fixing the proximal end of the anchor is formed between the wrapping structure and the limiter portion. The pusher is configured to move relative to the limiter under the action of an external force, so that the wrapping structure is separated from the limiter portion to release the anchor.

[0042] In the delivery device of this structure, three fixing heads are arranged at the proximal end of the anchor, and the anchor is made of memory metal. During installation, the three fixing heads are placed in three through grooves (limiting parts) on the surface of the limiting part, and then the pusher is pushed to move toward the limiting part alone until the wrapping structure is wrapped around the limiting part, thereby fixing the three fixing heads in the three through grooves. When releasing the anchor, the pusher is pushed to move away from the limiting part until the wrapping structure is separated from the limiting part. Since the anchor is made of memory metal, the three fixing heads can be separated from the three through grooves by themselves, thereby releasing the anchor.

[0043] 3. The present invention provides a conveying device, which also includes a protective sleeve, which is sleeved on the conveying member, and the protective sleeve is arranged at the proximal end of the airbag member. The anchoring member is configured to be pushed by the pushing assembly, passing through the surface of the protective sleeve to the surface of the bracket.

[0044] In the delivery device of this structure, the distal end of the protective cover is sleeved on the surface of the proximal part of the airbag. Since the anchor will move toward the airbag under the push of the pushing assembly until it moves to the outer surface of the airbag, in order to prevent the anchor from causing damage to the airbag during the movement, a protective cover is set on the proximal part of the airbag, and the distal end of the protective cover protrudes from the proximal end. Figure 2 As shown, when the anchor is pushed, the distal end of the anchor will protrude beyond the distal end of the protective sleeve and then reach the surface of the airbag, which can avoid direct contact between the anchor and the proximal end of the airbag and prevent the anchor from piercing the airbag during movement.

[0045] 4. The present invention provides an artificial valve, and the developing device assists the operator to quickly and accurately determine the front and back positions of the three coronary sinuses of the aortic valve in the projection direction angle through the different developing shapes of the three positioning claws (limiting protrusions), so as to realize the autonomous positioning of the anchor. Specifically, when the anchor locates the sinus bottom, the position of the anchor is adjusted, and the developing structure shown when the anchor correctly enters the sinus bottom is used as the standard. When the anchor enters the sinus bottom, the cross-valve angle is determined, and the different developing shapes of the three positioning claws assist the operator to quickly and accurately determine the front and back positions of the three sinuses in the projection direction angle, so as to realize the autonomous positioning of the anchor.

[0046] 5. The present invention provides an artificial valve. After the anchor is positioned at the sinus floor and before the stent is expanded, if the implantation depth of the stent needs to be adjusted, the anchor is pushed to continue to move distally. Under the support force of the sinus floor on the anchor, the strip-shaped through groove of the connecting wire on the anchor slides from the direction of the extension arm to the direction of the limiting protrusion, so that the position of the stent relative to the anchor can be made deeper, thereby realizing the readjustment of the implantation depth of the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0048] Figure 1 It is a schematic structural view of a delivery device and a delivery device in an artificial valve provided in an embodiment of the present invention;

[0049] Figure 2 It is a schematic structural view of a delivery device and an artificial valve provided in an embodiment of the present invention;

[0050] Figure 3 It is a schematic structural view of another state of the delivery device and the delivery device in the artificial valve provided in the embodiment of the present invention;

[0051] Figure 4 It is a schematic structural view of a delivery device and an artificial valve in an artificial valve provided in an embodiment of the present invention after the artificial valve is delivered into the sinus bottom;

[0052] Figure 5 for Figure 4 Magnified view of the artificial valve part in the middle;

[0053] Figure 6 It is a schematic structural view of a delivery device and an artificial valve provided in an embodiment of the present invention after the artificial valve is delivered into the sinus bottom and the artificial valve is expanded;

[0054] Figure 7 for Figure 6 Magnified view of the artificial valve part in the middle;

[0055] Figure 8 It is a schematic structural view of another state of the connecting wire of the delivery device and the artificial valve in the artificial valve provided in the embodiment of the present invention after the artificial valve is delivered into the sinus bottom;

[0056] Fig. 9 It is a schematic structural view of a conveying device and a stopper in an artificial valve provided in an embodiment of the present invention;

