CN116077253A - Support conveying device and support system - Google Patents

Abstract

The embodiment of the disclosure provides a stent conveying device and a stent system, wherein the stent conveying device comprises an outer tube, a support tube and a tail end connector which are sequentially connected, a core tube is arranged in the outer tube and the support tube, a limiter is arranged at the far end of the core tube and used for limiting the position of a stent, and the stent conveying device further comprises a spreading wire which is arranged in the outer tube and the support tube and can reach the limiter so as to limit the far end of the stent at the position of the limiter. The embodiment of the disclosure has the advantages of simple structure, easy realization, accurate release of the bracket, capability of simultaneously meeting the release force of the bracket of the middle and small cavity tube and the requirement on the outer diameter of the conveying outer tube, reduced access damage, safety and reliability, capability of effectively reducing the self sectional area of the loading position of the bracket and realization of the purpose of minimally invasive conveying of the flexible bracket.

Description

Support conveying device and support system

Technical Field

The present disclosure relates to the technical field of stents in medical devices, and in particular to a stent delivery device and stent system.

Background

In the medical field, endoluminal prostheses have been widely used for implantation into blood vessels, bile ducts or other similar lumens in the body. These prostheses are commonly referred to as stents, which are used to hold, open or dilate a lumen or isolate a focal lumen. In the vascular or non-vascular field, most parts needing to be implanted with the stent have serious tortuosity, the stent needs to conform to the twisted structure of the lumen space in the twisted lumen, so that the stent can realize the treatment function while minimizing the adverse effect on the lumen, and simultaneously needs to realize minimally invasive treatment by a delivery system as tiny as possible and reduce or avoid access injury as much as possible. In addition, the existing stent is conveyed in a severely tortuous lumen, so that the problems that the stent is difficult to release, the stent is folded after being released, the stent is blocked for a long time, the lumen is damaged by the edge of the stent, the requirement on an access is high, the access damage is not minimally invasive and the like are caused.

For example, loading and release of the stent is the process of relative movement of the stent and the delivery outer tube. In the loading and releasing process of the support, friction exists between the support and the conveying outer tube, so that the support is easy to accumulate in the loading process to cause loading difficulty, and the releasing force in the releasing process is overlarge to generate displacement, bouncing and unsatisfactory placement positions.

In the prior art, an axial fixed connection mode can be adopted for realizing loading and releasing of the bracket, but the bending performance of the bracket can be influenced by the axial fixed connection, so that the bending performance of the bracket is poor or the bending has obvious direction requirements. If the covered stent is adopted, the thicker covered layer is needed to ensure the integrity of the stent in the loading and releasing processes, but the bending property of the stent can be seriously influenced by the thicker covered film due to the self-resistance of the film, the thickness of the film is increased to directly increase the compression volume of the covered stent, and the required size of a conveying system is obviously increased to cause overlarge entrance trauma.

In the conveying process of the support, the detachable woven mesh is often adopted in the prior art to bind the support so as to realize the conveying of the flexible support. When the detachable woven mesh is used, the support cannot be bundled too tightly, when the woven mesh is too tightly, the support can directly prop open the woven mesh to cause failure, the support cannot be bundled too tightly, the compression diameter of the support is larger, and the support needs to be conveyed by a specific sheath tube to cause the outer conveying diameter to be larger. In the releasing process, the woven mesh on the outer side of the bracket is required to be pulled, and the bracket and the conveying system cannot be fixed, so that the positioning is poor. In addition, because the woven mesh needs to be detachable, and the whole support needs to be wrapped by the woven mesh, the woven mesh needs to be released in a single-point interlinking way, and the release of the support after the support is partially unfolded is blocked easily due to the interference of waveform convex points or other structures of the support.

Disclosure of Invention

An object of an embodiment of the present disclosure is to provide a stent delivery device and a stent system, so as to solve the problems in the prior art. In order to solve the problems of difficult loading and releasing of the bracket, oversized size of a required conveying system and inaccurate releasing, the embodiment of the disclosure adopts the following technical scheme:

an aspect of an embodiment of the present disclosure provides a stent delivery device, including an outer tube, a support tube, and a tail end joint connected in sequence, in which a core tube is disposed in the outer tube and the support tube, a limiter is disposed at a distal end of the core tube, the limiter is used to define a position of a stent, and an expanding wire disposed in the outer tube and the support tube and capable of reaching the limiter, so as to define a distal end of the stent at the position of the limiter.

In some embodiments, a head is disposed at the distal end of the core tube, the head being capable of extending beyond the distal end of the outer tube.

