Production method of a medical support device

Abstract

A medical support device. A medical support device (1), for use in a woman's breast as an implant without encapsulated material, wherein the medical support device (1) comprises at least one wall-shaped portion (2) having a first side (3) showing a bulge outward from a plane (4), and a second side (5) of the wall-shaped portion (2) having a corresponding cavity, for example, a dome shape, wherein the medical support device (1) comprises an elastomer. The device will hold endogenous tissue and / or fat and / or added material, such as hyaluronic acid, in place within the deep glandular tissue of a woman's breast by being fixed to tissue, such as muscle. A method of producing and using such a medical support device (1).

Description

1 / 9 “PRODUCTION METHOD FOR A MEDICAL SUPPORT DEVICE”

[0001] The present invention relates to a medical support device for use on a part of the human body, a method for producing and using it. Fundamentals

[0002] Previously, implants filled with a filler, such as silicone gel or saline solution, were known. There is always a risk of leakage of the filler or encapsulation of the implant.

[0003] The use of a matrix to support an implant within a part of the human body is also known; the matrix may or may not be absorbable by the human body. Summary of the Invention

[0004] The objective of the present invention is to be able to support and / or augment a part of the human body without the previously known drawbacks.

[0005] According to a first aspect of the invention, a medical support device for use on a part of the human body is provided. The device comprises at least one wall-shaped portion having a first side, which shows a bulge outward from a plane, and a second side of the wall-shaped portion having a corresponding cavity, for example, as a dome shape, in which the medical support device comprises an elastomer. The wall-shaped portion is curved around more than one axis or has a draped shape. The medical support device is open from the plane to the cavity, i.e., never closed, like, for example, a common breast implant filled with gel. Petition 870260083594, dated 08 / 18 / 2026, page 7 / 33 2 / 9 liquid silicone or saline solution.

[0006] With the medical support device according to the invention, it will be possible to maintain endogenous tissue and / or fat and / or added material, such as hyaluronic acid, in place in the part of the human body. An advantage of this solution is that it will be permeable to radiography when filled with endogenous tissue and / or fat, which is important for safe mammography.

[0007] According to one embodiment, the thickness of the wall, that is, between the first side and the second side, is more or less the same over the wall-shaped portion. Preferably, the medical support is pre-formed.

[0008] According to one embodiment, a rim in the plane is at least partially present along one edge of the cavity. The rim will facilitate the application of sutures to the medical support device by securing it to the tissue of the body part. The fixation of the medical support device, in turn, will lead to fewer problems with malpositioning, such as rotation and lateral and bottom movement of the implant. This will also ensure that the material in the cavity of the medical support device remains in place.

[0009] According to one embodiment, the device is produced from an elastomer and provided with a matrix at least in the rim.

[0010] According to one embodiment, the device is produced from an elastomer and provided with a matrix at least partially on the second side, cavity side, of the wall-shaped portion. Petition 870260083594, dated 08 / 18 / 2026, page 8 / 33 3 / 9

[0011] According to one embodiment, the device is used on a breast, preferably a woman's breast.

[0012] According to a second aspect of the invention, a method of producing a medical support device is provided, in which a mandrel having a desired shape is dipped into an unhardened elastomer to give shape to the device. Preferably, at least one piece of die is disposed in the mandrel before or in the device after immersion.

[0013] According to a third aspect of the invention, a method of using such a medical support device is provided. An implant without encapsulated material is formed, where the medical support device holds endogenous tissue and / or fat and / or added material, such as hyaluronic acid, in place in the part of the human body. Brief Description of the Drawings

[0014] The present invention will now be described in more detail with reference to the accompanying drawings, in which:

[0015] Figures 1a, b and c show an embodiment of the invention in a cross-sectional view, a plan view and a side view, respectively.

[0016] Figures 2a, b, c and c show different embodiments having a ring in a cross-sectional view and two plan views, respectively.

