Fillable envelope for soft endoprosthesis with different cohesion surfaces
Abstract
FIELD: medicine. SUBSTANCE: group of inventions relate to medicine. Endoprosthesis for implantation into person's body contains implanted element which contains envelope from elastomer, external surface of which is formed by front and back sides. On back or front side there is, at least, one section of cohesion, generally of elongated shape, which has texture, made by casting on external surface of envelope, different from the remaining part of external surface of envelope. Prosthesis is made in such a way that when implanted into the body near a group of muscles its cohesion section is in the same direction with said group of muscles. Brest endoprosthesis contains implanted element with silicone elastomeric envelope, on external surface of which there is, at least, one section of cohesion of elongated shape, which has texture, made by casting on external surface of envelope, different from the remaining part of external surface of envelope. Said, at least, one section of cohesion of elongated shape is made in such a way that when endoprosthesis is implanted into person's breast, said section is in the same direction with, at least, one of groups of smaller or greater pectoral muscles. EFFECT: inventions ensure reduction of probability of capsular contracture development. 14 cl, 8 dwg
Term
2.9 yearsleft in the term
Expires 13 August 2029.
- Priority
- Filed
- Granted
- Today
- Expires
14 claims: 2 independent, 12 dependent
- 1Эндопротез для имплантирования в тело человека, содержащий:имплантируемый элемент, содержащий оболочку из эластомера, наружная поверхность которого образована лицевой и тыльной сторонами;причем на тыльной либо на лицевой стороне имеется по меньшей мере один участок сцепления в целом вытянутой формы, имеющий текстуру, выполненную литьем на наружной поверхности оболочки, отличную от остальной части наружной поверхности оболочки;причем протез выполнен таким образом, что при его имплантации в тело по соседству с какой-либо группой мышц его участок сцепления оказывается в целом сонаправлен этой группе мышц.
- 2Эндопротез по п.1, отличающийся тем, что на участке сцепления имеется первая текстура, а на указанной остальной поверхности имеется вторая текстура, отличная от первой текстуры.
- 3Эндопротез по п.1, предназначенный для имплантации в грудь человека, отличающийся тем, что участок сцепления расположен и выполнен так, чтобы при имплантации эндопротеза в грудь оказаться сонаправленным группе грудных мышц.
- 4Эндопротез по п.1, предназначенный для имплантации в грудь человека, отличающийся тем, что участок сцепления расположен и выполнен так, чтобы при имплантации эндопротеза в грудь оказаться сонаправленным группам по меньшей мере большой или малой грудной мышцы.
- 5Эндопротез по п.1, отличающийся тем, что участок сцепления содержит несколько участков сцепления.
- 6Эндопротез по п.1, отличающийся тем, что участок сцепления содержит несколько участков сцепления, расходящихся веерообразно.
- 7Эндопротез по п.1, отличающийся тем, что участок сцепления простирается по существу через всю лицевую или тыльную сторону.
- 8Эндопротез по п.1, отличающийся тем, что участок сцепления имеет по существу постоянную ширину, а именно 2-15 мм.
- 9Грудной эндопротез, содержащий имплантируемый элемент с силиконовой эластомерной оболочкой, на наружной поверхности которого имеется по меньшей мере один участок сцепления вытянутой формы, имеющий текстуру, выполненную литьем на наружной поверхности оболочки, отличную от остальной части наружной поверхности оболочки;причем указанный по меньшей мере один участок сцепления вытянутой формы устроен так, что когда эндопротез имплантирован в грудь человека, этот участок оказывается сонаправлен по меньшей мере одной из групп малой или большой грудных мышц.
- 10Эндопротез по п.9, отличающийся тем, что его наружная поверхность образована лицевой и тыльной сторонами, а участок сцепления вытянутой формы проходит по меньшей мере по лицевой или тыльной стороне.
- 11Эндопротез по п.9, отличающийся тем, что его наружная поверхность образована лицевой и тыльной сторонами, а участок сцепления вытянутой формы проходит по лицевой стороне.
- 12Эндопротез по п.9, отличающийся тем, что указанный участок сцепления вытянутой формы содержит множество участков сцепления вытянутой формы, образующих по существу веерообразный рисунок.
