Minimally Invasive Breast Lifting System

Abstract

Breast fixation implants for lifting a patient's breast create new tissue planes within the breast that provide a more durable lift and are particularly useful for lifting breasts with high adipose tissue mass. The implants are implanted through a stab incision using blunt dissection and can provide improved aesthetic appearance with minimal scarring while shortening surgery time. The implants are designed to be temporary and have sufficient strength retention to allow the new tissue planes to form and support the lifted breast without significant loss of support during this regeneration period.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 141,743, filed January 26, 2021, the disclosure of which is incorporated by reference in its entirety into this specification.

[0002] FIELD OF THEINVENTION

[0002] The present invention relates generally to implants and systems that may be used to lift tissues and organs minimally invasively, and in particular to implants and systems that may be used in cosmetic surgical procedures, including mastopexy. The implants and systems may be used to minimize scar formation during lifting procedures, particularly in the upper pole of the breast. [Background technology]

[0003] 2. Background of the Invention

[0003] Numerous cosmetic surgical procedures are performed each year to restore or modify body shape or bodily functions. Many of these procedures seek to restore a youthful appearance or even enhance a current appearance. Natural factors, such as aging and gravity, contribute to the loss of a youthful appearance. For example, skin laxity, loss of muscle tone and weakened ligaments can lead to breast ptosis (sagging). Plastic surgeons have developed many surgical techniques to correct the ptosis of different anatomical structures that can occur with aging. These techniques differ in the type of incision, the direction of the incision, the plane of dissection, the amount of dissection, the extent of tissue repositioning, the use of different types of sutures, different suturing techniques and different fixation techniques.

[0004]

[0004] Plastic surgeons have developed several different mastopexy procedures to lift the breasts. However, these procedures can be very invasive, require extensive excision, and can leave the patient with visible scarring. For example, a lollipop or vertical mastopexy procedure is performed by making an incision around the areola and a vertical incision from the areola to the inframammary fold (IMF) at the lower pole of the breast. The Anchor or Wise procedure is a more invasive procedure than the lollipop procedure, in which an incision is made across the inframammary fold in addition to the vertical incision used in the lollipop procedure. Both the lollipop and anchor procedures can leave permanent scarring at the lower pole of the patient's breast and can provide poor cosmetic results in that regard.

[0005]

[0005] Less invasive suture-based mastopexy procedures have been developed that help minimize scarring. These include the Benelli mastopexy, where a donut-shaped piece of breast skin is excised from around the areola with a medial incision that follows the circumference of the areola and a lateral incision that circles the areola. Although this technique minimizes scarring, it can result in significant stretching or tissue necrosis of the areola, since all of the weight of the newly elevated breast parenchyma is supported by the sutures around the areola that are used to approximate the breast skin back around the areola.

[0006]

[0006] Some surgeons have attempted to use surgical mesh to reinforce lift procedures in open mastopexy and breast reconstruction procedures. Some of these techniques also incorporate the use of various reinforcement materials similar to those used in hernia repair, such as flat polymer mesh, allografts, xenografts, and autografts. However, materials wrapped around the parenchyma without the use of anchoring elements to shift the load of the skin at the lower pole may leave the breast exposed to the same ptosis forces that existed before breast surgery.

[0007]

[0007] In 1981, Johnson described the use of MARLEX® (polypropylene) mesh to redirect breast tissue support from dermal to skeletal after mastopexy by attaching it to the area of ​​the second rib (Johnson, Aesth. Plast. Surg. 5:77-84 (1981)). Flat MARLEX mesh is a permanent mesh made of polypropylene that is implanted to provide two slings for each breast to support the breast tissue. This procedure is based on the Wise open breast lift.

[0008] Auclair and Mitz have described mesh-assisted mastopexy using a flat absorbent mesh and a periareolar skin excision technique (Auclair and Mitz, Ann. Chir. Plast. Esthet. 38:107-113 (1993)). A rapidly absorbing VICRYL® mesh was placed around the anterior surface of the mammary gland to form an internal brassiere. The procedure requires open breast surgery and involves extensive excision.

[0009]

[0009] Goes has reported the use of polyglactin 910 (an absorbable copolymer of 90% glycolide and 10% L-lactide, also known as VICRYL) and a mixed mesh (containing 60% polyglactin 910 and 40% permanent polyester) in periareolar mammaplasty using a double skin technique (Goes, Plast. Reconstr. Surg. 97:959-968 (1996)). The open surgical technique involves peeling the soft tissue envelope from the stroma and encasing the breast stroma with mesh to help induce the formation of a tough connective scar and create an inner breast structure that may not be subject to ptosis.

[0010]

[0010] U.S. Patent No. 6,210,439 to Firmin et al. discloses a circular VICRYL mesh with V-shaped openings extending from the center and metal reinforcing wires running around the periphery. The implant is designed to be inserted in an invasive open surgical procedure, and when the reinforcing wires are tightened, it assumes a cone shape suitable for mammoplasty.

[0011]

[0011] U.S. Patent No. 7,476,249 to Frank discloses an implantable sling-type prosthetic device for supporting and positioning a breast implant within a patient, the device being constructed from a sheet of permanent, chemically inert material, such as polytetrafluoroethylene or silicone, to support the breast implant. The sling-type device is designed to be placed in an invasive procedure via open surgery.

[0012]

[0012] U.S. Patent Application Publication No. 2009 / 0082864 by Chen et al. also discloses a prosthetic device for supporting mesh breast implants. The device has a flat posterior wall, a concave anterior wall, and a curved transition region therebetween that forms a smoothly curved bottom perimeter. Insertion of the device requires an open surgical procedure with significant dissection.

[0013]

[0013] U.S. Patent Application Publication No. 2008 / 0097601 by Codori-Hurff et al. discloses mastopexy and breast reconstruction procedures assisted by the use of processed tissue material derived from intestine or dermis. The tissue material is cut into a crescent shape to form an implant for mastopexy and is implanted using an invasive open surgical procedure.

[0014]

[0014] U.S. Patent Application Publication No. 20160038269 to Altman discloses various woven silk implants that can be implanted using open surgery to support the lower breast.

[0015]

[0015] U.S. Patent Application Publication No. 20120185041 to Mortarino et al. discloses a knitted silk mesh that can be used to provide support to the lower pole of the breast.

[0016]

[0016] U.S. Patent Application Publication No. 20130304098 to Mortarino discloses a silk implant in the form of a pocket that can be used in breast reconstruction.

[0017]

[0017] WO 2009 / 001293 to Lauryssen discloses a polypropylene and polyester mesh implant formed into a cup shape that can be used in a mastopexy procedure. The mesh is implanted in an open surgical procedure to completely surround the breast tissue.

[0018]

[0018] International Publication No. 2004 / 096098 to Hamilton discloses a permanent implant that can be formed into a breast shape for soft tissue support, made from polytetrafluoroethylene (ePTFE), and used to create a predetermined breast shape.

[0019]

[0019] WO 2006 / 117622 to Lauryssen et al. discloses a permanent implant for soft tissue support of the breast that is generally L- or U-shaped and wraps around the breast to provide support.

[0020]

[0020] Van Deventer et al. (Aesth. Plast. Surg. 36:578-89 (2012)) disclose the use of an internal breast support system for mastopexy that uses a partially degradable mesh formed into a cone (van Deventer et al. Aesth. Plast. Surg. 36:578-89 (2012)). The mesh is implanted in an open surgical procedure to completely surround the upper and lower poles of the breast.

[0021]

[0021] US Patent No. 9,532,867 to Felix discloses an absorbable implant for breast surgery that conforms to the breast parenchyma and can support the newly elevated breast parenchyma.

[0022]

[0022] U.S. Patent Application Publication No. 20100023029 to Young discloses a sheet of VICRYL for use in breast reconstruction that includes several attachment areas for attaching the sheet to a patient's anatomy. The device can be used to partially cover and constrain tissue expanders or implants.

[0023]

[0023] WO 2007004214 to Popov discloses a basket-like device for supporting the lower pole of the breast. The device is designed to be implanted using open surgery.

[0024]

[0024] Several devices have been described for performing open surgical mastopexy procedures by mimicking the breast's own fascial support system, the ligaments at the inferior border of the breast.

[0025]

[0025] US Patent Application Publication No. 2017 / 0224471 to Rehnke discloses a circular tubular member with purse string sutures that can be used when the ligaments at the lower breast border are stretched or weakened to lift the breast. The device is inserted in an open surgical procedure to tighten the ligaments at the lower breast border. The device is placed behind the breast gland above the pectoral muscle, anchored to the ligaments at the lower breast border, and tightened to a smaller diameter using purse string sutures. The tightening narrows the footprint of the base of the breast and gathers the breast into a higher or more prominent position on the patient's chest.

[0026]

[0026] U.S. Patent Application Publication No. 2017 / 0231753 to Lee discloses a material that is placed into the pectoral muscles under the breast using an open procedure to encompass the circumference of the breast tissue, stretching and securing the material above the breast and attaching the material to the pectoral muscle tissue on the inside and outside of the breast to elevate the breast tissue.

[0027]

[0027] Several devices have been described for performing a minimally invasive mastopexy procedure using a sling.

[0028]

[0028] U.S. Patent Application Publication No. 2008 / 0027273 to Guterman discloses a minimally invasive breast fixation system having a soft tissue support sling. The device is designed to provide support by suspending the breast from the upper pole region using a sling.

[0029]

[0029] Moses et al., US Patent Application Publication No. 2012 / 0283826, discloses a minimally invasive breast fixation system having an insertion device, a lifting strut, and a lower pole support that is inserted beneath the lower pole of the breast as a suspension device to elevate the breast.

[0030]

[0030] US Patent Application Publication No. 20100217388 to Cohen discloses a subframe member for shaping the soft tissue of the breast, which acts as a sling device and is implanted to elevate the lower pole of the breast.

[0031]

[0031] U.S. Patent No. 7,670,372 to Shfaram et al. discloses a minimally invasive breast lifting system that incorporates one or more lifting members and a base frame member that is positioned under the inferior pole of the breast. The base frame member is connected to the lifting members and acts as a suspension device to lift the breast.

[0032]

[0032] U.S. Patent Application Publication No. 2010 / 0331612 to Lashinski et al., U.S. Patent Application Publication No. 2008 / 0082113 to Bishop et al., and U.S. Patent Application Publication No. 2009 / 0248071 to Saint et al. disclose devices for performing minimally invasive mastopexy procedures that include a sling and soft tissue anchors introduced superiorly to support the breast. U.S. Patent Application Publication No. 2012 / 0053689 to Martin et al. discloses PHA fibers for use in these devices. Summary of the Invention [Means for solving the problem]

[0033] Summary of the Invention

[0033] The implants and systems described herein assist surgeons in reshaping, repositioning or lifting the breast to provide a pleasing appearance.

[0034] In some aspects, an implant is provided. In some embodiments, the breast implant can include a unitary elongate member having a first end and a second end, the unitary elongate member being sized to surround the breast beneath the skin.

[0035] In some aspects, a breast fixation system is provided that includes an implantable, unitary elongate member having first and second ends and sized to surround the breast beneath the skin, and a sheath connected to and at least partially surrounding the elongate member.

[0036] In some aspects, a method is provided. In some embodiments, a method of lifting or tightening a breast includes providing one or more introduction devices and a breast implant, inserting the breast implant into the breast using the one or more introduction devices such that the breast implant surrounds the upper and lower poles of the breast under the skin, removing the one or more introduction devices from the breast, and lifting or tightening the breast using the breast implant.

[0037]

[0037] In some aspects, a method is provided. In some embodiments, a method of lifting or tightening a breast includes providing one or more introduction instruments and a breast implant, the breast implant including an assembly of an implantable integral elongate member having first and second ends sized to surround the upper and lower poles of the breast under the skin, and one or more sheaths connected to the member near one or more ends of the member and at least partially surrounding the member. The method also includes inserting the assembly into the breast using the one or more instruments such that the member surrounds the upper and lower poles of the breast under the skin, removing the one or more introduction instruments from the breast, removing the one or more sheaths from the breast, and lifting or tightening the breast using the member.

[0038]

[0038] In some aspects, a method is provided. In some embodiments, the method of lifting or tightening the breasts comprises any combination of the steps described herein.

[0039]

[0039] In some aspects, a kit is provided. In some embodiments, a kit for breast lifting or tightening includes an elongate member, a sheath, and an introduction device as described herein.

[0040]

[0040] In some aspects, kits are provided. In some embodiments, a kit for breast lifting or tightening includes any combination of components described herein.

[0041]

[0041] These advantages, as well as other objects and advantages of the present invention, will become apparent from the following detailed description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0042] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1]

[0042] A breast fixation system 1 for minimally invasive breast lift is shown comprising an assembly of an elongated member 2 partially covered by a sheath 3 and two introduction devices 4, the introduction devices being mounted at opposite ends of the sheath-covered elongated member assembly. [Figure 2A]

[0043] 1 illustrates steps for performing a minimally invasive mastopexy lift using the breast fixation system shown in Figure 1. Shown is the contour and NAC 11 of a patient's breast 10 and the insertion of a first introducer instrument 12 of a breast fixation system 13 through a first incision 14. Arrow 15 indicates the direction in which the first introducer instrument is advanced within the breast to encircle one side of the breast beneath the skin of the breast. [Figure 2B]

[0043] Steps for performing a minimally invasive mastopexy lift using the breast fixation system shown in Figure 1 are shown, showing the contour and NAC 21 of a patient's breast 20, the position of a first introducer instrument 22 of a breast fixation system 23 after insertion into the breast, and the location of a second incision 24 where a removable barrel tip 25 of the first introducer instrument exits the breast by moving the introducer instrument in the direction indicated by arrow 26. [Figure 2C]

[0043] Steps for performing a minimally invasive mastopexy lift using the breast fixation system shown in Figure 1 are shown, showing the contour and NAC 31 of the patient's breast 30, the position of the removable barrel tip 32 of the first introducer instrument exteriorized through a second incision 33 in the breast, the position of the sheathed elongate member assembly 34 encircling the breast beneath the skin of the breast from the first incision to the second incision after removal of the first introducer instrument (shown in Figure 2B), and the second introducer instrument 35 loaded with the remaining portion of the elongate member ready for insertion into the other side of the patient's breast. [Figure 2D]

[0043] Steps for performing a minimally invasive mastopexy lift using the breast fixation system shown in Figure 1 are shown, showing the contour and NAC 41 of a patient's breast 40, the position of a second introducer instrument 42 encircling the breast under the skin of the breast after insertion through a first incision 43, and a removable barrel tip 44 of the second introducer instrument intended to exit the breast through a second incision 45 by moving the introducer instrument in the direction indicated by arrow 46. [Figure 2E]

[0043] Steps are shown for performing a minimally invasive mastopexy lift using the breast fixation system shown in Figure 1. The contour and NAC 51 of a patient's breast 50 are shown with an elongated member 52 encircling the breast beneath the skin of the breast and an end 53 of the elongated member exposed from the breast through a second incision 54. An upwardly pointing arrow 55 indicates the direction for pulling the end 53 of the elongated member to lift the breast. [Diagram 3]

[0044] An exploded view of an exemplary system 60 for mastopexy is shown. An assembled view of the system is shown in FIG. 1. The system shows an elongate member 61 with a first end 61a and a second end 61b, two sheaths 62, two introducer instruments 63, and a latch 64 for connecting the assembly of elongate member 61 and sheath 62 to a removable barrel tip 65. Detail W of FIG. 3 shows a view of a C-shaped cross section 67 of the sheath 62. Detail V of FIG. 3 shows an enlarged view of the elongate member 61, showing the porous structure 68 of the elongate member. [Figure 4]

[0045] Shown is an exploded isometric view 70 of an assembly of an elongate member 71 and a sheath 72. Shown is the structure of the fused end 73 of the assembly of the elongate member 71 and the sheath 72. Detail T shows the cross-sectional structure of the sheath 72. Detail U shows the enlarged pores 74 of the elongate member. The fused end 73 of the elongate member and the sheath is shown provided with perforations 75. [Diagram 5]

[0046] 1 shows an introduction device 80 loaded with an assembly 81 of an elongate member surrounded by a sheath. Detail I shows an enlarged cross-section of assembly 81 showing elongate member 82 and sheath 83. The introduction device 80 shows a handle 84, a removable barrel tip 85, and a tubular section 86 with a first end 87 and a second end 88. The first end 87 of the tubular section 86 is shown connected to the removable barrel tip 85, and the second end 88 of the tubular section 86 is shown connected to the handle 84. Detail K shows an enlarged view 89 of the handle with a universal grip. A slit 90 is shown in the tubular section of the introduction device 80, dimensioned to allow for the insertion and removal of the assembly 81. Detail J is an enlarged view of the tubular section of the introduction device showing the slit 91 and tubular section 92. An entrance opening 93 of the introduction device 80 is shown where the assembly 81 is inserted into the tubular section 86 of the introduction device 80. Detail H is a close-up of the entry opening 93 through which the elongate member and sheath assembly is inserted. Detail C is a close-up of the removable barrel tip cutting edge 95. Detail F is a close-up of the removable barrel tip latch receiver 96 which is sized to receive an attachment feature (not shown) formed by the fusion of the ends of the elongate member and sheath assembly. [Figure 6]

[0047] 1 shows an exploded isometric view of an introducer 100 loaded with an elongate member and sheath assembly 101. Detail M shows a close-up of a removable barrel tip 102 attached to a first end 103 of the introducer tubular section and a sharp cutting edge 104 of the removable barrel tip. Detail M also shows an elongate member and sheath assembly 105 terminating in an attachment feature 106 formed by fusing the elongate member and sheath together, and a latch 107 with a locking pin 108 sized to pass through a bore 109 in the attachment feature 106. The removable barrel tip 102 is shown with a latch receiver 110 including two recessed holes 111 sized to receive the locking pin 108. A clip 112 of the latch 107 is sized to engage a recessed feature 113 of the latch receiver 110 to secure the attachment feature 106 to the removable barrel tip 102 for implantation of the assembly 101 and to allow removal after implantation of the assembly. [Figure 7A]

[0048] A side view of an introducer instrument 120 suitable for use in a mastopexy procedure is shown. [Figure 7B]

