CN111973318B

CN111973318B - Locking device and conveying system with same

Info

Publication number: CN111973318B
Application number: CN201910439503.1A
Authority: CN
Inventors: 刘通; 邱克劲; 刘小建; 赵轩铖; 张昱昕
Original assignee: Shanghai Shape Memory Alloy Material Co Ltd
Current assignee: Shanghai Shape Memory Alloy Material Co Ltd
Priority date: 2019-05-24
Filing date: 2019-05-24
Publication date: 2024-03-12
Anticipated expiration: 2039-05-24
Also published as: CN111973318A

Abstract

The invention discloses a locking device and a conveying system with the same, wherein the locking device comprises a fixing piece and a locking device, wherein the locking piece is provided with a lock catch capable of elastically deforming; the connecting piece is detachably connected with the fixing piece; the release piece is movably sleeved on the outer side of the lock catch and the connecting part; when the release member is disengaged from the catch, the catch pops up and holds the implant in a compressed state, and when the release member is disengaged from the connection, the fixing member and the connecting member are released. The delivery system comprises a locking device, a delivery sheath and a delivery handle, wherein the proximal ends of the components of the locking device are respectively connected with the delivery handle, the locking device compresses and stretches the implant under the control of the delivery handle, the implant is received in the delivery sheath during stretching, and the implant is placed outside the delivery sheath during compression. The locking device can lock the valve support in a stretching state into a compression state, so that the conveying system and the valve support are loosened to realize complete recovery, and the locking device is simple to operate and is not easy to cause conduction block.

Description

Locking device and conveying system with same

Technical Field

The invention relates to the technical field of medical equipment, in particular to a locking device for a heart valve replacement operation and a conveying system with the locking device.

Background

Cardiovascular disease is one of the most common cardiovascular diseases in China, heart valve surgery is a main means for treating the cardiovascular system, and heart valve surgery is to replace or repair a damaged heart valve by using a surgical means. For example, when there is a scar at the cusp or fusion occurs at the edges of the valves that contact each other, the valve She Bianbao or excessively elongated to form valve regurgitation, blood will flow back through the gaps between the leaflet lesions, and if the regurgitation continues to deteriorate, the valve will continue to enlarge and elongate, at this time, the damaged heart valve is repaired by surgical means, i.e. the mutually fused valve is excised with a surgical knife, so that the valve leaflets can move freely, and the stenosis is relieved, thereby restoring the normal functional needs of the valve; in the case of severe valve lesions, simple repair does not meet the therapeutic requirements, and therefore, the damaged valve needs to be surgically removed prior to replacement of the prosthetic heart valve, leaving a smooth, regular edge, and then the prosthetic heart valve is sutured to the edge for replacement.

However, traditional surgical approaches are traumatic, risky, prone to complications such as bleeding, infection, stroke, etc. when performing heart replacement surgery, and the recovery and treatment time of the patient is long. In recent years, minimally invasive or vascular interventional approaches have widely replaced surgical procedures for treating valve diseases, wherein Transcatheter Aortic Valve Implantation (TAVI) is introduced internationally as a minimally invasive method for treating aortic diseases, and the minimally invasive approaches are adopted, and a vascular access is utilized to introduce a guide wire from a femoral artery or a transapical manner to send a prosthetic heart valve into the aorta to replace a diseased valve, so that the surgical time is short, chest opening is not required, and the damage to a human body is small.

The current medical devices used for TAVI are various, especially for transvascular access, and most of the devices have self-expanding mechanical structures, and artificial heart valves (such as artificial mechanical valves and biological valves) are respectively conveyed to designated positions by adopting different design methods or materials, wherein the percutaneous catheter implantation type artificial heart valve system is widely adopted due to the small outline of a conveying system and low occurrence rate of perivalvular leakage, and can obtain obvious clinical benefit for patients with aortic stenosis and patients with aortic insufficiency, but the existing devices have the problems of complicated mechanical locking, difficult resetting or retracting during adjustment, poor coaxiality, easy conduction blocking and the like.

Disclosure of Invention

It is an object of the present invention to overcome the drawbacks of the prior art and to provide a locking device for a telescopic valve stent which is capable of locking the valve stent in a compressed state in a stretched state while allowing complete recovery of the delivery system and the valve stent by releasing the same, which is simple to operate and does not easily cause conduction block.

In order to achieve the above object, the present invention provides the following technical solutions:

a locking device, comprising:

the fixing piece is provided with a lock catch capable of elastically deforming;

the connecting piece is detachably connected with the fixing piece;

the release piece is movably sleeved on the outer sides of the lock catch and the connecting part;

when the release member is disengaged from the catch, the catch pops up and restrains the implant in a compressed state, and when the release member is disengaged from the connection, the fixing member is released from the connection.

