RU2719979C1 - Device and methods for producing radiopaque medical balloons - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to a medical balloon and to a method for forming a medical balloon (embodiments). Balloon comprises inflatable main part including radiopaque material representing nonwoven X-ray contrast material. Position of the balloon working surface is determined during the surgical procedure with high accuracy. Medical balloon formation method involves X-ray contrast material application, pipe extrusion and balloon workpiece inflation in the balloon formation mold.

EFFECT: technical result achieved by using a group of inventions consists in making a workpiece for a medical balloon with an X-ray contrast portion and enabling tracking of the inflated and folded balloon position during investigation with high accuracy.

7 cl, 35 dwg

Description

This application claims the convention priority for the filing date of the provisional patent application US 61 / 870,913, the contents of which are incorporated into this application by reference.

FIELD OF TECHNOLOGY

The present invention relates generally to cylinders for performing medical procedures, such as angioplastic procedures, and more particularly to cylinders that are at least partially radiopaque and to methods for forming such cylinders.

BACKGROUND OF THE INVENTION

Cylinders are used in carrying out standard procedures to solve problems associated with narrowing the flow section or even with complete blockage of tubular organs in the body, such as, for example, arteries or veins. In many clinical cases, narrowing is caused by hard masses, such as calcified plaques, in which case high pressures are required to seal such blocking masses. In the manufacture of cylinders available on the market, complex technologies are used that ensure the operation of the cylinders at high pressures without compromising the accuracy of keeping the profile of the cylinder. In addition to the requirements for withstanding high pressure, the cylinders must also meet the strength requirements for punctures, ease of tracking their position, as well as low profile, especially when used for angioplasty.

In clinical practice, the balloons used in angioplasty are expanded from a deflated, folded state into a swollen state inside the vessel to process the desired area, such as part of the circular inner wall I of blood vessel V, as shown in figures 1 and 2. Inflation is usually performed using radiopaque substances that provide good distinguishability during x-ray or other transillumination during the surgical procedure, as shown in figures 3 and 4. Usually to inflate the balloon with rovedenii angioplasty procedure using a mixture of contrast agent and saline made with regard to 70/30.

Generally speaking, it is desirable to shorten the inflation and deflation times of a balloon without compromising its profile, especially in the case of a large-volume balloon, which requires up to two minutes per ballooning / inflation cycle of the balloon with a contrast agent. Due to the relatively high viscosity of the contrast medium, it is desirable to exclude its use or at least reduce its amount for the purpose of inflating / deflating the balloon. The use of a contrast medium increases the inflation / deflation time of the balloon and also poses a risk to patients sensitive to iodine. In this regard, instead of a contrast medium, a substance transparent to transmission rays, such as, for example, saline or carbon dioxide, can be used, however, they are not visible during X-ray diffraction and, accordingly, do not provide the possibility of obtaining an image of the balloon during the procedure.

In addition, the doctor performing the angioplastic procedure should be able to determine the exact position of the undiluted balloon so that it can be located in the right place when it is inflated. This is usually achieved by attaching marker strips to the catheter shaft in the area corresponding to the working portion of the balloon. By the “working portion” of a balloon is meant the surface of the balloon that is used to achieve the desired treatment effect, such as a surface in contact with a calcified plaque, such as having a tapered or tapering section at the proximal and distal ends, usually has a length of the generally cylindrical portion of the balloon .

The offset of the marker strips on the catheter shaft from a predetermined position can lead to the fact that they will not correspond exactly to the length of the working part of the balloon, as shown in figure 4, where there is an offset between the marker strips M on shaft S and the working part W of balloon 12, A radiopaque tip P is installed on the distal end of the shaft. Even if special care is taken when positioning the markers on the shaft for their exact alignment with the estimated boundaries of the working part of the cylinder, when it is inflated displacements due to several possible factors are possible. One such factor is the summation of the tolerances, which is the result of fixing the balloon at the distal end of the shaft of the catheter. Cylinders also tend to expand in the longitudinal direction when they are inflated, especially in the case of large and especially long cylinders. Another factor is the tendency of the portion of the shaft of the catheter to bend during balloon inflating. All this can lead to a discrepancy between radiopaque markers attached to the shaft and the working part of the cylinder.

