WO2016133430A1

WO2016133430A1 - Product for forming a stent and method for forming same

Info

Publication number: WO2016133430A1
Application number: PCT/RU2016/000082
Authority: WO
Inventors: Игорь Валерьевич МИХАЙЛОВ; Иван Васильевич ЛЮТЯНСКИЙ
Original assignee: Игорь Валерьевич МИХАЙЛОВ; Иван Васильевич ЛЮТЯНСКИЙ
Priority date: 2015-02-20
Filing date: 2016-02-16
Publication date: 2016-08-25
Also published as: RU2580168C1

Abstract

The inventions relate to devices which prevent rupture, provide patency to, or prevent collapse of tubular structures of the body, and to methods for forming these devices. A product for forming a stent contains at least one tubular flexible module, which includes a module frame and one or more sealing collars. The module frame and the collars are designed in the form of hollow channels which can be filled with a liquid which solidifies after the channels have been filled. The inside surface of the frame contains flexible membranes which occlude the space at least between certain channels. Furthermore, the product is designed in such a way that it can be rolled into a tubular shape and delivered to the installation site of the stent. The method for forming a stent is characterised in that the product for forming a stent is placed in an instrument for inserting the product and forming the stent; furthermore, the hollow channels of the product are connected to at least one channel of said instrument for the delivery of a solidifying liquid. Using the instrument, the product is delivered to the formation site of the stent, is placed in the installation site of the stent, and the channels of the tubular structure and the collars are filled with liquid which solidifies after the channels are filled.

Description

PRODUCT FOR FORMING A STENT

AND METHOD FOR ITS FORMATION

FIELD OF TECHNOLOGY

The invention relates to devices to prevent tearing,

providing patency or preventing compression of the tubular structures of the body and methods of forming these devices.

BACKGROUND OF THE INVENTION

WO9840033, publication 14.01.1999, IPC A61 F2 / 06, discloses a method for creating a stent from a hardening liquid, which is formed by extruding a fluid material into a mold cavity formed by the porous surface of the container and the surrounding vessel wall. In this case, the balloon may be configured to expand the walls of the vessel. In this method, a hardening liquid is injected directly between the wall of the vessel and the wall of the container.

Known application WO2009108699, publication November 26, 2009, IPC A61F2 / 86 which discloses a method for creating a stent using a balloon having an outer surface with one or more grooves. These grooves, after inflating the stent, injecting fluid into the grooves of the balloon and solidifying the fluid, form the stent frame. The grooves in the balloon can configure a mesh pattern, a helical or spiral stent frame, or a frame of interconnected rods. In this method, a hardening liquid is injected directly between the wall of the vessel and the wall of the container.

Known international application WO2013161901, publication 10.31.2013, IPC A61F2 / 958 contains an article for the formation of a stent inserted into a vessel. The product contains a balloon and a series of nozzles through which a liquid substance is supplied to the walls of the vessel, which cures itself and forms a stent. And in this method, the curing agent for forming the stent is fed directly to the vessel wall.

The closest analogue is the invention according to the application US20020111673, publication 08/15/2002, IPC A61F2 / 06, in which the construction is disclosed

an artificial product for creating a stent and a method for creating a stent. The product for creating the stent is made in the form of a pipe soaked in glue or curing resin. The installation method consists in the fact that the pipe is inserted into the stent placement site, it is moved apart by an inflatable balloon, and then glue or the polymer resin is cured using a light source introduced into the pipe channel.

Known technologies for the formation of stents using hardening fluids allow the formation of stents in vessels. In doing so, the tools

5 introduced into the vessels for the formation of small stents and do not have a serious traumatic effect on the walls of the vessels along the route of administration.

At the same time, there remains a need to develop designs of stents made of curing liquids directly in vessels that

would provide the manufacture of stents of various shapes, including

Yu branching vessels. In this case, the design of the stents should provide

tight sealing of vessels in certain areas and permeability in other areas, for example, in the places of branching of small vessels.

SUMMARY OF THE INVENTION

The technical result of the claimed invention is the creation of products for

15 the formation of the stent and the method of its formation, which provide the creation of stents of various shapes, including branching vessels. Moreover, the manufactured products for the formation of stents provide the possibility of manufacturing stents according to individual sizes for a particular patient and a reliable installation in the patient's vessel. Other benefits and features

20 design of the product and manufactured stent will be clear from the description

manufacturing examples.

