Disclosure of Invention
The embodiment of the application provides a prosthetic heart valve holder, a prosthetic heart valve holding system and a folding method, which have simple structures, can realize the function of folding the valve corners without penetrating the positions of the sewn valve corners, and can reduce the possibility of cutting damage to the valve leaves.
In a first aspect, embodiments of the present application provide a prosthetic heart valve holder comprising a central post having axially opposed distal and proximal ends, and a central bore extending therethrough, a holder and a retainer; the valve holding piece is arranged on the central column; the valve holding piece and the central column can move relatively along the axial direction of the central column, a support arm protruding along the radial direction of the central column is arranged on the valve holding piece, and a threading hole is formed in the support arm; the clamping piece is detachably assembled between the proximal end of the center column and the valve holding piece and is respectively abutted with the proximal end of the center column and the valve holding piece; when the clamping piece is disassembled, the central column can move along the axial distal direction relative to the holding piece.
In the scheme, when the valve holding piece and the artificial heart valve are used for assembly, the threading holes are formed in the support arms, after the artificial heart valve is placed on the valve holding piece, the fixing wires are firstly adopted to pass through the threading holes of the support arms, and the artificial heart valve is bound and fixed on the support arms of the valve holding piece, so that the artificial heart valve is fixed. And then, a furling line segment is arranged at the outer side of each valve angle of the artificial heart valve, one end of the furling line passes through the threading hole on the support arm and is fixed on the support arm, the furling line does not need to be connected with the valve angle of the artificial heart valve in a sewing way through the central column, the other end of the furling line directly bypasses the outer side surface of the valve angle of the artificial heart valve and then enters the central hole from the far end of the central column and is connected to one side of the near end of the central column, and when the central column moves towards the far end along the axial direction relative to the valve holding piece, the furling line is tensioned, so that the constraint positioning of the valve angle is realized. When the valve holder is used for folding the valve angle, the folding line is in extrusion contact with the outer side face of the valve angle, the folding line is not in contact with the valve leaflet, and the folding line is not easy to scratch and damage the valve leaflet of the artificial heart valve. When the valve holder is withdrawn, the medical staff cuts the folding line, the central column is highest in the valve holding system of the artificial heart valve, the folding line is not easy to touch the free edge part of the valve leaflet of the artificial heart valve in the withdrawal process, the free edge of the valve leaflet is not easy to be cut and damaged, and the possibility of cutting and damaging the valve leaflet is reduced.
In some embodiments, either one of the central post and the petals is provided with a guide in the axial direction, and the other is provided with a guide slot that mates with the guide.
Through be provided with guide part and guide way respectively on center post and hold the lamella spare, guide part and guide way cooperation have reduced and have held the lamella spare and appear relative rotation's risk for the center post for hold the stability of lamella spare in the slip in-process on the center post higher.
In some embodiments, the petals have an upper positioning portion and a lower positioning portion, and the center post is provided with a resilient positioning arm; the petals have a first position and a second position in the axial direction of the central post, the first position being closer to the distal end of the central post than the second position; when the valve holding piece is positioned at the first position, the elastic positioning arm is clamped with the lower positioning part, and the clamping piece is arranged between the proximal end of the central column and the valve holding piece; when the valve holding piece moves to the second position towards the proximal end relative to the central column, the elastic positioning arm is clamped with the upper positioning part.
Because the valve holding piece can move between the first position and the second position on the central column, through the upper positioning part and the lower positioning part of the valve holding piece and the arrangement of the elastic positioning arm on the central column, when the valve holding piece is positioned at the first position, the elastic positioning arm is clamped with the lower positioning part, and the clamping piece is arranged between the proximal end of the central column and the valve holding piece, so that the valve holding piece is limited to move to the second position in the proximal direction of the central column, and the valve holding piece is kept fixed at the first position of the central column. When the valve angle is required to be folded, the clamping piece is taken down, the elastic positioning arm is separated from the lower positioning part, the valve holding piece can move to the second position towards the proximal end relative to the central column, and the elastic positioning arm is clamped with the upper positioning part, so that the valve holding piece is kept fixed at the second position on the central column, the valve angle is maintained in a folded state, and the folding stability of the valve angle is higher.
In some embodiments, the center post is provided with a relief hole at the resilient positioning arm in communication with the center hole; the elastic positioning arm comprises a body and an elastic claw, one end of the body is connected with the central column, the other end of the body is connected with the elastic claw, the elastic claw protrudes out of the outer surface of the central column, and the elastic claw can move in the avoidance hole when receiving external extrusion force so as to be separated from the upper positioning part or the lower positioning part.
Through being provided with on the center post and dodging the hole, when needs let elastic locating arm and last location portion or lower location portion unblock, only need apply the extrusion force alright to the elastic claw for the elastic claw is by the extrusion to dodging downthehole, just can realize the unblock of elastic claw and last location portion or lower location portion, holds the lamella piece like this and can switch between the position on the center post first position and second position. After the valve holding piece moves from the first position to the second position, the elastic claw protrudes out of the outer surface of the central column, and can be automatically clamped with the upper positioning part, so that the valve holding piece is kept fixed at the second position of the central column, the risk of displacement of the valve holding piece when the valve holding piece is subjected to axial external force is reduced, and the stability of the valve holding piece on the folding function of the artificial heart valve is improved.
In some embodiments, the lower positioning portion is a groove formed on the valve holder, the groove is formed radially through the inner side and the outer side of the valve holder, and when the valve holder is in the first position, the elastic claw is clamped into the groove to prevent the valve holder from moving axially towards the proximal end relative to the central column; the upper positioning part is a clamping groove arranged on the top surface of the holding piece, and the proximal end of the central column protrudes outwards along the radial direction to form a limiting table; when the valve holding piece moves from the first position to the second position from the proximal end, the elastic claw is extruded into the avoidance hole and stores elastic potential energy, the elastic potential energy is used for driving the elastic claw to reset to be clamped into the clamping groove when the valve holding piece moves to the second position, and the elastic claw and the limiting table are respectively clamped at two axial sides of the valve holding piece so as to prevent the valve holding piece from moving axially relative to the central column.
