CN215080274U - Interventional instrument and interventional system employing friction-assisted positioning - Google Patents

Abstract

The utility model provides an adopt friction assistance-localization real-time's intervention apparatus and intervention system, intervention apparatus include the support, the frame construction of support for having the fretwork district just has an axis in the space, the support has the loading state of radial compression to and the release state of radial expansion, intervention apparatus is still including increasing the part that rubs, it is a line body or many line bodies to increase the part that rubs, specifically includes: an anchoring portion directly connected to the bracket; and the outer convex part is connected with the anchoring part, and extends to the outer side of the bracket in a release state. The application discloses intervention apparatus, increase the part of rubbing and improve its mounted position through setting up, provide the mode of friction location on the one hand, avoided the adverse effect to loading in addition, eliminate the potential safety hazard as far as.

Description

Interventional instrument and interventional system employing friction-assisted positioning

Technical Field

The utility model relates to the technical field of medical equipment, especially relate to an adopt friction assistance-localization real-time's intervention apparatus and intervention system.

Background

Common interventional devices such as valves or blood vessel stents are mainly positioned in blood vessels or visceral organs by radial supporting force of metal stents, but the peripheries of the metal stents are generally smooth, and once the metal stents are displaced under the impact of blood flow, the effect is influenced and safety hazards also exist. In some patients, the adjacent tissues implanted by the interventional instrument have calcification, the elasticity of the tissues is poor, and the positioning problem is particularly obvious.

In order to solve the positioning problem, in the prior art, the anchoring thorn is arranged on the periphery of the stent of the interventional device for positioning or the attachment is arranged to fill the gap between the stent and the adjacent tissue, but the arrangement of the anchoring thorn can bring safety hidden trouble, the diameter of the interventional device is further increased by the attachment, particularly in the self-expanding interventional device, the loading is inconvenient due to the increase of the diameter, and the passing property during the intervention into the body is greatly reduced.

SUMMERY OF THE UTILITY MODEL

In order to further improve the location effect of intervention instrument in vivo, avoid increasing the loading degree of difficulty of intervention instrument as far as simultaneously, this application provides an intervention instrument who adopts friction assistance-localization real-time.

This application adopts friction assistance-localization real-time's intervention apparatus, which comprises a bracket, the frame construction of support for having the fretwork district, the support has the loading state of radial compression to and the release state of radial expansion, intervention apparatus is still including increasing the part of rubbing, it is a line body or many line bodies to increase the part of rubbing, specifically includes:

an anchoring portion directly connected to the bracket;

and the outer convex part is connected with the anchoring part, and extends to the outer side of the bracket in a release state.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, a sealing membrane is arranged on the bracket, the sealing membrane includes an inner sealing membrane located on the inner side of the bracket and/or an outer sealing membrane located on the outer side of the bracket, and the outer sealing membrane and the inner sealing membrane are of an integrated structure or a split structure.

Optionally, one of the outer sealing membrane and the inner sealing membrane extends to one end of the stent in the axial direction and is rolled and wrapped on the end of the stent;

or the two extend to the axial end of the bracket in the same direction and then are mutually connected with the end part of the wrapping bracket.

Optionally, the axial position of the outer closing membrane relative to the stent is fixed; or the external sealing membrane can be axially stretched or stacked along with the switching of the state of the bracket.

Optionally, the bracket is provided with a positioning hole, and the positioning hole is used for connecting the anchoring portion and/or the sealing film.

Optionally, in the loaded state, the outer convex portion extends towards the inner side of the bracket through the adjacent hollow-out area.

Optionally, one axial end of the stent is an inflow end, the other axial end of the stent is an outflow end, and the friction increasing component is arranged on one side adjacent to the inflow end.

Optionally, the friction increasing parts are multiple, and in a released state, the friction increasing parts are distributed along the circumferential direction of the stent.

Optionally, the friction increasing components are divided into a plurality of groups along the circumferential direction of the support, and adjacent groups are arranged in a staggered manner in the axial direction of the support.

Optionally, the frame structure includes frame strips, the frame strips extending in different directions intersect at the node portion, and the friction-increasing member is connected to the frame strips and/or the node portion.