In some embodiments, the head portion adopts a conical structure and is provided with a hollow cavity, the hollow cavity is communicated with the cavity of the mandrel pipe, a slot and a flushing groove are formed in the head portion, the slot is used for accommodating the distal end of the unfolding wire, and the flushing groove is attached to the outer pipe.

In some embodiments, the limiter comprises a fixed portion and a connecting wire, the fixed portion is disposed at the distal end of the core tube, two ends of the connecting wire are connected with the fixed portion to form a loop, and the deployment wire passes through the loop and the connection of the crest and trough of the mesh structure in the stent, so that the stent is disposed at the connection position of the connecting wire and the deployment wire.

In some embodiments, the support tube comprises a dual lumen tube comprising a first lumen that fits over the core tube and a second lumen that serves as a passageway for the deployment wire.

In some embodiments, a pull wire handle is also included and is coupled to the deployment wire and configured to pull the deployment wire.

In some embodiments, an outer tube connector is provided at the proximal end of the outer tube, through which the outer tube is connected to the support tube.

In some embodiments, the outer tube fitting is Y-shaped with a side tube for flushing, a locking device and a knob are provided at the end of the outer tube fitting, by means of which knob the relative position between the outer tube and the support tube is adjusted and locked, respectively.

In some embodiments, the trailing end fitting is Y-shaped having an axial port and a lateral port, the pull wire handle being removably attached to the lateral port.

Another aspect of the disclosed embodiments provides a stent system comprising a stent delivery device as described in any one of the above and a stent pre-disposed in the stent delivery device.

According to the embodiment of the disclosure, the problem that the support is easy to stack due to no axial supporting force of the flexible support in the loading and releasing process, so that loading and releasing are difficult, the size of a required conveying system is overlarge and releasing is inaccurate is avoided, the structure is simple, accurate release of the support can be realized, the requirements of the release force of the medium-small cavity tube support and the outer diameter of the conveying outer tube can be met simultaneously, access damage is reduced, the safety and the reliability are realized, the self sectional area of the loading position of the support can be effectively reduced, and the purpose of minimally invasive conveying of the flexible support is realized.

Drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the present disclosure, and other drawings may be obtained according to these drawings without inventive effort to a person of ordinary skill in the art.

FIG. 1 is a schematic view of a stent delivery device according to an embodiment of the present disclosure;

FIG. 2 is a schematic view of a stent delivery device according to an embodiment of the present disclosure;

FIG. 3 is an initial schematic view of a deployment wire of a stent delivery device according to an embodiment of the present disclosure;

FIG. 4 is a schematic illustration of deployment wire retraction of a stent delivery device according to an embodiment of the present disclosure;

FIG. 5 is a schematic illustration of deployment wire retraction of a stent delivery device according to an embodiment of the present disclosure;

fig. 6 is a schematic view of a stent delivery device according to an embodiment of the present disclosure with a stent fully released.

Reference numerals:

1-head; 101-a slot; 102-flushing a tank; 2-a limiter; 201-connecting lines; 202-a fixing part; 3-an outer tube; 4-an outer tube joint; 401-side tube; 402-flushing ports; 5-supporting the tube; 6-spreading the silk; 7-a stay wire handle; 8-tail end joint; 9-a core shaft tube; 100-stent delivery device; 200-bracket.

Detailed Description

Various aspects and features of the disclosure are described herein with reference to the drawings.

It should be understood that various modifications may be made to the embodiments of the application herein. Therefore, the above description should not be taken as limiting, but merely as exemplification of the embodiments. Other modifications within the scope and spirit of this disclosure will occur to persons of ordinary skill in the art.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the disclosure.

These and other characteristics of the present disclosure will become apparent from the following description of a preferred form of embodiment, given as a non-limiting example, with reference to the accompanying drawings.

It should also be understood that, although the present disclosure has been described with reference to some specific examples, a person skilled in the art will certainly be able to achieve many other equivalent forms of the present disclosure, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

The above and other aspects, features and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings.

Specific embodiments of the present disclosure will be described hereinafter with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well-known and/or repeated functions and constructions are not described in detail to avoid obscuring the disclosure in unnecessary or unnecessary detail.

Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

The specification may use the word "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the disclosure.

