Cross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 63/378,805, filed October 7, 2022, the entire contents of which is incorporated by reference herein.

Technical Field

[0001] The present disclosure generally relates to the field of surgical implants. More specifically, the disclosure relates to bioabsorbable surgical implants having increased flexibility and degradation in situ and techniques for fabricating the same.

Introduction

[0002] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described in any way.

[0003] Breast cancer treatment and/or prevention typically includes surgery to remove an area of tissue believed or proven to be cancerous or at high risk for developing cancer over time. Various surgical procedures are used to remove tissue of this nature, but in general, at least a section of the breast is removed to prevent further growth of abnormal tissue. Such surgical procedures include the removal of a portion of the breast (partial mastectomy), or if needed, the entire breast may be removed (mastectomy). Surgery is often followed by additional treatments to prevent the recurrence of cancer, and these treatments may include radiation therapy and/or chemotherapy. Soon after surgery is performed, bodily fluids known as seroma fluid usually fill in the surgical cavity. This fluid contains varying amounts of bloody and proteinaceous materials, cells that help the body during the healing process, as well as anti-inflammatory biological elements. Seroma fluid almost immediately fills the surgical cavity and may temporarily appear to restore the shape of the breast. However, over time, the body absorbs the seroma fluid, resulting in the cavity collapsing on itself to varying degrees. In many cases, scar tissue develops and can cause adherence of the margins or walls of the cavity as a natural part of the healing process. This process can result in undesirable breast deformities, ranging from dimpling of the overlying skin to large divots and unsightly and painful concavities. In addition, radiation of the area compounds these effects and makes correction of these painful abnormalities very challenging to address. When a mastectomy is performed, inadequate amounts of skin and tissue may remain to effectively reconstruct the breast to an acceptable aesthetic appearance.

[0004] Recent advances in breast cancer treatment combine the philosophy and/or principles of plastic surgery with the principles and techniques of surgical oncology in an attempt to restore the form and/or function of the breast at the time of (or after) removal of abnormal tissue. This field of surgery, called oncoplastic surgery, generally involves removing cancerous tissue and then manipulating and utilizing various body tissues or rearranging the adjacent remaining tissue to help correct any defects or gaps created by the surgery. In this manner adjacent tissue is used to fill the voids left in surgery, which can decrease seroma formation and improve the ultimate outcome, particularly in regard to the shape and contour of the breast. For example, tissue flaps may be created to provide easier manipulation, approximation, rotation, and closure of tissues in and around the surgical wound. There may be situations, however, when insufficient tissue is present to create these flaps in the size needed or to create a flap at all resulting in a smaller or malformed (deformed) breast after surgery. In other instances, the flap may be created in such a way that its blood supply is compromised, ultimately causing the flap and surrounding tissues to die, leading to fat necrosis and other undesirable patient outcomes.

[0005] In recent years, devices and/or techniques have emerged to employ in circumstances where wound tension and sparsity of tissue may otherwise cause a longstanding deformity, such as following the removal of a portion of the breast, for instance. Exemplary such devices and techniques are described in commonly owned U.S. Patent Numbers 9,615,915 and 10,500,014. Devices such as those described in these patents are formed of a bioabsorbable material such that a second surgical procedure is not necessary to remove the device from the patient (it is reabsorbed in situ in the patient’s body). After surgery, the device is implanted to help fill the surgical cavity and to act as a marker for further treatments such as radiation as the device biodegrades in place. Often these implants are made of a hard bioabsorbable material, such as Poly Lactic Acid (PLA), and this may result in the implant being palpable, an effect patients may find uncomfortable or unpleasant. In some instances, however, as the device degrades in situ, the brittleness of the bioabsorbable material can result in the device breaking into sharp fragments causing discomfort and/or pain for the patient. As such, devices, and techniques for fabricating the same, that maintain sufficient flexibility and compliance upon in situ degradation so as to diminish or minimize patient discomfort and/or pain are desirable Summary

[0006] The present disclosure addresses one or more of the above-mentioned problems and/or achieves one or more of the above-mentioned desirable features. Other features and/or advantages may become apparent from the description which follows.

[0007] In accordance with various exemplary embodiments of the present disclosure, a method of fabricating a surgical implant (e.g., a bioabsorbable surgical breast implant) may include forming an open framework body from a bioabsorbable material. The method further may include treating the open framework body with a solution configured to alter or modify a molecular structure of the bioabsorbable material. Still further, the method may include removing the solution from the altered or modified molecular structure of the bioabsorbable material forming the open framework body.

[0008] In accordance with various additional exemplary embodiments of the present disclosure, a method of fabricating a surgical implant (e.g., a bioabsorbable surgical breast implant) may include forming an implant body including a continuous framework element from a Poly Lactic Acid (P A) material. The method further may include modifying a molecular structure of the PLA material to reduce a crystalline portion of the molecular structure and to increase an amorphous portion of the molecular structure.

[0009] In accordance with various further exemplary embodiments of the present disclosure, a surgical implant sized for placement within a surgically created cavity may include a body having a continuous framework element formed from a bioabsorbable material, the bioabsorbable material having a modified molecular structure in which a crystalline portion of an original molecular structure of the bioabsorbable material is reduced and an amorphous portion of the original molecular structure of the bioabsorbable material is increased. The modified molecular structure may be configured to increase both flexibility and degradation of the framework element.

[0010] In accordance with various additional exemplary embodiments of the present disclosure, a method of reconstructing a breast may include placing a surgical implant within a cavity or space. The cavity or space may be formed by surgical removal of tissue of a breast. The surgical implant may include an open framework body formed of a bioabsorbable material having a modified molecular structure. The modified molecular structure may have a reduced crystalline portion and an increased amorphous portion. The method further may include forming one or more tissue flaps in subcutaneous tissue defining the cavity or space. Still further, the method may include draping the one or more tissue flaps over the open framework body. Further still, the method may include restoring a contour of the breast by supporting the one or more tissue flaps with the open framework body, while allowing seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body.

[0011] In accordance with various further exemplary embodiments of the present disclosure, a method of reconstructing a breast may include placing a surgical implant within a cavity or space. The cavity or space may be formed by surgical removal of tissue of a breast. The surgical implant may include an open framework body formed of a bioabsorbable material having a modified molecular structure. The modified molecular structure may have a reduced crystalline portion and an increased amorphous portion. The method further may include forming one or more tissue flaps surrounding the cavity or space. Additionally, the method may include draping the one or more tissue flaps over the open framework body. Further still, the method may include attaching the one or more tissue flaps to the open framework body by pulling the tissue flaps through the open framework body, suturing the tissue flaps through the open framework body, wrapping the tissue flaps around the open framework body, and/or suturing the tissue flaps to the open framework body. The method may additionally include restoring a contour of the breast by supporting the one or more tissue flaps with the open framework body while allowing seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body.

[0012] In accordance with various additional exemplary embodiments of the present disclosure, a surgical implant for placement within a cavity or space is provided. The cavity or space may be formed by surgical removal of tissue. The surgical implant may be made by a process including forming an open framework body from a bioabsorbable material. The process further may include treating the open framework body with a solution configured to alter or modify a molecular structure of the bioabsorbable material. Still further, the process may include removing the solution from the modified molecular structure of the bioabsorbable material forming the open framework body.

