Patent Application
20230293324
The present disclosure relates to the field of interventional therapeutics, in particular to a beaded component, a manufacturing method and application thereof.
Vascular stents (or “stents” for short) may be implanted into blood vessels via the vascular interventional procedure for the treatment of a variety of vascular diseases, for example, the blood flow guiding technique treating hemangiomas, and the vascular reconstruction technique treating stenosis or occlusion of the lumens of the blood vessels.
Some problems may be present when a vascular stent is delivered into the blood vessel. For example, upon reaching the treatment site, the stent in a compressed state is restricted from self-expansion due to being affected by torsional stresses. As another example, during stent delivery, a delivery system has poor passibility, poor vessel compliance and poor rotational coaxiality, making it difficult for the surgeon to precisely manipulate the morphology and position of the stent implant within the blood vessel during an interventional procedure.
The poorer control on the stent implant by the above delivery system reduces the stent delivery efficiency, reduces the success rate of the stent arriving at the lesion, and extends the procedure time, resulting in high risks of failure procedure and postoperative complications.
Therefore, it is necessary to propose a new solution for stent delivery.
The technical problems to be solved by the present disclosure are that, on the one hand, a stent cannot be released automatically due to being affected by torsional stresses; and, on the other hand. the operation in the stent delivery process is laborious and difficult, reducing the stent delivery efficiency.
The present disclosure proposes the following technical solutions:
In a first aspect, a beaded component is provided, including an expandable body and at least two shaping assemblies, each shaping assembly includes a first part and a second part;
the first part has a columnar inner cavity, and a partial section of the expandable body is bundled within the columnar inner cavity to form a shrinkage section of the beaded component; or the first part has a columnar outer surface, and an inner surface of the partial section of the expandable body is fixedly connected to the columnar outer surface to form a shrinkage section of the beaded component;
the second part is a tubular part, and the shrinkage section is sheathed in the second part;
an expansion section of the beaded component is formed between two adjacent shrinkage sections.
Preferably, the ends of the second part are provided with the chamfering structures;
preferably, the first part has a columnar inner cavity, and the first part has a shape selected from a cylinder, a prism, a sphere or a truncated cone;
preferably, the first part has a columnar outer surface;
preferably, the columnar inner cavity is cylindrical, or the columnar outer surface is cylindrical.
Preferably, the partial section of the expandable body and the columnar inner cavity are connected in a manner selected from welding, bonding, hot melt or tight fit;
preferably, the inner surface of the partial section of the expandable body and the columnar outer surface are connected in a manner selected from welding, bonding or hot melt;
preferably, the second part and the shrinkage section are connected in a manner selected from welding, bonding, hot melt or tight fit.
Preferably, the expandable body is a meshed tube, a solid-wall tube, or an expandable balloon;
preferably, the second part employs a metallic material or a polymeric material;
preferably, the second part is a heat shrink tube;
preferably, the material of the second part is selected from polyolefin material, fluorinated ethylene propylene copolymer, neoprene or fluororubber.
Preferably, a distance L between two adjacent shaping assemblies satisfies equation (1):
L>D (1)
wherein D is an outer diameter of the second part;
preferably, the expandable body includes a first expandable body and a second expandable body. The first expandable body is sheathed in the second expandable body, and a plurality of sections of the second expandable body is bundled within the columnar inner cavity.
In a second aspect, a method manufacturing the beaded component according to any embodiment in the first aspect of the present disclosure is provided, including:
shrinking the expandable body;
sheathing the expandable body in at least two first parts, or placing at least two first parts inside the expandable body;
fixedly connecting the columnar inner cavities or the columnar outer surfaces of the first parts to the expandable body;
sheathing the junction of the first parts and the expandable body in the at least two second parts; and
fixedly connecting the second parts to the first parts or the expandable body to obtain the beaded component.
Preferably, the second part is heat shrink tube. The step of fixedly connecting the second parts to the first parts or the expandable body includes:
heating the second parts to cause the second parts to be connected to the first parts or the expandable body in a hot melt manner.
In a third aspect, a stent delivery system is provided, including a delivery catheter, a delivery guidewire, and the beaded component according to any embodiment in the first aspect of the present disclosure;
a distal end of the delivery guidewire is fixedly connected to a proximal end of the beaded component;
the beaded component is positioned within the delivery catheter and is in a compressed state.
