CN121101813A - Circumferential positioning push rod for loading cardiac intervention valve, loading system and method - Google Patents

Abstract

The application provides a circumferentially positioning push rod for loading a heart intervention valve, a loading system and a method. The medical device comprises a push rod (60), a plurality of hanging lug locating grooves (63) and a locating part (64), wherein one end part of the push rod (60) in the axial direction is formed into a butt joint end (60 a), the peripheral wall of the push rod (60) at the butt joint end (60 a) is partially recessed to form the hanging lug locating grooves (63), the number and the positions of the hanging lug locating grooves (63) are matched with those of a heart intervention valve (F), each hanging lug locating groove (63) extends along the axial direction, the hanging lug can extend into the hanging lug locating groove (63) to be located in the circumferential direction, and the end wall of the butt joint end (60 a) is formed with the locating part (64) which can be in butt joint with a conveyer of the heart intervention valve. According to the circumferential positioning push rod, the loading of the heart valve can be realized to provide circumferential positioning, and the circumferential positioning push rod is simple in structure and convenient to use.

Description

Circumferential positioning push rod for loading cardiac intervention valve, loading system and method

The application takes China patent application with the application number 2023108558617 and the application date 2023, month 07 and day 13, named as a storage device and a transfer device of heart intervention valves as a mother case.

Technical Field

The application relates to the field of medical instruments, in particular to a circumferential positioning push rod for loading a heart intervention valve, a loading system and a method related to transcatheter valve replacement.

Background

Transcatheter valve replacement allows placement of a heart valve (hereinafter referred to as a valve) by minimally invasive interventional procedures, i.e., by introducing the valve transcatheter into the patient with very little surgical trauma.

Due to the structural complexity of heart access valves (e.g., telescoping biological valves), it is often necessary to attach the valve to a valve holder, with the valve being stored in a storage device along with the holder. During surgery, the operator removes the valve (typically along with the bioabsorbable stent) from the storage device, loads it into the catheter via another set of transfer devices, and introduces it further into the patient.

The valve storage device and the valve transfer device in the prior art are two independent devices, and the transfer of the valve during operation is a very complex operation.

For example, chinese patent publication CN114191143a discloses a valve loading tool (which can be analogous to the transfer device of the present application), and when using the tool to transfer a valve, the valve needs to be compressed in two steps, and the guide seat needs to be reversed in two steps. In addition, the loading of the valve by the loading tool is performed intraoperatively, i.e. the valve is loaded into the loading tool first, and then the valve is transferred in two steps. The device has high cost and great operation difficulty.

Meanwhile, when the heart intervention valve preloaded in the storage device is transferred and loaded to the conveyor, the hanging lugs on the valve support are connected with the top ring at the end part of the conveyor, the loading process needs to be aligned accurately to ensure that the hanging lugs can slide into the top ring smoothly, in the prior art, the alignment process mostly depends on experience of operators, and effective circumferential positioning is lacked, so that the operation difficulty is high and the time consumption is long.

Disclosure of Invention

The application aims to overcome or at least alleviate the defects in the prior art, and provides a circumferential positioning push rod for loading a heart intervention valve, a loading system and a method, wherein the circumferential positioning push rod is used for circumferentially positioning and butting the heart intervention valve and a conveyor, so that loading is realized.

According to a first aspect of the present application, there is provided a circumferential positioning push rod for loading a heart valve, one end of the push rod in an axial direction being formed as a butt end, the push rod being partially recessed in a peripheral wall at the butt end to form a plurality of lug positioning grooves, the number and positions of the lug positioning grooves being adapted to lugs of the heart valve, each of the lug positioning grooves extending in the axial direction, the lugs being capable of being positioned in the circumferential direction by being inserted into the lug positioning grooves,

A positioning part which can be docked with a conveyer of the heart intervention valve is formed at the end wall of the docking end.

In at least one embodiment, the push rod is hollow in a region near the butt joint end to form an inner cavity, and the butt joint end is formed into a bifurcation structure comprising a plurality of lobes which can be spread towards the radial outside after being stressed.

In at least one embodiment, the internal cavity of the butt end is formed as a tapered bore with a bore diameter that gradually decreases toward the end of the butt end.

In at least one embodiment, the inner diameter of the tapered bore at the point of greatest aperture is greater than the outer diameter of the end of the conveyor, and the inner diameter of the tapered bore at the point of least aperture is less than the outer diameter of the end of the conveyor.

