Disclosure of Invention
The invention discloses a prosthetic valve conveying device and a prosthetic valve conveying system, and aims to solve the technical problems in the prior art.
The invention adopts the following technical scheme:
in one aspect, the present invention provides a prosthetic valve delivery device comprising a capsule portion and a catheter portion;
the capsule part comprises a near-end capsule part, a loading part and a far-end capsule part which are axially and sequentially arranged, wherein the near-end capsule part and the far-end capsule part are axially connected in a conveying state and are in a capsule shape, and the loading part is arranged in the far-end capsule part;
the loading part is sequentially provided with a proximal guide section, a coaxial section and a distal guide section from the proximal end to the distal end, the proximal guide section extends from the distal end to the proximal end towards the axis of the loading part, the distal guide section extends from the proximal end to the distal end towards the axis of the loading part, the diameter of the outer surface of the coaxial section is consistent, the coaxial section, the proximal capsule part and the distal capsule part are coaxially arranged, and the coaxial section is provided with a fixing groove for connecting a prosthetic valve;
the catheter part comprises a first control tube, a second control tube and a third control tube which are sequentially sleeved from inside to outside, the first control tube, the second control tube and the third control tube can axially slide relative to each other, the distal end of the first control tube is fixedly connected with a distal capsule part, the distal end of the second control tube is fixedly connected with a loading part, and the distal end of the third control tube is fixedly connected with a proximal capsule part.
As a preferred solution, at least a partial region of the circumferential outer side of the distal guide section is configured as a distal guide structure extending obliquely from the proximal end to the distal end towards the axis of the load member, the angle of inclination of the distal guide structure being α, α < 90 °.
As a preferred embodiment, the distal guide structure is configured as a cone, a truncated cone, a semi-sphere or a semi-ellipsoid.
As a preferred solution, the distal guiding structure is configured as a plurality of obliquely arranged plate-like structures or rod-like structures, which are circumferentially distributed between them.
As a preferred solution, at least a partial region of the circumferential outer side of the proximal guide section is configured as a proximal guide structure extending obliquely from the distal end to the proximal end towards the axis of the load member, the angle of inclination of the proximal guide structure being β < 90 °.
As a preferred solution, the proximal guide structure is configured as conical, frustoconical, semi-spherical or semi-ellipsoidal.
As a preferred solution, the proximal guiding structure is configured as a plurality of obliquely arranged plate-like structures or rod-like structures, which are circumferentially distributed between them.
As a preferred solution, the axial length of the distal guide section is the same or different from the axial length of the proximal guide section.
As a preferable technical scheme, the outer diameter of the coaxial section is matched with the inner diameter of the far-end capsule piece and/or the near-end capsule piece, and the outer diameter of the coaxial section is slightly smaller than the inner diameter of the far-end capsule piece and/or the near-end capsule piece.
As the preferable technical proposal, at least one fixed groove is internally provided with an elastic limiting piece which can be compressed and rebounded along the radial direction; the elastic limiting piece is inwards concave in the fixed groove in a compression state, and outwards convex outside the fixed groove in a rebound state; the outer diameter of the coaxial section in the rebound state of the elastic limiting piece is slightly larger than the inner diameters of the far-end capsule piece and the near-end capsule piece, and/or the outer diameter of the coaxial section in the rebound state of the elastic limiting piece is not larger than the outer diameters of the far-end capsule piece and the near-end capsule piece.
As the preferable technical scheme, the near end of the far-end capsule part and/or the far end of the near-end capsule part are/is provided with a limit groove which can be matched with the elastic limit part in the rebound state.
As a preferable technical scheme, the axial length of the near-end capsule part is smaller than that of the far-end capsule part, and the outer diameter of the near-end capsule part is the same as that of the far-end capsule part.