- 13Эндопротез по п.9, отличающийся тем, что остальная часть его наружной поверхности по существу гладкая.
- 14Эндопротез по п.9, отличающийся тем, что его наружная поверхность образована лицевой и тыльной сторонами и участком по периметру между лицевой и тыльной сторонами, и при этом участок сцепления проходит как по периметру, так и по меньшей мере по одной из указанных лицевой или тыльной сторон.
Independent claims14
80 paragraphs in 5 sections, as filed
TECHNICAL FIELD
The present invention relates to a soft endoprosthesis, e.g. breast implant, namely its textured outer surface.
BACKGROUND OF THE INVENTION
Implants are commonly used to fill or increase of body tissues. When breast cancer is sometimes necessary to remove some or all of the mammary gland and surrounding tissue, thereby forming a void that can be filled with the endoprosthesis. It allows you to put on him, and the surrounding tissue to maintain the normal appearance of the body. Restoration of normal appearance provides a highly positive psychological effect on the postoperative patient, largely eliminating it from shock and depression that often follow a major surgery. Also, implants are widely used to restore the appearance of soft tissues in various parts of the body such as the buttocks, calves, chin, and similar areas.
Soft prosthesis usually has a relatively thin and quite flexible envelope of vulcanized (cured) silicone elastomer. The casing is filled with silicone gel or normal saline, and the content may be performed both before and after places sheath through an incision in the patient's body.
In the US, women have a choice of shell breast implants with the surface of one of two types: smooth or textured. The surgeon usually makes recommendations on the choice of the type of surface, based on the techniques used by them, as well as forms of breast implant is adjusted for the needs of the individual patient.
Installation breast implants possible complications, one of which is known as capsular contracture. It is expressed in the grip of a fibrous capsule forming around the implant, causing the implant is usually contracted in the hard ball and gives the body unattractive. Under the leadership of «Breast Implant Consumer Handbook», published in 2004 by the US to oversee the quality of food and drugs, the scientific literature shows that the use of breast implants with a textured surface reduces the likelihood of capsular contracture.
The textured surface can be obtained in several ways. In the 1980s, were quite popular breast implants filled with silicone gel and covered with a thin layer of textured polyurethane foam as they are surprisingly well counteract the development of capsular contracture in the early stages. For example, in US Patent 3293663 discloses a gel №US prosthesis with a porous fabric on the back side for tissue ingrowth and enhance its body on the chest wall. Although later in the US, such devices have been forbidden to use their medical and commercial success aroused interest in silicone implants with a textured surface.
Despite the many advances in the design of safe and convenient implants, they still require improvements.
SUMMARY OF THE INVENTION
The present invention provides prostheses suitable for implantation in the human body, such as breast implants, suitable for use in reconstruction or augmentation. The endoprosthesis is typically implantable member such as a soft shell filled or intended to contain a liquid or gel. On the outer surface of the implanted element has one or more surfaces of the clutch, which gives the shape, position and structure, stimulating or guides tissue ingrowth or adhesion.
According to one aspect of the present invention, the bonding surface are separate, typically elongated, the portions extending across the front or rear of the implant. On these surfaces, referred to as binding sites, there is texture, pitted or rough, other than the texture or roughness of the pitted surface of the implant adjacent areas.
In some embodiments, the coupling portions have enhanced texture as compared with the rest of the front or rear of the implant. In other words, the rest of the surface texture is weaker than in the areas of adhesion. In some embodiments, the coupling portions have a texture and adjacent surfaces, for example, outside the binding sites, substantially less textured, or are relatively smooth.
The endoprosthesis can be designed with the expectation that the areas of adhesion stimulated ingrowth or tissue adhesion, better compared with the same surface without a texture, pitted or rough.
In one aspect of the present invention, portions of the clutch are arranged such, and / or have such shape, that the endoprosthesis after its installation in the body involved in the natural movements of the body, such as a whole moves in concert with the muscles. It is understood that the inventive implants, participating in the natural movements of the body is less prone to wear due to stresses in the material, compared to conventional implants without such binding sites. It is also intended that such implants because they participate in the movements of the body, are more comfortable for the patient.