[0013] Additional objects and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present teachings. At least some of the objects and advantages of the present disclosure may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

[0014] Additional objects and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present teachings. At least some of the objects and advantages of the present disclosure may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

[0015] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure and claims, including equivalents. It should be understood that the present disclosure and claims, in their broadest sense, could be practiced without having one or more features of these exemplary aspects and embodiments.

Brief Description of the Drawings

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some exemplary embodiments of the present disclosure and together with the description, serve to explain certain principles. These drawings depict only typical embodiments of the disclosed invention and are not therefore to be considered limiting of its scope. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment can, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element can nevertheless be claimed as included in the second embodiment. In the drawings:

[0017] FIG. l is a flow diagram illustrating a method of fabricating a surgical device in accordance with some implementations of the present disclosure;

[0018] FIG. 2 is a flow diagram illustrating another method of fabricating a surgical device in accordance with some implementations of the present disclosure;

[0019] FIG. 3 is a schematic diagram illustrating a modification of the molecular structure of a portion of a framework element of a surgical implant from crystalline to amorphous upon treatment in accordance with the techniques described in the present disclosure; [0020] FIG. 4 is a schematic diagram showing one variation of a surgical implant comprising a single, U-shaped framework element and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0021] FIG. 5 is a schematic diagram showing another variation of a surgical implant comprising a single, circular framework element and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0022] FIG. 6 is a schematic diagram showing another variation of a surgical implant comprising a single, spiral-shaped framework element and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0023] FIG. 7 is a schematic diagram showing another variation of a surgical implant comprising a plurality of framework elements and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0024] FIG. 8 is a schematic diagram showing another variation of a surgical implant having a modified crystallinity and flexibility and comprising a plurality of framework elements configured to impart compressibility to the implant in accordance with implementations of the present disclosure;

[0025] FIG. 9 is a schematic diagram showing another variation of a surgical implant comprising a plurality of framework elements configured to impart compressibility to the device and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0026] FIG. 10 is a schematic diagram showing another variation of a surgical implant comprising a plurality of framework elements and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0027] FIG. 11 is a schematic diagram showing another variation of a surgical implant comprising a plurality of framework elements and having a modified crystallinity and flexibility, where one of the framework elements is a circular base and another framework element spans the diameter of the circular base in accordance with the present disclosure;

[0028] FIGS. 12-14 illustrate perspective views of other variations of surgical implants comprising a plurality of framework elements and having a modified crystallinity and flexibility, where the framework elements include a circular base (FIG. 12), an oval base (FIGS. 13A — 13C), and cross-member elements of varying heights (FIG. 14) in accordance with the present disclosure; [0029] FIGS. 15A and 15B are schematic diagrams showing other variations of surgical implants comprising spheroid framework elements and having a modified crystallinity and flexibility in accordance with the present disclosure;

[0030] FIGS. 16A-16D illustrate various methods by which breast tissue adjacent to the surgically created cavity can be manipulated using an example surgical implant;

[0031] FIG. 17 illustrates another variation of the method by which breast tissue adjacent to the surgically created cavity can be manipulated using other example devices; and [0032] FIG. 18 is an infrared absorption spectrum comparing the composition of an example surgical device before and after treatment to modify the molecular structure of the surgical implant material in accordance with the present disclosure.

[0033] FIG. 19 is a differential scanning calorimetry curve of a surgical implant formed of poly lactic acid (PLA) prior to treatment to modify the molecular structure thereof in accordance with the present disclosure.

[0034] FIG. 20 is a differential scanning calorimetry curve of a surgical implant formed of PLA after treatment to modify the molecular structure thereof in accordance with the present disclosure.

Detailed Description of the Illustrated Embodiments

[0035] Described herein are implantable devices for use in surgery, and methods for fabricating such devices, that maintain sufficient flexibility and compliance upon in situ degradation so as to diminish and/or minimize patient discomfort and/or pain. The methods and devices may be useful in oncoplastic surgery, where it is desirable to preserve and/or improve the shape, size, and contour of an area of the body where tissue has been surgically removed, such as the breast. While the example implants and methods of surgery described herein are related to use in the breast, the present disclosure is not so limited and the implant modifications described herein may be used for any implantable device formed from a material that exhibits hardness and/or brittleness and would benefit from reduced crystallinity or brittleness of the material (to reduce fragmentation or formation of sharp pieces during breakage or degradation of the material of the implantable device and/or to reduce palpability of the implantable device), increased flexibility of the material to make the implantable device more flexible, and/or an increased rate of degradation of the material of the implantable device in situ. [0036] The present disclosure relates to implantable devices made from a bioabsorbable material, where the bioabsorbable material is found substantially in its crystalline form in the formed implantable device, and methods of modifying the implantable devices to make the material of the implantable device less crystalline and more amorphous, to yield a modified implantable device which retains desirable physical characteristics of the bioabsorbable material, such as strength, biocompatibility, and degradability in situ while other characteristics of the implant are improved as relates to performance in an implantable device, such as increased flexibility of the material and modified implantable device, reduced brittleness of the material and modified implantable device, and an increased rate of degradation of the material and modified implantable device in situ.

[0037] Materials and implantable devices suitable for modification in this manner are disclosed, for example, in U.S. Patent No. 10,500,014 B2, filed March 13, 2018, and entitled “Surgical Implant for Marking Soft Tissue” and U.S. Patent No. 9,615,915, filed July 24, 2015, and entitled “Implantable Devices and Techniques for Oncoplastic Surgery,” the entire contents of each of which are incorporated herein by reference.

[0038] Described herein are methods of fabricating an implantable device, such as a marking device or a device suitable or useful in oncoplastic surgery, and methods of implanting the device. In some aspects of fabricating the device, the process includes modifying an already existing implantable device to reduce the crystalline portion of the material forming the implantable device by increasing the amorphous portion of the material forming the implantable device. In other aspects, treating the material forming the implant to include a relatively larger portion of amorphous material and a relatively smaller portion of crystalline material (when compared to an implantable product made of the same material without such a treatment) is a part of the implant fabrication process. Reducing the crystalline amount of material while simultaneously increasing the amorphous amount of the material yields a material and implant having reduced hardness/brittleness, increased flexibility, and an increased degradation rate of the material as compared to a material and implant in which the crystallinity and amorphousness have not been altered. In example embodiments, the amount of crystallinity of the material used to form the implantable device may be reduced by about 6.0 - 7.0%. Additionally, the amount of increase in the amorphous portion of the material used to form the implantable device may be about 6.0 - 7.0%, and the reduction in crystallinity also may be about 6.0 - 7.0%, a 1 : 1 correspondence for this process. The methods of fabrication described generally include forming an open framework body from a bioabsorbable material, treating the open framework body with a solution (e.g., a liquid solvent) configured to modify a molecular structure of the bioabsorbable material, and removing the solid open framework body from the solution. In some implementations, the framework body may be filtered or decanted to remove the solution therefrom. Subsequently, the body may be rinsed in warm water and rinsed with a 70% ethanol solution. Afterward, the framework body may be dried at room temperature or upon the application of heat (e.g., in an oven). In some implementations, the solution treatment can be applied after heating to form an implantable device in accordance with embodiments of the present disclosure. However, heating after treating with the solution allows the framework body to obtain increased flexibility relative to solution-treating after heating and high heating temperatures are not required to obtain the implant design shape.