In another aspect, the present invention also provides a prosthetic valve delivery system comprising a prosthetic valve delivery device according to any one of the preceding claims and a prosthetic valve; the distal end of the prosthetic valve is provided with a connector that releasably connects with a securing slot on the loading element of the prosthetic valve delivery device.
The technical scheme adopted by the invention can achieve the following beneficial effects:
the invention mainly provides a prosthetic valve conveying device and a system, wherein the prosthetic valve conveying device comprises a capsule part and a catheter part, the capsule part is in a capsule shape when being conveyed and recovered, the prosthetic valve is loaded in the capsule part after being compressed and is radially constrained by the capsule part, the capsule part consists of a far-end capsule part, a loading part and a near-end capsule part, the far-end capsule part, the loading part and the near-end capsule part are respectively connected with a first control pipe, a second control pipe and a third control pipe in the catheter part, the three control pipes are sequentially arranged from inside to outside, and the separation of the near-end capsule part and the far-end capsule part can be realized through the movement of the first control pipe and the third control pipe.
Further, guide structures are arranged at two ends of the loading piece of the capsule part, the middle part is a coaxial section, the guide structures at the two ends can guide the near-end capsule part and the far-end capsule part to gradually tend to be coaxial when being recovered, and the damage to a patient caused by scraping blood vessels or tissues when the capsule part is retracted is avoided.
In addition, can still further set up the elasticity locating part in the fixed slot of loading piece, the elasticity locating part can compress when carrying to rebound when the valve release, after the elasticity locating part rebound, on the one hand can assist the release of prosthetic valve, avoid the connecting piece of valve to block and cause the release failure, on the other hand can avoid near-end capsule to surpass coaxial section in the removal in-process to cause far-end capsule unable by distal end guide structure and guide.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
In the description of the present invention, it should be noted that the terms "mounted," "connected," and "connected" are to be construed broadly, unless otherwise specifically defined and limited. In addition, in the description of the present application, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance. The term "proximal" as used herein refers to the end of the prosthetic valve delivery device that is proximal to the operator in the longitudinal direction of the prosthetic valve delivery device, and the term "distal" refers to the end of the prosthetic valve delivery device that is distal to the operator in the longitudinal direction of the prosthetic valve delivery device. As described herein, "capsule," "conical," "frustoconical," "hemispherical," "semi-ellipsoidal," and the like are not absolute or standard shapes, but may be generally presented relative shapes, and the like. Those skilled in the art will appreciate that the specific shape/size/angle, etc. of each structure may be adapted to achieve the respective function while meeting the requirements of the surgical procedure.
It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. 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.
To solve the problems in the prior art, the embodiment of the present application provides a prosthetic valve delivery device, including a capsule portion 10 and a catheter portion 20; the capsule part 10 comprises a proximal capsule part 13, a loading part 12 and a distal capsule part 11 which are axially arranged in sequence, wherein the proximal capsule part 13 and the distal capsule part 11 are axially connected in a conveying state and are in a capsule shape, and the loading part 12 is arranged between the two; the loading piece 12 is sequentially provided with a proximal guide section, a coaxial section 122 and a distal guide section from the proximal end to the distal end, wherein the proximal guide section extends from the distal end to the proximal end towards the axis of the loading piece 12, the distal guide section extends from the proximal end to the distal end towards the axis of the loading piece 12, the diameter of the outer surface of the coaxial section 122 is consistent, the coaxial section 122 is coaxially arranged with the proximal capsule piece 13 and the distal capsule piece 11, and the coaxial section 122 is provided with a fixed groove 1221 for connecting the artificial valve 30; the catheter part 20 comprises a first control tube 21, a second control tube 22 and a third control tube 23 which are sleeved in sequence from inside to outside, wherein the first control tube 21, the second control tube 22 and the third control tube 23 can axially slide relative to each other, the distal end of the first control tube 21 is fixedly connected with the distal capsule part 11, the distal end of the second control tube 22 is fixedly connected with the loading part 12, and the distal end of the third control tube 23 is fixedly connected with the proximal capsule part 13.