In a particular aspect of the present invention, the surface of the clutch can be arranged in certain locations on the front (front side) of the shell, i.e. surface, which is facing forward after proper insertion of the implant into the patient. Instead of or together with the one or more separate surface coupling may be around the perimeter (e.g., over the entire circumference) of the skin and / or on the back (rear) side thereof, i.e. surface, which is turned back upon proper insertion of the implant into the patient.
In an even more particular aspect, the number of clutch sections comprises at least one elongated portion disposed on the front side of the shell. This could be, for example, a site or multiple sites in the form of a strip, which is made or rendered a relief texture, pitted or rough.
Elongated coupling portions may be arranged so that they have the same direction with one of the largest groups or pectoralis minor while inserting the implant into the patient. For example, in one embodiment of the present invention include elongated portions has a section in the form of diagonally oriented strips configured so that when installing the implant in the patient's body be codirectional with the pectoralis major muscle. In another embodiment, the number of binding sites has a plurality of elongated portions which diverge like a fan about reproducing in the body of the implant installed in the direction of the beams pectoralis minor.
In a broader aspect of the present invention, the endoprosthesis is a breast implant, the jacket surface of which has a coupling portion with a first texture, and the rest surface has a second texture different from the first. In other words, in some embodiments, all or substantially all of the outer surface of a breast implant shells textured, and in some areas enhanced texture as compared with the rest of the surface texture.
It is understood that such differing textures will stimulate to varying degrees of tissue ingrowth or adhesion at the different coupling sites. For example, in one embodiment, the first coupling portion is located on the front side of the implant and a second coupling portion located on its rear side. The first clutch portion is formed texture which interact better and has a high adhesion to the tissues, while the second portion is formed texture, less conducive to reaction and adhesion.
According to another aspect of the present invention, the shell of the endoprosthesis, intended to come in contact with the tissues of the body has a first engagement surface formed by the first cell structure with open pores, and a second engagement surface formed by the second honeycomb structure with open pores, wherein the second structure is different from the first. When the first and second clutch surface disposed so that, to varying degrees stimulate tissue ingrowth or adhesion at the relevant point of contact between the body and the shell.
For example, the first cell structure has a relatively large open pores, and the second - is relatively small. Instead of or together with the first honeycomb structure can be characterized by a first pore distribution law, and the second - the second law, the law of the first pore density higher than in the second.
According to another particular aspect of the present invention, the first honeycomb structure is formed by a relatively large rounded open pores, and the second - a relatively small rounded pores. Alternatively, the first honeycomb structure is formed relatively rounded pores, and the second - are relatively angular.
In some embodiments, it is desirable to make the first and second surfaces of the clutch arrangement and such a structure that they can at least to some extent disrupt or prevent the formation of the tissue capsule surrounding the prosthesis after its implantation into the patient.
Furthermore, the present invention provides a breast prosthesis shell intended for implantation into the human body, produced by performing the following steps:
- It takes the workpiece,
- It is applied to the layer of silicone elastomer,
- Before the layer is fully cured silicone elastomer is applied to the solid particles of the first configuration of the area of this layer, and on another part of the area - the solid particles of the second configuration.
After the layer with recessed therein particulate hardened, dissolved solids, such as using a solvent which does not dissolve the silicone elastomer to any appreciable extent.
The resulting shell portion has a first open cell structure with pores formed by solid particles of the first configuration and the second portion of the honeycomb structure with open pores formed by solid particles of the second configuration.
In yet another aspect, the present invention provides a method of increasing or human breast reconstruction. The method generally includes the following steps:
- Taking an implantable member with at least one elongated grip portion, as described elsewhere herein.
- Is implanted in the chest of the patient so that the coupling portion was generally the same direction as the group is large or small chest muscle.
The method can also include filling the implantable member with liquid or gel before or after implantation.
The essence and advantages of the present invention is explained in detail in the following description and claims taken in conjunction with the accompanying drawings, wherein like elements are designated by identical reference numerals.
BRIEF DESCRIPTION OF DRAWINGS
The features and advantages of the present invention will be described and explained in the following description, claims and the accompanying drawings.
