Conveying interface of human heart implantation instrument and using methodTechnical Field
The invention relates to the technical field of medical instruments, in particular to a human heart implantation instrument conveying interface and a using method thereof.
Background
The small size of the human heart implant instrument and the need to operate at the handle end, require a functional and reliable delivery system and separable structural interface (or called a joint) for the instrument. The interface structure used in the prior art is complex, the size is large, the wall thickness of the pipe leads to insufficient design space of other elements, and the structure interface also has the problems that the interface structure is not easy to separate, or the separation external force is too large, the interface structure is damaged or the interface is abraded and the like. Therefore, there is a need to provide a new delivery interface and method for a human heart implantation device to solve at least one of the above problems of the prior art.
Disclosure of Invention
In order to overcome the problems, the invention provides a human heart implantation instrument conveying interface and a use method thereof. The connector can be designed into a thin-wall element, so that the size of the connector is reduced, the connector can be conveniently connected and separated, and sufficient space is provided for the design or assembly of other elements. And simultaneously controlling the connection and disconnection states of the connection member by using the insertion position of the lining core. In addition, the magnetic element reduces the separation difficulty of the buckle and the clamping groove, avoids the change of the position of the instrument in place due to the action of external force, and improves the installation precision of the instrument.
To achieve the above object, according to an aspect of an embodiment of the present invention, there is provided a human heart implant instrument delivery interface, including:
the first connecting piece is provided with at least one buckling groove at one end, and the buckling groove is matched with a buckle arranged at the end part of the second connecting piece so as to control the connection and the separation of the first connecting piece and the second connecting piece;
the end part of the second connecting piece is provided with a buckle matched with the buckle groove of the first connecting piece;
a lining core mounted on the inner peripheral sides of the first and second connectors to control the connection and disconnection of the first and second connectors;
the buckling surface of the buckling groove and the buckle in matching is an inclined surface, and when the lining core is arranged in the buckling area, the first connecting piece and the second connecting piece are in a connecting state; when the lining core is pulled out of the buckling area, the second connecting piece is pulled to generate radial component force on the buckling surface, so that the buckle moves towards the axial direction of the interface and leaves the buckling groove, and the first connecting piece and the second connecting piece are separated.
Optionally, the buckle and the buckle groove are both arranged on the circumferential side wall of the connecting piece, so that the connecting part of the first connecting piece and the second connecting piece does not protrude out of the inner side wall and the outer side wall in the radial direction.
Optionally, the radial depth dimension of the buckle groove is the same as the wall thickness dimension of the first connecting piece, and the radial wall thickness of the buckle is the same as the wall thickness of the second connecting piece.
Optionally, the inner contour sizes of the first connecting piece and the second connecting piece are the same; and/or the outer contour sizes of the first connecting piece and the second connecting piece are the same; and/or the outer contour dimension of the lining core is the same as the inner contour dimension of the first connecting piece and the second connecting piece, and the lining core is arranged on the inner peripheral side of the first connecting piece and the second connecting piece to keep the buckle from generating radial movement.
Optionally, the outer contours of the first connecting piece and the second connecting piece are cylindrical; and/or; the inner profiles of the first and second connectors are cylindrical.
Optionally, an included angle between the buckling position surface matched with the buckling groove and the buckle and the axis of the conveying interface is an acute angle, so that when the second connecting piece is pulled, the buckle moves towards the axis of the interface along the buckling position surface.
Optionally, the buckle is arranged at one end of the cantilever, and the other end of the cantilever is connected with the end of the second connecting piece; when the first connecting piece and the second connecting piece are separated, the cantilever bends along with the movement of the buckle; when the first connecting piece and the second connecting piece are in a connecting state, the cantilever is in a linear extending state along the side wall without deformation.
Optionally, the cantilever is an elastic arm, so that after the first connecting piece and the second connecting piece are separated, the elastic arm is bent to return to an original shape.
Optionally, a first positioning surface is arranged on a side wall of the one end of the first connecting piece, which is far away from the fastening groove;
a second positioning surface matched with the first positioning surface is arranged on the side wall of the end part of the second connecting piece;
the first positioning surface and the second positioning surface are matched to enable the buckling area to bear thrust.