Optionally, the support has a unit lattice structure distributed circumferentially near the inflow end, the hollow areas are inside the unit lattices, the frame strips serve as the side edges of the unit lattices, and the node positions are located at the vertexes of the unit lattices.

Optionally, the friction enhancing members are all connected to the node location.

Optionally, the connection mode of the anchoring portion and the bracket is at least one of binding, bonding and radial penetrating anchoring.

Optionally, the friction increasing component further comprises a supporting portion, and the supporting portion is located at a connecting portion of the convex portion and the anchoring portion.

Optionally, the friction-increasing component is a wire body, and the support part is formed by winding the wire body; or the friction increasing component is a plurality of wire bodies, and the supporting part is formed by mutually winding the plurality of wire bodies; the wire body further extends from the support part to form the outer convex part.

Optionally, the intertwining manner is knotting or twisting.

Optionally, the support portion has higher rigidity relative to the outer convex portion in a manner that the wire body is locally reinforced.

Optionally, the local reinforcement mode is at least one of knotting of a wire body, thickening of the wire body, and material change of the wire body.

Optionally, an end of the convex portion away from the anchor portion is divergent or the convex portion is divergent as a whole.

Optionally, the specific manner of the divergence is end-of-thread opening twist or local hot melt deformation.

Optionally, in the released state, the friction-increasing component extends to the outside of the stent for friction positioning with adjacent tissues at the implantation position of the interventional instrument.

Optionally, the inside of the stent is an axial channel, and in a release state, the axial channel is kept through, or a valve leaflet capable of changing the through state of the axial channel is arranged in the stent.

Optionally, the valve leaflet corresponds to an aortic valve, a pulmonary valve, a mitral valve, a tricuspid valve or a venous valve according to the use position of the interventional device, and the stent has a shape corresponding to the use position.

Optionally, the scaffold is of the balloon type or self-expanding type.

Optionally, the stent is integrally manufactured by adopting a tube cutting mode or a weaving mode, or manufactured by adopting a mode of combining tube cutting and weaving.

Optionally, the stent is provided with an auxiliary positioning structure for interacting with adjacent tissues, and the auxiliary positioning structure at least comprises one of the following modes:

the support is provided with a corrugated structure which is radially fluctuated;

the bracket is provided with barbs;

the outer surface of the bracket is provided with anti-skid grains.

Optionally, an outer sealing film is arranged on the periphery of the support, the outer sealing film is a flexible skirt edge, the outer sealing film axially extends to shield the friction increasing component in a loading state, and the outer sealing film axially stacks and exposes the friction increasing component in a releasing state.

Optionally, a traction cable penetrates through the outer sealing film, penetrates through the whole along the circumferential direction of the support, and fluctuates in the axial direction of the support to form a wave structure.

The application still provides an intervention system, including sheath pipe subassembly, brake valve lever and intervention apparatus, the sheath pipe subassembly has relative distal end and near-end, intervention apparatus load in the distal end of sheath pipe subassembly, brake valve lever connect in the near-end of sheath pipe subassembly, brake valve lever accessible drive the release of sheath pipe subassembly intervention apparatus, intervention apparatus is this application context intervention apparatus.

The application discloses intervention apparatus, increase the part of rubbing and improve its mounted position through setting up, provide the mode of friction location on the one hand, avoided the adverse effect to loading in addition, eliminate the potential safety hazard as far as.

Drawings

FIG. 1 is a schematic view of an embodiment of an interventional instrument in a released state;

FIG. 2 is a schematic illustration of frictional positioning of an interventional instrument (partially) with adjacent tissue in a released state in one embodiment;

FIG. 3 is a schematic view of an embodiment of the interventional instrument in a released state;

FIG. 4 is a schematic illustration of frictional positioning of an interventional instrument (partially) with adjacent tissue in a released state in one embodiment;

FIG. 5 is a schematic view of a friction enhancing member distribution of the interventional instrument in accordance with one embodiment;

FIG. 6 is a schematic view of a friction enhancing member distribution of the interventional instrument in accordance with one embodiment;

