CN112587287A

CN112587287A - Support and support conveying system

Info

Publication number: CN112587287A
Application number: CN202011322196.8A
Authority: CN
Inventors: 孙安强; 陈雅兮; 樊瑜波; 邓小燕; 康红艳
Original assignee: Beihang University
Current assignee: Beihang University
Priority date: 2020-11-23
Filing date: 2020-11-23
Publication date: 2021-04-02

Abstract

The invention discloses a stent and a stent conveying system. The support comprises a diameter-variable structure, and the diameter-variable structure can be arranged along the body pipeline in a retractable and adjustable manner. According to the stent with the structure, the variable diameter structure is arranged, so that the variable diameter structure can be better matched with the tube wall of a body pipeline through a balloon dilatation operation along with the growth of the body pipeline of a patient, namely the variable diameter structure can be expanded along with the change of the tube diameter of the body pipeline, so that the normal and supply of the body pipeline can be ensured; compared with the operation of replacing the bracket again in the prior art, the balloon dilatation operation belongs to a minimally invasive operation, the wound of the operation is small, the operation belongs to an open operation, the wound of the operation is larger, and the balloon dilatation operation is more beneficial to the recovery of a patient.

Description

Support and support conveying system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a stent and a stent conveying system.

Background

There are numerous and countless body ducts in the body, which are thick, thin, and curved, and spread throughout the body, but they have different shapes and different functions, but they are not suitable for different workers. Body conduits include blood vessels, including aorta and branch vessels, trachea, alimentary tract, ureters, and the like.

According to statistics, about 10 ten thousand newborns in China suffer from congenital heart disease every year, and the disease rate is about 6.7 per thousand. Aortic stenosis (CoA), which is a less common cardiovascular abnormality in children, is considered to be a complex vascular disease, not limited to aortic stenosis, which includes multiple segmental or long-term dysplasia. The site of the stenosis is usually at the arterial line, and is also characterized in part by a pressure gradient in the ascending aorta, descending aorta, and abdominal aorta that results in a significant pressure gradient near and distal to the stenosis. Aortic stenosis accounts for 5% -8% of congenital heart disease, 3 of 10000 newborns have aortic stenosis, and the survival rate and growth and development of patients are seriously affected by the vascular stenosis congenital heart disease. Percutaneous balloon angioplasty was used for the treatment of aortic stenosis as reported earlier in 1982, and is also used more frequently for congenital stenosis of pulmonary artery and restenosis after surgical operation. With respect to stenosis and restenosis in neonates and infants, all conventional stents available today have limited their use in pediatrics, particularly in neonates and small infant patients with congenital heart disease, due to deficiencies in their inherent design and the growth of pediatric patients.

In addition, in recent years, "fenestrated branch stent technique" and "chimney stent technique" have been applied to the intraluminal repair of the aorta, and also have been used in the case of aortic lesions, in order to cover the diseased aorta with a stent without affecting the important branch vessels. The windowing branch stent technology is a customized stent technology for windowing on an aortic stent corresponding to a branch vessel opening according to the position relation of an aortic lesion part and a branch vessel part of a patient.

However, when the fenestration branch stent technology is applied to aortic repair of a pediatric patient, the fenestration branch stent technology cannot adapt to diameter change of a blood vessel of the patient, namely, the stent is fixed and has non-growing property, so that the possibility of displacement and internal leakage of a main stent exists, and even the blood flow field and blood supply of a branch blood vessel are affected, so that postoperative complications are caused; and to accommodate the change in diameter of the patient's branch vessels, surgical dissection or resection is still required to replace the new stents, which can cause surgical trauma to the patient and require a longer recovery period. And other body ducts such as the trachea, the digestive tract, and the ureter may require the use of a stent, but the stent may not be adapted to the corresponding body duct, which may cause inconvenience to the patient.

Disclosure of Invention

Therefore, the technical problem to be solved by the present invention is to overcome the defect that the stent in the prior art cannot adapt to the diameter change of the body duct of the patient, thereby providing a stent and a stent delivery system.

A support comprises a diameter-variable structure, and the diameter-variable structure can be arranged along a body pipeline in a retractable and adjustable manner.

Further, it is including the main part support and the structure of windowing that link to each other the setting, main part support adaptation is in main body pipeline just the structure of windowing is in branch's body pipeline, wherein the structure of windowing and/or main part support is reducing structure.

Furthermore, the reducing structure comprises a structure body and a reducing assembly, and the reducing assembly is arranged on the structure body.

Further, the reducing assembly comprises a ratchet wheel and a pawl, the ratchet wheel and the pawl are respectively arranged at two ends of the structure body, and the ratchet wheel is meshed with the pawl.