Optionally, at least one axially extending protruding strip is disposed on a sidewall of the one end of the first connecting member;
at least one groove extending along the axial direction is arranged on the side wall of the end part of the second connecting piece;
when the first connecting piece is connected with the second connecting piece, the protruding strips are inserted into the grooves so as to control the circumferential butt joint precision of the first connecting piece and the second connecting piece.
Optionally, each buckle is provided with a first magnetic element;
and a second magnetic element matched with the first magnetic element is arranged on the lining core, so that the second magnetic element attracts the buckle to move towards the axis of the interface only when the first connector and the second connector are separated.
Optionally, at least a portion of each of the snaps comprises a ferromagnetic material;
and a second magnetic element matched with the ferromagnetic material is arranged on the lining core, so that the second magnetic element attracts the buckle to move towards the axis of the interface only when the first connector and the second connector are separated.
Optionally, the first magnetic element and/or the second magnetic element is a permanent magnet or an electromagnet.
Optionally, the second magnetic element is a permanent magnet or an electromagnet.
Optionally, the lining core is provided with concave surfaces equal to the number of the buckles, and when the two connecting pieces are in a connection state, the concave surfaces are arranged corresponding to the buckles or the buckle grooves, so that when the second magnetic element attracts the buckles, the buckles move towards the concave surfaces and are separated from the buckle grooves.
Optionally, a surface of the outer peripheral side of the bushing core, which is not the concave surface, supports the buckle, so that in a connected state of the first connecting piece and the second connecting piece, the surface of the outer peripheral side of the bushing core, which is not the concave surface, prevents the buckle from moving towards the interface axis;
and when the lining core rotates to the concave surface and the buckle or the buckle groove are correspondingly arranged, the second magnetic element attracts the buckle to move towards the interface axis.
Optionally, the lining core is provided with concave surfaces equal to the number of the buckles, and when the two connecting pieces are in a connection state, the concave surfaces are arranged corresponding to the buckles or the buckle grooves, so that when the second magnetic element attracts the buckles, the buckles move towards the concave surfaces and are separated from the buckle grooves.
Optionally, a surface of the outer peripheral side of the bushing core, which is not the concave surface, supports the buckle, so that in a connected state of the first connecting piece and the second connecting piece, the surface of the outer peripheral side of the bushing core, which is not the concave surface, prevents the buckle from moving towards the interface axis;
and when the lining core rotates to the concave surface and the buckle or the buckle groove are correspondingly arranged, the second magnetic element attracts the buckle to move towards the interface axis.
According to a second aspect of embodiments of the present invention, a method of using a delivery interface for a human cardiac implant device is provided.
Wherein a method of use comprises the human cardiac implant device delivery interface described in the first aspect without magnetic elements;
when the first connecting piece and the second connecting piece are separated, the lining core is firstly drawn out to leave the position where the buckle is matched with the clamping groove;
and pulling the second connecting piece to enable the buckle to move along the axis of the inclined buckle position surface towards the interface and to be separated from the clamping groove, and then continuously pulling the second connecting piece to realize the separation from the first connecting piece.
Wherein another method of use comprises the human cardiac implant device delivery interface described in the first aspect having a magnetic element;
when the first connecting piece is separated from the second connecting piece, the second magnetic element of the lining core is firstly controlled to be matched with the buckle, so that the buckle moves towards the axis of the interface under the action of a magnetic field and is separated from the clamping groove, and then the second connecting piece is continuously pulled to realize the separation from the first connecting piece.
The technical scheme of the invention has the following advantages or beneficial effects:
(1) the connection or the separation of the first connecting piece and the second connecting piece can be conveniently controlled by arranging the inclined buckling surface and the lining core, and the separation of the connecting pieces is promoted by fully utilizing radial component force generated on the inclined buckling surface.
(2) The connection and the separation of the connecting piece are convenient through the design of the cantilever or the elastic arm.
(3) Through the cooperation of protruding strip and recess, improved connecting piece circumference positioning accuracy.
