JP5646704B2 - Medical implant assembly having an interface - Google Patents

Description

  The present invention relates to medical implants, and more specifically, the present invention relates to an implantable prosthesis that resists coating contracture. The preferred form of the medical implant is a breast prosthesis well known in the art. Other applications include adjustable breast implants and breast tissue dilators. Using the preferred method for assembling the present invention, the surgeon can efficiently and accurately assemble the implantable prosthesis just prior to inserting the implantable prosthesis into the human body.

  The use of an implantable breast prosthesis to enhance the aesthetic form that a breast should have to meet the needs of breast enlargement, reconstruction or correction is an acceptable and well-known practice . These devices generally have a non-reactive supple (ie flexible) outer surface or shell (shell) containing a gel or liquid filling.

  Unfortunately, when an implant is inserted into a host, the implant is recognized as foreign by the host's immune system, and the implant is surrounded, isolated, or encapsulated by other parts of the host's human body. . Encapsulation can have many undesirable effects.

  Surgical correction is often required to address such encapsulation, but despite the high patient satisfaction and quality of life indicated in the reports, a high rate of surgical correction or reoperation Some things are unacceptable. In fact, the content of the recently published US Food and Drug Administration (FDA) PMA (pre-and post-market approval) study on silicone gel breast implants is the severity of social demands. It is to convey. According to it, the proportion of patients with primary breast enlargement who had to undergo reoperation within 4 years after the first operation is indeed over 23 percent. And about 40 percent of these reoperations are done to correct capsule contractures. Furthermore, 35 percent of these orthodontic patients are forced to perform a new operation, and the main cause of the second operation is also capsule contracture.

  For patients who have undergone primary breast reconstruction (following mammectomy with breast cancer treatment) using silicone gel type breast implants, the need for public support is even greater. 23.5 percent of these women needed to undergo a reoperation, mainly due to capsule contractures or implant position defects (also usually due to capsule contractures). Also, 33 percent of these corrective patients need another correction. The same is true for the rate of reoperation in women using implants with saline as the contents, again with capsule contractures.

  Spherical capsule contractures (often accompanied by implant displacement, deformation, pain and discomfort) may occur due to the inability to suppress the process of stubborn scarring or encapsulation. The capsule contracture that occurs in a spherical shape is the largest cause of the excessive height of the reoperation rate described above. Other causes of re-surgery include implant displacement and the ability of the implant to be touched through the skin (i.e., touching the skin reveals that the implant is inside) Is mentioned.

  Encapsulating contractures that occur in a spherical shape (i.e., deform the breast into a round shape) have been a particularly painful problem for scientists, surgeons and patients for nearly 50 years already. Silicone elastomers (often constituting the outer surface of the implant) may be regarded as inert substances, however the host, however, regards the implant as a foreign body and forms a fibrous sheath that surrounds the implant's peripheral surface, Responds to implant implantation in the form of isolating the implant from the host tissue. This spontaneous process is harmless, that is, unless the degree of linear scar formation is excessive and deforms in contact with the periphery of the silicone device where the capsule is cured or implanted As long as it does not cause implant displacement, implant palpability, and patient pain and discomfort, this naturally occurring process is harmless. These characteristic adverse effects are the largest cause of excessive reoperation rates as documented by the FDA. And because the reaction between the device and host tissue cannot be controlled, breast implant patients must endure these adverse effects.

  Tissue manipulation during surgery has been proposed as a possible treatment method for the problem of capsule contracture, but in addition to this, a large surgical pocket is provided. Placing an implant therein, surgical methods that do not harm tissue (“atramatic”), use of a sub-muscular surgical pocket for implant placement, and steroids and / or Or pocket cleaning with a liquid containing antibiotics. Post-surgical exercise or implant displacement manipulation, such as moving the arm or manipulating the body position, is also recommended (Maxwell, GP; Hartley, RW; “Breath Augmentation”, Masters: Plastic Surgical, Second Edition. (Ed. ) See Saunders Philadelphia, VoI 6.pi, 2006).