[0057] Fig.10 It is a schematic structural view of the delivery device and the anchoring member and the stent in the artificial valve provided in the embodiment of the present invention;

[0058] Fig.11 Another structural schematic diagram of the delivery device and the anchoring member in the artificial valve provided in the embodiment of the present invention;

[0059] Fig.12It is another structural schematic diagram of the delivery device and the anchoring member in the artificial valve provided in the embodiment of the present invention;

[0060] Fig.13 It is a structural diagram of a conveying device and a limiting member and a pushing member in an artificial valve provided in an embodiment of the present invention;

[0061] Fig.14 Another structural schematic diagram of a connecting wire in a delivery device and an artificial valve provided in an embodiment of the present invention;

[0062] Fig.15 Another structural schematic diagram of the delivery device and the anchoring member in the artificial valve provided in the embodiment of the present invention;

[0063] Fig.16 It is another structural schematic diagram of the delivery device and the anchoring member in the artificial valve provided in the embodiment of the present invention;

[0064] Fig.17 for Fig.16 Enlarged view of the center circle A;

[0065] Fig.18 It is a schematic diagram of the delivery device and the anchoring member in the artificial valve provided in the embodiment of the present invention in a semi-compressed state;

[0066] Description of reference numerals:

[0067] 1-Conveying parts;

[0068] 2-push component; 21-limiting member; 22-propelling member;

[0069] 3- Airbag parts;

[0070] 4- Protective cover;

[0071] 5-anchoring member; 51-limiting protrusion; 52-developing member; 53-fixing head; 54-extension arm; 55-limiting track;

[0072] 6- Bracket;

[0073] 7-Connecting wire;

[0074] 8-Human valve leaflets. DETAILED DESCRIPTION

[0075] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0076] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0077] For the convenience of explanation, in this embodiment, one side of the airbag is defined as the distal end, and the opposite side is defined as the proximal end.

[0078] Example 1

[0079] The artificial valve is generally installed in a compressed state in the loading section and advanced through the patient's circulatory system until the artificial valve reaches the implantation site. Then, the artificial valve expands to its functional size at the site of the defective natural valve. The artificial valve can have a self-expanding stent or a balloon-expandable stent. The actual shape and configuration of any particular transcatheter artificial valve depends to some extent on the problem and characteristics of the valve being repaired (i.e., the aortic valve, mitral valve, tricuspid valve or pulmonary valve).

[0080] The applicant has found in practice that most current products for aortic regurgitation indications contain a special anchoring structure, which provides radial centripetal force and works together with the radial centrifugal force of the valve body to clamp the native valve leaflets and achieve an anchoring effect. Therefore, compared with stenosis indications, regurgitation indication devices can anchor the valve in the absence of a calcified anchoring area.

[0081] However, the introduction of the anchoring structure may increase the diameter of the entire delivery system. In cases with a smaller vascular access diameter, devices with a delivery system that is too large cannot be used. Even if the delivery system can be punctured into the patient's circulatory system, the larger diameter will make it more difficult for the valve to pass through the vascular access, which will increase vascular complications and reduce the safety of device use.

[0082] In order to solve the above problems, this embodiment provides a delivery device for delivering an artificial valve, wherein the artificial valve includes an anchor 5 and a stent 6 .

[0083] like Figure 1 , Figure 4 and Figure 5 As shown, the conveying device includes a conveying member 1 ( Figure 4), a push assembly 2, an airbag 3 and a protective cover 4. The conveying member 1 is rod-shaped and hollow inside. The airbag 3 is fixed to the distal end of the conveying member 1, and gas can be filled into the airbag 3 through the hollow part inside the conveying member 1 to expand the airbag 3. The push assembly 2 and the protective cover 4 are both sleeved on the outer surface of the conveying member 1, and the protective cover 4 is arranged at the proximal end of the push assembly 2. When the artificial valve is conveyed, the stent 6 is sleeved on the outside of the airbag 3, the anchor 5 is sleeved on the outside of the protective cover 4, and the anchor 5 is connected to the push assembly 2.