The lower positioning part is a groove which radially penetrates through the inner side and the outer side of the holding piece, so that when the holding piece is positioned at the first position, the elastic claw is clamped into the groove, and the axial movement of the holding piece relative to the center column is prevented under the clamping action of the elastic claw and the groove, so that the holding piece is kept fixed at the first position. The upper positioning part is a clamping groove arranged on the top surface of the valve holding part, the proximal end of the central column is provided with a limiting table protruding outwards along the radial direction, when the valve angle is required to be folded, the clamping part is taken down, the elastic claw is extruded into the avoidance hole to be separated from the lower positioning part, the elastic claw accumulates elastic potential energy, the valve holding part can move from the first position to the second position at the moment, the elastic potential energy can drive the elastic claw to automatically reset and clamp into the clamping groove after the valve holding part moves to the second position, and thus, the elastic claw and the limiting table are respectively clamped on two axial sides of the valve holding part, so that the valve holding part can not move axially relative to the central column, the valve holding part is kept fixed at the second position of the central column, the risk of displacement of the valve holding part when the valve holding part is subjected to axial external force is reduced, and the folding function stability of the valve holding part on the artificial heart valve is improved.
In some embodiments, the distal end of the center post is provided with a wire slot.
Through being provided with the wire casing in the distal end of center post, draw in the line and get into when in the centre bore of center post behind the lamella angle, the wire casing can supply to draw in the line to wear to establish, and the wire casing can play spacing function to drawing in the line, avoids drawing in the line and appears the phenomenon of shifting in the distal end of center post, has improved the drawing in precision of drawing in the line to lamella angle.
In some embodiments, the number of wire slots is a plurality, the plurality of wire slots being spaced circumferentially about the center post and extending through the distal end of the center post.
Because the quantity of lamella angle is a plurality of, then the quantity of drawing in the line is many, through the circumference interval distribution of a plurality of wire casings at the center post, every wire casing can hold one and draw in the line or many and draw in the line like this for the position homoenergetic that many draw in the line effectively obtains spacingly, has reduced the probability that the knot appears between many draws in the line. And the wire casing runs through the distal end setting of center post, like this when arranging the line that draws in, compare in the far end that the wire casing did not run through the center post need draw in the line and get into in the center post after passing from the hole of wire casing, can directly draw in the line and penetrate in the centre bore from the distal end of center post, draw in the line and can directly follow the distal end of center post and impress in the corresponding wire casing, reduced the degree of difficulty of arranging of drawing in the line.
In some embodiments, the number of the threading holes of each support arm is four, and the threading holes comprise two first threading holes and two second threading holes; the two first threading holes positioned at the radial inner side are used for threading the fixing wire of the artificial heart valve, and the two second threading holes positioned at the radial outer side are used for threading the gathering wire of the valve foot of the artificial heart valve.
Through setting up the quantity at the through holes of every support arm to four, four through holes two first through holes and two second through holes, wear to establish the fixed line through two first through holes like this and can fix prosthetic heart valve on the support arm of holding the lamella piece, can supply to draw in the line through two second through holes and arrange, utilize to draw in the line and realize the function of drawing in to the lamella angle, the fixed line with draw in the line and wear to establish through different through holes respectively, reduced and draw in the line and the fixed line appear knotting the probability between, also be convenient for follow-up medical personnel to the fixed line respectively or draw in the line and cut the operation respectively.
In some embodiments, the arm of the valve holder is provided with a relief groove located between the two first threading holes and the two second threading holes, and the relief groove penetrates the arm radially outwards.
Through being provided with the groove of dodging that is located two first through wires holes and is located between two second through wires holes on the support arm, dodge the groove and can expose the fixed line or draw in the line, give way for cutting the line instrument, reduced medical personnel and adopted the degree of difficulty that cutting the line instrument cut the fixed line or draw in the line. And dodge the groove and radially outwards run through the support arm, so that medical personnel can directly adopt the thread cutting tool to stretch into in dodging the inslot from dodging the outside in groove and cut the fixed line or draw in the line, more easily cut the fixed line or draw in the line.
In some embodiments, the prosthetic heart valve holder includes a connector that is assembled to the proximal end of the central post, the connector including an insertion portion that is insertable into the central bore, the insertion portion having a through-wire bore, and a threaded connection portion having a knot-wire bore extending radially therethrough.
Through being provided with the connecting piece at the proximal end of center post, the threaded connection portion that sets up on the connecting piece can supply between center post and the handle threaded connection, realizes the connection of handle and center post, and the male portion of connecting piece can insert in the centre bore, realizes the grafting cooperation of connecting piece and center post. The insertion part is provided with a through line hole, the threaded connection part is provided with a radially penetrating knot line hole, so that one end of the furling line can penetrate through the central hole and the through line hole and then be knotted at the knot line hole, and the connection between the connecting piece and the furling line is realized.
In some embodiments, the prosthetic heart valve holder includes a handle that is threadably coupled to the threaded connection.
The setting of handle does benefit to medical personnel and holds the lamella ware, and the length of lamella ware is held in the handle can be increased, does benefit to medical personnel and places the prosthetic heart valve on the lamella ware in patient's target position.
In a second aspect, embodiments of the present application provide a prosthetic heart valve retention system comprising a prosthetic heart valve having a plurality of valve corners, a prosthetic heart valve retainer, and a wire for connecting the prosthetic heart valve and the retainer, the wire comprising a gathering wire passing through a threading hole and a central hole of a support arm, the gathering wire forming gathering wire segments located on both sides of each valve corner.