The disclosed embodiments provide a stent delivery device, which can be placed in a human body by a guide wire, and is used for delivering a stent to a predetermined position in the human body and releasing the stent, as shown in fig. 1 to 6, and the stent delivery device 100 according to the present embodiment is used for expanding and releasing the stent 200 after delivering the stent 200 to the predetermined position in the human body. The embodiment of the disclosure can restrain the support 200 in the process of conveying the support 200 to a preset position, so that the support 200 is prevented from being separated and shifted in the conveying and releasing processes, and the purpose of accurate release is achieved. The stent 200 herein employs a mesh-type stent having a plurality of rows, each of which is of a wave-like structure, such as a structure having peaks and valleys.

Considering that in the vascular or non-vascular field, the problems of tortuosity or repeated bending deformation exist at most positions where the stent needs to be implanted, and the problems of stent fracture, stent port damage to a lumen, stent occlusion discounting and the like are caused by insufficient flexibility of the existing stent, the stent 200 is made of a high-flexibility material, so that the problems can be solved and the minimally invasive delivery of the stent 200 can be realized. The stent delivery device herein can meet any shape of curve in a vessel, meet the precise release of the stent 200, and meet the requirements of simple operation and minimally invasive access.

Specifically, as shown in fig. 1 and 2, the stent delivery device 100 includes an outer tube 3, a support tube 5, and a tail joint 8 connected in sequence, and the stent 200 needs to be previously set in the outer tube 3 of the stent delivery device 100. Wherein the distal end of the support tube 5 is connected to the proximal end of the outer tube 3, and the proximal end of the support tube 5 is fixedly connected to the tail end joint 8.

Considering that the stent 200 is compressed within the outer tube 3 during delivery, the cross-sectional area of the outer tube 3 is made smaller, as close as possible to the compressed cross-sectional area of the stent 200, to reduce the access requirements for the stent delivery device 100 to enter the human body and to reduce access injuries. In this and the following descriptions, the proximal end means an end closer to the operator, and the distal end means an end farther from the operator.

A mandrel tube 9 is provided in the support tube 5 and the outer tube 3, wherein the mandrel tube 9 is accommodated in the outer tube 3 and the support tube 5, and has a single-lumen structure. At the distal end of the mandrel tube 9 a head 1 is provided, which head 1 is capable of protruding beyond the distal end of the outer tube 3 and is in contact with the distal end of the outer tube 3.

Further, the head 1 is made of soft polymer material and is provided with a hollow cavity, and a through hole is arranged upwards in the center of the hollow cavity and can be used as a passage port of a guide wire; the cavity of the mandrel tube 9 is communicated with the hollow cavity of the head 1. Furthermore, in order to facilitate the insertion into the human body, the head 1 may have a tapered structure, and in this embodiment, the head 1 may have a hollow cavity structure similar to a cone. Wherein the mandrel tube 9 with the head 1 is capable of sliding within the outer tube 3, the head 1 and the distal end of the outer tube 3 should be closely configured in a snug fit such that it is too smooth to scrape hands.

Further, a stopper 2 is provided at the distal end of the mandrel tube 9 at a position spaced apart from the head 1, the stopper 2 being used to define the position of the stent 200 in the stent delivery device during delivery and release of the stent 200.

Further, the stent delivery device further includes a deployment wire 6, the deployment wire 6 being disposed in the outer tube 3 and the support tube 5, the deployment wire 6 being capable of sequentially passing through the distal end of the stent 200 and the stopper 2 to define the distal end of the stent 200 at the position of the stopper 2, thereby fixing the position of the stent 200.

In addition, a spreading wire slot 101 and a flushing groove 102 are further arranged on the head 1, the slot 101 is used for accommodating the distal end of the spreading wire 6, the flushing groove 102 is attached to the outer tube 3 and used for flushing the inside of the outer tube 3, and the transition between the flushing groove and the mandrel tube 9 should be ensured to be smooth as much as possible.

Further, the stopper 2 includes a fixing portion 202 and a connection wire 201, wherein the connection wire 201 may be a polyester wire so as to be disposed in the human body without affecting the human body, and wherein the fixing portion 202 is disposed at the distal end of the core tube 9, and is formed in a ring-like structure so as to be fixed to the outer wall of the core tube 9, for example.

Further, both ends of the connection wire 201 are connected with the fixing portion 202 to form a snare loop, and the deployment wire 6 passes through the snare loop and the connection point of the peak and trough of the mesh structure in the stent 200, thereby restraining the stent 200 at the connection position of the connection wire 201 and the deployment wire 6. Thus, when the outer tube 3 is withdrawn in the proximal direction of the operator and the deployment wire 6 is pulled, the stent 200 is not only restrained in position by the stopper 2, but also deployed as the outer tube 3 is withdrawn and released as the deployment wire 6 is pulled. Any one of the peak-valley hooked portions of the stent 200 can be connected with the connection position of the connection wire 210 and the deployment wire 6, so that the stent structure is not damaged during the loading and releasing process of the stent 200.