[0084] like Figure 3 As shown, the pushing assembly 2 includes a limit member 21 and a propulsion member 22, both of which are sleeved on the protective sleeve 4, and a wrapping structure is provided on the side of the propulsion member 22 close to the limit member 21. In this embodiment, the wrapping structure is a through hole opened on the side of the propulsion member 22 close to the limit member 21, and the inner diameter of the through hole is larger than the outer diameter of the limit member 21, so that the operator can push the propulsion member 22 to move toward the limit member 21 alone until the wrapping structure is wrapped around the limit portion, so that a limit space suitable for fixing the proximal end of the anchor member 5 is formed between the wrapping structure and the limit portion. In this embodiment, as shown in FIG. Fig.13 As shown, the length of the wrapping structure of the pusher 22 is greater than the length of the stopper 21, so that when the proximal end of the anchor 5 is connected to the stopper 21, the wrapping structure of the pusher 22 can cover the middle part of the anchor 5, so that the anchor 5 can remain in a compressed state, and the pushing assembly ensures that the anchor 5 does not move sideways during the sliding process along the axial direction. In some other embodiments, the wrapping structure of the pusher 22 can also wrap to other positions of the anchor 5, such as wrapping the entire surface of the anchor 5.

[0085] Specifically, Figure 3 and Fig. 9 As shown, the limiting member 21 is provided with a limiting portion. In this embodiment, the limiting portion is three through grooves ( Fig. 9 The lower part of the middle limit part), such as Fig. 9 As shown, the three through slots are all provided with openings at the bottom, and the width of the openings at the bottom is smaller than the width of the through slots to prevent the components in the through slots from escaping from the through slots through the openings at the bottom.

[0086] like Figure 4 , Figure 5 and Fig.10As shown, three fixing heads 53 are arranged at the proximal end of the anchor 5, and the material of the anchor 5 is memory metal. When installing, the three fixing heads 53 are placed in the three through grooves on the surface of the limiter 21, and then the pusher 22 is pushed to move toward the limiter 21 until the wrapping structure is wrapped around the limiter, thereby fixing the three fixing heads 53 in the three through grooves. When releasing the anchor 5, the pusher 22 is pushed to move away from the limiter 21 until the wrapping structure is separated from the limiter. Since the anchor 5 is made of memory metal, the three fixing heads 53 can be separated from the three through grooves by themselves, thereby releasing the anchor 5. It can be understood that in some other embodiments, the number of fixing heads 53 and through grooves can also be other numbers.

[0087] like Fig. 9 As shown, three arc-shaped elastic sheets are arranged on the upper part of the limit member 21. When the limit member 21 is sleeved on the surface of the protective cover 4, the three arc-shaped elastic sheets can be tightly attached to the surface of the protective cover 4 to prevent the limit member 21 from sliding freely on the surface of the protective cover 4. It can be understood that when the propulsion member 22 is pushed to move toward the distal end, the limit member 21 can be pushed to move together.

[0088] like Figure 1 and Figure 2 As shown, the distal end of the protective cover 4 is sleeved on the surface of the proximal part of the airbag 3. Since the anchor 5 will move toward the airbag 3 under the push of the pushing assembly 2 until it moves to the outer surface of the airbag 3, in order to prevent the anchor 5 from causing damage to the airbag 3 during the movement, the protective cover 4 is arranged on the proximal part of the airbag 3, and the distal end of the protective cover 4 protrudes from the proximal end thereof. Figure 2 As shown in FIG. 1 , when the anchor 5 is pushed, the distal end of the anchor 5 will protrude beyond the distal end of the protective sleeve 4 and then reach the surface of the airbag 3, thereby preventing the anchor 5 from directly contacting the proximal end of the airbag 3 and preventing the anchor 5 from piercing the airbag 3 during the movement (e.g., Fig.18 As shown). It can be understood that in some other embodiments, the distal end of the protective sleeve 4 can also be sleeved onto the proximal surface of the upper bracket 6 of the airbag component 3 to achieve better protection of the airbag component 3.