[0048] A longitudinal cross-section of the introducer device shown in Figure 7A is shown along the axis designated by QQ. A longitudinal cross-section of the tubular section 121, the lumen 122 of the tubular section and the removable barrel tip 123 of the introducer device is shown. [Figure 7C]Detail R shown in FIG. 7C shows a longitudinal cross-section of a removable barrel tip 124 fastened to a first end 125 of a tubular section of an introducer instrument 126 by a fastening mechanism. The fastening mechanism is shown with a mounting pin 127 located on the removable barrel tip sized for insertion into the first end 125 of the tubular section of the introducer instrument 126, and a disengagement notch 128 for releasing the removable barrel tip 124 from the first end 125 of the tubular section of the introducer instrument 126 by releasing the mounting pin 127. The removable barrel tip 124 is also shown with a lumen 129 for inserting an attachment feature (not shown) of an elongate member and sheath assembly (not shown). Detail R also shows a latch 130 with two locking pins 131 inserted into latch receivers 132 of the removable barrel tip 124. The removable barrel tip 124 is shown with a blunt stripping tip 133. [Figure 8A]

[0049] A front view of an introducer device 140 is shown, onto which an elongate member and sheath assembly 141 is loaded. [Figure 8B] 8A shows a cross-section of an introducer device taken along axis OO in the direction of the arrow shown in FIG. 8A shows a tubular section 142 of the introducer device, a removable barrel tip 143 connected to a first end 144 of the tubular section 142, a slit 145 in the tubular section 142 of the introducer device, and a cross-section 146 of the tubular section surrounding an elongate member and sheath assembly 147 folded over into a C-shape. [Figure 8C]

[0049] A close-up of detail P shown in Figure 8B is shown. Detail P shown in Figure 8C shows a cross-sectional view of the tubular section 148 of the introducer with a C-shape, a slit 149 in the tubular section of the introducer, and a sheath 150 encasing an elongate member 151 formed in a C-shape within the tubular section 148 of the introducer. The sheath 150 encasing the elongate member 151 is formed in a C-shape within the tubular section 148. [Figure 9]

[0050] An introduction instrument 160 is shown with a removable barrel tip 161 connected to a first end 162 of a curved tubular section 163 of the introduction instrument 160, a second end 164 of the curved tubular section 163 connected to a first end 165 of a straight tubular section 166, and a second end 167 of the straight tubular section connected to a handle 168. The removable barrel tip 161 has a cutting tip or blunt stripping tip 169 attached. [Figure 10]

[0051] An implant (170) for mastopexy is shown made of an elongate member (171) with a fastening anchor (172) for securing the elongate member to the breast. The fastening anchor (172) is shown to be T-shaped with a T-shaped cap pin (173) and an arm (174) connected to the T-shaped cap pin (173) and to the elongate member (171). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] Detailed Description of the Invention

[0052] The inventors have recognized that, despite the advances discussed above, most mastopexy procedures require open surgical procedures that create long surgical incisions that leave noticeable, permanent scars in the breast, especially in the immediate post-procedure period. These scars can leave patients dissatisfied with the aesthetic results of the procedure and disappointed that the procedure did not meet their expectations. Furthermore, the procedures described generally involve extensive dissection of tissue planes in the lower pole of the breast and insertion of a sling or other structure to elevate or shape the lower pole. The extensive dissections in these existing procedures typically require the use of general anesthesia and long recovery times.

[0044]

[0053] In some embodiments, implants and systems for mastopexy may be used to provide defined cosmetic results without open surgery, large incisions, and extensive tissue dissection and manipulation, which minimizes the formation of permanent scars in the breast, particularly in the upper pole of the breast. In particular, it would be desirable to provide implants and systems for mastopexy that may be used to avoid the use of scarring surgical incisions, tissue plane dissection, excess skin removal, and the use of sutures to close the incisions. In particular, it would be desirable to provide mastopexy implants that may be implanted through small stab incisions. Such a procedure may shorten the surgery time and reduce the need for general anesthesia. The latter not only eliminates the potential risks associated with general anesthesia and long recovery times associated with open surgical procedures, but also provides a more attractive and simple mastopexy procedure, especially for some younger patients who may prefer to delay more invasive procedures such as those mentioned above. It may also be desirable to provide implants and systems for minimally invasive mastopexy that may be used in patients with fatty breasts, i.e., low-density breast tissue, where breast tissue is more difficult to lift due to the high amount of fatty tissue present in such breasts.

[0045]

[0054] Before describing the present invention in detail, it should be understood that the present invention is not limited to the specific variations described herein, since various changes or modifications to the described invention may be made without departing from the spirit and scope of the present invention, and equivalents may be substituted. As will be apparent to one skilled in the art upon reading this disclosure, each of the individual embodiments described and shown herein has separate components and features that can be easily separated or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Furthermore, many modifications may be made to adapt a particular situation, material, composition of matter, process, act(s) or step(s) of a process to one or more objectives, spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

[0046]

[0055] The methods described herein may be carried out in any order of the described events and in the sequence of the described events that is logically possible. Moreover, when a range of values ​​is provided, it is understood that every intermediate value between the upper and lower limit of that range, and any other stated or intermediate value within that stated range, is included within the invention. It is contemplated that any optional feature of the described inventive variations may be described and claimed independently or in combination with any one or more of the features described herein.

[0047]

[0056] All existing subject matter discussed herein (e.g., publications, patents, patent applications, and hardware) is incorporated herein by reference in its entirety, unless that subject matter may conflict with the subject matter of the present invention, in which case what is presented herein takes precedence.

[0048]

[0057] Reference to a singular item includes the possibility of a plural of the same items. More specifically, the singular forms "a," "an," "said," and "the," as used in this specification and the appended claims, include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement shall serve the function of the preceding description regarding the use of exclusive terminology, such as "solely," "only," and the like, in connection with the recitation of the claimed elements or the use of a "negative" limitation.

[0049]

[0058] In embodiments, the implants and systems for mastopexy are designed to minimize scar formation, shorten surgery time, and shorten patient recovery time. The implants can be implanted into the patient's breast through one or more small openings using blunt dissection. The implants and systems for mastopexy avoid using traditional surgical approaches such as crescent mastopexy, donut (or Benelli) mastopexy, lollipop (or vertical) mastopexy, and anchor (or Weiss or Wise) mastopexy, all of which typically require extensive surgical incisions along with removal of patient tissue to insert the mastopexy implant into the breast. In embodiments, the implants are implanted through a single opening in the lower pole of the breast or a single opening in the upper pole of the breast. In embodiments, the implants for mastopexy are implanted by creating one opening in the lower pole of the breast and one opening in the upper pole of the breast.

[0050]

[0059] In embodiments, implants and systems for mastopexy include a unitary elongate member sized to encircle the breast beneath the skin of the breast, the unitary elongate member having a first end and a second end. In embodiments, the elongate member is sized to encircle the superior and inferior poles of the breast beneath the skin of the breast. After implantation into the breast, a force may be applied to the elongate member to lift or tighten the breast. In embodiments, the ends of the elongate member are secured after lifting the breast by affixing the ends of the elongate member to tissue. In embodiments, the ends of the elongate member are secured after lifting the breast by tying the ends of the elongate member together or connecting the ends of the elongate member.

[0051]

[0060] In embodiments, the implants and systems for mastopexy are designed for use with minimal surgical intervention. In embodiments, the implants are implanted into the breast using stab incision and blunt dissection. In embodiments, the implants are designed for implantation without the use of general anesthesia.

[0052]

[0061] The length and surface area of ​​the elongate members of the implant allow for the load of the lifted tissue to be distributed and not localized. The distribution of load by the elongate members helps to maintain the breast lift and prevent subsequent ptosis. The elongate members are particularly useful for lifting a patient's breast when the breast contains fatty breast tissue, i.e., low-density breast tissue, and when sutures cannot be reliably held within fatty breast tissue.

[0053]

[0062] In particular, the elongate member of the implant is not a sling with support lines that are fastened to tissue inside and outside the breast. Instead, the elongate member is designed to encircle and lift the breast beneath the skin of the breast. The elongate member may be secured to the breast by either fastening the ends of the elongate member to tissue or by tying the ends of the elongate member together to tighten the breast.

[0054]

[0063] The implant is designed to encourage tissue ingrowth. In embodiments, the elongate member of the implant is porous. In embodiments, the elongate member comprises a fabric or textile. In embodiments, the elongate member of the implant comprises a mesh, knitted mesh, crocheted mesh, woven mesh, non-woven mesh, tape, braid, and film or porous film. In embodiments, the elongate member of the implant comprises a tangle-free mesh. In embodiments, the elongate member of the implant comprises a monofilament. In embodiments, the elongate member of the implant comprises an oriented monofilament. In embodiments, the oriented monofilament of the elongate member is resorbable. In embodiments, the average diameter of the fibers of the elongate member is between 0.02 mm and 0.7 mm, between 0.05 mm and 0.25 mm, between 0.07 mm and 0.175 mm, and / or any other suitable range of diameters.

[0055]

[0064] In an embodiment, the elongate member of the implant is resorbable. In an embodiment, the elongate member comprises one or more resorbable polymers. In an embodiment, the elongate member retains strength in vivo for a sufficient length to allow transfer of breast support from the elongate member to new tissue without losing support to the lifted breast tissue. In an embodiment, the elongate member retains at least 15% of its initial strength, at least 30% of its initial strength, and / or at least 50% of its initial strength 12 weeks after implantation in the breast. In an embodiment, the elongate member acts as a temporary scaffold to lift or tighten the breast, providing initial support to the breast, but degrades over time and is replaced by host tissue.

[0056]

[0065] In embodiments, the elongate member of the implant is capable of withstanding a load of at least 5 N, at least 10 N, or at least 60 N. In embodiments, the elongate member of the implant is capable of withstanding a load of less than 500 N.

[0057]

[0066] In embodiments, the elongate member of the implant is capable of withstanding a burst force of at least 1 N, or at least 10 N. In embodiments, the elongate member is capable of withstanding a burst force of less than 1,000 N.

[0058]

[0067] In embodiments, the elongate member of the implant may have at least one of the following characteristics: (i) a suture pull-out strength of at least 1 kgf; (ii) a burst strength of 0.1-100 kg, 1-50 kg, 5-100 kg, 10-50 kg, and / or any other suitable burst strength; (iii) a thickness of 0.05 mm; (iv) a thickness of 5-800 g / m 2 , 10~1000g / m 2 , 20~500g / m 2 , 5~1000g / m 2 , 10~100g / m 2 , 200~800g / m 2and / or any other suitable areal density, and (v) a pore size of 5 μm to 10 mm, 10 μm to 1 mm, 100 μm to 10 mm, 10 μm to 100 μm and / or any other suitable pore size. In some embodiments, the elongate member of the implant may have at least one of the following properties: (i) a suture pull-out strength of 1 kgf to 20 kgf, (ii) a burst strength of 1 to 50 kg or 10 to 50 kg, (iii) a thickness of 0.1 to 1 mm, 0.5 to 2 mm, 0.1 to 0.5 mm and / or any other suitable thickness, (iv) a pore size of 100 to 300 g / m 2 areal density, and (v) pore size ranging from 100 μm to 1 mm.

[0059]

[0068] In some embodiments, the burst strength of the elongate member of the implant is between 0.6 and 90 N / cm 2 and / or 1.2 to 30N / cm 2 In embodiments, the elongate member of the implant may have at least one of the following characteristics: (i) a burst strength of 0.1-100 kg, 1-50 kg, 5-100 kg, 10-50 kg, and / or any other suitable burst strength, (ii) a suture pull-out strength of at least 1 kgf, (iii) a burst strength of 0.1-100 kg, (iv) a thickness of 0.05-5 mm, 0.1-1 mm, 0.1-0.5 mm, and / or any other suitable thickness, (v) a thickness of 5-800 g / m 2 , 10~1000g / m 2 , 20~500g / m 2 , 5~1000g / m 2 , 10~100g / m 2 , 200~800g / m 2 and / or any other suitable areal density, and (vi) pore size from 5 μm to 10 mm, 10 μm to 1 mm, 100 μm to 10 mm, 10 μm to 100 μm and / or any other suitable pore size.

[0060]

[0069] In embodiments, the elongate member of the implant comprises a fabric, mesh or cloth, and the fabric, mesh or cloth may have at least one of the following characteristics: (i) a suture pull-out strength of at least 1 kgf; (ii) a burst strength of 0.1-100 kg, 1-50 kg, 5-100 kg, 10-50 kg, and / or any other suitable burst strength; (iii) a thickness of 0.05 mm; (iv) a thickness of 5-800 g / m 2 , 10~1000g / m 2 , 20~500g / m 2 , 5~1000g / m 2 , 10~100g / m 2 , 200~800g / m 2 and / or any other suitable areal density, and (v) a pore size of 5 μm to 10 mm, 10 μm to 1 mm, 100 μm to 10 mm, 10 μm to 100 μm and / or any other suitable pore size. In some embodiments, the elongate member of the implant comprises a fabric, mesh or cloth, and the fabric, mesh or cloth may have at least one of the following properties: (i) a suture pull-out strength of 1 kgf to 20 kgf, (ii) a burst strength of 1 to 50 kg or 10 to 50 kg, (iii) a thickness of 0.1 to 1 mm, 0.5 to 2 mm, 0.1 to 0.5 mm and / or any other suitable thickness, (iv) a pore size of 100 to 300 g / m 2 areal density, and (v) pore size ranging from 100 μm to 1 mm.

[0061]

[0070] In an embodiment, the elongate member of the implant comprises poly-4-hydroxybutyrate (P4HB) or a copolymer thereof. In an embodiment, the elongate member of the implant comprises poly(butylene succinate) (PBS) or a copolymer thereof. In an embodiment, the elongate member of the implant comprises polydioxanone. In an embodiment, the elongate member of the implant comprises P4HB or a copolymer thereof, PBS or a copolymer thereof, or polydioxanone in the form of a woven fabric, cloth or mesh, a monofilament woven fabric, mesh or cloth made of monofilaments and / or made of oriented monofilaments. In an embodiment, the elongate member comprises one or more polymers, which may be synthesized from or comprise one or more of the following monomers: glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, adipic acid, and succinic acid.

[0062]

[0071] In an embodiment, a system for mastopexy includes an implant integral elongate member sized to encircle the breast beneath the skin of the breast, with a first end and a second end, and a sheath connected to the member and at least partially surrounding the member. In an embodiment, the implant elongate member is sized to encircle the superior and inferior poles of the breast beneath the skin of the breast. In an embodiment, an end of the sheath is connected to one end of the elongate member to form an elongate member and sheath assembly. In an embodiment, an end of the sheath is fused to one end of the elongate member to form the assembly. In an embodiment, the sheath assembly fused to the elongate member further includes an attachment feature for connecting the implant and sheath assembly including the elongate member to an introduction instrument. In an embodiment, the attachment feature includes one or more holes drilled in the area where the elongate member is fused to the sheath. In an embodiment, the attachment feature of the elongate member and sheath assembly is connected to an introduction instrument. In an embodiment, the introducer includes a tubular section with a first end and a second end, the first end of the tubular section being connected to a removable barrel tip, the second end of the tubular section being connected to a handle, and the tubular section includes a slit extending at least a portion of its length. In an embodiment, the slit of the tubular section is sized to receive at least a portion of the elongate member and sheath assembly. In an embodiment, a cross-section of at least a portion of the tubular section of the introducer has a C-shape with a cavity sized to allow insertion of an implant including an elongate member inside the introducer tubular section. In an embodiment, at least a portion of the cross-section of the implant and sheath assembly including an elongate member is formed or folded into a C-shape to fit within at least a portion of the introducer tubular section. In an embodiment, the introducer further includes a removable barrel tip with a latch receiver to secure an attachment feature of the elongate member and sheath assembly to the removable barrel tip.In an embodiment, the system for mastopexy further includes a latch, which may be used to secure the attachment feature of the elongate member and sheath of the implant to the latch receiver of the removable barrel tip. In an embodiment, the latch includes one or more locking pins, which may be inserted through one or more holes in the attachment feature. In an embodiment, the introducer instrument includes a fastening mechanism that allows the removable barrel tip to be attached or detached from the first end of the tubular section of the introducer instrument. In an embodiment, the fastening mechanism includes one or more mounting pins that attach the removable barrel tip to the first end of the tubular section of the introducer instrument and a disengagement notch for releasing the removable barrel tip from the first end of the tubular section of the introducer instrument. In an embodiment, the removable barrel tip includes a blunt dissection or cutting tip. In an embodiment, the tubular section of the introducer instrument further includes an entrance opening. In an embodiment, the entrance opening is located near the second end of the tubular section of the introducer instrument. In an embodiment, the breast fixation system is constructed by at least partially inserting an implant and sheath assembly including an elongate member into a tubular section of an introducer instrument, optionally through an entrance opening in the tubular section of the introducer instrument. In an embodiment, the breast fixation system is constructed by (i) inserting a fusion section of the assembly through an entrance opening located near a second end of the tubular section of the introducer instrument, (ii) advancing the fusion section within the tubular section toward a first end of the tubular section of the introducer instrument until it exits the first end of the tubular section of the introducer instrument, (iii) inserting the fusion section of the assembly into a latch receiver of a removable barrel tip that is attached to the first end of the tubular section of the introducer instrument, and (iv) inserting a locking pin of the latch through a mounting feature of the assembly and securing the latch in the latch receiver to secure the fusion section to the removable barrel tip.

[0063]

[0072] In an embodiment, the breast fixation system includes an implant that includes an elongate member that includes one or two fastener anchors. The fastener anchors are designed to hold the elongate member in place after the breast has been lifted. In an embodiment, the fastener anchors may include holes sized to receive sutures. Sutures may be passed through the holes and used to fasten the fastener anchors to tissue to secure the elongate member in place. The fastener anchors are located near one or both ends of the elongate member and approximately 2-10 cm from both ends of the elongate member. In an embodiment, the fastener anchors have a T-shape. In an embodiment, the fastener anchors are formed with a T-shaped cap pin that includes holes sized to receive sutures and two arms that connect the T-shaped cap pin to the elongate member.