Specifically, the deployment wire 6 passes through the loop formed by the two ends of the connection wire 201, and the distal end of the stent 200 is restrained at the connection position formed between the connection wire 201 and the deployment wire 6. The diameters of the expansion wire 6 and the connecting wire 201 are smaller, so that the occupied volume is small to ensure the minimally invasive performance of the stent delivery device, and the expansion wire 6 is simply and conveniently pulled towards the direction of an operator to realize the expansion and release of the stent 200, and the release mode is safe and reliable. In this way, the distal end of the stent 200 is kept fixed in position relative to the head 1 based on the action of the connecting wire 201, so that the problems of stent stacking, loading and releasing difficulty, inaccurate releasing positioning and the like are solved by positioning the distal end of the stent 200 to realize accurate releasing,

the stent 200 with high flexibility can be conveyed and precisely released by the stent conveying device 100, and the position of the stent 200 is limited by arranging the limiter 2 with a simple structure, so that the stent 200 is kept in an axial single-layer state in the process of loading, conveying and releasing the stent into the stent conveying device 100, thereby realizing minimally invasive access and reducing access requirements and damage.

Further, an outer tube joint 4 is provided at the proximal end of the outer tube 3, the outer tube 3 is connected with the support tube 5 through the outer tube joint 4, and the relative position between the outer tube 3 and the support tube 5 can be adjusted and locked through the outer tube joint 4, so that the stability of the stent 200 during the conveying and releasing processes is ensured.

Specifically, as the outer tube joint 4 connecting the outer tube 3 and the support tube 5, a Y-joint is used, which includes a side tube 401, the side tube 401 having a flushing port 402, the flushing port 402 being used for an external device to flush the inside of the outer tube 3, for example, the stent 200 may be flushed through, for example, the flushing port 402.

Furthermore, a knob is provided at the tail of the outer pipe joint 4, and the relative position between the outer pipe 3 and the support pipe 5 can be locked by screwing the knob.

Further, a locking device may be further provided at the end of the outer tube joint 4, wherein the locking device is used for locking after adjusting and locking the position of the outer tube 3 relative to the support tube 5, and only when the locking device is opened, the outer tube 3 can be retracted for releasing the support 200, so as to prevent the support 200 from being released in advance during transportation and conveying.

Further, the stent system further comprises a stay wire handle 7, the stay wire handle 7 is fixedly connected with the expansion wire 6 through a stay wire, and the stay wire handle is used for driving the expansion wire 6 to move in a stay wire mode after the stent 200 is expanded after the outer tube 3 is retracted, so as to realize the detachment between the stent 200 and the mandrel tube 9.

Further, the tail joint 8 is a Y-joint, and the tail joint 8 includes an axial port 8a and a lateral port 8b. The tail end joint 8 is fixedly connected with the proximal end of the mandrel pipe 9, wherein the head 1, the mandrel pipe 9 and the tail end joint 8 are communicated with each other in an axial cavity so as to form a guide wire channel, so that the stent conveying device 100 can reach a preset position in a human body under the guidance of a guide wire, and in addition, the guide wire cavity can be flushed through the axial port 8a of the tail end joint 8.

The lateral port 8b of the tail connector 8 is configured to detachably connect to the lateral port 8b of the tail connector 8 through the deployment wire 6, for example, the pull wire handle 7 is fastened to the lateral port 8b in an interference manner, so that release failure caused by movement of a pull wire in a conveying process can be effectively avoided, and the deployment wire 6 can be pulled through a pull wire by operating the pull wire handle 7 on the tail connector 8.

Further, the support tube 5 comprises a double-lumen tube, and a thickening layer and a reinforcing tube are arranged on the outer side of the double-lumen tube to improve the strength of the support tube 5, wherein the double-lumen tube comprises a first lumen and a second lumen, the first lumen is sleeved on the core tube 9, the second lumen is used as a passage for the expanding wire 6 and the pulling wire, and the second lumen can be used as a pulling wire lumen, for example, the expanding wire 6 is connected with the pulling wire of the thin metal wire and passes through the pulling wire lumen to the tail end of the pulling wire handle 7.