[0039] In some additional implementations, to increase the stability of the amorphous molecular material of the bioabsorbable material and to help reduce the potential for recrystallization of the material, the framework body (e.g., after modification of the molecular structure of the bioabsorbable material) may be further treated with a sonochemical process. In some implementations, for example, citric acid and/or glycerol can be used as plasticizers, which are added to the PLA material of the framework body, by placing the framework body into an ultrasonic bath. In this manner, in some implementations, after initial modification of the molecular structure of the material of the framework body, the framework body can be placed in an ultrasonic bath comprising a water solution containing glycerol, citric acid, or a combination thereof. The bath can then be turned on (e.g., placed in a “sonic” setting) for a set period of time and at a relatively warm temperature. In some implementations, the sonochemical process can be applied directly to the unaltered bioabsorbable material (i.e., such that the molecular structure of the bioabsorbable material is not altered prior to the sonochemical process). However, altering the molecular structure of the material (i.e., to increase the amorphous portion) first can serve to reduce the hydrophobic properties of the PLA, thereby allowing the material to absorb more water during the ultrasound bath. In this manner, the plasticizes that are used in the sonochemical process, which are in the water solution of the bath, are more easily absorbed into the polymer molecular chains of the bioabsorbable material to stabilize the amorphous portion and increase the flexibility of the polymer.

[0040] In some further implementations, radiographically visible elements may be applied to the open framework body to aid in the visualization of the implantable device after placement. Such radiographically visible elements generally are not affected by the solution treatment or heating and, accordingly, may be positioned on the body before or after treatment.

[0041] FIG. 19 illustrates a differential scanning calorimetry curve of a surgical implant formed of poly lactic acid (PLA) prior to treatment in accordance with embodiments of the present disclosure to modify the molecular structure thereof. The bioabsorbable material of the framework body before treatment to modify the molecular structure thereof exhibits a glass transition temperature in the range of 50-70 °C. Below the glass transition temperature at 64 °C, PLA is rigid and brittle, but after that, the glass transition temperature changes from brittle polymer to ductile polymer. Above Tg (64 °C), at 108 °C, the chains have enough energy to form ordered arrangements and undergo crystallization (crystallization peak). FIG. 20 illustrates a differential scanning calorimetry curve of a surgical implant formed of PLA after treatment in accordance with embodiments of the present disclosure to modify the molecular structure thereof. After modifying the molecular structure of the bioabsorbable material (PLA) of the framework body, the crystallization peak at 108 °C disappears, the melting point is reduced by 10 degrees Celsius, and the melting enthalpy is reduced as well. The bioabsorbable material of the framework body after the treatment has more thermal stability and the material processability is enhanced. It is possible to heat the material below the melting point without a modification risk in the crystallinity properties. [0042] Described herein are methods of breast surgery and devices to be implanted during such surgeries, the implantable devices being formed in accordance with the fabrication method(s) described herein. The surgical methods and implantable devices may be useful in oncoplastic surgery, where it is desirable to preserve and/or improve the shape, size, and contour of an area of the body where tissue has been surgically removed, such as the breast. In some aspects, the surgical methods and implantable devices provide support for the tissue and may help to reapproximate tissues after surgery to prevent deformity of the skin overlying the cavity. For example, the surgical methods and implantable devices may be beneficial when insufficient tissue is present to create a tissue flap, or in the instance where sufficient tissue is present to form a tissue flap but its creation would compromise the blood supply to the tissue, causing tissue death and ultimately fat necrosis.

[0043] The methods of breast surgery described herein generally include the steps of removing tissue (such as breast tissue) to create a cavity or void (where the cavity or void may disrupt and/or deform the shape, size, or contour of the breast); placing surgical implant, formed in accordance with the fabrication methods described herein, into the cavity, where the surgical implant comprises a body having an open framework formed primarily of a supportive bioabsorbable material having an altered or modified crystallinity; manipulating, or otherwise mobilizing, undermining, and/or rotating adjacent tissues surrounding the cavity; and at some time during the surgical procedure, attaching the open framework to the surrounding tissue, typically via monofilament absorbable suture. This approach eliminates the need for the device to fill the defect, cavity, or void with foreign material, as is described in, for example, U.S. Pat. No. 7,637,498 to Corbitt, Jr (“Corbitt”). In contrast to the approach described by Corbitt, the approaches described herein include using a patient's native tissue in combination with a bioabsorbable open framework device to help reconstruct the cosmetic deformity caused by the surgical tissue resection.

[0044] Alternatively, the methods of breast surgery may include removing an area of breast tissue to create a cavity, an opening, or a space; placing a surgical implant into the cavity, the opening, or the space, the surgical implant comprising a body having an open framework and formed of a bioabsorbable material having an altered or modified molecular structure, the open framework comprising an anterior, a posterior, and lateral regions, and a plurality of framework elements that impart an ellipsoid profile to the open framework; manipulating tissue surrounding the cavity, the opening, or the space; and attaching the open framework to the manipulated tissue.

[0045] The surgical implants described herein are implantable and may include a body formed of a bioabsorbable material having an altered or modified molecular structure, resulting in a bioabsorbable material having a reduced crystallinity, an increased flexibility, and/or an increased rate of degradation as compared to the bioabsorbable material without an altered or modified molecular structure. The surgical implants described herein progressively degrade by a process of hydrolysis whereby the degradation products of the implant material are metabolized by the body into which they are implanted. Complete resorption may take one year or more. Through increasing degradation by altering or modifying the molecular structure of the implant material, the rate of absorption also may be increased.

[0046] The body is generally configured to have an open framework so that it can be attached to tissues surrounding the cavity, e.g., by passing sutures around or through the open framework and also through the adjacent tissue. The body has a length, width, and height, and may be comprised of one or more framework elements. In some variations, the body has a geometric profile that is generally of the form of a tri-axial ellipsoid or an oblate ellipsoid of revolution. The framework typically has sufficient rigidity to be sutured to adjacent tissue without significantly deforming the shape of the framework element. It also may be useful for the framework elements to have a degree of compliance, or “give” whereby the device elements are able to move while in position to accommodate patient movement. The compliant nature of the device framework, combined with the open architecture of the framework may allow the surrounding tissues to be integral within the body of the device and may create a feeling of resilience or compliance when the area of the body overlying the device is touched or pressed upon through the skin, giving the device a natural feel to the patient. This compliance in the framework elements may also serve as a “strain relief’ to the tissue that is sutured to the device, to minimize disruption of the suture/tissue interface. In some variations, it may be beneficial for the implantable surgical devices to include a body formed of a bioabsorbable material having an altered or modified molecular structure, resulting in a bioabsorbable material having a reduced crystallinity, an increased flexibility, and/or an increased rate of degradation as compared to the bioabsorbable material without an altered or modified molecular structure, the body having an open framework having a length, width, and height, and wherein the open framework comprises a periphery and a plurality of framework elements.