  Various improvements and modifications to the breast implant design have been made to reduce the capsular contracture, visibility and tactility that occur in the sphere. For example, U.S. Pat. No. 4,889,744 proposes to minimize the coating contracture around the implant by making it a texture type with a rough texture on the outer surface of the implant. U.S. Pat. No. 4,648,880 also uses a woven netting as a polymeric outer cover over the implant to reduce scar formation. Furthermore, US Pat. No. 6,913,626 states that coating contracture is reduced by covering the elastic skin of the implant with a bioabsorbable cover.

  For unrelated use in the human body, biologically derived materials have been developed based on allografts and xenografts (such as pigs or cattle) ( Treated in a predetermined manner (adjusted by biotechnology) and used as a skin graft tissue matrix. It is believed that these biologically derived materials can be utilized as non-absorbable collagen scaffolds (generally the composition is acellular dermis). This is to facilitate the organization of the healing process, thereby facilitating regenerative repair rather than scar formation. These materials are used to temporarily correct large wounds, hernias and other defects caused by trauma or surgical removal of cancer. For biological materials, specifically, acellular dermal graft or acellular dermal matrix (ADM) comprising allografts or xenografts, Life Cell Corporation “Alloderm” and “Stratice” manufactured by TEI Biosciences, “Cosmatrix / Surgimend” manufactured by TEI Biosciences, “Neoform” manufactured by Tutogen Medical, and “Dermatrix” manufactured by MTF are not limited thereto. However, in any of these applications, it is not envisaged that the material will be the interface component of a medical implant.

  The main functional use of these acellular dermal materials in the prior art is the tissue extension in the abdominal musculature and / or facial defects in the repair of abdominal wall hernias, tissue replacement, tissue replacement. ) Or tissue supplement. In these situations, the abdominal musculature is stretched, weakened, or inadequate for repair, thus requiring complementary tissue replacement.

  Another use of these materials is as tissue expansion, complementation or replacement following removal of cancer from the breast. The pectoral muscle is partially excised, stretched, or insufficient to provide tissue coverage in a basic reconstruction. In this way, skin grafts have been used to mimic the overall muscle area using tissue-like material on the lower lateral aspect in basic reconstruction. (Gamboa-Bobadilla, G.M .; Implant Breast Reconstruction using Acellular Dermal Matrix, Annals of Plastic Surgery, 56; p.22, 2006, and, Salzberg, CA .; Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft, Annals of Plastic Surgery, 57, p.l, 2006). In these various applications, acellular skin grafts are “sponsored to function as a natural tissue” (Spear, S .; Use of Regenerative Human Aqueous Tissue to Recycled Pedestrian Wall Folding Tissues. Surgery 118, p.8, 2006, and Spear, SL, Pelletiere, C.V., and Lockwood, M. Immediate Breast Construction with Tissue Expanders and Expanders. stic Reconstructive Surgery of the Breast, p.489, referring to 2006, etc.).

US Pat. No. 4,889,744 U.S. Pat. No. 4,648,880 US Pat. No. 6,913,626

Maxwell, GP; Hartley, RW; “Break Augmentation”, Mothers: Plastic Surgical, Second Edition. (Ed) Saunders Philadelphia, VoI6. pi, 2006 Gamboa-Bobadilla, G. M.M. Impr. Breast Reconstruction using Cellular Dermal Matrix, Anals of Plasticity, 56; p. 22, 2006 Salzberg, CA. Nonexpandive immediate breast restructuring using human cellular tissue matrix, Anals of Plasticity, 57, p. l, 2006 Spear, S.M. Use of Regenerative Human Human Tissue to Restructive the Abdomen Wall Flowing Pedal TRAM Flap Blast Reconstruction; 8, 2006 Spear, S.M. L. Pelletiere, C .; V. , And Lockwood, M.M. Immediate Breast Construction with Tissue Expanders and Alloderm, Plastic Reconstructive Surgical of the Breast, p. 489, 2006 Duncan, D.M. I. Correction of Implant rippling using allograf dermis. Aesthetic Surgery Journal 21, p. 81, 2001