Discrepancies that arise, regardless of their cause, may prevent the doctor from accurately determining the location of the working surface of the balloon during the surgical procedure. This can lead to improper installation (or "miss") of the planned contact between the target section T and the working part W of the cylinder 12 (see figure 2). This situation is especially undesirable when the balloon is designed to deliver a payload, such as a drug and / or stent, or a work item to a specific location in the vascular system, since a miss may delay the procedure, for example, it may require reintroduction of balloon 12 or the use of another balloon catheter in the case of a drug-coated balloon.

When deflated, the balloon may flatten. In this case, the balloon 12 is folded with the formation of a “pancake”, as shown in figure 5. As a result, when observing the course of the procedure using fluoroscopy, the balloon can be seen as in a swollen state, since in this case the full width of the balloon can be observed. Thus, the doctor can conclude that the balloon remains in a swollen state, which is not true.

Accordingly, there is a need for a cylinder, the working surface of which can be determined during the operational procedure with increased accuracy.

SUMMARY OF THE INVENTION

The present invention provides a method for forming a medical balloon, comprising forming a medical balloon containing radiopaque and radiopaque parts obtained by co-extrusion. For example, the formation step may include the use of a rotating mold to form a medical balloon. Formation may include the preparation of a cylinder blank using a rotating mold. The forming step may also further comprise inflating the preform in the mold to form a medical balloon.

The invention also provides a medical balloon containing an inflatable body with radiopaque non-woven material. The radiopaque non-woven material can be laminated on the wall of the inflatable body. The balloon may contain tapering end sections, and a radiopaque non-woven material may correspond to the end sections. The cylinder may comprise a cylindrical portion, and a radiopaque non-woven material may correspond to this cylindrical portion.

A suitable method for forming the above medical balloon may include applying a radiopaque non-woven material to the tube. The tube can then be extruded to form a preform, which can then be inflated into a mold to form a balloon. A suitable method may also include applying a radiopaque non-woven material to the balloon, followed by laminating the material on the balloon.

The invention also provides a method for providing a medical balloon or preform for forming a medical balloon with a radiopaque portion. The method may include introducing the mandrel and radiopaque material into the medical balloon or into the blank and expanding the mandrel.

In one embodiment, the radiopaque material is a film inserted into the preform prior to insertion of the mandrel. The method may also include removing the mandrel after its expansion. The mandrel can be adapted for applying radiopaque material to the inner surface of a medical balloon or workpiece at the stage of expansion of the mandrel. Dorn may be partially resilient. Dorn may contain expandable interwoven rods. The dorn may contain a deformable balloon.

The method may also include the step of inflating the preform in the mold to form a medical balloon after the mandrel expansion step. The method may also include the step of applying to the mandrel a solution containing a radiopaque material, prior to the step of introducing the mandrel. The method may include the step of expanding the preform to form a medical balloon prior to the steps of introducing and expanding the mandrel.

The radiopaque material may contain one or more radiopaque fibers connected to the mandrel. The mandrel expansion step may be performed to connect the radiopaque fibers to the preform or to a medical balloon. The method may also include attaching fibers to the inner surface of the preform or medical balloon. This attachment can be carried out using adhesive material.

The radiopaque material may also be a grating, and the method includes connecting the grating to a workpiece or to a medical balloon. The method may also include introducing the lattice into the preform or into the cylinder using a mandrel. This can be done after compression of the mandrel.

The invention also provides a device comprising a combination of a medical balloon or blank for forming a medical balloon and mandrel with a grill containing radiopaque material adapted to be inserted into a medical balloon or blank and then expanded.

A suitable method for providing a preform for forming a medical balloon with a radiopaque portion includes introducing a radiopaque material into the preform and inflating the preform in the mold. The radiopaque material may be a film, and the method also includes the step of attaching the film to the preform. The radiopaque material may be a grating, and the method includes connecting the grating to a workpiece or to a medical balloon. The method may also include sealing the grating, followed by introducing it into the workpiece or into the container using a mandrel.

The invention also provides a method for providing a workpiece for forming a medical balloon with a radiopaque part. The method includes introducing a grating containing radiopaque material into the preform and inflating the preform in the mold. The method may also include sealing the grating, followed by introducing it into the workpiece or into the container using a mandrel.

The invention also provides a method for providing a medical balloon or preform for forming a medical balloon with a radiopaque portion. The method includes attaching a radiopaque material to the inner surface of a medical balloon or preform. The attachment step may include applying adhesive material to the inner surface of the medical balloon or preform, and applying radiopaque material to the adhesive material. The attachment step may include applying an adhesive material containing a radiopaque material to the inner surface of the container or preform. In any case, the radiopaque material may be a powder.