[0047] Additionally, the surgical implants disclosed herein are generally structured in a way that helps to support the tissue during healing, while allowing body fluids, e.g., seroma fluid, to flow freely within them. The seroma fluid can organize within the surgical implant and heal in a manner that reconstitutes the form, shape, size, and or contour of the breast. This process of regrowth generally mimics the ability of the breast to fill in the defect as seen with autologous fat grafting. Accordingly, due to their structure, the devices generally provide a means of autologous fat grafting without having to harvest and process fat from a remote surgical site. This in turn allows the breast to heal in a more natural manner and avoid potential mammographic artifacts such as calcifications associated with fat necrosis (unsuccessful fat grafting). As a result of the breast tissue being able to heal in a less stressful manner, the mammographic results may provide a more acceptable method for following the tumor resection area for the recurrence of cancer.

[0048] The surgical implants may further include a plurality of discrete radiographically visible elements, e.g., marker elements or marker clips, to aid in the visualization of the device as it was placed at the site of the surgical resection cavity and sutured to the tissues at the greatest risk for cancer recurrence. Given the specific arrangement of the spacing of these radiographically visible elements, they define the area to which the radiologist or other clinicians may direct their attention when they are seen using clinical imaging techniques such as x-ray, ultrasound, CT, etc. Treatments after surgery often include radiation, and these visible elements of the device may be useful in a variety of clinical circumstances, such as when focusing external radiation to target tissue surrounding the cavity if radiation therapy is subsequently employed.

[0049] Additionally, or alternatively, the framework of the surgical implant may be composed of a bioabsorbable element that has a relatively tissue-equivalent z-number that allows it to be relatively radiolucent on some types of imaging such as mammography, while marker clip components coupled thereto are radiopaque and easily seen on many forms of clinical imaging (e.g., CT, MR, kV X-ray).

[0050] With reference to FIG. 1, a flow diagram is shown illustrating a method 100 of fabricating a surgical implant, in accordance with some implementations of the present disclosure. The surgical implants described herein are implantable and may include an open framework body formed of a bioabsorbable material. Exemplary bioabsorbable materials may include, without limitation, collagen, polyglycolic acid (PGA, e.g., Dexon, Davis & Geek); polyglactin material (VICRYL, Ethicon); and poliglecaprone (MONOCRYL, Ethicon). Other exemplary materials may include moldable bioabsorbable materials such as poly lactic acid (PLA), including Poly L-lactic acid (PLLA), and various PLA/PGA blends, caprolactone, lactide, glycolide, and copolymers and blends thereof, and synthetic absorbable lactomer 9-1 (POLY-SORB, United States Surgical Corporation) and polydioxanone. These blends can include caprolactone, DL lactide, L lactide, glycolide and various copolymers or blends thereof. Mixtures of any of the aforementioned materials can also be used.

[0051] The surgical implant can be fabricated using injection molding to form an open framework body, as shown in step 110. In some embodiments, the open framework body may be formed in a planar configuration. If desired, the open framework body can be heat formed so that the body is reconfigured from a planar configuration to a three- dimensional configuration. Though not intended to limit the scope of embodiments of the present disclosure, several exemplary three-dimensional configurations are more fully described below.

[0052] As shown in step 112, once formed, the planar or three-dimensional body can be treated in a solution configured to modify or alter a molecular structure of the bioabsorbable material, for instance, a ketone solution. In some embodiments, the framework body may be immersed in a ketone solution bath. In some embodiments, the ketone solution may be comprised of a mixture of a ketone and an alcohol. In some embodiments, the alcohol may be ethanol. In some embodiments, the alcohol may be isopropanol. In some embodiments, the ketone solution may be comprised of a 1 : 1 solution. In some embodiments, the ketone solution may be comprised of a 1 : 1 solution of acetone and ethanol, though ketones other than acetone that are capable of modifying the crystallinity of the bioabsorbable material (increasing the flexibility and/or the degradation rate) without changing the mechanical properties of the bioabsorbable material may be used within the scope of embodiments of the present disclosure. In some embodiments, the ketone solution may be comprised of a ketone and water. In some embodiments, the ketone may be acetone. In some embodiments, the ketone may be one of ethyl acetate, methyl ethyl ketone, or cyclohexanone, although acetone is more soluble in water than any of these ketones and thus renders removing the treatment solution from the bioabsorbable material post-treatment more efficient. The framework body may be immersed for a prescribed period of time. In some embodiments, the prescribed period of time may be 10-15 hours. In some embodiments, the prescribed period of time may be 11-14 hours. In some embodiments, the prescribed period of time may be 12 hours. The flexibility of the material can be controlled with a reduction or an increase of the prescribed immersion time (that is, the longer the implant body is immersed, the greater the flexibility attained).

[0053] As shown in step 114, the solution may be removed from the modified molecular structure of the bioabsorbable material forming the open framework body. In some embodiments, the solution may be removed by heating the solution-treated open framework body to evaporate the solution. In some embodiments, the solution-treated body may be heated to 30°C to 50°C. In some embodiments, the solution-treated body may be heated to 30° to 40°C. The solution-treated body may be heated for a prescribed period of time. In some embodiments, the prescribed period of time may be 2-12 hours. In some embodiments, the prescribed period of time may be 2-10 hours. Subjecting the body to soaking and heating in this manner can modify the molecular structure of the bioabsorbable material. That is, subjecting the body to soaking and heating in this manner can reduce the crystalline regions of the framework body and increase the amorphous regions of the body. Such molecular change can cause surgical implants treated in this manner to retains desirable physical characteristics of the bioabsorbable material, such as strength, biocompatibility, and degradability in situ while other characteristics of the implant are improved as relates to performance in an implantable device, such as increased flexibility of the material and modified implantable device, reduced brittleness of the material and modified implantable device, and an increased rate of degradation of the material and modified implantable device in situ. This, in turn, can diminish or minimize the amount of pain or discomfort experienced by patients upon in situ degradation of the device.

[0054] In some additional embodiments, to increase the stability of the amorphous molecular material of the bioabsorbable material (i.e., to strengthen the amorphous material) and to help reduce the potential for recrystallization of the material, the framework body may be further subjected to a sonochemical process, such that the material is irradiated with ultrasonic waves. In various embodiments, for example, the now modified open framework body (i.e., made from a PLA material with a now modified molecular structure) can be further treated with biodegradable plasticizers, such as, for example, citric acid and/or glycerol, by placing the treated framework body in an ultrasonic bath and placing the bath in a “sonic” setting for a set period and at a relatively warm temperature. In some embodiments, the open framework body can be placed in a bath comprising a water solution containing glycerol, citric acid, or a combination thereof, and the bath may be placed in the “sonic” setting for about 1 - 15 minutes at a temperature of about 23°C to 35°C. The introduction of one or more plasticizers into the modified molecular structure of the bioabsorbable material forming the open framework body may also improve the degradation rate of the bioabsorbable material. Those of ordinary skill would understand that various sonochemical synthesis processes and/or techniques can be employed to increase the amorphous molecular material stability of the bioabsorbable material and/or to help reduce the potential for the recrystallization of the material, including but not limited ultrasonic baths and high-power probes (e.g., ultrasonic horns), and that various different and/or additional plasticizers may be employed via such processes to strengthen and/or improve the properties of the modified molecular structure of the bioabsorbable material of the open framework body.