The artificial heart valve is bound and fixed on the support arm of the valve holding piece by adopting the threading holes which are penetrated by the wire piece back and forth, so as to finish the fixation of the artificial heart valve. The wire piece further comprises a gathering line penetrating through the threading hole of the support arm and the central hole, a gathering line segment is arranged at the outer side of each valve angle of the artificial heart valve, one end of the gathering line penetrates through the threading hole of the support arm and is fixed on the support arm, the other end of the gathering line directly bypasses the outer side face of the valve angle of the artificial heart valve and then enters into the central hole from the far end of the central column and is connected to one side of the near end of the central column, and when the central column moves towards the far end along the axial direction relative to the valve holding piece, the gathering line is tensioned, so that the constraint positioning of the valve angle is realized. When the valve holder is used for folding the valve angle, the folding line is in extrusion contact with the outer side face of the valve angle, the folding line is not in contact with the valve leaflet, and the folding line is not easy to scratch and damage the valve leaflet of the artificial heart valve. When the medical staff withdraws from the valve holder and cuts off the furling line, the central column is highest in the valve holding system of the artificial heart valve, the furling line is not easy to touch the free edge part of the valve leaflet of the artificial heart valve in the withdrawing process, the free edge of the valve leaflet is not easy to be cut and damaged, and the possibility of damage to the cut of the valve leaflet is reduced.
In some embodiments, the distal end of the central post is provided with a plurality of wire slots spaced circumferentially about and extending through the distal end of the central post; the wire slot is used for at least one gathering wire to pass through.
Through being provided with a plurality of wire casings in the distal end of center post, the wire casing can supply to draw in the line and wear to establish, and the wire casing can play spacing function to drawing in the line, avoids drawing in the line and appears the phenomenon that shifts in the distal end of center post, of course, the wire casing can supply one to draw in the line or many to draw in the line to wear to establish, specifically can be according to actual conditions and decide.
In some embodiments, each lobe angle is correspondingly provided with two gathering lines; two gathering lines for the same lobe angle are distributed in a crossed way on the outer side surface of the lobe angle.
Two furling lines are correspondingly arranged on each valve angle, the outer side surfaces of the two furling lines are distributed in a crossing manner, and the two furling lines are provided with overlapping parts in the tensioning and furling process of the furling lines, so that compared with the fact that the two furling lines do not have overlapping parts, the two furling lines can interact, and further force facing the direction of the center column is applied to the valve angles together, so that the valve angles are easier to furl.
In some embodiments, the prosthetic heart valve holder comprises a connector that is assembled to the proximal end of the central post, the connector comprising an insertion portion that is insertable into the central bore, the insertion portion having a through-wire hole, and a threaded connection portion having a knot-wire hole extending radially therethrough; one end of the furling wire is penetrated in the wire through hole and the wire connecting hole so as to suture and connect the connecting piece and the central column.
The connecting piece is provided with a threaded connecting part, the handle of the valve holder can be connected with the connecting piece through the threaded connecting part, and the connecting piece plays a role in connecting the central column and the handle. The inserting part of the connecting piece can be inserted into the central hole, the inserting part is provided with a through line hole, the threaded connecting part is provided with a radially penetrating knot line hole, one end of the furled line can penetrate through the central hole and the through line hole and then be knotted at the knot line hole, and the connecting piece and the central column are connected.
In a third aspect, an embodiment of the present application further provides a method for folding a prosthetic heart valve holding system, where the folding method based on the prosthetic heart valve holding system includes the following steps: removing the clamping piece from the center column; the valve holding piece and the artificial heart valve move towards the proximal end relative to the central column, and the wire piece serving as the furling wire drives the valve angle to furl towards the central column.
When the valve angle is folded, only the clamping part is required to be dismounted, the valve holding part and the artificial heart valve move towards the proximal end relative to the central column, the wire part serving as the folding line can drive the valve angle to be folded towards the central column, the folding procedure of the valve angle is simplified, the operation of medical staff is simple, and the operation difficulty of the medical staff is reduced. When the valve holder is used for folding the valve angle, the folding line is in extrusion contact with the outer side face of the valve angle, the folding line is not in contact with the valve leaflet, and the folding line is not easy to scratch and damage the valve leaflet of the artificial heart valve. When the medical staff withdraws from the valve holder and cuts off the furling line, the central column is highest in the valve holding system of the artificial heart valve, the furling line is not easy to touch the free edge part of the valve leaflet of the artificial heart valve in the withdrawing process, the free edge of the valve leaflet is not easy to be cut and damaged, the possibility of damage to the cut of the valve leaflet is reduced, and the practical service life of the artificial heart valve is prolonged.
In some embodiments, when the valve holder and the prosthetic heart valve move proximally relative to the central post, wherein the elastic positioning arm is disengaged from the lower positioning portion on the valve holder and retracted into the avoidance hole, the valve holder moves from the first position to the proximal end of the central post to the second position, the elastic positioning arm resets and snaps into the upper positioning portion of the valve holder, and the wire serving as the gathering wire drives the valve angle to gather towards the central post.
After the clamping part is taken down, the elastic positioning arm and the lower positioning part are separated and retracted in the avoidance hole, the valve holding part loses the limiting function of the elastic positioning arm, the valve holding part can move to the second position towards the proximal end relative to the center column, and the elastic positioning arm is automatically reset and clamped with the upper positioning part, so that the second position of the valve holding part on the center column is kept fixed, the valve angle is maintained in a furled state, and the furled stability of the valve angle is higher.
Additional features and advantages of the application will be set forth in the detailed description which follows.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments of the present application. The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the application, as presented in the figures, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.
In the description of the embodiments of the present application, it should be noted that, the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship that is conventionally put when the application product is used, which is merely for convenience in describing the present application and simplifying the description, and is not indicative or implying that the apparatus or element referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present application. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.
In the description of the present application, it should also be noted that, unless explicitly stated and limited otherwise, the terms "disposed" and "connected" are to be interpreted broadly, and may be, for example, fixedly connected, detachably connected, or integrally 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 application will be understood in specific cases by those of ordinary skill in the art.