1A and 1B show, respectively, front and side view of an example of
round breast implant of the present invention.
2A and 2B show, respectively, front and side view of an example of
shaped breast implant of the present invention.
3A and 3B schematically show the upper torso of the woman and the location, respectively the major and minor pectoralis muscles on one side of the chest.
4A and 4B show a sagittal section of the breast and surrounding thorax, illustrating, respectively, placing the breast implant under the gland and under the muscle.
5A and 5B show front and side views of an example of a round breast implant of the present invention with an elongated grip surface strip-shaped.
6A and 6B show front and side views of an example of a shaped breast implant of the present invention with an elongated grip surface strip-shaped.
7 shows another example of the front breast implant according to the present invention, the first portion having a first coupling structure and a second portion engaging a second texture different from the first.
8A and 8B show an example of the front and rear round breast implant of the present invention which is different textures on the front and back side.
DETAILED DESCRIPTION OF THE INVENTION
In the present invention, a soft shell, preferably a silicone elastomer for the implant to be filled with saline solution or gel, wherein the exterior shell has an engagement surface. Such implants are designed primarily for the reconstruction or breast augmentation. The invention can be applied to implants for the buttocks, testes, calves and other body parts.
Beneath the surface or portion of the clutch in the present application refers to a part of the outer surface of the shell of the implant is located, constructed and designed to stimulate the ingrowth or tissue adhesion. For example, the coupling portion may be a texture, pitted or rough, other than, for example, more pronounced, from the adjacent surfaces of the implant, which do not stimulate tissue ingrowth or adhesion to the same extent as the coupling portion.
Coupling portion may be formed in any suitable manner, such as, in particular, for the process to remove salt, as described in US patent number 500 729, mutatis mutandis. Alternatively, the bonding surface may be made of separate elements such as patches or films, to be applied externally to the implant. Another method of forming discrete surfaces clutch - casting shell shape with a relatively rough portion of the inner surface. Another way - machined outer surface of the implant after casting. The present invention is not limited to any particular type of surface texture to grip, although one or more of these techniques may be some advantages associated.
1A and 1B show front and side views of an example of a round breast implant 20 of the present invention. Its surface is formed by a relatively smooth face 21, a textured surface on the back side 22 and the textured portion 24 along the perimeter between the front side 21 and back side 22. The relatively smooth face side may have a less pronounced texture as compared with the back side 22, such as fine texture or matting. In some embodiments, the back side of the implant 20 is relatively smooth, textured front side, and the area around the perimeter of smooth or textured. Sami surface 22, the clutch 24 may be textured to varying degrees. The diameter D and the projection T of the implant are chosen to the size of the patient's chest and aesthetic reasons.
In this embodiment, the back surface 22 of the clutch reaches the top of the generator 26 or 20. The convex perimeter of the implant surface 24 on the perimeter of the clutch comes to the front side 21 of the implant at a slight distance S. In some embodiments, the distance S is on the order of 10-30% of the projection T . In some embodiments, the coupling surface 24 formed around the perimeter of the circular implant 20, which makes it completely axisymmetric. In other embodiments, the coupling surface 24 may be shortened, i.e. cover only a portion of the perimeter of the implant, for example the lower or upper half, or may be divided into separate segments with gaps therebetween, in certain embodiments, the adhesion surface 24 is divided into evenly spaced segments resulting in alternating smooth areas with textured.
2A-2B is shaped implant 30 of the present invention, the lower anterior lobe 32 which simulates the natural shape of the breast. Like implant 20, it has a grip surface 34 on the back side and surface 36 around the perimeter. Showing the width W, the height H and the projection T implant. If the front projection implant round, then W = H, otherwise W may be greater than or less than N. At the natural form of the implant 30 and acquires the regular position, namely, that in which the lower lobe 32 located below the center. Accordingly, the coupling surface 36 may cover the entire perimeter of the implant, or may be formed as separate portions and have an orientation relative to its natural shape. For example, the coupling surface 36 may cover only the lower half of the implant, or be formed only on the sides.