In at least one embodiment, the positioning portion is a convex structure in the axial direction.

According to a second aspect of the present application, there is provided a heart valve loading system comprising:

The butt end of the push rod can penetrate through the compression main body and extend out from the small end of the compression main body;

a compression body having a tubular shape with a small end and a large end in an axial direction, the heart valve being capable of being partially pushed out of the small end, and a hanger of the heart valve being capable of extending into the hanger positioning groove;

a conveyor, the end part of which is provided with a pairing part paired with the positioning part and a top ring capable of connecting with a hanging lug of the heart intervention valve;

Wherein the top ring is aligned with the hanger positioning groove in a circumferential direction with the positioning portion abutted with the mating portion.

In at least one embodiment, the loading system further comprises a compression base that is at least partially extendable into the interior cavity of the compression body and slidable between a first position in the axial direction in which the compression base is capable of abutting against the heart valve received in the interior cavity and preventing the heart valve from falling out of the large end, and a second position in which the compression base is capable of partially pushing the heart valve out of the small end.

In at least one embodiment, the axial middle region of the push rod is formed with an annular limit portion that can abut against a portion of the compression base located within the compression body when the butt end of the push rod passes through the compression body and protrudes from the small end of the compression body.

According to a third aspect of the application, there is provided a method of loading a heart valve, using the loading system of the first aspect of the application, comprising the steps of:

After the hanging ear end of the heart intervention valve extends out of the small end of the compression body, the push rod penetrates through the compression body containing the heart intervention valve, so that the abutting end extends out of the small end of the compression body;

Adjusting the relative positions of the heart intervention valve and the push rod to enable the hanging lugs of the heart intervention valve to enter the hanging lug positioning grooves;

Abutting the mating portion of the conveyor with the positioning portion of the push rod such that the top ring of the conveyor is circumferentially aligned with the lug positioning groove of the push rod;

the compression main body is enabled to displace relative to the push rod in the direction of the axial butt joint part, and the hanging lugs of the heart intervention valve are driven to slide into the top ring of the conveyor, so that loading is completed.

In at least one embodiment, when the end of the conveyor is docked with the locating portion, the end of the conveyor presses the pushrod lobes radially apart and into the inner cavity of the pushrod.

According to the circumferential positioning push rod and the loading system, circumferential positioning loading of the heart valve is realized, and the system is simple and convenient to use.

Drawings

Fig. 1 is a schematic structural view of a transfer device for a heart valve in accordance with one embodiment of the present application.

Fig. 2 is a cross-sectional view of fig. 1.

Fig. 3 is an exploded schematic view of fig. 1.

Fig. 4 and 5 are exploded views of a portion of the structure of fig. 1.

Fig. 6 is a cross-sectional view of a portion of the structure of a storage device for a heart valve in accordance with one embodiment of the present application.

Fig. 7 is an exploded schematic view of a compression body and compression base of a storage device for a heart valve in accordance with one embodiment of the present application.

Fig. 8 is a schematic structural view of a storage device for a heart valve in accordance with an embodiment of the present application.

Fig. 9 is a cross-sectional view of a storage device for a heart valve in accordance with an embodiment of the present application with the valve pre-loaded.

Fig. 10 is a schematic view of the compression base of fig. 9 being pushed into a second position.

Fig. 11 is a schematic view of a pushrod extending into a storage device of a heart valve intervention according to an embodiment of the present application.

Fig. 12 is a schematic view of the pushrod of fig. 11.

Fig. 13 and 14 are schematic diagrams in cross-section during docking of a sheath of a transfer device of a heart valve interventional procedure with a compression body, according to one embodiment of the application.

Fig. 15 is a schematic structural view of a sheath feeder of a transfer device of a heart valve in accordance with an embodiment of the present application.

Fig. 16 is a cross-sectional view of fig. 15.

Fig. 17-19 are schematic illustrations of a process of transferring a valve from a storage device to a sheath feeder using a transfer device of a heart access valve according to one embodiment of the application.

Reference numerals illustrate:

10. The compression body comprises a compression body, an outer clamping arm, a 110-ring matching part, a 12-outlet cylinder part, a 12g first gap, an inner clamping arm, a 121-pipe matching part, a 13-buckle first matching part, a 14-buckle second matching part and a 15-chute;

20. A compression base, a base body, a clasp, 22;

30. Sheath feeding device, 31 first section, 311 first section large area, 312 first section small area, 313 first step surface, 32 second section, 33 third section, 34 clamping groove and 35 hook part;

40. A 41-ring mating portion;

50. a 51-pipe mating part;

60. the device comprises a push rod, a 60a butt joint end, a 61 gap, 62 lobes, 63 hanging ear positioning grooves, 64 positioning parts, 65 taper holes, 66 limiting parts and 70 guide pipes.