Examples
Referring to fig. 1 to 8, a prosthetic heart valve holder 100 includes a central post 10, a holder 20 and a retainer 30, the central post 10 having a distal end 13 and a proximal end 12 axially opposite each other, and a central hole 11 extending through the proximal end 12 and the distal end 13; the flap 20 is mounted on the central post 10; along the axial direction of the central column 10, the valve holding piece 20 and the central column 10 can relatively move, the valve holding piece 20 is provided with a support arm 21 protruding along the radial direction of the central column 10, and the support arm 21 is provided with a threading hole 22; the clamping piece 30 is detachably assembled between the proximal end 12 of the central column 10 and the valve holding piece 20 and is respectively abutted against the proximal end 12 of the central column 10 and the valve holding piece 20; wherein, when the retainer 30 is removed, the central post 10 can move axially toward the distal end 13 relative to the petals 20.
In this scheme, when the valve holder 20 is assembled with the prosthetic heart valve 200, the threading holes 22 are formed in the support arms 21, and after the prosthetic heart valve 200 is placed on the valve holder 20, the fixing wires are firstly adopted to pass through the threading holes 22 formed in the support arms 21 back and forth, so that the prosthetic heart valve 200 is bound and fixed on the support arms 21 of the valve holder 20, and the fixing of the prosthetic heart valve 200 is completed. Then, a furling line segment is arranged at the outer side of each valve angle 201 of the artificial heart valve 200, one end of the furling line 202 passes through the threading hole 22 on the support arm 21 and is fixed on the support arm 21, the center hole 11 is penetrated and arranged on the center post 10, the furling line 202 does not need to be connected with the valve angle 201 of the artificial heart valve 200 in a sewing way, the other end of the furling line 202 directly bypasses the outer side surface of the valve angle 201 of the artificial heart valve 200 and then enters the center hole 11 from the distal end 13 of the center post 10 and is connected to one side of the proximal end 12 of the center post 10, and when the center post 10 moves towards the distal end 13 along the axial direction relative to the valve holding piece 20, the furling line 202 is tensioned, so that the constraint positioning of the valve angle 201 is realized. When the valve holder 100 is used for folding the valve angle 201, the folding line 202 is in extrusion contact with the outer side surface of the valve angle 201, the folding line 202 is not in contact with the valve leaflet, and the folding line 202 is not easy to scratch and damage the valve leaflet of the artificial heart valve 200. When the medical staff withdraws the valve holder 100 to cut the gathering line 202, the central column 10 has the highest height in the valve holding system of the artificial heart valve, the gathering line 202 is not easy to touch the free edge part of the valve leaflet of the artificial heart valve 200 in the withdrawal process, the free edge of the valve leaflet is not easy to be cut and damaged, and the possibility of damage to the cut of the valve leaflet is reduced.
Specifically, when the valve holder is used to fold the valve angle 201, since the valve holder 20 is movably mounted on the central post 10, the central post 10 is provided with the clamping piece 30, and only the clamping piece 30 needs to be removed, so that the valve holder 20 and the artificial heart valve 200 can move towards the proximal end 12 direction relative to the central post 10, and the wire serving as the folding wire 202 is further tensioned so as to drive the valve angle 201 to fold towards the central post 10, thereby realizing folding of the valve angle 201. In the folding process of the valve angle 201, as the folding line 202 and the outer side surface of the valve angle 201 are in extrusion contact, the valve leaflet is positioned at the inner side of the valve angle 201, the folding line 202 cannot contact with the valve leaflet, and the valve leaflet of the artificial heart valve 200 is not easy to be cut. Compared with the valve holder structure in the prior art, the valve holder 100 is simple in structure, and the medical staff is easy to operate, so that the operation difficulty of the medical staff is reduced. When the valve holder is withdrawn, the medical staff only needs to cut the gathering line 202 sewn on the support arm 21 in advance, the gathering line 202 is separated along the central hole 11 of the central column 10, the height of the distal end 13 of the central column 10 is higher than the top of the artificial heart valve 200, namely the central column 10 is highest in the valve holding system of the artificial heart valve, the gathering line 202 is not easy to touch the free edge part of the valve leaflet of the artificial heart valve 200 in the withdrawal process, the free edge of the valve leaflet is not easy to wear and damage, the function of not damaging the free edge of the valve leaflet is achieved, the practical service life of the artificial heart valve 200 is prolonged, and finally the fixing line is cut off, so that the valve holder 100 is withdrawn.
Wherein, the distal end 13 and the proximal end 12 are the proximal end 12 at the end of the center post 10 closer to the medical staff and the distal end 13 at the end farther from the medical staff. The middle part of the holding piece 20 is provided with a through hole 25 which is matched with the size of the central column 10, and the holding piece 20 is sleeved on the central column 10 through the through hole 25. The cross-sectional shape of the center post 10 may be various, for example, the cross-sectional shape of the center post 10 may be circular, square, triangular, or the like. In this embodiment, the cross-sectional shape of the center post 10 is circular.
The clamping piece 30 and the central column 10 can be connected in various ways, and the clamping piece 30 and the central column 10 can be connected in clamping, screwing, inserting or interference connection and the like.
Optionally, the clamping piece 30 is clamped with the central column 10, the clamping piece 30 is provided with a buckle, the central column 10 is correspondingly provided with a clamping groove matched with the buckle, and medical staff can take down the clamping piece 30 from the central column 10.
In some embodiments, referring to fig. 1 and 5, either the central post 10 or the petals 20 is provided with an axial guide 15, and the other is provided with a guide slot 26 that mates with the guide 15. By providing the guide portion 15 and the guide groove 26 on the central post 10 and the flap member 20, respectively, the guide portion 15 and the guide groove 26 cooperate to reduce the risk of relative rotation of the flap member 20 with respect to the central post 10, resulting in a higher stability of the flap member 20 during sliding on the central post 10.