  Prior art acellular skin grafts have been used for soft tissue deficient patients with pectoralis denervation (Duncan, DI Collection of Implanting packaging allergy dermatology. Aesthetic Energy Journal 21). p. 81, 2001). In these applications, the natural tissue was inadequate due to “very thin skin flaps” (see ibid.). In this conventional application, the graft was also fixed “in the recipient site where the blood vessel was born” in the host tissue, because this contributes to the expansion of the pectoral muscles (ibid. reference). The purpose was to “increase soft tissue” in order to mask out the waves visible from the outside of the device existing underneath. And this rippling is visible or present only when no capsular contracture occurs around the breast implant (see ibid.). Another way to describe this prior art is that skin grafts are used as natural tissue replacements, expansions or complements, regardless of what they cover.

  Although the prior art offers a variety of solutions to reduce the spherical capsule contracture that occurs in implantable prostheses, none have been optimized. Thus, what is needed is an implant with an integral interface component composed of acellular skin graft material (the effect of an implant having an interface is the roughness of the implant surface). And it is independent of the dissolution of the cover part) and thereby reducing the contracture of the capsule, the displacement of the implant and / or the palpability of the implant.

  The present invention relates to an implantable prosthesis, and more particularly to an implantable prosthesis that prevents and reduces film contracture. The present invention includes a medical implant and a biological interface. This medical implant has a rough or smooth outer skin surface and is liquid such as saline, gel, non-form stable silicone gel or reinforced cohesive It has a filler consisting of a form-stable silicone gel or some more solid material. Further, the medical implant may be a fixed volume, a variable volume, or a temporary tissue dilator.

  The biological interface is attached to the external surface of the medical implant. The biological interface may be pre-attached to the medical implant (in fact, the biological interface can be considered a coating on the medical implant), or a space provided to accommodate the medical implant or It may be sandwiched in the pocket or attached to the medical implant at the time of insertion of the medical implant into the host.

  The biological interface is composed of a dermis material having an action of inhibiting the contracture of the capsule. The dermis material is composed of acellular skin grafts or substrates, which are composed of allografts or xenografts (such as pigs or cattle). In addition, the dermal material may be prepared in the form of a sheet, pouch, band, gel, liquid or powder.

  Importantly, the biological interface and the medical implant are in intimate contact with each other and are positioned such that the biological material is disposed between the medical implant and the host tissue. Biological material can be medical implants by a variety of methods including, but not limited to, suturing, gluing or engaging with recipient flaps or other appendages placed on the outer surface of the medical implant. Can be attached to. Furthermore, the biological material may encompass the entire medical implant, or may surround only a portion thereof.

  Because the biological material is placed between the medical implant and the host tissue (the ability of the biological material to promote regenerative repair rather than scar formation), the host does not treat the biological material and hence the medical implant as foreign Therefore, film contracture can be prevented or reduced. As such, the present invention leads to a reduction and / or elimination of coating contractures associated with implantable prostheses.