[0064]

[0073] In an embodiment, the breast fixation system includes two identical introducers and an elongate member of the implant, the elongate member being at least partially surrounded by one or more sheaths, the elongate member including fused sections of the elongate member and sheath at each end, which can be fastened to a removable barrel tip at a first end of each introducer.

[0065]

[0074] In embodiments, the elongate member of the implant comprises a fabric, a tape, a ribbon, a film, a porous film, a cloth, a knitted mesh, a woven mesh, or a tangle-free mesh. In embodiments, the elongate member comprises one or more polymers. In embodiments, the one or more polymers comprise one or more monomers selected from the group consisting of glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, adipic acid, and succinic acid.

[0066]

[0075] In an embodiment, a method of breast lifting is provided that includes the steps of (i) inserting one or more introducing instruments and an implant including an elongate member sized to surround the upper and lower poles of the breast in the breast such that the elongate member surrounds the upper and lower poles of the breast under the skin of the breast, (ii) removing the one or more introducing instruments from the breast, and (iii) lifting or clamping the breast using the elongate members. In an embodiment, the method of breast lifting further includes at least partially covering the elongate members with one or more sheaths to form an assembly prior to inserting the elongate members into the breast, inserting the assembly of the elongate members and the one or more sheaths into the breast using the one or more introducing instruments, removing the one or more introducing instruments from the breast, and removing the one or more sheaths from the breast prior to lifting or clamping the breast with the elongate members. In an embodiment, the method of lifting further includes forming attachment features on one or both ends of the elongate members at least partially covered by the sheaths, attaching an introducing instrument to the attachment feature, and inserting the elongate members into the breast using the introducing instruments. In an embodiment, the method of lifting further includes providing an introducer instrument with a tubular section and a slit extending at least a portion of its length, connecting an attachment feature of the assembly to a removable barrel tip located at an end of the introducer instrument, and inserting the elongate member and sheath assembly at least partially into the tubular section of the introducer instrument. In an embodiment, the method of lifting further includes providing a removable barrel tip with a stripping or cutting tip, and using the tip to form a channel surrounding the upper and lower poles of the breast under the skin of the breast. In an embodiment, the method of lifting further includes implanting an implant including the elongate member in the channel surrounding the upper and lower poles of the breast.In an embodiment, the method of lifting further comprises providing a removable barrel tip with a fastening mechanism for attachment and removal of the removable barrel tip from an introduction instrument, connecting an attachment feature of an elongate member to the removable barrel tip using the fastening mechanism, inserting an introduction instrument with an elongate member into the breast, and detaching the removable barrel tip from the introduction instrument using the fastening mechanism and removing the removable barrel tip from the breast. In an embodiment, the method of lifting further comprises removing the removable barrel tip connected to the attachment feature from the breast, and then withdrawing the introduction instrument minus the removable barrel tip from the breast. In an embodiment, the method of lifting further comprises removing the removable barrel tip through a small opening in the upper pole of the breast and removing the remaining portion of the introduction instrument through a small opening in the lower pole of the breast. In an embodiment, the method of lifting further comprises removing the removable barrel tip through a small opening in the lower pole of the breast and removing the remaining portion of the introduction instrument through a small opening in the upper pole of the breast. In an embodiment, the method of lifting further includes providing a removable barrel tip with a latch receiver and a latch, and inserting the latch through the attachment feature and into the latch receiver to secure the elongate member to the introduction instrument.

[0067]

[0076] In an embodiment, a method of lifting a breast includes the steps of: (i) providing an implant including an elongated member having a first end and a second end; (ii) introducing the first end of the elongated member into the lower pole of the breast or into the IMF such that the elongated member surrounds the lower and upper poles of the breast under the skin of the breast on the outside of the breast; (iii) exteriorizing the first end of the elongated member from the upper pole of the breast; (iv) introducing the second end of the elongated member into the lower pole of the breast or into the IMF at the same location where the first end of the elongated member was introduced such that the elongated member surrounds the lower and upper poles of the breast under the skin of the breast on the inside of the breast; (v) exteriorizing the second end of the elongated member at the same location where the first end of the elongated member was exteriorized from the upper pole of the breast; (vi) tensioning the first and second ends of the elongated member to lift the breast; and (vii) securing the ends of the elongated member to maintain the lift of the breast.

[0068]

[0077] In an embodiment, a method of lifting a breast includes the steps of: (i) providing an implant including an elongated member having a first end and a second end; (ii) introducing the first end of the elongated member into an upper pole of the breast such that the elongated member surrounds the upper and lower poles of the breast under the skin of the breast on the outside of the breast; (iii) exteriorizing the first end of the elongated member from the lower pole or IMF of the breast; (iv) introducing the second end of the elongated member into the upper pole of the breast at the same location where the first end of the elongated member was introduced such that the elongated member surrounds the upper and lower poles of the breast under the skin of the breast on the inside of the breast; (v) exteriorizing the second end of the elongated member at the same location where the first end of the elongated member was exteriorized from the lower pole or IMF of the breast; (vi) pulling the first and second ends of the elongated member to lift the breast; and (vii) securing the ends of the elongated member to maintain a lift of the breast.

[0069]

[0078] In an embodiment, a method for lifting a breast includes the steps of: (i) providing an implant including an elongated member having a first end and a second end; (ii) introducing the first end of the elongated member into the lower pole of the breast or into the IMF in the breast such that the elongated member surrounds the lower and upper poles of the breast under the skin of the breast; (iii) exteriorizing the first end of the elongated member from the breast at a location where the first end of the elongated member was introduced into the breast or into the IMF; (iv) pulling the first and second ends of the elongated member to lift the breast; and (v) securing the ends of the elongated member to maintain a lift of the breast. In an embodiment, the method of lifting further includes: (a) introducing a first end of the elongate member using an introducing instrument having a detachable tip, the detachable tip being connected to one end of the elongate member; (b) exteriorizing the end of the elongate member from the breast by directing the detachable tip of the introducing instrument toward the skin of the breast; (c) advancing the introducing instrument until the tip is exteriorized from the breast; (d) detaching the tip connected to the elongate member from the introducing instrument; (e) removing the introducing instrument from the breast; (f) applying tension to the end of the elongate member to lift the breast; and (g) optionally trimming the end of the elongate member and securing the elongate member to maintain the position of the lifted breast.

[0070]

[0079] In an embodiment, a method of breast lift includes implanting an implant including an elongate member into the breast and using the elongate member to lift the breast by making a single incision for implantation and lifting the breast. In an embodiment, a method of breast lift includes implanting an elongate member into the breast and using the elongate member to lift the breast by making a single incision in the IMF or in the lower breast.

[0071]

[0080] In an embodiment, a method of lifting a breast includes (i) providing one or more introducing devices and an assembly including an implantable implant including a unitary elongate member having first and second ends sized to encircle the upper and lower poles of the breast under the skin of the breast, and one or more sheaths connected to the member near one or more ends of the elongate member and at least partially surrounding the member, (ii) inserting the assembly into the breast using the one or more introducing devices such that the elongate members encircle the upper and lower poles of the breast under the skin of the breast, (iii) removing the one or more introducing devices from the breast, (iv) removing the one or more sheaths from the breast, and (v) lifting or clamping the breast with the elongate members. In an embodiment, the method of lifting a breast further includes forming attachment features on one or both ends of the elongate members, connecting the attachment features to one or more introducing devices at one or both ends of the elongate members, and inserting the elongate members into the breast using the one or more introducing devices. In an embodiment, the method of breast lifting further comprises inserting the elongate member and sheath assembly at least partially into a tubular section of an introducer instrument, the tubular section having a slit extending at least a portion of its length with an entrance opening for insertion of the assembly, a first end connected to a removable barrel tip, and a second end connected to a handle. In an embodiment, the method of breast lifting further comprises connecting an attachment feature of the elongate member to the removable barrel tip. In an embodiment, the method of breast lifting further comprises using the removable barrel tip of the introducer instrument to form a channel sized for implantation of the elongate member and surrounding the upper and lower poles of the breast under the skin of the breast. In an embodiment, the method of breast lifting further comprises removing the removable barrel tip from the introducer instrument after inserting the elongate member and sheath assembly into the breast, and withdrawing the introducer instrument from the breast.

[0072]

[0081] In an embodiment, the method of lifting the breast includes lifting or clamping the breast and then attaching an elongate member to tissue or lifting or clamping the breast and then tying the ends of the elongate member together.

[0073]

[0082] In an embodiment, a method of breast lift includes implanting a resorbable elongate member. In an embodiment, the resorbable elongate member is formed from one or more polymers, which may be synthesized from or include one or more of the following monomers: glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, adipic acid, and succinic acid.

[0074]

[0083] In an embodiment, the method of forming a breast fixation system includes forming an implant including an elongate member by knitting, weaving, braiding, extruding or casting, and inserting the elongate member at least partially into a sheath. In an embodiment, the elongate member is knit into a mesh, and the mesh is tangle-free. In an embodiment, the method of forming a breast fixation system further includes forming an assembly of an elongate member and a sheath by connecting or fusing the sheath and the member at one end of the elongate member to form an attachment feature, and connecting the assembly to an introduction device using the attachment feature. In an embodiment, the method of forming a breast fixation system further includes connecting or fusing the elongate member and the sheath at both ends of the elongate member to form two attachment features, and connecting each attachment feature to an introduction device. In an embodiment, the attachment feature is formed by fusing the elongate member and the sheath to form an assembly of an elongate member and a sheath, and drilling one or more holes where the member and the sheath are fused. In an embodiment, the method of forming a breast immobilization system further comprises forming one or more introducers comprising a tubular section with a first end and a second end and a slit extending at least a portion of the length of the tubular section, connecting a removable barrel tip to the first end of the tubular section, and attaching a handle to the second end of the tubular section. In an embodiment, the method of forming a breast immobilization system further comprises forming a removable barrel tip with a blunt stripping or cutting tip. In an embodiment, the method of forming a breast immobilization system further comprises forming a latch receiver to secure the attachment feature to the removable barrel tip. In an embodiment, the method of forming a breast immobilization system further comprises forming an introducer comprising a fastening mechanism to enable attachment and removal of the removable barrel tip from the first end of the tubular section.In an embodiment, the fastening mechanism is formed using one or more mounting pins for attaching the removable barrel tip to the tubular section of the introducer instrument and a disengagement notch for releasing the removable barrel tip from the tubular section of the introducer instrument. In an embodiment, the method of forming the breast fixation system further comprises securing the attachment feature of the elongate member and sheath assembly to a latch receiver of the removable barrel tip using a latch, the latch having one or more locking pins. In an embodiment, the method of forming the breast fixation system further comprises inserting the elongate member and sheath assembly at least partially into the tubular section of the introducer instrument through a slit in the tubular section.

[0075]

[0084] In an embodiment, a method of performing a mastopexy includes forming a loop around the breast under the skin with a unitary elongate member, reducing the diameter of the loop to elevate the breast, and securing the ends of the elongate member together after the reducing step. In an embodiment, the method is performed through no more than two stab incisions. In an embodiment, the method is performed without attaching the elongate member to bone or ligaments.

[0076]

[0085] In an embodiment, the cross-section of the elongate member is similar to the cross-section of a ribbon or tape.

[0077]

[0086] In embodiments, the breast immobilization system includes a tensioner that can be used to adjust the tension of the elongate member, thereby adjusting the degree of breast lift or clamping.

[0078]

[0087] In embodiments, the elongate members may be implanted without removing tissue from the patient.The elongate members may be implanted without removing skin from the patient.

[0079]

[0088] In embodiments, an implant including an elongate member is implanted using blunt dissection by inserting a blunt dissection instrument into the breast and forcing the instrument through the breast tissue with sufficient penetrating force to penetrate the tissue and form a channel in the breast for the elongate member.

[0080]

[0089] In embodiments, implants comprising elongated members serve to provide the surgeon with a means to deliver cells, stem cells, gels, hydrogels, bioactive agents, drugs, biological agents, adipose tissue, autologous fat, lipoaspirate, adipocytes, fibroblasts and other materials to the implantation site.

[0081]

[0090] In embodiments, the endotoxin content of the implant including the elongate member is less than 20 endotoxin activity units. In embodiments, the implantable components of the breast fixation system are sterile. The implantable components may be sterilized by ethylene oxide, low temperature ethylene oxide, electron beam irradiation or gamma irradiation.

[0082]

[0091] The implants, breast fixation systems and methods described herein are substantially different from other implants and methods previously disclosed for mastopexy and breast reconstruction.

[0083]

[0092] First, the implant is designed to be implanted in a minimally invasive manner, rather than through an open surgical procedure that would result in extensive breast ablation and significant scarring of the breast. The implant is designed to be implanted in the breast using one or two small incisions (e.g., stab incisions). The elongated member of the implant is not placed in the breast through a highly invasive open surgical procedure, and the breast is not lifted by pulling on a drawcord. Second, the implant is designed to be fastened in a single location within the breast, unlike slings that are typically fastened in two locations, on the outside and inside of the breast, to form a hammock under the lower pole of the breast. In some embodiments, the implant can be designed to be fastened in front of the NAC at the IMF or in the lower breast, or alternatively, the implant is designed to be fastened superior to the NAC (as opposed to fastening on the inside and outside of the breast). Third, the implant includes an integral elongated member for lifting the breast. The implant is not formed by implanting multiple components in the breast. The elongate member is present in both the upper and lower breast of the patient. Fourth, the implant is sized to lift the breast by encircling the breast under the skin of the breast. The implant is not sized to form a sling device that cannot encircle the breast. Fifth, the elongate member of the implant is designed to be deployed in vivo at least partially from at least one sheath. Sixth, the breast fixation system is designed with an introducer including a removable barrel tip connected to the elongate member of the implant. After implanting the elongate member in the breast, the removable barrel tip can be exteriorized from the breast and removed from the introducer. Seventh, the breast is not slinged using sutures, but rather the elongate member is used to encircle the entire breast under the skin of the breast to tighten and lift the breast. Eighth, the elongate member of the implant is implanted by forming a channel that encircles the breast. Ninth, the elongate member has a first and second end. The elongate member does not have a ring or circular structure.

[0084]

[0093] Referring now to Figures 1 and 2A-E, a system for minimally invasive breast lift and a procedure for using the system for breast lift on a patient's breast are shown to facilitate an understanding of the present invention. In particular, Figure 1 shows a system for minimally invasive breast lift 1 comprised of an implant assembly including an elongated member 2 partially covered by a sheath 3 and two introducer instruments 4 on which opposite ends of the sheathed elongated member assembly are loaded. The introducer instruments include a tubular section and are provided with a slit 5 that allows for insertion of the sheathed elongated member assembly into the tubular section. The introducer instruments 4 are fitted with a removable barrel tip 6 that is connected to the end of the elongated member and sheath assembly. The system 1 is implanted into a patient's breast to lift or tighten the breast, for example, as shown in Figures 2A-E. Figure 2A shows the contour and NAC 11 of a patient's breast 10 and the insertion of a first introducer instrument 12 of a system for minimally invasive breast lift 13 into the patient's breast through a first incision 14. An introducer instrument 12 is inserted either within the lower pole of the patient's breast and / or at the patient's IMF and advanced in the direction indicated by arrow 15 beneath the skin of the breast and around the breast.

[0085]

[0094] FIG. 2B shows the contour and NAC 21 of a patient's breast 20 with a first introducer instrument 22 of a breast immobilization system 23 inserted within the breast, and the location of a second incision 24 where a removable barrel tip 25 of the first introducer instrument exits the breast at the upper pole of the breast by moving the introducer instrument in the direction indicated by arrow 26.

[0086]

[0095] FIG. 2C shows the contour and NAC 31 of the patient's breast 30 with the removable barrel tip 32 of the first introducer instrument being exteriorized through a second incision 33 at the upper pole of the breast, the position 34 of the sheathed elongate member assembly within the breast after removal of the first introducer instrument with the assembly surrounding the breast beneath the breast skin from the first incision to the second incision, and the second introducer instrument 35 loaded with the remaining portion of the elongate member ready for insertion on the other side of the patient's breast.

[0087]

[0096] FIG. 2D shows the contours and NAC 41 of a patient's breast 40 with a second introducer instrument 42 inserted through first incision 43 and encircling the opposite side of the breast under the skin of the breast with a removable barrel tip 44 of the second introducer instrument intended to exit the breast through second incision 45 by moving the introducer instrument in the direction indicated by arrow 46.

[0088]

[0097] 2E shows the contour of the patient's breast 50 and the NAC 51 with the elongated member 52 encircling the breast beneath the skin of the breast after the end 53 of the elongated member has been exteriorized at the second incision 54 and after the removable barrel tip and sheath have been removed from the elongated member. The mastopexy procedure is completed by pulling the end 53 of the elongated member upwardly, as shown by arrow 55, and securing and trimming the elongated member to maintain the breast lift.

[0089]

[0098] To facilitate further understanding, the following definitions are set forth below: However, it should also be recognized that unless otherwise defined as described herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0090] definition

[0100] "Bioactive agents," as generally used herein, are used to refer to therapeutic, prophylactic or diagnostic agents, preferably agents that promote healing and regeneration of host tissue, and also therapeutic agents that prevent, inhibit or eliminate infection. "Bioactive agents" includes a single such agent, and is intended to include a plurality of such.

[0091]

[0101] A "blend," as generally used herein, means a physical combination of different polymers, as opposed to a copolymer formed from two or more different monomers.

[0092]

[0102] "Burst strength" as used herein, unless otherwise specified, is determined by a test method based on ASTM D6797-02, "Standard test method for bursting strength of fabrics constant rate of extension (CRE) ball burst test," using an MTS Q-Test Elite universal testing machine or similar equipment, except that the test fixture uses a 3 / 8 inch diameter ball with a 1 / 2 inch diameter opening.

[0093]

[0103] "Copolymer of poly-4-hydroxybutyrate" as generally used herein means any polymer containing 4-hydroxybutyrate with one or more different hydroxy acid units.