The locking device is suitable for medical implants, in particular for medical implants which can expand in a telescopic mode, such as a heart valve bracket and the like, when the heart valve bracket is in a stretching state, the distal end of the fixing piece is connected with the heart valve bracket and the heart valve arranged in the valve bracket, the proximal end of the fixing piece is detachably connected with the distal end of the connecting piece, the proximal end of the connecting piece is connected with a conveying handle of a conveying system, the proximal end and the distal end of the connecting piece are relative to the conveying handle, the release piece is movably sleeved outside the lock catch and the connecting part, the implant in the stretching state can expand after reaching a designated position when in a transplanting operation, the implant in the stretching state is switched into a compression state, the release piece in the locking device can move along the outer wall of the fixing piece and/or the connecting piece under the action of external force (such as the handle of the conveying device is pulled), and has an elastically deformed lock catch to pop-up the release piece when moving to be separated from the lock catch, and is clamped at the proximal end of the implant, and the implant is prevented from rebounding to the implant fixing points due to the fact that the distal end of the fixing piece and the fixing piece are arranged on the fixing piece and the lock catch are connected with the conveying handle. And along with the movement of the release piece, when the release piece breaks away from the connection part of the fixing piece and the connecting piece, the connecting piece and the fixing piece fall off, so that implantation and locking of the implant are realized, of course, if the position of the implant is still required to be adjusted, further movement of the release piece can be delayed until the implant is placed at a proper position, and even more, if an operator needs to retrieve the implant again due to other external factors, the situation can be completely realized, and only when the position of the implant is determined, the movement of the release piece out of the connection part can be completed.

In order to enable the locking device of the invention to further simplify the surgical operation, it is also possible to provide the locking device with a force application member for providing a pushing force to the implant to switch the implant to a compressed state. In this case, the state of the implant can be changed by controlling the force-exerting element of the locking device, preferably the connecting element, the release element and the force-exerting element are moved independently of one another as a preferred embodiment. Further, when the force application member is moved distally, the connector member and the release member move proximally relative to each other.

Because each part in the locking device works in a one-to-one correspondence mode, the force application part, the connecting part and the release part are preferably arranged in equal quantity and correspond to each other. Of course, considering that the locking device not only performs a locking function, but also an indirect actuation function, i.e. auxiliary delivery, it is necessary to maintain coaxiality during delivery to achieve a good surgical effect, it is preferable that the number of the force application member, the connecting member and the release member is not less than 3.

In order to enable the lock catch to be smoothly released, a concave surface can be formed on the force application member, the concave surface is a key part on the force application member, and the concave surface is arranged corresponding to the lock catch and is used for providing a containing space for the ejected lock catch.

Of course, in order to ensure the stability of the force transmission, a claw may be provided at the distal end of the force application member, the claw being configured to provide a point of application to the implant, the resulting pushing force compressing the implant, wherein the release member and the connecting member may have a proximal relative movement with respect to the force application member.

In order to stably recover the implant into the delivery system and to facilitate the detachment of the fixing element provided on the implant from the connecting element during the release phase, the proximal end of the jaws are provided in sequence with a plane for limiting the deformation and/or displacement of the proximal end of the implant and a bevel for guiding the detachment of the proximal end of the implant from the locking means.

Of course, in order to limit the distal end of the force application member and enable the distal end of the force application member to work stably, the locking device may further comprise a force application member, the force application member is arranged on the implant, guide channels corresponding to the clamping jaws one by one are arranged on the force application member, and the guide channels are in clearance fit with the clamping jaws.

In order to ensure the coaxiality of the components, the stress piece is further provided with a guide groove, and the proximal end of the fixing piece penetrates through the guide groove and then is detachably connected with the connecting piece. The guide channels are preferably two, the two guide channels are arranged on two sides of the guide groove, and the guide channels and the guide groove are axially arranged.

Meanwhile, a fixed channel can be arranged on the force application part, and the connecting part and the release part are arranged through the fixed channel.

Wherein the fixing piece and the connecting piece are preferably connected in a hook type. Specifically: the proximal end of the fixing piece is provided with a hook or a hanging lug, and the distal end of the connecting piece is correspondingly provided with an adaptive hanging lug or a hanging lug. Further: the hanger and the hook are in snap-buckle arrangement, the hook is omega-shaped, L-shaped, E-shaped, C-shaped or zigzag, and the shape of the hanger structure is sequentially and correspondingly T-shaped, L-shaped, E-shaped, C-shaped or zigzag.