(4) By defining the inner and outer dimensions or shapes of the first and second connectors; or the connecting parts of the two connecting pieces are limited not to protrude out of the inner side wall and the outer side wall in the radial direction; the connector can keep the two connecting pieces as thin-walled elements, reduce the size of the interface and provide sufficient space for the design or assembly of other elements.
(5) Through constructing the magnetic field between buckle and bushing core to the spatial distribution in rational control magnetic field, avoided the unexpected separation of connected state, axial force when also effectively eliminating or having reduced buckle and draw-in groove separation has improved the implantation precision of apparatus.
Drawings
The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:
FIG. 1 is a schematic diagram of an interface connection state according to an embodiment of the invention;
FIG. 2 is an exploded view of an interface element according to an embodiment of the invention;
FIG. 3A is a schematic diagram in cross-section at a non-axial line of an interface connection state according to an embodiment of the invention;
FIG. 3B is a schematic illustration in cross-section at an interface connection status axis according to an embodiment of the invention;
FIG. 4 is a schematic view of a first connector according to an embodiment of the present invention;
FIG. 5 is a schematic illustration in cross-section of a first connector according to an embodiment of the invention;
FIG. 6 is a schematic view of a second connector according to an embodiment of the present invention;
FIG. 7 is a schematic illustration in cross-section of a second connection according to an embodiment of the invention;
FIG. 8 is a schematic diagram of an interface disconnect state according to an embodiment of the present invention;
FIG. 9A is a schematic illustration of a cross-section at a non-axial line with the interfaces disconnected in accordance with an embodiment of the present invention;
FIG. 9B is a schematic illustration of a cross-section at the axis with the interfaces disconnected in accordance with an embodiment of the present invention;
FIG. 10 is a schematic illustration of a cross-sectional view of an interface having a magnetic element according to an embodiment of the invention;
fig. 11 is a schematic view of an implantation instrument using an interface according to an embodiment of the present invention.
Detailed Description
Exemplary embodiments of the present invention are described below with reference to the accompanying drawings, in which various details of embodiments of the invention are included to assist understanding, and which are to be considered as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.
It should be noted that, for clarity of illustration of the structure of the interface of the present invention, fig. 3A, 5, 7, 9A and 10 are not cross-sectional views taken along the axis of the interface.
According to one aspect of an embodiment of the present invention, a human heart implant instrument delivery interface is provided.
The delivery interface according to the embodiment of the present invention may be used for delivering the human heart valve leaflet clipping device 1101, and may be used for delivering other devices according to the actual use requirement. In the embodiment shown in fig. 11, the first connecting member is fixedly mounted on the human heart valve leaflet clipping device, and the second connecting member is detachably connected with the first connecting member.
Specifically, as shown in the embodiment of fig. 1 to 7, at least oneslot 401, such as the one shown in fig. 2, is provided at one end of thefirst connector 101 near thesecond connector 102. The catching groove is engaged with acatch 601 provided at an end of thesecond connector 102 to control engagement (i.e., connection) and disengagement of the first connector with the second connector. After thebuckle 601 is clamped into thebuckle slot 401, the first connecting piece and the second connecting piece are connected in an axial positioning manner. One end of thesecond connector 102 close to the first connector is provided with at least one buckle matched with the buckle slot of the first connector. In order to solve at least one problem provided by the invention, the first connecting piece and the second connecting piece are both of thin-wall structures, and the outer contour of the buckle does not protrude or exceed the outer contour of the connecting pieces. In one embodiment, the radial depth dimension of the snap groove is the same as the wall thickness dimension of the first connector, and the radial wall thickness of the snap is the same as the wall thickness of the second connector. In order to improve the strength of the structure and the strength of the joint, the embodiment of the invention enables the inner contour sizes of the first connecting piece and the second connecting piece to be the same; and/or the outer contour sizes of the first connecting piece and the second connecting piece are the same. For example, the first and second connectors are hollow cylinders, and the wall thickness of the cylinders is the same, and the inner and outer diameters are the same. It should be noted that the shape of the connecting member is not limited to this, and may also be an oval shape, a square shape, or the like. Correspondingly, the buckle and the clamping groove are arranged on the pipe wall, so that the connecting part of the first connecting piece and the second connecting piece does not protrude out of the inner pipe wall and the outer pipe wall in the radial direction. Of course, the catch can also be provided as a separate element and be