The invention also provides a method for providing a medical balloon or preform for forming a medical balloon with a radiopaque portion. The method includes introducing an insert containing a radiopaque material into a medical balloon or into a workpiece, and transferring the radiopaque material from the insert to a medical balloon or onto the workpiece. The method may also include expanding the insert. A radiopaque material may be applied so that it indicates the working surface of the medical balloon by defining the edges of the working surface, passing along the working surface, or passing through other parts of the balloon.

The invention also provides a medical balloon or blank for forming a medical balloon and mandrel with a grill containing radiopaque material adapted for insertion into a medical balloon or blank with subsequent expansion. The size of the grating in the longitudinal direction may correspond to the working surface of the cylinder.

The invention also provides a medical balloon or blank for forming a medical balloon and mandrel, containing a radiopaque non-woven material. The mandrel is adapted for insertion into a medical bottle or into a workpiece with subsequent expansion. Dorn may contain many radially arranged radiopaque fibers.

The invention also provides a medical balloon containing adhesive material along the inner surface and a radiopaque material attached to the balloon using adhesive material. The radiopaque material may be selected from the group consisting of a lattice, fiber, powder, and combinations thereof. A mandrel may be provided for transferring radiopaque material. The adhesive material may be a radiopaque adhesive material. BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1-9 are illustrations of known structures;

figure 10 is a view of a medical balloon according to the first embodiment of the present invention;

figures 11, 11a and 12, 12a are views in which a method of manufacturing the container shown in figure 10 is illustrated;

figures 13, 14 are additional illustrations of a method for manufacturing a balloon;

figure 15 is a view of a container according to another embodiment of the present invention;

figures 16, 17 are views of another variant of the container of the present invention;

figures 18-21 are views of other variants of the container of the present invention;

figures 22, 22a are side and end views of sections of another embodiment of the container of the present invention;

Figure 23 is a side cross-sectional view of a balloon catheter formed in accordance with one embodiment of the present invention;

figures 24, 25 are views of another variant of the container of the present invention;

figures 26-35 are views of other variants of the container of the present invention.

MODES FOR CARRYING OUT THE INVENTION

Unless otherwise indicated, the following description, along with the accompanying figures, applies to all variants, and features common to all variants are shown in the same way and are indicated by the same reference numbers.

The invention provides a catheter 10 with a distal portion 11, and a balloon 12 is mounted on the catheter tube 14. As shown in Figures 6, 7 and 8, the balloon 12 has a middle section 16 or “cylinder” and end sections 18, 20. In one embodiment, the end sections 18, 20 have a tapering shape for attaching the middle section 16 to the catheter tube 14, and accordingly, parts 18, 20 are usually referred to as cones or conical sections. The balloon 12 is sealed at its ends (proximal end 15a and the distal end 15b) along the conical sections 18, 20 to allow balloon 12 to inflate through one or more lumens 17 extending inside the catheter tube 14 and communicating with the interior of the balloon 12.

The tube 14 of the catheter also contains an elongated tubular shaft 24, forming a lumen 23 for the guide 26, which guides the guide through the catheter 10 along the distal end, which can be located balloon 12. As shown in figure 8, this guide 26 can pass through the proximal end of the catheter 10 and the first port 25 of connector 27 to the lumen 23 to provide a “over the wire” delivery system, however, a “rapid exchange” configuration may also be provided in which the conductor 26 exits the side opening 14a closer to the distal end (see figure 9) or is passed through the tip at the distal end of the cylinder 12 (not shown). A second port 29 may also be connected to the catheter 10, for example, through a connector 27, for supplying a fluid (for example, a radiopaque substance and / or physiological saline) into the interior of the balloon 12 through the balloon inflating space 17.

The cylinder 12 may have a single-layer or multilayer wall 28, forming the inner space of the cylinder for incoming fluid inflating. The balloon 12 may have a non-deformable structure in which the wall 28 retains its shape and its size in one or more directions when the balloon is inflated. Examples of such non-deformable cylinders can be found in US patent No. 6,746,425 and in the publication of US applications No. 2006/0085022, US 2006/0085023 and 2006/0085024, the contents of which are introduced here by reference. In this case, the cylinder 12 also has a given surface area, which remains constant during and after inflation, and also has a predetermined length and a predetermined diameter, which individually or together remain constant during and after inflation. However, depending on the particular application, the balloon 12 may be slightly deformable or deformable.

