WO2023081981A1

WO2023081981A1 - An implant and surgical procedures for the implanting thereof

Info

Publication number: WO2023081981A1
Application number: PCT/AU2022/051355
Authority: WO
Inventors: David Goltsman
Original assignee: Maya Surgical Pty Ltd
Current assignee: Maya Surgical Pty Ltd
Priority date: 2021-11-11
Filing date: 2022-11-11
Publication date: 2023-05-19
Anticipated expiration: 2024-05-11

Abstract

Disclosed herein is an implant such as biodegradable implant for implanting into a cavity formed in a patient during a surgical procedure, the implant comprising a porous structure. and a method for implanting the implant into a patient during a surgical procedure. The method comprises performing the surgical procedure, whereby a cavity is formed within the patient; selecting an implant shaped to conform with the cavity, the implant being formed from a plastic material and comprising a porous structure; infusing a vascular ingrowth promotant collected from the patient into the shaped implant; implanting the shaped implant into the cavity; and completing the surgical procedure.

Description

AN IMPLANT AND SURGICAL PROCEDURES FOR THE IMPLANTING THEREOF

Technical Field

[0001] Described herein is a shaped implant for a patient and methods for implanting the shaped implant into the patient. The implant may be used in reconstructive or aesthetic surgical procedures and is particularly suited for use in breast reconstruction following a mastectomy or in breast augmentation or implant exchange procedures.

Background Art

[0002] One in eight women in Australia under the age of 85 are diagnosed with breast cancer. The standard treatment for breast cancer is a lumpectomy or mastectomy, which affords a 90% 5-year survival rate, but which leaves the patient with a disfiguration and can have significant negative psychological sequelae through loss of identity. Breast reconstruction is a surgical possibility, although only a small proportion of patients elect to undergo such because of factors including the desire to avoid additional surgery (which can be long and complicated procedures with high risks of morbidity), cost and potential complications.

[0003] Breast reconstructions broadly fall into two categories, implant-based reconstructions and autologous reconstructions. Implant based reconstructions conventionally involve a surgeon inserting a silicone or fluid filled prosthesis with a textured or smooth outer silicone shell into the cavity formed during the patient’s mastectomy, either in a single stage or two- stage procedure. Complications with implant-based reconstructions include capsular contractures, implant migration, distortion of anatomical planes (i.e. bottoming out of the inferior mammary fold), as well as the risk of cavity and prosthesis infections, and breast implant associated cancers. Furthermore, such implants are artificial and are not generally customised to the patient, which results in an unnatural feeling breast. Additionally, prosthetic silicone implants require exchange and replacement every 8-10 years due to the inevitability of these complications occurring.

[0004] More recently, implants made of biodegradable materials have been proposed, where the implants are custom made for a patient and have a scaffold structure that includes a void system for the generation of prevascularized connective tissue with void spaces for cell and/or tissue transplantation. However, such implants are typically hard pre-formed structures that are not flexible and can thus place a significant limitation on reconstruction. Further, they are relatively expensive, need to be prepared well in advance of an operation, based on pre-operative characteristics of the patient, and have a limited shelf life. They also have a limited ability to truly fit the reconstruction or augmentation required at the time of surgery to achieve the desired outcome. Pre-fabrication of implants does not allow the surgeons to adapt to the clinical setting they are working in, limiting their capacity to provide patients with the best service.

[0005] Autologous reconstructions involve a surgeon transplanting a tissue flap taken from the patient (typically the patient’s abdominal region) into the cavity formed during the patient’s mastectomy. Flaps can be moved to the breast as a free tissue transfer where the artery and vein supplying the flap is detached from its donor site and then re-attached to an artery and vein with microsurgery at the mastectomy recipient site (free flap) or on a vascular pedicle (pedicled flap) where attaching the blood vessels is not necessary.

[0006] Autologous reconstructions advantageously use a patient’s own tissues and are therefore less susceptible to rejection. However, complications of autologous reconstructions include flap failure (either venous, arterial or intra-flap), donor site morbidity, more complicated surgery (i.e. compared to implants), prolonged anaesthetic time, prolonged recovery, 1CU admission postoperatively, limited patient suitability, as well as limited salvage options as it can be difficult to find other autologous donor tissue.

[0007] Similar disadvantages are present for implant procedures in other body areas.

It would be advantageous to provide alternative options for surgical reconstructions or augmentation for different body areas, and particularly breast reconstructions.

Summary of Invention

[0008] According to a first aspect, there is provided herein a biodegradable implant for implanting into a cavity formed in a patient during a surgical procedure, the implant comprising a porous structure.

[0009] According to one example, porous structure includes one or more pores where one or more channels are formed on one or more walls between the one or more pores for fluid communication between the one or more pores.

[0010] In yet a further example, the implant includes an inner porous layer and an outer porous layer, the outer porous layer being configured to at least partially surround the inner porous layer.

[0011] According to another example, the outer porous layer has no or limited channels between pores in the outer porous layer thereby limiting fluid communication between pores in the outer porous layer. [0012] In a further form, the outer porous layer is 0.1% to 50% of the overall implant mass or volume.

[0013] According to yet another example, the one or more channels are formed on a plurality of walls of a pore.

[0014] According to another form, the one or more channels are formed by a cut, slice, or puncture through a pore wall.

[0015] In yet another example, an average pore size in the porous structure is between about 50pm and about 200pm.

[0016] According to another example, the implant is formed from a synthetic or a biological plastic material.

[0017] In a further form, the implant is formed from polyurethane or poly(s-caprolactone) (polycaprolactone).

[0018] According to another example, the implant is formed from collagen, protein or acellular or extracellular based scaffolds.

[0019] In yet another example, the implant is formed from a polyurethane sponge or matrix.

[0020] According to a further form, the implant is a round or anatomically shaped sponge or matrix.

[0021] According to another aspect, the present invention provides a method for implanting a shaped implant into a patient during a surgical procedure. The method comprises performing the surgical procedure, whereby a cavity is formed within the patient; providing a shaped implant for receipt in the cavity, the implant being formed from a plastic material and comprising a porous structure; infusing a promotant collected from the patient into the shaped implant; implanting the shaped implant into the cavity; and completing the surgical procedure.

[0022] The inventor of the invention the subject of the present application recognised that implants having a particular shape and configuration, even if produced based on pre-operative characteristics of the patient, may not be appropriately sized given the unexpected developments that often occur during operations. Thus, the implant described herein can allow for intraoperative modifications or adjustments.