Wherein, either the central column 10 or the valve holding piece 20 is provided with a guiding part 15 along the axial direction, the other is provided with a guiding groove 26 matched with the guiding part 15, which means that the central column 10 can be provided with the guiding part 15, and the valve holding piece 20 is correspondingly provided with the guiding groove 26; or the central column 10 is provided with a guide groove 26 and the flap 20 is provided with a guide 15.
Illustratively, the central column 10 is convexly provided with a guiding part 15, the guiding part 15 is a guiding column, the valve holder 20 is correspondingly provided with a guiding groove 26, and the guiding groove 26 is in guiding fit with the guiding part 15. The number of the guide portions 15 may be one or a plurality. In the case that the number of the guide parts 15 is plural, the plural guide parts 15 are circumferentially spaced on the center post 10, and the number and positions of the petals 20 in the guide grooves 26 are in one-to-one correspondence with the number and positions of the guide parts 15.
In some embodiments, referring to fig. 5 and 6, the valve holder 20 has an upper positioning portion 23 and a lower positioning portion 24, and the central post 10 is provided with a resilient positioning arm 40; the petals 20 have a first position and a second position in the axial direction of the central post 10, the first position being closer to the distal end 13 of the central post 10 than the second position; wherein, as shown in fig. 5, when the valve holder 20 is located at the first position, the elastic positioning arm 40 is engaged with the lower positioning portion 24, and the retainer 30 is installed between the proximal end 12 of the central post 10 and the valve holder 20; as shown in fig. 6, when the petals 20 are moved to the second position relative to the central post 10 toward the proximal end 12, the resilient positioning arms 40 snap into engagement with the upper positioning portions 23. Because the valve holder 20 is movable between the first position and the second position on the central post 10, by the arrangement of the upper positioning portion 23 and the lower positioning portion 24 of the valve holder 20 and the elastic positioning arm 40 on the central post 10, when the valve holder 20 is located at the first position, the elastic positioning arm 40 is clamped with the lower positioning portion 24, and the clamping member 30 is mounted between the proximal end 12 of the central post 10 and the valve holder 20, so that the valve holder 20 is limited to move to the second position in the direction of the proximal end 12 of the central post 10, and the valve holder 20 is kept stationary at the first position of the central post 10. When the valve angle 201 needs to be folded, the clamping piece 30 is removed, the elastic positioning arm 40 is separated from the lower positioning portion 24, the valve holding piece 20 can move to the second position towards the proximal end 12 relative to the central column 10, and the elastic positioning arm 40 is clamped with the upper positioning portion 23, so that the valve holding piece 20 is kept fixed at the second position on the central column 10, the valve angle 201 is maintained in the folded state, and the folding stability of the valve angle 201 is higher.
In some embodiments, referring to fig. 3,5 and 6, the center post 10 is provided with a relief hole 17 at the elastic positioning arm 40, which communicates with the center hole 11; the elastic positioning arm 40 includes a body 41 and an elastic claw 42, one end of the body 41 is connected with the center column 10, the other end of the body 41 is connected with the elastic claw 42, the elastic claw 42 protrudes out of the outer surface of the center column 10, and the elastic claw 42 can move in the avoidance hole 17 when receiving an external extrusion force so as to be separated from the upper positioning portion 23 or the lower positioning portion 24. Through being provided with dodging hole 17 on center post 10, when needs let elastic locating arm 40 and last location portion 23 or lower location portion 24 unblock, only need apply the extrusion force alright to elastic claw 42 for elastic claw 42 is extrudeed to dodging in the hole 17, just can realize elastic claw 42 and last location portion 23 or lower location portion 24's unblock, holds lamella 20 like this and can be in the first position and the second position on center post 10 between the position switch. After the valve holding piece 20 moves from the first position to the second position, the elastic claw 42 protrudes out of the outer surface of the central column 10, and the elastic claw 42 can be automatically clamped with the upper positioning part 23, so that the valve holding piece 20 is kept fixed at the second position of the central column 10, the risk of displacement of the valve holding piece 20 when the valve holding piece 20 receives axial external force is reduced, and the stability of the function of closing the valve holding piece 20 to the artificial heart valve 200 is improved.
The shape of the avoidance hole 17 may be various, the shape of the avoidance hole 17 is a long-strip-shaped hole, and the extending direction of the long-strip-shaped hole is the axial direction of the center column 10.
In some embodiments, referring to fig. 1, 5 and 6, the lower positioning portion 24 is a groove formed on the valve holder 20, the groove being disposed radially through the inner and outer sides of the valve holder 20, and the resilient claw 42 being engaged in the groove when the valve holder 20 is in the first position to prevent the valve holder 20 from moving axially relative to the central post 10 toward the proximal end 12; the upper positioning part 23 is a clamping groove arranged on the top surface of the holding piece 20, and the proximal end 12 of the central column 10 protrudes outwards along the radial direction to form a limiting table 16; when the valve holder 20 moves from the first position to the second position toward the proximal end 12, the elastic claw 42 is pressed into the avoidance hole 17 and accumulates elastic potential energy, the elastic potential energy is used for driving the elastic claw 42 to reset to be clamped into the clamping groove when the valve holder 20 moves to the second position, and the elastic claw 42 and the limiting table 16 are respectively clamped at two axial sides of the valve holder 20 so as to prevent the valve holder 20 from moving axially relative to the central column 10.