Example 1
The present embodiments provide a prosthetic valve delivery device that is preferably adapted for delivery and release of a prosthetic mitral valve; in this embodiment, the prosthetic valve 30 assumes a compressed cylindrical configuration upon delivery, radially expands after release at the native annulus, and the prosthetic valve 30 in its expanded state can be supported and secured at the native annulus to replace the physiological function of the native valve. Preferably, the prosthetic valve 30 described in this embodiment is a self-expanding prosthetic valve 30 whose valve holder is made of a shape memory alloy that is capable of radial self-expansion upon loss of radial constraint and anchoring at the native annulus.
It should be noted that, the prosthetic valve delivery device in this embodiment does not include the prosthetic valve 30 itself, and the specific structure of the prosthetic valve 30 is not limited in this embodiment because the prosthetic valves 30 of different manufacturers have a certain difference in structure after being expanded.
As shown in fig. 1 to 3, the prosthetic valve delivery device includes a capsule part 10 and a catheter part 20, the capsule part 10 being disposed at a distal end for loading and releasing the prosthetic valve 30, and a plurality of pipe members in the catheter part 20 being connected to respective elements in the capsule part 10, respectively, and the separation and reconnection at the time of the capsule part 10 being enabled by the axial relative movement of the plurality of pipe members.
In a preferred embodiment, the capsule part 10 is in a capsule shape when in delivery, the capsule part 10 comprises a proximal capsule part 13, a distal capsule part 11 and a loading part 12 arranged between the proximal capsule part 13 and the distal capsule part, the loading part 12 is used for connecting a compressed artificial valve 30, the catheter part 20 comprises a first control tube 21, a second control tube 22 and a third control tube 23 which are sequentially arranged from inside to outside, the distal end of the first control tube 21 is fixedly connected with the distal capsule part 11, the inside of the first control tube can be fixedly connected with the loading part 12 through a guide wire, the distal end of the second control tube 22 is fixedly connected with the proximal capsule part 13, the proximal end of the catheter part 20 is arranged outside the body, and the axial movement of the first control tube 21 and the second control tube 22 is realized through external operation.
17 a-17 d, in a preferred embodiment, upon release of the prosthetic valve 30, the second control tube 22 and its attached carrier 12 remain stationary, the third control tube 23 moves proximally relative to the second control tube 22, driving its attached proximal capsule 13 to retract proximally, the inflow end of the prosthetic valve 30 is exposed first, and then the first control tube 21 moves distally relative to the second control tube 22, driving its attached distal capsule 11 to retract distally, releasing the body of the prosthetic valve 30, completing replacement of the valve; when the capsule part 10 is recovered, the third control tube 23 is controlled to move distally to advance the connected proximal capsule part 13 distally, and the first control tube 21 is controlled to move proximally to retract the connected distal capsule part 11 proximally, so that the reconnection of the proximal capsule part 13 and the distal capsule part 11 is finally realized, and the capsule part is formed into a capsule shape together with the loading part 12 and then is withdrawn from the body.
In a preferred embodiment, the distal capsule 11 is fixedly connected to the distal end of the first control tube 21 by means of bonding, hot melting or threading, and the distal end of the distal capsule 11 is provided with a guide head, in which an axially through channel is provided, the channel being in communication with the first control tube 21 for the passage of a guide wire, the middle and proximal ends of the distal capsule 11 being substantially tubular for receiving the loading element 12 and the prosthetic valve 30 in a compressed state and radially constraining and supporting the prosthetic valve 30 to facilitate the axial transport of the whole delivery device in the body while avoiding the radial pressure of the intravascular blood pressure on the delivery device.
As shown in fig. 4, the middle and proximal ends of the distal capsule member 11 preferably have the same inner diameter a, which is slightly larger than the outer diameter of the loading member 12 and the outer diameter of the prosthetic valve 30 in the compressed state, and the outer diameter of the loading member 12 and the outer diameter of the prosthetic valve 30 in the compressed state are the same, which are B, to ensure that the loading member 12 and the prosthetic valve 30 are free to move within the distal capsule member 11.