Further, the reducing assembly further comprises a protective shell, and the ratchet wheel and the pawl are located in the protective shell.

Furthermore, the structure body is provided with one part and extends along the axial direction of the branch body pipeline; or the structure bodies are arranged in a plurality and are arranged in parallel along the axial direction of the branch body pipeline.

Further, the reducing structure is claw-shaped body, claw-shaped body includes claw arm and claw root, claw arm stretches into branch health pipeline just follows branch health pipeline's axial extension, the claw root is close to the main part support sets up.

Furthermore, the reducing structure is a first wavy annular body, and the wave direction of the first wavy annular body faces the wall surface of the branch body pipeline.

Furthermore, the first wavy annular body is provided with one and extends along the axial direction of the branch body pipeline; or a plurality of first wavy annular bodies are arranged along the axial direction of the branch body pipeline in parallel.

Further, the window opening structure comprises a covering film, and the covering film is connected to the main body support and/or the window opening structure.

Further, the body conduit is a blood vessel and/or a trachea and/or an alimentary tract and/or a ureter.

A stent delivery system comprises the stent.

The technical scheme of the invention has the following advantages:

1. the support comprises a diameter-variable structure, and the diameter-variable structure can be arranged along a body pipeline in a retractable and adjustable manner. According to the stent with the structure, the variable diameter structure is arranged, so that the variable diameter structure can be better matched with the tube wall of a body pipeline through a balloon dilatation operation along with the growth of the body pipeline of a patient, namely the variable diameter structure can be expanded along with the change of the tube diameter of the body pipeline, so that the normal and supply of the body pipeline can be ensured; compared with the operation of replacing the bracket again in the prior art, the balloon dilatation operation belongs to a minimally invasive operation, the wound of the operation is small, the operation belongs to an open operation, the wound of the operation is larger, and the balloon dilatation operation is more beneficial to the recovery of a patient.

2. The support provided by the invention further comprises a protective shell, and the ratchet wheel and the pawl are located in the protective shell. The support with the structure can prevent the ratchet wheel and the pawl from being dislocated during movement by arranging the protective shell.

3. The invention provides a stent, which comprises a main body stent and a plurality of second wavy annular units and a main body connecting piece, wherein the second wavy annular units are connected through the main body connecting piece, and the wave direction of the second wavy annular units faces to the axial direction of a main body pipeline. The stent with the structure can provide flexible flexibility and good axial supporting strength by being provided with the second wavy annular units and the main body connecting pieces, so that the stress on the main body stent and the stress on a body pipeline caused by the main body stent are smaller, and the possibility of restenosis of the main body stent is reduced.

4. The invention provides a stent delivery system, which comprises the stent. The stent delivery system of this structure, including the stent described above, naturally brings about advantages due to the inclusion of the stent described above.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic structural view of a stent provided in example 1 of the present invention;

FIG. 2 is a schematic structural view of the windowing structure shown in FIG. 1;

FIG. 3 is a schematic structural view of a stent provided in example 2 of the present invention;

FIG. 4 is a schematic structural view of the windowing structure shown in FIG. 3;

FIG. 5 is a schematic structural view of a stent provided in example 3 of the present invention;

description of reference numerals:

1-a second wavy annular body, 2-a main body connecting piece, 31-a ratchet, 32-a pawl, 33-a structural body, 34-a protective shell, 41-a claw arm, 42-a claw root and 5-a first wavy annular body.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Example 1

The present embodiment provides a stent as shown in fig. 1 and fig. 2, the stent includes a diameter-variable structure, and the diameter-variable structure can be radially retractable and adjustable along a body pipeline. Specifically, the stent comprises a covering film, a main body stent and a windowing structure, wherein the main body stent and the windowing structure are connected, the main body stent is adapted to a main body pipeline, the windowing structure is adapted to a branch body pipeline, and the windowing structure and/or the main body stent is of a reducing structure; the cover is attached to the main body stent and/or the fenestration. Of course, the window structure is not needed, and the window structure can be determined according to the use requirement. Wherein the body conduit may be a blood vessel and/or a trachea and/or a digestive tract and/or a ureter, for example when the stent is delivered into a blood vessel, and the corresponding blood vessel comprises an aorta or a branch blood vessel, then the main body conduit is the aorta and the branch body conduit is the branch blood vessel.