connected to the end of the connecting piece. The design scheme can reduce the size and the volume of the connecting piece to the maximum extent, so that the saved space can be used for designing or mounting other parts, and the space utilization rate is improved. Further, the connector comprises alining core 103 which is arranged on the inner peripheral side of the first connector and the second connector and can move along the axial direction of the interface to insert or extract the first connector and the second connector, thereby controlling the clamping and separation of the first connector and the second connector. Specifically, when the bushing is inserted into the inner peripheral sides of the first connecting piece and the second connecting piece and is located at the position of the buckle and the clamping groove (i.e., the buckling area), the outer peripheral side of the bushing is used as a supporting surface for supporting the buckle, so that the buckle cannot move along the axis of the radial direction interface, and the first connecting piece and the second connecting piece are kept in a connected state, as shown in fig. 3A or 3B. When the lining core moves along the inner peripheral sides of the first connecting piece and the second connecting piece and is not positioned at the position of the buckle and the clamping groove, the buckle can move along the axial line of the radial direction interface, and then the first connecting piece and the second connecting piece are separated. Optionally, the fastening surface of the fastening groove and the snap fit is an inclined surface (see the connection portion in fig. 3A), and when the lining core is disposed in the fastening region, the first connecting piece and the second connecting piece are in a connection state; and after the lining core is pulled out of the buckling area, the second connecting piece is pulled to generate radial component force on the buckling surface, the radial component force pushes the buckle to move towards the axial direction of the interface and leave the buckling groove, and then the second connecting piece is pulled continuously to separate the first connecting piece from the second connecting piece.
In one embodiment, the inner contours of the first and second connectors are the same size or shape; and/or the first connecting piece and the second connecting piece have the same outer contour size or shape; and/or the outer contour size or shape of the lining core is the same as the inner contour size or shape of the first connecting piece and the second connecting piece. Optionally, the outer contour of the first connecting piece and the second connecting piece is cylindrical; and/or; the inner profiles of the first connecting piece and the second connecting piece are cylindrical; and/or; the outer contour shape or size of the lining core is the same as the inner contour shape or size of the first connecting piece and the second connecting piece. Through the design, the lining core can be smoothly inserted into or pulled out of the two connecting pieces, and in the inserted state, the outer surface of the lining core can be used for supporting the buckle, so that the buckle is kept not to move radially.
In the embodiment shown in fig. 6, the latch is disposed at one end of the cantilever, and the other end of the cantilever is connected to the end of the second connecting member. When the first and second connectors are separated, the cantilever bends with the movement of the buckle (see fig. 8); when the first connecting piece and the second connecting piece are in a connecting state, the cantilever is not deformed and linearly extends along the side wall, and is in a straight state as shown in fig. 1. Optionally, the cantilever is an elastic arm, so that after the first connecting piece and the second connecting piece are separated, the elastic arm is restored from a bending state, and restoring force comes from elastic deformation of the elastic arm. It will be appreciated that during separation, the resilient arm needs to flex in the axial direction to urge the catch out of the catch.
In one embodiment, afirst positioning surface 404 is arranged on the wall surface of the first connecting piece, which is far away from the buckling groove, at one end of the first connecting piece, which is close to the second connecting piece, a first bucklingsurface 501 is arranged on the wall surface of the buckling groove, which is close to the first positioning surface, and at least oneaxial groove 402 matched with the elastic arm of the second connecting piece is arranged on the wall surface between the first positioning surface and the first buckling surface; the buckle is connected with one end, close to the first connecting piece, of the second connecting piece through anelastic arm 602, a second bucklingsurface 603 matched with the first buckling surface is arranged on the buckle, and asecond positioning surface 701 matched with the first positioning surface is arranged on the wall surface of the one end of the second connecting piece; the first connecting piece is clamped or separated with the second connecting piece by adjusting the matching relation of the first fastening surface and the second fastening surface. Specifically, after the lining core is pulled out, the second connecting piece is pulled to enable the buckle to move along the buckling surface to the axial direction of the interface, and then the elastic arm bends towards the axis, so that the matching relation of the first buckling surface and the second buckling surface is changed. After the first buckling surface and the second buckling surface are separated, the first connecting piece and the second connecting piece can be separated along the axis.