Preferably, the stent delivery system further includes a stent, the stent is positioned between the delivery catheter and the beaded component and is in a compressed state;
preferably, the stent delivery system further includes a delivery clip;
the delivery clip includes a base and at least two clip wings. The at least two clip wings are rotationally connected to the base, respectively. The at least two clip wings, when in a first position state, jointly form a constricting part having a prismatic shape, and the constricting part has an interior space for constriction of at least a part of the stent. The at least two clip wings, when rotating from the first position state to a second position state, are separated from each other such that the constricting part expands;
the proximal end of the beaded component is fixedly sheathed in the base of the base of the delivery clip. The clip wings of the delivery clip are in the first position state and constrict at least a part of the stent therein.
The present disclosure has the following beneficial effects:
In the beaded component, the manufacturing method and application thereof provided by the present disclosure, a partial section of the expandable body is bundled within the columnar inner cavity, or the inner surface of the partial section of the expandable body is fixedly connected to the columnar outer surface such that the partial section of the expandable body shrinks to form the beaded component. When a stent is delivered using the beaded component (i.e., the beaded component is sheathed in the stent for delivery), on one hand, the expansion of the beaded component facilitates smooth release of the stent to make the stent completely fit with the lesional vessel. On the other hand, since the shaping assemblies make the partial section of the expandable body shrink, the contact area of the expandable body with the inner walls of other devices or the inner wall of the blood vessel is reduced, thereby reducing the accidental damage to the lining of the blood vessel. Meanwhile, the expansion section of the expandable body may correspondingly deform according to the course and shape of the vessel, thereby being beneficial to reducing stent delivery resistance and improving stent delivery smoothness.
Furthermore, in the beaded component, the manufacturing method and application thereof provided by the present disclosure, the beaded component may be formed on the basis of the existing expandable body (e.g., the meshed tube, the solid-wall tube, and the expandable balloon) without changing the existing manufacturing method of the expandable body, which makes the beaded component has simple structure, high manufacturability convenience and high reliability.
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings, which are to be used in the description of the embodiments of the present disclosure, will now be briefly introduced below. The drawings set forth herein are provided to further understand the present disclosure and constitute a part of the present disclosure. Illustrative embodiments of the present disclosure and descriptions thereof are used to explain the present disclosure and do not constitute an undue limitation of the present disclosure.
Reference numerals: 1-expandable body; la-first expandable body; 1b-second expandable body; 2-shaping assembly; 201-first part; 202-second part; 202a-chamfering structure; 2a-first shaping assembly; 2b-second shaping assembly; 2c-third shaping assembly; 3-delivery guidewire; 4-delivery catheter; 5-stent; 6-beaded component; 8-delivery clip; 801-base; 802-clip wing; 802a-first clip wing; 802b-second clip wing.
The present disclosure will now be further described in detail in conjunction with the drawings and embodiments. It should be understood that the specific embodiments described herein are merely for explaining the relevant disclosure, rather than limiting the present disclosure. Furthermore, it should be noted that the drawings only show the parts related to the relevant disclosure in order to facilitate the description.
In the description of the present disclosure, the terms “upper”, “lower”, “inner”, “outer” and the like are only used for facilitating the description of the present disclosure and simplifying the description instead of indicating or implying that the indicated device or element has a specific orientation and is constructed and operated in the specific orientation, so that the terms cannot be understood as the limitation on the present disclosure. Further, the terms “first”, “second”, “third” are only for the descriptive purpose, but cannot understood as indicating or implying relative importance.
In the description of the present disclosure, it should be noted that the terms “mount”, “connect”, “link” and the like are understood in a broad sense, unless otherwise specified and defined., For example, it may be fixed connection, detachable connection or integrated connection; it may be mechanical connection or electrical connection; and it may be direct connection or indirect connection through intermediate media. Those skilled in the art may understand the specific meanings of the terms in the present disclosure according to specific conditions.
In the description of the present disclosure, it should be noted that the embodiments and features in the embodiments of the present disclosure may be combined with each other without conflicts.
As shown in
Since the first part 201 is sectioned in
In the embodiment, the first part 201 has a cylinder shape. In other embodiments, the shape of the first part 201 may also be a prism, a sphere, or a truncated cone, etc.
In the present embodiment, an inner cavity of the first part 201 is cylindrical. That is, the first part 201 is a round tubular part as a whole. In other embodiments, the inner cavity of the first part 201 may also be in prism or other shapes.
In this embodiment, the first part employs a metallic material or a polymeric material.
In the embodiment, each shaping assembly 2 further includes a second part 202. The second part 202 is a tubular part. The shrinkage section of the beaded component is sheathed within the second part 202.
Since the second part 202 is sectioned in
In the embodiment, the second part 202 employs a polymeric material. More specifically, the second part 202 is a heat shrink tube, which has the characteristics of heat shrinkage. In other embodiments, the second part 202 may also employs a metallic material.
In one example, the material of the second part is selected from a polyolefin material, fluorinated ethylene propylene copolymer, neoprene, or fluorine rubber.