Wherein the stent can be made of filaments with the diameter of more than or equal to 0.1 mm and less than or equal to 0.5 mm, and the filaments can be metal filaments made of nickel-titanium alloy, stainless steel or titanium, etc. It should be noted that, the main body stent and the windowing structure are directly connected without a coating film, or one of the main body stent and the windowing structure is provided with a coating film; the covering film may also be extruded or coated or wrapped with other materials, which may be metallic materials, polymeric materials, biodegradable materials, natural materials, etc., and more specifically, 316L stainless steel, cobalt chromium-nickel-molybdenum-iron alloys, other cobalt alloys such as L605, tantalum, nitinol; and the second reducing knot can be the same as or different from the reducing structure in the embodiment.

By arranging the reducing structure, along with the growth of the body pipeline of a patient, the reducing structure can be better matched with the pipe wall of the body pipeline through a balloon dilatation operation, namely the reducing structure can be dilated along with the change of the pipe diameters of the corresponding main body pipeline and branch body pipelines, so that the normal and supply of the body pipeline is ensured; compared with the operation of replacing the bracket again in the prior art, the balloon dilatation operation belongs to a minimally invasive operation, the wound of the operation is small, the operation belongs to an open operation, the wound of the operation is larger, and the balloon dilatation operation is more beneficial to the recovery of a patient.

As shown in fig. 1, the main body support in the figure is not a diameter-variable structure, but may be a diameter-variable structure according to the use requirement. Specifically, the main body support comprises a plurality of second wavy annular units and a main body connecting piece 2, the second wavy annular units are connected through the main body connecting piece 2, and the wave direction of the second wavy annular units faces the axial direction of the main body pipeline. Specifically, each second wavy annular unit comprises two second wavy annular bodies 1, the two second wavy annular bodies 1 are connected in a staggered manner, and one of the second wavy annular bodies 1 in the adjacent second wavy annular unit is connected through a main body connecting piece 2. Of course, each second wavy annular unit may also include one second wavy annular body 1, or include three or more second wavy annular bodies 1, and two second wavy annular bodies 1 are connected in a staggered manner.

By providing a plurality of second wavy annular elements and the main body connecting member 2, flexible flexibility and good axial supporting strength can be provided, so that the stress on the main body stent and the stress on the body duct caused by the main body stent are small, and the possibility of restenosis of the main body stent is reduced.

As shown in fig. 2, the windowing structure in the figure is a diameter-variable structure, the diameter-variable structure includes a structure body 33 and a diameter-variable component, and the diameter-variable component is disposed on the structure body 33. Specifically, the reducing assembly comprises a ratchet wheel 31, a pawl 32 and a protective shell 34, the ratchet wheel 31 and the pawl 32 are respectively arranged at two ends of the structure body 33, the ratchet wheel 31 is connected with the pawl 32 in a meshed mode, and the ratchet wheel 31 and the pawl 32 are located in the protective shell 34. Wherein the shape of the ratchet wheel 31 and the pawl 32 can be circular, oval, triangular or other geometric shapes. By providing the protective case 34, the ratchet 31 and the pawl 32 are prevented from being dislocated when moved.

Wherein the structural body 33 is provided with one and extends in the axial direction of the branched body duct. As an alternative embodiment, the structural body 33 may be provided in plurality, and a plurality of structural bodies 33 are arranged in parallel along the axial direction of the branched body passage.

The use process of the stent in this embodiment: in the sacculus dilatation operation, after contrast is finished and a diseased part is determined, the diseased part is sent into a stent conveying system through a guide wire, wherein the stent conveying system comprises a sacculus and a stent, and the sacculus with the stent can smoothly pass through the balloon after the sacculus is pre-expanded; when the stent conveying system reaches a preset position, the main body stent is unfolded, the windowing structure is aligned with the inlet of the branch body pipeline, the main body stent is released to cover the lesion part, and the narrow body pipeline is thickened after being placed into the stent, so that blood flows normally pass through the narrow body pipeline; along with the growth of the patient, the diameter of the body pipeline of the patient is gradually enlarged, and the pawl 32 slides along the ratchet wheel 31 in a single direction, so that the diameter of the windowing structure is enlarged to adapt to the growth of the body pipeline, the blood flow field and the blood supply of the branch body pipeline are ensured, and the probability of postoperative complications is reduced.

Example 2

This example provides a stent which differs from the stent provided in example 1 in the diameter-varying structure. Referring to fig. 3 and 4 in particular, the diameter-variable structure in this embodiment is a claw-shaped body, and the claw-shaped body includes a claw arm 41 and a claw root 42, where the claw arm 41 extends into the branch body duct and extends along the axial direction of the branch body duct and is disposed close to the inside, that is, like a truncated cone-shaped structure, and the claw root 42 is disposed close to the main body support.