[0023] In a mastectomy, for example, it is generally not possible to accurately determine the size and shape of the cavity (also referred to as a volume-deficit or an area of dead-space) that will actually be formed within a patient during the operation based on measurements taken preoperation. The true size of the cavity formed and the tension placed on the mastectomy flap by the implant can only be determined intra-operatively. Whilst a general idea of cavity size can be ascertained pre-operation, the inventor recognised that the lack of opportunity to resize or reshape an implant intra-operation, may result in a mis-sized implant being used, placing too much tension on the mastectomy flap and possibly leading to the most major complication of breast surgery, being mastectomy flap necrosis, which often results in further sequalae of major medical and psychological morbidity to the patient.

[0024] In embodiments of the present invention, however, based on the mastectomy flap formed post removal of the breast tissue, a surgeon can shape the implant described herein (e.g. using a saline implant sizer system to select the best sized and shaped implant for the cavity and then finalise the shape with their hands to physically re-shape the implant due to its plasticity, or a scalpel or the like to reduce its size) such that it does not compromise or limits flap perfusion. The intra-operative sizing and shaping features of the present invention can give surgeons the ability to tailor their operation to the most appropriate reconstruction to significantly reduce the likelihood of morbidity occurring.

[0025] The shaped implant may thus be configured to occupy the entire dead-space as is (or modified in size to account for the associated in vivo biodegradation, shrinkage, surrounding tissue tension, desired aesthetic outcome parameters or surgeon’s preference), resulting in an immediate effect for the patient. As noted above, patients can have significant negative psychological sequelae following surgeries such as a mastectomy. The present invention can achieve this a single operation, providing enormous benefits for patients.

[0026] Embodiments of the present invention enable intra-operative modifications or adjustments to be made to the shaped implant, which can be advantageous when patients are being evaluated intra-operatively. Adjustments are able to be made based on the patients’ mastectomy flap post oncological resection or in terms of their aesthetic goals in breast augmentation surgery (to take two specific examples).

[0027] The pore structure of the implant is configured for a vascular ingrowth to create a vascular domain allowing for small to large volume autologous cells (e.g. fat cells) to populate the territory and have adequate vascularity from the perfusion formed by the developed network of vessels. Once inserted into the patient’s cavity, the implant of the present invention facilitates vascular ingrowth whilst maintaining its structural integrity (at least for an appropriate amount of time). This creates an environment suitable for subsequent moderate to large volume autologous tissue grafting (e.g. fat grafting) for the purpose of reconstructive or aesthetic surgery.

[0028] According to one example, the promotant is derived from the patient (comprising of both vascular ingrowth factors and patient derived stem cells) and infused into the (appropriately sized) implant during the course of the surgical procedure. It will be appreciated that this can help to reduce the likelihood of complications such as rejection or infection due to the bodies innate immunological response from foreign biological material being introduced into the body. Further, as promotant materials are biological materials, their storage can be challenging, even over short periods of time. It is postulated that implants for use in the present invention (i .e. containing no vascular ingrowth promotants until the time of the operation) can be stored for significant periods of time.

[0029] In some embodiments, the shape of the shaped implant may be based on measurements taken from the patient before the surgical procedure. In the case of a mastectomy, for example, the implant may be shaped to conform with the cavity based on measurements taken from the patient pre-operation. The native breast could be pre operatively sized, assessing base width, projection and nipple to inferior mammary fold measurements in order to give a good idea of the likely size and shape of the shaped implant.

[0030] As noted above, however, it is often the case that the exact shape of implant required will not be known until the operation is well underway. Thus, a selected shaped implant may need to be adapted in order to best fit the cavity and reduce the risk of complications such as those described above (whilst these complications relate to breast surgery, they will be appreciated to have more general applicability). In some embodiments therefore, the method may further comprise a step in which the shape of the shaped implant is modified to even better conform with the cavity (e.g. by hand-moulding the implant, given its plasticity, or by cutting off a portion of the implant). Again, better surgical outcomes and patient wellbeing are likely to occur if there is less visual difference pre- and post-operation.

[0031] According to one example, the promotant may be selected from one or more of the group consisting of: stem cells and growth factors. The promotant may, for example, be selected from one or more of the group consisting of: endothelial cells, mesenchymal stem cells, adipocytes, adipose derived stem cells, fibroblasts, plasma and muscle stem cells.

[0032] According to another example, the promotant collected from the patient may be infused into the shaped implant by soaking, dipping, spraying, injecting or vapour infusing.

[0033] In yet another example, an average pore size in the porous structure may be between about 50pm and about 200pm. Such pore sizes would be expected to facilitate vascular ingrowth, adipocyte and immature cell implantation, differentiation and cellular regeneration.

[0034] In one example, the shaped implant may be formed from a synthetic plastic material, such as polyurethane or poly(e-caprolactone). Alternatively (or in addition), the shaped implant may be formed from a natural plastic material, such as collagen, protein or acellular or extracellular based scaffolds. The porous structure may, for example, be provided by a shaped implant in the form of a polyurethane sponge.

[0035] In one example, an antibiotic may be distributed throughout the porous structure in order to reduce the risk on a bacterial infection post operation.

[0036] According to another example, where it is beneficial to do so, the method may further comprise a subsequent procedure in which autologous tissue is grafted into the implant once a viable vascular domain is established. The viable vascular domain formed within the implanted implant provides an immediate supply of blood for the grafted tissue, reducing the likelihood of tissue necrosis and its attendant problems.

[0037] In another example, grafting autologous tissue into the implanted shaped implant may commence from between about one to eighteen months after the original surgical procedure (i.e. when the shaped implant was implanted), this generally being a sufficient amount of time to expect that significant vascular ingrowth into the implant will have occurred and that a blood supply will be available to grafted tissue and thus prevent it from becoming morbid.

[0038] According to another example, grafting autologous tissue into the shaped implant may comprise collecting the autologous tissue from another part of the patient and injecting it into the shaped implant.

[0039] In some embodiments (e.g. for breast implants), the autologous tissue may be autologous fat. Autologous fat grafting is a technique currently used to varying effect in some reconstructive and aesthetic surgical procedures. One of the disadvantages with current practices of fat grafting is that the grafted tissue is inset into territories which do not have adequate vascularity. This leads to the grafted tissue not being able to survive from the native blood supply to the area, hence the importance of facilitating vascular ingrowth into the implant the subject of the present invention. Further issues with current fat grafting practice include the requirement of multiple fat grafting procedures in order to reach the desired volume in the area. Only small amounts of fat survive these procedures due to the aforementioned poor vascularity, and it also exposes the patient to a high risk of recipient site infection due to the necrotic fat cells becoming an environment suitable for bacterial invasion.