[0089] In this embodiment, the protective cover 4, the limiting member 21 and the pushing member 22 are sequentially arranged from the inside to the outside, and the proximal ends of the three are connected to the operating handle, so that the operating handle can independently control the independent movement of the three, and then can send the anchor 5 to the surface of the airbag member 3. Here, the operating handle adopts the handle in the prior art. It can be understood that when the three are independent of each other, the limiting member 21 not only fixes the anchor 5 but also is the power to push the anchor 5 forward. Specifically, as Figure 2 and Figure 3 As shown, the workflow is as follows:

[0090] First, the anchor 5 is sleeved on the surface of the protective cover 4, and the three fixed heads 53 of the anchor 5 are placed in the three through grooves on the surface of the limiter 21, and then the propulsion member 22 is pushed alone to move in the direction of the limiter 21 until the wrapping structure is wrapped around the limiter, and the three fixed heads 53 are fixed in the three through grooves; when the anchor 5 needs to be transported, the limiter 21 and the propulsion member 22 are pushed in the distal direction at the same time by the operating handle, and then the anchor 5 is pushed in the distal direction on the surface of the protective cover 4, and the anchor 5 will pass over the distal protrusion of the protective cover 4 and then reach the surface of the airbag member 3.

[0091] like Figure 4 , Figure 5 As shown, after the anchoring member 5 is released, the pushing assembly 2 and the protective cover 4 are pulled toward the proximal end of the conveying member 1, so that the pushing assembly 2 and the protective cover 4 are away from the airbag member 3; Figure 6 As shown, air is inflated into the airbag member 3 through the hollow structure inside the conveying member 1 , so that the airbag member 3 expands.

[0092] For stenosis indications, traditional reflux indication devices can anchor the valve in the absence of a calcified anchoring area. However, the introduction of the anchoring structure may increase the diameter of the entire delivery system. In cases with a smaller vascular access diameter, devices with a delivery system that is too large cannot be used. Even if the delivery system can be punctured into the patient's circulatory system, the larger diameter will make it more difficult for the valve to pass through the vascular access, which will increase vascular complications and reduce the safety of device use.

[0093] The delivery device provided in this embodiment can minimize the overall compressed diameter of the artificial valve by arranging the anchor 5 and the stent 6 in series on the delivery member 1, reducing the diameter of the delivery system and allowing the valve to pass through the blood vessel more smoothly. At the same time, a pushing assembly 2 and a protective sleeve 4 are arranged, which can form a structure in which the anchor 5 and the stent 6 connected in series are located outside the stent 6. At this time, the anchor and the stent are concentrically arranged to facilitate the anchoring of the artificial valve.

[0094] Example 2

[0095] This embodiment provides a conveying device, which is different from the conveying device in Embodiment 1 in that:

[0096] In the conveying device provided in this embodiment, the limiting member 21 and the pushing member 22 are fixed to each other so that the wrapped structure on the pushing member 22 is always wrapped around the limiting portion. Fig.12As shown, the three fixing heads 53 of the anchor 5 are all sheet-like structures, and the sheet-like structure is placed in the limiting space between the wrapping structure and the peripheral side of the limiting portion, and this limiting space is an annular groove, and the sheet-like structure is not placed in the limiting portion on the limiting member 21. During transportation, the conveying device pushes the anchor 5 toward the airbag member 3 through the groove wall of the annular groove. After the anchor 5 is on the peripheral side of the airbag member 3, the conveying device is pulled away from the airbag member 3. Since the sheet-like structure is not placed in the limiting portion on the limiting member 21, the conveying device will not drive the sheet-like structure to move when it moves, thereby realizing the transportation and release of the anchor 5.

[0097] In some other implementations of this embodiment, Fig.11 As shown, the sheet structure may not be provided below the anchor 5. Fig.11 The middle lower bend is arranged in the limiting space between the wrapping structure and the peripheral side of the limiting portion. Among them, the fixing head 53 is not limited to a sheet structure, such as Fig.11 As shown, the bending part below the anchor 5 is arranged in the limiting space between the wrapping structure and the peripheral side of the limiting part, as long as it can cooperate with the propulsion component of the conveying device to realize the conveying and release of the anchor.

[0098] In some other implementations of this embodiment, the connecting surface between the limiting member 21 and the pushing member 22 can also be tightly fitted, that is, no limiting space is set. When the anchor member 5 is pushed, the anchor member 5 is against the limiting member 21, and under the pushing force of the pushing member 22, the anchor member 5 moves toward the direction of the balloon member.