It is the front view which showed the medical implant of this invention in the state in which the biological interface covered a part of outer surface of this medical implant. It is sectional drawing which showed the medical implant of this invention in the state in which the biological interface covered the whole outer surface of the medical implant. 1 is a cross-sectional view of a medical implant of the present invention with a biological interface covering a portion of the front and bottom of the medical implant. It is sectional drawing of the medical implant of this invention shown in the state which the biological interface covered the front part surface and the whole lower surface of the medical implant. Of the medical implant of the present invention, wherein the biological interface is fixed to the medical implant except for its distal and / or peripheral portion, and can be attached to maintain the position of the biological interface itself of the present invention. It is sectional drawing. 1 is a cross-sectional view of a medical implant of the present invention shown with a biological interface covering relatively small anterior and posterior surfaces of the medical implant. FIG. 3 is a cross-sectional view of a medical implant of the present invention with various biological interface thicknesses. It is the figure which showed the biological interface in which the biological interface is couple | bonded in the pouch as a means which covers a medical implant. FIG. 9 is a cross-sectional view of a medical implant positioned within the biological interface pouch of FIG. 8 that constitutes the present invention. 1 is a front view of a medical implant of the present invention showing a biological interface partially perforated or modified to improve functionality economically or hygienically. FIG. It is the front view which showed the biological interface made into the shape of a mesh form, and applied to the medical implant. FIG. 3 is an explanatory diagram showing the interaction between a tissue pocket, a medical implant and a biological interface. FIG. 3 is an explanatory diagram showing the interaction between a tissue pocket, a medical implant and a biological interface. FIG. 3 is an explanatory diagram showing the interaction between a tissue pocket, a medical implant and a biological interface. FIG. 3 is an explanatory diagram showing the interaction between a tissue pocket, a medical implant and a biological interface. FIG. 3 is a front view and a side view of the medical implant of the present invention showing a thickened skin portion and a rounded injection site disposed on the outer surface. FIG. 3 is a front view and a side view of the medical implant of the present invention showing a thickened skin portion and a rounded injection site disposed on the outer surface. FIG. 3 is a rear view of a specific embodiment of the medical implant of the present invention with a plurality of mounting flaps attached to the outer surface of the medical implant. FIG. 15 is a rear view of the medical implant of FIG. 14 showing the biological interface attached across each attachment flap. FIG. 16 is a front view of the medical implant of FIG. 15 with the biological interface covering the entire surface. It is an attachment flap sectional view of Drawing 14. It is the figure which showed the attachment flap of FIG. 17 in the open position. It is the figure which showed the attachment flap of FIG. 17 in the state in which a part of biological interface was spanned over the flap. It is a front view of the medical implant which concerns on other embodiment of this invention with which the some attachment flap was provided in the outer surface. FIG. 21 is a front view of the medical implant of FIG. 20 showing a biological interface covering a portion of the medical implant. FIG. 6 shows a plurality of potential configurations for the mounting flap of the present invention. FIG. 6 shows a plurality of potential configurations for the mounting flap of the present invention. FIG. 6 illustrates multiple embodiments of a biological interface having various perforation openings or attachment openings. FIG. 7 is a front view of another embodiment of the medical implant of the present invention where the biological interface is attached to the thickened skin portion of the medical implant by stitching. FIG. 26 is a rear view of the medical implant of FIG. 25 with the biological interface covering a portion of the medical implant and attached to the medical implant by stitching.

  The present invention relates to a medical implant assembly 10 and, more particularly, to a medical implant assembly 10 for preventing / reducing capsule contracture. Although the medical implant assembly 10 may be any implantable prosthesis, a preferred embodiment of the present invention is a medical implant primarily used for breast enlargement, correction, and reconstruction. It is about.

  As shown in FIGS. 1 to 26, the medical implant assembly 10 includes a medical implant (or prosthesis) 12 and a biological interface 18. The medical implant 12 is relatively non-compliant or has a well-defined shape, but in a preferred embodiment, it is flexible. The medical implant 12 has an outer shell 16 or shell 16 made of silicone elastomer. By using the flexible skin 16, the medical implant 12 can be easily deformed without impairing the integrity of the medical implant 12. Such characteristics facilitate the positioning of the medical implant 12 within the host (or implant recipient). The outer skin 16 may be rough (textured type) and smooth (smooth type).