In order to strengthen the intensity of junction, avoid the fixing piece to become flexible with the connecting piece the fixing piece and all be equipped with the kink of looks adaptation on the connecting piece. Preferably: the fixing piece is provided with a containing groove at the position corresponding to the lock catch, and when the release piece is sleeved outside the lock catch, the lock catch deforms to enter the containing groove.

Further: the lock catch is made of nickel-titanium alloy with a shape memory effect.

The fixing piece is arranged at the proximal end of the implant, and the distal end of the fixing piece is provided with a fastening hole for fixing on the implant. The fastening holes may be two kinds, one being arranged axially along the fixing member, for fixing the prosthetic valve, and the other being arranged radially for connection with the valve holder on the implant.

As a preferred embodiment, the release member is mainly composed of an integrally formed connecting rod and an unlocking sleeve, the unlocking sleeve is provided with an inner cavity, the unlocking sleeve and the connecting rod can be independently generated, the unlocking sleeve is fixed on the connecting rod, the cross section of the inner cavity is V-shaped, the resistance of the release member when moving between the fixing member and the implant can be reduced by the V-shaped cross section, and the release member plays a guiding role. Further: and chamfer angles are arranged on two end surfaces of the inner cavity.

Preferably: the implant comprises leaflets and a valve stent for fixing the leaflets, the valve stent being compressible and stretchable under the control of the locking means.

Further: the wire at the proximal end of the valve stent has at least one inflection point for limiting the locking means.

Another object of the present invention is to provide a delivery system with the above locking device, which has a small profile, is easy to control the opening and closing of the locking device, and has good coaxiality when delivering medical instruments.

A delivery system comprises a locking device, a delivery sheath and a delivery handle, wherein the proximal ends of all components of the locking device are respectively connected with the delivery handle, the locking device compresses and stretches the implant under the control of the delivery handle, the implant is received in the delivery sheath when stretched, and the implant is placed outside the delivery sheath when compressed.

The conveying system of the invention controls the movement of the conveying sheath tube through the conveying handle so as to indirectly control the movement of each component of the locking device, and the locking device is controlled by the related components of the conveying handle to realize the mutual movement between the distal end and the proximal end.

Preferably: the delivery sheath comprises an outer tube and an inner tube, and each component of the locking device is connected with the inner tube and controlled by the delivery handle.

Further: a protective mesh is provided at the distal end of the inner tube to guide the implant into the delivery sheath.

Compared with the prior art, the invention has the following beneficial effects:

the locking device provided by the invention is suitable for a self-expanding telescopic valve support, can lock the valve support in a stretching state into a compression state, and simultaneously enables the conveying system and the valve support to be loosened to realize complete recovery. The conveying system provided by the invention has the advantages of small outline, easiness in controlling the opening and closing of the locking device and good coaxiality when conveying medical instruments.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is an assembly view of a locking device according to an embodiment of the present invention;

FIG. 2 is a side view of a fastener in one embodiment of the invention;

FIG. 3 is a schematic view showing the assembly of the locking device and the implant according to an embodiment of the present invention;

FIG. 4 is a schematic view of an implant coupled to a locking device according to one embodiment of the present invention;

FIG. 5 is a schematic view of a connector according to an embodiment of the present invention;

FIG. 6 is a schematic view of a fixing member according to an embodiment of the present invention;

FIG. 7 is a schematic view of a release member according to an embodiment of the present invention;

FIG. 8 is a schematic view showing the assembly of the locking device and the implant according to another embodiment of the present invention;

FIG. 9 is a schematic diagram of a force application member according to an embodiment of the present invention;

FIG. 10 is a partial top view of the force application member of FIG. 9 in accordance with the present invention;

FIG. 11 is a schematic view of the assembly of a locking device with an implant in accordance with yet another embodiment of the present invention;

FIG. 12 is a schematic view of a force-bearing member according to an embodiment of the present invention;

FIG. 13 is a cross-sectional view of FIG. 12;

FIG. 14 is a schematic diagram of a conveyor system of the present invention;

FIG. 15 is a schematic view of the structure of a protective screen of the conveyor system of the present invention;

FIG. 16 is a schematic view of the structure of an active valve portion of a heart artery to be implanted in accordance with the present invention;

FIG. 17 is a schematic view showing an initial locking state of the locking device of the present invention;

FIG. 18 is a schematic view showing a locking device of the present invention in a mid-lock state;

FIG. 19 is a schematic view showing the locking end state of the locking device of the present invention;

FIG. 20 is a schematic view showing a pre-release state of the locking device of the present invention;

FIG. 21 is a schematic view showing a release late state of the locking device of the present invention;

fig. 22 is a simulated view of the delivery system of the present invention with the implant fully released.

Detailed Description

The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.