In a preferred embodiment, as shown in fig. 2, the outer diameter of the distal capsule 11 is not greater than 26F, avoiding large damage caused by excessive outer diameter, and the length L2 is not greater than 40mm, avoiding too long a length that would render the prosthetic valve 30 unreleasable and would cause the distal capsule 11 to abut the ventricular wall. More preferably, the axial length L2 of the distal capsule member 11 is greater than the axial length L3 of the proximal capsule member 13, since the atrial height of a typical patient is significantly less than that of the heart chamber.
In a preferred embodiment, the proximal end of the proximal capsule 13 is fastened to the distal end of the third control tube 23 by means of adhesion, hot melting or threading, and the proximal end and the distal end of the third control tube 23 are axially penetrated for penetration by the second control tube 22, and the distal end and the middle of the proximal capsule 13 are cylindrical with the same inner diameter for accommodating the inflow segment of the prosthetic valve 30, and the proximal end thereof may be configured into a reducing structure and smoothly transited with the third control tube 23 to avoid damaging the inner wall of the blood vessel during the delivery or retraction process.
Preferably, the inner diameter of the proximal capsule part 13 is the same as the inner diameter of the distal capsule part 11, and is A, so that the prosthetic valve 30 can move freely and cannot be damaged, the outer diameters of the proximal capsule part 13 and the distal capsule part 11 are the same, the smooth transition of the outer surfaces of the two connected parts is ensured, and the damage to the inner wall of a blood vessel in the conveying or withdrawing process is avoided.
In a preferred embodiment, the outer diameter of the proximal capsule member 13 is consistent with the outer diameter of the distal capsule member 11, and is no greater than 26F, avoiding significant injury due to an excessive outer diameter, and the length L3 is no greater than 20mm, avoiding the inability of the prosthetic valve 30 to release due to excessive length, and the proximal end thereof will abut the fossa ovalis of the atrial septum.
In a preferred embodiment, the total length L1 of the capsule portion 10 is less than 60mm, the length L2 of the distal capsule member 11 is no greater than 40mm, and the length L3 of the proximal capsule member 13 is no greater than 20mm to ensure that there is sufficient space for movement of both the proximal capsule member 13 and the distal capsule member 11 within the patient's heart to avoid the distal capsule member 11 from pushing against the ventricle wall when moved forward or from being blocked by the fossa ovalis when the proximal capsule member 13 is retracted backward.
Preferably, the loading member 12 is fixedly connected to the distal end of the second control tube 22 by means of bonding, hot melting or threading, etc., and since the prosthetic valve 30 in a compressed state maintains its axially penetrated state, after the distal end of the prosthetic valve 30 is connected to the loading member 12, the main body portion thereof is sleeved on the outer periphery of the second control tube 22, and the two are coaxially arranged, preferably, the distal end of the second control tube 22 penetrates through the third control tube 23 and the proximal capsule 13 and then penetrates out, and the first control tube 21 penetrates out from the distal end of the second control tube 22.
In a preferred embodiment, as shown in fig. 5 and 6, the loading member 12 is sequentially provided with a proximal guiding section, a coaxial section 122 and a distal guiding section from the proximal end to the distal end, the proximal guiding section extends from the distal end to the proximal end toward the axis of the loading member 12, and is used for guiding the proximal capsule 13 to advance distally when being recovered, the distal guiding section extends from the proximal end to the distal end toward the axis of the loading member 12, and is used for guiding the proximal capsule 11 to retract proximally when being recovered, the diameter of the outer surface of the coaxial section 122 is consistent, and the coaxial section 122 is coaxially arranged with the proximal capsule 13 and the distal capsule 11, so as to ensure that the proximal capsule 13 and the distal capsule 11 can keep coaxial when being recovered, and avoid damaging blood vessels or tissues.