  To complement the flexible skin 16, the core portion of the medical implant 12 is filled with a liquid such as a gel (preferably a cohesive silicone gel) or physiological saline. Referring generally to FIGS. 13-26, in one embodiment, an adjustable medical implant 12 is used, and after insertion of the medical implant 12 into a human body, The liquid can be injected into. An injection dome 42 for injecting liquid is attached to the outer surface 16 of the medical implant 12. As shown in FIGS. 13 a and 13 b, the injection dome 42 can be provided at a desired location as long as the outer surface 16 of the medical implant 12 is within the range of the skinned portion 44.

  The medical implant assembly 10 also includes a biological interface 18 or a non-bioabsorbable dermic interface 18. The biological interface 18 is attached to the outer skin 16 of the medical implant 12. In one embodiment, the biological interface 18 is a biologically harvested dermal material 20 or a biotechnologically prepared material 20 and is cellular. Or an acellular, allograft or xenograft (from cattle or pig). However, regardless of the exact composition of the dermis material 20, the critical property that the dermis material 20 should have has the effect of inhibiting capsule contracture properties. It is in that it is. Further, in one embodiment, the biological interface 18 is not bioabsorbable.

  The biological interface 18 in one embodiment is attached to the medical implant 12 when the medical implant assembly 10 or medical implant 12 is inserted into the host (which will be described in detail later). In other embodiments, the biological interface 18 may be pre-attached to the medical implant 12 or attached to a host tissue that interfaces (ie, contacts) the medical implant 12. Alternatively, it may be sandwiched in the space between the medical implant 12 and the surrounding host tissue pocket.

  Biological interface 18 is attached to medical implant 12 by suturing, surgical adhesive, staples, or any other method known to those skilled in the art. Furthermore, as envisaged by the present invention, the biological interface 18 may function as the outer skin 16 of the medical implant 12 after the outer skin 16 and the biological interface 18 are formed by a single process. .

  As shown in FIG. 8, the biological interface 18 may be provided in a pocket (or receptacle) that houses the medical implant 12. The pocket may cover a portion of the medical implant 12 or may cover the entirety thereof.

  The interaction / engagement between the medical implant 12 and the biological interface 18 can be described as an alternative as follows. That is, the outer skin 16 has a contour 22, and the biological interface 18 is applied to the medical implant 12 such that the biological interface 18 or more specifically the dermal material 20 corresponds to the contour 22 of the outer skin 16. Closely engaged.

  The dermal material 20 is chopped, diced, meshed, chopped (see FIGS. 10 and 11), applied as a strip or segment, and / or having a different thickness. (See FIG. 7). Multiple objectives are achieved by allowing the dermal material 20 to have various configurations / forms. For example, if cost is a major concern, the dermal material 20 may be meshed to cover only a portion of the medical implant 12. However, if the focus is on performance optimization, the dermal material 20 may be an integral sheet that envelops the entire medical implant 12, as shown in FIG.

  Regardless of which embodiment is chosen, the purpose of the biological interface 18 is to make the healing of the host tissue around and near the foreign device (eg, the medical implant 12) more natural or immunologically more harmful. Facilitates in a lesser manner, i.e., without excessive scar tissue (capsular contracture) deformation, device displacement (displacement), or device visibility and palpability when assessed externally There is. Thus, the medical implant assembly 10 provides a regenerative and compatible host tissue response rather than a “foreign body” and a scar response thereto.

  Although the medical implant assembly 10 has been described in detail, it is appropriate to have a more in-depth analysis of the biological interface 18 and more specifically the dermal material 20 and its use in the prior art.

  Biological materials such as dermis or dermis material 20 which includes subcutaneous tissue deeper than the epidermis can be used without other immunological rejection (reaction) (so-called graft versus host reaction). It has been shown that it can be modified in a variety of ways to be immunologically acceptable when utilized in a living host. Therefore, it is said that it is prepared by biotechnology (biotechnologically prepared). The source of the material is an animal or, more specifically, a mammal, and is often subject to technical changes to make it acellular, which can cause a foreign body reaction when reimplanted into another host. Rather, to serve as a substrate or basis for a tissue regeneration process that creates a flexible healing environment rather than an undesired reactive cure. Therefore, the material must be capable of revascularization and must not cause infection. Various processes are known in the art, such as making the material cell-free for the former, terminal sterilization or irradiation sterilization for the latter.