[0040] In contrast to present techniques, it will be appreciated that in the present invention, due to the highly vascularised nature of the implanted implant, a single fat grafting procedure, using conventional equipment, may suffice. Thus, the implant of the present invention can establish a vascular network which will allow large volume many hundreds of cell layers thick to survive. Accordingly, the current implant can significantly improve survival rates of fat cells and can thus decrease the operative risks and morbidity from multiple operations, decreasing the anaesthetic risk, decreasing the risk of fat necrosis from fat being transferred and not having a viable supply to survive, and significantly reducing operation costs by only requiring one procedure.

[0041] Typically multiple grafts of autologous tissue would be performed until the desired volume is reached.

[0042] In one example, the shaped implant may be biodegradable. In some embodiments, the implant may be bioabsorbable. Such properties provide that, after an appropriate time, the implant can effectively disappear, leaving behind the vascular system and other ingrowth, as well as any grafted tissue.

[0043] In one example, the surgical procedure may be a mastectomy, with the implant being shaped for receipt in the cavity formed by removing the patient’s breast tissue. In alternative embodiments, the surgical procedure may be augmentation surgery, with the implant being shaped for receipt in a cavity formed in a part of the patient to be augmented (e.g. the patient’s breast, head or neck, lower limbs or pelvic region).

[0044] The methods of the present invention generally can significantly simplify surgical procedures for implanting the implant (e.g. by only requiring a single stage large volume fat grafting procedure to achieve the desired volume, rather than in excess of three grafting sessions). Further, the implant can be added at the end of the surgical procedure, meaning only one anaesthetic and potentially in a single day procedure, placing less of a fiscal strain on the healthcare system. The methods may also provide an autologous reconstruction which is less likely to cause major patient morbidity, may not require post-operative intensive care admission, and reduce the risk of complications occurring (e.g. because autologous tissue is grafted into a viable vascular domain).

[0045] Notably, the advantages described herein can further encourage an increase in especially breast reconstructive surgery following procedures such as a mastectomy, with the attendant benefits thereof.

[0046] In yet another aspect, the present invention provides a method for reconstructing a part of a patient following a surgical procedure that resulted in the formation of a cavity (e.g. a mastectomy). The method comprises implanting into the cavity an implant shaped to conform with the cavity, the implant being formed from a plastic material and comprising a porous structure throughout which a promotant collected from the patient is infused at the time of the surgical procedure and, once a viable vascular domain is established, grafting autologous tissue into the implant.

[0047] According to a further aspect, the present invention provides a method for augmenting a part of a patient (e.g. a breast augmentation). The method comprises performing a surgical procedure at the part, whereby a cavity is formed within the patient; implanting a shaped implant into the cavity, the implant being formed from a plastic material and comprising a porous structure throughout which a promotant collected from the patient is infused at the time of the surgical procedure; and once a viable vascular domain is established, grafting autologous tissue into the implant.

[0048] In another aspect, the present invention provides a method for infusing a promotant into a shaped implant comprising a porous structure. The method comprises collecting the cellular components of the promotant, and contacting the shaped implant with the end product promotant comprising from a range of the aforementioned cells, whereby the promotant infuses throughout the porous structure.

[0049] In some embodiments, the cellular components of the promotant may be collected from the patient into which the implant is to be implanted.

[0050] In accordance with another aspect, the present invention provides a biodegradable implant for implanting into a cavity formed in a patient during a surgical procedure, the implant being shaped to conform with the cavity and formed from a plastic material comprising a porous structure throughout which a promotant collected from the patient is infusible (or is infused) at the time of the surgical procedure.

[0051] In a further aspect, the present invention provides a biodegradable implant for implanting into a cavity formed in a patient during a surgical procedure, the implant being formed from a plastic material comprising a porous structure throughout which a promotant collected from the patient is infusible (or is infused) at the time of the surgical procedure.

[0052] According to a further aspect, there is provided herein a biodegradable implant for implanting into a cavity formed in a patient during a surgical procedure, the implant including a porous structure.

[0053] In one example, an average pore size in the porous structure is between about 50pm and about 200pm. According to another example, the implant is formed from a synthetic or a biological plastic material. In yet a further form, the implant is formed from polyurethane or poly(s-caprolactone). According to another example, the implant is formed from collagen, protein or acellular or extracellular based scaffolds. In yet another example, the implant is formed from a polyurethane sponge or matrix.

[0054] It will be appreciated that any of the features of the aspects, forms, and examples as described herein can be combined.

Brief Description of the Drawings

[0055] Figure 1 A is a cross-sectional view of an example of a breast prior to mastectomy;

Figure IB is a cross-sectional view of an example of a breast post mastectomy with breast tissue removed and reconstructed with an implant of the present invention, the implant being placed sub-pectorally;

[0056] Figure 1C is a cross-sectional view of an example of a breast with vascular ingrowth;

[0057] Figure ID is a cross-sectional view of a breast showing an example of the implant being completely dissolved, leaving behind a vascular domain that has been fat grafted;

[0058] Figure 2A is a cross-sectional view of an example of an implant placed pre-pectorally;

[0059] Figure 2B is a cross-sectional view of an implant sitting in a dual plane - partially sub- pectorally and partially within the breast cavity (glandular space);

[0060] Figure 3 A is a cross-sectional view of an example of an implant placed sub-glandularly’

[0061] Figure 3B is a cross-sectional view of an example of an implant placed pre-pectorally;

[0062] Figure 3C is a cross-sectional view of an example of an implant sitting partially subpectorally and partially within the breast cavity (glandular space);

[0063] Figure 3D is a cross-sectional view of an example of an implant placed sub-pectorally;

[0064] Figures 4A and 4B are photographic images of example implants, showing as an example, porous and sponge like consistency;

[0065] Figure 5A shows a top view of an example of a shaped implant;

[0066] Figure 5B shows a cross-section of the example implant of Figure 5 A;

[0067] Figure 5C shows a side view of an example of a shaped implant;

[0068] Figure 5D is a cross-section of the example implant of Figure 5C;

[0069] Figure 6A shows a top view of an example of a shaped implant;

[0070] Figure 6B shows a cross-section of the example implant of Figure 6A;

[0071] Figure 6C shows a side view of an example of a shaped implant; [0072] Figure 6D is a cross-section of the example implant of Figure 6C;

[0073] Figure 7 shows an example of a portion of the example implants of Figures 5B, 5D, 6B and 6D further showing example inner and outer layers;

[0074] Figure 8 shows a further zoomed view of the pores and channels of the example implants of Figures 5 A to 7; and,

[0075] Figures 9A to 9D show sections of slides from a study performed an example implant of the present invention.