[0055] Turning to FIG. 2, a flow diagram is shown illustrating another method 200 of fabricating a surgical implant in accordance with some implementations of the present disclosure. At step 210, an implant body is formed from a Poly Lactic Acid (PLA) material, the implant body including a continuous framework element. As stated with regard to FIG. 1, the implant body can be fabricated using injection molding to form an open framework body which, if desired, can be heat formed so that the body is reconfigured from a planar configuration to a three-dimensional configuration. At step 212, a molecular structure of the PLA material may be modified to reduce a crystalline portion of the molecular structure and to increase an amorphous portion of the molecular structure. A visual representation of such a change from a semicrystalline makeup to an amorphous makeup is illustrated in FIG. 3. A change in the molecular structure of the framework body in this manner may allow the surgical implant to maintain a higher degree of compliance and flexibility than it would without such a molecular structure change, resulting in fewer sharp edges, less breakage, and improved comfort to patients. FIG. 18 is an infrared absorption spectrum comparing the composition of an example surgical implant before and after treatment to modify the molecular structure of the surgical implant material in accordance with the present disclosure.

Example Surgical Implants

[0056] FIG. 4 depicts one variation of a surgical implant. The surgical implant 400 has an open framework body 410 that includes a single, U-shaped framework element 412. A plurality of radiographically visible elements (not shown) may be provided in structures 414 that are spaced upon the framework element 412. The framework element 412 may be slightly undulated so that upon placement within a tissue cavity, the marker elements may be positioned to prescribe a three-dimensional (3D) volume. In another variation, as shown in FIG. 5, the surgical implant 500 includes an open framework body 510 comprising a single, continuous circular framework element 512 having a plurality of radiographically visible elements 514 spaced thereon. In yet a further variation, as shown in FIG. 6, the surgical implant 600 includes an open framework body 610 comprising a single, spiral-shaped framework element 612. A plurality of radiographically visible elements (not shown) may be provided in structures 612 that are spaced upon the framework elements.

[0057] FIGS. 7-11 depict variations of surgical implants that include a plurality of framework elements. Referring to FIG. 7, surgical implant 700 has an open framework body 710 that includes a circular base element 712 and two curved or arcuate spacer elements 714. As shown in the figure, the ends of the spacer elements 714 are fixed to the base element 712. Further the curved or arcuate spacer elements 714 are offset from one another in the longitudinal plane. It may be easier to manufacture (e.g., by molding) a surgical implant having this configuration. Again, a plurality of radiographically visible elements, such as elements 716, may be spaced upon the framework elements effectively at the extremities of the x, y, and z axes of the device (as shown) or along other portions of the framework elements.

[0058] FIG. 8 depicts another variation of a surgical implant including a plurality of framework elements. The surgical implant 800 has an open framework body 810 including an ovoid base element 812 and two curved or arcuate spacer elements 814. In this variation, one end 816 of the spacer elements 814 is not attached to the base element 812 to impart some compliance or compressibility to the overall device. A plurality of radiographically visible elements 818 (e.g., titanium, pyrolytic carbon, gold, or other radiopaque biocompatible substance) also is spaced upon and/or embedded within the framework elements, at desired locations.

[0059] FIG. 9 depicts yet another variation of a surgical implant including a plurality of framework elements. In FIG. 9, surgical implant 900 includes an open framework body 910 comprised of circular base element 912 and a single curved or arcuate spacer element 914. In this variation, the ends 916a, 916b of the base element 912 are separated, and one end 916b curved outward in the direction away from the opposing spacer element 914. The end 918 of spacer element 914 and end 916b of base element 912 are shown as attached to other areas of the base element 912, but they need not be attached, e.g., if increased compressibility and or torsional deflection of the base element 912 is desired. A plurality of radiographically visible elements 920 are also spaced along the framework elements.

[0060] A further variation of a surgical implant comprising a plurality of framework elements is shown in FIG. 10. Referring to the figure, surgical implant 1000 includes an open framework body 1010 having an ovoid base element 1012 and two pairs of spacer elements 1014a and 1014b (for a total of four) with each pair residing in orthogonal planes. Spacer elements 1014b are attached to the other pair of spacer elements 1014a at fixation points 1016. The ends 1018 of spacer elements 1014a are attached to base element 1012. A plurality of radiographically visible elements 1020 also are spaced along the framework elements.

[0061] Alternatively, the surgical implant may be configured as shown in FIG. 11. In FIG. 11, surgical implant 1100 comprises an open framework body 1110 formed by a plurality of framework elements, circular base element 1112, and a solid, planar, spacer element 1114, which is attached to the base element 1116. It may be easier to manufacture (e.g., by molding) a surgical implant having this configuration. Again, a plurality of radiographically visible elements such as elements 1118 may be spaced upon the framework elements. Cutouts 1120 in the solid, planar spacer element also may be provided to hold radiographically visible elements.

[0062] Additional variations of the surgical implant are provided in FIGS. 12-14. Perspective views of these figures illustrate various configurations of the framework elements and base elements of the devices. FIG. 12 shows a surgical implant 1200 that is configured to include a circular base element 1210 with opposing cantilevered cross-member elements (framework elements 1212). The framework elements 1212 function as spacer elements and are configured to impart or provide the surgical implant with an overall profile (or 3D perimeter) in the form of an oblate ellipsoid of revolution. FIGS. 13A-13C show a surgical implant 1300 that is configured to include an oval base element 1310 with multiple (or an array of) cantilevered cross-member elements (framework elements, 1312). The profile of the framework elements 1310 and 1312 correspondingly form a tri-axial ellipsoid. These cantilevered cross member elements 1312 may appear straight when viewed from about (see FIG. 13B), but may be non-straight (e.g., arcuate, “dog-legged”) in shape (e.g., when viewed from the side) (see FIG. 13C) to provide additional height in the transverse direction (orthogonal to the general place of the base). As can be seen in FIG. 13B, the cross-member elements may or may not have radiopaque marker elements attached to them. An important function of the cross-member is to prevent opposing tissue surfaces from contacting each other during the healing process, thereby minimizing the growth of scar tissue at that location. FIG. 14 shows another surgical implant 1400 structured to include an oval base element 1410 with multiple cantilevered cross-member elements (framework elements, 1412) that impart an overall profile to the device 1400 that takes the form of a tri -axial ellipsoid. In this variation, the cantilevered cross-member elements 1412 are of greater height than the analogous elements of the variation in FIGS. 13A-13C, thereby providing greater tissue separation of potential spaces or providing for the accommodation of larger tissue cavities. [0063] As illustrated in FIGS. 15A and 15B, the surgical implant 1510 of the invention is formed as a spiral. The spiral nature can permit the implant 1510 to be more flexible than it otherwise might be. For example, the implant 1510 can flex along its axis 1524 in the manner of bendable coil spring. In addition, the lack of continuous walls can allow the implant to flex in directions other than along its axis. Such flexibility can allow for the target tissue, and the cavity into which the implant 1510 is placed, to flex as the patient moves, making the implant more comfortable for the patient. In addition, the open nature of the spiral can allow tissue growth and insinuation into the cavity which may reduce the incidence or effects of seroma, and in some instances may be able to reduce the volume of the target to be irradiated.