Detailed Description

Exemplary embodiments of the present application are described below with reference to the accompanying drawings. It should be understood that these specific illustrations are for the purpose of illustrating how one skilled in the art may practice the application, and are not intended to be exhaustive of all of the possible ways of practicing the application, nor to limit the scope of the application.

Unless otherwise specified, referring to fig. 1, axial, radial, and circumferential directions, hereinafter, are referred to as axial, radial, and circumferential directions of the compression body.

Referring to fig. 1 to 4, a storage device (hereinafter, simply referred to as a storage device) of a heart valve according to the present embodiment includes a compression body 10, a compression base 20, a fixing ring 40, and a sliding tube 50. The transfer device of the heart valve according to the present embodiment (hereinafter referred to as transfer device) includes the above-described storage device and the sheath feeder 30 and the pusher bar 60, or may further include a conveyor and a guide tube 70.

The storage device according to the present embodiment has both storage and transfer functions for the valve. Prior to surgery, the valve may be pre-stored in a storage device, for example, the valve may be loaded into the storage device in a sterile production plant. During operation, the particular configuration of the storage device may allow the valve to be conveniently and gradually withdrawn for transfer to the guide tube 70 via the introducer sheath 30.

Next, referring first to fig. 1 to 10, a specific structure and a method of using the storage device will be described.

The compression body 10 has a tubular shape with a large end and a small end. The valve F may be preloaded via the large end of the compression body 10 into the lumen of the compression body 10. The small end of the compression body 10 provides an outlet for the valve F to undergo compression transfer during surgery.

Referring to fig. 7, a chute 15 extending in the axial direction is formed on the wall of the compression body 10. In the axial direction, one end of the chute 15 is closed, which is close to the small end of the compression body 10, and the chute 15 extends from the closed end to the large end of the compression body 10 and forms an open opening at the large end. The chute 15 provides a motion guide, or limit stop, for the compression base 20.

The compression base 20 is adapted to be disposed at the large end of the compression body 10, and to act as a fixation and/or push for the valve F. The compression base 20 includes a base body 21 and a catch 22.

The base body 21 is adapted to extend into the lumen of the compression body 10 and to rest against the valve F. Optionally, the base body 21 forms a clearance fit or a transition fit with the compression body 10. Alternatively, the outer circumferential surface of the end portion of the base body 21 for facing the small end of the compression body 10 is substantially tapered so that the compression base 20 does not interfere with the inner wall of the compression body 10 at the small end during the subsequent movement.

A catch 22 is attached to the outer periphery of the base body 21, the catch 22 being adapted to extend through the chute 15 to the outside of the compression body 10. Preferably, in the circumferential direction of the compression body 10, the root of the catch 22 housed in the runner 15 is adapted to the runner 15, so that the runner 15 acts as a limit for the catch 22, so that the compression base 20 can only translate axially along the runner 15.

The compression body 10 is also formed on the outer peripheral wall thereof with snap first fitting portions 13 and snap second fitting portions 14 spaced apart in the axial direction. The clip 22 has a hook-like structure at its tail portion, and can be snapped with the clip first mating portion 13 or the clip second mating portion 14, so as to define the axial position of the compression base 20 on the compression body 10.

For example, referring to fig. 9, in this state, the latch 22 is engaged with the latch first engaging portion 13, and the compression base 20 is also referred to as a first position in the axial direction of the compression body 10. This position is a pre-device position of the valve F, which can be fixed in a suitable configuration in the lumen of the compression body 10.

Referring to fig. 10, in this state, the latch 22 is engaged with the latch second engaging portion 14, and the compression base 20 is also referred to as a second position in the axial direction of the compression body 10. This position is the position where the valve F starts to be transferred, and the valve F partially protrudes from the small end of the compression body 10 by being pushed by the compression base 20.

The retaining ring 40 and the slide tube 50 provide assistance for radial compression and smooth transfer of the valve F.