[0099] In some other implementations of this embodiment, the limiting member 21 and the pushing member 22 are relatively fixed, that is, an elastic member or a connecting wire can be arranged between the limiting member 21 and the pushing member 22 to control the movement range of the limiting member 21 .

[0100] Example 3

[0101] This embodiment provides a conveying device, which is different from the conveying devices in Embodiment 1 and Embodiment 2 in that:

[0102] In the conveying device provided in this embodiment, the limiting member 21, the pushing member 22 and the protective cover 4 are all fixed by adhesion or the like. The structure of the anchor member 5 in this embodiment is the same as that of the anchor member 5 in Example 2. When conveying the anchor member 5, first, as in Example 2, the three fixing heads 53 of the anchor member 5 are all sheet structures, and the sheet structure is placed in the limiting space between the wrapping structure and the peripheral side of the limiting part. This limiting space is an annular groove, and the sheet structure is not placed in the limiting part on the limiting member 21. In this embodiment, the protective cover 4 is fixed to the limiting member 21 and the pushing member 22, so the protective cover 4 will move toward the direction close to the airbag member 3 together with the limiting member 21 and the pushing member 22. When the anchor member 5 is on the peripheral side of the airbag member 3, the protective cover 4 also covers the peripheral side of the airbag member 3. At this time, the protective cover 4 can also play a role in protecting the airbag member 3. After the anchoring member 5 is released, the conveying device and the protective cover 4 are pulled away from the airbag member 3 , and the conveying device and the protective cover 4 are away from the airbag member 3 .

[0103] In some other embodiments, the limiting member 21 and the protective cover 4 may also be relatively fixed, that is, an elastic member or a connecting wire may be provided between the limiting member 21 and the protective cover 4 to control the movement range of the limiting member 21 .

[0104] Example 4

[0105] This embodiment provides an artificial valve, including an anchor 5, a stent 6 and a connecting wire 7. The artificial valve is transported by the transport device in embodiments 1-3. The anchor 5 and the stent 6 are arranged in series on the surface of the transport member 1 in the transport device.

[0106] like Fig.10 As shown, the anchor 5 includes a limiting protrusion 51, a developing member 52, a fixing head 53, an extension arm 54, a limiting track 55 and a body. The body is annular and includes a plurality of connecting ribs. The developing member 52 is wound around the limiting protrusion 51 and the limiting protrusion 51. The developing member 52 is a developing wire. Figure 10-12 As shown, in this embodiment, the number of developing wires wound around the three limiting protrusions 51 is different. The developing wire can be a developing wire in the prior art.

[0107] In some other implementations of this embodiment, the developing line may also be wound around the connecting rib only, without being wound around the limiting protrusion 51. Specifically, in this embodiment, the three developing marks are:

[0108] 1. Remove the developing wire from the positioning claw (i.e. Figure 10-12 The middle part of the middle limit protrusion 51 is continuously wound to the upper part of the anchor connecting rib;

[0109] 2. Winding the developing wire around the middle of the positioning claw and above the connecting rib respectively, but the gap between the two is discontinuous;

[0110] 3. Wrap the developing wire only above the anchor connecting rib.

[0111] It can be understood that the difference in the number and position of the developing wires on the anchor 5 can satisfy the function of assisting the surgeon to quickly and accurately determine the anterior and posterior positions of the three sinuses in the projection direction. The position of the developing wire relative to the connecting ribs is based on assisting the surgeon to quickly and accurately determine the anterior and posterior positions of the three sinuses in the projection direction. The position of the developing wire relative to the connecting ribs and the number of developing wires can be adjusted according to actual conditions.

[0112] At present, since the human aortic valve is a three-dimensional anatomical structure, in order to confirm the three positioning claws (i.e. Fig.10 To determine the state of the sinus floor (the middle limit protrusion 51 is located), the three coronary sinuses of the aorta must be located in the same plane under DSA planar imaging. When the anchoring angle needs to be adjusted during the operation, although the three positioning claws have development marks, the development marks have the same shape. Even if the position and projection angle of one of the sinuses are confirmed, due to lack of reference, the operator cannot quickly determine whether the anchor 5 and the three coronary sinuses of the aorta are really in the correct position relationship (usually the transvalvular angle will select the center position of the right coronary sinus, and it is not ruled out that the DSA angiography machine angle is adjusted during release or repeated operations. The repeated adjustment process will cause the operator to be unable to identify the anatomical spatial structure that has been previously confirmed).