In a preferred embodiment, at least a partial region of the circumferential outer side of the distal guiding section is configured as distal guiding structure 121, and at least a partial region of the circumferential outer side of the proximal guiding section is configured as proximal guiding structure 123, and distal guiding structure 121 and proximal guiding structure 123 may be configured as symmetrical structures or asymmetrically arranged, and may be the same or different in length or size.
In a preferred embodiment, distal guide structure 121 extends obliquely from proximal to distal to the axis of loading element 12 at an angle α, α < 90 °; proximal guide structure 123 extends obliquely from distal to proximal to the axis of loading element 12 at an angle β < 90 °; alternatively, α and β may be the same or different.
Preferably, when the angle α and/or β is too small, it may result in too long a length of the distal guiding structure 121 and/or the proximal guiding structure 123, which may affect the size and operation of the entire capsule part 10, whereas when the angle α and/or β is too large, it may result in poor guiding effect of the distal guiding structure 121 and/or the proximal guiding structure 123, and even cause jamming of the two, so that it is preferable that α is 30 to 80 °, and β is 30 to 80 °.
In a preferred embodiment, the distal guiding structure 121 is configured as conical, frustoconical, hemispherical or semi-ellipsoidal to ensure that the distal capsule member 11 is able to follow its contour proximally after abutting the distal guiding structure 121, eventually abutting the proximal capsule member 13.
In a preferred embodiment, as shown in fig. 7 and 8, the distal guiding structure 121 is configured as a plurality of obliquely arranged plate-like structures or rod-like structures, such as the distal guiding rod 1211, circumferentially distributed between the plurality of plate-like structures or rod-like structures, and also guides the running direction of the distal capsule 11 during proximal withdrawal.
In a preferred embodiment, as shown in fig. 5 and 6, the proximal guiding structure 123 is configured as conical, frustoconical, hemispherical or semi-ellipsoidal to ensure that the proximal capsule member 13, after abutting the proximal guiding structure 123, is able to follow its contour distally, eventually abutting the distal capsule member 11.
In another preferred embodiment, as shown in fig. 7 and 8, the proximal guiding structure 123 is configured as a plurality of obliquely arranged plate-like structures or rod-like structures, such as proximal guiding rods 1231, circumferentially distributed between the plurality of plate-like structures or rod-like structures, and can also guide the movement direction of the proximal capsule member 13 during the distal advancement.
As shown in fig. 5, 6 and 9, the coaxial segment 122 is preferably provided with a plurality of retaining grooves 1221 circumferentially for engaging the connector 31 of the prosthetic valve 30 and limiting axial movement of the prosthetic valve 30, and the retaining grooves 1221 are preferably provided as an axially through and radially outwardly opening groove that is capable of being released directly from the carrier 12 radially outwardly when the prosthetic valve 30 loses radial restraint of the distal capsule 11.
Specifically, the number and the size of the fixing grooves 1221 on the loading member 12 are matched with those of the connecting pieces 31 on the prosthetic valve 30, and the shape, the number, the size, etc. of the fixing grooves 1221 on the loading member 12 can be adaptively adjusted according to specific conditions, and are not limited herein, because the prosthetic valves 30 of different specifications, different structures and different manufacturers have the connecting pieces 31 of different structures.
In a preferred embodiment, the length of the coaxial segment 122 is L4 from 1 to 3mm.