Description of Embodiments

[0076] There is provided herein an implant for implanting into a cavity formed in a patient during a surgical procedure, where the implant comprises a porous structure. Typically, the implant is biodegradable and the porous structure can include one or more pores where one or more channels are formed on or in one or more walls between the one or more pores for fluid communication between the one or more pores. The implant can further include an inner porous layer and an outer porous layer, the outer porous layer being configured to at least partially surround the inner porous layer. Further, the outer porous layer can have no or limited channels between pores in the outer porous layer thereby limiting fluid communication between pores in the outer porous layer. Further, the one or more channels can be formed on a plurality of walls of a pore. It will be appreciated that the one or more channels are formed by a cut, slice, or puncture through a pore wall. The implant can be shaped and prepared for implanting in a surgical procedure.

[0077] The present invention can further provide a method for implanting the shaped implant into a patient during a surgical procedure. The method comprises performing the surgical procedure, whereby a cavity is formed within the patient; providing a shaped implant for receipt in the cavity, the implant being formed from a plastic material and comprising a porous structure; infusing a promotant collected from the patient into the shaped implant; implanting the shaped implant into the cavity; and completing the surgical procedure.

[0078] The present invention can also provide a method for reconstructing a part of a patient following a surgical procedure that resulted in the formation of a cavity, where adjustments are able to be made based on the patients’ intra-operative presentation (e.g. the patient’s mastectomy flap post oncological resection, in the case of a mastectomy, or the patient’s desired breast shape and volume in breast augmentation) The method comprises implanting into the cavity an implant shaped to conform with the cavity, the implant being formed from a plastic material and comprising a porous structure throughout which a promotant collected from the patient is infused at the time of the surgical procedure and, once a viable vascular domain is established, grafting autologous tissue into the implant.

[0079] The present invention can also provide methods for augmenting a body part of a patient, such as their breasts, buttock, head and neck or thighs, where intra-operative adjustments are able to be made based on the patients’ aesthetic goals of the augmentation surgery. The method comprises performing a surgical procedure at the part, whereby a cavity is formed within the patient, implanting a shaped implant into the cavity, the implant being formed from a plastic material and comprising a porous structure throughout which a promotant collected from the patient is infused at the time of the surgical procedure; and once a viable vascular domain is established, grafting autologous tissue into the implant.

[0080] The present invention will be described below primarily in the context of breast reconstruction following a mastectomy. It will be appreciated, however, that the present invention is equally applicable to other aesthetic and reconstructive surgeries, such as facial aesthetic surgery, and head and neck reconstructive surgery post oncological procedures. It may also be applicable to lung regenerative surgery in reconstruction of lung parenchyma or liver tissue regeneration post liver resection. As will also be described below, the present invention may also find application in augmentation surgery, such as in breast augmentation, or structured aesthetic body contouring procedures. The present invention may also find application in breast implant exchange procedures, where a silicone implant is replaced in the already preformed cavity.

[0081] In the context of the present invention, a “plastic material” is to be understood as a material having plastic properties, i.e. a substance or material that is easily shaped or moulded. The plastic material may be formed from a plastic (i.e. one of a wide range of synthetic or semisynthetic materials that use polymers as a main ingredient) but could also be formed from nonsynthetic plastic materials such as collagen, protein, acellular or extracellular based scaffolds.

[0082] The steps in the method of the invention for implanting a shaped implant into a patient during a surgical procedure will be described in further detail below.

[0083] The first step in the method involves performing a surgical procedure, during which a cavity is formed within the patient. The inventor envisages that the methods disclosed herein will be generally applicable to a number of reconstructive and augmentive surgeries, where biodegradable implants having the properties described herein can beneficially be used to improve the patient’s outcome. The nature of the surgical procedure will depend on many factors and will likely be unique for every single patient. In one example, the surgical procedure typically involves the removal of body tissue, leaving a relatively large cavity in the patient which the shaped implant is intended to fill, effectively resulting in the patient’s body having the same shape post-operation. According to another example, however, the surgical procedure may involve the removal of none, or very little, body tissue, with the shaped implant augmenting the shape of the patient’s body in a desired manner.

[0084] An example of a surgical procedure is shown in Figures 1 A to ID where Figure 1 A shows an example of the breast mound intact with its native tissue (breast parenchyma, ductules and lobules) and Figure IB shows the breast mound with its native inner parenchymal tissue removed.

[0085] Next, an implant, which can be a shaped implant for receipt in the cavity is provided. Figures IB to 3D show an example of an implant 20 inserted into a cavity 25 formed in the breast 10 after the native tissue has been removed. The shaped implant is typically formed from a plastic material and has a porous structure.

[0086] In these examples, Figure IB shows an example of a breast 10 post mastectomy, where the breast tissue has been removed. In this example, the breast has been reconstructed with the implant being placed sub-pectorally. Figure 1C shows an example of when after a period of time, there has been vascular ingrowth into the implant developing a vascular domain which can allow for fat grafting to occur in high volumes to allow for cell survival. Figure ID shows an example of an end result where the implant has completely dissolved, leaving behind a vascular domain which has been fat grafted. In this example, the end result is a breast reconstructed from autologous fat fashioned to fit in a customized cavity which has been defined by the biological implant.

[0087] It will be appreciated that the implant can be placed at different positions with respect to the pectoral muscle. Figure 2A shows an example of the implant alternatively placed implant sitting supra-pectorally. Figure 2B shows an alternatively placed implant sitting partially subpectorally and partially within the breast cavity. The inferior pole of the implant may or may not have a biological or symthetic material covering to form the inferior aspect of the pectoralis major. Further examples are shown in Figures 3 A to 3C where in Figure 3 A, the implant is subglandular, and in Figure 3B, the implant is prepectoral. Figure 3C shows another example of the implant sitting partially subpectorally and partially within the breast cavity. The inferior pole of the implant may or may not have a biological or symthetic material covering to form the inferior aspect of the pectoralis major. Figure 3D shows another subpectoral example. [0088] According to a further example, Figures 4A and 4B show example images of the implants showing porous and sponge like consistency. Thus, in one particular example, the implant 20 can have one or more pores formed therein in a manner that is like a sponge, where the pores are typically holes formed in random manner throughout the implant 20.