In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification. The numerical values mentioned herein are not explicitly indicated, and may refer to numerical ranges that are considered equivalent to the stated values by those skilled in the art. As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. "proximal" and "distal" in this specification generally refer to the movement, relative position or orientation of one element with respect to the other element from the perspective of a user using the described device. These locations are closer to the user than the "proximal" and, conversely, are further from the user than the "distal". In this specification, "outwards" and "inwards" generally refer to "inwards" in which a force applied to an element is directed toward the center of a circle, and vice versa, with respect to the center of the circle of the metal bracket.

In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other. The following detailed description is to be read with reference to the drawings, in which like reference numerals refer to like elements throughout. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Cardiovascular diseases are one of the most common cardiovascular diseases in China. Traditionally, treatment of the cardiovascular system has often involved significant trauma to the patient by surgical means. This treatment involves a certain risk and the recovery and treatment time of the patient is long. Percutaneous, transcatheter implantable therapy has been accepted by patients as a less invasive therapy.

The percutaneous catheter implantation type artificial heart valve system brings remarkable clinical benefit for patients suffering from aortic stenosis and aortic insufficiency due to the small outline of the delivery system, accurate positioning, low incidence rate of paravalvular leakage and resettable and retractable. Disclosed herein are medical devices that deliver the medical device to a portion of the cardiovascular system through a catheter delivery system and that can be repaired, replaced, and treated. The devices disclosed herein are applicable at least to the delivery and replacement of heart valves.

Example 1

The present invention provides a locking device comprising a connector 3, a fixing member 4 and a release member 5, as shown in fig. 1, wherein the fixing member 4 has an elastically deformable catch 404, as shown in fig. 2; the connecting piece 3 is detachably connected with the fixing piece 4; the release piece 5 is movably sleeved outside the lock catch 404 and the connecting part; when the release member 5 is disengaged from the catch 404, the catch 404 springs out and restrains the implant in a compressed state, and when the release member 5 is disengaged from the connection, the fixing member 4 is released from the connection member 3.

In an embodiment of the invention, as shown in fig. 3-4, the locking device is adapted for use with a medical implant, in particular a telescopically expandable medical implant, in particular, as shown in fig. 4, the implant is a valve holder 6 with leaflets 8, the leaflets 8 being fixed inside the valve holder 6; the valve holder 6 can be compressed and stretched under the control of the locking means. Of course, the implant may also comprise a skirt 7, the skirt 7 being fixed to the outside of the valve holder 6 in correspondence of the leaflets 8, the wire at the proximal end of the valve holder 6 having at least one inflection point 19, see fig. 21, for being restrained by the locking means. The valve holder 6 may be made of a material having linear elasticity or non-superelasticity. The skirt 7 covers the outer surface of the implant, starting from the distal end of the implant as much as possible over the entire implant. The various elements and materials that may be used for implantation and the tubular elements disclosed herein may include general-purpose medical devices. These materials may be made of metals, metal alloys, polymers, metal-polymer composites, and other suitable materials.

The working process of the invention is as follows: in the preoperative period, the valve support 6 is in a stretching state in the conveying process, at the moment, the distal end of the fixing piece 4 in the locking device is connected with the valve support 6 and the valve leaves 8 arranged in the valve support 6, the proximal end of the fixing piece 4 is detachably connected with the distal end of the connecting piece 3, the proximal end of the connecting piece 3 is connected with conveying handles (10, 11, 12 and 13) of an external conveying system, the proximal end and the distal end are both relative to the conveying handles (10, 11, 12 and 13), the release piece 5 is movably sleeved outside the lock catch 404 and the connecting part, in the transplanting operation period, the implant in the stretching state is expanded after reaching a designated position, and is switched into a compression state from the stretching state, the release piece 5 in the locking device can move along the outer wall of the fixing piece and/or the connecting piece under the action of external force (such as the handle of the conveying system is pulled), and the lock catch 404 with elastic deformation pops up and is clamped at the proximal end of the implant when moving to be separated from the lock catch 404, and the distal end of the fixing piece 4 is connected with the implant 4 in the transplanting operation period, and the implant is prevented from expanding to the implant fixing point 4. And along with the movement of the release member 5, when the release member 5 is separated from the connection part of the fixing member 4 and the connecting member 3, the connecting member 3 and the fixing member 4 are separated, so that the implant can be input and locked, of course, if the position of the implant is still required to be adjusted, the further movement of the release member can be delayed until the implant is placed at a proper position, and even more, if an operator needs to retrieve the implant again due to other external factors, the situation can be completely realized, and only when the position of the implant is determined, the movement of the release member 5 out of the connection part can be completed.