[0094]

[0104] "Poly(butylene succinate) copolymer" as generally used herein means any polymer of succinic acid and 1,4-butanediol monomers incorporating one or more additional monomers. Examples of poly(butylene succinate) copolymers include poly(butylene succinate-co-adipate), poly(butylene succinate-co-terephthalate), poly(butylene succinate-co-ethylene succinate) and poly(butylene succinate-co-propylene succinate). Poly(butylene succinate-co-adipate) can be made, for example, by condensation polymerization from succinic acid, adipic acid and 1,4-butanediol. Copolymers of poly(butylene succinate) include polymers that include (i) succinic acid and 1,4-butanediol units, and (ii) one or more of the following additional units, such as chain extenders, crosslinkers, and branching agents. Examples of these agents or agents include malic acid, citric acid, tartaric acid, and glycerol. Examples of copolymers of poly(butylene succinate) include succinic acid-1,4-butanediol-malic acid copolyester, succinic acid-1,4-butanediol-citric acid copolyester, succinic acid-1,4-butanediol-tartaric acid copolyester, succinic acid-1,4-butanediol-malic acid copolyester further comprising citric acid, tartaric acid, or a combination thereof, succinic acid-adipic acid-1,4-butanediol-malic acid copolyester, succinic acid-adipic acid-1,4-butanediol-citric acid copolyester, succinic acid-adipic acid-1,4-butanediol-tartaric acid copolyester, or succinic acid-adipic acid-1,4-butanediol-malic acid copolyester further comprising citric acid, tartaric acid, or a combination thereof. Copolymers of poly(butylene succinate) include polymers containing succinic acid units and 1,4-butanediol units and one or more hydroxycarboxylic acid units or triol units. The copolymers may also contain maleic acid units or fumaric acid units or a combination thereof.

[0095]

[0105] "Diameter" as generally used herein is determined in accordance with the United States Pharmacopeia (USP) standard for surgical suture diameters (USP 861).

[0096]

[0106] "Endotoxin content" as generally used herein refers to the amount of endotoxin present in an implant or sample, and is determined using the Limulus amebocyte lysate (LAL) assay.

[0097]

[0107] "Inframammary fold" or "IMF" as generally used herein is the location where the lower pole of the breast meets the chest wall.

[0098]

[0108] "Lower pole" as generally used herein means that portion of the breast that lies between the inframammary fold (IMF) and the nipple meridian reference and protrudes from the chest wall.

[0099]

[0109] "Molecular weight," as generally used herein, unless otherwise specified, refers to the weight average molecular weight (Mw) rather than the number average molecular weight (Mn), and is measured by GPC on polystyrene.

[0100]

[0110] "Orientation," as generally used herein, refers to the alignment of polymer chains within a material or structure. For example, an oriented fiber means that some or all of the polymer chains in the fiber are aligned.

[0101]

[0111] As used herein, "PBS" means poly(butylene succinate).

[0102]

[0112] "Poly-4-hydroxybutyrate" as generally used herein means a homopolymer containing 4-hydroxybutyrate units. As used herein, it may also be referred to as P4HB or TephaFLEX® biomaterial (manufactured by Tepha, Inc., Lexington, Mass.).

[0103]

[0113] "Pore size" as generally used herein is calculated using the open source 25 ImageJ software available at https: / / imagej.nih.gov / ij / index.html.

[0104]

[0114] "Resorbable" as generally used herein means that a material is broken down within the body and the breakdown products are eliminated or excreted from the body. The terms "absorbable", "resorbable", "degradable" and "erodible", with or without the prefix "bio", may be used interchangeably herein to describe materials that are broken down and gradually absorbed, excreted or eliminated by the body, regardless of whether the breakdown is primarily by hydrolysis or via metabolic processes.

[0105]

[0115] "Strength retention" refers to the amount of time a material maintains a particular mechanical property after implantation into a human or animal. For example, if the tensile strength of a resorbable fiber decreases by half at 3 months from the time of implantation into an animal, the strength retention of the fiber at 3 months would be 50%.

[0106]

[0116] "Subglandular" as used herein in relation to breast implant placement means that the implant is placed below the gland of the breast but superficial to the pectoral muscle.

[0107]

[0117] "Subpectoral" as used herein in relation to breast implant placement means that the implant is placed in the chest below the pectoral muscle.

[0108]

[0118] "Suture pull-out strength" as used herein means the peak load (kg) at which the implant cannot hold the suture. It is determined using a tensile tester by clamping the implant to a horizontal holding plate, threading a loop of suture through the implant at a distance of 1 cm from the edge of the implant, and clamping the suture arm to a fiber grip positioned above the implant. The test is performed at a crosshead rate of 100 mm / min and the peak load (kg) is recorded. The suture is selected so that the implant fails before the suture fails.

[0109]

[0119] "Integral" as generally used herein means a single unit or continuous entity.

[0110]

[0120] "Upper pole" as generally used herein means the upper part of the breast that is located between the upper pole reference and the nipple meridian reference and rises from the chest wall.

[0111]

[0121] "Yarn" as used herein means a continuous strand of textile fiber or filament. Yarns may be twisted, untwisted, or substantially parallel strands.

[0112]

[0122] Materials for making implants and systems for mastopexy - Patent application

[0123] In embodiments, implants and breast fixation systems have been developed that use a variety of materials to perform minimally invasive mastopexy procedures. The implants lift tissue within the breast, resulting in a more aesthetically pleasing breast. The systems and implants eliminate the need for extensive dissection of the breast, which typically leads to skin scarring. The use of implants and breast fixation systems eliminates the need to use sling devices in mastopexy procedures to lift the lower pole of the breast. The breast fixation systems reduce the time required to lift the breast and reduce patient morbidity. The implanted extension members can be made of resorbable materials that degrade after implantation and do not leave foreign material in the breast. While the resorbable material is being resorbed, tissue ingrowth into the extension members provides new tissue planes that support the breast lift and prevent ptosis.

[0113]

[0124] A. Polymers for Making Implants and Systems for Mastopexy

[0125] Breast fixation implants may include permanent materials, such as non-degradable thermoplastic polymers, such as ethylene and propylene polymers and copolymers, such as ultra-high molecular weight polyethylene, ultra-high molecular weight polypropylene, nylon, polyesters, such as poly(ethylene terephthalate), poly(tetrafluoroethylene), polyurethane, poly(ether-urethane), poly(methyl methacrylate), polyether ether ketone, polyolefins, and poly(ethylene oxide). However, implants may include resorbable materials, thermoplastic or polymeric resorbable materials, and in some embodiments, implants may be made from substantially resorbable materials. In embodiments, a system for mastopexy may include an implant that includes a permanent material and a resorbable material used to facilitate delivery of the implant. For example, a breast fixation system may include an implant that includes an elongate member that includes a resorbable material, and one or two introducers that include a sheath and metal that are used to deliver the implant made from a permanent material.

[0114]

[0126] In some embodiments, the implants are made from one or more resorbable polymers and / or resorbable thermoplastic polymers and copolymers. Implants may be made, for example, of polymers, including, but not limited to, polymers of glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 1,4-butanediol, succinic acid, adipic acid, 3-hydroxybutyrate, 4-hydroxybutyrate, ε-caprolactone, such as polyglycolic acid, polylactic acid, polydioxanone, polycaprolactone, copolymers of glycolic acid and lactic acid, such as VICRYL®, MAXON®, and MONOCRYL® polymers, and polymers of poly(lactide-co-caprolactone); poly(orthoesters); polyanhydrides; poly(phosphazenes); polyhydroxyalkanoates (PHAs); synthetic or biologically prepared polyesters; polycarbonates; tyrosine polycarbonates; polyamides (including synthetic and natural polyamides, polypeptides, and poly(amino acids)); polyesteramides; poly(alkylene alkylates); polyethers (e.g., Polyethylene glycol, PEG and polyethylene oxide, PEO); polyvinylpyrrolidone or PVP; polyurethanes; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene) / poly(oxypropylene) copolymers; polyacetals, polyketals; polyphosphoric acids; (phosphorous acid-containing) polymers; polyphosphate esters; polyalkylene oxalates; polyalkylene succinates; poly(maleic acid); silk (including recombinant silk and silk derivatives and analogues); chitin; chitosan; modified chitosan; keratin, biocompatible polysaccharides; hydrophilic or water-soluble polymers, such as polyethylene glycol (PEG) or polyvinylpyrrolidone (PVP) with blocks of other biocompatible or biodegradable polymers, such as poly(lactide), poly(lactide-co-glycolide) or polycaprolactone and copolymers thereof, such as random and block copolymers thereof. In some embodiments, the resorbable polymer or copolymer is substantially resorbed within a time frame of 1 to 24 months and / or within a time frame of 3 to 18 months after implantation.Resorbable polymers retain some residual strength for at least two weeks to three months.

[0115]

[0127] Blends of polymers, such as resorbable polymers, may also be used to create breast fixation implants. Resorbable polymer blends are prepared from resorbable polymers, such as, but not limited to, polymers including glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 1,4-butanediol, succinic acid, adipic acid, 3-hydroxybutyrate, 4-hydroxybutyrate, ε-caprolactone, or copolymers thereof.

[0116]

[0128] In some embodiments, poly-4-hydroxybutyrate (Tepha's P4HB™ polymer, Lexington, MA) or copolymers thereof are used to make the implant. The copolymers include P4HB with another hydroxy acid, such as 3-hydroxybutyrate, and P4HB with glycolic or lactic acid monomers. Poly-4-hydroxybutyrate is a strong, flexible thermoplastic polyester that is biocompatible and resorbable (Williams, et al. Poly-4-hydroxybutyrate (P4HB): a new generation of resorbable medical devices for tissue repair and regeneration, Biomed. Tech. 58(5):439-452 (2013)). Upon implantation, P4HB hydrolyzes to its monomers, which are metabolized by the Krebs cycle to carbon dioxide and water. In some embodiments, the weight average molecular weight Mw of the P4HB homopolymers and their copolymers is in the range of 50 kDa to 1,200 kDa (by GPC against polystyrene) and / or 100 kDa to 600 kDa. Weight average molecular weights of polymers of 50 kDa and above may enhance processing and mechanical properties.

[0117]

[0129] In another embodiment, the breast fixation implant comprises a polymer comprising at least a diol and a diacid. In some embodiments, the polymer used to make the breast fixation implant is poly(butylene succinate) (PBS), the diol is 1,4-butanediol, and the diacid is succinic acid. The poly(butylene succinate) polymer can be a copolymer with other diols, other diacids, or combinations thereof. For example, the polymer can be a poly(butylene succinate) copolymer further comprising one or more of 1,3-propanediol, 2,3-butanediol, ethylene glycol, 1,5-pentanediol, glutaric acid, adipic acid, terephthalic acid, malonic acid, methylsuccinic acid, dimethylsuccinic acid, and oxalic acid. Examples of poly(butylene succinate) copolymers are poly(butylene succinate-co-adipate), poly(butylene succinate-co-terephthalate), poly(butylene succinate-co-butylene methyl succinate), poly(butylene succinate-co-butylene dimethyl succinate), poly(butylene succinate-co-ethylene succinate), and poly(butylene succinate-co-propylene succinate). The poly(butylene succinate) polymer or copolymer thereof may further comprise one or more of a chain extender, a coupling agent, a crosslinking agent, and a branching agent. For example, poly(butylene succinate) polymers or copolymers thereof may be branched, chain extended or crosslinked by adding one or more of the following agents or agents: malic acid, trimethylolpropane, trimesic acid, glycerol, citric acid, glycerol propoxylate and tartaric acid. Agents or agents for branching, chain extending or crosslinking poly(butylene succinate) polymers or copolymers thereof are triol, tricarboxylic acid and hydroxycarboxylic acid units. Hydroxycarboxylic acid units may have two carboxylic acid groups and one hydroxyl group, two hydroxyl groups and one carboxyl group, three carboxyl groups and one hydroxyl group or two hydroxyl groups and two carboxyl groups. In some embodiments, breast implants may include poly(butylene succinate) with malic acid as a branching, chain extending or crosslinking agent.This poly(butylene succinate) copolymer may be referred to as poly(butylene succinate) cross-linked or chain-extended with malic acid, succinic acid-1,4-butanediol-malic acid copolyester, or poly(1,4-butylene glycol-co-succinic acid) cross-linked or chain-extended with malic acid. It should be understood that references to malic acid and other cross-linking, coupling, branching, and chain-extending agents include polymers prepared with these agents or agents, and that the agents or agents have been further reacted during processing. For example, the agents or agents may be dehydrated during polymerization. Thus, poly(butylene succinate)-malic acid copolymer refers to a copolymer prepared from succinic acid, 1,4-butanediol, and malic acid. In another embodiment, malic acid may be used as a branching, chain extender or crosslinking agent to prepare copolymers of poly(butylene succinate) and adipate, which may be referred to as poly[(butylene succinate)-co-adipate] crosslinked or chain extended with malic acid. As used herein, "poly(butylene succinate) and copolymers" include polymers and copolymers prepared with one or more of chain extenders, coupling agents, crosslinkers and branching agents. In some embodiments, poly(butylene succinate) and copolymers thereof include at least 70%, 80%, 90% and / or any other suitable weight percentage of succinic acid and 1,4-butanediol units. In another embodiment, the breast implant includes poly(butylene succinate) or copolymers thereof including glyelcol as a branching, chain extender or crosslinking agent. Polymers comprising a diacid and a diol, such as poly(butylene succinate) and its copolymers and others described herein, can have a weight average molecular weight (Mw) based on gel permeation chromatography (GPC) versus polystyrene standards of 10,000 Da to 400,000 Da, 50,000 Da to 300,000 Da, and / or 100,000 Da to 200,000 Da. In some embodiments, the weight average molecular weight of the polymers and copolymers is 50,000 Da to 300,000 Da, and / or 75,000 Da to 300,000 Da.In some embodiments, the poly(butylene succinate) or copolymers thereof used to make the implant or components of the implant have the following properties: 1.23-1.26 g / cm. 3 a glass transition temperature of -31°C to -35°C, a melting point of 113°C to 117°C, a melt flow rate (MFR) of 2 to 10g / 10min at 190°C / 2.16kgf, and a tensile strength of 30 to 60MPa.

[0118]

[0130] B. Additives

[0131] Some additives may be incorporated into the implant, for example, the resorbable polymer, its copolymers or blends used to make the implant. These additives may be incorporated during the compounding process to produce pellets that can then be melt processed. For example, the pellets may be extruded into fibers suitable for making the implant. In another embodiment, the additives may be incorporated using a solution-based process, for example, fibers may be spun from a solution of the polymer and one or more additives.

[0119]

[0132] In some embodiments, the additive can be biocompatible, hi some embodiments, the additive can be both biocompatible and resorbable.

[0120]

[0133] In one embodiment, the additives may be nucleating agents and / or plasticizers. These additives may be added in amounts sufficient to produce the desired results. Generally, these additives may be added in amounts of 1% to 20% by weight. Nucleating agents may be incorporated to increase the crystallization rate of the polymer, copolymer, or blend. Such additives may be used, for example, to facilitate implant fabrication and improve the mechanical properties of the implant. Examples of nucleating agents include, but are not limited to, salts of organic acids such as calcium citrate, polymers or oligomers of PHA polymers and copolymers, high melting point polymers such as PGA, talc, micronized mica, calcium carbonate, ammonium chloride, and aromatic amino acids such as tyrosine and phenylalanine.

[0121]

[0134] Plasticizers that may be incorporated into the composition to create an implant include, but are not limited to, di-n-butyl maleate, methyl laurate, dibutyl fumarate, di(2-ethylhexyl)(dioctyl) maleate, paraffin, dodecanol, olive oil, soybean oil, polytetramethylene glycol, methyl oleate, n-propyl oleate, tetrahydrofurfuryl oleate, epoxidized linseed oil, 2-ethylhexyl epoxytarrate, glycerol triacetate, methyl linoleate, dibutyl fumarate, acetyl cellulose ... Examples of plasticizers include methyl ricinoleate, acetyl tri(n-butyl) citrate, acetyl triethyl citrate, tri(n-butyl) citrate, triethyl citrate, bis(2-hydroxyethyl) dimerate, butyl ricinoleate, glyceryl tri-(acetyl ricinoleate), methyl ricinoleate, n-butyl acetyl ricinoleate, propylene glycol ricinoleate, diethyl succinate, diisobutyl adipate, dimethyl azelate, di(n-hexyl) azelate, tri-butyl phosphate, and mixtures thereof. An example of a plasticizer is a citrate ester.

[0122]

[0135] C. Bioactive Agents

[0136] The implant may be loaded or coated with a bioactive agent. Bioactive agents may be included in the implant for a variety of reasons. For example, bioactive agents may be included to improve tissue ingrowth into the implant, improve tissue maturation, provide in vivo active agent delivery, improve implant wettability, prevent infection, and improve cell attachment. Bioactive agents may also be incorporated into the structure of the implant.

[0123]

[0137] The implant may include a cell adhesion factor, such as a cell adhesion polypeptide. The term "cell adhesion polypeptide" as used herein refers to a compound that has at least two amino acids per molecule and can bind cells by cell surface molecules. Cell adhesion polypeptides include any of the proteins of the extracellular matrix that are known to play a role in cell adhesion, such as fibronectin, vitronectin, laminin, elastin, fibrinogen, collagen type I, type II and type V, as well as synthetic peptides with similar cell adhesion properties. Cell adhesion polypeptides also include peptides derived from any of the above proteins, including fragments or sequences that include binding domains.

[0124]

[0138] The implant may incorporate wetting agents designed to improve the wettability of the surface of the implant structure, so that fluids can be easily absorbed onto the implant surface, promote cell attachment, and / or modify the water contact angle of the implant surface. Examples of wetting agents include polymers of ethylene oxide and propylene oxide, such as polyethylene oxide, polypropylene oxide, or copolymers thereof, such as PLURONICS®. Other suitable wetting agents include surfactants or emulsifiers.

[0125]

[0139] The implants may comprise gels, hydrogels or living hydrogel hybrids. These materials may be used to further improve the wettability of the implant or to encourage cell growth throughout the thickness of the implant. Hydrogel hybrids consist of living cells encapsulated within biocompatible hydrogels such as gelatin, methacrylated gelatin (GelMa), silk gel and hyaluronic acid (HA) gel.