As shown in fig. 10-14, preferably, at least one fixing groove 1221 is provided with an elastic limiting member 124, and the elastic limiting member 124 may be configured as a polymer compound with elasticity, or a limiting member provided with elasticity by a spring, and the elastic limiting member 124 may be compressed and rebound in the radial direction in the fixing groove 1221, and in the compressed state, the elastic limiting member 124 is concaved in the fixing groove 1221 under the pressure of the connecting member 31 of the prosthetic valve 30, as shown in fig. 10 and 12; in the rebound state, the elastic limiting member 124 protrudes outside the fixing groove 1221, as shown in fig. 11 and 13, and at this time, the outer diameter C of the coaxial section 122 is slightly larger than the inner diameter a of the distal capsule member 11 and/or the proximal capsule member 13, so that the proximal capsule member 13 can be prevented from exceeding the coaxial section 122 in the moving process, and the distal capsule member 11 cannot be guided by the distal guiding structure 121, and in addition, after the elastic limiting member 124 rebounds, the release of the prosthetic valve 30 can be assisted, and the release failure caused by the jamming of the connecting member 31 of the prosthetic valve can be avoided; more preferably, in the rebound state, the elastic limiting member 124 protrudes outside the fixing groove 1221, but at this time, the outer diameter C of the coaxial section 122 is not larger than the outer diameter of the distal capsule member 11 and/or the proximal capsule member 13, so as to ensure that the elastic limiting member 124 does not protrude outside the outer surface of the capsule portion 10 after the distal capsule member 11 and the proximal capsule member 13 are connected, and prevent the capsule portion 10 from scratching the inner wall of the blood vessel during the retraction process.
Preferably, the distal end of the proximal capsule member 13 and/or the proximal end of the distal capsule member 11 are provided with limit grooves 14, the number of the limit grooves 14 is the same as that of the elastic limit members 124, and the limit grooves can be matched with the elastic limit members in a rebound state, so that the proximal capsule member 13 and the distal capsule member 11 can be completely aligned when being recovered, as shown in fig. 14, the unstable connection caused by gaps between the two is avoided, or the inner wall of a blood vessel is scratched.
15 a-15 e, in a preferred embodiment, after the prosthetic valve 30 is released, because the tubing inside the delivery device is easily bent, at this time, the proximal capsule 13, the distal capsule 11 and the loading member 12 are not coaxial, the proximal capsule 13 is advanced by pushing the third control tube 23, the proximal capsule 13 contacts the proximal guiding structure 123 of the loading member 12 during the advancing process, the proximal capsule 13 is gradually coaxial with the loading member 12 and moves to the coaxial section 122 under the guidance of the proximal guiding structure 123, during the operation, the position where the proximal capsule 13 moves needs to be observed under the imaging device cannot exceed the coaxial section 122 of the loading member 12, preferably, an elastic limiting member 124 is provided in the fixing groove 1221 of the coaxial section 122, and because the elastic limiting member 124 loses the circumferential limit after the prosthetic valve 30 is released, the proximal capsule 13 can rebound and protrudes out of the fixing groove 1221, the proximal capsule 13 is moved to the elastic limiting member 124 and is not advanced any more, and the proximal capsule 13 and the elastic limiting member 14 and the elastic limiting member 124 can axially abut against the proximal capsule 13; then, the first control tube 21 is retracted to realize the recovery of the distal capsule 11, when the distal capsule 11 is retracted, the distal guide structure 121 of the loading member 12 is contacted, the distal capsule 11 is gradually coaxial with the loading member 12 under the guidance of the distal guide structure 121 and moves to the coaxial section 122, in the operation process, the moving position of the distal capsule 11 needs to be observed under the imaging device, and cannot exceed the coaxial section 122 of the loading member 12, preferably, the distal capsule 11 can be supported by the elastic limiting member 124 and cannot retract any more, and the limiting groove 14 of the distal capsule 11 and the elastic limiting member 124 can be clamped to realize the axial and circumferential limiting of the distal capsule 11, and finally, the coaxial of the proximal capsule 13 and the distal capsule 11 is realized to ensure that the prosthetic valve delivery device can be safely withdrawn outside the body.
Preferably, the axial lengths of the first control tube 21, the second control tube 22, and the third control tube 23 are sequentially reduced.