[0113] The artificial valve provided in this embodiment has three positioning claws (i.e. Fig.10 The different developing shapes of the middle limiting protrusion 51) assist the operator to quickly and accurately determine the front and rear positions of the three coronary sinuses of the aortic valve in the projection direction angle, and realize the autonomous positioning of the anchor 5. Specifically, when the anchor 5 locates the sinus bottom, the position of the anchor 5 is adjusted, and the developing structure shown when the anchor 5 correctly enters the sinus bottom is used as the standard. After the anchor 5 enters the sinus bottom, the cross-valve angle is determined. The different developing shapes of the three positioning claws assist the operator to quickly and accurately determine the front and rear positions of the three sinuses in the projection direction angle, and realize the autonomous positioning of the anchor 5.

[0114] Still reading Figure 10-12 Two connecting ribs are connected on both sides of any limiting protrusion 51, one of the connecting ribs is wound with a developing line, and the other connecting rib is provided with a strip-shaped through groove, one end of the connecting wire 7 is wound in the strip-shaped through groove and can slide relative to the strip-shaped through groove, and the other end of the connecting wire 7 is fixed to the proximal area of ​​the bracket 6. It can be understood that in some other embodiments, the other end of the connecting wire 7 can also be connected to other positions of the bracket 6.

[0115] In some other embodiments, Fig.15As shown, instead of providing a strip-shaped through groove, the connecting wire 7 can be directly sleeved on the connecting rib, and the limiting protrusion 51 at the upper end of the connecting rib and the upper end of the lower extension arm 54 are used for limiting. Fig.16 and Fig.17 As shown, a groove is directly provided on the connecting rib, and the connecting wire 7 is directly sleeved in the groove.

[0116] like Figure 2 As shown, when the anchor 5 is in a compressed state, the connecting wire 7 is on the side of the limiting protrusion 51 of the anchor 5. Figure 2 The status shown is Figure 4 and Figure 5 In the state shown, the connecting wire 7 slides from the limiting protrusion 51 along the strip-shaped through groove to the proximal part of the anchor 5. At the same time, the anchor 5 is gradually released from the compressed state and radially expands to the expanded state to achieve autonomous positioning. At this time, the anchor 5 is in a fully expanded state and the stent 6 is in a compressed state.

[0117] like Figure 6 and Figure 7 As shown, after the anchor 5 is precisely positioned at the sinus bottom, the stent 6 is pulled to move axially along the balloon part under the action of the connecting wire 7 until the stent 6 contacts the junction between each defective human valve leaflet 8 and the blood vessel wall. At this time, the anchor 5 and the stent 6 are concentrically sheathed, and then the balloon part is expanded to clamp the native valve leaflet between the stent 6 and the anchor 5. At this time, the anchor 5 and the stent 6 are both in a fully expanded state, and the aortic valve anchoring of the regurgitation case is achieved. It can be understood that after the anchor 5 is positioned at the sinus bottom and before the stent 6 is expanded, if the implantation depth of the stent 6 needs to be adjusted, the anchor 5 is pushed to continue to move distally. Under the support force of the sinus bottom of the anchor 5, the strip-shaped through groove of the connecting wire 7 on the anchor 5 slides from the extension arm 54 to the limit protrusion 51, so that the stent 6 can be positioned deeper relative to the anchor 5, and the implantation depth of the stent 6 can be adjusted again.

[0118] The wrapping structure in the delivery device prevents the stent 6 from expanding prematurely. When the anchor 5 is half released and takes the shape of a trumpet (such as Fig.18 As shown in the figure, due to the presence of the extension arm 54 and the fixed head 53 in the anchor 5, the bracket 6 will not be fully opened when the wrapping structure is withdrawn. If the initial positioning of the anchor 5 is inaccurate, the wrapping structure can be pushed to move in the direction of the limit member 21, and the anchor 5 can be compressed to an unreleased state for repeated positioning.