[0017] Figures 3a-g show different embodiments of the invention in cross-sectional views.

[0018] Figures 4a and b show modalities Petition 870260083594, dated 08 / 18 / 2026, page 9 / 33 4 / 9 of different shapes on the side.

[0019] Figures 5a and 5b show models with different shapes in a plan view.

[0020] Figures 6a, b and c show different embodiments of mandrels for the production of embodiments of the invention.

[0021] Figure 7 shows an example of a use of the invention.

[0022] Figure 8 shows an example of a use of the invention. Detailed Description of the Embodiments of the Invention

[0023] In Figures 1a, b, and c, an embodiment of a medical support device 1 of the present invention is shown. The medical support device 1 comprises at least one wall-shaped portion 2. It has a first side 3, which shows a bulge outward from a plane 4, and a second side 5 which has a corresponding cavity. For example, the wall-shaped portion 2 may have a dome shape, although it is possible to have any particular shape according to the purpose of the support on the human body.

[0024] The wall-shaped portion 2 is curved about at least two different axes of thought or draped, i.e., it does not have the shape of a partial cylinder. Preferably, it has a thickness between the first side 3 and the second side 5 that is more or less the same over the protrusion / cavity. In Figure 1b, the medical support device 1 is shown in a plan view of the first side 2. In the embodiment shown, the device has a more or less circular footprint, although any shape is Petition 870260083594, dated 08 / 18 / 2026, p. 10 / 33 5 / 9 possible. In Figure 1c, the modality of Figures 1a and 1b is shown on the side.

[0025] Medical support device 1 is for supporting endogenous tissue and / or fat in place in a part of the human body. Any suitable body part can receive medical support device 1, such as the buttocks or breasts, although it is probably most commonly used in women's breasts. Medical support device 1 will support endogenous tissue or fat or both against gravitational pull. It is also conceivable to add other materials suitable for being in a human body, such as hyaluronic acid. Or simply use other material or materials in the cavity part of medical support device 1.

[0026] The medical support device 1 comprises an elastomer or matrix, or both. The elastomeric material may be of any type suitable for use with a human body and be flexible. The elastomer may be, for example, a silicone rubber, preferably of the type used in breast implants. The matrix may be constructed of biological or synthetic materials or a combination thereof. It may comprise absorbable and / or non-absorbable material. For example, it may be an acellular dermal matrix.

[0027] In Figure 2a, an embodiment of a medical support device 1 is shown in cross-section, wherein at least a portion of a hoop 6 is provided on an edge 7 of the cavity or protrusion in plane 4. At least a portion of the edge 6 can be more easily fixed to tissue in a human body than the Petition 870260083594, dated 08 / 18 / 2026, page 11 / 33 6 / 9 fixation of the edge only 7. Preferably, any suture can be used for this, absorbable or not.

[0028] In Figure 2b one embodiment is shown in a plan view where several portions of the hoop 6 are provided and in Figure 2c a complete hoop 6 encircling the edge 7 is shown. In Figure 2d another embodiment is shown where the wall-shaped portion 2 is cut 8 in its upper portion and having a hoop 6 around the edge 7 left in plane 4 so that a pouch is formed when attached to tissue in the human body. All embodiments shown in Figure 2 may comprise an elastomer and / or matrix.

[0029] Different embodiments of how a combination of an elastomer and matrix will now be exemplified in Figures 3a-g. In Figure 3a a dome-shaped medical support device 1 is shown made of elastomer and having a portion of the matrix 9 provided on the second side 5 in the lower region. Obviously, the matrix 9 can be provided on the whole second side 5 or, as shown in Figure 3b, on the whole first side 3, or on a portion of the first side 3, or on a portion of the first side 3. In Figure 3c a medical support device 1 having a hoop 6 is shown where the matrix 9 is provided on the hoop 6 on the same side as the second side 5 of the wall-shaped portion 2. It is also conceivable to have the matrix 9 on the other side, as shown in Figure 3f, or on both sides. In Figure 3d, matrix 9 is provided both in the cavity, on the second side 5, and in the rim 6. In Figures 3e and 3g, matrix 9 is provided in a lower portion of the cavity and protrusion. Petition 870260083594, dated 08 / 18 / 2026, p. 12 / 33 7 / 9 respectively, as well as along rim 6.