In one embodiment, a first positioning surface is arranged on the side wall of the end of the first connecting piece far away from the buckling groove; a second positioning surface matched with the first positioning surface is arranged on the side wall of the end part of the second connecting piece; the first positioning surface and the second positioning surface are matched to enable the buckling area to bear thrust. Such as during implantation of the instrument, the instrument may be advanced into the target site by engagement of the locating surfaces.
In one embodiment, in order to reduce the difficulty of separation, the included angle between the first catching surface and the second catching surface and the axis of the conveying interface is set to be an acute angle, so that when the second connecting piece is pulled, a component force, such as a radial component force, can be generated on the catching surface, the component force pushes the buckle to move towards the axis, and finally when the second connecting piece is pulled, the elastic arm and the buckle bend towards the axis, so that the first catching surface and the second catching surface are separated easily.
As mentioned above, the provision of at least one resilient arm and its corresponding axial slot limits the circumferential rotational movement between the first and second coupling members, ensuring a precise fit between the two. However, due to errors in the machining process, a fit clearance exists between the elastic arm and the axial groove, and therefore the circumferential positioning precision is difficult to control. For this purpose, in a preferred embodiment, at least one axially extending protrudingstrip 403 is optionally provided on the side wall of said one end of the first connecting member, as shown in particular in fig. 4; at least one axially extendinggroove 604 is provided in the sidewall of said one end of said second connector, as shown in fig. 6; when the first connecting piece and the second connecting piece are connected, the protruding strips are inserted into the grooves; thereby utilizing the protruding strips and the grooves to limit circumferential movement between the two connecting pieces and maintain the circumferential positioning precision of the two connecting pieces. It should be noted that, because the protruding strip does not have a bending motion like the elastic arm, the processing precision of the protruding strip and the groove can be improved, the matching precision between the protruding strip and the groove can be improved, and finally the positioning precision of the first connecting piece and the second connecting piece can be improved. It will be appreciated that the positions of the grooves and the raised strips described above may be interchanged, i.e. the side wall of said one end of the first connector is provided with at least one axially extending groove; at least one protruding strip extending along the axial direction is arranged on the side wall of one end of the second connecting piece. Similarly, the positions of the structures such as the catching groove and the cantilever can be interchanged between the two connecting pieces, that is, the connecting portion of the first connecting piece and the connecting portion of the second connecting piece can be interchanged.
In actual use, after the implantation instrument is installed in place, the separation difficulty can be expected to be reduced as much as possible, and the abrasion of parts is reduced. For this purpose, a preferred embodiment provides for the first magnetic element to be arranged on each of said catches; and a second magnetic element matched with the first magnetic element is arranged on the lining core, so that the second magnetic element attracts the buckle to move towards the axis of the interface only when the first connector and the second connector are separated. Specifically, as shown in fig. 10, which shows the position relationship between the two magnetic elements at the moment of separation, it should be noted that the structure of the core is simplified here for the sake of clearly showing the positions of the magnetic elements, and the view is not a sectional view at the interface axis. In the non-separation stage, the magnetic pole position relationship between the two magnetic elements needs to be reasonably set according to the characteristics of the magnetic elements; to avoid the magnetic field forces causing the clasp to undesirably move toward or away from the axis. For example, when the magnetic elements are all permanent magnets and have fixed magnetic poles, the magnetic elements on the lining core should not be opposite to the magnetic elements on the buckle; the term "opposite" herein includes either a homopolar magnetic pole opposite or a heteropolar magnetic pole opposite. When the lining core needs to be separated, the lining core can be rotated, so that the magnetic poles of the lining core are opposite to the magnetic poles of the buckles, the buckles are easily sucked into the pipe wall, and the two connecting pieces are separated. And under the non-separating state, the magnetic elements on the lining core are kept vertical to the first magnetic elements, so that the central position of the second magnetic element is over against the magnetic poles of the first magnetic elements, the acting force between the two magnetic elements is reduced, and the separation of the buckle and the clamping groove is avoided. Optionally, at least a portion of each of the snaps comprises a ferromagnetic material, rather than a magnetic