By employing the lower positioning portion 24 as a groove radially penetrating through the inner and outer sides of the flap 20, when the flap 20 is located at the first position, the elastic claw 42 is clamped into the groove, and under the clamping action of the elastic claw 42 and the groove, the flap 20 is prevented from moving axially relative to the center post 10, so that the flap 20 is kept stationary at the first position. The upper positioning part 23 is a clamping groove arranged on the top surface of the valve holding piece 20, the proximal end 12 of the central column 10 is radially outwards protruded to form a limiting table 16, when the valve angle 201 needs to be folded, the clamping piece 30 is taken down, the elastic claw 42 is extruded into the avoidance hole 17 to be separated from the lower positioning part 24, the elastic claw 42 accumulates elastic potential energy, at the moment, the valve holding piece 20 can move from a first position to a second position, the elastic potential energy can drive the elastic claw 42 to automatically reset and clamp into the clamping groove after the valve holding piece 20 moves to the second position, and thus, the elastic claw 42 and the limiting table 16 are respectively clamped on two axial sides of the valve holding piece 20, so that the valve holding piece 20 cannot axially move relative to the central column 10, the valve holding piece 20 is kept fixed at the second position of the central column 10, the risk of displacement of the valve holding piece 20 when the valve holding piece 20 receives axial external force is reduced, and the stability of the valve holding piece 20 on the folding function of the artificial heart 200 is improved.
Of course, the upper positioning portion 23 may have the same groove structure as the lower positioning portion 24, i.e., the upper positioning portion 23 may have a groove structure disposed radially through the inner and outer sides of the flap member 20, in which case the stop 16 need not be disposed at the proximal end 12 of the center post 10.
It should be noted that, there may be various ways to squeeze the elastic claw 42 to move toward the direction of the avoiding hole 17, for example, a tool may be directly inserted into the groove and squeeze the elastic claw 42 to move the elastic claw 42 toward the direction of the avoiding hole 17. Or the outer side of the elastic claw 42 can be provided with a guiding inclined plane, the holding piece 20 is forcefully slid towards the proximal end 12 direction of the central column 10, the elastic claw 42 is automatically extruded into the avoidance hole 17 by the inner wall of the holding piece 20 under the guiding action of the guiding inclined plane, and the elastic claw 42 can also move towards the avoidance hole 17.
In some embodiments, referring to fig. 1,2 and 3, the distal end 13 of the center post 10 is provided with a wire slot 14. By arranging the wire groove 14 at the distal end 13 of the center post 10, when the folded wire 202 enters the center hole 11 of the center post 10 after passing through the flap angle 201, the wire groove 14 can be used for the folded wire 202 to penetrate, the wire groove 14 can play a limiting role on the folded wire 202, the phenomenon that the folded wire 202 shifts at the distal end 13 of the center post 10 is avoided, and the folding precision of the folded wire 202 to the flap angle 201 is improved.
In some embodiments, the number of wire slots 14 is a plurality, with the plurality of wire slots 14 being spaced circumferentially about the center post 10 and extending through the distal end 13 of the center post 10. Because the number of the flap angles 201 is multiple, the number of the furling wires 202 is multiple, and the plurality of wire grooves 14 are distributed at intervals in the circumferential direction of the central column 10, so that each wire groove 14 can accommodate one furling wire 202 or multiple furling wires 202, the positions of the furling wires 202 can be effectively limited, and the knotting probability among the furling wires 202 is reduced. And the wire slot 14 runs through the distal end 13 of the center post 10 to be arranged, so when the furling wire 202 is arranged, compared with the situation that the furling wire 202 is required to pass through the hole of the wire slot 14 and then enter the center post 10 when the wire slot 14 does not run through the distal end 13 of the center post 10, the furling wire 202 can be directly penetrated into the center hole 11 from the distal end 13 of the center post 10, and the furling wire 202 can be directly pressed into the corresponding wire slot 14 from the distal end 13 of the center post 10, so that the arrangement difficulty of the furling wire 202 is reduced.
In the present embodiment, the number of the lobe angles 201 is three, and the three lobe angles 201 are circumferentially spaced apart.
In some embodiments, please refer to fig. 1 and 4, the number of the threading holes 22 of each arm 21 is four, including two first threading holes 221 and two second threading holes 222; the two first threading holes 221 located at the radial inner side are used for threading the fixing wire of the fixing prosthetic heart valve 200, and the two second threading holes 222 located at the radial outer side are used for threading the gathering wire 202 of the valve foot of the pulling prosthetic heart valve 200. Through setting the number of the threading holes 22 of each support arm 21 to four, two first threading holes 221 and two second threading holes 222 of the four threading holes 22, the artificial heart valve 200 can be fixed on the support arm 21 of the valve holding piece 20 through the two first threading holes 221 in a threading way, the folding wires 202 can be arranged through the two second threading holes 222, the folding function of the valve corner 201 is realized by utilizing the folding wires 202, the fixing wires and the folding wires 202 are respectively threaded through different threading holes 22, the knotting probability between the folding wires 202 and the fixing wires is reduced, and the subsequent medical staff can also conveniently cut the fixing wires or the folding wires 202 respectively.
In some embodiments, referring to fig. 1 and 4, the arm 21 of the flap member 20 is provided with a relief groove 211 located between two first threading holes 221 and two second threading holes 222, and the relief groove 211 penetrates the arm 21 radially outwards. By arranging the avoidance grooves 211 between the two first threading holes 221 and the two second threading holes 222 on the support arm 21, the avoidance grooves 211 can expose the fixed line or the furled line 202, and the line cutting tool is given way, so that the difficulty of cutting the fixed line or furled line 202 by the line cutting tool by medical staff is reduced. And dodge the groove 211 and run through the support arm 21 radially outwards, so that medical staff can directly adopt the thread cutting tool to stretch into the dodge groove 211 from the outside of dodging the groove 211 to cut the fixed thread or furl the thread 202, and the fixed thread or furl the thread 202 is easier to cut.