In the embodiment, the second part 202 is connected to the first part 201 or the expandable body 1 in a hot melt manner. That is, the second part 202 is a heat shrink tube, which is heated after the shrinkage section is sheathed into the second part 202 such that the second part 202 is connected to the first part 201 and the expandable body 1. In other embodiments, the second part is connected to the first part or the expandable body in a manner of welding, bonding, tight fit, etc.
In the embodiment, the diameter of the columnar inner cavity of the first part 201 is smaller than the outer diameter of the expandable body 1 in an expansion state. Thus, the partial section of the expandable body 1 is bundled within the columnar inner cavity of the first part 201 in a compressed state.
In the embodiment, the partial section of the expandable body is bundled within the columnar inner cavity such that the partial section of the expandable body shrinks, thereby forming a beaded component. When a stent is delivered using the beaded component, on the one hand, the expansion of the beaded component facilitates smooth release of the stent to make the stent completely fit with the lesional vessel. On the other hand, since the shaping assemblies make the partial section of the expandable body shrink, the contact area of the expandable body with the inner walls of other devices or the inner wall of the blood vessel is reduced, thereby reducing accidental damage to the lining of the blood vessel. Meanwhile, the expansion section of the expandable body may correspondingly deform according to the course and shape of the vessel, thereby being beneficial to reducing stent delivery resistance and improving stent delivery smoothness. Disposing the second parts 202, i.e., using the shaping assemblies with a double-layer structure, further facilitates the stability and reliability of the beaded component.
Furthermore, the beaded component may be formed by using the above shaping assemblies on the basis of the existing expandable body without changing the existing manufacturing method of the expandable body, and the beaded component has simple structure, high manufacturability and high reliability.
In the embodiment in which the second part employs the heat shrink tube, the hot melt connection manner does not involve production particles caused by welding or bonding connection manner, to avoid the danger to human health by preventing the production particles from falling into the blood vessels. Furthermore, due to the wrapping of the second part on the outermost layer, the risk that the part material enters the blood vessels may be further reduced.
In the embodiment, two ends of the second part 202 both have chamfering structures 202a. The chamfering structure 202a may provide a smooth transition between the outer surface of the second part 202 and the outer surface of the expandable body 1 in a form of slope. It should be noted that the chamfering structure in the present disclosure may be any beveled structure capable of achieving the smooth transition, which may be formed in other manners besides cutting. For example, the chamfering structure may be formed by injection molding. For another example, the chamfering structure may be formed by hot molding, such as the chamfering structure 202a in
It is advantageous to further reduce the resistance during stent delivery by providing the chamfering structure at the end parts of the second part. In the embodiment, three partial sections of the expandable body 1 are bundled within the columnar inner cavities of the first shaping assembly 2a, the second shaping assembly 2b, and the third shaping assembly 2c in sequence. In other embodiments, inner surfaces of a plurality of sections of the expandable body may be fixedly connected to columnar outer surfaces of a plurality of shaping assemblies.
In the embodiment, the expandable body 1 is a meshed tube. In other embodiments, the expandable body 1 may also be a solid-wall tube or an expandable balloon. Under the condition that the expandable body is an expandable balloon, the amounts of expansion of the respective expansion sections of the beaded balloon can be limited by controlling the distance between the shaping assemblies, and the delivery capability of a delivery system in an axial direction may also be improved by controlling the value of pressure charged into the balloon in combination with a beaded structure.
In the embodiment, a distance L between two adjacent shaping assemblies satisfies equation (1):
L>D (1)
wherein D is an outer diameter of the second part. As shown in
In the embodiment, the first part 201 has a cylindrical outer surface. Furthermore, similar to the first embodiment, the first part 201 also has a cylindrical penetrating inner cavity, i.e., the first part 201 is a circular tubular part as a whole.
In the embodiment, the inner surface of the partial section of the expandable body 1 is fixedly connected to the columnar outer surface of the first part 201 in a bonding manner. For example, the inner surface of the partial section of the expandable body 1 is coated with an adhesive and is press-fitted to the columnar outer surface of the first part 201, so that the inner surface of the partial section is fixedly connected to the columnar outer surface. Alternatively, the columnar outer surface of the first part 201 is coated with an adhesive, and the inner surface of the partial section of the expandable body 1 is press-fitted to the columnar outer surface of the first part 201 so that the inner surface of the partial section is fixedly connected to the columnar outer surface. In other embodiments, the inner surface of the partial section of the expandable body 1 and the columnar outer surface of the first part 201 can also be fixedly connected in a manner of welding, hot melt, etc.
In the embodiment, two ends of the second part 202 are likewise have chamfering structures 202a.