Preferably, the inner diameters of the first control tube 21, the second control tube 22 and the third control tube 23 are sequentially increased, and a gap is reserved between adjacent tubes to ensure that the adjacent tubes can move relatively axially.
Preferably, the inner cavity of the first control tube 21 should at least allow the Xu Yiyong guide wire to pass through, and since the medical guide wires have different specifications, the medical guide wires of different specifications have different diameters, so that the diameters of the inner cavity of the first control tube 21 can be adaptively adjusted according to specific conditions on the premise of meeting the requirements in operation for different patients or different lesions, and the optional diameters of the inner cavity are not listed one by one.
Preferably, the first control tube 21 may be manufactured by using a sheath or a tube, and it will be understood by those skilled in the art that when selecting different specifications of guide wires, a tube or a sheath adapted thereto should be selected, so that the wall thickness of the first control tube 21 is not limited in this embodiment.
Preferably, the inner diameters and wall thicknesses of the second control tube 22 and the third control tube 23 can be adjusted according to actual needs by those skilled in the art by referring to the first control tube 21, and will not be described herein.
In a preferred embodiment, the prosthetic valve delivery device is used by first passing through the fossa ovalis via the femoral vein to the mitral valve annulus 60 of the patient, where the boundary between the proximal and distal capsule members 13, 11 is at the mitral valve annulus 60, as shown in fig. 16, and by an extracorporeal operation, the third control tube 23 is retracted proximally, with the proximal capsule member 13 retracted, with the atrial side of the prosthetic valve 30 expanded, and continued operation, with the first control tube 21 advanced distally, with the distal capsule member 11 advanced, with the ventricular side of the prosthetic valve 30 gradually expanded, and with the distal capsule member 11 no longer surrounding the carrier member 12, the prosthetic valve 30 is released. After the release is completed, the third control tube 23 is controlled to advance distally until the proximal capsule part 13 wraps a part of the loading part 12 under the guidance of the proximal guiding structure 123, so as to realize the coaxial recovery of the proximal capsule part 13, and then the first control tube 21 is controlled to retract proximally until the distal capsule part 11 wraps a part of the loading part 12 under the guidance of the distal guiding structure 121, and finally realize the coaxial closure with the proximal capsule part 13.
Example 2
This embodiment provides a prosthetic valve delivery system comprising a prosthetic valve delivery device as described in embodiment 1, further comprising a prosthetic valve 30; the respective features already included in embodiment 1 are naturally inherited in this embodiment.
In this embodiment, the prosthetic valve 30 includes at least a valve stent and leaflets.
Preferably, the valve holder is substantially cylindrical in shape with an inflow section disposed in the left atrium 40 and an outflow section opening in the left ventricle 50, the inflow end of the valve holder being further provided with a radially outwardly flared or funnel-shaped skirt, preferably a connector 31 being provided at the distal end of the valve holder, the connector 31 being adapted to the fixation groove 1221 of the carrier 12; in a preferred embodiment, the valve stent is a self-expanding valve stent made of nickel titanium alloy having a shape memory effect, which is radially compressed and held in its compressed state by the radial constraint of the distal capsule 11 when the prosthetic valve 30 is loaded onto the delivery device, as shown in fig. 18; when the prosthetic valve 30 reaches the diseased native valve, release from the proximal and distal capsule members 13, 11, radial self-expansion can occur, eventually gradually disengaging from the carrier member 12.
Preferably, the valve leaflet is made from a commercial porcine aortic valve, bovine pericardial valve or porcine pericardial valve for replacing the physiological function of the native valve leaflet; the leaflets are sutured within the valve holder and extend distally from the proximal end.
In other preferred embodiments, the surface of the valve holder may also be sewn with a skirt sealing membrane for preventing paravalvular leakage or the like complications after valve replacement.
In this embodiment, the method of using the prosthetic valve delivery system is the same as the method of using the prosthetic valve delivery device of embodiment 1, and will not be described in detail here.
The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.