In this embodiment, the fixing member 4 is connected with the connecting member 3 by a hook, as shown in fig. 5-6, the proximal end of the fixing member 4 is provided with a hook 405 or a hanging lug, and the distal end of the connecting member 3 is correspondingly provided with an adapted hanging lug 301 or a hook. The hanger 301 and the hook 405 are provided as a snap, for example, when the hook 405 is omega-shaped, the hanger is T-shaped; when the hook 405 is L-shaped, the hanging lugs are L-shaped; when the hook 405 is E-shaped, the hanging lugs are E-shaped; when the hook 405 is C-shaped, the hanging lugs are C-shaped; when the hanger 405 is zigzag, the lugs are zigzag. Of course, the form of the hook hanging lugs is not limited to the distance, and can be any form of snap-fastening.

Fig. 5 shows the structure of the connecting member 3, fig. 6 shows the structure of the fixing member 4, and fig. 7 shows the structure of the releasing member 5. As can be seen in connection with fig. 1 and 5-7, the hook 301 portion cooperates with the tab 405 of the anchor 4 and is then placed within the cavity 501 of the release member 5. During the lock release phase, the hook, tab portion is released from the cavity 501 of the release member 5, whereby the securing member is separated from the connecting member, enabling the release of the locking device.

As described above, fig. 6 shows the structure of the fixing member 4, the fixing member 4 is provided at the proximal end of the implant, and the distal end of the fixing member 4 is provided with fastening holes (401, 402) for fixing to the implant. As shown in fig. 1, 4 and 6, the fastening holes 402 are a row of suture holes that function to secure the leaflet 8. The fastening holes 401 are holes arranged transversely in order to fix the fixing element 4 to the metal bracket 6. The hook 405 portion of the securing member 4 mates with the hook 301 portion of the connecting member 3. The fixing member 4 is made of a nickel-titanium memory alloy material, which has a shape memory effect. The latch 404 is shaped like a hook by high temperature and returns to the shaped form in an unbound state. The hook 405 and the lock catch 404 are placed in the inner cavity 501 of the release member 5 at the initial stage of locking, the shape of the lock catch 404 is compressed because the lock catch 404 is pressed by the release member 5, and when the release member 5 moves proximally to release the lock catch 404, the shape of the lock catch 404 is restored, and the lock catch 404 is sprung to realize the locking function.

As shown in fig. 6, a step 403 may be provided between the fastening hole 402 and the lock catch 404 to limit the displacement of the release member 5, so as to ensure that the connection portion and the lock catch are placed in the cavity 501 of the release member 5 without being removed from the proximal end of the cavity 501.

Fig. 7 shows the structure of the release 5. As shown in fig. 1 and 7, the inner cavity 501 is a moving passage of the connecting member 3 and the fixing member 4. The unlocking sleeve 502 is mainly composed of an integrally formed connecting rod 504 and an unlocking sleeve 502, the unlocking sleeve 502 is provided with an inner cavity 501, the cross section of the inner cavity 501 is V-shaped, and chamfer angles are arranged on two end faces of the inner cavity. The V-shaped cross-section of the unlocking sleeve 502 reduces the resistance to movement of the release 5. It should be noted that the release member 5 is disposed in two ways, one is a V-shaped cross section facing the center of the valve holder, and the other is an opposite direction (as shown in fig. 1). The main function of the release member 5 is to allow the attachment member 3 and the fixing member 4 to be stably fitted into the inner cavity 501 and to compress the lock catch 404. Thus, the function of this element can be achieved both in the direction of the centre of the valve holder 6 and in the opposite direction.

Example 2

Fig. 8 shows a modified structure of the locking device, which includes a connecting piece 3, a fixing piece 4, a releasing piece 5, and a force application piece 1, wherein, the fixing piece 4 and the connecting piece 3 are respectively provided with an adaptive bending part (not marked in the figure), so that the connection part is not coaxial with the force application direction of the connecting piece 3, the problem that the connection part is easy to loosen is avoided, and the strength of the connection part is enhanced. Referring to fig. 19, the connecting portion is preferably disposed at a distal end of the bending portion, and a receiving groove 406 is formed in the fixing member 4 at a position corresponding to the lock catch 404, and when the release member 5 is sleeved outside the lock catch, the lock catch deforms into the receiving groove.