  The cell-free material is comprised of dermal material 20 in a preferred embodiment, but is generally rich in collagen and further comprises proteins, proteinaceous substances, enzymes, antigens, amino acids, peptides, sugars, and carbohydrates. It may be configured. Among the current state of the art are: Cosmatrix / surgimend from bovine fetal dermis (manufactured by TEI); Alloderm from human dermis and Stratice from porcine dermis (both from LifeCell); human Neoform (manufactured by Tutogen) derived from human dermis; and Dermatrix (manufactured by MTF) derived from human dermis.

  For purposes of illustration, consider the following example of applying the present invention in the field of breast augmentation. First, a surgical pocket is provided under the skin, breast parenchyma or pectoral muscle to accommodate the medical implant assembly 10. In some embodiments, the biological interface 18 is pre-attached to a silicone elastomeric skin 16 (or external surface 16). However, in other embodiments, the medical implant assembly 10 procures each component (biological interface 18 and medical implant 12) separately and places them in contact with each other, thereby “hybrid”. ) "Or" fused "as a medical implant having an interface can be" created "in the surgical pocket during the surgical process. In this way, just prior to insertion into the human body, the medical implant assembly 10 can be created efficiently and accurately in a sterile condition in the operating room.

  In the embodiment of the invention outlined in FIGS. 14-23, a plurality of fixtures 40 are disposed on the outer surface 16 of the medical implant 12 to facilitate attachment of the biological interface 18. ing. The fixture 40 is comprised of a recipient attachment flap, tab, loop, or various equivalent alternative conventional products, attached to the outer surface 16 of the medical implant 12 or integral with the medical implant 12. Is provided. The fixture 40 of the present invention is different from the suture tabs known in the art, since these known suture tabs are typically flexible, soft, or compositionally non-rigid. It is because it is said. Alternatively, the fixture 40 of the present invention generally allows a more rigid composition, generally a stable positioning of the material on the outer surface 16 of the medical implant 12. Will be comprised of a harder composition. Various embodiments of shapes or configurations are possible for the fixture 40 of the present invention, examples of which are shown in FIGS.

  The fixture 40 is disposed on the rear surface or front surface of the medical implant 12 or generally on the periphery of the medical implant 12. It is envisioned that the fixture 40 may be created within the inflexible skin 16 of the medical implant 12. The outer skin 16 of the medical implant 12 may be provided with a particularly thick region 44 at the portion where the fixture 40 is provided.

  As shown in FIG. 14, the attachment 40 has an attachment flap 40 that is disposed on the rear surface of the medical implant 12 and opens toward the periphery of the medical implant 12. While the mounting flaps 40 are provided separately and are spaced equidistantly from each other, in alternative embodiments, the flaps 40 are designed according to a desired random or continuous pattern. It is envisaged that The biological interface 18 may be provided with slots 46 or openings 46 in its body or along its periphery, thereby allowing it to wrap around, around or in a plurality of mounting flaps 40 ( Draping can facilitate attachment of the dermal material 20 having an interface to the medical implant 12 (see FIG. 15). FIG. 16 shows a front view of the medical implant 12 with the biological interface 18 attached in this manner.

  In certain embodiments of the invention, the medical implant 12 will be injected at least partially with a liquid, such as saline, after insertion into the human body. It is envisioned that the attachment of the biological interface 18 to the fixture 40 disposed on the medical implant 12 may not remain rigid as a result of the medical implant 12 expanding. However, this is not a problem because the purpose of the method of the present invention with respect to the fixture 40 is specifically to provide primarily a safe assembly prior to insertion. The biological interface 18 will remain securely positioned around the medical implant 12 when expanded, despite being attached to the fixture 40.