3A shows the upper part of the female torso and shown on one side of the position of the pectoralis major muscle, and 3B shows the position of the pectoralis minor muscle. These two muscles overlapping one another and begin the shoulder or collarbone, extending down the chest below the breast. In one aspect, the present invention provides an implant with coupling surfaces such as described elsewhere herein, which are oriented substantially co-directional beams muscle implant when installed into the body.
Without being bound by any particular theory explaining the principle of operation, note that the areas or lines of contact between the implant and the main chest muscles exposed engine loads to a greater extent than the other area of the implant which do not interact with the muscles. The inventors believe that the engagement surface is substantially coincident or collinear with the muscles do not have the best chance to break away from them (i.e., they move with the muscle). In contrast, the engagement surface located at a distance from the muscle, may be subject to greater efforts at separation from her.
It is also intended that such separate areas of coupling advantageous in that they prevent the formation of fibrous capsule and / or reduce the likelihood of developing capsular contracture.
4A, given sagittal section illustrating the anatomy of the breast and surrounding chest wall and shows the placement of the implant 40 under the breast. The implant 40 is placed on top of the pectoralis major muscle 42 which, in turn, overlies the pectoralis minor 44 below illustrates the pectoralis minor chest wall 48 with a plurality of ribs 50. In Figure 4, in the same way as in 4A shows the placement of the implant 40 under the pectoralis major muscle 42. One of the two accommodation options are selected depending mainly on clinical judgment of the surgeon, sometimes taking into account the interview with the patient and the desired result. Depending on the placement of the implant 40 may be in contact with one or both muscle In some embodiments, the implant has portions clutch substantially elongated shape as shown and described herein, and these portions substantially collinear with the associated muscle with which contacts the implant after its installation in the patient's body.
5A-5B shows a front and side view of an example of a round breast implant 60 of the present invention, the surface on the back side of the clutch 62, the perimeter surface 64 and the surface 66 in the form of stripes on the front side. The surface of the clutch 66 in the form of strips oriented generally diagonally and starts from the front surface of the border 64 around its perimeter. As shown in Figure 5A embodiment, the clutch surface 66 has a constant width in a front W. In one embodiment, the width W of 1-20 mm, eg 2-15 mm. As a variant, not shown in the drawings, the surface 66 may have a variable width.
In one embodiment, the coupling surface 66 in the form of strips oriented after insertion of the implant codirectional with large or small with the chest muscle. For example, if the implant 60 is designed to fit under the muscle, as shown in Figure 4B, the clutch surface 66 may be oriented collinear with the pectoralis major muscle, as shown in Figure 3A. Alternatively, the angle of the inclined surface 66 may approximately correspond to the average inclination angle is large or small chest muscle. In this case, the clutch surface 66 of the implant 60 promotes tissue ingrowth or adhesion along the major lines of the mechanical load on the implant. Desirably, the surface 66 is inclined at an angle of 30-60 ° to the vertical plane cutting through the implant 60. Of course, if the implant is circular as shown in Figure 5A, the surface 66 can be given any desired orientation. In one embodiment, the coupling surface 66 in the form of strips extends over the center of the implant 60, the implant has a two symmetrical orientations spaced by about 180 °. It is easy to handle, since the surgeon may attach to it any of the two orientations.
Coupling portions 66 in the form of strips may extend substantially across the face of the implant may be formed and texture different from the rest of the surface texture of the front side. Also, the clutch portion 66 can have a texture that is different, for example, a more pronounced or more aggressive from the back of the texture of the surface 62 or 64 at the perimeter of the clutch.
6A-6B illustrate another example of a shaped breast implant 70 of the present invention. It has exactly the same engagement surface 72 on the rear side, the perimeter surface 74 and a plurality of individual surfaces 76a, 76b, 76c in the form of coupling bars. Separated surface 76a, 76b, 76c are arranged co-directional coupling with one or more of the above muscles. For example, three surfaces 76a, 76b, 76c may diverge like a fan, reproducing beams orientation pectoralis minor. Since the shaped implant 70 is a full-time orientation, if properly placed the surface 76a, 76b, 76c clutch themselves will be codirectional with individual bundles of muscle. As noted above, the various surfaces 72, 74, 76a, 76b, 76c clutch can be similar extent pitted, or some of them may have a less pronounced texture, such matting. For example, the surfaces 72, 74 on the back side and along the perimeter may have a fine, matte texture, whereas the faces 76a, 76b, 76c have a firmer texture. The present invention covers all possible combinations of textures.