[0126]

[0140] The implant may contain active agents designed to stimulate cellular ingrowth, including growth factors, cell differentiation factors, cell recruitment factors, cell receptors, cell binding factors, cell signaling molecules, such as cytokines and molecules that promote cell migration, cell division, cell proliferation and extracellular matrix deposition. Such active agents include fibroblast growth factors (FGF), transforming growth factors (TGF), platelet-derived growth factors (PDGF), epidermal growth factors (EGF), granulocyte-macrophage colony-stimulating factors (GMCSF), vascular endothelial growth factors (VEGF), insulin-like growth factors (IGF), hepatocyte growth factors (HGF), interleukin-1-B (IL-1 B), interleukin-8 (IL-8) and nerve growth factors (NGF), and combinations thereof.

[0127]

[0141] Other bioactive agents that may be incorporated into the implant include antimicrobial agents, especially antibiotics, bactericides, oncological agents, anti-scarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-angiogenic and pro-angiogenic factors, immunomodulators and blood coagulants. Bioactive agents may be proteins, such as collagen and antibodies, peptides, polysaccharides, such as chitosan, alginic acid, keratin, hyaluronic acid and their derivatives, nucleic acid molecules, small molecular weight compounds, such as steroids, minerals, such as hydroxyapatite or complex mixtures, such as platelet-rich plasma. Suitable antimicrobial agents include bacitracin, biguanides, triclosan, gentamicin, minocycline, rifampin, vancomycin, cephalosporins, copper, zinc, silver and gold. Nucleic acid molecules may include DNA, RNA, siRNA, miRNA, antisense or aptamers.

[0128]

[0142] Implants may also include allograft and xenograft materials, such as acellular dermal matrix material and small intestinal submucosa (SIS).

[0129]

[0143] Additionally, human fat, such as autologous fat grafts, can be added or injected over or into the implant. Lipoaspirate adipose tissue from the patient can be added to the inner or outer surface of the implant. In areas where the implant is porous, the adipose tissue and globules can be held in place within the pores of the implant.

[0130]

[0144] In another embodiment, the harvested adipose tissue is mixed with a natural or synthetic fluidized scaffold matrix that is added to the implant to help retain the fat globules in place within the implant. Examples of natural and synthetic fluidized scaffold matrices include, but are not limited to, hydrogels, water soluble polymers, polyesters, and hydrophilic polymers such as polyethylene oxide, polyvinyl alcohol, and polymers of fibrin, thrombin, alginate, collagen, chitosan, and silk.

[0131]

[0145] In some embodiments, the implant may incorporate a system for controlled release of the therapeutic or prophylactic agent.

[0132]

[0146] Components for creating breast fixation implants

[0147] A variety of methods may be used to manufacture implants and systems for mastopexy. The implants may include the fibers disclosed herein.

[0133]

[0148] Long Members

[0149] In an embodiment, the implant of the breast fixation system includes an elongate member. The elongate member may be used to elevate the patient's breast. The elongate member is not a sling designed to create a hammock under the lower pole of the breast, and the elongate member is not fastened to the chest wall on either side of the breast to elevate the breast. Instead, the elongate member is implanted under the skin of the breast to surround the breast, and the breast is elevated by tightening the elongate member. The breast may be tightened by tightening the elongate member surrounding the breast. Tightening the elongate member surrounding the breast reduces the diameter of the elongate member surrounding the breast. When the elongate member is tightened, the breast is gathered in a higher position. When the elongate member is tightened, the breast is positioned in a more raised position on the chest. In an embodiment, the elongate member is resorbable and constitutes an internal resorbable brassiere that lifts and stabilizes the breast. In an embodiment, the elongate member is a temporary scaffold. That is, the elongate members are designed to lift the breast and then be replaced by new tissue as the elongate members degrade. Over time, the support of the breast provided by the elongate members is replaced by support from the host tissue. In this way, the breast is lifted by the elongate members but maintained in its lifted position over time by the ingrowth of breast tissue. In embodiments, the elongate members retain at least 15% of their initial strength, at least 30% of their initial strength, and / or at least 50% of their initial strength 12 weeks after implantation.

[0134]

[0150] In embodiments, the elongate members are designed to provide new tissue planes at the breast that can be used to support the lifted breast as the elongate members degrade and lose strength. In embodiments, the elongate members are designed to distribute the load of the lifted breast over the area of ​​the new tissue plane. The use of elongate members to distribute the load of the breast provides a more durable result and avoids load concentration, potential cheese-wiring and loss of tissue traction that can occur when sutures alone are used in breast lift procedures. In this regard, elongate members may be particularly desirable for lifting breasts with high fatty tissue masses where sutures tend to pull through breast tissue. The elongate members spread the load of the lifted breast over an extended area.

[0135]

[0151] In embodiments, the elongated members have a width of 0.2-5 cm, 0.4-2 cm, 0.8-1.5 cm, and / or any suitable range. In embodiments, the elongated members have a length of 10-85 cm, 25-63 cm, 25-47 cm, and / or any other suitable range. In embodiments, the elongated members have a length of 0.01-4 mm. 2 and / or 0.01 to 1 mm 2 In an embodiment, the elongated member has a thickness of 0.25 to 2 mm and / or 0.4 to 1 mm.

[0136]

[0152] In an embodiment, the elongate member includes at least one end that terminates in a fused end, in an embodiment, the elongate member includes at least one end that terminates in a fused end, the fused end being perforated.

[0137]

[0153] In embodiments, the elongate member is not anchored to the chest wall as with other breast lift devices. In embodiments, the elongate member is not anchored to the ligaments at the inferior border of the breast.

[0138]

[0154] In embodiments, the elongate member is designed to support a load of at least 5N, 10N, 60N and / or any other suitable load less than 500N.

[0139]

[0155] In embodiments, the elongate member includes a porous component that allows for tissue ingrowth.

[0140]

[0156] In an embodiment, the elongate member is sized for implantation through a stab incision made in the patient's breast. In an embodiment, the elongate member is designed for use without extensive dissection of the patient's tissue. In an embodiment, the elongate member is designed for use without removal of the patient's tissue. In an embodiment, the elongate member is designed for minimally invasive delivery. In an embodiment, the elongate member is designed to be folded or rolled, for example into a C-shape, prior to implantation in the patient. After implantation, the folded or rolled elongate member can be deployed to its desired shape in the breast. In an embodiment, the elongate member has shape memory. After implantation, the elongate member with shape memory can be deployed to its desired shape in the breast. In an embodiment, the elongate member is designed to be implanted into a channel created in the breast, for example by blunt dissection. In an embodiment, the elongate member is designed to be implanted into a channel created in the breast by an introducer instrument. In an embodiment, the elongate member is designed to be implanted through one or more entry points within the IMF or the inferior pole of the breast. In an embodiment, the elongate member is designed to be implanted through an entry point within the inferior pole of the breast.

[0141]

[0157] In embodiments, the implant comprises an elongate member and one or more bioactive agents. The bioactive agents may be coated onto or incorporated into the elongate member. Examples of bioactive agents include antimicrobials, antibiotics, proteins, and agents that promote tissue ingrowth. In embodiments, the implant comprises an elongate member and one or more of cells, stem cells, gels, hydrogels, adipose tissue, autologous fat, lipoaspirate, adipocytes, and fibroblasts. These cells and materials may be coated onto the surface of the elongate member or incorporated into the body of the elongate member.

[0142]

[0158] In an embodiment, the endotoxin content of the elongated member is less than 20 endotoxin activity units.

[0143]

[0159] In an embodiment, the elongate member is sterile, hi an embodiment, the elongate member is sterilized with ethylene oxide, low temperature ethylene oxide, electron beam radiation or gamma radiation.

[0144]

[0160] In embodiments, the elongate member comprises a resorbable polymer. In embodiments, the elongate member comprises one or more of the polymers listed in Section A. In some embodiments, the elongate member may comprise one or more of poly-4-hydroxybutyrate or copolymers thereof, poly(butylene succinate) or copolymers thereof, or polydioxanone.

[0145]

[0161] Fibers for making elongated implant components

[0162] In embodiments, the implant may include fibers. In embodiments, the elongate member may include fibers. The fibers may be made of resorbable thermoplastic polymers and / or resorbable thermoplastic polyesters. The fibers may preferably be made of resorbable materials listed above. The fibers may be monofilament fibers, multifilament fibers, or combinations thereof. In some embodiments, the implant may include monofilament fibers. The fibers may be unoriented, partially oriented, oriented, highly oriented, or combinations thereof. By oriented, it is meant that the fibers have been stretched. The stretching of the fibers causes molecular alignment of the polymer chains in the fibers to increase the tensile strength of the fibers (in this context, "oriented" does not relate to the geometric shape of the fibers in relation to another object). The elongation at break value of the fibers may be 3% to 120% and / or 3% to 50%. In embodiments, the diameter of the fibers may range from 1 micron to 5 mm, 10 microns to 1 mm, and / or 50 microns to 500 microns. The weight average molecular weight of the fibers may range from 10 kDa to 1,200 kDa and / or from 50 kDa to 600 kDa. The fibers may retain at least 50% of their initial strength in vivo for 1 to 6 months and / or 2 to 4 months. The fibers may substantially degrade within 5 years after implantation and / or within 2 years after implantation. The initial tensile strength of the fibers may range from 1 to 1,300 MPa and / or from 50 MPa to 1,000 MPa.

[0146]

[0163] In one embodiment, the implant or elongate member comprises fibers having one or more of the following properties: elongation at break of 10-100% and tensile strength of 300-1,000 MPa.

[0147]

[0164] In some embodiments, the elongate member of the implant comprises fibers made from P4HB. In some embodiments, the elongate member of the implant comprises fibers made from P4HB monofilament fibers. The P4HB monofilament fibers can be partially oriented or fully oriented (i.e., partially or fully stretched after extrusion). In one embodiment, the P4HB monofilament fibers can be produced according to the following method: Bulk P4HB resin in pellet form is dried to less than 300 ppm moisture using a rotary vane vacuum pump system. The dried resin is conveyed to an extruder feed hopper with a nitrogen purge to keep the pellets dry. The pellets are gravity fed into a cooled feeder section and introduced into an extruder barrel fitted with a 1.5 inch (3.8 cm) diameter extruder screw with a 30:1 L / D ratio. The extruder barrel can include five heating zones (or extrusion zones) and is manufactured by American Kuhne. The heated and softened resin from the extruder is fed to a heated metering pump (melt pump), and the extruded resin from the melt pump is fed to a heated block and 8-hole spinneret assembly. Suitable processing profile ranges are temperatures of 40°C to 260°C and pressures of 400 psi to 2000 psi (2.76 MPa to 13.8 MPa). The molten filaments can be water quenched and optionally conveyed into an orientation line (e.g., a three-stage orientation line) and optionally relaxed in-line before winding the monofilaments onto a spool. This procedure can be used, for example, to produce P4HB monofilament fibers with one or more of the following properties: elongation at break of 10 to 100%, tensile strength of 50 to 1,300 MPa, and tensile modulus of 70 to 1,000 MPa. The average diameter of the P4HB monofilament fibers can range from 20 microns to 1 mm and / or 50 microns to 500 microns. In one embodiment, USP (United States Pharmacopeia) absorbable suture sizes for P4HB monofilament fiber are 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0, 2-0, 3-0, 4-0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0, 11-0, and 12-0.

[0148]

[0165] In another embodiment, the elongate member of the implant comprises fibers made from P4HB multifilament fibers. Multifilament fibers of P4HB or its copolymers can be spun, for example, by pelletizing and drying the polymer, its copolymer, or blend to a moisture content of less than 300 ppm. The dried pellets are placed in the extruder feed hopper and protected from moisture, for example, with a dry nitrogen purge. The pellets are gravity fed into a cooled feeder section and introduced into a suitable extruder barrel with an extruder screw. One suitable extruder barrel is 0.75 inches (1.91 cm) in diameter and 25.69 inches (65.3 cm) long, and is fitted with an extruder screw with a L / D ratio of 30:1. American Kuhne manufactures suitable extruders. In some embodiments, the extruder barrel contains four heating zones and the processing profile is set at temperatures ranging from 40°C to 300°C and pressures from 200 psi to 3,000 psi (1.38 MPa to 20.7 MPa). The heated and softened polymer, copolymer or blend is sent to a metering pump, from which the resin is sent to a heated block. The spin head is attached to a spin pack containing a filter medium (screen) and a spinneret containing a desired number of holes to form the individual filaments of the multifilament yarn. For example, the spinneret may have 15, 30, 60, 120 or more or less holes. The extruded filaments exit the spinneret and pass through a heated chimney before being allowed to cool. A spin finish is applied to the multifilaments, which can be collected either on a winder or oriented in-line. Suitable spin finishes include PEG 400 and Tween 20™. The tensile strength of the multifilament fiber may be from 1 to 12 grams per denier. In embodiments, the multifilament fiber may be twisted to form a yarn. In embodiments, the elongate member comprises a yarn.

[0149]

[0166] In some embodiments, the elongate member of the implant comprises fibers made of poly(butylene succinate) or its copolymers and / or monofilament fibers of poly(butylene succinate) or its copolymers. The monofilament fibers of poly(butylene succinate) or its copolymers can be partially oriented or fully oriented (i.e., partially or fully stretched after extrusion). In one embodiment, monofilament fibers of poly(butylene succinate) or its copolymers can be produced according to the following method: Bulk resin is dried overnight under vacuum to less than 0.01% (w / w) moisture. Dried pellets of polymer are fed under a blanket of nitrogen into the extruder barrel of a 2.5 inch American Kuhne single screw extruder (30:1 L:D, 3:1 compression) equipped with a Zenith type metering pump model HPB917, a die with a 0.5 mm-8 hole spinneret, and 8 heating zones. The eight heating zones of the extruder are set at 40°C to 200°C. The extruder is fitted with a quench bath filled with water at 35 to 70°C, with a 10 mm gap between the bottom of the spinneret and the water surface. After the quench bath, two 5-roll godets are positioned, followed by three sets of high-temperature conduction chambers fed by the godets to orient the fibers in multiple stages. The temperature of the high-temperature chambers is set at a temperature of 50 to 90°C. After the last chamber another godet is positioned, followed by a multi-position Sahm winder. This procedure can be used, for example, to produce monofilament fibers of poly(butylene succinate) or its copolymers with one or more of the following properties: elongation at break of 10 to 100% and / or 10 to 50%, tensile strength of 50 to 1,300 MPa and / or 400 to 1,200 MPa, and tensile modulus of 50 to 3,000 MPa. The average diameter of monofilament fibers of poly(butylene succinate) and its copolymers ranges from 20 microns to 1 mm and / or from 50 microns to 500 microns.In certain embodiments, USP (United States Pharmacopeia) absorbable suture sizes for monofilament fibers of poly(butylene succinate) or copolymers thereof are 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0, 2-0, 3-0, 4-0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0, 11-0, and 12-0.

[0150]

[0167] In another embodiment, the elongate member of the implant comprises multifilament fibers made from poly(butylene succinate) and its copolymers. Multifilament fibers of poly(butylene succinate) or its copolymers can be partially oriented or fully oriented (i.e., partially or fully stretched after extrusion). In one embodiment, multifilament fibers of poly(butylene succinate) or its copolymers can be produced according to the following method: Bulk resin is dried under vacuum to less than 0.01% (w / w) moisture. Dried pellets of polymer are fed into the extruder barrel of an AJA (Alex James Associates, Greer, SC) 3 / 4 inch single screw extruder (24:1 L:D). The extruder barrel contained four heating zones, a metering pump, and a spin pack assembly. The pellets are gravity fed into a cooled feeder section and introduced into the extruder with a temperature profile set as follows: Chimney 40°C-100°C, Spinneret 170°C±30°C, Pump 170°C±30°C, Block 170°C±30°C, Zone 4 160°C±40°C, Zone 3 150°C±40°C, Zone 2 120°C±50°C, Zone 1 30°C-40°C, Feed Zone: Ambient temperature. The heated and homogenized molten resin from the extruder is delivered to a heated metering pump (melt pump) from which the extruded resin is delivered to a heated block and spinneret assembly. The spinneret has 30 holes, a capillary diameter of 0.200 millimeters and an L / D ratio of 2:1. (The spinneret can be configured in other alternative ways as well. For example, spinnerets can be configured with capillary diameters of 0.150-0.300 millimeters (6 mils-12 mils) and 15, 120 and 240 holes, as well as larger and smaller diameters and greater and fewer numbers of holes.) A suitable processing temperature profile ranges from 35° C. to 250° C., with pressures ranging from 200 to 5,000 psi (1.38 MPa to 34.5 MPa) in the barrel and 200 to 5,000 psi (1.38 MPa to 34.5 MPa) in the spin pack.As the molten filaments exit the spin pack, they pass through a heated chimney collar, 6-12 inches long and with temperatures ranging from 40°C to 100°C, and then through an air-chill box. The spin pack is suspended vertically above the yarn take-up roll at a distance sufficient to allow crystallization of the molten filaments and application of a spin-finish lubricant. A spin-finish solution of 25% polyethylene 25 glycol 400 (PEG 400) in water is used to hold the filaments together to form a yarn bundle. The speed of the yarn take-up roll (typically 3-18 meters per minute) is set in proportion to the flow rate of the molten filaments to control the denier of the spun bundle. The spun bundle is then conveyed to a Lessona winder for later off-line orientation or to a take-up roll for in-line orientation over a series of cooling and heating godet pairs and separator rolls. If necessary, the spin finish can be reactivated by rewetting the yarn bundle with pure water and drawing the yarn at a ratio of 5-14X and a temperature ranging from 50° C. to 90° C. This procedure can be used, for example, to produce multifilament fibers of poly(butylene succinate) or copolymers thereof with one or more of the following properties: elongation at break of 10-100% and / or 10-50% and tensile strength greater than 1 gram per denier and / or greater than 4 grams per denier, but in some embodiments less than 14 grams per denier.

[0151]

[0168] Fabric or woven material for making elongated members of implants

[0169] In an embodiment, the elongate member comprises a fabric or textile. Fabrics or textiles include meshes, braids, woven meshes, and knitted meshes. The fabric may comprise resorbable fibers, such as, but not limited to, resorbable monofilament fibers. In an embodiment, the resorbable monofilament fibers are polymeric and oriented. In this embodiment, oriented means that the fibers have been stretched to increase the molecular alignment of the polymer chains in the fibers.