The slide tube 50 is intended to be disposed at the small end of the inner cavity of the compression body 10. The inner wall of the slide tube 50 is formed in a tapered shape, and the inner diameter of the slide tube 50 is smaller as it is closer to the small end, so that the valve F can be gradually compressed during the transfer of the valve F.

Specifically, an outlet cylinder 12 is formed at the small end of the compression body 10. The outlet cylinder 12 is formed with four axially extending first slits 12g, and a spring-like inner clip arm 120 is defined between circumferentially adjacent ones of the first slits 12 g. The inner clip arms 120 can be slightly shifted in the radial direction to provide a hugging and releasing action on the slide tube 50.

Preferably, the inner clip arm 120 is formed with a protruding pipe fitting portion 121 on the radially inner side. The slide tube 50 has an annular groove-shaped tube mating portion 51 formed on the outer periphery thereof. With the slide tube 50 mounted on the outlet cylinder 12, the tube fitting 121 projects into the tube counterpart 51, or the tube fitting 121 engages with the tube counterpart 51 in a form-fitting manner, so that the slide tube 50 is axially limited relative to the outlet cylinder 12.

The fixing ring 40 is used to be sleeved on the outer periphery of the outlet cylinder 12, so as to prevent the inner clamping arm 120 from being elastically deformed towards the radial outer side. Specifically, the small end of the compression body 10 is further formed with two cantilever-shaped outer clamp arms 11 at the outer circumference of the outlet cylinder 12, and in the case that the fixing ring 40 is sleeved to the outer circumference of the outlet cylinder 12, the outer clamp arms 11 can clamp the fixing ring 40 around to achieve positioning of the fixing ring 40. Alternatively, the inner diameter of the retaining ring 40 is equal to or slightly smaller than the outer diameter of the outlet barrel 12, and the outer diameter of the retaining ring 40 is equal to or slightly larger than the inner diameter of the region defined by the outer clip arms 11.

In the present embodiment, the outer periphery of the fixing ring 40 is formed into a ring-shaped ring mating portion 41 having a convex tooth shape, and the inner peripheral wall of the outer clip arm 11 is formed into a recessed ring mating portion 110. In the case of a fastening ring 40 which is fitted over the outlet cylinder 12, the ring counterpart 41 projects into the ring counterpart 110, or the ring counterpart 41 engages in a form-locking manner with the ring counterpart 110, so that the fastening ring 40 is axially limited relative to the outlet cylinder 12 or the outer clamping arm 11.

The cooperation of the fixing ring 40 with the outer clip arm 11 forms a locking means for the slide tube 50. When the outer clip arms 11 hold the fixing ring 40, the locking device is locked, the sliding tube 50 is fixed at the small end of the inner cavity of the compression body 10, when the fixing ring 40 is separated from the clamping of the outer clip arms 11, the locking device is unlocked, the sliding tube 50 can press the inner clip arms 120 to deform and expand outwards under the condition of axial force, and then the sliding tube 50 can leave the inner cavity of the compression body 10 from the small end, so that the valve F can be conveniently transferred later.

The reader will now understand how the storage device pre-stores the valve F and how, in the event that it is desired to transfer the valve F, the valve F is gradually exposed to the compression body 10 in a radially contracted manner from the small end of the compression body 10 by pushing or pressing the compression base 20. During the gradual exposure of the valve F, the slide tube 50 is locked at the outlet of the small end, acting as a aid to the contraction of the valve F.

Next, a transfer device according to the application and a transfer procedure thereof to the valve F will be described.

After one end of the valve F is exposed to the compression body 10, the valve F can be articulated to the conveyor by means of the push rod 60.

The conveyor is not shown in the figures. It will be appreciated that the delivery device has a delivery guidewire and a tip ring at the end that can be attached to a hanger (not shown) at the valve F. The connection structure of the delivery device and the valve F is known in the art, and reference is made here to the utility model CN213641419U previously filed by the inventor. The entire content of the present utility model is incorporated into the present utility model, and the relevant structure is not described in detail.

The push rod 60 can provide a guide for the attachment of the lugs of the valve F to the top ring of the conveyor.

In an embodiment of the present application, a circumferentially positioned pushrod for loading a heart valve is disclosed, referring to fig. 11 and 13, one end of the pushrod 60 is formed as a butt end 60a for butt-joint with the end of a conveyor. The docking end 60a is hollow and the tip of the conveyor can extend into the interior of the docking end 60 a.