The use process of the stent in this embodiment: in the sacculus dilatation operation, after contrast is finished and a diseased part is determined, the diseased part is sent into a stent conveying system through a guide wire, wherein the stent conveying system comprises a sacculus and a stent, and the sacculus with the stent can smoothly pass through the balloon after the sacculus is pre-expanded; when the stent conveying system reaches a preset position, the main body stent is unfolded, the windowing structure is aligned with the inlet of the branch body pipeline, the main body stent is released to cover the lesion part, and the narrow body pipeline is thickened after being placed into the stent, so that blood flows normally pass through the narrow body pipeline; along with the growth of a patient, the diameter of the body pipeline of the patient is gradually enlarged, and the claw-shaped body is gradually extended through a balloon dilatation operation again or periodically, so that the diameter enlargement of the windowing structure is suitable for the growth of the body pipeline, the blood flow field and the blood supply of the branch body pipeline are ensured, and the probability of postoperative complications is reduced.

Example 3

This example provides a stent which differs from the stent provided in example 1 in the diameter-varying structure. Referring to fig. 5, the diameter-variable structure in this embodiment is a first wavy annular body 5, and the wave direction of the first wavy annular body 5 faces the wall surface of the branch body pipeline. The first wavy annular body 5 is provided with one and extends in the axial direction of the branch body duct. As an alternative embodiment, the first wavy annular body 5 may be provided in plurality, and the plurality of first wavy annular bodies 5 are arranged in parallel along the axial direction of the branch body duct.

The use process of the stent in this embodiment: in the sacculus dilatation operation, after contrast is finished and a diseased part is determined, the diseased part is sent into a stent conveying system through a guide wire, wherein the stent conveying system comprises a sacculus and a stent, and the sacculus with the stent can smoothly pass through the balloon after the sacculus is pre-expanded; when the stent conveying system reaches a preset position, the main body stent is unfolded, the windowing structure is aligned with the inlet of the branch body pipeline, the main body stent is released to cover the lesion part, and the narrow body pipeline is thickened after being placed into the stent, so that blood flows normally pass through the narrow body pipeline; along with the growth of a patient, the diameter of the body pipeline of the patient is gradually enlarged, and the first wavy annular body 5 is gradually extended through a balloon dilatation operation again or periodically, so that the diameter enlargement of the windowing structure adapts to the growth of the body pipeline, the blood flow field and blood supply of the branch body pipeline are ensured, and the probability of postoperative complications is reduced.

Example 4

This embodiment provides a stent delivery system, which includes a balloon and any one of the stents of embodiments 1 to 3, wherein during the balloon dilatation operation, after the imaging is completed and the lesion site is determined, the balloon is delivered into the stent delivery system through a guide wire, and after the balloon is pre-expanded, the stent with the balloon can pass through smoothly.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. The support is characterized by comprising a reducing structure, wherein the reducing structure can be arranged along a body pipeline in a retractable and adjustable manner.

2. A support according to claim 1, comprising a main body support and a fenestration structure connected, wherein the main body support is adapted to a main body pipeline and the fenestration structure is adapted to a branch body pipeline, and wherein the fenestration structure and/or the main body support is the diameter-variable structure.

3. A support according to claim 1 or 2, wherein the diameter-changing structure comprises a structural body and a diameter-changing assembly, the diameter-changing assembly being provided on the structural body.

4. The support according to claim 3, wherein the diameter-changing assembly comprises a ratchet wheel and a pawl, the ratchet wheel and the pawl are respectively arranged at two ends of the structure body, and the ratchet wheel is meshed with the pawl.

5. A support as claimed in claim 4, wherein the diameter-changing assembly further comprises a protective housing, the ratchet and the pawl being located within the protective housing.

6. A stent according to claim 3, wherein said structural body is provided with one and extends in the axial direction of said branch body conduit; or the structure bodies are arranged in a plurality and are arranged in parallel along the axial direction of the branch body pipeline.

7. A support as claimed in claim 1 or claim 2, wherein the reducing formation is a claw-like body including claw arms extending into and axially along the branch body duct and a claw root disposed adjacent the main body support.

8. A stent according to claim 1 or 2, wherein said reducing structure is a first wavy annular body, the direction of the waves of said first wavy annular body being towards the wall of said branch body duct.

9. A stent according to claim 8, wherein said first undulating annular body is provided with one and extends in the axial direction of said branch body conduit; or a plurality of first wavy annular bodies are arranged along the axial direction of the branch body pipeline in parallel.

10. A stent according to claim 2, further comprising a cover, the cover being connected to the main stent and/or the fenestration.

11. A stent according to claim 1, wherein said body vessel is a blood vessel and/or trachea and/or alimentary canal and/or ureter.

12. A stent delivery system comprising a stent as claimed in any one of claims 1 to 11.