  FIG. 17 shows a cross-sectional view in which one of the fixtures (ie, attachment flaps) 40 is in its standard closed position. FIG. 18 shows the mounting flap 40 in the open position to accommodate the biological interface 18. FIG. 19 shows a portion 18 of the biological interface being attached to the medical implant 12 by wrapping the opening 46 in the attachment flap 40 where the biological interface 18 is attached. The mounting flap 40 has now returned to the closed position again in order to position it securely in its place. In this way, component displacement and premature displacement within the entire medical implant assembly 10 are substantially eliminated.

  FIG. 20 shows an alternative arrangement of the attachment flap 40. FIG. The attachment flap is here arranged on the skin portion 44 with a thickened front surface rather than the rear surface of the medical implant 12. In this embodiment, the biological interface 18 is applied only to a part of the front surface of the medical implant 12 as shown in FIG. This keeps the injection dome 42 available and allows the injection dome 42 to be used to inject liquid into the adjustable medical implant 12 without having to remove the biological interface 18 prior to surgery. is there.

  Referring to FIG. 25, the thickened skin portion 44 of the front surface of the medical implant 12 facilitates the suture fitting 48 of the biological interface 18 and further generally provides for attachment or engagement of the medical implant 12. To stabilize. The suture fitting 48 may also be considered as another alternative method of stabilizing the attachment of the biological interface 18 to the medical implant 12, where the fitting 40 is not used. Referring to FIG. 26, a suture attachment 48 is further formed along the reinforced portion 44 of the posterior surface of the medical implant 12.

  Another way to achieve this intraoperative assembly is to attach biological interface 18 or dermal material 20 to medical implant 12 using a tissue adhesive. The dermal material 20 may be diced, shredded, or pulverized and then adhered to the medical implant 12 as a strip or layer or coating film.

  Another alternative assembly option could be to sandwich the biological interface 18 in a continuous space provided for and bonded to the medical implant 12. It should be noted that this operation forms the components of the medical implant 12 and not the tissue cover that covers the space around the prosthesis, where the medical implant is its enhanced tissue. It may be separated from the cover by a fluid. This described operation will maintain its continuity as a device while creating an in vivo medical implant assembly 10.

  Alternatively, as described with reference to FIGS. 12 a and 12 b, the medical implant 12 can be positioned within a surgically created tissue pocket 24, the tissue pocket 24 being A pocket surface 26 defining a pocket shape 28 is provided. Similar to the tissue pocket 24, the medical implant 12 has an implant surface 30 that defines an implant shape 32. After the medical implant 12 is positioned within the tissue pocket 24, the biological interface 18 (having an inner interface surface 34 and an outer interface surface 36 defining an interface shape 38) is formed between the pocket surface 26 and the implant surface. It is inserted into the tissue pocket 24 between 30.

  Further, the pocket shape 28, the interface shape 38, and the implant shape 32 optimize the contracture inhibiting action of the biological interface 18 after the biological interface 18 and the medical implant 12 are both placed in the tissue pocket 24. As appropriate, it is selected. More specifically, selection is made in such a way that the biological interface 18 is engaged with the medical implant 12 such that the dermal material 20 and thus the biological interface 18 and the medical implant 12 are reasonably engaged. Is done. This engagement ensures a tight bond between the medical implant 12 and the biological interface 18. Although a biological interface 18 is shown in FIGS. 12 a and 12 b that covers a portion of the medical implant 12, it is also envisioned that the biological interface 18 completely encases the medical implant 12. Further, the scope of the present invention includes inserting the biological interface 18 into the tissue pocket 24 prior to the medical implant 12.

  This embodiment is facilitated by temporary percutaneous withdrawal and suturing that is useful in re-stucking the pinched material in order to be sufficiently fixed close to the (dense) space. be able to. This may create an outer cover having a medical implant interface contiguous with the soft tissue pocket.