[0089] A further example of an implant 20 is shown in Figures 5A to 8. As an example, Figures 5A to 5D and 6A to 6D show an implant having a porous structure which includes one or more pores 35. As discussed herein, the implant is typically biodegradable and is formed to be implanted into a cavity in a patient during a surgical procedure.

[0090] As shown more specifically in Figures 7 and 8, the porous structure can include one or more pores 35 where one or more channels 40 are formed on or in one or more walls 45 between the one or more pores 35 to allow for fluid communication between the one or more pores 35. The one or more channels 40 can be formed in any wall 45 of the pore 35, and can be formed in all walls 45 of the pore 35.

[0091] It will be appreciated that the channels 40 between the pore walls 45 can provide a mechanism by which cells within the pores 35 can be mobile such that they can move through the channels and distribute homogenously through the pores 35 to allow for vascular ingrowth in the implant. Thus, not only can material within the implant (such as cellular material) move between the pores 35 through the pore openings, but also through the channels 40 that have been formed in the pore walls 45.

[0092] According to another example, the implant 20 can be formed such that the implant 20 has an inner porous layer 50 and an outer porous layer 55. Typically, the outer porous layer 55 is configured to at least partially surround the inner porous layer 50. In one example, the outer layer 55 can entirely surround the inner layer 50 of the implant such that the outer layer 55 forms an outer casing of the implant 20.

[0093] In one specific example, the outer porous layer 55 has no or limited channels 40 between pores 35 in the outer porous layer 55 thereby limiting fluid communication between pores 35 in the outer porous layer 55. Thus, the outer layer 55 can stop or inhibit movement of any material (such as cells or the like) in the implant 20 to the outer surface.

[0094] It will be appreciated that the outer layer 55 is typically a thinner layer than that of the inner layer 50 and can be 0.1% to 50% of the overall implant mass or volume. It will further be appreciated that there may be no outer layer at all such that there can be pores with punctured or channelled walls dispersed throughout the implant. [0095] Typically, the channels 40 are formed in or on a plurality of walls 45 in a pore 35. Thus, a pore 35 can have channels 40 formed in one or all of its walls 45. Further, the channels 40 can be formed symmetrically in the middle of a wall 45 or asymmetrically or randomly in any wall 45. A wall 45 can also have just one channel or a plurality therein. Typically, the one or more channels 45 are formed by a cut or slice through the pore wall 45 to thereby connect or provide fluid communication between two pores that share the wall 45.

[0096] As described herein, the implant can be formed from a polyurethane sponge. Although the sponge can be shaped in any shape that is required by a particular surgery, in one example, and in particular for breast surgery, the implant is formed as a round sponge or anatomical shape sponge which can be used for proposed of reconstructive or aesthetic breast surgery. The Implant in the breast may be placed into a space made in any of the anatomical domains used in the art (glandular space, dual plane, pre-pectoral or sub pectoral space). Further, as described below, the shape of the implant 20 can be modified to what is required during surgery.

[0097] It will be appreciated that the shaped implant may be formed from any suitable material that has plastic properties which enable it to be relatively easily shaped or moulded. The shaped implant may, for example, be formed from synthetic plastic materials such as polyurethane or poly(e-caprolactone). Alternatively (or in addition), the shaped implant may, for example, be formed from non-synthetic plastic materials such as collagen, protein, acellular or extracellular based scaffolds. In a specific form envisaged by the inventor, the shaped implant may be formed from a polyurethane sponge or matrix, such as those commercially available from PolyNovo Biomaterials Pty Ltd, and as described in AU Patent No. 2003281481.

[0098] The shaped implant has a porous structure, into which pores can be infused the promotant and, subsequently, a vascular domain established. An example of this is shown in Figure 1C, which shows an injection of the promotant 30. The pore structure of the implant is configured for a vascular ingrowth to create a vascular domain allowing for small to large volume autologous cells (e g. fat cells) to populate the implant and have adequate vascularity from the perfusion formed by the developed network of vessels. Once inserted into the patient’s cavity, the implant of the present invention facilitates vascular ingrowth whilst maintaining its structural integrity (at least for an appropriate amount of time). It will be appreciated that this can create an environment suitable for subsequent moderate to large volume autologous tissue grafting (e g. fat grafting) for the purpose of reconstructive or aesthetic surgery. [0099] An average pore size in the porous structure is between about 50pm and about 200pm is expected to provide an appropriate functionality in these regards, although any pore size and structure that enables these functional requirements should be suitable.

[0100] Notably, for breast implants, the dimensions can be based on a sizer system which can aim to replicate the excised tissue volume. Accordingly, the implant acts as a vascular ingrowth template, compartmentalising the breast cavity, allowing for vascular ingrowth to facilitate the survival of fat cells and also facilitate fat regeneration. The chambers can further create a physical barrier that aids in minimizing the foreign body response and helps prevent encapsulation. As regeneration progresses, fat cells can thus be given the opportunity to survive in the matrix and regenerate.

[0101] When inset into the cavity, the implant matrix can be rapidly infiltrated with hemoserous fluid. As cellular migration begins, the chambers are then typically infiltrated by a variety of cell types with the interconnecting pores allowing exchange of nutrients and waste. As vascular ingrowth develops, fat cells are given the optimal environment to survive, and the mature stem cells are able to differentiate into mature fat cells and also commence fat cell regeneration through the matrix.

[0102] The shaped implant is configured for receipt into a cavity formed during surgery. As described above, the primary advantages of the present invention relate to the inventor recognising that implants having a particular shape and configuration, even if produced based on pre-operative characteristics of the patient, may not be appropriately sized given the unexpected developments that often occur during operations. The shaped implant of the present invention can be intra-operatively sized and shaped, giving surgeons the ability to tailor their operation to the most appropriate reconstruction or augmentation, thus reducing the likelihood of complications occurring. Thus, for example, the present implant can be reshaped as the structure is formed of a soft porous structure which can be compressed and fill a cavity; the implant can be cut to size based on the cavity via tailoring the shape to the cavity using scissors; and intraoperatively, the most appropriate size can also be selected using a saline sizer implant technique (which is further described below) and can ensure that any operative changes (especially in the context of oncological resection) can be incorporated into the reconstruction, rather than basing reconstruction on perioperative sizing which only serves as a guide (rather the appropriate reconstruction measurements.

[0103] This being said, the shape of the shaped implant may be based on measurements taken from the patient before the surgical procedure. In the case of a mastectomy, for example, the implant may be shaped to conform with the cavity based on measurements taken from the patient pre-operation. The native breast could be preoperatively sized, assessing base width, projection and nipple to inferior mammary fold measurements in order to give a good idea of the likely size and shape of the shaped implant. Even if not ultimately the exact shape for the cavity, these measurements will result in the selection of an implant that will be close to the right size. Easy to perform modifications (described below) are all that would be required to perfect the shaped implant.