The force application member 1, the connecting member 3 and the release member 5 can move independently of each other, for example, the proximal ends of the three can be respectively connected with the corresponding inner tube and placed in the interior of the 8 sheath tube. The force application member 1, the connecting member 3 and the release member 5 are driven by the inner tube to move relatively. The implant portions may be stretched and compressed by relative movement of the various components of the locking device, and when the implant is in a stretched state, the implant may be received within the delivery sheath 9 and delivered into the heart. When the system is delivered to the corresponding position of the heart, the delivery sheath 9 is retracted or the relevant components of the locking device are pushed to remove the implant from the delivery sheath 9, the force application member 1 is pushed to the distal position to expand and anchor the implant in the heart, if the implant is not properly positioned, the force application member 1 can be retracted to move proximally, the implant is stretched to reduce the supporting force on the vessel wall, and the repositioning is again compressed. After proper positioning, release member 5 is moved proximally to release catch 404 on anchor member 4, holding the implant in a compressed state and securing the implant in place on the heart. The specific locking process will be described in detail in the following description of the parts. The relevant elements of the locking device can be made of medical metal materials such as nickel-titanium memory alloy, 305 stainless steel or 316 stainless steel which can be inserted into human bodies.

Fig. 9 shows a detailed construction of the urging member 1. This element is generally not used independently in the medical device, and it is necessary that 3 or more than 3 elements work together, and at the same time, the force application member 1, the connection member 3, and the release member 5 are disposed in equal amounts and correspond to each other. Wherein the distal end of the force application member is provided with a jaw 104, the jaw 104 being adapted to provide a point of application of force to the implant. The jaws are preferably double jaws 104, and during compression of the implant, the double jaws 104 push against the implant to compress it, at which point there is a rearward relative movement of the release member 5 and the attachment member 3 and the force application member 1. As shown in fig. 10, the force applying member is further provided with a concave surface 105, the concave surface 105 is disposed corresponding to the lock catch 404, so as to provide a receiving space for the ejected lock catch 404, the concave surface 105 is a key portion of the force applying member 1, and the concave space can smoothly release the lock catch 404 on the fixing member 4.

As shown in fig. 9, in order to facilitate the detachment of the proximal end portion of the implant during the release phase, a bevel 103 is provided on the force application member 1 for guiding the detachment of the proximal end of the implant from the locking means, while a flat surface 102 is provided at the proximal end of the bevel, the flat surface 102 being connected to the bevel 103, the flat surface 102 and the release member 5 being adapted to limit the deformation and/or displacement of the proximal end of the implant during the extension thereof, giving the implant a stable pulling force for feeding it into the delivery sheath 9.

As shown in fig. 9, the force application member 1 may further be provided with a fixing channel 101, where the fixing channel 101 is disposed at a proximal end or an intermediate position of the force application member 1, so as to provide a movement path for the release member 5 and the connection member 3, and ensure stability during the relative movement.

Example 3

Unlike embodiment 2, the locking device of this embodiment further comprises a force-bearing member 2, as shown in fig. 11-13, which corresponds to the number of force-applying members 1, which are sewn or otherwise secured to the valve holder 6 by means of holes 203. The force application piece 1 is matched with the force application piece 2, guide channels 202 which are in one-to-one correspondence with the clamping claws 104 are formed in the force application piece 2, the guide channels 202 are in clearance fit with the clamping claws 104, the problem that release is difficult due to large friction force caused by too tight fit is avoided, the distal end of the force application piece 1 is assembled in the force application piece 2, and after the valve system is completely released, the force application piece 1 can be released in the force application piece 2.

As shown in fig. 13, the stress element 2 is further provided with a guide groove 201, and the inner wall of the guide groove 201 is a guide plane of the fixing element 4, so that the proximal end of the fixing element 4 passes through the guide groove 201 and is detachably connected with the connecting element 3.

Example 4

This embodiment provides a delivery system, as shown in fig. 14, comprising the locking device, a delivery sheath 9 and delivery handles (10, 11, 12, 13), wherein the proximal ends of the components of the locking device are respectively connected with the delivery handles (10, 11, 12, 13), the locking device compresses and stretches the implant under the control of the delivery handles (10, 11, 12, 13), and the locking device is received in the delivery sheath 9 when stretched and is placed outside the delivery sheath 9 when compressed.

As shown in fig. 14, the delivery sheath 9 comprises an outer tube and an inner tube (not shown in the figures), the components of the locking device being connected to the inner tube and being controlled by a delivery handle (10, 11, 12, 13) comprising a grip 10, a first moving member 11, a second moving member 12 and a third moving member 13 arranged in sequence, the first moving member 11 controlling the movement of the delivery sheath 9, the second moving member 12 controlling the release member 5, the third moving member 13 controlling the force application member 1. In this embodiment, when the force applicator 1 is moved proximally, the implant is pulled into the delivery sheath 9, and the corresponding force applicator 1 is moved distally, compressing the implant into the vessel.