In order to improve the detection ability of the balloon 12 during the operational procedure, it may have a modified part providing radiopacity. In one embodiment, such radiopacity is ensured in such a way that the doctor can relatively easily and with high accuracy distinguish one part of the balloon 12 from the other, for example, the cylindrical part 16 with the working surface W from the conical sections 18, 20. This helps the doctor to ensure accurate positioning of the balloon 12, and in particular part or all of the working surface W, at a specific site of treatment, which is especially desirable when delivering drugs on the working surface W, as described in more detail below .

In one embodiment, which is illustrated in FIG. 10, radiopaque is provided by applying one or more at least partially radiopaque marks 30. A mark or marks 30 can be provided along the balloon 12 to form some portion of the working surface that is radiopaque compared to the entire length L balloon. For example, the mark 30 may extend longitudinally along the cylinder 12 along the cylindrical portion 16 along the cylinder 12, covering the entire working surface W. In other embodiments, the mark 30 may extend only along part of the working surface W or may extend along a completely different part of the cylinder 12, such as for example, conical sections 18, 20, as described below.

The mark 30 may be provided during the formation of the container 12 having the desired shape created by the laminated wall 28. In particular, the design of the container may be used, in which the first tube 50 of a thin layer of material, such as polymer, can be inserted into the second tube 52 to form the preform 54, as shown in figures 11 (perspective view) and 11a (cross-sectional view). The second tube 52 may comprise a compatible polymer material, but may also be formed of another material, such as a metal, possibly in the form of a film. The second tube 52 contains one or more radiopaque marks 30, the lengths of which can correspond to the length of the cylindrical part 16 of the finished cylinder, as shown in figure 11, however, the second tube can extend along the entire length of the cylinder 12, as described below and illustrated by the inner tube 62 in the figure 18. Then, the first, inner tube 50 can be expanded to form a multilayer balloon 12 (Figure 12) with a second, outer tube 52 forming a radiopaque outer shell, as can be seen in the cross section and the cylinder shown in figure 12A.

Figure 13 shows that such balloon formation can be accomplished using a blow mold 54 consisting of separable parts forming a cavity 56, the shape of which corresponds to the desired shape of the balloon. The outer tube 52 can be pre-positioned precisely in the mold cavity 56, inside a corresponding recess formed along one or more inner surfaces of the mold 55. Then, the inner tube 50 can be expanded using heat and pressure to form a balloon 12 having the desired shape, with attached to it the outer tube 52.

Figure 14 shows that instead of one tube 52, two spaced tubes, such as radiopaque rings 52a, 52b, may be provided on the inner tube 50 to receive the spaced marks 30 on the finished balloon 12 (see Figure 19). Like the tube 52, these rings 52a, 52b can be pre-installed in the mold cavity 56 so that they enclose the inner tube 50. As with the tube 52, the rings 52a, 52b can be made of thin flexible material, for example, polymer, such as nylon, compatible with a material, such as a polymer, such as nylon, of an adjacent layer formed by the tube 50, however, it may be other materials, such as metal foil. After expanding the inner tube 50, the rings 52a, 52b are firmly attached to it to form a balloon 12 with spaced annular marks, which, as a result of their preliminary placement in certain places of the mold cavity 56, can be precisely aligned with the edges of the working surface W.

Marks 30 can be provided on the tube 52 (or on the tubes 52a, 52b) in various ways. For example, the marks 30 can be provided by applying a radiopaque material to the tube 52 in the right place to obtain any shape, including, for example, alphanumeric designations to provide information that can be read during transmission, for example, length, diameter, logo, trademark sign, nominal burst pressure or type of cylinder. The application can be carried out by printing, spraying or coloring the radiopaque material on the surface of the tube 52, possibly using a mask, in which case methods for immersion in the radiopaque material or applying the material with a roller can be used. In other embodiments, the label 30 may be embedded in the tube 52, including, for example, providing it as part of a film or non-woven material, or in a bonding agent used to bond layers of materials to form the tube 52 (see, for example, publication of US application No. 2011 / 0160661, the contents of which are incorporated herein by reference). The mark 30 may be provided during the manufacturing process of the tube 52, for example, during the co-extrusion process. Examples of such technologies are described in international application PCT / US13 / 29974, the contents of which are incorporated herein by reference.