During the release process of the stent 200, the outer tube 3 is retracted towards the operator to realize gradual expansion of the stent 200, the stent 200 is still limited in position by the connecting wire 201 and the expansion wire 6 after the stent 200 is fully expanded, at this time, the stay handle 7 is operated to pull the stay towards the operator, and the distal end of the expansion wire 6 is separated from the snare loop formed by the connecting wire 201 by the stay, so that the stent 200 is separated from the outer tube 3, and the stent 200 is completely released.

Further, the stent 200 is maintained in an axially single-layered state during the delivery and release process in the stent delivery device, and the distal end of the stent 200 is maintained in a fixed position relative to the head 1, so that only a single-point fixation between the stopper 2 and the stent 200 is required, and the volume overlapping with the stent 200 in the delivery system is as small as possible. In addition, the stent 200 does not undergo stacking and displacement during the release process and the release force is small. Thus, the disclosed embodiments can realize minimally invasive delivery of the stent 200 and accurate positioning and release, and can conform to tortuous anatomy after the stent 200 is released and implanted, maintain long-term patency of a lumen, reduce side effects of stent implantation, and reduce access requirements and injuries.

A second embodiment of the present disclosure provides a stent system including the stent delivery device 100 and the stent 200 in the above-described first embodiment, the stent 200 being required to be previously set in the stent delivery device 100, the stent delivery device 100 being for delivering the stent 200 to a predetermined position in a human body and effecting release of the stent 200.

According to the embodiment of the disclosure, the problem that the support is easy to stack due to no axial supporting force of the flexible support in the loading and releasing process, so that loading and releasing are difficult, the size of a required conveying system is overlarge and releasing is inaccurate is avoided, the structure is simple, accurate release of the support can be realized, the requirements of the release force of the medium-small cavity tube support and the outer diameter of the conveying outer tube can be met simultaneously, access damage is reduced, the safety and the reliability are realized, the self sectional area of the loading position of the support can be effectively reduced, and the purpose of minimally invasive conveying of the flexible support is realized.

Moreover, although operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order. In certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the present disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are example forms of implementing the claims.

While various embodiments of the present disclosure have been described in detail, the present disclosure is not limited to these specific embodiments, and various modifications and embodiments can be made by those skilled in the art on the basis of the concepts of the present disclosure, which modifications and modifications should fall within the scope of the claims of the present disclosure.

Claims (10)

1. The utility model provides a support conveyor, includes outer tube, stay tube and the tail end joint that connects gradually the outer tube with set up the core shaft tube in the stay tube the distal end of core shaft tube sets up the stopper, the stopper is used for prescribing a limit to the position of support, its characterized in that still includes the expansion silk, the expansion silk sets up in the outer tube with in the stay tube and can reach the stopper, in order to with the distal end of support is prescribing a limit to the position of stopper.

2. The stent delivery device of claim 1, wherein a head is disposed at a distal end of the core tube, the head being capable of extending beyond a distal end of the outer tube.

3. The stent delivery device of claim 2, wherein the head portion is of a conical configuration and has a hollow cavity in communication with the lumen of the mandrel tube, and wherein a slot for receiving the distal end of the deployment wire and a flushing groove are provided in the head portion, the flushing groove being in registry with the outer tube.

4. The stent delivery device of claim 1, wherein the stopper includes a fixing portion provided at a distal end of the core tube and a connection wire having both ends connected to the fixing portion to form a loop, and the deployment wire passes through the loop and a junction of a peak and a trough of a mesh structure in the stent to thereby position the stent at a junction of the connection wire and the deployment wire.

5. The stent delivery device of claim 1, wherein the support tube comprises a dual lumen tube comprising a first lumen that is sleeved over the core tube and a second lumen that is a passage for the deployment wire.

6. The stent delivery device of claim 1, further comprising a pull wire handle coupled to the deployment wire and configured to pull the deployment wire.

7. The stent delivery device of claim 6, wherein an outer tube connector is provided at a proximal end of the outer tube, the outer tube being connected to the support tube by the outer tube connector.

8. The stent delivery device of claim 7, wherein the outer tube fitting is Y-shaped having a side tube for flushing, a locking device and a knob are provided at an end of the outer tube fitting, and the relative position between the outer tube and the support tube is adjusted and locked by the knob and the locking device, respectively.

9. The stent delivery device of claim 6 wherein the trailing end connector is Y-shaped having an axial port and a lateral port, the puller handle being removably attached to the lateral port.

10. A stent system comprising the stent delivery device of any one of claims 1-9 and a stent pre-disposed in the stent delivery device.

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