FIG. 7 is a schematic view of a friction enhancing member of the interventional instrument coupled to a stent in accordance with one embodiment;

FIG. 8 is a schematic view of a friction enhancing member of the interventional instrument in accordance with one embodiment;

FIG. 9 is a schematic view of a friction enhancing member of the interventional instrument in accordance with one embodiment;

FIG. 10 is a schematic view of a friction enhancing member of the interventional instrument in accordance with one embodiment;

FIG. 11 is a schematic view of a friction enhancing member of the interventional instrument in accordance with one embodiment;

FIG. 12 is a schematic view of a friction enhancing member of the interventional instrument in accordance with one embodiment;

FIG. 13 is a schematic view of a friction enhancing member of the interventional instrument in accordance with one embodiment;

FIG. 14 is a schematic view of an embodiment of an interventional instrument in a loaded state;

FIG. 15 is a schematic view of the interventional instrument of FIG. 14 in a released state;

FIG. 16 is a schematic view of an embodiment of an interventional instrument in a loaded state;

FIG. 17 is a schematic view of the interventional instrument of FIG. 16 in a released state;

FIG. 18 is a schematic structural diagram of an interventional system according to an embodiment of the present application;

FIG. 19 is a schematic view of the sheath core assembly of FIG. 18;

figure 20 is a schematic view of the interventional instrument in a pre-release, i.e., compressed, state;

figure 21 is a schematic view of the distal end partially expanded during release of the interventional instrument.

The reference numerals in the figures are illustrated as follows:

1. a support; 11. frame strips; 12. a node location; 13. positioning holes;

2. an inner sealing film;

3. a friction increasing member; 31. an anchoring portion; 32. a support portion; 33. an outer convex portion;

4. adjacent tissue;

5. binding wires;

6. an outer sealing film; 61. penetrating a lead hole;

7. and (4) pulling a rope.

8. A control handle; 81. a conduit; 82. an interventional instrument; 83. a sheath tube;

9. a sheath-core assembly; 91. a core tube; 92. a lock; 93. and a guide head.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to the drawings, the interventional device adopting friction-assisted positioning comprises a support 1, wherein the support 1 is of a frame structure with a hollow area, the support 1 has a loading state of radial compression and a release state of radial expansion, the interventional device further comprises a friction increasing component 3, and the friction increasing component 3 is a line or a plurality of lines and specifically comprises:

an anchoring portion 31 directly connected to the stent 1;

and an outward protrusion 33 connected to the anchor portion 31, wherein the outward protrusion 33 extends outward of the holder in the released state.

In this application can adopt conventional technique about support 1 itself, but adopts radial compression's structure, and the loading and transport of being convenient for after arriving internal predetermined position, utilize the ball to expand or self elasticity can release, and be close to operator one side and be the near-end, get into the internal one side that is close to the focus and be the distal end.

The friction enhancing member 3 itself may be of a biocompatible material, preferably with a certain elasticity, which also in the released state better maintains the close fit and tension with the adjacent tissue 4. In a preferred embodiment, the friction increasing members 3 extend outside the stent in the released state, e.g. in fig. 4, the friction increasing members 3 fill or tighten between the stent 1 and the adjacent tissue 4, further improving the positioning effect by means of increased friction.

The anchoring portion 31 of the friction increasing member 3 is directly connected to the stent 1 in the present application without the need for additional connectors or spacers in order to reduce the radial dimension of the interventional instrument in the loaded state.

The stent 1 is approximately in a shape of a mesh tube, and is made of stainless steel or nickel-titanium alloy, and the inside of the stent 1 is an axial channel, and in different embodiments, the axial channel is kept through in a release state, or a valve leaflet capable of changing the through state of the axial channel is arranged in the stent 1. If the interventional device only plays a supporting role and does not need to control and interfere blood flow, the axial channel can be always kept through in a release state, if the blood flow direction needs to be controlled, for example, backflow is prevented, valve leaflets can be arranged in the stent, and the valve leaflets can be commonly single-leaf, two-leaf or three-leaf and fixed in the stent in a stitching or bonding mode to interfere the opening and closing or the opening and closing degree of the axial channel. The shape characteristics and functions of the valve leaflets can be configured according to the use position of the interventional device, in different embodiments, the valve leaflets are an aortic valve, a pulmonary valve, a mitral valve, a tricuspid valve or a venous valve according to the use position of the interventional device, and the support has a shape corresponding to the use position.