In cross-section the textured implant shell according to the present invention may be single- or multilayered. The total thickness thereof may exceed the thickness of the shell with a similar smooth surface due to the extra layers of texture.
Referring to Figure 7, there is shown a front one breast implant 110 according to the present invention. It has a shell 112 on the outer surface of which are made a first portion 114 coupling the first texture 116 and a second portion 118 coupling a second texture 122 that is different from the texture 116. In this embodiment, the first texture 116 more "aggressive" than the second texture 122, those. it is made with the expectation to encourage interaction with the tissue to a greater extent than the 122 texture.
It is understood that instead of the second texture 122 on the second clutch portion 118, and possibly to the remaining surface of the shell 112 may have a thin burr such matte finish.
Let us turn to 8A and 8B, which shows, respectively, the front and rear of another breast implant 210 of the present invention. It has a shell 212 - the front side 212a and back side 212b, - which is provided with a first clutch portion 214 with a first texture 216 and a second portion 218 coupling a second texture 222 that is different from the texture 216. In this embodiment, the first texture 216 may cover All or substantially all of the front face 212a of the implant 210. The first texture 216 is characterized by the first distribution law pores, crevices or caverns in which the density is relatively lower than the second texture 222. The second texture 222, which may cover all or substantially all of the back side 221b of the implant 210 is configured so as to encourage interaction with the tissue to a greater degree than the first 216 texture.
Casings 112 and 212 can be manufactured by the claimed method, which includes the following steps:
- Take a pig,
- It is applied to the layer of silicone elastomer,
- Before the layer is fully cured silicone elastomer is applied to the solid particles of the first type on the part of the area of this layer, and on another part of the area - the solid particles of the second type.
After the layer with recessed therein particulate hardened, dissolved solids, such as using a solvent which does not dissolve the silicone elastomer to any appreciable extent.
The resulting shell portion has a first open cell structure with pores formed by solid particles of a first type and a portion of the second honeycomb structure with open pores formed by solid particles of the second type.
In one of the processes for preparing flexible membranes endoprosthesis core corresponding shape is immersed in a solution of silicone elastomer. The industry used a lot of solutions. Basically they contain a silicone elastomer and a solvent. As the elastomer usually take polydimethylsiloxane polidisrenilsiloksan or a mixture thereof in certain proportions. Typical solvents include xylene, and 1,1,1-trichloroethane. Different manufacturers vary the components and the proportions in the solution, and the viscosity and percentage solids. However, the present invention is expected to be adapted for use with a wide range of solutions of silicone rubbers.
The core is removed from the solution and excess solution allowed to drain. Thereafter, the core is dried, so that at least part of the solvent has evaporated or disappeared. Usually this solution coated core blown air stream of controlled humidity and temperature. Different manufacturers of flow rate and direction of air flow, as well as keep him temperature and humidity vary, but in all cases be prosecuted the same goal - to remove the solvent.
Often manufacturers of prostheses, this cycle is repeated immersion in a solution and drying repeatedly superimposing several layers onto the core to achieve the desired coating thickness. The multilayer structure, which has most modern shells of silicone elastomers can be obtained by successively immersing the core in different solutions. Alternatively, the cycle can be repeated, dipping the core in the same solution, resulting in a uniform layer. That is, the process solution is set on the core can be carried out in several stages, each of which is gaining some of the material, and nevertheless, ready shell without distinct layers is entirely uniform in composition and structure.
The following describes an exemplary process for performing clutch surfaces on one- or multilayer coating. After the core is removed from the solution by typing on a material for the last layer, the layer is allowed to stabilize, i.e. is maintained until it is no longer free flowing. This occurs as it evaporates with the solvent, increasing its viscosity.
Again, note that the present invention is, covers and other methods of producing a flexible envelope for subsequent texturing. The advantage of molding by dipping in the fact that the resulting shell is worn directly on the core that can then be used in the texturing process. However, if the flexible shell is made otherwise, for instance by centrifugal casting, it can then be put on the core and continue the process in the same order.