[0030] Obviously, the shape of the medical support device 1 may differ according to its use and purpose. Figure 4a shows a more or less dome-shaped form, preferably a partial sphere, and Figure 4b shows an anatomical form. The projection may also differ, as may the height of a projection point 12. The footprint of the medical support device 1 may also differ according to its use and purpose. Figures 5a and 5b show two different examples, circular having the same height as width; or having different height in relation to width, respectively. The height may be greater than the width or vice versa. For example, the footprint may be oval or, as shown in Figure 5b, teardrop-shaped.

[0031] Now, examples of how a medical support device 1 can be produced will be described. In Figures 6a, b and c three different mandrels are shown. The mandrel is immersed in an elastomer in a flow condition. Then, it is absorbed and the elastomer hardens into a flexible condition. This can be accomplished by means of heat or the addition of substances, for example. The immersion is usually repeated a desired number of times. The elastomer is removed from the mandrel and, if necessary, cut into the desired shape. It is possible to turn it inside out, that is, the surface of the elastomer closest to the mandrel will instead become the protruding side, the first side 3.

[0032] If a special surface is desired, such as a textured surface, it is Petition 870260083594, dated 08 / 18 / 2026, page 13 / 33 8 / 9 It is possible to make it available on the first side 3 or on the second side 5, respectively, or on both sides. Different roughnesses from fine to coarse can be provided by having a surface structure on the mandrel. It is also possible to print a texture on the outermost layer before hardening. For example, it is possible to use polyurethane or a salt to print.

[0033] If a ring 6 is desired, a mandrel according to Figures 6b and 6c may be used. If a combination of elastomer and matrix is ​​desired, parts of the matrix may be arranged in the mandrel in the desired positions, or over the entire surface of the mandrel, before dipping. Alternatively, the matrix is ​​arranged after dipping before hardening.

[0034] The medical support device 1 can be supplied in various sizes, allowing you to find a size that suits the special needs of each patient.

[0035] Figure 7 shows an application of the medical support device 1. The medical support device 1 is positioned within a part of the human body 10, in this case a female breast. In this case, the deep glandular tissue and / or fat is separated and a portion of it is provided within the cavity, i.e., on the second side 5 of the medical support device 1. The medical support device is fixed with sutures 11. The sutures are preferably of the absorbable type. The medical support device can, for example, be fixed to a muscle, the pectoral muscle in the case shown. It is also conceivable to provide fat or other tissue, preferably endogenous, within the cavity of the device. Petition 870260083594, dated 08 / 18 / 2026, page 14 / 33 9 / 9 medical support, in addition to glandular tissue or just fat or just other tissue. It is also conceivable to add hyaluronic acid or other medical injectable material into the cavity, alone or mixed with endogenous tissue of any or several types.

[0036] Figure 8 shows the possibility of adding, for example, hyaluronic acid or fat, by means of a syringe, into a cavity of a medical support device already installed in a part of the human body 10. This puncture will not cause any damage, as no harmful material can leak out as would occur with a common breast implant filled with silicone gel. Petition 870260083594, dated 08 / 18 / 2026, page 15 / 33

Claims

1 / 1 CLAIMS 1. Method of producing a medical support device (1), characterized in that a mandrel having a desired shape is dipped into an elastomer one or more times and hardened in order to give shape to a medical support device (1), wherein a die piece (9) is disposed in the mandrel or in the device (1) after immersion. Petition 870260083594, dated 08 / 18 / 2026, page 16 / 33

Images