The stent has corresponding shape characteristics to adapt to peripheral tissues according to the use position of the interventional device, for example, when the interventional device is an aortic valve, for example, the stent 1 and the valve leaflet are adapted thereto according to fig. 1.

Depending on the manner in which the stent is released in vivo, in one embodiment the stent is balloon-expandable, and in a preferred embodiment the stent is self-expanding. Aiming at the self-expanding bracket, the loading space is limited, and the self-expanding bracket is more sensitive to the change of the outer diameter in the loading state, so that the friction increasing component mode adopted in the application has more outstanding advantages in the self-expanding bracket.

In different embodiments, the stent is integrally made by adopting a tube cutting mode or a weaving mode, or is made by adopting a mode of combining tube cutting and weaving. In order to further improve the positioning effect, the bracket can be further improved in different embodiments on the basis of adopting the friction increasing component.

In one embodiment, the stent is provided with an auxiliary positioning structure which is acted with adjacent tissues, the auxiliary positioning structure is formed in a mode that barbs are arranged on the stent along the circumferential direction of the stent, and the barbs can anchor the adjacent tissues in a release state to prevent the intervention instrument from being displaced.

The auxiliary positioning structure in one embodiment is characterized in that the support is provided with anti-skid grains, the anti-skid grains can be arranged on part or all of the circumference of the support, at least one section of the support in the axial direction is provided with the anti-skid grains, the anti-skid grains can be simultaneously processed in the cutting process of the support, and the anti-skid grains can act on adjacent tissues to improve friction force in a release state to prevent the intervention instrument from shifting.

In one embodiment, the auxiliary positioning structure is formed by a corrugated structure on the stent, the corrugated structure at least has radial undulations which can be arranged on part or all of the circumference of the stent, at least one section of the corrugated structure in the axial direction is provided with the corrugated structure, the corrugated structure can be obtained by means of heat setting, and the corrugated structure can act on adjacent tissues to improve friction force in a release state so as to prevent the interventional device from shifting.

With reference to fig. 1 to 4, the frame structure of the bracket 1 includes frame strips 11, the frame strips 11 extending in different directions intersect at the node portion 12, and the friction-increasing member 3 is connected to the frame strips 11 and/or the node portion 12.

For example, in the embodiment of fig. 2, the friction-increasing member 3 is connected to the frame strip 11, whereas in the embodiment of fig. 4, the friction-increasing member 3 is connected to the node portion 12.

In order to facilitate radial compression and loading, in one embodiment, the stent 1 has a circumferentially distributed cell structure adjacent to the inflow end, the interior of the cell is a hollow area, the frame strips 11 serve as the sides of the cell, the node portions 12 are located at the vertices of the cell, and in a preferred embodiment (e.g., fig. 4), the friction-increasing members 3 are connected to the node portions.

When the interventional device is placed in the blood flow channel, the side adjacent to the inflow end is first subjected to the impact of the blood flow, so that in a preferred embodiment, one axial end of the stent 1 is the inflow end and the other axial end is the outflow end, and the friction increasing member 3 is disposed on the side adjacent to the inflow end.

In one embodiment, the friction increasing members 3 are multiple, and in the released state, the friction increasing members 3 are distributed along the circumferential direction of the stent 1, and in the circumferential direction, each unit cell corresponds to one friction increasing member 3 on average, or the friction increasing members 3 are distributed at intervals, for example, in fig. 5, each two unit cells correspond to one friction increasing member 3 on average.

Referring to fig. 6, in another embodiment, the friction increasing components 3 are divided into a plurality of groups along the circumferential direction of the stent, two friction increasing components in the square frames can be regarded as one group, and adjacent groups are arranged in a staggered manner in the axial direction of the stent, that is, the axial positions of two adjacent square frames are different, so that the friction increasing components in the adjacent groups are arranged in a staggered manner in the axial direction during loading, and mutual pressing interference is avoided.