[0064] The shape of the illustrated implant 1510 in FIG. 15A is spherical, however, the implant could also be made in other shapes, such as a football-shaped ellipsoid (illustrated in FIG. 15B) or cylindrical. As used herein, the term “spheroid” is expressly intended to include both spherical and ellipsoid shapes for the implant 1510 - as such, both the embodiments of FIG. 15 A and FIG. 15B are spheroid. The choice of shape may depend on the shape and nature of the cavity into which the implant 1510 is being placed. In the case of a lumpectomy cavity commonly related to breast cancer, a relatively spherical shape is a common choice.

[0065] While the implant 1510 could have any shape, regular shapes that are readily modeled by external radiation beam treatment devices are preferred. Such shapes can include spherical, scalene ellipsoid, prolate spheroid, and oblate spheroid shapes. Again, the use of the term “spheroid” herein is intended to include all of these spherical and ellipsoid shapes. Other regular shapes such as cylinders or squares could also be used, however, sharp comers might make it more difficult to shape radiation doses to the target tissue. In general, the implant 1510 can have polar regions 1516, 1518 with extending portions 1520, 1522 extending between the polar regions. F In the illustrated embodiment, the extending portions 1520, 1522 extend inward toward the center of the spherical shape.

[0066] In addition, the open framework can be designed to provide specific levels of flexibility. As noted elsewhere herein, the illustrated spiral design acts as a spring. By varying the rigidity of the material making up the body 1512 and/or by varying the thickness of the body 1512, a spring constant for the device 1510 can be varied to achieve a desired flexibility. That is, by design, the spring constant may provide a certain amount of force in order to keep the markers in their position along the margins of the cavity but allow sufficient flexibility for patient comfort and to minimize scarring, therefore the device 1510 can be optimized for its intended purposes.

[0067] The devices described herein may be differentiated from implantable elements used for aesthetic or prosthetic reconstruction such as permanent implants (for example, for the breast or chin) as the disclosed devices provide a temporary structure that enables the surgeon to use the patient’s own tissues to reconstruct and minimize anatomic deformities or irregularities that would otherwise be caused by the surgical removal of tissue. In addition, the external perimeter surface of these devices is generally non-contiguous as compared to a typical prosthetic breast implant, which has a contiguous surface. Rather, the devices disclosed herein are based upon an open framework rather than a closed contiguous framework. The bioabsorbable nature of the implant absorbs slowly during the healing process but maintains its structural integrity while it is supporting the surrounding tissue flaps as they heal in place and reconstitute the size, shape, form, and/or contour of the surgical area. They may be used at the time of surgical removal or may be inserted into an area previously deformed by a surgical intervention (e.g., used at a later time following the excision of tissue after a deformity has occurred due to seroma resorption and subsequent fibrotic scarring).

[0068] Furthermore, after a given period of time (e.g., after the tissue healing response is complete), the bulk of the device is resorbed by the body, leaving behind the tissue that has grown into or moved into the original region of tissue removal, as well as leaving behind any permanent radiographically visible elements. This attribute can contribute to reduced scarring, and minimal contour deformities, as well as contribute to reconstruction, reconstitution of, or preservation of prior contour, shape, and size of the original anatomic region. By providing support to the tissues underneath the surgical wound, the devices allow the subcutaneous tissues, and in particular the subcutaneous and/or dermal lymphatics, to heal in a more efficient and direct manner, thereby decreasing the amount of post-surgical swelling (edema) and allowing for expedited and improved healing and overall improved aesthetic/cosmetic appearance. Also, prior to the complete degradation of the bioabsorbable element(s), the radiographic elements are held in their three-dimensional array during the tissue healing process, limiting their migration from their original surgically placed positions. Further, as the devices degrade in situ, flexibility and compliance are maintained so as to minimize patient discomfort and/or pain.

[0069] The devices described herein may be configured to allow for tissue to be incorporated into the open framework, by way of suturing or other attachment methods (e.g., surgical clips, wires, etc.). The tissue may be mobilized (detached) from the overlying skin and surrounding tissues in order to secure the tissue to the open framework. One way this mobilization can be achieved in breast surgery is by surgically dissecting breast tissue along the mastectomy plane, a relatively avascular plane of tissue that lies deep to the dermal layers to create a flap, which can then be mobilized and secured to the framework of the surgical implant. The tissue can be secured in many different ways to the device and, in particular, the design of the device may allow the surgeon to customize how the local reconstruction of the area is accomplished in order to avoid anatomic irregularities. The device can be used to reconstruct the area or otherwise improve the contour of the region surrounding the tissue that was removed during the surgical procedure. Such tissues might include anything that is concerning, troublesome, suspicious for cancer, or has a known biopsy -proven cancer requiring removal. This can be glandular tissue (e.g., breast, prostate), subcutaneous tissue (fat and fibrous tissue), and other soft tissue structures (e.g., muscle). The devices described herein may allow the surgeon to rearrange adjacent tissue to reconstitute and/or reconstruct the region that was excised. Accordingly, breast reconstruction for mastectomy, partial mastectomy, and mastopexy may be facilitated by using a temporary bioab sorbable open framework breast implant.

Methods

[0070] The methods of breast surgery described herein generally include the steps of removing breast tissue to create a cavity, placing a surgical implant into the cavity, the surgical implant comprising a body having an open framework formed of a modified bioabsorbable material that is less crystalline and more amorphous than a similar unmodified bioabsorbable material, and having an anterior, posterior, and lateral regions, manipulating tissue surrounding the cavity, and attaching (e.g., via suture) the open framework of the surgical implant to the manipulated tissue, as illustrated in FIGS. 16A-16D and 17. An exemplary surgically created cavity (90) in breast tissue (92), and tissues (94) (shaded area) surrounding the cavity (90) are shown in FIG. 16 A. The manipulation of tissue may comprise tissue flap creation, moving, displacing, mobilizing, or dissecting tissue (including skin) in the proximity of the removed tissue (including the tissue surrounding a cavity). Alternatively, the manipulation of tissue may include an approximation of tissues to or within the open framework. In some instances, it is useful at the time of surgery to perform tissue manipulation before, during, or after placing the surgical implant into the cavity. In other instances, it is useful to perform tissue manipulation before, during, or after securing elements (e.g., framework elements) of the open framework of the surgical implant to the tissue. In yet further instances, it may be useful to place a cavity sizing instrument in the cavity prior to selection of the proper size of surgical implant and placement of the surgical implant.

[0071] Some variations of the method include removing an area of breast tissue to create a cavity, an opening, or a space; placing a surgical implant into the cavity, the opening, or the space, the surgical implant comprising a body having an open framework and formed of a modified bioabsorbable material that is less crystalline and more amorphous than a similar unmodified bioabsorbable material, the open framework comprising an anterior, a posterior, and lateral regions, and an array of cross-member elements that impart an ellipsoid profile to the open framework; manipulating tissue surrounding the cavity, the opening, or the space; and attaching the open framework to the manipulated tissue.