The stent forming article comprises at least one tubular-shaped flexible module that includes a module frame and one or more sealing cuffs. The module frame and cuffs are made in the form of hollow channels,

25 configured to fill the channels with liquid that hardens after filling the channels. The inner surface of the frame contains flexible membranes that overlap the space at least between the individual channels. At the same time, the product is made with the possibility of rolling it into a tubular form and delivery to the installation site of the stent.

30 A feature of the product for stent formation is that it is initially manufactured for a particular setting site, with specified sizes and shapes. This product can also take into account specific features of the structure of blood vessels at the deployment site of the stent of a particular person. The product may contain one module, or several modules that are connected in the process

35 formation of a stent for branched vessels. The product contains channels, filled with liquid hardening after installation of the product at the stent formation site.

Formed stent, contains channels filled with solidified liquid, forming the structure of the stent and flexible membranes that overlap the space between the channels, where necessary. In other places, the membrane may be absent, for example, forming a passage of blood into the small arteries. The sealing cuffs of the product allow the stent to be securely fixed at the installation site.

The stent forming article is flexible and is made with

the possibility of rolling it into a tubular form and delivering it to a place

stent deployment. This allows you to enter it without injuring the cavity through which the product is delivered.

The individual modules of the flexible frame made with the possibility of interconnection at the place of formation of the stent. In order to be able to connect, the individual modules of the flexible carcass contain connection elements, including, in particular, annular channels located in planes transverse to the axis of the carcass at the junction.

In particular, the cuff includes annular channels located in planes transverse to the axis of the carcass together with the formation of the cuff.

The channels of the frame and cuff, as well as the membrane between the channels, can be made by joining two or more films superimposed on one another and hermetically fastened along the boundaries of the channels. In this case, the bonding of the films can be accomplished by gluing or welding.

The frame channels and cuffs can be made by gluing or welding tubular channels from a flexible material to a flexible film,

acting as a membrane between the channels.

In particular, the product can be formed by 3D printing.

The product may additionally contain a gate for supplying a hardening fluid into the channels for the formation of a tubular structure and cuff.

The channels may contain reflective and light-reflecting surfaces, providing the penetration of light energy throughout the volume of the inner frame to solidify the light-curing fluid.

The stent forming method is characterized in that the product for forming the stent is placed in the tool for introducing the product and forming the stent, while the hollow channels of the product are connected to at least one channel of the tool for delivering the hardened liquid. Using tool deliver the product to the stent formation site, place it at the stent installation site and fill the tubular structure channels and cuffs with liquid,

hardening after filling the channels.

In particular, a protective element can be located on top of the product - a cover 5, which, when removed, provides the possibility of placing the product at the stent formation site. The case can consist of two layers, freely

moving relative to each other.

The instrument is provided with at least one high pressure cylinder corresponding to the diameter of the inner lumen of the stent. Cuff products

Yu is fixed to the wall of the aorta or large arteries using a high balloon

pressure.

During product installation, individual product modules are joined together and then the annular channels of the joints are filled with solidifying liquid.

In particular, a light curing liquid 15 is used as the hardening liquid. In this particular case, after filling the product channels

light-hardening liquid, the liquid is exposed to the light flux causing solidification of the liquid.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is illustrated by drawings.

20 In FIG. 1 shows a General view of a stent made in a vessel, consisting of two modules and intended for the treatment of aortic aneurysm and iliac arteries.

In FIG. 2 is a view of the same stent as in FIG. 1 in side view.

In FIG. 3 shows the connection of the two modules of the stent shown in FIG. one.

25 FIG. 4 is a view along AA of the cross section of the stent.

In FIG. Figure 5 shows the stent installed in the ascending aorta, the aortic arch, and the descending aorta.

In FIG. b shows a stent for a straight portion of the vessel.

In FIG. Figure 7 shows an example of a complex stent consisting of two modules and 30 designed for complex anatomical zones.

In FIG. 8 is a side view of a portion of the stent shown in FIG. 7

In FIG. 9 is a sectional view of the sealing collar.

in FIG. 10 cuff element for curved areas.