In order to further improve the sealing effect, the support 1 is provided with a sealing film, for example, the sealing film adopts an inner sealing film 2 positioned at the inner side of the support, and the inner sealing film 2 can be fixed on the support 1 by means of stitching.

Referring to fig. 7, in order to facilitate the positioning of the inner sealing film 2 and the friction-increasing member 3, in an embodiment, the bracket 1 is provided with positioning holes 13, the inner sealing film 2 may be stitched on the bracket 1 by the binding wires 5, and the frame strip 11 provided with the positioning holes 13 may be widened appropriately, so as to facilitate the processing of the positioning holes 13.

The friction increasing component 3 can also be directly bound on the bracket 1 through the positioning hole 13 with the corresponding position, and the inner closing film 2 and the friction increasing component 3 can also share the positioning hole 13 with the corresponding position.

Referring to fig. 8-13, in order to provide better contact of the friction enhancing member with the surrounding adjacent tissue and maintain the necessary interaction, in one embodiment the friction enhancing member further comprises a support portion 32, the support portion 32 being located at the junction of the male portion 33 and the anchor portion 31. The support portion has a higher stiffness relative to the male portion 33 for better holding of the male portion 33. For example, at least one of knotting, thickening and material change of the thread is adopted.

The friction increasing means is a wire body, which is not the point of improvement of the present application as such, e.g. in different embodiments the wire body is a single wire, a core wire or a twisted multiple wire. In consideration of specific application environment and performance requirements, the surface of the wire body should have certain roughness, which can be obtained by surface treatment of the wire body, and can also be selected from proper materials, in a preferred embodiment, the wire body is made of polyester materials.

The line body is as increasing the part that rubs, and it has certain elasticity itself, especially for matching at the use scene of organism to intervene the apparatus, intervene the peripheral tissue of apparatus (if do not have obvious calcification) also have certain elasticity, can with increase and rub and realize mutual adaptive deformation between the part, in the use scene of commonly used, take aortic valve as the example, its inner periphery is smooth relatively and produce the week easily and leak, adopt this application to have the intervention apparatus of increasing the part that rubs, not only further guarantee the locate effect, also direct or indirect reduction week risk of leaking.

The mutual winding and fixing between the wire bodies are simple and easy, an additional connecting piece or a locking piece can be omitted, in this respect, the cross-sectional shape of the wire bodies also has certain influence on the firmness of the winding and fixing, and in the preferred embodiment, the wire bodies are flat strip-shaped.

In the figure, the specific arrangement of the anchoring portion 31, the supporting portion 32 and the external convex portion 33 can be seen, the three portions all adopt a wire body structure, and the wire bodies are convenient to wind, lap and connect with each other, so that the number of the wire bodies included in the friction-increasing component is not strictly limited as a whole. For example, the anchoring portion 31, the supporting portion 32, and the outer protrusion 33 each independently adopt one or more wires, or at least one wire is shared between the two wires, or the three are integrated, i.e., one wire.

Referring to fig. 8, in one embodiment, the interventional device includes a support 1, and the friction increasing component on the support 1 is a linear structure and includes an anchoring portion 31 bound on the support 1; a support portion 32 located outside the bracket in a released state; and an outer convex part 33 extending outwards from the supporting part 32 and used for being in friction positioning with adjacent tissues, wherein the wire body at the supporting part 32 is knotted so as to have higher rigidity, and the outer convex part 33 has a further supporting function. The end of the outer protrusion 33 away from the anchor portion 31 is divergent, or the outer protrusion 33 is divergent as a whole, and the specific mode of the divergent mode is the end opening twist or the local thermal deformation, in this embodiment, the end opening twist.

Referring to fig. 9, in one embodiment, the interventional device includes a stent 1, and the friction increasing component on the stent 1 is a linear structure and includes an anchoring portion 31 connected to the stent 1; a support portion 32 located outside the bracket in a released state; an outer protrusion 33 extending laterally outward from the support 32 for frictional positioning with adjacent tissue.