As best seen in Figures 15 and 16, a mold cavity can be formed to form a balloon 12 of any desired shape and appearance, as well as to form shoulders 12a on the finished balloon 12. These shoulders 12a can help hold the outer tube 52 providing a modified part of the cylinder 12, from moving in the longitudinal direction and, thus, the tube 52 will remain in the desired position (in one embodiment, the tube 52 is aligned with the full length of the working surface W). Additionally or instead, as shown in figure 17, the inner surface of the outer tube 52 can be made for frictional interaction with the outer surface of the tube 50, for example, by providing a rough or textured surface 58.

Additionally or instead, an adhesive can be used to improve adhesion between the tubes 50, 52. This adhesive can be provided on any of the tubes before blowing the balloon. The adhesive may also additionally contain a radiopaque substance to improve the radiopacity of the cylinder 12 (see, for example, publication of US application No. 2011/0160661).

In another embodiment, the cylinder 12 is formed with a modified part by blowing in the form of a multilayer preform, in which at least one layer contains radiopaque material. Thus, the blank 60 in this embodiment may include an inner layer containing a radiopaque film 62, and an outer layer 64, which is a conventional film without the addition of radiopaque material. The inflation process in the mold allows the preform 60 to expand to form a balloon 12 having an X-ray contrast corresponding to the length of the inner layer containing the X-ray contrast material, which may be equal to the full length L of the balloon 12.

The cylinder can be formed by stretching a polymer tube having a uniform wall thickness to the desired or preferred shape, the diameter of the cylindrical part being larger than the diameter of the remaining parts, which can be conical sections or shoulders of the finished cylinder. Such a process can be carried out by placing the blank of the container in the form and changing the characteristics of the physical medium, for example, increasing the temperature and / or the operating pressure of the fluid (gas or liquid), as a result of which the blank will take the necessary shape.

Cylinders 12 containing coatings with drugs that must be applied to the walls of the vessel can also be made using the above method. For example, as shown in FIG. 19, a cylinder 12 having a predetermined working surface W with radiopaque marks 30 at the transitions between the cylindrical part 16 and the conical sections 18, 20, may contain a part coated with, for example, drug D, which provides the necessary therapeutic effect drawing on the inner walls of the vessel. The radiopaque marks 30 may also correspond to the location on the balloon 12 of the drug D, for example, along the length of the entire working surface W or only along part of this length. Drug D may be applied to the inflated balloon in the manufacturing process, before folding the balloon for insertion into a blood vessel. Thus, the doctor can use the x-ray apparatus to determine the exact position of the working surface W before inflating the balloon 12 in the blood vessel to deliver the drug D to the desired location and ensure the necessary treatment regimen.

Marks 30 can also be provided in the form of one or more longitudinal strips 66, which do not cover the entire circumference of the cylinder 12, as shown in figures 20 and 21. This can be achieved by providing one or more layers 62, 64 or tube radiopaque material corresponding to the strips 66, for example, using a co-extrusion process. Further information can be found in documents PCT / US13 / 29959, PCT / US13 / 29967, PCT / EP13 / 54748 and PCT / US13 / 29977, the contents of which are incorporated herein by reference. Using multiple spaced marks 30 may also help distinguish between the state of the inflated balloon in which the marks are spaced and the state of the properly deflated balloon since the marks will be closer together when the balloon is folded.

In another embodiment, blow molding may be used to form a balloon 12 with various types of modified layer. For example, as shown in FIG. 22, a modified insert 52 may be provided whose outer surface is textured or etched and connected to the inner tube 50. Additionally, the insert 52 may be partially or fully radiopaque (see, for example, FIG. 10). In one embodiment, the multilayer insert 52 may be provided with an external radiopaque layer 51a and an internal support layer 5lb that does not contain radiopaque material, and holes 53 extending to the surface of the inner layer are etched in the outer layer (see figure 22a). As a result, a certain pattern can be seen in X-rays, which can provide an opportunity to determine the places on the cylinder 12 where the drug is present (in etched areas or between them, which, as in previous cases, can correspond to the working surface W).

In any case, when the preform 54 is blown in the corresponding shape 55 (see Figures 13 and 14), a balloon 12 may be formed comprising a layer 28a with a textured or etched surface of the wall of the balloon 28. This layer 28a may extend along the entire working surface W, as shown in FIG. 23, or along any part thereof. In the case of etching, texturing or other surface treatment, the material forming the insert 52 must have a sufficiently high melt flow rate so that the formed surface roughness does not disappear under the influence of heat or pressure used in the process of inflating the mold.