[0072] In other variations, the method may be used in a breast lumpectomy procedure including all or some of the following steps: a lumpectomy cavity is created by surgically removing breast tissue via a carefully designed and contoured, cosmetically chosen skin incision that may be distinctly different from the site of the tissue removal (e.g., which may include tunneling from a circumareolar incision); the cavity is sized using a sizer and/or other sizing methods (e.g., direct examination of the lumpectomy specimen or cavity); estimating the location, size, shape and orientation of the tumor; placing an appropriately sized three- dimensional open architecture bioabsorbable tissue marker (implanted) directly into the lumpectomy cavity (preferably using a device size, shape, and location that corresponds to the size, shape, location and/or orientation of the tumor site) via the surgical incision causing the breast tissue at the margin of the cavity to actively (e.g., via suture closure) or passively insinuate or otherwise move across the peripheral boundary of the device; closing the surgical site via single or multiple layered closure techniques; and then closing the skin. Creation and mobilization of tissue flaps may be performed at any time during the above-described procedure, prior to skin closure.

[0073] Alternatively, the device may be used as above but with the added step of passing suture around one or more portions of the device and then passing the suture through adjacent tissue to tether or otherwise further secure the device to the adjacent tissue.

[0074] In one variation, as shown in FIG. 16B, the manipulation of tissue includes forming tissue flaps (96) by dissection beneath the skin (98) and draping the flaps (96) over an anterior region (100) of a surgical implant (102), in a manner somewhat analogous to an awning or tent. Although a spiral-shaped device is shown in the figure, it is understood that any surgical implant described herein may be implanted. Cross-sectional views of the implant (A) and the surgical device implanted within the cavity (B) are shown to provide further understanding of how the tissues may be manipulated and attached using the device. Again, FIG. 16B depicts closure of the tissue flaps (96) over an anterior region (100) of surgical implant (102). This closure of tissue layers beneath the skin, e.g., by suturing may help to prevent dimpling or divoting of the skin overlying the cavity, and thus preserve the natural contour of the breast. The surgical implant (102) is also secured to the tissue surrounding the cavity at other locations desired by the surgeon, (e.g., lateral attachment point (104)).

[0075] In other variations, the tissues can be mobilized and/or integrated within the device and sutured to the device at various locations through the device or along various aspects of its structural elements. The tissues may be attached to the perimeter (superior, inferior, lateral, medial) regions of the device with the device being used as a "bridge" to decrease tension on an area of tissue closure. For example, as shown in FIGS. 16C and 17, tissue surrounding the cavity, e.g., tissue flaps (106, 114) can be pulled through the device (102, 116) and secured together.

[0076] Tissues may alternatively be connected to posterior regions of a device, as shown in FIG. 16D. Referring to the figure, device (102) is used to help close the posterior aspect of cavity (108). Specifically, tissues (110) that lie posterior to the device (102) are attached to a posterior region (112) of the device (102). In many cases a combination of these approaches can be used in a single patient. These are just a few examples of how the tissues may be secured to the device in a fashion that envelopes tissue around or integrates tissue within the device in order to minimize the undesirable contour effects that the original tissue/tumor removal would otherwise have had on the surgical area.

[0077] The methods and devices described herein generally enable surgeons to mobilize tissues into a region where they have removed tissue, and that would otherwise cause a void, fill with seroma fluid after surgery, and ultimately create an anatomic deformity or irregularity. It facilitates learning and practice in the field of oncoplastic surgery, which can be described as combining the principles, philosophy, and techniques of surgical oncology (adequate tissue removal with an adequate margin), with the principles, philosophy, and techniques of aesthetic and reconstructive surgery. The ability to perform oncoplastic surgery in this manner may be facilitated by the device because it holds the tissues in place during healing, since the tissues are secured directly to the device. This allows the surgeon to suture the adjacent tissues (particularly after mobilization) to the device and support the tissues during healing, thereby preserving the contour, shape, and size of an anatomic location such as the breast. In addition, tissues may also be wrapped entirely or in part around the periphery of the device so as to envelope the entirety or portions of the device.

[0078] Further modifications and alternative embodiments will be apparent to those of ordinary skill in the art in view of the disclosure herein. For example, the devices and methods may include additional components that were omitted from the diagrams and description for clarity of operation. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the devices and methods of the present disclosure. It is to be understood that the various embodiments shown and described herein are to be taken as exemplary. Elements and materials, and arrangements of those elements and materials, may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the present teachings may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of the description herein. Changes may be made in the elements described herein without departing from the scope of the present disclosure.

[0079] Examples

[0080] Illustrative examples of the surgical implants, methods of fabricating the surgical implants, and methods of reconstructing a breast are provided below. Embodiments of the surgical implants and the fabrication and reconstruction methods described herein may include any one or more, and any combination of, the clauses described below:

[0081] Clause 1. A method of fabricating a surgical implant, the method comprising: forming an open framework body from a bioabsorbable material; treating the open framework body with a solution configured to alter or modify a molecular structure of the bioabsorbable material; and removing the solution from the altered or modified molecular structure of the bioabsorbable material forming the open framework body.

[0082] Clause 2. The method of clause 1, wherein forming the open framework body from the bioabsorbable material comprises forming the open framework body from a Poly Lactic Acid (PLA).

[0083] Clause 3. The method of clause 1 or clause 2, wherein treating the open framework body with a solution configured to alter or modify the molecular structure of the bioabsorbable material comprises immersing the open framework body within a ketone solution.

[0084] Clause 4. The method of any one of clauses 1 - 3, wherein immersing the open framework body within the ketone solution includes immersing the open framework body in a solution comprised of one part ketone and one part alcohol.

[0085] Clause 5. The method of clause 4, wherein the ketone is acetone and the alcohol is ethanol. [0086] Clause 6. The method of any one of clauses 1-5, wherein treating the open framework body with the solution configured to alter or modify the molecular structure of the bioabsorbable material comprises immersing the open framework body within a ketone solution for 10-15 hours.

[0087] Clause 7. The method of any one of clauses 1-6, wherein treating the open framework body with the solution configured to alter or modify the molecular structure of the bioabsorbable material comprises immersing the open framework body within a solution comprised of one part ketone and one part alcohol for 10-15 hours.

[0088] Clause 8. The method of any one of clauses 1-7, wherein treating the open framework body with the solution configured to alter or modify the molecular structure of the bioabsorbable material comprises immersing the open framework body within a solution comprised of one part ketone and one part alcohol for 12 hours.

[0089] Clause 9. The method of clause 8, wherein the ketone is acetone and the alcohol is ethanol.

[0090] Clause 10. The method of any one of clauses 1-9, wherein removing the solution from the modified molecular structure of the bioabsorbable material forming the open framework body comprises heating the solution-treated open framework body to evaporate the solution.

[0091] Clause 11. The method of any one of clauses 1-10, wherein removing the solution from the modified molecular structure of the bioabsorbable material forming the open framework body comprises heating the solution-treated open framework body to 30°C - 50°C.

[0092] Clause 12. The method of any one of clauses 1-11, wherein removing the solution from the altered or modified molecular structure of the bioabsorbable material forming the open framework body comprises heating the solution-treated open framework body to 30°C - 40°C.

[0093] Clause 13. The method of any one of clauses 1-12, wherein removing the solution from the altered or modified molecular structure of the bioabsorbable material forming the open framework body comprises heating the solution-treated open framework body for 2-12 hours.

[0094] Clause 14. The method of any one of clauses 1-13, wherein removing the solution from the altered or modified molecular structure of the bioabsorbable material forming the open framework body comprises heating the solution-treated open framework body for 2-10 hours.