The bracket 1 is provided with a through hole, the anchoring part 31 expands and anchors on the inner side of the bracket 1 after radially penetrating through the through hole on the bracket 1, and the connection mode of the anchoring part 31 and the bracket 1 in different embodiments is at least one of binding, bonding and radially penetrating anchoring. The wire body at the supporting part 32 is thickened, so that the rigidity is higher, and the outer convex part 33 is further supported.

Referring to fig. 10, in one embodiment, the interventional device includes a stent 1, and the friction increasing component on the stent 1 is a linear structure and includes an anchoring portion 31 connected to the stent 1; a support portion 32 located outside the bracket in a released state; an outer protrusion 33 extending laterally outward from the support 32 for frictional positioning with adjacent tissue. Compared with the embodiment in fig. 9, in this embodiment, the wire body at the supporting portion 32 is knotted, so that the rigidity is higher, and the external convex portion 33 is further supported.

Referring to fig. 11, in one embodiment, the interventional device includes a support 1, and the friction increasing component on the support 1 is a linear structure and includes an anchoring portion 31 bound on the support 1; a support portion 32 located outside the bracket in a released state; and the outer convex part 33 extends outwards from the supporting part 32 and is used for being positioned by friction with adjacent tissues, wherein the wire body at the supporting part 32 is knotted, and the number of the knotted wires is multiple, so that the rigidity is higher, and the outer convex part 33 has a further supporting effect.

Referring to fig. 12 to 13, in one embodiment, the interventional device includes a stent 1, and the friction increasing component on the stent 1 is a linear structure and includes an anchoring portion 31 connected to the stent 1; a support portion 32 located outside the bracket in a released state; an outer protrusion 33 extending laterally outward from the support 32 for frictional positioning with adjacent tissue.

The support 1 is adjacent to the inflow end and is provided with a unit lattice structure distributed in the circumferential direction, hollow areas are arranged inside the unit lattices, the frame strips are used as the side edges of the unit lattices, the node parts are positioned at the top points of the unit lattices, the friction increasing parts are connected to the node parts, and in a loading state, the supporting parts 32 and the outer convex parts 33 extend towards the inner side of the support through the adjacent hollow areas.

Fig. 12 to 13 show different embodiments with the difference that the number of the knotted supporting portions 32 is the same, the compression loading process is illustrated, and the stent 1 is not yet completely collapsed, and the supporting portions 32 and the outward protruding portions 33 both fall down to the side of the inflow end, which is also the end of the after-loading, and when the stent 1 is further compressed, the supporting portions 32 and the outward protruding portions 33 extend further from the hollowed-out areas to the inside of the stent as much as possible, in order to reduce the radial dimension.

Referring to fig. 14 to 17, the stent 1 may be provided with not only the inner cover 2 but also the outer cover 6, and the inner cover 2 and the outer cover 6 may be integrally or separately formed.

One of the outer sealing membrane 6 and the inner sealing membrane 2 extends to one axial end of the bracket and is rolled and wrapped on the end part of the bracket; or the two extend to the axial end of the bracket in the same direction and then are mutually connected with the end part of the wrapping bracket.

The end part of the bracket is likely to have a spine structure, so that potential safety hazards exist, the safety can be improved by wrapping the outer sealing film 6 or the inner sealing film 2, the outer sealing film 6 and the inner sealing film 2 can also adopt an integrated structure, for example, the inner sealing film 2 extends to the end part of the bracket in the bracket and then is outwards rolled to form the outer sealing film 6, the cutting during sewing can be reduced, and the integrity of a product is kept.

When the outer sealing film 6 is stacked, the top edge can be fixed, the bottom edge can move upwards to realize axial folding and stacking, and the bottom edge can be fixed, and the top edge can move downwards to realize axial folding and stacking.

The material of the outer sealing membrane 6 can be the same as or different from that of the inner sealing membrane 2, on one hand, the outer sealing membrane 6 can block blood flow at the position, in addition, the outer sealing membrane 6 can also be a skirt edge structure at least partially suspended at the periphery of the support, and the skirt edge structure is linked with the state switching of the support.