To avoid accidental removal of the tip of the conveyor after it enters the push rod 60, the interior of the abutment end 60a is formed as a tapered bore 65, with the bore diameter of the tapered bore 65 being smaller closer to the end. The inner diameter of the tapered bore 65 at the largest bore diameter is greater than the outer diameter of the tip of the conveyor, and the inner diameter of the tapered bore 65 at the smallest bore diameter is less than the outer diameter of the tip of the conveyor.

While the abutment end 60a is formed in a bifurcated configuration for facilitating access of the delivery tip into the interior cavity of the push rod 60. In this embodiment, the butt end 60a includes three lobes 62, and gaps 61 are formed between adjacent lobes 62. The tapered bore 65 can then be opened by pressing the lobes 62 radially outward at the tip of the conveyor, and after the tip has completely entered the lumen of the pushrod 60, the lobes 62 are repositioned to receive the tip in the lumen of the pushrod 60.

An annular flange-like stopper 66 is formed in an axially middle region of the push rod 60. During the extension of the push rod 60 into the compression body 10 such that the butt end 60a extends from the small end of the compression body 10, the stop 66 will abut against the portion of the compression base seat 20 within the compression body 10 to indicate to the operator that the push rod 60 has been extended into position, with the lobes 62 fully extending out of the compression body 10.

The outer peripheral wall of the push rod 60 is formed with a plurality of (3 in this embodiment) axially extending lug positioning grooves 63 at the abutting end 60 a. The width of the lug positioning groove 63 in the circumferential direction is adapted to the width of the lug of the valve F, so that the lug of the valve F can be accommodated in the lug positioning groove 63 exactly. The push rod 60 is formed with a plurality of (3 in the present embodiment) axially protruding positioning portions 64 at the end wall located at the abutting end 60 a.

Although not shown in the drawings, it is understood that the end of the conveyor is formed with a counterpart that interfaces with the positioning portion 64. With the positioning portion 64 abutting against the mating portion, the lug positioning groove 63 is aligned in the circumferential direction with the top ring at the end of the conveyor. In this case, after the lugs of the valve F are pushed into the lug positioning grooves 63, the valve F is pushed further in the axial direction, and the lugs can smoothly enter the top ring at the end part of the conveyor to achieve butt joint.

In an embodiment of the present application, a method for loading a heart valve is disclosed, and the specific loading method may refer to fig. 11 (the valve F and the conveyor are not shown in the drawing), after the hanging end of the valve F extends from the small end of the compression body 10, the push rod 60 is passed through the compression body 10, so that the docking end 60a also extends from the small end of the compression body 10.

The tip of the delivery device is then extended into the lumen of the push rod 60. The relative position between the valve F and the push rod 60 is adjusted so that the lugs of the valve F enter the lug positioning grooves 63. And the positioning portion 64 is brought into abutment with the counterpart portion of the conveyor end.

Then, the compression body 10 is displaced relative to the push rod 60 in the axial direction toward the abutting portion 60a, and the lugs of the valve F are driven to slide into the top ring at the end of the conveyor, so that the valve F is loaded with the conveyor.

After this, the valve F needs to be further contracted into the interior of the guide tube 70 by means of the sheath introducer 30. The sheath driver 30 has a large diameter section and a small diameter section inside, and the valve F will first enter the large diameter section and then gradually be pulled into the small diameter section to achieve radial contraction. The transfer device according to the present application skillfully utilizes the connection structure of the sheath feeder 30 and the compression body 10, and realizes the transfer of the sliding tube 50 to the interior of the sheath feeder 30 following the movement of the valve F.

In the embodiment of the application, a loading system is disclosed, which comprises a compression body 10, a push rod 60, a conveyor and other structures, wherein when the positioning part 64 of the push rod is in butt joint with the counterpart part of the conveyor, the top ring is aligned with the hanging lug positioning groove 63 in the circumferential direction, the hanging lugs of the valve F slide into the top ring at the end part of the conveyor, and the valve F is loaded with the conveyor.

Next, with reference to fig. 13 to 19, a specific structure of the sheath feeding device 30 and a method of using the same will be described.

The sheath feeder 30 is in the shape of a variable diameter tube and comprises a first section 31, a second section 32 and a third section 33. The first section 31 has the largest inner diameter, the second section 32 has the smallest inner diameter, and the third section 33 has the smallest inner diameter. The second section 32 and the third section 33 define a second step surface 36 therebetween.