[0152]

[0170] The above-mentioned fibers can be processed into a fabric, for example by knitting, sewing, weaving or crocheting, and used to form an elongate member. An exemplary fabric for making the elongate member of the implant is a two-loop pillar configuration. Another exemplary fabric for use in making the elongate member of the implant is a mesh, warp knit mesh and / or a resorbable warp knit mesh.

[0153]

[0171] In an embodiment, the fabric used to make the elongate member of the implant has a burst strength of 0.6 to 90 N / cm 2 and / or 1.2 to 30N / cm 2 In embodiments, the fabric used to make the elongate member of the implant may have at least one of the following properties: a burst strength of 0.1-100 kg, 1-50 kg, 5-100 kg, 10-50 kg, and / or any other suitable burst strength; (i) a suture pull-out strength of at least 1 kgf; (ii) a burst strength of 0.1-100 kg; (iii) a thickness of 0.05-5 mm, 0.1-1 mm, 0.1-0.5 mm, and / or any other suitable thickness; (iv) a thickness of 5-800 g / m 2 , 10~1000g / m 2 , 20~500g / m 2 , 5~1000g / m 2 , 10~100g / m 2 , 200~800g / m 2 and / or any other suitable areal density, and (v) a pore size of 5 μm to 10 mm, 10 μm to 1 mm, 100 μm to 10 mm, 10 μm to 100 μm, and / or any other suitable pore size. In some embodiments, the elongate member of the implant comprises a fabric, and the fabric may have at least one of the following properties: (i) a suture pull-out strength of 1 kgf to 20 kgf, (ii) a burst strength of 1 to 50 kg or 10 to 50 kg, (iii) a thickness of 0.1 to 1 mm, (iv) a thickness of 100 to 300 g / m 2 areal density, and (v) pore size ranging from 100 μm to 1 mm.

[0154]

[0172] In an embodiment, the burst strength of the fabric used to construct the elongate member of the implant is at least 40% of its initial burst strength value three months after implantation.

[0155]

[0173] In embodiments, the fabric used to create the elongated members of the implant is porous and can be replaced by host tissue growing in and around the fabric in vivo, which is strong enough to support a breast lift. The diameter of the pores of the implant or pores in the fabric can be greater than 25 μm, 75 μm, and / or 250 μm, but less than 20 mm, 10 mm, and / or 5 mm to encourage tissue ingrowth.

[0156]

[0174] The elongated members of implants including fabrics, such as knitted and woven meshes and two-loop pillar fabrics, can be produced using fibers of P4HB or its copolymers and / or fibers of poly(butylene succinate) or its copolymers. The fibers can be monofilament fibers. The elongated members of implants including oriented or partially oriented monofilament fibers of these polymers and copolymers have a long-term strength retention profile and can maintain some residual strength for as long as one year. The long-term strength retention of these fibers provides an extended period for tissue ingrowth into fabrics made from these fibers. Tissue ingrowth into these fabrics can lead to the formation of new tissue planes within the breast, which can support a breast lift. Furthermore, the long-term strength retention of the fibers and fabrics means that breast fixation implants including these fibers and fabrics can provide short-term support to the lifted breast while new tissue planes develop within the breast.

[0157]

[0175] In other embodiments, elongate members of implants including fabrics including a two-loop pillar configuration or knitted mesh may be produced using fibers of polydioxanone, such as monofilament fibers of polydioxanone and / or oriented monofilament fibers of polydioxanone.

[0158]

[0176] A suitable woven P4HB mesh for making the elongated members of the implant can be made, for example, by the following method: P4HB monofilament fibers from 49 spools are pulled under uniform tension onto the surface of a warp beam. The warp is a large, wide spool onto which individual fibers are wound in parallel to provide a sheet of fibers ready for coating with a 10% solution of Tween® 20 lubricant. The Tween 20 lubricant is applied to the surface of the sheet of fibers by a "contact" roller that is rotating and immersed in a bath filled with Tween 20. The top surface of the roller is brought into contact with the sheet of fibers and the roller is rotated at a uniform speed to consistently apply the Tween 20 finish. After application of the Tween 20, the sheet of fibers is placed in a creel position so that each fiber wound on a spool is aligned and wound side-by-side with the fiber wound on the next spool on the warp beam. The warp beams are then converted into a finished mesh fabric by intertwining the knit loops. Eight warp beams are mounted in parallel on a tricot knitting machine feed and fed to the knitting elements at a constant speed determined by the "runner length". Each individual monofilament fiber from each beam is fed down through a series of dynamic tension elements to the knitting "guide". Each fiber is passed through a single guide, which is fixed to a guide bar. The guide bar directs the fibers around needles forming a mesh structure. The mesh fabric is then removed from the needles by a take-down roller at a constant speed. The mesh fabric is then wound and wound onto a roll. P4HB monofilament mesh produced according to this method is ultrasonically scored with water, optionally heat set in warm water, and optionally washed with a 70% aqueous ethanol solution.

[0159]

[0177] In embodiments, fabrics (including meshes) made from P4HB monofilament that may be used to make implants have one or more of the following properties: (i) a suture pull-out strength of at least 1 kgf, (ii) a burst strength of 0.1-100 kg, (iii) a thickness of 0.05-5 mm, (iv) a density of 5-800 g / m2 and (v) a pore size of 5 μm to 5 mm. In embodiments, the P4HB fabric, such as a monofilament P4HB mesh, has one or more of the following properties: (i) a suture pull-out strength of 1 kgf to 20 kgf, (ii) a burst strength of 1 to 50 kg and / or 10 to 50 kg, (iii) a thickness of 0.1 to 1 mm, (iv) a pore size of 100 to 300 g / m 2 and (v) a pore size of 100 μm to 1 mm. In an embodiment, the P4HB monofilament mesh or P4HB fabric has substantially one or more of the following characteristics: a pore size of 500±100 μm, a thickness of 0.5±0.2 mm, and a mass of approximately 182±50 g / m 2 areal density of 0.01 mm, suture pull-out strength of 5.6±2 kgf and burst strength of at least 15 kg and / or at least 24.5 kg.

[0160]

[0178] A suitable knitted mesh of poly(butylene succinate) or its copolymers for use in implants can be made, for example, by the following method: Monofilament fibers from 49 spools are loaded onto a creel, aligned side-by-side, and pulled under uniform tension onto the top surface of a "contact" roller. The "contact" roller rotates while half-immersed in a bath filled with a 10% solution of polyethylene glycol sorbitan monolaurate, polyethylene glycol, or other suitable lubricant. Lubricant is deposited on the surface of the sheet of fibers. After applying the lubricant, the sheet of fibers is passed through a comb guide and then wound onto a warp beam. The warp is a large, wide cylinder on which the individual fibers are wound in parallel to provide the sheet of fibers. The warp beam is then converted into a finished mesh fabric by intertwining the knit loops. Eight warp beams are loaded in parallel onto a tricot knitting machine feed and fed to the knitting elements at a constant speed determined by the "runner length". Each individual monofilament fiber from each beam is fed down through a series of dynamic tension elements to a braiding "guide." Each fiber is passed through a single guide, which is fixed to a guide bar. The guide bar directs the fiber around the needles to form a mesh fabric structure. The mesh fabric is then removed from the needles by a take-down roller at a constant speed determined by the "quality" of the fabric. The mesh fabric is then wound and wound onto a roll, ready for scoring. The poly(butylene succinate) or copolymer monofilament mesh may then be ultrasonically scored with water and (i) heat set (e.g., in a hot conductive liquid bath or oven) and then (ii) washed with a 70% aqueous ethanol solution.

[0161]

[0179] Meshes and other fabrics made from monofilaments or multifilaments of poly(butylene succinate) or its copolymers, including a two-loop pillar configuration, suitable for making implants may have at least one of the following properties: (i) a suture pull-out strength of at least 10 N or at least 20 N; (ii) a burst strength of 0.1-100 kgf and / or 1-50 kgf or greater than 0.1 kPa; (iii) a thickness of 0.05-5 mm; (iv) a thickness of 5-800 g / m 2 (v) a pore size of 5 μm to 5 mm and / or 100 μm to 1 mm, and (vi) a Taber stiffness of at least 0.01 Taber stiffness units and / or 0.1 to 19 Taber stiffness units. In some embodiments, these monofilament or multifilament meshes and other fabrics have one or more of the following properties: (i) a suture pull-out strength of 1 kgf to 20 kgf, (ii) a burst strength of 1 to 50 kgf and / or 5 to 30 kgf, (iii) a thickness of 0.1 to 1 mm, (iv) a thickness of 100 to 300 g / m 2 and (v) a pore size of 100 μm to 1 mm. In another embodiment, a monofilament or multifilament mesh or other fabric of poly(butylene succinate) or a copolymer thereof suitable for fabricating an elongate member of an implant has substantially one or more of the following characteristics: a pore size of 500±100 μm, a thickness of 0.4±0.3 mm, and a mass of approximately 182±50 g / m. 2 areal density of 0.01 mm, suture pull-out strength of 5.6±2 kgf and burst strength of at least 3 kgf and / or at least 6 kgf.

[0162]

[0180] Film for forming elongated member

[0181] The elongate members may include films or laminates. In some embodiments, the films or laminates may be porous, allowing for tissue ingrowth. The elongate members may be formed from polymers such as those mentioned above, including resorbable polymers.

[0163]

[0182] In embodiments, the films or laminates include P4HB or copolymers thereof. These polymers can be converted into films by any suitable method, such as extrusion, solvent casting, injection molding, and compression molding.

[0164]

[0183] In some embodiments, films comprising P4HB or its copolymers are extruded either directly from a powder or granular form or from pellets. The polymer may be dried prior to extrusion. Melt extrusion may be used to create films of P4HB suitable for making elongated members using barrel and T-die temperatures, for example, 80-250°C and / or 100-220°C. In some embodiments, the molten P4HB film exiting the T-die is cooled by casting it over the top of one or more rotating cast rollers with surface temperatures of 5-100°C and / or 5-20°C. The solidified film is then wound up in a winding step to collect the film. Films of P4HB suitable for forming elongated members of different thicknesses may be produced using this process by adjusting the gap of the T-die slit and varying the polymer flow rate and cast roll speed.

[0165]

[0184] Films of P4HB or its copolymers suitable for forming elongated members can also be made by extrusion using a blown film process, where a circular blown film die is used instead of a T-die to extrude a cylindrical film. After exiting the circular die, the molten cylindrical film is cooled by blowing cold air from the center of the circular die. Once the polymer has solidified, the film can be collected using a winder. P4HB films of different thicknesses can be produced by changing the gap of the blown film die slit, changing the polymer flow rate, the cooling air pressure, the temperature of the air, and the winding speed.

[0166]

[0185] Suitable films of P4HB and their copolymers for forming elongated members can also be made by compression molding. In one embodiment, a composition including P4HB can be pressed into a film using a Carver hydraulic press. In some embodiments, a composition including P4HB powder, granules, or pellets can be pressed into a film by heating the platens of the press to 115° C. and pressing the P4HB composition between two sheets of Mylar using a metal spacer. After pressing, the film is removed from the press, allowed to cool and solidify, and removed from the Mylar backing. The thickness of the metal spacer can be adjusted to produce a film of the desired thickness.

[0167]

[0186] Suitable films of P4HB and their copolymers for forming elongated members can also be made by solvent casting. In some embodiments, a solution of P4HB can be made by dissolving the P4HB polymer in a solvent at a concentration of 10-15 wt / vol% or such that the viscosity of the P4HB solution is 400-7,400 cP. Suitable solvents include tetrahydrofuran, 1,4-dioxane, acetone, chloroform, and methylene chloride. The polymer solution can be pumped through a slot die onto a moving web, such as aluminum foil. The distance traveled by the moving web before being wound onto a collection roller can be adjusted to ensure evaporation of the solvent, and one or more air drying zones (e.g., at elevated temperatures) can be used to speed evaporation of the solvent. In one embodiment, the slot die has a width of 150 mm and a die gap of 400 μm, the web speed is 0.5 m / min, and the web travels 5 m before the film is collected into a final roll. Pump speed, die gap and width, polymer concentration and web speed can all be varied to produce a P4HB film of the desired thickness and width for forming an elongated member.

[0168]

[0187] The P4HB or copolymer film may be oriented. Suitable methods for orienting the P4HB or copolymer film include roll stretching and / or tenter frame stretching. In some embodiments, the film may be stretched at temperatures between room temperature and 150°C and / or between 40 and 80°C and at a stretch ratio between 0.25 and 15. The film may be uniaxially stretched to form a uniaxially oriented film, sequentially biaxially stretched to form a biaxially oriented film, or simultaneously biaxially stretched to form a planar oriented film.

[0169]

[0188] In some embodiments, the oriented film of P4HB or its copolymers can be heat set by restraining the film in the desired stretched dimension and heating to a temperature of less than 60° C. and / or between 35-45° C.

[0170]

[0189] In some embodiments, the films of P4HB or its copolymers used to form the elongated members are porous or fibrillated. These films can be made by mechanical or laser drilling, punching, or any similar method to create pores in the film.

[0171]

[0190] In embodiments, films or laminates for making elongated members include polymer compositions comprising 1,4-butanediol units and succinic acid units or copolymers thereof as described herein. These polymers can be converted into films by any suitable method, such as extrusion, solvent casting, injection molding, and compression molding.

[0172]

[0191] In an embodiment, a film of PBS polymer or its copolymer for forming an elongated member can be made by a solution casting method as follows: A homogeneous solution of PBS polymer or copolymer in a suitable solvent is made. The polymer solution is pumped through a slot die with a suitable die gap onto a moving web, for example, of aluminum foil. The web speed can be, for example, approximately 0.5 m / min and can travel 5 m before being collected on a collection roller. The speed is adjusted to ensure evaporation of the solvent. One or more separate air drying zones set at suitable temperatures are used to remove the solvent from the polymer film before collection on a final roll. Several parameters can be modified to control the film thickness, including but not limited to pump speed, die gap and die width, polymer concentration, and web speed.

[0173]

[0192] In an embodiment, the film of PBS polymer or its copolymer to form a long member can be made by melt extrusion method. Exemplary methods include T-die extrusion method or inflation method. In forming the film by melt extrusion, a suitable barrel and T-die temperature is selected to perform the formation, which ensures the melting of the PBS polymer or its copolymer, but is not so high as to cause unacceptable thermal decomposition. However, the temperature of the part of the barrel just below the hopper can be below the melting temperature of the PBS polymer or its copolymer. The molten film can be cast on one or more rotating cylindrical casting rollers, a cooled moving surface with a surface temperature maintained below the melting temperature of the PBS polymer or its copolymer, after exiting the T-die. This step is followed by a winding step to wind up the extruded film. The film thickness can be changed by changing the gap of the T-die slit, the polymer flow rate and the casting roll speed.

[0174]

[0193] In an embodiment, a film of PBS or its copolymer to form an elongated member is extruded by a process including: (i) drying the PBS polymer or its copolymer until the moisture content is less than 0.01 wt% moisture; (ii) feeding the dried polymer or copolymer into an extruder barrel equipped with a film extrusion die, the heating zone of the extruder and die being set at a temperature of 60°C to 240°C and / or 70°C to 220°C; and (iii) casting the extrudate onto a chilled roll stack set at a temperature below the melting temperature of the PBS polymer or copolymer, for example, but not limited to, 5°C to 50°C.

[0175]

[0194] In forming a film of PBS or its copolymer by the blown film process, a circular blown film die is used instead of a T-die to extrude a cylindrical film. The molten cylindrical film is cooled and solidified by blowing cold air from the center of the circular die, and the cylindrical film exposed to the cold air is collected by a winder. The film thickness can be changed by changing the gap of the blown film die slit, the polymer flow rate, the cooling air pressure and temperature, and the winding speed.

[0176]

[0195] Films formed from PBS polymers or copolymers thereof, such as melt extruded and solvent cast films, can be oriented by stretching using any suitable method, including roll stretching and / or stretching methods using a tenter frame. Melt extruded PBS films can be stretched, for example, at a stretch ratio of 0.25 to 15. Stretching can be uniaxial stretching to form uniaxially oriented films, sequential biaxial stretching to form biaxially oriented films, and simultaneous biaxial stretching to form planar oriented films.

[0177]

[0196] A sheath for at least partially covering the elongate member.

[0197] In embodiments, the elongate member of the implant is partially or fully inserted into one or more removable sheaths to deliver the elongate member to the implantation site. All or a portion of the elongate member is inserted into one or more sheaths to facilitate delivery of the elongate member to the implantation site. In particular, one or more removable sheaths may be used to prevent the elongate member from engaging breast tissue prematurely during implantation, particularly before the elongate member is placed in a desired position within the breast. In embodiments, the elongate member is partially or fully inserted into a removable sheath, the sheath containing the elongate member is implanted within the breast, and the removable sheath is removed from the breast to deploy the elongate member within the breast. In embodiments, the elongate member may be at least partially covered by a single sheath. In embodiments, the elongate member may be at least partially covered by two or more sheaths. In embodiments, the sheath may be a continuous tube or may include multiple sections where the elongate member remains exposed. In embodiments, the sheath may include a tear-away region. The tear away region allows the sheath to tear at specific points.

[0178]

[0198] In an embodiment, the removable sheath comprises a polymer, hi an embodiment, the sheath is formed from nylon, high density polyethylene, polytetrafluoroethylene, and low density polyethylene.

[0179]

[0199] Tensioner

[0200] In an embodiment, the breast fixation system further includes a tensioner designed to increase or decrease the tension of the elongate member on the breast tissue to provide adjustable breast lift.

[0180]

[0201] Examples of tensioners include a pulley system or a spool tensioner. In embodiments, the tensioner may be adjusted during implantation, for example to apply more tension to the elongate member to lift the breast, or the tensioner may be adjusted after implantation. In embodiments, the tensioner may be adjusted using a small tool inserted through a small incision.

[0181]

[0202] In embodiments, the tensioner may be incorporated into the elongate member of the implant and / or into the first or second ends of the elongate member.

[0182]

[0203] In embodiments, the tensioner comprises an absorbent polymer. In embodiments, the tensioner comprises one or more of the polymers listed in Section A. In some embodiments, the tensioner may comprise one or more of poly-4-hydroxybutyrate or copolymers thereof, poly(butylene succinate) or copolymers thereof, or polydioxanone.