In another embodiment, the receipt of the cylinder 12 with a modified layer in the insert 52 provide one or more holes. For example, as shown in FIG. 24, insert 52 may be configured as a lattice or mesh structure, for example, made of a grid or a lattice consisting of a plurality of intersecting elements 57 forming holes 53. The structure 52 may have a tubular shape, as shown in the figure 24, and may consist of several parts similar to rings 52a, 52b. As in previous cases, the material forming the insert 52 must have a sufficiently high melt flow rate so that the formed surface roughness does not disappear under the influence of heat or pressure used in the process of inflation in the mold.

When the insert 52 is placed in the mold, then after inflating the billet in the mold, the insert 52 is attached to the inner tube 50 and forms the outer layer of the finished container 12. In the case of the insert 52 considered, the openings 53 extend to the surface of the cylinder wall 28, which can be used for the modified layer, for example, containing radiopaque material. The insert 52 may extend along the entire working surface W, and may additionally be fully or partially radiopaque. In other embodiments, insert 52 may be coated, for example, in the form of a medicament or glidant.

You can also modify the mold 55 to provide surface treatment of the finished cylinder 12. For example, as shown in figure 25, the inner surface of the cavity 56 of the form can be processed using etching, engraving or other methods, resulting in the formation of an ordered set of protrusions extending into the mold. Such machined parts of the inner surfaces correspond to the working surface W of the cylinder 12, for example, its cylindrical part. Then, when the preform 54, which may contain one layer of material, is inflated in the mold cavity 56 (Figure 26), the surface of the resulting balloon will be covered with prints of a plurality of protrusions of the inner surfaces of the mold 55. In other words, the protrusions forming the ordered plurality 56a of the mold will form impressions on the outer surface of the wall 28 of the cylinder.

Additionally, in this embodiment, material may be placed in the cavity 56 for partially or completely filling any spaces or depressions in an ordered configuration 56a, for example, with radiopaque material 59. As shown in figures 27 and 28, the balloon 12 obtained by inflation in form 55 with this the type of aggregate surface configuration 56a will have a surface layer modified to contain the selected aggregate material, so that in the case of radiopaque material 59, the surface will partially radiopaque, as shown by the darkened parts of the wall of the balloon 28 in FIG. 28. The material can be placed inside the mold 59 by feeding it through the opening of the internal passage inside the cavity 56, before or during molding of the balloon, including, for example, spraying the filler material inside the cavity 56 molds, for example, when the mating parts forming the mold 56 are separated, and the protrusion configuration 56a on the walls of the mold is opened.

A balloon catheter 10 may be formed by forming a balloon preform with discrete radiopaque segments obtained by co-extrusion. The process of co-extrusion may include the use of a rotating form (see, for example, publication of application No. 2003/0100869, the contents of which are introduced here by reference) to form discrete segments of one or more materials inside the tube, including radiopaque material. Then, the preform can be inflated to form a balloon into the walls of which a radiopaque material is interspersed, for example, between the ends of the working surface, along the entire working surface, along one or both end sections or cones (see, for example, Figures 19-21), and In all cases, partial or full coverage of the respective surfaces is provided.

Labels 30 can also be inserted into balloon 12 by applying a radiopaque non-woven material. The attachment of a radiopaque non-woven material 72 to the cylinder blank 70 (FIG. 29) may enable accurate identification of each zone of the cylinder, for example, by indicating the part containing the working surface relative to other parts. As shown in FIG. 30, a radiopaque non-woven material 72 can also be applied to the outer surface of the formed balloon 12, after which an auxiliary process, such as lamination with a film 74, can be additionally carried out to fix the non-woven material. In another embodiment, as shown in FIG. 31, a radiopaque non-woven material 72 may be applied to the extruded tube 76, after which an auxiliary extrusion step, such as a cable coating, may be carried out to fix the non-woven material. In this case, the two-layer tube can then be formed into a cylinder 12 using inflation in the form or other similar methods known in the art.