The first section 31 is for fitting over the outer periphery of the small end of the compression body 10, the maximum inner diameter of the first section 31 is not smaller than the outer diameter of the outlet cylinder 12, and the minimum outer diameter of the first section 31 is not larger than the minimum inner diameter of the inscribed circle of the inner clip arm 11.

The second section 32 is a transition zone, also corresponding to the large diameter section described above, for smooth transfer of the valve F from the compression body 10 to the introducer 30. The outer diameter of the second section 32 is not smaller than the outer diameter of the slide tube 50.

The third section 33 is a small diameter section for further collapsing the valve F.

The first section 31 further includes a first section large area 311 and a first section small area 312, the inner diameter of the first section large area 311 is larger than the inner diameter of the first section small area 312, and a first step surface 313 is formed between the first section large area 311 and the first section small area 312. The inner diameter of the first section large area 311 is not smaller than the outer diameter of the fixed ring 40, and the inner diameter of the first section small area 312 is smaller than the outer diameter of the fixed ring 40. Thus, during the process of the first section 31 being sleeved on the small end of the compression body 10, the first step surface 313 presses the fixing ring 40 in the axial direction, so that the fixing ring 40 is released from the outer clip arm 11. Once the securing ring 40 is disengaged from the outer clip arms 11, this means that the locking of the slide tube 50 is released.

Optionally, the peripheral wall of the first section 31 is formed with a notch 34, the notch 34 being just capable of receiving the outer clip arm 11. The bottom of the notch 34 is formed with a hook 35, and the hook 35 can be engaged with the end of the outer clip arm 11. Referring to fig. 14, after the fixing ring 40 is pushed by the sheath feeding device 30 to be separated from the binding of the outer clip arm 11, the sheath feeding device 30 is pushed to the bottom, and the hook 35 can be just buckled by the end of the outer clip arm 11, so that the firm connection between the sheath feeding device 30 and the compression body 10 is realized.

After this, referring to fig. 17-19, if the conveyor (not shown) to which the valve F has been connected is pulled further, the valve F will first pull the slide tube 50 away from the outlet barrel 12. This is because the uncontracted portion of the valve F will exert an axial force on the slide tube 50, tending to move the slide tube 50 in the direction of the second stepped surface 36 of the sheath feeder 30, during which the inner clip arms 120 will be forced radially outwardly. Also, since the inner diameter of the first section 31 is slightly larger than the outer diameter of the outlet barrel 12, the stressed inner clip arms 120 will elastically deform radially outwardly, releasing the slide tube 50. The released slide tube 50 will eventually abut the second step surface 36 with the movement of the valve F.

During this process, the slide tube 50 is moved away from the outlet barrel 12, freeing up radial space in the outlet barrel 12, and allowing the valve F to enter the sheath introducer 30 more smoothly. In addition, the slide tube 50 abutting the second step surface 36 can also exert a secondary guiding action there, providing guidance for the contraction of the valve F in the third section 33.

Thereafter, the conveyor connected to the valve F is pulled further, the valve F can be further contracted in the third section 33 and finally collapsed into the guide tube 70.

It will be appreciated that the above-described embodiments and portions of aspects or features thereof may be suitably combined.

The present application has at least one of the following advantages:

(i) The storage device according to the application can be pre-loaded with the valve and can be part of the transfer device during transfer of the valve.

(Ii) In case a transfer of the valve is required, the storage device can be pushed from the first position to the second position by a very simple operation, i.e. pushing the seat from the first position to the second position, so that the valve is partly extended.

(Iii) The smart matching of the fixed ring and the slide tube enables the transfer of the valve to be completed simply and smoothly. The sliding tube can play a guiding role when the valve extends out of the compression body for the first time, can enter the interior of the sheath inlet device when the sheath inlet device is in butt joint with the compression body, can open a channel at the outlet of the compression body when the valve is suitable, and can be reused in the interior of the sheath inlet device.

(Iv) The hanging lug positioning groove and the positioning part positioned on the push rod can realize automatic alignment of the valve and the top ring of the conveyer, so that the valve and the conveyer are accurately and conveniently loaded.

Of course, the present application is not limited to the above-described embodiments, and various modifications may be made to the above-described embodiments of the present application by those skilled in the art in light of the present teachings without departing from the scope of the present application. For example:

(i) The number of the outer clip arms 11, the inner clip arms 120, and the lobes 62 is not limited in the present application.