In some embodiments, referring to fig. 1 and 2, the prosthetic heart valve holder 100 includes a connector 50 that is assembled to the proximal end 12 of the central post 10, the connector 50 including an insertion portion 51 that is insertable into the central bore 11 and a threaded connection portion 52, the insertion portion 51 having a threaded bore 511, the threaded connection portion 52 having a knot bore 521 extending radially therethrough. The connecting piece 50 is arranged at the proximal end 12 of the central column 10, the threaded connecting part 52 arranged on the connecting piece 50 can be used for connecting the central column 10 and the handle 60 in a threaded manner, so that the handle 60 and the central column 10 are connected, and the inserting part 51 of the connecting piece 50 can be inserted into the central hole 11, so that the connecting piece 50 and the central column 10 are in plug-in fit. The insertion portion 51 is provided with a through hole 511, the threaded connection portion 52 is provided with a knot hole 521 penetrating radially, so that one end of the gathering wire 202 can be knotted at the knot hole 521 after penetrating through the central hole 11 and the through hole 511, and one end of the gathering wire 202 is connected to the connecting piece 50.
In some embodiments, referring to fig. 8, prosthetic heart valve holder 100 includes a handle 60, handle 60 being threadably coupled to threaded connection 52. The arrangement of the handle 60 is beneficial for medical staff to hold the valve holder 100, and the handle 60 can increase the length of the valve holder 100, thereby facilitating the medical staff to put the artificial heart valve 200 on the valve holder 100 at the target position of the patient.
The embodiment of the application provides a prosthetic heart valve holding system, which comprises a prosthetic heart valve 200 with a plurality of valve angles 201, a prosthetic heart valve holder 100 and a wire for connecting the prosthetic heart valve 200 and the prosthetic heart valve holder 100, wherein the wire comprises a threading hole 22 penetrating through a support arm 21 and a gathering line 202 of a central hole 11, and the gathering line 202 forms gathering line segments positioned at two sides of each valve angle 201.
The artificial heart valve 200 is bound and fixed on the support arm 21 of the valve holder 20 by adopting the threading holes 22 of the support arm 21 through which the wire piece passes back and forth, so as to finish the fixation of the artificial heart valve 200. The wire member further comprises a threading hole 22 passing through the support arm 21 and a furling line 202 passing through the central hole 11, so that a furling line segment is arranged at the outer side of each valve corner 201 of the artificial heart valve 200, one end of the furling line 202 passes through the threading hole 22 on the support arm 21 and is fixed on the support arm 21, the other end of the furling line 202 directly bypasses the outer side surface of the valve corner 201 of the artificial heart valve 200 and then enters the central hole 11 from the distal end 13 of the central column 10 and is connected to the connecting piece 50 at the side of the proximal end 12 of the central column 10, and when the central column 10 moves towards the distal end 13 along the axial direction relative to the valve holding piece 20, the furling line 202 is tensioned, so that the constraint positioning of the valve corner 201 is realized. When the valve holder 100 is used for folding the valve angle 201, the folding line 202 is in extrusion contact with the outer side surface of the valve angle 201, the folding line 202 is not in contact with the valve leaflet, and the folding line 202 is not easy to scratch and damage the valve leaflet of the artificial heart valve 200. When the medical staff withdraws the valve holder 100 to cut the gathering line 202, the central column 10 has the highest height in the valve holding system of the artificial heart valve, the gathering line 202 is not easy to touch the free edge part of the valve leaflet of the artificial heart valve 200 in the withdrawal process, the free edge of the valve leaflet is not easy to be cut and damaged, and the possibility of damage to the cut of the valve leaflet is reduced.
The wire piece comprises a fixing wire and a gathering wire 202, the fixing wire and the gathering wire 202 can be common medical suture lines, the material can be PET, PP and other materials, and the thickness of the wire piece can be selected according to actual requirements.
In some embodiments, the distal end 13 of the central post 10 is provided with a plurality of wire slots 14, the plurality of wire slots 14 being spaced apart along the circumference of the central post 10 and extending through the distal end 13 of the central post 10; the wire slot 14 is penetrated by at least one gathering wire 202. Through being provided with a plurality of wire casings 14 at the distal end 13 of center post 10, wire casing 14 can supply to draw in the line 202 and wear to establish, and wire casing 14 can play spacing function to draw in the line 202, avoids drawing in the line 202 and appears shifting the phenomenon at the distal end 13 of center post 10, of course, wire casing 14 can supply one to draw in the line 202 or draw in the line 202 to wear to establish, specifically can be according to actual conditions.
In some embodiments, as shown in fig. 7, each flap angle 201 is provided with two gathering lines 202; two gathering lines 202 for the same lobe 201 are distributed in a crossing manner on the outer side surface of the lobe 201. Two folding lines 202 are correspondingly arranged on each valve corner 201, the two folding lines 202 are distributed in a cross mode on the outer side surface of the valve corner 201, and in the tensioning and folding process of the folding lines 202, as the two folding lines 202 are provided with overlapping parts, compared with the fact that the two folding lines 202 are not provided with overlapping parts, the two folding lines 202 can interact, and then force towards the direction of the center column 10 is applied to the valve corner 201 together, so that the valve corner 201 is easier to fold.
In some embodiments, referring to fig. 1 and 2, the prosthetic heart valve holder 100 comprises a connector 50 assembled to the proximal end 12 of the central post 10, the connector 50 comprising an insertion portion 51 insertable into the central bore 11 and a threaded connection portion 52, the insertion portion 51 having a through-hole 511, the threaded connection portion 52 having a knot-hole 521 extending radially therethrough; one end of the gathering line 202 is inserted through the line passing hole 511 and the line tying hole 521 to connect the connecting piece 50 with the center post 10 by sewing. The connecting piece 50 is provided with a threaded connecting part 52, the threaded connecting part 52 can be used for connecting the handle 60 of the valve holder with the connecting piece 50, and the connecting piece 50 plays a role in connecting the central column 10 and the handle 60. The insertion portion 51 of the connecting member 50 may be inserted into the central hole 11, the insertion portion 51 is provided with a wire passing hole 511, and the threaded connection portion 52 is provided with a wire tying hole 521 penetrating radially, so that one end of the folded wire 202 can be tied at the wire tying hole 521 after passing through the central hole 11 and the wire passing hole 511, thereby realizing connection between the connecting member 50 and the central column 10. When the gathering wire 202 of the arm 21 is cut, the connector 50 can pull the gathering wire 202 together out of the center post 10.