element; and a second magnetic element matched with the ferromagnetic material is arranged on the lining core, so that the second magnetic element attracts the buckle to move towards the axis of the interface only when the first connector and the second connector are separated. Of course, the first magnetic element and/or the second magnetic element is a permanent magnet or an electromagnet. It should be noted that, when at least one of the first magnetic element and/or the second magnetic element is an electromagnet, the magnetic field and the polarity thereof can be controlled by controlling the energization state, so that the magnetic pole angle can be adjusted without rotating the lining core, that is, the magnetic structures can be always kept in relative arrangement under such a condition. However, to match the user's habit of using a permanent magnet type interface, one embodiment of the present invention selects an electromagnet type interface, and the magnetic pole orientation can also be adjusted by rotating the core. Preferably, in order to adjust the position of the magnetic element and the position of the magnetic pole on the lining core, two limit structures can be arranged on the lining core, the first connecting piece or the second connecting piece. One limiting structure limits the axial insertion amount of the lining core during insertion, and ensures that the second magnetic element and the first magnetic element are at the same axial position basically. The second limiting structure is used for limiting the circumferential position between the second magnetic element and the first magnetic element, namely controlling the rotation angle of the lining core; for example, the lining core can be limited to rotate by 90 degrees basically, and then the opposite magnetic poles of the second magnetic element and the first magnetic element are opposite; or the magnetic structure on the lining core is opposite to the ferromagnetic material on the buckle.
As shown in fig. 10, the lining core is provided with concave surfaces equal to the number of the buckles, and when the two connectors are in a connection state, the concave surfaces are arranged corresponding to the buckles or the buckle grooves, so that when the second magnetic element attracts the buckles, the buckles move towards the concave surfaces and are separated from the buckle grooves. The concavity herein provides room for movement of the clip so that the clip or resilient arm does not interfere with the core as it moves axially. The concave surface can also be arranged into a groove structure and the like. Preferably, the surface of the outer peripheral side of the lining core, which is not the concave surface, is matched with the buckle, that is, a supporting surface is provided to support the buckle, so that in the connection state of the first connecting piece and the second connecting piece, the surface of the outer peripheral side of the lining core, which is not the concave surface, prevents the buckle from bending towards the interface axis; and when the lining core rotates to the concave surface and the buckle or the buckle groove are correspondingly arranged, the second magnetic element attracts the buckle to move towards the interface axis. Through the scheme described above, the separation of the buckle and the buckle groove can be realized by the acting force generated by the magnetic field, the abrasion loss between the two parts is reduced, and the service life of the device is prolonged.
According to yet another aspect of an embodiment of the present invention, a method of using a delivery interface for a human cardiac implant device is provided, with particular reference to the embodiment illustrated in fig. 8-9. In the non-separated state, the outer peripheral surface of the core serves as a support surface for the latch to prevent axial movement toward the interface. When the first connecting piece and the second connecting piece are separated, the lining core is firstly drawn out to leave the position where the buckle is matched with the clamping groove; and then the second connecting piece is pulled to enable the buckle to move towards the axis of the interface and separate from the clamping groove, and the second connecting piece is continuously pulled to realize the separation from the first connecting piece. When the buckling surface is an inclined surface, radial component force is generated on the buckle when the second connecting piece is pulled, so that the second connecting piece can move towards the axis of the connector easily, and the separation difficulty of the two connecting pieces is reduced.
In the non-separated state, the outer circumferential surface of the core serves as a support surface for the latch to prevent axial movement of the latch toward the interface. When the first connecting piece is separated from the second connecting piece, the second magnetic element of the lining core is firstly controlled to be matched with the buckle, so that the buckle moves towards the axis of the interface under the action of a magnetic field and is separated from the clamping groove, and then the second connecting piece is continuously pulled to realize the separation from the first connecting piece. Specifically, the position relationship between the second magnetic element and the buckle can be adjusted by rotating the lining core.
The above-described embodiments should not be construed as limiting the scope of the invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions can occur, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.