For example, in one embodiment, the outer enclosing film 6 is provided on the periphery of the holder 1, the outer enclosing film 6 is a flexible skirt, and in the loading state, the outer enclosing film 6 extends axially to cover the friction increasing member 3, and in the release state, the outer enclosing film 6 is stacked axially to expose the friction increasing member 3.

The skirt edge is in a spreading state before the support 1 is released, extends axially and surrounds the periphery of the support 1, and after the support 1 is released, the skirt edge is in a stacking state, is folded and stacked in the axial direction of the released support and forms an annular peripheral leakage blocking part.

In a preferred embodiment, the outer closing film 6 is further provided with a traction rope 7 in a penetrating way, and the traction rope 7 integrally penetrates along the circumferential direction of the support and simultaneously undulates in the axial direction of the support to form a wave structure with corresponding wave crest and wave trough structures. The axial positions of all wave crests are the same and the axial positions of all wave troughs are the same in the spreading state, and the wave crests can be staggered properly.

In order to facilitate threading of the traction rope 7, a group of threading holes 61 are formed in the outer closed film 6 corresponding to each wave crest, another group of threading holes are formed in the outer closed film corresponding to each wave trough, the traction rope 7 alternately penetrates through the threading holes in different groups to form a wavy structure, and the traction rope 7 alternately sinks and floats on the inner surface and the outer surface of the outer closed film 6 in the threading process.

Two adjacent wave crests have the change of circumferential span before and after the support is released, and when the support is released, under the traction of the deformation of the support, each wave crest is relatively far away in the circumferential direction to drive the wave trough to lift, so that the axial stacking of the outer sealing film 6 is realized.

The so-called peaks and troughs are only relative, i.e. one peak and the other trough, and when the stent is released, the troughs are also relatively far from the carrying peaks in the circumferential direction under the traction of the stent deformation, so that the two motions are opposite to each other in order to draw each other in the axial direction.

Referring to fig. 18-21, an interventional system is further disclosed in an embodiment of the present application, which includes a sheath assembly having opposite distal and proximal ends, a control handle 8 and an interventional device 82, wherein the interventional device 82 can be used with the interventional devices of the above embodiments, the interventional device 82 is loaded on the distal end of the sheath assembly, the control handle 8 is connected to the proximal end of the sheath assembly, and the control handle can release the interventional device 82 by driving the sheath assembly.

Wherein the sheath assembly comprises a sheath 83 and a sheath core assembly 9, wherein the sheath 83 is a sliding fit to the outer periphery of the sheath core assembly 9. Wherein the sheath core assembly 9 includes a core tube 91 and a locking element 92 secured to the core tube 91 for connection to the interventional instrument 82. The distal end of core tube 91 further extends out of locking element 92 and is secured to guide head 93. The distal end of guide head 93 has a converging rounded configuration to facilitate navigation through the body, and the location between guide head 93 and locking element 92 serves as a loading location for interventional instrument 82, in which location interventional instrument 82 is in a compressed state and in positive engagement with locking element 92.

In other embodiments, the interventional system may further comprise a catheter 81 fixed relative to control handle 8, catheter 81 being used to create a channel to prevent sheath 83 from injuring body tissues during reciprocation.

The interventional device 82 is loaded on the sheath core assembly 9 and enters the body together with the catheter 81 under the wrapping of the sheath tube 83, and then the sheath tube 83 can slide and retract relative to the sheath core assembly 9 towards the near end under the driving of the control handle 8, so that the interventional device 82 is gradually exposed and released.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above examples only show some embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims (17)

1. Adopt intervention apparatus of friction assistance-localization real-time, including the support, the support is the frame construction that has the fretwork district, the support has the loading state of radial compression to and the release state of radial expansion, its characterized in that, the intervention apparatus still includes the part that rubs that increases, the part that rubs is a line body or many line bodies, specifically includes:

an anchoring portion directly connected to the bracket;

and the outer convex part is connected with the anchoring part, and extends to the outer side of the bracket in a release state.