The embodiment of the application also provides a folding method of the artificial heart valve holding system, which is based on the artificial heart valve holding system and comprises the following steps of: removing the retainer 30 from the center post 10; the valve holder 20 and prosthetic heart valve 200 are moved proximally 12 relative to the central post 10, and the wire element, which acts as a gathering wire 202, draws the valve corners 201 toward the central post 10. When the valve angle 201 is folded, only the clamping piece 30 is required to be dismounted, the valve holding piece 20 and the artificial heart valve 200 move towards the proximal end 12 relative to the central column 10, and the wire piece serving as the folding wire 202 can drive the valve angle 201 to be folded towards the central column 10, so that the folding procedure of the valve angle 201 is simplified, the operation of medical staff is simple, and the operation difficulty of the medical staff is reduced. In the process of folding the valve angle 201 by using the valve holder 100, the folding line 202 is in extrusion contact with the outer side surface of the valve angle 201, the folding line 202 is not in contact with the valve leaflet, and the folding line 202 is not easy to scratch and damage the valve leaflet of the artificial heart valve 200. When the medical staff withdraws the valve holder 100 to cut the gathering line 202, the central column 10 has the highest height in the valve holding system of the artificial heart valve, the gathering line 202 is not easy to touch the free edge part of the valve leaflet of the artificial heart valve 200 in the withdrawal process, the free edge of the valve leaflet is not easy to be cut and damaged, and the possibility of damage to the cut of the valve leaflet is reduced.
In some embodiments, when the valve holder 20 and the prosthetic heart valve 200 are moved proximally 12 relative to the central post 10, wherein the resilient positioning arms 40 are disengaged from the lower positioning portions 24 on the valve holder 20 and retracted within the relief holes 17, the valve holder 20 is moved from the first position toward the proximal end 12 of the central post 10 to the second position, and the resilient positioning arms 40 are reset and snap into the upper positioning portions 23 of the valve holder 20, the wire member acting as the tucking wire 202 pulls the valve corners 201 toward the central post 10. After the clamping piece 30 is removed, the elastic positioning arm 40 is separated from the lower positioning part 24 and is retracted into the avoidance hole 17, the valve holding piece 20 loses the limiting function of the elastic positioning arm 40, the valve holding piece 20 can move to the second position towards the proximal end 12 relative to the central column 10, the elastic positioning arm 40 is automatically reset to be clamped with the upper positioning part 23, the valve holding piece 20 is kept fixed at the second position on the central column 10, the valve angle 201 is kept in a folded state, and the folding stability of the valve angle 201 is higher.
The whole implementation process and principle of the artificial heart valve holding system are described below:
1. Sewing: the assembly of the valve holder 100 is completed, the retainer 30 is mounted to the central post 10, the valve holder 20 is in the first position on the central post 10, and the resilient positioning arms 40 are snapped into engagement with the lower positioning portions 24 on the valve holder 20. The prosthetic heart valve 200 is secured to the valve holder 20 using a securing thread through the first threaded aperture 221 of the valve holder 20, and then the gathering thread is sewn. The fixing line and the furling line can be common medical suture lines. For each valve angle, two furling wires 202 are adopted, one end of each furling wire 202 is fixed on the support arm 21 of the valve holding piece 20 through the second threading hole 222, and the other ends of the two furling wires 202 bypass the corresponding valve angle 201 of the artificial heart valve 200 towards the distal end 13 direction of the central column 10 and are knotted and fixed on the connecting piece 50 at the proximal end of the central column 10 after penetrating into the central hole 11 from the distal end 13 of the central column 10, so that the furling wires 202 are ensured to be bound and kept normally tightened. The two gathering lines 202 are distributed outside the valve angle 201 in a crossing way, and the gathering lines 202 limit and fix the valve angle 201 of the artificial heart valve 200 on the valve holding piece 20.
2. The valve angle is folded: the retainer 30 is removed to disengage the resilient positioning arms 40 from the lower positioning portion 24 on the valve holder 20, and the surgeon uses a sterile tool to advance the valve holder 20 from the first position to the second position along the central post 10 in the proximal direction 12. The resilient positioning arms 40 snap into the upper positioning portion 23. The stop abutment 16 on the central post 10 and the resilient positioning arms 40 cooperate to axially stop the valve holder 20, keeping the valve holder 20 relatively stationary. At this time, the gathering line 202 is forced to be tightened due to the pushing stroke, and after the gathering line 202 which is in the position of the cross binding valve angle 201 is tightened, the cross position of the gathering line 202 pushes the valve angle 201 to the axial direction of the artificial heart valve 200, so as to achieve the function of gathering the valve angle 201. The gathering line 202 achieves the function of gathering the flap angle 201 without weaving at the position of the sewing flap angle 201.
3. Withdrawal of the valve holder: when the gathering line 202 is withdrawn, the surgeon cuts the gathering line 202 pre-sewn to the arm 21, and removes the connector 50 from the center post 10 together with the gathering line 202 pre-knotted to the connector 50. At this time, the furling wire 202 is integrally pulled out along the central hole 11 of the central post 10, and because the distal end 13 of the central post 10 is highest in the valve holding system of the whole artificial heart valve, the furling wire 202 is not easy to touch the free edge part of the valve leaflet of the artificial heart valve 200, is not easy to wear and damage the free edge of the valve leaflet, plays a role of not damaging the free edge of the valve leaflet, and prolongs the practical service life of the artificial heart valve 200. Finally, the surgeon cuts the fixing wire of the prosthetic heart valve integrally fixed on the arm 21, and the whole valve holder 100 is entirely detached from the body, so that the prosthetic heart valve 200 remains in the pre-operation sewing position, and the operation is finished.
It should be noted that the features of the embodiments of the present application may be combined with each other without conflict.
The above description is only of the preferred embodiments of the present application and is not intended to limit the present application, but various modifications and variations can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.