Once the flexible shell has stabilized and, if appropriate, is fitted on the core, with its outer surface is removed antistatic hairdryer loose fibers and particles. Then put a layer of tack. It can be sprayed on, but it is better to immerse the core with a flexible sheath to tack it in solution. The operator immerses the flexible shell into the solution, and then returns to the core holder for stabilization, which usually takes 5-20 minutes. It is desirable to carry out the tack layer of the same material as the core layers.
Thereafter applied granular solids (e.g., salt crystals) on that part of the outer surface which is supposed to perform the engagement surface. They may be applied manually prisypaya their surface and simultaneously turning the core or the machine may be used such as sand or grit supply to the shell on the core even flow of solid particles with appropriate speed. However, the preferred method - dip coated core in a container with solids or suspension of solids. Note that the present invention is not limited to any particular method of application of the particles. To make them stick to the sheath only at the required portions, it is possible, in particular, apply a mask to the rest of the surface and cause the particles only in areas not covered by the mask.
The flexible sheath with the tack layer is then immersed in a fluidized boiling bed salt bath, where the conventional cubic crystals of 10-600 microns or rounding crystals of 50-2000 microns or a mixture thereof. In the process of removing salt can be obtained in different parts of the shell surface to varying degrees expressed texture due to the use of granules of a particular size and shape, such as rounding or angular crystals, large or small, high or low density. The casing is rotated to its uniform coating, then allowed to stabilize. After an appropriate period of time, for example 5-20 minutes, the flexible casing is immersed in the coating solution. It is desirable to perform the coating solution from the same material as the core layers. Then the flexible envelope on the core are laid out to dry in the holder, for example, for about 15 minutes.
Then the shell of silicone elastomer is vulcanized in an oven at elevated temperature. The furnace temperature is desirable to maintain a 200-350 ° F, and the curing time is preferably from 20 minutes to 1 hour 40 minutes. Recovered from the furnace core coated is placed in a solvent and allow the solids to dissolve the particles. The solvent harmless to the integrity or structure of silicone elastomer. After dissolution of the solid core particle with a shell removed from the solvent and the solvent allowed to evaporate. Thereafter, the shell is removed from the mandrel. It is desirable to immerse the casing in the particulate solvent and gently shake to ensure their complete dissolution. The casing is then removed from the solvent and allowed to evaporate.
When dissolved salt particles in their place in the envelope remains open interconnecting cavities.
Further steps to obtain the final thoracic endoprosthesis following the above-described, may coincide with those that apply in the industry. For example, close the hole left by dipping the molding process, uncured sheet, usually of silicone rubber. Then, if the prosthesis is intended for filling with silicone gel, the gel is administered and cured it endoprosthesis packaged and sterilized in the package. If it is intended to fill with physiological saline, collected and mounted on the check valve therein, again cured if required cleaned, packaged and sterilized. Also can be made breast implants combined with the gel capsule is placed inside the shell, intended for filling with saline.
In addition to the above-described forming process for dipping the flexible shell molding endoprosthesis may be used, such as centrifugal, as described in US patent number 6602452. All disclosed in this patent includes the information herein. For surface texture may be applied by dipping a molding molded over an envelope, but may also be roughened inner surface of the mold. For example, using the form that has a generally smooth surface, except for some rough areas as described above, can be prepared for the implant shell surfaces with separate coupling. The advantage of centrifugal casting is that the finished shell can be obtained for a smaller number of process steps.
Although the description of the present invention comprises a number of particulars, it is understood that they are only examples. It is subject to numerous changes apparent to those skilled without affecting its substance, is disclosed in the following claims.