[0104] In this regard, the method may also involve the surgeon modifying the shape of the shaped implant to conform with the cavity, once the operation is underway and the exact shape of the cavity is known. For example, a portion of the originally selected implant may be cut off in the event of the cavity being smaller than originally envisaged Alternatively (or in addition), the plastic nature of the shaped implant lends itself to being moulded and contoured by the surgeon into a shape that more closely conforms to the shape of the cavity produced in the patient as a result of the surgery.

[0105] A saline implant sizer system (such as those conventionally used in implantations) may be used intra-operatively to help select and size the implant for use. This system provides a significant advantage to the patient as perfusion and tissue vascular flow technology such as indocyanine green fluorescence angiography can be used to assess the integrity of the mastectomy flap, in the case of the surgical procedure being a mastectomy. By visualising the tension placed on the mastectomy flap in real time intra-operatively, an implant which places minimal tension on the flap can be selected and, if necessary, physically shaped to facilitate maximal reconstructive and aesthetic outcome and minimise poor outcome and morbidity. It will be appreciated that this can be performed clinically by assessing tension on the flap via capillary refill time and also via the degree of skin stretch (tension) placed on the flap or via methods such as near infrared laser angiography using intravenous indocyanine green dye.

[0106] The shaped implant may thus be configured to occupy the entire dead-space as is (or modified in size to account for the associated in vivo biodegradation, shrinkage, surrounding tissue tension, desired aesthetic outcome parameters or surgeon’s preference), resulting in an immediate effect for the patient. As noted above, patients can have significant negative psychological sequelae following surgeries such as a mastectomy. The present invention achieves this a single operation, which can thus provide benefits for patients.

[0107] A multi-function promotant, collected from the patient at any convenient time preceding the surgical procedure (or even during the procedure), is typically infused into the shaped implant. The promotant is infused into the (appropriately sized) implant during the course of the surgical procedure, which helps to reduce the likelihood of complications such as rejection or infection due to the bodies innate immunological response to foreign biological material.

Further, as promotants are typically biological materials, their storage can be challenging, even over short periods of time. The inventor expects that implants for use in the present invention (i.e. which contain no promotants until the time of the operation) will be able to be stored for significant periods of time.

[0108] It will be appreciated that the promotant can have multiple properties including: promoting vascular ingrowth to establish a vascular network essential for large volume fat grafting and it also has a range of stem cells (early and mature, including early adipocytes and fibroblasts) and blood products (plasma) which facilitate for cellular differentiation and regeneration.

[0109] The implant described herein is thus optimised for fat transfer and large volume fat grafting to allow for large volumes of fat to homogeneously distribute within it. This allows for optimised vascular access to the large volume of grafted fat. The rapidly established vascular network can also improve the vascularity of the overlying mastectomy skin flaps which may be damaged from the oncological excision processes. By re-establishing a reliable blood supply to the overlying mastectomy flap, one of the most major morbidities associated with breast surgery may be avoided, and can thus reduce the significant morbidity associated with this complication.

[0110] The promotant may be collected from the patient at any convenient time. For example, the promotant may be collected from the patient in a pre-admission procedure, or in the early stage of the surgical procedure. The promotant may be collected from the patient using any suitable technique, such as a skin or subcutaneous fat biopsy. If necessary, the volume of the promotant may be increased using any suitable technique.

[0111] Once collected, the promotant may be infused into the shaped implant using any suitable technique. The inventor expects that the promotant collected from the patient may be infused into the shaped implant by soaking, dipping, spraying, injecting or vapour infusing, to name a few techniques. Infusion is only expected to take a short period of time, so as to not significantly extend the duration of the surgical procedure.

[0112] The promotant may be any substance that can be collected from the patient and which can promote vascular ingrowth into the pores of the shaped implant (i.e. once implanted into the patient’s body). The promotant may, for example, be the patient’s stem cells and/or growth factors. The promotant may, for example, be endothelial cells, mesenchymal stem cells, adipocytes, adipose derived stem cells, fibroblasts, plasma and/or muscle stem cells collected from the patient, and can further include plasma and other blood products as required.

[0113] In some embodiments, additional substances may be contained within the shaped implant, provided such do not detrimentally affect the performance of the present invention. In some embodiments, for example, an antibiotic may be distributed throughout the porous structure in order to reduce the likelihood of bacterial infection such as via dipping, soaking, or injecting anti-bacterial substances.

[0114] Typically, the shaped implant (containing the promotant) is subsequently inserted into the cavity and, once the implant is appropriately located within the cavity, the surgical procedure is completed. In order to inset the implant into the cavity a sling may be used to extend the size of the cavity in the setting of subpectoral breast reconstruction, or a biological or synthetic fixation bra fashioned onto the pectoralis major muscle in the setting of a prepectoral reconstruction. These steps in the method of the present invention involve conventional techniques specific to the procedure and which would be well known to persons of ordinary skill in the art.

[0115] Subsequent to the surgical procedure described above, a further procedure may be performed, where autologous tissue is grafted into the shaped implant after a viable vascular domain has been established. The length of time taken to establish viable vascular domain will depend on factors such as the location and severity of the surgery as well as the patient’s factors such as nutrition, co-morbidities and compliance with post operative recovery plan, and can be assessed using conventional techniques (e.g. contrast enhanced CT or ultrasound). It is envisaged that grafting autologous tissue into the shaped implant may be commenced about one to eighteen months after the surgical procedure.

[0116] Autologous tissue grafting typically comprises collecting the autologous tissue from another part of the patient and injecting it into the shaped implant. Any autologous tissue may be used in the grafting procedures, with autologous fat being preferred in the case of breast reconstructions and augmentations, at least, because of its physical properties.

[0117] In a specific embodiment envisaged by the inventor, the shaped implant is provided in the form of a breast implant which is bioabsorbable and biodegradable. The implant is composed of either synthetic or natural plastic material, in a sponge or matrix structure with pores throughout, and is seeded with a liquid or gel constituted of patient derived stem cells and growth factors via methods such as dipping, soaking and injecting. [0118] Once inset into an area of dead-space/volume-deficit/cavity, the implant facilitates vascular ingrowth, whilst maintaining structural integrity in the templated area, creating an environment suitable for moderate to large volume fat grafting for the purposes of reconstructive or aesthetic breast surgery.