[0095] Clause 15. The method of any one of clauses 1-14, further comprising stabilizing the altered or modified molecular structure of the bioabsorbable material by irradiating the treated open framework body with ultrasonic waves.

[0096] Clause 16. The method of clause 15, wherein irradiating the treated open framework body with ultrasonic waves comprises placing the treated open framework body in an ultrasonic bath, the ultrasonic bath comprising a water solution including glycerol and/or citric acid.

[0097] Clause 17. A method of fabricating a surgical implant, the method comprising: forming an implant body including a continuous framework element from a Poly Lactic Acid (PLA) material; and modifying a molecular structure of the PLA material to reduce a crystalline portion of the molecular structure and to increase an amorphous portion of the molecular structure.

[0098] Clause 18. The method of clause 17, wherein modifying the molecular structure of the PLA material to reduce the crystalline portion of the molecular structure and to increase the amorphous portion of the molecular structure comprises treating the implant body with a ketone solution.

[0099] Clause 19. The method of clause 18, wherein treating the implant body with a ketone solution comprises immersing the implant body within a solution comprised of one part ketone and one part alcohol.

[0100] Clause 20. The method of clause 18 or clause 19, wherein treating the implant body with a ketone solution comprises immersing the implant body within a solution comprised of one part acetone and one part ethanol for 10-15 hours.

[0101] Clause 21. The method of any one of clauses 18-20, wherein treating the implant body with a ketone solution comprises immersing the implant body within a solution comprised of one part acetone and one part ethanol for 11-14 hours.

[0102] Clause 22. The method of any one of clauses 18-21, wherein treating the implant body with a ketone solution comprises immersing the implant body within a solution comprised of one part acetone and one part ethanol for 12 hours [0103] . Clause 23. The method of any one of clauses 18-22, wherein modifying the molecular structure of the PLA material to reduce the crystalline portion of the molecular structure and to increase the amorphous portion of the molecular structure further comprises removing the solution from the implant body.

[0104] Clause 24. The method of clause 23, wherein removing the solution from the implant body comprises heating the implant body.

[0105] Clause 25. The method of clause 24, wherein heating the implant body includes placing the implant body in a space heated to 30°C - 50°C.

[0106] Clause 26. The method of any one of clauses 23-25, wherein heating the implant body includes placing the implant body in a space heated to 30°C - 40°C.

[0107] Clause 27. The method of any one of clauses 23-26, wherein heating the implant body includes placing the implant body in a heated space for 2-12 hours.

[0108] Clause 28. The method of any one of clauses 23-27, wherein heating the implant body includes placing the implant body in a heated space for 2-10 hours.

[0109] Clause 29. The method of any one of clauses 17-28, further comprising stabilizing the amorphous portion of the molecular structure of the PLA via a sonochemical process.

[0110] Clause 30. The method of claim 29, wherein stabilizing the amorphous portion of the molecular structure of the PLA via the sonochemical process includes treating the modified molecular structure of the PLA in an ultrasonic bath including glycerol and/or citric acid.

[OHl] Clause 31. A surgical implant sized for placement within a surgically created cavity, the surgical implant comprising: a body including a continuous framework element formed from a bioabsorbable material, the bioabsorbable material having a modified molecular structure in which a crystalline portion of an original molecular structure of the bioabsorbable material is reduced and an amorphous portion of the original molecular structure of the bioabsorbable material is increased, wherein the modified molecular structure is configured to increase both flexibility and degradation of the continuous framework element.

[0112] Clause 32. The surgical implant of clause 31, wherein the continuous framework element forms a spiral extending between a first end portion and a second end portion and having an open center. 1 [0113] Clause 33. The surgical implant of clause 31 or clause 32, wherein the continuous framework element has a flattened or low-profile shape.

[0114] Clause 34. The surgical implant of any one of clauses 31-33, wherein the body further includes a radiographically visible element.

[0115] Clause 35. A method of reconstructing a breast, the method comprising: placing a surgical implant within a cavity or space, the cavity or space being formed by surgical removal of tissue of a breast, the surgical implant comprising an open framework body formed of a bioabsorbable material having a modified molecular structure, the modified molecular structure having a reduced crystalline portion and an increased amorphous portion; forming one or more tissue flaps in subcutaneous tissue defining the cavity or space; draping the one or more tissue flaps over the open framework body; and restoring a contour of the breast by supporting the one or more tissue flaps with the open framework body, while allowing seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body.

[0116] Clause 36. A method of reconstructing a breast, the method comprising: placing a surgical implant within a cavity or space, the cavity or space being formed by surgical removal of tissue of a breast, the surgical implant comprising an open framework body formed of a bioabsorbable material having a modified molecular structure, the modified molecular structure having a reduced crystalline portion and an increased amorphous portion; forming one or more tissue flaps surrounding the cavity or space; draping the one or more tissue flaps over the open framework body; attaching the one or more tissue flaps to the open framework body by pulling the tissue flaps through the open framework body, suturing the tissue flaps through the open framework body, wrapping the tissue flaps around the open framework body, and/or suturing the tissue flaps to the open framework body; and restoring a contour of the breast by supporting the one or more tissue flaps with the open framework body, while allowing seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body. [0117] Clause 37. A surgical implant for placement within a cavity or space, the cavity or space formed by surgical removal of tissue, wherein the surgical implant is made by a process comprising the steps of: forming an open framework body from a bioabsorbable material; treating the open framework body with a solution configured to alter or modify a molecular structure of the bioabsorbable material; and removing the solution from the modified molecular structure of the bioabsorbable material forming the open framework body.

[0118] Clause 38. The surgical implant of clause 37, further comprising placing the treated open framework body in an ultrasonic bath, the ultrasonic bath including glycerol and/or citric acid.

[0119] Clause 39. The surgical implant of clause 37, further comprising stabilizing an amorphous portion of the altered or modified molecular structure of the bioabsorbable material by introducing one or more biodegradable plasticizers into the altered or modified molecular structure of the bioabsorbable material.

[0120] Clause 40. The surgical implant of clause 39, wherein the one or more biodegradable plasticizers are citric acid and/or glycerol.

[0121] Clause 41. The surgical implant of clause 39 or clause 40, wherein introducing one or more biodegradable plasticizers into the altered or modified structure of the bioabsorbable material includes placing the treated open framework body in an ultrasonic bath containing the one or more biodegradable plasticizers.

[0122] The method of fabricating a surgical implant of any one of clauses 1-30 can be practiced with the surgical implant of any one of clauses 31-34 and 37-41 and/or in conjunction with the method of reconstructing a breast of any one of clauses 35 and 36.

[0123] The surgical implant of any one of clauses 34-31 and 37-41 can be used with any one of the methods of fabricating of any one of clauses 1-30 and/or the methods of reconstructing a breast of any one of clauses 35 and 36.

[0124] The method of reconstructing a breast of any one of clauses 35 and 36 can be practiced with the surgical implant of any one of clauses 31-34 and 37-41 and/or in conjunction with the method of fabricating a surgical implant of any one of clauses 1-30.

[0125] It is to be understood that the particular examples and embodiments set forth herein are non-limiting, and modifications to structure, dimensions, materials, and methodologies may be made without departing from the scope of the present disclosure. Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with being entitled to their full breadth of scope, including equivalents.