Contents5
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| RU2626267C1 | Cited by | Russian Federation | Search report |
| RU2626274C1 | Cited by | Russian Federation | Search report |
| RU2671587C1 | Cited by | Russian Federation | Search report |
| US2003205846A1 | Cites | United States of America | – |
| SU1516110A2 | Cites | Soviet Union (until 1991) | – |
| UA14927A | Cites | Ukraine | – |
| RU2180803C1 | Cites | Russian Federation | – |
| RU2150898C1 | Cites | Russian Federation | – |
| US2007198085A1 | Cites | United States of America | – |
| EP1532942A1 | Cites | European Patent Office (EPO) | – |
| US2008154366A1 | Cites | United States of America | – |
| US5354338A | Cites | United States of America | – |
| WO2006133366A1 | Cites | World Intellectual Property Organization (WIPO) | – |
| US4840628A | Cites | United States of America | – |
| EP0230672A2 | Cites | European Patent Office (EPO) | – |
| US3600718A | Cites | United States of America | – |
| US6203570B1 | Cites | United States of America | – |
48 members in 12 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 61088418 | United States of America | – | |
| 8841808 | United States of America | P | |
| 2009053689 | United States of America | W |
Members48
| Document | Office | Kind | |
|---|---|---|---|
| AU2009281945A1 | Australia | A1 | |
| CA2734084A1 | Canada | A1 | |
| US2010042212A1 | United States of America | A1 | |
| WO2010019761A1 | World Intellectual Property Organization (WIPO) | A1 | |
| KR20110057155A | Republic of Korea | A | |
| EP2346440A1 | European Patent Office (EPO) | A1 | |
| CN102176883A | China | A | |
| JP2012500052A | Japan | A | |
| RU2011108717A | Russian Federation | A | |
| US8506627B2 | United States of America | B2 | |
| US2013261745A1 | United States of America | A1 | |
| US2013310934A1 | United States of America | A1 | |
| RU2500366C2This record | Russian Federation | C2 | |
| WO2013184569A1 | World Intellectual Property Organization (WIPO) | A1 | |
| JP5485271B2 | Japan | B2 | |
| US2014243973A1 | United States of America | A1 | |
| JP2014158745A | Japan | A | |
| AU2009281945B2 | Australia | B2 | |
| EP2854707A1 | European Patent Office (EPO) | A1 | |
| US9050184B2 | United States of America | B2 | |
| JP5763797B2 | Japan | B2 | |
| US9138311B2 | United States of America | B2 | |
| CN102176883B | China | B | |
| JP2015180307A | Japan | A | |
| US2015289964A1 | United States of America | A1 | |
| BRPI0917987A2 | Brazil | A2 | |
| EP2965718A1 | European Patent Office (EPO) | A1 | |
| US9393106B2 | United States of America | B2 | |
| US2016324627A1 | United States of America | A1 | |
| JP6053874B2 | Japan | B2 | |
| US9848972B2 | United States of America | B2 | |
| CA2734084C | Canada | C | |
| EP2346440B1 | European Patent Office (EPO) | B1 | |
| US9918829B2 | United States of America | B2 | |
| US2018092726A1 | United States of America | A1 | |
| ES2666946T3 | Spain | T3 | |
| US2018200045A1 | United States of America | A1 | |
| EP3400904A1 | European Patent Office (EPO) | A1 | |
| DE202009019201U1 | Germany | U1 | |
| US10675144B2 | United States of America | B2 | |
| US10765501B2 | United States of America | B2 | |
| US2020297479A1 | United States of America | A1 | |
| US2020397554A1 | United States of America | A1 | |
| EP2854707B1 | European Patent Office (EPO) | B1 | |
| ES2875895T3 | Spain | T3 | |
| US2024041586A1 | United States of America | A1 | |
| US2024225810A1 | United States of America | A1 | |
| US2025312144A1 | United States of America | A1 |
Numbers
- Publication
- 2500366
- Application
- 201110871714
Titles2
- Russian
- НАПОЛНЯЕМАЯ ОБОЛОЧКА ДЛЯ МЯГКОГО ЭНДОПРОТЕЗА С РАЗНЫМИ ПОВЕРХНОСТЯМИ СЦЕПЛЕНИЯ
- English
- FILLABLE ENVELOPE FOR SOFT ENDOPROSTHESIS WITH DIFFERENT COHESION SURFACES
Classification
- CPC, 8
- A61F2/12
- A61F2002/30322
- A61F2250/0026
- A61F2250/0051
- B29C41/14
- B29K2995/0072
- A61F2250/0025
- A61F2002/0081
- IPC, 2
- A61F2 12
- A61F2 08