Fig. 15 shows a block diagram of the inner tube distal end protection net 20 in the delivery system. The protective mesh 20 may assist in sheathing the implant into the sheath 9. As shown in fig. 15, the protective net 20 has three protruding claws, and the three claws are inserted into one inflection point 19 of the wire to cross the valve holder 6. The number of claws of the protective net 20 may be equal to the number of all inflection points of the valve stent 6 minus the number of connectors 1.

In the present invention, the implant, locking means and related parts (including the delivery sheath 9 and inner tube) may be surface treated. In these embodiments, the surface of the component may be coated, for example: lubrication, hydrophilicity, protection, and other related coatings. For example: the lubricating coating can improve the maneuverability of the invention and reduce friction between parts; the protective coating may protect the implant from damage to the vessel wall and other body structures.

The assembly steps and the working principle of the conveying system of the invention are given below:

fig. 16 shows the implantation of the present invention into the aortic valve. As shown in fig. 16, the delivery system is passed through the aorta 16 to the diseased aortic valve AV of the patient, and the distance it extends into the left ventricle 14 is controlled as much as possible during implantation. To reduce the effects on the left and right coronary 17, 18 after implantation, the device may be repositioned after the implant is compressed. Once the position is confirmed, blood flow between the left ventricle 14 and the aorta 16 is complete through the invention and there is no adverse effect, and the mobile release 5 secures the implant in a compressed state. The medical device is fixed on a lesion site of a patient to replace a lesion leaflet to play a role.

A. Assembling step of conveying system

1. Assembling the locking device: as shown in fig. 1, the force-bearing members 2 are first evenly distributed and pre-fixed to the valve support 6, and the number of other locking elements of the locking device is required to be the same as the number of force-bearing members 2. After the force application member 1 and the force receiving member 2 are mounted, a moving channel for the connecting member 3, the releasing member 5 and the fixing member 4 is formed. The shape of the force application member 1 may be pre-shaped into an "S" shape suitable for locking movement. The release member 5 and the connecting member 3 pass through the inner cavity of the fixing passage 101 and pass through the moving passages of the connecting member 3, the release member 5 and the fixing member 4, and then are engaged with the fixing member 4.

2. Mounting of the valve holder 6: as shown in fig. 3, the valve holder 6 is placed outside the locking device and serves to fix the locking device related elements. Since the valve stent 6 is braided from wires (e.g., nitinol wires), its unique structure allows the valve stent 6 to stretch and compress under tension and pressure. When the holder 4 is moved distally, the valve holder 6 is in a stretched state, it being noted that the formation of its stretched state may also be caused by the distal movement of the delivery sheath 9. When the implant is moved out of the delivery sheath 9, the movable force applicator 1 places the valve holder 6 in compression.

3. Fixation of the delivery sheath 9 to the valve stent 6: the protective net at the distal end of the inner tube in the delivery sheath is extended out of the three jaws, which are respectively inserted into one inflection point 19 of the wire and placed across the valve holder 6.

B. Principle of operation of a conveying system

Fig. 17 shows an initial construction of the locking device in locking and a specific construction of how the locking device is assembled with the valve holder 6. The wire at the inflection point 19 is placed between the connector 3, the release member 5 and the force application member 1. The elastic force of the wire gives the connecting member 3 and the releasing member 5 outward, and at the same time, the connecting member 3 and the releasing member 5 are also pressed by the fixing path 101 to keep their positions against the elastic force of the wire. It can be seen that the connecting element 3 and the release element 5 have a certain bending deformation under different forces.

Fig. 18 shows a structure of the locking device in a mid-lock stage. During mid-lock, the force application member 1 is controlled to move distally by turning the third movement member 13 of the delivery handle, and the corresponding release member 5 and the connecting member 3 will move proximally relative to each other. As the force application member 1 moves, the valve holder 6 in the implant compresses, the distance between the wires decreases with the compression, and at this stage the wires in the area of the inflection point 19 are also subjected to the tensile force exerted by the surrounding wires, but due to the presence of the plane 102 in the force application member 1, the displacement of the wires is limited to the position of the plane 102.

Fig. 19 is a structural view showing the locking end of the locking device. As shown, at the end of the locking period, the release member 5 is controlled to move proximally by rotating the moving member 12 in the delivery handle, and as the catch 404 on the securing member 4 moves out of the lumen 501, the catch 404 resumes its set shape and catches the wire. Because the lock catch 404 can prop against the concave surface 105 of the force application member 1 after the shape is restored, and the wire has outward elasticity, the lock catch 404 can be completely fixed on the wire without falling off, and the locking function of the locking device is completed.