2. The interventional instrument adopting friction-assisted positioning as claimed in claim 1, wherein the stent is provided with a sealing membrane, the sealing membrane comprises an inner sealing membrane positioned on the inner side of the stent and/or an outer sealing membrane positioned on the outer side of the stent, and the outer sealing membrane and the inner sealing membrane are of an integral structure or a split structure;

one of the outer sealing membrane and the inner sealing membrane extends to one end of the axial direction of the bracket and is rolled and wrapped on the end part of the bracket; or the two extend to the axial end of the bracket in the same direction and then are mutually connected with the end part of the wrapping bracket.

3. The interventional instrument employing friction assisted positioning as claimed in claim 2, wherein the axial position of the outer closure membrane relative to the stent is fixed; or the external sealing membrane can be axially stretched or stacked along with the switching of the state of the bracket.

4. The interventional instrument employing friction assisted positioning as claimed in claim 1, wherein the outward protrusion extends inward of the stent through adjacent hollowed-out regions in the loaded state.

5. The interventional instrument employing friction assisted positioning as claimed in claim 1, wherein the stent has an inflow end at one axial end and an outflow end at the other axial end, the friction increasing member being disposed at a side adjacent to the inflow end;

the friction increasing parts are multiple, and in a release state, the friction increasing parts are distributed along the circumferential direction of the support.

6. The interventional instrument adopting friction assisted positioning as claimed in claim 5, wherein the friction increasing members are divided into a plurality of groups along the circumferential direction of the stent, and adjacent groups are arranged in a staggered manner in the axial direction of the stent.

7. The interventional instrument with friction-assisted positioning as defined in claim 1, wherein the frame structure comprises frame strips, the frame strips extending in different directions meet at a node portion, and the friction-increasing member is connected to the frame strips and/or the node portion.

8. The interventional instrument adopting friction-assisted positioning as claimed in claim 7, wherein the stent has a circumferentially distributed cell structure adjacent to the inflow end, the hollow areas are formed inside the cells, the frame strips serve as the sides of the cells, and the node positions are located at the vertexes of the cells.

9. The interventional instrument employing friction assisted positioning as defined in claim 1, wherein the anchoring portion is connected to the stent by at least one of ligating, bonding, and radially penetrating anchoring.

10. The interventional instrument employing friction assisted positioning as defined in claim 1, wherein the friction enhancing component further comprises a support portion at a connection location of the outrigger portion and the anchor portion.

11. The interventional instrument adopting friction-assisted positioning as claimed in claim 10, wherein the friction-increasing member is a wire body, and the support part is formed by winding the wire body; or the friction increasing component is a plurality of wire bodies, and the supporting part is formed by mutually winding the plurality of wire bodies; the wire body further extends from the support part to form the outer convex part.

12. The interventional instrument with friction assisted positioning as recited in claim 11, wherein the intertwining is by knotting or twisting.

13. The interventional instrument adopting friction assisted positioning as claimed in claim 10, wherein the support portion has a higher rigidity relative to the outrigger by way of local reinforcement of a wire body;

the local reinforcing mode of the wire body adopts at least one of knotting, thickening and material change of the wire body.

14. The interventional instrument employing friction assisted positioning as claimed in claim 1, wherein the end of the outrigger portion distal to the anchoring portion is divergent or the outrigger portion is divergent as a whole; the specific mode of the divergence shape is that the thread end is twisted or is locally hot-melted and deformed.

15. The interventional instrument with friction assisted positioning as recited in claim 1, wherein the stent has an outer sealing membrane disposed around its periphery, the outer sealing membrane having a flexible skirt, the outer sealing membrane extending axially to shield the friction increasing member in the loaded state and being axially stacked to expose the friction increasing member in the released state.

16. The interventional instrument adopting friction-assisted positioning as defined in claim 15, wherein a traction cable is threaded through the outer closing membrane, the traction cable being integrally threaded along the circumference of the stent and undulating in the axial direction of the stent.

17. An interventional system comprising a sheath assembly having opposite distal and proximal ends, a control handle and an interventional instrument, the interventional instrument being carried on the distal end of the sheath assembly, the control handle being connected to the proximal end of the sheath assembly, the control handle being operable to actuate the sheath assembly to release the interventional instrument, wherein the interventional instrument is as claimed in any one of claims 1 to 15.

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