As shown in FIG. 32, a radiopaque material may also be applied to the inner walls of the blank 80 of the balloon or the fully formed balloon 12 using the expandable mandrel 82. For example, the mandrel 82 may comprise a rigid portion 82a with a distally attached sliding portion 82b that may be folded or apart. The distal part of the mandrel can be dimensioned so that it completely fills the inner space of the blank 80 of the balloon in the extended state, and can pass through the proximal or distal ends in the folded state. The distal end of the mandrel 82 should be made of a material that can withstand the pressure of gas and / or liquid, for example, it can be a deformable balloon.

The mandrel 82 can also be made of opposite and / or interwoven elements arranged so that the mandrel expansion is achieved when it is reduced (for example, a braid with a spiral winding, such as two-way winding, in which the angle between the warp and the weft is reduced at the points their intersection leads to a decrease in the radial distance between opposite sides) or from opposite elements connected in the middle and at the ends, the action of which is carried out by a swivel joint (for example, a pantograph cal mechanism).

The radiopaque material or part thereof may also be introduced into the blank of the balloon before being inflated in the mold. For example, a radiopaque material in the form of a film or non-woven material containing a radiopaque substance (for example, tungsten, barium, tantalum, gold, platinum) with the addition of polymers to provide a structural matrix, as well as additional stabilizers and / or plasticizers, can be applied to the preform molding a balloon. Coagulation or folding of the radiopaque material makes it possible to fill the inner space of the preform when it expands after insertion and before / during the process of inflating the preform. The addition of an adhesive applied to the outer surface of the radiopaque material before being introduced into the preform can further improve the adhesion of the material to the inner walls of the balloon catheter. Those skilled in the art will understand that expanding the distal portion of the above mandrel may further facilitate the attachment of a radiopaque material.

Labels 30 can also be introduced into the cylinder 12 in the form of a solution. For example, as shown in figure 33, a solution containing X-ray contrast material 86 in suspension, possibly with the addition of stabilizers, can be applied to the outer surface of the sliding mandrel 82. Then, the distal part of the sliding mandrel can be introduced into the cylinder blank (see, for example , the variant shown in figure 32) with the mandrel in the folded state, for example in a deflated state in the case of a cylinder). Then the mandrel 82 can be placed in expanded position to adhere to the inner walls of the preform and, in a similar way, will apply the solution to the surface of the walls, after which the preform will be used to form the balloon 12. In another embodiment, the radiopaque solution can be applied with a sliding mandrel after full molding balloon.

Labels 30 may also contain radiopaque fibers. Fibers containing a radiopaque material, such as tungsten, tantalum, platinum and the like, can be obtained using a polymer matrix and further formed by extrusion. Then the fibers can be introduced into the container using the expanding mandrel 80 described above. The dimensions of the mandrel 82 can be selected so that it can be inserted through the proximal or distal ends of the blank 80 of the balloon and completely cover the inner walls of the blank into apart state. As shown in FIG. 34, fibers 88 can be arranged radially around mandrel 82 before being inserted into preform 80. After expanding mandrel 82, fibers can be placed on the surface of the inner walls of preform 80, after which the mandrel can be folded and removed from the preform. The fibers can be glued to the surface of the inner walls using an adhesive, which is then further cured using UV radiation, heat or evaporating solvents.

The label 30 can be introduced into the cylinder 12 in the form of a grating or matrix 90 of radiopaque material, as shown in FIG. 35. Plastic polymers embedded in the radiopaque material can be formed by extrusion, after which a lattice can be formed by cutting, resulting in reduced surface area to increase product flexibility. The outer diameter of the grating or matrix 90 can be chosen so that it is adjacent to the surface of the inner walls of the blank 80 of the container, and the length of the grating is chosen to match the length of the cylindrical part of the container and / or conical sections or shoulders. The grill can be compressed to reduce the diameter so that it can be inserted into the workpiece 80 through the open ends corresponding to the proximal or distal conical sections. Additionally, an adhesive may be added to facilitate the attachment of the grill to the inner walls.