(Ii) The specific shape of all positioning or limiting members is not limited in the present application, for example, the ring mating portion 41 may be a concave ring structure, and the corresponding ring mating portion 110 may be a convex structure.

Claims (10)

1. A circumferential positioning push rod for loading a heart intervention valve is characterized in that one end part of the push rod (60) in the axial direction is formed into a butt joint end (60 a), the peripheral wall of the push rod (60) at the butt joint end (60 a) is partially recessed to form a plurality of hanging lug positioning grooves (63), the number and the positions of the hanging lug positioning grooves (63) are matched with those of a heart intervention valve (F), each hanging lug positioning groove (63) extends along the axial direction, and the hanging lugs can extend into the hanging lug positioning grooves (63) to be positioned in the circumferential direction,

A positioning portion (64) capable of docking with a conveyor of the heart valve is formed at an end wall of the docking end (60 a).

2. The circumferentially positioned pushrod for loading a heart valve according to claim 1, characterized in that the pushrod (60) is hollow in the region close to the abutment end (60 a) forming an inner cavity, the abutment end (60 a) being formed as a bifurcated structure comprising a plurality of lobes (62), the plurality of lobes (62) being expandable radially outwards upon being stressed.

3. The circumferential positioning push rod for loading a heart valve according to claim 1, wherein the inner cavity of the abutting end (60 a) is formed as a tapered hole (65), and the aperture of the tapered hole (65) gradually decreases toward the end of the abutting end (60 a).

4. A circumferentially positioned pushrod for loading a heart valve according to claim 3, characterized in that the inner diameter of the tapered bore (65) at the maximum aperture is larger than the outer diameter of the end of the delivery device, and the inner diameter of the tapered bore (65) at the minimum aperture is smaller than the outer diameter of the end of the delivery device.

5. The circumferential positioning push rod for loading a heart valve according to claim 1, wherein the positioning portion (64) is of a convex structure in the axial direction.

6. A heart valve loading system, comprising:

the pushrod (60) of any one of claims 1-5, a butt end (60 a) of the pushrod (60) being insertable through the compression body (10) and extending from a small end of the compression body (10);

-a compression body (10) having a tubular shape with a small end and a large end in the axial direction, the heart valve (F) being able to be pushed partly out of the small end and the lugs of the heart valve (F) being able to extend into the lug positioning slots (63);

A conveyor, the end of which is formed with a counterpart to the positioning part (64) and a top ring to which the lugs of the heart valve (F) can be connected;

wherein the top ring is aligned in the circumferential direction with the lug positioning groove (63) with the positioning portion (64) abutting against the mating portion.

7. The heart valve loading system of claim 6, further comprising a compression base (20), the compression base (20) being capable of extending at least partially into the interior cavity of the compression body (10) and sliding between the first and second positions in the axial direction, the compression base (20) being capable of abutting against the heart valve (F) received in the interior cavity and preventing the heart valve (F) from falling out of the large end with the compression base (20) in the first position and the compression base (20) being capable of pushing the heart valve (F) partially out of the small end with the compression base (20) in the second position.

8. The heart valve loading system of claim 7, wherein an axially central region of the pushrod (60) is formed with an annular stop (66), the stop (66) being capable of abutting against a portion of the compression base (20) located within the compression body (10) when the abutment end (60 a) of the pushrod (60) passes through the compression body (10) and protrudes from the small end of the compression body (10).

9. A method of loading a heart valve, using the loading system of claim 6, comprising the steps of:

after the lug end of the heart valve (F) protrudes from the small end of the compression body (10), the push rod (60) is inserted through the compression body (10) containing the heart valve (F) so that the butt end (60 a) protrudes from the small end of the compression body (10);

Adjusting the relative positions of the heart intervention valve (F) and the push rod (60) to enable the hanging lugs of the heart intervention valve (F) to enter the hanging lug positioning grooves (63);

abutting the mating portion of the conveyor with a positioning portion (64) of the push rod (60) such that a top ring of the conveyor is circumferentially aligned with a lug positioning groove (63) of the push rod (60);

the compression main body (10) is enabled to displace relative to the push rod (60) in the axial direction towards the butt joint part (60 a), and the hanging lugs of the heart intervention valve (F) are driven to slide into the top ring of the conveyor, so that loading is completed.

10. The method of claim 9, wherein the end of the delivery device presses the petals (62) of the pushrod (60) radially apart and into the lumen of the pushrod (60) when the end of the delivery device is docked with the positioning portion (64).