[0119] The invention provides a tailor made self-standing implant template (or scaffold or matrix) capable of establishing a vascular domain to facilitate for moderate to large volume fat cell survival in breast reconstruction/restoration surgery or aesthetic/cosmetic breast surgery.

[0120] The implant may or may not require a supportive biodegradable capsular exoskeleton with or without biodegradable tension columns/bracketing throughout its structure. The capsule and tension columns/bracketing may or may not be formed from PU or another biodegradable and bioabsorbable material with the same or a different pore size to the inner foam. Exoskeleton and bracketing will be selected based on the volume of the dead-space/volume deficit/cavity being addressed and/or the tension form the surrounding tissues of the dead-space/volume deficit/cavity being addressed surgically.

[0121] The shaped implant may occupy the entirety of the dead-space/volume deficit/cavity without any modifications, or may be modified in size to account for the associated in vivo biodegradation, shrinkage, surrounding tissue tension, desired aesthetic outcome parameters or surgeons preference.

[0122] The shaped implant may, in another embodiment, be provided in the form of a slab of foam, with or without an exoskeleton, and a shape preserving internal supportive structure which preconditions the area by creating a vascular network suitable for large volume fat grafting.

[0123] The patient derived stem cells and growth factors may include endothelial cells, mesenchymal stem cells, adipocytes, adipose derived stem cells, fibroblasts, plasma and muscle stem cells, and would be impregnated into the sponge at the time of surgery to ensure increase vascularity being indrawn, immunomodulation, and to decrease infection risk.

[0124] It will be appreciated that in the context of reconstructive breast surgery the implant described herein can be used to replace the dead-space/volume deficit/cavity formed in oncological breast surgery with a templated bespoke or preformed matrix, occupying the entire dead-space/volume deficit/cavity, facilitating vascular ingrowth to create an environment appropriate for small to large volume fat grafting at the time of the initial operation or subsequent operations. [0125] It will also be appreciated that the context of aesthetic breast surgery, the implant described herein can be used to replace the dead-space/volume deficit/cavity formed when creating a (i) prepectoral, (ii) sub glandular, (iii) submuscular or (iv) duel plane space with a bespoke or preformed sponge or matrix, occupying the entire dead-space/volume deficit/cavity, facilitating vascular ingrowth to create an environment appropriate for small to large volume fat grafting at the time of the initial operation or subsequent operations.

[0126] In a specific embodiment, once the dead-space/volume deficit/cavity has been created by the surgeon post mastectomy or post dissection, a saline sizer is placed within the developed cavity. The sizer will determine the shape and size of the shaped implant available and once selected, the implant will undergo the described impregnation/incorporation process either via injection, soaking or spray prior to the implant being inset into the dead-space/volume deficit/cavity.

[0127] In specific embodiments, the method of the present invention may be used to the following effects:

1. To fill the dead-space/volume deficit/cavity as a result of:

(i) skin sparing, nipple sparing mastectomy,

(ii) skin sparing, nipple sacrificing mastectomy,

(iii) skin sacrificing, nipple sparing mastectomy +/- tissue expansion,

(iv) skin sacrificing, nipple sacrificing mastectomy +/- tissue expansion, and

(v) oncoplastic wide local excisions with resultant tissue deficit

2. To fill the dead-space/volume deficit/cavity required to successfully complete breast reconstruction using pedicled reconstruction/restoration methods of a Latissimus Dorsi flap and/or Lateral Intercostal Artery Perforator Flaps.

3. To fill the dead-space/volume deficit/cavity formed during breast augmentation procedures. The shaped implant is placed in the breast in one of several different positions, depending on desired outcome, and/or patient and surgeon preference, these include:

(i) a Subpectoral/Submuscular plane,

(ii) a Duel plane - partial submuscular and subglandular with or without an inferior pectoral sling

(iii) a Subglandular plane, and

(iv) a Prepectoral plane 4. To fill a dead-space/volume deficit/cavity once an implant has been explanted during implant exchange procedures.

[0128] The sites do not contain adequate vascular territories or domains to facilitate for large volume fat grafting/transfer survival without the shaped implant that establishes these vascular domains.

[0129] For Reconstructive/Restorative breast surgery procedures, the shaped implant may be placed in the breast in one of several different positions, depending on desired outcome, and/or patient and surgeon preference, these include:

(i) Prepectoral with or without a being fixed in position using glue, sutures or a structural mesh/other material bra fixed onto the pectoralis major muscle.

(ii) Subpectoral/Submuscular with or without structural support sling

(iii) Duel plane - partial submuscular and subglandular with or without an inferior pectoral sling

(iv) Underneath a pedicled flap needed to provide skin coverage due to volume and skin deficit

[0130] For Aesthetic breast surgery (or breast augmentation) procedures, the shaped implant may be placed in the breast in one of several different positions, depending on desired outcome, and/or patient and surgeon preference, these include:

(i) Subpectoral/Submuscular plane with or without an inferior pectoral sling

(ii) Duel plane - partial submuscular and subglandular with or without an inferior pectoral sling

(iii) Subglandular plane

(iv) Prepectoral plane

(v) In a previously formed pocket during implant exchange procedures once the breast implant has been explanted

(i) It will be appreciated that advantages of specific embodiments of the present invention can include and are not limited to:

• Reduced or no risk of capsular contractures

Minimise donor site morbidity

More accessible • More cost effective

• Bespoke

• Natural feel

• Pre-pectoral reconstruction avoiding animation deformity

• Soft tissue reconstruction without microsurgery

• No prolonged hospital admission, or ICU requirement postoperatively

• No more silicone required for implant based breast surgery (which has been shown to be causative of Breast Implant- Associated Anaplastic Large Cell Lymphoma)

• Aid in the vascularity of the overlying skin envelope reducing the most significant complication of mastectomy being mastectomy flap necrosis.

[0131] Examples of a result from an in-vivo study conducted to form an example implant as described herein is shown in Figures 9A to 9D. The study showed that a polyurethane based synthetic, biodegradable, and biocompatible scaffold is able to allow fat stem cells to implant, survive and aggregate in an in-vitro model provided by the physiological conditions of an organ bath.

[0132] In this example study, a dissolvable implant was formed which can be used for reconstructive and aesthetic surgery to facilitate autologous reconstruction with large volume fat grafting. It will be appreciated that fat grafting can be a single stage or multiple stage process. The implant formed was a synthetic, biodegradable, and biocompatible scaffold which facilitates vascular ingrowth to provide an ideal environment (or domain) for large volume fat grafting in a templated space which is maintained by the implant

[0133] A use of the implant formed is reconstructive and aesthetic breast surgery. However, the implant can also be used for head and neck reconstruction, muscle regenerative template, lymphatic stream shunting using strips of the novel material, lung regenerative template, liver regenerating template, and the like.