Labels 30 may also be introduced into the powder container 12. The attachment of the radiopaque powder can be achieved by selective application of an adhesive to the surface of the inner walls of the balloon preform. An insert (for example, such as a hypotube) can be introduced through one end of the preform, which can be equipped with an applicator, for example, a swab or sponge at the distal end, which can be retractable, to contact the surface of the inner walls of the preform. Then the tampon or sponge can be used for selective interaction with the conical section of the container, followed by the introduction of an adhesive through the insert. As a result, the adhesive will be selectively applied with a sponge to the surface of the inner walls. Then the cylinder should be rotated to more evenly distribute the adhesive. Then the insert can be removed and, if necessary, repeat the procedure from the other end of the container. After applying the adhesive to the surface of the inner walls, a radiopaque material can be applied, for example, in the form of a powder, followed by shaking or rotation of the workpiece. Then, powder that does not adhere to the walls can be removed before the catheter shaft is inserted. In other embodiments, the powder may be combined with an adhesive, followed by application to the surface of the inner walls using various technologies, such as brushing, spraying or irrigation and filling. Example

The X-ray contrast (PK) powder was weighed in a 20 ml glass tube, and then UV-cured 208-CTH-F Dymax adhesive (Torrington, Connecticut) was added to the powder. The percentages of these components in the amount amounted to 100%. The PK coating mixture was mixed thoroughly and filled into a 3 ml polypropylene syringe, which was placed in a syringe pump for coating. An EFD needle was attached to the syringe, which was inserted inside the tapering part of the balloon to cover the inner surface, with the coating applied only in the region of the conical section of the balloon. The injection rate was set equal to 0.5 ml / min. Once the PK coating mixture reached the transition line of the shoulder-cylindrical portion, the mixture was pumped back into the syringe to complete the coating cycle. The coating was cured using Dymax BlueWave 200 equipment. The coating process was repeated for the other conical part of the container.

In figures 35A - 35E shows x-rays obtained for various PK materials.

Examples of radiopaque materials include (without limitation): finely divided tungsten, tantalum, bismuth, bismuth trioxide, bismuth chloride, basic bismuth carbon dioxide, other bismuth compounds, barium sulfate, silver, silver compounds, rare earth oxides and many other compounds commonly used for absorption x-ray radiation. The polymer used to make the film, possibly with a radiopaque material, can be any polymer material that can be saturated with the radiopaque material and formed into a sufficiently thin film. As such polymers, for example, thermoplastic and thermoset polymers can be used. Some examples of thermoplastic polymers include (without limitation): polyurethanes, polyamides (nylon-11, nylon-12), polyester-polyamide copolymers such as REAC, polyethylene terephthalate or other polyesters, polyvinyl acetate, polyvinyl chloride and many other thermoplastic materials that can be used for the manufacture of films. Some examples of thermosetting polymers include (without limitation): crosslinked polyurethanes, polyureas, epoxies, acrylics, silicones, and many other thermosetting materials from which thin structures can be made, including films. Any adjacent structures that can be adhered, such as tubes 50, 52 or layers 62, 64, can be formed from compatible materials, as a result of which additional processing steps or the addition of compatibilizing agents or connecting layers, etc. can be omitted. P.

In the present description, to illustrate the basic ideas of the invention, several options for its implementation are considered, however, various modifications and changes of the considered options are possible without going beyond the scope and essence of the invention, which are determined by the attached claims. For example, any numerical values and their ranges indicated in different versions can vary due to manufacturing tolerances, changes in environmental characteristics and quality of materials, as well as in connection with modifications to the design and shape of the container, and, accordingly, can be considered approximate, and the term “about” means that the corresponding value may at least vary due to these factors. Accordingly, it should be understood that the present invention is not limited to the described options, and its full scope is determined by the paragraphs of the attached claims and their equivalents.

Claims (13)

1. A method of forming a medical balloon, including: the formation of a medical cylinder having radiopaque and radiopaque parts using a rotating form, and the radiopaque material is applied so that it indicates the working surface (W) of the medical cylinder (12), by determining the edges of the working surface (W), passing along the working surface ( W) or passing along sections of the container other than the working surface (W). 2. The method according to p. 1, in which the stage of formation includes: obtaining a cylinder blank using a rotating mold; and inflating the blank of the balloon in the mold to obtain a medical balloon. 3. A medical balloon containing an inflatable main body including a radiopaque material, which is a non-woven radiopaque material. 4. The medical balloon of claim 3, wherein the non-woven radiopaque material is laminated to the wall of the inflatable body. 5. The medical bottle according to claim 3, containing a tapering end sections, and a non-woven radiopaque material corresponds to the end sections. 6. The medical bottle according to claim 3, containing a cylindrical part, and a non-woven radiopaque material corresponds to the cylindrical part. 7. The method of forming a medical balloon according to any one of paragraphs. 3-6, including: applying non-woven radiopaque material to the tube; extruding a tube to form a preform; and inflating the blank of the balloon in the mold to form a medical balloon.

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