[0119] At the same time, in this embodiment, the extension arm 54 is extended a certain distance toward the proximal end, and the existence of the wrapping structure prevents the anchor 5 from "bouncing" at the moment of full release, making the release of the anchor 5 more stable.

[0120] In some other implementations of this embodiment, Figure 8 As shown, the connecting wire 7 can also be fixedly connected to the bottom end of the proximal part of the stent 6, making it easier to adjust the implantation depth.

[0121] In this embodiment, the connecting wire 7 is braided with a single strand or multiple strands of wire. In some other embodiments, such as Fig.14 As shown, the connecting wire 7 is woven from three strands of silk thread, and a developing wire can be wound around any position on it. The addition of the developing structure of the connecting wire 7 can help determine the situation of the tension in the anchor 5 during the release. A sleeve is provided on the outside of the connecting wire 7, and a connecting ring is provided at one end of the connecting wire close to the anchor 5, which is convenient for the movement of the connecting wire and prevents the connecting wire from scratching the myocardium. It can be understood that in some embodiments, when the connecting wire 7 is a single strand, a sleeve can also be provided on the outside to facilitate the movement of the connecting wire and prevent the connecting wire from scratching the myocardium. Of course, the sleeve may not be provided on the outside of the connecting wire 7, or both ends of the connecting wire 7 may be provided with rings, and a plurality of rings may be provided at the connection between the connecting wire 7 and the bracket 6. A single or multiple rings can limit displacement and prevent violent sliding of relative positions.

[0122] The artificial valve of this embodiment, such as Figure 2 As shown, at this time, the anchor 5 and the stent 6 are both in a compressed state, and the pushing component 2 pushes the anchor 5 along the axial direction of the conveying member 1 in the direction of the stent 6 until the anchor 5 passes through the protective sleeve 4. At this time, the anchor 5 is in a semi-expanded state, and the stent 6 is in a compressed state, roughly reaching the defective valve ring. When the anchor 5 enters the sinus floor, the position of the anchor 5 is adjusted, and the imaging structure shown when the anchor 5 correctly enters the sinus floor shall prevail. After the anchor 5 enters the sinus floor, the cross-valve angle is determined, and the front and rear positions of the three sinuses in the projection direction are quickly and accurately determined according to the different imaging shapes of the anchor 5. In this process, the connecting wire 7 is moved from the limiting protrusion 51 of the anchor 5 to the side of the extension arm 54 of the anchor 5. At the same time, the anchor 5 is gradually released from the compressed state, and radially expands to the expanded state to achieve autonomous positioning. At this time, the anchor 5 is in a fully expanded state, and the stent 6 is in a compressed state (see attached Figure 4 and Figure 5 ), thereby correctly aligning the stent 6 and its leaflets in the valve ring. After the anchor 5 is accurately positioned at the sinus bottom, the stent 6 is pulled axially by the connecting wire 7 until the stent 6 contacts the junction between each defective human leaflet 8 and the vascular wall. At this time, the anchor 5 and the stent 6 are concentrically arranged, and then the balloon is expanded to clamp the human leaflet 8 between the stent 6 and the anchor 5. At this time, the anchor 5 and the stent 6 are both in a fully expanded state (see the attached figure). Figure 6 and Figure 7 ), achieving aortic valve anchoring in regurgitation cases.

[0123] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A delivery device for delivering an artificial valve, the artificial valve comprising an anchor (5) and a stent (6), characterized in that: The device includes: A conveying member (1) on which an anchor member (5) and a bracket (6) are placed, and the anchor member (5) and the bracket (6) are asynchronously coaxially arranged in series; A pushing component (2) is sleeved on the conveying member (1), the pushing component (2) is connected to the anchor member (5), and the pushing component (2) is configured to drive the anchor member (5) to move toward the support (6) under the action of an external force until the anchor member (5) and the support (6) are coaxially and concentrically sleeved.

2. The conveying device according to claim 1, characterized in that The push component (2) comprises: A limiting member (21) is sleeved on the conveying member (1), and a limiting portion is provided on the limiting member (21); The propulsion member (22) is provided with a wrapping structure on one side close to the limiting member (21), and the wrapping structure is configured to wrap around the limiting portion so that a limiting space suitable for fixing the proximal end of the anchor member (5) is formed between the wrapping structure and the limiting portion.