In the embodiment, the inner surfaces of a purity of sections of the expandable body are fixedly connected to the columnar outer surfaces of the first parts such that a purity of sections of the expandable body shrink, thereby forming a beaded component. Moreover, the second part wraps the connection region of the first part and the expandable body at the outermost layer. Thus, the beaded component in the embodiment can achieve similar technical effects as in the first embodiment, which will not be repeated herein.
Furthermore, since the first part in this embodiment is disposed within the expandable body, the first part in this embodiment can prevent further shrinkage of the expandable body at the position where the expandable body connects with the first part, which avoids detachment of the expandable body from the shaping assemblies due to the shrinkage of the expandable body when a tight fit connection is adopted, thereby improving the structure stability.
The first part in this embodiment employs the solid structure, which is advantageous in reducing the manufacturing difficulty and increasing the structural strength of the beaded component.
In this embodiment, the second expandable body 1b is sheathed in the first expandable body 1a, and a partial section of the second expandable body 1b is bundled within the columnar inner cavity of the first part 201. In this way, it is advantageous to improve the bending resistance and kinking resistance of the beaded component.
A fifth embodiment of the present disclosure provides a manufacturing method of a beaded component, including the following steps.
First, tightening an expandable body. For example, stretch the expandable body to make the expandable body tightened.
Second, sheathing the expandable body in at least two first parts, or place at least two first parts are inside the expandable body.
Third, fixedly connecting columnar inner cavity or columnar outer surface of the first part to the expandable body. For example, a columnar inner cavity or a columnar outer surface of first part is fixedly connected to the expandable body in a manner of welding, bonding, hot melt, or tight fit.
Thereafter, sheathing the junction of the first parts and the expandable body in the at least two second parts.
Finally, fixedly connecting the second parts to the first parts or the expandable body to obtain the beaded component. For example, the first parts and the expandable body are fixedly connected to the second parts, respectively in a hot melt manner.
In some optional embodiments, the second part is a heat shrink tube. The step of fixedly connecting the second parts to the first parts or the expandable body includes: heating the second parts to cause the second parts to be connected to the first parts or the expandable body in a hot melt manner.
In this embodiment, a distal end of the delivery guidewire 3 (i.e., the left end in
In some optional embodiments, the stent delivery system further includes a stent 5. The stent 5 is positioned between the delivery catheter 4 and the beaded component 6 and is in a compressed state.
In the stent delivery process, the delivery catheter 4 may firstly be delivered into the human body, and a distal opening of the delivery catheter 4 is positioned nearby a target position. Then, the delivery guidewire 3 may be pushed to deliver the beaded component 6 connected thereto distally, and the beaded component 6 drive the stent 5 to move jointly.
After the stent 5 reaches the distal opening of the delivery catheter 4, the delivery guidewire 3 continues to be pushed to gradually move the beaded component 6 and the stent 5 out of the delivery catheter 4. Due to the self-expansion characteristic of the expandable body 1, the expansion sections of the beaded component 6 which have moved out of the catheter may expand in a radial direction and drive the stent 5 in which the expansion sections sheathed to expand, so that the stent 5 is smoothly released.
In some optional embodiments, the stent delivery system further includes a delivery clip 8.
As shown in
In this embodiment, the delivery clip 8 in
In this embodiment, the at least two clip wings, when in the first position state, jointly form a constricting part having a prismatic shape, and the constricting part has an interior space for the constriction of at least a part of the stent. The at least two clip wings, when in the second position state, are separated such that the constricting part expands. On the one hand, the stent can be withdrawn in the event of a wrong stent release position or a need for adjustment of the stent release position. On the other hand, a stent delivery component keeps line contact with the inner wall of the delivery catheter, which reduces the contact area to reduce the frictional resistance, thereby advantageously lowering the operation difficulty and improving the delivery efficiency.
The above descriptions are only the preferred embodiments of the present disclosure and the explanation of the applied technical principle. Those skilled in the art should understand that the inventive scope involved in the present disclosure is not limited to the technical solutions formed by specific combinations of the above technical features, and also should cover other technical solutions formed by optional combinations of the above technical features or equivalent features thereof without departing from the inventive concept of the present disclosure, for example, the technical solution formed by replacing the above features with (but not limited to) technical features with similar functions disclosed in the present disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202011195618.X | Oct 2020 | CN | national |
| 202022479731.2 | Oct 2020 | CN | national |
This application is the national phase entry of International Application No. PCT/CN2021/125205, filed on Oct. 21, 2021, which is based upon and claims priority to Chinese Patent Applications No. 202022479731.2 and 202011195618.X, both filed on Oct. 30, 2020, the entire contents of which are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CN2021/125205 | 10/21/2021 | WO |