[0134] The study included using a biodegradable sponge made from polyurethane with communicative pores to allow adipocytes to be able to easily migrate throughout the implant. In this study, the communicative pores were created by homogenously perforating the pores in longitudinal, transverse and oblique axes allowing the pores to communicate in all directions in the implant. Adipose mesenchymal stem cells were purified from human subcutaneous fat and two 1cm x 1cm sheets of novel implant material were impregnated/seeded with mesenchymal stem cells using a sterile technique. These sheets were then suspended within an organ bath for 14 days. Following suspension these sheets were assessed by a pathologist using fresh tissue smear and frozen section techniques.

[0135] The results of the study are shown in Figures 9A and 9D.

[0136] Figure 9A shows an example frozen section showing well-formed nuclei and cytoplasm’s of mesenchymal stem cells. Figure 9A shows that the cells have been able to survive and aggregate within the scaffold. These cells have been able to attach around a porous structure seen centrally.

[0137] Figure 9B shows an example frozen section showing well-formed nuclei and cytoplasm’s of mesenchymal stem cells. In this example, these cells have been able to survive and aggregate within the scaffold. This slide further shows cell formed nuclei which are starting to expand to support differentiation to a mature adipocyte.

[0138] Figure 9C shows an example frozen section showing well-formed nuclei and cytoplasm’s of mesenchymal stem cells. In this example, these cells have been able to survive and aggregate within the scaffold. This sample was taken from the inferior aspect of the novel implant material supporting that fat stem cells have been able to migrate, attach, and accumulate within the implant material.

[0139] Figure 9D shows an example of a fresh tissue smear showing well-formed crisp nuclei of mesenchymal stem cells. These cells have been able to survive and aggregate within the scaffold. This supports the finding of cells being able to attach, survive, aggregate and then commence their differentiation to mature adipocytes. This supports cellular regeneration within the implant material.

[0140] It will be appreciated that the fresh smears and frozen section confirm the presence of mesenchymal stem cells present within the scaffold after impregnation and 14 days of treatment in in-vitro conditions. The slides obtained from the fresh smears and frozen sections show that there are well formed and attached mesenchymal stem cells (fat stem cells) with crisp nuclei, and aggregated clustering of stem cells. These results support the finding of stem survival, cell attachment within the scaffold, cellular aggregation and growth of these cells within the novel structure. Accordingly, it is contended that the material supports the growth of fat cells, and with further time would promote cellular differentiation and regeneration with the formation of mature adipocytes from the fat stem cells.

[0141] It will be understood to persons skilled in the art of the invention that many modifications may be made without departing from the spirit and scope of the invention. [0142] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

CLAIMS:

1. A biodegradable implant for implanting into a cavity formed in a patient during a surgical procedure, the implant comprising a porous structure.

2. The implant of claim 1, wherein the porous structure includes one or more pores where one or more channels are formed on one or more walls between the one or more pores for fluid communication between the one or more pores.

3. The implant of claim 2, wherein the implant includes an inner porous layer and an outer porous layer, the outer porous layer being configured to at least partially surround the inner porous layer.

4. The implant of claim 3, wherein the outer porous layer has no or limited channels between pores in the outer porous layer thereby limiting fluid communication between pores in the outer porous layer.

5. The implant of claims 3 or 4, wherein the outer porous layer is 0.1% to 50% of the overall implant mass or volume.

6. The implant of any one of claims 2 to 5 wherein the one or more channels are formed on a plurality of walls of a pore.

7. The implant of any one of claims 2 to 6, wherein the one or more channels are formed by a cut, slice, or puncture through a pore wall.

8. The implant of any one of claims 1 to 7, wherein an average pore size in the porous structure is between about 50pm and about 200pm.

9. The implant of any one of claims 1 to 8, wherein the implant is formed from a synthetic or a biological plastic material.

10. The implant of any one of claims 1 to 8, wherein the implant is formed from polyurethane or poly(e-caprolactone).

11. The implant of any one of claims 1 to 8, wherein the implant is formed from collagen, protein or acellular or extracellular based scaffolds.

12. The implant of any one of claims 1 to 8, wherein the implant is formed from a polyurethane sponge or matrix.

13. The implant of any one of claims 1 to 12, wherein the implant is a round or anatomically shaped sponge or matrix.

14. A method for implanting the implant of claims 1 to 13 into a patient during a surgical procedure, the method comprising: performing the surgical procedure, whereby a cavity is formed within the patient;

25 providing a shaped implant for receipt in the cavity, the implant being formed from a plastic material and comprising a porous structure; infusing a promotant collected from the patient into the shaped implant; implanting the shaped implant into the cavity; and completing the surgical procedure. The method of claim 14 wherein the shape of the shaped implant is based on measurements taken from the patient before the surgical procedure. The method of claim 14 or claim 15, further comprising modifying the shape of the shaped implant to conform with the cavity. The method of any one of claims 14 to 16, wherein the promotant is selected from one or more of the group including: stem cells, plasma and growth factors. The method of any one of claims 14 to 17, wherein the promotant is selected from one or more of the group including: endothelial cells, mesenchymal stem cells, adipocytes, adipose derived stem cells, fibroblasts and muscle stem cells and plasma. The method of any one of claims 14 to 18, wherein the promotant collected from the patient is infused into the shaped implant by soaking, dipping, spraying, injecting or vapour infusing. The method of any one of claims 14 to 19, wherein an antibiotic is distributed throughout the porous structure. The method of any one of claims 14 to 20, further comprising a subsequent procedure in which autologous tissue is grafted into the shaped implant once a viable vascular domain is established. The method of claim 21, wherein grafting autologous tissue into the shaped implant starts about one to eighteen months after the surgical procedure. The method of claim 21 or claim 22, wherein grafting autologous tissue into the shaped implant comprises collecting the autologous tissue from another part of the patient and injecting it into the shaped implant. The method of any one of claims 21 to 23, wherein the autologous tissue is autologous fat. The method of any one of claims 14 to 24, wherein the surgical procedure is a mastectomy or a wide local excision. The method of any one of claims 14 to 25, wherein the surgical procedure is an augmentation. The method of any one of claims 14 to 25, wherein the surgical procedure includes reconstruction in a part of a patient following a surgical procedure that resulted in formation of a cavity.