[0183]

[0204] Fastening anchor

[0205] In embodiments, the breast fixation system implant includes one or more, or optionally two, fastener anchors to secure the elongate member in place after the breast is lifted. In embodiments, the fastener anchors include features that allow the fastener anchors to be sutured to tissue. In embodiments, the fastener anchors have a T-shape. In embodiments, the fastener anchors have a T-shaped cap pin. In embodiments, the T-shaped cap pin has a suture hole sized to pass a suture through.

[0184]

[0206] In an embodiment, the fastening anchor has two arms. The arms are connected at one end to an elongate member and at the other end to an opposing end of a T-shaped cap pin. In an embodiment, the T-shaped cap pin is formed by injection molding. In an embodiment, the arms are formed from a monofilament fiber, such as, but not limited to, a P4HB monofilament fiber.

[0185]

[0207] Introduction equipment

[0208] Implants including elongate members are designed to be implanted using one or more introducers. The elongate members may be at least partially covered by one or more sheaths and delivered to a desired location within the breast using one or more introducers.

[0186]

[0209] In an embodiment, the introduction instrument has a handle. In an embodiment, the handle is made from medical grade polypropylene. In an embodiment, the handle may be 10-15 cm and / or 12 cm in length and may have a diameter of 2-3 cm and / or 2.5 cm. In an embodiment, the introduction instrument has a universal handle design to allow for use with both left and right hands.

[0187]

[0210] In embodiments, the introducer instrument comprises an introducer needle. In embodiments, the introducer needle is made from 316L stainless steel. In some embodiments, the introducer needle comprises a tubular section provided with an entrance opening for insertion of an elongate member or an assembly of elongate members at least partially covered by a sheath.

[0188]

[0211] In an embodiment, the introducer instrument further comprises a removable barrel tip, hi an embodiment, the removable barrel tip is made from 316L stainless steel.

[0189]

[0212] Methods of Making Breast Fixation Implants and Systems for Mastopexy - Patent application

[0213] A variety of methods may be used to manufacture breast fixation implants and systems for mastopexy. In some embodiments, breast fixation implants are designed to be resorbable and to support the mechanical forces acting on the breast during daily activities when implanted, allowing the mechanical forces to be stably transferred to regenerated host tissue, which can support the same mechanical forces once the implant is degraded.

[0190]

[0214] Breast Fixation System

[0215] In an embodiment, a breast fixation system includes (i) an implant including an elongate member, (ii) one or more sheaths at least partially covering the implant that are used to deliver the implant to an implantation site and then removed from the breast, and (iii) one or more introducers for implanting the implants covered by the one or more sheaths. In an embodiment, a breast fixation system includes an assembly of elongate members at least partially covered by one or more sheaths and one or two introducers loaded with the assembly of elongate members at least partially covered by one or more sheaths.

[0191]

[0216] 3-9 show embodiments of components of a breast fixation system, the design of the components and how a system for minimally invasive mastopexy can be assembled from the components.

[0192]

[0217] FIG. 3 shows an illustrative system for mastopexy according to one embodiment of the present invention. FIG. 3 shows an exploded view 60 of the assembled breast fixation system shown in FIG. 1. The breast fixation system includes an implant elongate member 61, a sheath 62 that at least partially covers the elongate member 61, an introduction instrument 63, and a latch 64 that is used to connect the elongate member 61 and sheath 62 assembly to a removable barrel tip 65. The elongate member 61 has a first end 61a and a second end 61b. The elongate member 61 and sheath 62 assembly is shown rolled into a C-shape for insertion into a tubular section 66 of the introduction instrument 63. Detail W of FIG. 3 shows a cross section 67 of the C-shape of the sheath 62. The elongate member may be porous. The porous elongate member may encourage tissue ingrowth into the structure of the elongate member. Detail V of FIG. 3 shows a porous structure 68 of the elongate member 61.

[0193]

[0218] Further details of the embodiment of the breast fixation system shown in FIG. 3 are provided in FIG. 4. FIG. 4 shows an exploded isometric view 70 of an assembly of an implant elongate member 71 and a sheath 72. In FIG. 4, the elongate member 71 and the sheath 72 include fused ends 73. In an embodiment, the breast fixation system is formed by placing the implant elongate member 71 at least partially within the sheath 72 and fusing the ends of both the elongate member and the sheath to form an assembly. The assembly is then inserted into a tubular section of an introducer instrument to form a system for minimally invasive mastopexy. Detail T of FIG. 4 shows the cross-sectional structure of the sheath 72 that is designed to receive the elongate member 71. Detail U of FIG. 4 shows an exemplary embodiment, where the elongate member is porous 74. In an embodiment, the fused ends 73 of the elongate member and sheath assembly include perforations 75. The perforations 75 are made to form attachment features for connecting the elongate member and sheath assembly to a removable barrel tip of an introducer instrument. The bore 75 is sized to allow the elongate member and sheath assembly to be latched to the removable barrel tip of the introducer instrument using a latch with a pin that passes through the bore.

[0194]

[0219] In an embodiment, an introducer 80 of the breast immobilization system includes an elongate member and sheath assembly 81, as shown in Figure 5, at least partially loaded into the introducer. An enlarged view of the elongate member 82 and sheath 83 assembly is shown in Detail I. In the embodiment shown in Figure 5, the introducer 80 includes a handle 84, a removable barrel tip 85, and a tubular section 86 having a first end 87 that connects to the removable barrel tip 85 and a second end 88 that connects to the handle 84.

[0195]

[0220] A close-up of the handle 89 is shown in Detail K. The introducer handle 89 may have a universal grip designed for use with either the right or left hand. In an embodiment, at least a portion of the tubular section includes a slit 90 as shown in FIG.

[0196]

[0221] Detail J shows an enlarged tubular section of the introducer tool, illustrating slit 91 in tubular section 92. Slit 90 is dimensioned to allow for insertion and removal of elongate member and sheath assembly 81 into the tubular section. In an embodiment, the introducer tool includes an entrance opening 93 in the tubular section of the introducer tool positioned to allow insertion of elongate member and sheath assembly 81 into tubular section 86.

[0197]

[0222] A close-up of the entrance opening 93 is shown in Detail H. In an embodiment, the removable barrel tip 85 includes a blunt stripping tip 95 as shown in close-up Detail C. In an embodiment, the removable barrel tip 95 is fitted with a sharp tip instead of a blunt stripping tip. In an embodiment, the removable barrel tip 85 includes a latch receiver 96, shown in close-up in Detail F of FIG. 5. The latch receiver 96 is designed to receive an attachment feature formed by fusing the elongate member and sheath, followed by drilling of the fused area.

[0198]

[0223] In an embodiment, the breast fixation system includes an introducer with a removable barrel tip and an elongate member and sheath assembly loaded onto the introducer. Figure 6 shows an exploded view of an introducer 100 with an elongate member and sheath assembly 101 partially loaded onto the introducer. Detail M of Figure 6 shows an embodiment of a breast fixation system including a first end 103 of the tubular section of the introducer, a removable barrel tip 102 attached to the end of the elongate member and sheath assembly, and a latch for securing the assembly to the removable barrel tip. The removable barrel tip 102 is shown with a rounded tip 104 for blunt dissection. In other embodiments, the removable barrel tip is attached with a sharp tip for dissection.

[0199]

[0224] As shown in detail M of FIG. 6, the breast immobilization system may further include an elongate member and sheath assembly 105 terminating in an attachment feature 106 and a latch 107 with a locking pin 108. In an embodiment, the attachment feature 106 of the elongate member and sheath assembly is connected to the removable barrel tip 102 by inserting the latch 107 through a drilling 109 in the attachment feature 106 and into a latch receiver 110 of the removable barrel tip 102. In an embodiment, the attachment feature 106 is formed by fusing the end of the elongate member with the end of the sheath and drilling the fusing section to create a hole 109 sized to receive the locking pin 108 of the latch 107. In an embodiment, the attachment feature 106 may be secured to the latch receiver 110 of the removable barrel tip 102 by inserting the locking pin 108 through the drilling 109 in the attachment feature 106 and into a recessed hole 111 in the latch receiver 110. In embodiments, the latch 107 may be secured to the latch receiver 110 by a clip 112 located on the side of the latch that engages a recessed feature 113 in the latch receiver 110. In embodiments, after implantation, the attachment feature 106 may be removed from the latch receiver 110 by releasing the clip 112 from the recessed feature 113 in the latch receiver 110.

[0200]

[0225] A side view of an introducer instrument 120 suitable for use in an embodiment of a breast fixation system is shown in FIG. 7A. FIG. 7B shows a longitudinal cross-sectional view of the introducer instrument shown in FIG. 7A along axis designated QQ. FIG. 7B shows a tubular section 121, a lumen 122 of the tubular section, and a removable barrel tip 123 of the introducer instrument. In an embodiment, the removable barrel tip is fastened to a first end of the tubular section of the introducer instrument, as shown in the enlarged longitudinal cross-sectional view shown in FIG. 7C, which corresponds to detail R shown in FIG. 7B. FIG. 7C shows a removable barrel tip 124 connected to a first end 125 of the tubular section of the introducer instrument 126 by a fastening mechanism. In an embodiment, the fastening mechanism allows the removable barrel tip 124 to be released from the first end 125 of the tubular section of the introducer instrument 126. In an embodiment, the fastening mechanism of the introducer instrument includes a removable barrel tip mounting pin 127 that can be inserted (as shown) into the first end 125 of the tubular section of the introducer instrument 126, and a disengagement notch 128 designed to release the removable barrel tip 124 from the first end 125 of the tubular section of the introducer instrument 126 by releasing the mounting pin 127. In an embodiment, the removable barrel tip 124 includes a lumen 129, as shown in FIG. 7C, for insertion of an attachment feature (not shown) of an elongate member and sheath assembly (not shown). In an embodiment, the breast fixation system includes a latch 130 with two locking pins 131 that can be inserted into a latch receiver 132 with the locking pins 131 located within the removable barrel tip 124. The removable barrel tip 124 is shown in FIGS. 7A-C with a sharp cutting tip 133. In an embodiment, the removable barrel tip 133 may be fitted with a blunt stripping tip.

[0201]

[0226] In an embodiment, the breast immobilization system includes an introducer 140 loaded with an elongate member and sheath assembly 141, as shown in a front view of the system in Figure 8A. Figure 8B shows a view of the introducer in the direction of the arrow along the axis indicated by OO in Figure 8A. Figure 8B shows an introducer including a tubular section 142, a removable barrel tip 143 connected to a first end 144 of the tubular section 142, a slit 145 in the introducer tubular section 142, and a cross section 146 of the tubular section shown in more detail in Detail P. In an embodiment, the elongate member and sheath assembly 147 is folded over into a C-shape as shown in Detail P. FIG. 8C is an enlargement of detail P shown in FIG. 8B, showing in cross-section that tubular section 148 of the introducer includes a C-shaped cross-section, slit 149 for loading and unloading the elongate member and sheath assembly, and sheath 150 encasing elongate member 151 formed into a C-shape within tubular section 148.

[0202]

[0227] An example of the dimensions and design of the introduction tool is shown in FIG. 9. In this embodiment, the introduction tool 160 includes a removable barrel tip 161 connected to a first end 162 of a curved tubular section 163, a second end 164 of the curved tubular section 163 connected to a first end 165 of a straight tubular section 166, and a second end 167 of the straight tubular section 166 connected to a handle 168. In an embodiment, the outer diameter of the removable barrel tip 161, the curved tubular section 163, and the straight tubular section 166 is 0.7 cm. In an embodiment, the removable barrel tip is fitted with a cutting tip or blunt stripping tip 169, and the overall length of the removable barrel tip and the cutting or blunt stripping tip is 3 cm. In an embodiment, the handle 168 has an outer diameter of 2.5 cm and a length of 9 cm.

[0203]

[0228] In an embodiment, the breast fixation system includes an elongate member with one or two fastener anchors for fastening the elongate member to tissue. FIG. 10 shows an elongate member 171 with a fastener anchor 172. In an embodiment, the fastener anchor has a T-shape. In an embodiment, the T-shaped fastener anchor is formed by injection molding a T-shaped cap pin and attaching an arm to the end of the T-shaped cap pin 173. In an embodiment, the T-shaped cap pin has a hole sized for a suture to pass through so that the fastener can be sutured to tissue. In an embodiment, the T-shaped cap pin is tapered such that the center of the pin has a larger diameter than the end of the pin. In an embodiment, the arm 174 is made from a monofilament fiber, such as, but not limited to, a resorbable monofilament fiber. In an embodiment, the resorbable monofilament fiber is made from P4HB. In an embodiment, the monofilament fiber has an average diameter of 0.05-0.4 mm and / or 0.07-0.3 mm. In embodiments, the arms of the fastening anchor are attached to the elongate member, for example, by tying, gluing, stapling, or fusing. In embodiments, the arms are 2-10 cm and / or 4-6 cm long. In embodiments, the fastening member is attached to the elongate member 2-10 cm from the end of the elongate member.

[0204]

[0229] In embodiments, the breast fixation system may include only one introducer device that is used to implant a first end of the elongate member into the breast, then removed from the breast, loaded with a second end of the elongate member, and reinserted into the breast to deliver the second end of the elongate member. However, in some embodiments, the breast fixation system includes two introducer devices, such as shown in FIG. 1, such that each end of the elongate member is implanted using a different introducer device.

[0205]

[0230] In an embodiment, the system for mastopexy is designed for minimally invasive delivery. The implants have designs and properties that allow them to be delivered through small incisions. In an embodiment, the implants are designed so that they can be rolled or folded to allow delivery through small incisions. This minimally invasive approach may reduce patient morbidity, scarring, and the chance of infection. In an embodiment, the implants have shape memory properties that allow them to assume their original shape unassisted after being delivered to the implantation site. For example, the implants may be temporarily deformed by rolling into a small diameter cylindrical or C-shape for delivery to the implantation site, and then allow them to assume their original shape unassisted in vivo.

[0206]

[0231] How to implant breast implants

[0232] The implants and systems described herein are best suited for use in breast surgery, and more particularly, in mastopexy procedures.

[0207]

[0233] 2A-E illustrate a method of performing a breast lift using an exemplary breast fixation implant system. FIG. 2A illustrates the contours of a patient's breast 10, the NAC 11 of the breast, and a first introducer instrument 12 of an exemplary breast fixation system 13. The implantation method includes making a stab incision 14 in the breast (e.g., at the IMF of the lower pole of the breast) and inserting the first introducer instrument 12 into the stab incision. The distal end of the introducer instrument inserted into the breast may have a removable barrel tip designed for blunt dissection of breast tissue. In an embodiment, the introducer instrument is advanced within the breast to form a defined channel, e.g., by blunt dissection, by applying force to the introducer instrument in the direction of arrow 15 shown in FIG. 2A. The first introducer instrument is advanced in a circular motion around the patient's breast 20 under the skin of the breast as shown in FIG. 2B until the distal end of the first introducer instrument 22 of the breast fixation system 23 is positioned within the upper pole of the breast, e.g., above the NAC 21. In an embodiment, the removable barrel tip 25 of the introducer instrument is then moved in the direction indicated by arrow 26 to cause the removable barrel tip 25 to exit the breast. In an embodiment, a small incision may be made in the breast to facilitate exteriorization of the removable barrel tip 25. In an embodiment, the implantation method includes detaching the removable barrel tip 25 from the first introducer instrument and withdrawing the first introducer instrument from the breast by moving the instrument in a direction opposite to the insertion direction. The method may include holding the sheath assembly covering the removable barrel tip or an elongate member implant attached to the removable barrel tip while the introducer instrument is being withdrawn. Holding the removable barrel tip in this manner prevents the removable barrel tip from being withdrawn back into the breast during removal of the first introducer instrument.

[0208]

[0234] FIG. 2C shows the patient's breast 30 together with the NAC 31, the position of the removable barrel tip 32 after it has been exteriorized from the patient's breast through a small incision 33 in the upper pole of the breast, and the position of the sheathed elongate member implant assembly 34 within the breast 30 after removal of the first introducer instrument from the breast. Thus, the sheathed elongate member implant assembly 34 is implanted within the breast to encircle the first side of the breast under the skin of the breast from the site where the introducer instrument is introduced to the site where the removable barrel tip is exteriorized. After removal of the first introducer instrument from the breast, the implanted assembly remains connected to the second introducer instrument 35 to which the remaining portion of the elongate member implant and sheath assembly is loaded for implantation on the opposite side of the breast. In an embodiment, the method further includes inserting a second introducer instrument 42 into the breast 40 at the same IMF, i.e., incision site 43 in the lower pole of the breast, as used for insertion of the first introducer instrument into the breast as shown in FIG. 2D. After insertion of the second introducer instrument 42 into the incision site 43, the second introducer instrument 42 is used to form a channel under the skin of the breast around the opposite side of the breast, as shown in FIG 2D, until the removable barrel tip 44 of the second introducer instrument is positioned to be exteriorized from the upper pole of the breast. The removable barrel tip 44 may be exteriorized from the breast 40 at the same site 45 as the removable barrel tip of the first introducer instrument. The removable barrel tip 44 is exteriorized by moving the second introducer instrument 42 in the direction shown by arrow 46.

[0209]

[0235] After the removable barrel tip 44 is exteriorized, the removable barrel tip 44 or the sheath assembly attached to the removable barrel tip covering the elongate member implant is held while the second introducer instrument is withdrawn. In an embodiment, the method further includes removing the removable barrel tip from the sheath covered elongate member implant and separating the end of the elongate member implant from the sheath, for example by cutting. The sheath may then be removed from the breast by pulling the sheath upwardly, leaving the elongate member implant surrounding the breast with the end of the elongate member implant slightly exposed from the breast.

[0210]

[0236] FIG. 2E shows a patient's breast 50, the NAC 51, the implanted elongate member implant 52 encircling the breast under the skin of the breast after the sheath has been removed from the breast, and the end 53 of the elongate member implant exposed from the breast 50 through a second incision 54. The method further includes lifting the breast by pulling the end 53 of the elongate member implant in an upward direction as indicated by arrow 55. Once the breast 50 has been lifted to a satisfactory position, the end 53 of the elongate member implant is secured under the skin. The end 53 may be secured by tying or securing the end 53 to tissue, such as the chest wall. If necessary, the end of the elongate member implant may be trimmed.