On Fig shows an example of the product for the formation of the stent, when 35 channels of the frame and cuff, as well as the membrane between the channels are made by connecting two or more films superimposed on one another and hermetically fastened along the boundaries of the channels.

In FIG. 12 shows an example of a product for forming a stent when the frame and cuff channels are made by gluing or welding 5 tubular channels from a flexible material to a flexible film acting as a membrane between the channels.

In FIG. 13 shows the steps of the folding process for forming a stent into a tubular shape. Moreover, in FIG. 13a shows the product in a section before folding, in FIG. 13b in the intermediate phase of coagulation of FIG. 13c after Yu coagulation.

In FIG. 14 shows a view of a part of a tool for introducing an article and forming a stent, a handle of a tool, and FIG. 15 the head part of the tool.

In FIG. 16 shows a cover removal mechanism.

In FIG. 17 shows an embodiment of a tool for inserting an article and 15 forming a stent.

DETAILED DESCRIPTION OF THE INVENTION

The product for stent formation in different versions (Fig. 1- Fig. 17) consists of one (Fig. 6) module 3 or of two (Fig. 1,2,3,7) modules Za and Zb. There may be more complex cases (not shown in the drawings) when the product for forming

20 stents are made of more modules. The number of modules 3 is determined mainly by the need to form branched stents located in the vessels, as a whole.

The product for the formation of the stent can be made of certain sizes for standard situations. However, this technology allows

25 adjust the configuration of the product and then the stent to individual

features of the anatomy of the recipient. The product for forming the stent is created in the form of flexible tubular modules (Fig. 1 - Fig. 9) having channels b for filling with liquid that hardens after filling the channels. The product is manufactured in advance, coiled into a tubular shape (Fig. 13a, b, c) and

30 is delivered to the stent installation site. In FIG. 1,2,3,7 shows a product consisting of two modules Za and Zb, after installing it in place, filling it with liquid and solidifying it, after which the product becomes a stent. In FIG. 5,6 shows a product consisting of one module. The product is installed in a vessel 1 in the aneurysm zone 9 (Fig. 1,5), each module of the product contains a frame 4, one or

35 several sealing cuffs 5 and a flexible membrane 7, made between b channels of the frame 4 where insulation of the vessel wall is necessary

(Fig. 1,2,3,4,11,12,13a). The product contains sealing cuffs 5, which allow fixing the stent structure outside the anatomical lesion zone. In FIG. 3 shows an element 8 for connecting the modules Za and Zb, including annular 5 channels located in planes transverse to the axis of the frame at the junction. In FIG. 4 shows a section along A-A of the stent frame, in the place where the membrane 7 is made between the channels b.

Fig. 5 shows a stent construction made by this technology on the ascending aorta, the aortic arch, and the descending aorta. In places of branches from the aorta

South vessels 2 in the frame 4 openings are made, and in places of bending of the aorta, the product may have a special structure 12 in the form of extended annular channels. The product is fixed in the aorta with cuffs 5. A more detailed structure 12 is shown in FIG. 10, where the annular channels b are connected to the membranes 7.

In FIG. 7 - FIG. 8 shows a more complex product design for

15 stent formation. When the aneurysm spreads to the level of the renal arteries and there is no zone for securing the cuff (aneurysm neck) in the infrarenal part, the stent in the upper part is fixed by two sealing cuffs 5, which are connected by the connecting element 10 of the frame 4, while the connecting element 10 also contains a channel for filling it with liquid hardening

20 after filling the channel. In the same stent, in the lower part of the module Za and in the second module 36, the connecting elements 10 of the frame 4 between the cuffs 5 are made.

The section of the cuff 5 (Fig. 9) shows that the annular channels b are aligned with the sprue 11 for filling with liquid that hardens after filling the channels.

The cuff may have a cone configuration that creates a cork effect when

25 installation under the renal arteries (in the infrarenal section). This property

provides isolation of aneurysm bag from blood flow in the absence of aneurysm “neck”.

As a hardening fluid, fluids that harden under the influence of light, ultrasound or chemical components can be used. For,

30 so that the curing of the photopolymer composition takes place more efficiently, the inner surface of the channels b, as well as the gates H and the annular channels of the cuffs 5, can be made of light reflecting or refracting material. When performing the product, transparent materials can also be used, then the solidification of the liquid can occur under the influence of

35 light source placed in the internal cavity of the product module. The product for forming the stent, or rather the individual modules 3 of the product can be formed in different ways.