Fig. 20 shows a structure diagram of a lock device before release. In the early stage of release of the locking system, the moving part 12 in the delivery handle is continuously rotated to control the release member 5 to move proximally until the hook 301 and the hanging lug 405 are completely released, and the hanging lug 405 is separated from the pressure constraint given by the release member 5 and only has the outward elasticity of the wire, so that the hanging lug 405 can deform outwards. Similarly, the hook 301 will be adjacent to the concave surface 105 of the force application member 1. Thus, the two elements will deform inversely to separate.

Fig. 21 shows the locking device in a post-construction. The latter locking requires withdrawal of the force application member 1, and in one embodiment the option of pulling back the delivery handle directly or in another embodiment moving a third movement member 13 in the delivery handle controls the proximal movement of the force application member 1. As shown, the catch 404 is fully secured to the wire, the securing member 4 is in close proximity to the force applying member 2 and limits movement of the securing member 4 so that the securing member 4 can secure the implant in a compressed state without affecting the opening and closing of the leaflets 8. After the lock catch 404 is locked with the wire, the wire moves to the inclined plane 103 first, the wire moves to the upper edge of the double claw 104 with the continued proximal movement of the wire by the force application member 1, and finally the locking device is completely released with the double claw 104 moving out of the inner hole 202 of the force application member 2.

Fig. 22 shows a fully released view of the locking device. The locking device is completely separated from the implant, which is fixed into the blood vessel. To prevent scraping of the vessel wall by the locking means, the first moving part 11 of the delivery handle is moved, the delivery sheath 9 is moved distally, the components inside the vessel are fully retracted into the sheath 9, and the delivery handle is retracted to complete the surgical procedure.

The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any changes or substitutions easily contemplated by those skilled in the art within the scope of the present invention should be included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A locking device, comprising:

the fixing piece is provided with a distal end and a proximal end, an elastically deformable lock catch is arranged on the fixing piece, and the lock catch is arranged close to the proximal end of the fixing piece;

the connecting piece is detachably connected with the fixing piece;

when the release piece breaks away from the lock catch, the lock catch ejects out of the release piece, the lock catch is clamped at the proximal end of the implant, the distal end of the fixing piece is connected with the implant, the lock catch and the distal end of the fixing piece form two fixing points for the implant, so that the implant in a compressed state is limited, the rebound of the compressed and expanded implant is avoided, and when the release piece breaks away from the connecting part, the fixing piece is loosened from the connecting piece.

2. The locking device of claim 1, further comprising a force applying member for providing a pushing or pulling force to the implant to switch the implant between a compressed state and a stretched state.

3. The locking device of claim 2, wherein the connecting member, the release member and the force application member move independently of each other and are disposed in equal amounts relative to each other.

4. A locking device according to claim 2 or 3, wherein the force application member is further provided with a concave surface, the concave surface being arranged corresponding to the lock catch for providing a receiving space for the ejected lock catch.

5. A locking device as claimed in claim 2 or claim 3, wherein the distal end of the force application member is provided with a jaw for providing a point of application of force to the implant.

6. The locking device of claim 5, wherein the jaws are provided with a flat surface and a bevel surface in sequence at the proximal end, the flat surface being adapted to limit deformation and/or displacement of the proximal end of the implant, the bevel surface being adapted to guide disengagement of the proximal end of the implant from the locking device.

7. The locking device of claim 5, further comprising a force-bearing member disposed on the implant, wherein the force-bearing member defines guide channels in one-to-one correspondence with the jaws, and wherein the guide channels are in clearance fit with the jaws.

8. The locking device of claim 7, wherein the force-bearing member is further provided with a guide slot, and the proximal end of the securing member is removably coupled to the coupling member after passing through the guide slot.

9. A locking device as claimed in any one of claims 2 to 3 or 6 to 8, wherein the force applying member is provided with a securing channel through which both the connector and the release member are disposed.

10. A locking device according to any one of claims 1-3 or 6-8, wherein the securing member is a hook-type connection with the attachment member.

11. The locking device according to any one of claims 1-3, 6-8 and 10, wherein a receiving groove is formed in the fixing member at a position corresponding to the lock catch, and when the release member is sleeved outside the lock catch, the lock catch deforms into the receiving groove.

12. A locking device as claimed in any one of claims 1-3, 6-8, 10, wherein the release member consists essentially of an integrally formed connecting rod and an unlocking sleeve having an inner cavity with a V-shaped cross section.

13. A delivery system comprising a locking device according to any one of claims 1 to 12, a delivery sheath and a delivery handle, the proximal ends of the components of the locking device being connected to the delivery handle respectively, the locking device being adapted to compress and stretch the implant under the control of the delivery handle, the locking device being adapted to be received in the delivery sheath when stretched and to be positioned outside the delivery sheath when compressed.