  In all of these potential applications, the desired effect of the medical implant assembly 10 is achieved, i.e., facilitating accommodation of the medical implant 12 within the host via a tissue reconstruction process, and An event that occurs frequently in the current state of the art, ie minimizing excessive foreign body hardening response to the presence of the medical implant 12, is achieved.

  Is the biological interface 18 attached to the medical implant 12 before the medical implant assembly 10 is inserted into the host, or is the medical implant 12 and the biological interface 18 pressed into the tissue pocket 24? In any case, there are no special requirements for suturing the biological interface 18 to the host tissue, such as muscle extension or a cover on the medical implant 12. Specifically, in the case of breast implants, the present invention eliminates the need to sew the dermal material 20 (or more generally biological interface 18) to the impaired muscle cover, and a fascial flap. And reducing the need for latissimus flaps is expected to simplify surgery, surgery time and patient morbidity (not to mention reducing the rate of reoperation) The Furthermore, again with respect to breast prostheses, there is no need to provide a lower pole “muscle-extension” cover, and it can simply be placed under the skin flap. Similarly, there is no need to provide an additional upper pole cover. This will lead to a significant reduction in the time required for surgery, post-operative pain and morbidity, and a shorter recovery period.

  Further, according to the present invention, it becomes possible to use a prosthesis even at a site that could not be used conventionally. For example, today's breast cancer treatment more often consists of partial (fragmented) mastectomy or partial mastectomy and can be reconstructed using previously available medical implants Use a small flexible medical implant 12 covered with dermal material 20 that is not practically possible (especially due to capsule contracture due to post-operative irradiation) but simply inserted into the cavity by mammary massectomy This will provide new solutions to previously unmet needs (as taught by the present invention), increase outcomes, reduce morbidity, and reduce health care costs can do.

  As described above, specific embodiments of the present invention of medical implants having an interface have been described, but such citations, references and references are intended to be construed as limiting the present invention. Rather, the invention is not intended to limit the scope of the invention, except as set forth in the claims set forth below.

Claims (3)

(A) a breast implant having a pliable and deformable silicone elastomer skin, said skin containing a gel or liquid filling;
(B) a layer that inhibits continuous coating contracture of the acellular dermis material, and is located on the outer surface of the outer skin, with respect to only a part of the outer surface of the outer skin, (I) attached, (ii) closely engaged, and (iii) extends along its contour by engaging a mounting flap that is integral or continuous with the external surface. A layer that inhibits the continuous capsule contracture;
(C) an attachment flap receiving hole of the layer that inhibits the film contracture, the shape being configured to receive the attachment flap;
A medical breast implant assembly for in vivo implantation comprising:
The breast implant assembly is configured such that sutures to the living tissue are not required ,
The outer surface of the outer skin further includes a thickened outer skin portion;
The medical breast implant assembly , wherein the attachment flap extends from the thickened skin portion . (A) a breast implant having a pliable and deformable silicone elastomer skin, said skin containing a gel or liquid filling;
(B) a layer that inhibits continuous coating contracture of the acellular dermis material, and is located on the outer surface of the outer skin, with respect to only a part of the outer surface of the outer skin, (I) attached, (ii) closely engaged, and (iii) extends along its contour by engaging a mounting flap that is integral or continuous with the external surface. A layer that inhibits the continuous capsule contracture;
(C) an attachment flap receiving hole of the layer that inhibits the film contracture, the shape being configured to receive the attachment flap;
A medical breast implant assembly for in vivo implantation comprising:
The breast implant assembly is configured such that sutures to the living tissue are not required ,
The outer surface of the outer skin is provided with a plurality of reinforced portions,
The attachment flap, milk tufts implant assembly characterized in that extending from the plurality of reinforcing portions. The breast implant assembly according to claim 1 or 2 , wherein the breast implant assembly is press-fitted into the living body when mounted on the living body.

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