For example, as shown in FIG. 11, the channels 6 of the frame and the cuff, as well as the membrane 7 between the channels 6 are performed by connecting two or more films superimposed on one another and hermetically fastened along the boundaries of the channels b. Bonding of the films can be carried out by gluing, welding, heat treatment or other known methods.

In another embodiment (Fig. 12), separately made channels b of flexible tubular material can be attached by gluing or welding the tubular channels b to a flexible film acting as a membrane 7 between the channels b.

Also, the entire product for the formation of the stent, or its individual parts can be formed by 3D printing on special printers. Such a method

manufacturing allows you to quickly produce products directly in hospitals, taking into account the individual characteristics of the anatomy of the recipient.

As materials for the manufacture of channels of the frame and cuffs, as well as membranes, elastomers or other polymers can be used. Such polymers may include latex, styrene block copolymers, thermoplastic elastomers or thermoplastic polyolefin elastomers,

polytetrafluoroethylene.

As liquids for filling the channels, hardening after filling the channels, many suitable combinations of monomers and photoinitiators can be used. Options are also possible without activators. As examples, polymer compositions containing photoinitiators, such as:

Acyl phosphine oxide, phenylketone, hydroxyl ketone and others.

The main monomer, for example, bisphenol - A - diglycidyl methacrylate (bis-GMA) and others.

Viscosity modifiers: triethylene glycol dimethacrylate, alkoxylated diacrylate cyclohexanedimethanol and other monomers and others. May

plasticizers and other active ingredients are also used.

It is also possible the use of polymer compositions activated

ultrasound, laser radiation, as well as other energy sources of wave nature. It is also possible to use various epoxy resins based on oligomers and other compounds.

A first example of the design of a tool for introducing an article and forming a stent is shown in FIG. 14 - FIG. 15. The tool contains a multi-channel tubular element 13, a control handle 14, a channel 15 for the conductor 16, a cylinder 17 filled with liquid along the channel 18, a channel 19 for filling the channels 6 of the module 3 of the product with liquid for forming the stent. The tool can be equipped with a light source (not shown in the figures). On the multi-channel tubular element (Fig. 15), the assembly module Z is installed for forming the stent, covered with a cover 20. The cover 20 (FIG. 16) can be made in the form of a duplicate, one edge of which is connected to the tip 21, the other to the shell of the module Za. When the cover 20 is completely removed from the shell of the module Za, the cover 20 holds the upper edge of the shell, preventing the module Za from moving relative to the cylinder. When pumping the balloon 17 of FIG. 15, detachment (detachment) of the upper edge of the module cover Z from the cover 20 of FIG. 16 takes place.

On the example of the module Za (Fig. 1 - Fig. 2) implantation of the product for the formation of the stent is as follows. Access to the femoral arteries can be carried out as an open surgical method, and puncture. Unlike analogues, the direction of disclosure of the Stent module is from bottom to top.

The multichannel tubular element 13 of the tool for introducing the product and forming the stent (Fig. 14) is inserted by X-ray marks of the upper edge of the membrane of the module Za (Fig. 1) to the level of the necessary aortic overlap. From the lower part of the membrane of the module Za (Fig. 1), located in the iliac artery, the cover 20 is removed upward (Fig. 15.16) by shifting the head part 21 (Fig. 15.16). Cylinder 17 is injected with liquid (Fig. 14.15). The cover 20 is removed from the upper part of the membrane of the module Za located in the abdominal aorta. The liquid cylinder 17 continues to be pumped (Fig. 14, 15), the shell of the module Za (Fig. 14) and the cover 20 (Fig. 16) are disconnected - the positioning of the system is completed.

The product for forming the stent of the module Za is filled with a hardening liquid, for example, polymer. The filling of the channels 6 of the product may occur under pressure. It is possible to fill the channels 6 by creating a vacuum from another part of the product, the opposite side of the product from which is introduced

hardening fluid in channels 6. Next, hardening of the fluid is carried out, using one of the methods mentioned above. In case of use

hardening liquid, polymerized by exposure to light on liquid, a light source is used, mounted on the instrument to insert the product and form the stent, or an autonomous light source. The multi-channel tubular element 13 (Fig. 14) with a cover 20 is removed, the hole in the artery is sutured.