[0211]

[0237] In embodiments, the method of implanting the elongate member implant may include only one introducer instrument. The one introducer instrument is used to implant a first end of the sheathed elongate member implant assembly into the breast. The removable barrel tip is then detached from the one introducer instrument and the one introducer instrument is removed from the breast. The one introducer instrument is then loaded with a second end of the sheathed elongate member implant assembly and implanted on the other side of the breast. The removable barrel tip is then detached from the one introducer instrument and the one introducer instrument is removed from the breast.

[0212]

[0238] In embodiments, a method of implanting an implant may include the use of a single sheath assembly covering an elongate member implant. The assembly may be implanted in a breast as described herein, and the sheath removed from the breast by pulling only the end of the sheath, or by cutting or tearing the sheath to expose the elongate member implant (e.g., at a first incision site) and pulling the cut pieces of the sheath to remove them from the breast.

[0213]

[0239] In an embodiment, a method for implanting an implant includes creating a channel for the implant in the breast by ablation, for example blunt ablation.

[0214]

[0240] In an embodiment, a method of implanting an implant includes introducing an assembly including a sheathed elongate member implant into the upper pole of the breast.

[0215]

[0241] In an embodiment, a method of implanting an implant includes implanting an assembly including a sheathed elongate member implant using only one incision in the breast. In this embodiment, for example, a single incision is made in the IMF or in the lower pole of the breast, an introducer instrument loaded with an assembly including an elongate member implant and a sheath is introduced at the incision site, and the introducer instrument is used to completely encircle the breast under the skin of the breast to implant the assembly including the sheathed elongate member implant. The removable barrel tip of the introducer instrument is then exteriorized at the incision site and detached from the introducer instrument, which is removed from the breast. After removing the sheath or sheaths from the breast, tension is applied to the end of the elongate member implant to lift the breast, and the end of the elongate member implant is secured and trimmed as necessary.

[0216]

[0242] In an embodiment, a method of lifting a breast includes providing an implant including a unitary elongated member implant sized to surround the breast, the unitary elongated member implant having a first end and a second end, providing one or more introducer instruments, inserting the implant into the breast using the one or more introducer instruments such that the implant surrounds the upper and lower poles of the breast under the skin of the breast, removing the one or more introducers from the breast, and using the implant to lift or tighten the breast.

[0217]

[0243] In an embodiment, the method of breast lift further comprises providing an implant comprising an elongate member, the elongate member being a tape, a film, a porous film, a fabric, a textile, a knitted mesh, a woven mesh, a non-woven mesh or a tangle-free mesh.

[0218]

[0244] In an embodiment, a method of lifting a breast includes providing one or more introduction instruments and an assembly including an implantable, unitary elongate member implant sized to surround the upper and lower poles of the breast with a first end and a second end, and one or more sheaths connected to the elongate member near one or both ends of the elongate member and at least partially surrounding the elongate member, inserting the assembly into the breast using the one or more introduction instruments such that the elongate members surround the upper and lower poles of the breast under the skin of the breast, removing the one or more introduction instruments from the breast, removing the one or more sheaths from the breast, and lifting or tightening the breast using the elongate member implant. In an embodiment, the method further includes providing an elongate member implant with attachment features, and inserting the elongate member implant into the breast using the introduction instruments by connecting the attachment features to the introduction instruments. In an embodiment, the method further includes providing an elongate member implant comprising attachment features at both ends of the elongate member, and inserting the elongate member into the breast using one or more introduction devices by connecting the attachment features to the one or more introduction devices.

[0219]

[0245] In an embodiment, the method includes providing an introduction instrument comprising a tubular section having a first end and a second end, the tubular section including a slit extending at least a portion of its length with an entrance opening, the first end of the tubular section being connected to a removable barrel tip, and the second end of the tubular section being connected to a handle, and further includes inserting an assembly of the elongate member implant and sheath at least partially into the tubular section of the introduction instrument through the entrance opening prior to implantation of the elongate member implant into the breast. In an embodiment, the method further comprises providing an elongate member with an attachment feature and an introduction instrument comprising a tubular section with a first end and a second end, the tubular section including a slit extending at least a portion of its length with an entrance opening, the first end of the tubular section connected to a removable barrel tip, and the second end of the tubular section connected to a handle, the removable barrel tip including a latch receiver for securing the attachment feature of the elongate member to the removable barrel tip and the blunt dissecting or cutting tip, and forming a channel surrounding the superior and inferior poles of the breast for implantation of the elongate member using the blunt dissecting or cutting tip. In an embodiment, the method further comprises providing an introduction instrument with a removable barrel tip, the removable barrel tip including a fastening mechanism for attachment and detachment of the removable barrel tip to the introduction instrument, attaching the assembly to the removable barrel tip, inserting the introduction instrument into the breast, and detaching the barrel tip from the introduction instrument using the fastening mechanism after insertion of the assembly into the breast. In an embodiment, the method further includes providing an introduction instrument comprising a removable barrel tip with a latch receiver, an elongate member comprising a latch and an attachment feature, and inserting a latch through the attachment feature and into the latch receiver to secure the elongate member to the removable barrel tip.In an embodiment, the method further includes providing an introduction instrument comprising a removable barrel tip with a latch receiver, a latch with one or more locking pins, and an elongate member with an attachment feature, and inserting the locking pin of the latch through the attachment feature and into the latch receiver to secure the elongate member to the removable barrel tip.

[0220]

[0246] In an embodiment, the method further comprises providing an elongate member in the form of a tape, film, porous film, fabric, knitted mesh, woven mesh or tangle-free mesh. In an embodiment, the method further comprises providing an elongate member with one or two attachment anchors and, after the breast has been lifted, fixing the one or two attachment anchors in the breast, for example by suturing the one or two attachment anchors to tissue. In an embodiment, the method further comprises providing an elongate member made of one or more polymers, which may be synthesized from or include one or more of the following monomers: glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, adipic acid and succinic acid. In an embodiment, the method further comprises attaching an elongate member implant to tissue after lifting or tightening the breast or tying the ends of the elongate member together after lifting or tightening the breast.

[0221]

[0247] Modifications and variations of the methods and compositions will become apparent from the above detailed description and are intended to fall within the scope of the appended claims.

[0222]

[0248] The invention will be further understood by reference to the following non-limiting examples. EXAMPLES

[0223]

[0249] Working Example

[0250] Example 1: Creation of a Minimally Invasive Breast Fixation System

[0251] The minimally invasive breast fixation system can be made from (i) an elongated member made by weaving a poly-4-hydroxybutyrate (P4HB) structure, (ii) two sheaths made of low-density polyethylene (LDPE), and (iii) two curved stainless steel introducers.

[0224]

[0252] A knitted P4HB elongate member may be fabricated by warp knitting size 6-0 P4HB monofilament (P4HB Mw 340 kDa), heat setting the knit at 54° C. for 5 minutes, and laser cutting the knit to form an elongate member implant with a first end and a second end and dimensions of 10 mm wide by 55 cm long. The elongate member has an average tensile strength of 78 N, an average pore size of 0.36 mm 2 and has a thickness of 0.65 mm.

[0225]

[0253] Two sheaths of LDPE are made, each with a first end and a second end. Each sheath has a diameter of 8 mm (or 14 mm when the sheath is flattened), a length of 20 cm, and a wall thickness of 0.07 mm. The first end of the elongate member implant is placed into the second end of the first sheath, and the elongate member slides within the first sheath until its first end is aligned with the first end of the first sheath. The second end of the elongate member implant is placed into the second end of the second sheath, and the elongate member slides within the second sheath until its second end is aligned with the first end of the second sheath. In this way, an assembly of elongate member and sheath can be formed with a section of the elongate member of 20 cm, measured from its first and second ends, surrounded by the sheath, and an intermediate portion of the elongate member of 15 cm not surrounded by the sheath. To secure the sheaths in place, each sheath is heat fused to the elongate member at the first and second ends of the elongate member. After fusing the sheaths to the elongate member, two 2 mm diameter holes, spaced 8 mm apart, are cut through each fused section to form attachment features at each end of the fused section of the elongate member and sheath assembly.

[0226]

[0254] Two blunt-tipped curved introducers are made using 316L stainless steel for machining the tubular sections and medical grade polypropylene for making the handles. The tubular section of the instrument is 38 cm long and consists of three sections: a first section with a straight removable barrel tip that is 2.5 cm long, a second section with a first end, a second end and a cold bent main body with a radius of curvature of 20 cm, and a third section with a first end, a second end and a 7 cm long straight section with an entrance opening at the first end. The tubular section of the introducer is formed such that the removable barrel tip can be attached to or removed from the first end of the second section of the tubular section. For delivery of the sheathed elongate member assembly, the main body of the needle has a 10 mm x 14 mm C-shaped cross section (for the elongate member) with an internal cavity with a 7 mm x 9 mm C-shaped cross section to be machined. The third section of the tubular section is machined with a 0.5 cm by 1.0 cm inlet opening at the first end. The second section of the tubular section is connected to the first end of the third section such that a channel in the tubular section is formed between the interior cavity of the second section and the inlet opening of the third section. A handle is connected to the second end of the third section of the tubular section. The removable barrel tip is machined with (a) a blunt tip for blunt dissection of breast tissue, (b) a latch receiver for receiving the fused end of the elongate member and sheath assembly, (c) a mounting pin for insertion into the first end of the second section of the tubular section, and (d) a disengagement notch for releasing the removable barrel tip from the first end of the second section of the tubular section. The latch receiver is also machined with a recessed feature for receiving a locking knob located on the latch. The latch is machined from 316L stainless steel with dimensions of 4 mm x 15 mm and fits into a latch receiver in the removable barrel tip with a pin for insertion through the elongate member and sheath fusion assembly, and a knob on the latch is designed to engage the latch receiver to lock the latch in place.

[0227]

[0255] The breast fixation system is assembled by rolling the elongate member and two sheath assembly. The first fused end of the rolled assembly is then inserted into the first introducer instrument while at least a portion of the elongate member and first sheath assembly is held within the cavity of the second section of the tubular section of the first introducer instrument by passing the first fused end through an entrance opening in the third section of the tubular section and into the internal cavity of the second section of the tubular section until the first fused end of the rolled assembly can exit the first end of the second section of the tubular section and be positioned within the latch receiver of the removable barrel tip. The first fused section of the assembly is secured to the removable barrel tip by inserting a latch with two pins passing through two 2 mm diameter holes in the first fused section and into the latch receiver of the removable barrel tip, with the knob of the latch engaged in the recessed feature of the latch receiver. The second fused end of the rolled assembly is then inserted into the second introducing instrument in the same manner as described for inserting the first fused end, so that the second fused end can be positioned and secured with a second latch on the removable barrel tip of the second introducing instrument and at least a portion of the second sheath and elongate member assembly retained within the cavity of the second section of the tubular section of the second introducing instrument.

[0228]

[0256] Example 2: Creation of a Minimally Invasive Breast Lift System with Fastening Anchors

[0257] In this embodiment, a breast fixation system can be created that is fitted with two fastener anchors that allow the elongate member to be fixed in place after breast lift. FIG. 10 shows an implant (170) that includes an elongate member (171) with a fastener anchor (172) at one end. The fastener anchor is incorporated into the elongate member in an area adjacent to where the elongate member and sheath are fused. The fastener anchor has a T-shape and is formed with an injection molded T-cap pin (173) and an arm (174) that connects to the T-cap pin and the elongate member. The T-cap pin features a central hole sized to pass a suture through to secure the fastener anchor to breast tissue. The dimensions of the T-cap pin are 1 cm long and 2 mm in diameter at the center of the pin, tapering to 1 mm at each end of the pin. The T-cap pin is made from P4HB (Mw 340 kDa). The arms of the fastening anchors are formed from size 3-0 P4HB monofilament and each have a length of 5 cm. The overall length of elongate member (171) is 30 cm. The arms (174) of each fastening anchor (172) are attached to the elongate member 5 cm from each end of the elongate member by tying the size 3-0 P4HB monofilament arms of each fastening anchor to the elongate member.

[0229]

[0258] Apertures may be formed at the other end of the elongate member (175) to provide a means for securing a T-shaped cap pin (173) near the other end of the elongate member (shown in FIG. 10 as Detail Y). The apertures are formed with sufficient dimensions to allow the pins of the T-shaped cap pin to be inserted into the elongate member. For example, the apertures may be formed with dimensions 1.5×3 mm and arranged in an array. A suitable array may have 2×20 apertures. When the elongate member is formed from a P4HB fabric, such as a tight warp knit crochet design made with P4HB monofilament suture size 6-0, the array of apertures may be formed using a rectangular array of 2×20 needles, each with dimensions 1.5×3 mm, which are heated to 57° C. and forced through the elongate member in the area shown as Detail Y. Once inserted, the perforated elongate member may be heat set, for example, at 54° C. for 5 minutes and then cooled. Removal of the array of needles from the elongate member leaves the structure shown in Detail Y with an array of heat-set pores.

Claims

1. A breast implant comprising a unitary elongate member having a first end and a second end, the unitary elongate member being sized to surround the breast beneath the skin.

2. 10. The breast implant of claim 1, wherein the member is a tape, film, porous film, fabric, braided, knitted, woven or non-woven mesh or fabric, or a tangle-free mesh.

3. an implantable unitary elongate member having first and second ends and sized to surround the breast beneath the skin; a sheath connected to the elongate member and at least partially surrounding the member; A breast fixation system including:

4. The breast fixation system of claim 3 , wherein the sheath is fused to the member.

5. The breast immobilization system of claim 3 , further comprising an introduction device, the elongate member including an attachment feature for connecting the elongate member to the introduction device.

6. 6. The breast immobilization system of claim 5, including attachment features at or adjacent the first and second ends of the member, and each attachment feature is connected to the introduction device.

7. 7. The breast fixation system of claim 5 or 6, wherein the introducer instrument includes a tubular section having a first end and a second end, a barrel tip removably connected to the first end of the tubular section, and the second end of the tubular section is connected to a handle, the tubular section including a slit extending at least a portion of its length.

8. 8. The breast fixation system of claim 7, wherein the tubular section of the introducer further includes an entrance opening, and the member and sheath assembly is at least partially inserted into the tubular section of the introducer through the entrance opening of the tubular section.

9. 8. The breast immobilization system of claim 7, wherein the removable barrel tip includes a latch receiver for securing the attachment feature of the member to the removable barrel tip, and a blunt stripping or cutting tip.

10. 10. The breast immobilization system of claim 9, further comprising a latch, wherein the attachment feature of the member can be secured to the removable barrel tip of the introduction instrument by inserting the latch through the attachment feature of the member and into the latch receiver.

11. The breast immobilization system of claim 10 , wherein the latch includes one or more locking pins.

12. 8. The breast fixation system of claim 7, wherein the introducer instrument includes a fastening mechanism for attachment and detachment of the removable barrel tip to the first end of the tubular section.

13. 13. The breast fixation system of claim 12, wherein the fastening mechanism includes one or more mounting pins that attach the removable barrel tip to the first end of the tubular section of the introducer instrument and a disengagement notch for releasing the removable barrel tip from the first end of the tubular section of the introducer instrument.

14. 4. The breast immobilization system of claim 3, wherein the unitary elongate member is a tape, a film, a porous film, a fabric, a braided, knitted, woven or non-woven mesh or fabric, or a tangle-free mesh.

15. 4. The breast fixation system of claim 3, wherein the unitary elongate member comprises one or more polymers synthesized from or including one or more of the following monomers: glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, adipic acid, and succinic acid.

16. 4. The breast fixation system of claim 3, wherein the unitary elongate member further comprises one or more fastening anchors, the fastening anchors being used to secure the elongate member to tissue.

17. 4. The breast fixation system of claim 3, wherein the unitary elongate member comprises at least one characteristic selected from the group consisting of: (i) a suture pull-out strength of at least 1 kgf, (ii) a burst strength of 0.1-100 kg, (iii) a thickness of at least 0.05 mm, (iv) an areal density of 5-800 g / m2, and (v) a pore size of 5 μm-10 mm.

18. 4. A method of forming a breast fixation system as described in claim 3, comprising the steps of forming the elongate member by knitting, weaving, braiding, extruding or casting, inserting the elongate member at least partially into the sheath, and connecting an end of the sheath to the elongate member.

19. The method of claim 18 , wherein the elongate member and sheath are fused together.

20. The member includes one or two attachment features at one or both ends of the member.

20. The method of claim 18, wherein the one or two attachment features are formed and used to connect the member to one or two introduction instruments.

21. The method of claim 20 , wherein the one or two attachment features are formed by drilling one or more holes in the member.

22. 21. The method of claim 20, wherein the introducer instrument comprises a tubular section having a first end and a second end, a slit extending at least a portion of the length of the tubular section, a removable barrel tip connected to the first end of the tubular section, and a handle attached to the second end of the tubular section.

23. 23. The method of claim 22, wherein the removable barrel tip is formed with a blunt peeling or cutting tip and a latch receiver for securing the attachment feature of the member to the removable barrel tip, and the introduction instrument is formed with a fastening mechanism to enable attachment and removal of the removable barrel tip from the first end of the tubular section.

24. 24. The method of claim 23, wherein the fastening mechanism is formed using one or more mounting pins for attaching the removable barrel tip to the first end of the tubular section of the introduction instrument and a disengagement notch for releasing the removable barrel tip from the first end of the tubular section of the introduction instrument.

25. 24. The method of claim 23, further comprising forming a latch and connecting the attachment feature of the member to the introduction instrument by inserting the latch through the attachment feature and into the latch receiver.

26. 26. The method of claim 25, wherein the latch is formed with one or more locking pins.

27. The method of any one of claims 22 to 26, further comprising inserting the member and sheath assembly at least partially into the tubular section of the introducer instrument through the slit in the tubular section.

28. 20. The method of claim 18, wherein the elongate member is woven into a mesh, and the mesh is tangle-free.

29. 20. The method of claim 18, wherein the elongate member comprises one or more polymers, the polymers being synthesized from or comprising one or more of the following monomers: glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, and succinic acid.

30. A kit for lifting or tightening the breasts comprising an elongate member, a sheath and an introducer device as described herein.

31. A kit for lifting or tightening the breasts comprising any combination of the components described herein.

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