3. The conveying device according to claim 2, characterized in that: The propulsion member (22) is configured to move relative to the limiting member (21) under the action of an external force, so as to separate the wrapping structure from the periphery of the limiting portion, thereby releasing the anchoring member (5).

4. The conveying device according to claim 3, characterized in that: The limiting portion is a plurality of through holes formed on the limiting member (21), and the fixing head (53) on the anchor member (5) is disposed in the through holes.

5. The conveying device according to claim 2, characterized in that: The limiting member (21) and the pushing member (22) are fixed or relatively fixed.

6. The conveying device according to any one of claims 2 to 5, characterized in that: It also comprises an airbag component (3) which is arranged at the distal end of the conveying component (1), the bracket (6) is sleeved on the surface of the airbag component (3), and the airbag component (3) is configured to be inflated to drive the bracket (6) to expand.

7. The conveying device according to claim 6, characterized in that It also includes a protective sleeve (4) which is sleeved on the conveying member (1), the protective sleeve (4) being arranged at the proximal end of the airbag member (3) or covering the surface of the bracket (6), and the anchor member (5) being configured to be pushed by the pushing assembly (2) and pass through the surface of the protective sleeve (4) to the surface of the bracket (6).

8. The conveying device according to claim 6, characterized in that: It also includes a protective sleeve (4) fixed to the pushing component (2), the anchoring component (5) being sleeved on the surface of the protective sleeve (4), and the protective sleeve (4) being configured to be driven by the pushing component (2) and cover the surface of the airbag component (3) until the anchoring component (5) is sleeved on the surface of the bracket (6).

9. The conveying device according to claim 8, characterized in that The limiting member (21) in the pushing component (2) is fixed to the protective cover (4); Or the limiting member (21) in the pushing component (2) is relatively fixed to the protective sleeve (4) to limit the movement range of the protective sleeve (4).

10. The conveying device according to claim 7 or 9, characterized in that: The distal end of the protective sleeve (4) protrudes beyond the proximal end thereof.

11. The conveying device according to claim 10, characterized in that The pushing component (2) is sleeved on the surface of the protective sleeve (4).

12. An artificial valve, characterized in that: The artificial valve comprises an anchor (5) and a stent (6), and the artificial valve is transported by a transport device according to any one of claims 1 to 11, and the anchor (5) and the stent (6) are sleeved on the surface of the transport member (1) in the transport device.

13. The artificial valve according to claim 12, characterized in that: The anchoring member (5) comprises: The main body is annular and includes a plurality of connecting ribs; A limiting protrusion (51) is provided at the distal end of the body; A developing member (52) is arranged outside the connecting rib; The delivery device is suitable for being connected to the body to limit the body to be in a compressed state, and the body is configured to enter a released state after being separated from the delivery device.

14. The artificial valve according to claim 13, characterized in that: It also comprises a connecting wire (7), one end of which is slidably connected to the connecting rib, and the other end of which is connected to the bracket (6).

15. The artificial valve according to claim 14, characterized in that: The connecting wire (7) is connected to the middle part of the stent (6), or the connecting wire (7) is connected to the proximal part of the stent (6).

16. The artificial valve according to claim 15, characterized in that: The connecting wire (7) is braided from a single strand or multiple strands of silk thread, and a connecting ring is provided at one end of the connecting wire (7) close to the anchor (5), or rings are provided at both ends of the connecting wire (7).

17. The artificial valve according to claim 16, characterized in that: The connecting wire (7) is covered with a sleeve.

18. The artificial valve according to claim 16, characterized in that: The connecting wire (7) is provided with a developing wire.

19. The artificial valve according to any one of claims 14 to 18, characterized in that: The anchor member (5) further comprises: A fixing head (53) connected to the proximal end of the body, wherein the fixing head (53) is suitable for connecting to the conveying device; An extension arm (54) connected between the fixing head (53) and the body; A limiting track (55) is arranged inside the connecting rib; Wherein, the connecting wire (7) is slidably connected to the limiting track (55).

Citation Information

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