5 On the opposite side, in the same way, through the connecting sleeve 8 of the module Za (Fig. 3), a tool conductor 22 is inserted for introducing the product and forming the stent (Fig. 17) into the interior of the module Za (Fig. 3), along the conductor and x-ray marks module 36 is positioned (Fig.1,3). The tip 23 is removed (Fig. 17), the balloon 24 is pumped, the product

Yu is pulled up to jamming the cylinder 24 in the connecting cuff of the module Za (Fig.Z). The cover 25 is removed (Fig. 17), down, the balloon 26 is pumped, while the shell of the module 36 is disconnected from the balloon 24. The channels b are filled

hardening fluid. It is rejected. In particular, rejection is carried out using light sources. Multichannel tubular element 27

15 (Fig. 17) with a cover 25 are removed, the hole in the artery is sutured.

INDUSTRIAL APPLICABILITY

The use of these inventions will make it possible to produce stents of various shapes and purposes, including in branched vessels. Moreover, stents can be made taking into account the individual anatomical features of the affected 20 vessels of individual recipients.

Claims

Claim

1. A product for forming a stent, characterized in that it contains at least one flexible module of tubular shape, which includes a module frame and one or more sealing cuffs; the module frame and cuffs are made in the form of hollow channels, configured to fill the channels with liquid that hardens after filling the channels; the inner surface of the frame, contains flexible membranes overlapping the space at least between the individual channels, while the product is made with the possibility of rolling it into a tubular shape and delivery to the installation site of the stent.

2. The product according to p. 1, characterized in that the individual modules of the flexible frame made with the possibility of connection between themselves at the place of formation of the stent.

3. The product according to claim 2, characterized in that the individual modules of the flexible frame contain connection elements, including annular channels,

located in planes transverse to the axis of the frame at the junction.

4. The product according to claim 1, characterized in that said cuff includes

annular channels located in planes transverse to the axis of the carcass together forming a cuff.

5. The product according to claim 1, characterized in that the channels of the frame and cuff, as well as the membrane between the channels, are made by connecting two or more films superimposed on one another and hermetically fastened along the boundaries of the channels.

6. The product according to p. 5, characterized in that the bonding of the films is made by gluing or welding.

7. The product according to p. 1, characterized in that the channels of the frame and cuff

made by gluing or welding tubular channels from a flexible material to a flexible film that acts as a membrane between the channels.

8. The product according to claim 1, characterized in that it is formed by 3D printing.

9. The product according to claim 1, characterized in that it further comprises a gate for supplying a hardening liquid into the channels for the formation of a tubular structure and cuff.

10. The product according to claim 1, characterized in that the channels contain light-reflecting and light-reflecting surfaces, ensuring the penetration of light energy throughout the volume of the inner frame.

11. A method of forming a stent, characterized in that the product for

the stent formation is placed in the tool for insertion of the product and the formation of the stent, while the hollow channels of the product are connected to at least one channel of the tool for the delivery of hardened liquid, with the help of the tool deliver the product to the place of formation of the stent, place in the place of installation of the stent and fill channels of the frame and cuffs with liquid that hardens after filling the channels.

12. The method according to p. 11, characterized in that a protective element is placed on top of the product - a cover, which, when removed, provides the ability to place the product at the stent formation site.

13. The method according to p. 12, characterized in that the said cover consists of two layers freely moving relative to each other.

14. The method according to p. 11, characterized in that the tool is supplied, according to

at least one high-pressure balloon corresponding to the diameter of the inner lumen of the stent.

15. The method according to p. 14, characterized in that the cuff of the product is fixed to the aortic wall using a high-pressure balloon.

16. The method according to p. 11, characterized in that the individual modules of the product

join with each other and then fill the annular channels of the compounds with hardening fluid.

17. The method according to p. 11, characterized in that as the hardening fluid used light-curing fluid.

18. The method according to p. 17, characterized in that after filling the channels

articles with a light-hardening liquid, the liquid is exposed to a light flux causing solidification of the liquid.