• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    An implementation of a mesh pocket includes a mesh wall that defines an enclosure having an opening at one end. The mesh pocket additionally includes a stretch cord configured to close the opening when stretched so as to prevent the surgical implant from leaving the enclosure. The mesh pocket may additionally include a mesh flap that extends from the mesh wall, the mesh flap providing a surface for suturing the mesh pocket to an inner surface of the patient's body. The mesh pocket may additionally include a thread that extends from the mesh wall and a needle attached to a terminal of the thread. The wire can be configured to tighten the mesh wall around the surgical implant when pulled.
    公开号:BR112020009087B1
    申请号:R112020009087-5
    申请日:2018-11-12
    公开日:2021-06-08
    发明作者:Alexei Mlodinow；Stephanie Wiegel；Todd Cruikshank
    申请人:Surgical Innovation Associates, Inc；
    IPC主号:
    专利说明:

    [001] This application claims the priority benefit of US Provisional Patent Application 62/585,402, filed November 13, 2017 and incorporated herein by reference in its entirety. TECHNICAL FIELD
    [002] The present description generally refers to mesh covers for implants and, more particularly, to a mesh bag for an implant and method for using it. FUNDAMENTALS
    [003] The present description refers to the field of surgically implantable devices. Aspects of this description specifically relate to the support and stabilization of a breast implant using flexible, bioabsorbable mesh bags.
    [004] Synthetic implants composed of silicone or saline are commonly used in both breast augmentation and breast reconstruction, but in both cases the soft tissue envelope alone is sometimes insufficient to hold the implant in place. Also, in many cases it is difficult to achieve or maintain an anatomically appropriate breast shape when a round implant is used. Due to these deficiencies in native tissue, revision surgery is often required to reshape, reposition, lift, or otherwise modify the implant and/or periprosthetic tissue. Revision surgery could be avoided if an additional conformation location support structure for the breast implant were provided. Sometimes an inner bra in a sling or net configuration is used to provide additional breast implant support over time. Common materials for the inner bra mesh are surgical mesh and decellularized tissue.
    [005] These inner bras provide additional support for the breast implant, but improved support and stabilization is still needed to ensure long-lasting results in breast augmentation and reconstruction procedures. DRAWINGS
    [006] While the appended claims present the characteristics of the present techniques with particularity, these techniques can be better understood from the following detailed description, taken in conjunction with the attached drawings, in which: Figure 1 is a top view of a pouch Figure 2 is a perspective close-up of a mesh pocket opening together with a draw cord; Figure 3 is a rear perspective view of the mesh pocket; Figure 4 is a rear view of the mesh bag; Figure 5 and Figure 6 represent a method for using the mesh bag in surgeries according to a modality. DETAILED DESCRIPTION
    [007] The description is generally directed to a mesh bag to secure an implant to a patient's body. In accordance with various embodiments, the mesh pocket includes a mesh wall that defines an enclosure having an opening. The mesh pocket additionally includes a stretch cord configured to close the opening when stretched so as to prevent the surgical implant from leaving the enclosure. The mesh pocket may additionally include a mesh flap that extends from the mesh wall, the mesh flap providing a surface for suturing the mesh pocket to an inner surface of the patient's body. The mesh pocket may additionally include a thread that extends from the mesh wall and a needle affixed to a terminal of the thread. The wire can be configured to tighten the mesh wall around the surgical implant when pulled.
    [008] The mesh bag presented here provides extra support and stabilization. After the implant is inserted into the mesh pocket and the flaps are sutured to the chest wall, the 360-degree mesh enclosure keeps the implant localized during the healing process period and relieves the surrounding soft tissue of the weight of the implant. This latter benefit is particularly advantageous in post-mastectomy breast reconstruction, which is commonly performed in a setting of tenuous blood supply to the remaining skin flaps. The flaps on the outer wall of the mesh pouch provide additional surface area for suturing and supporting the coated breast implant, without risking piercing the implant by suturing directly through the outside wall of the pouch. Compared to the mesh method, which only provides support and location in the craniocaudal plane, the bag method described here can fully support the weight of the implant, force the implant into the desired shape, and keep the implant located mediolaterally. In addition, it is more time-efficient to place an implant in a pre-molded pouch, gird it closed, and suture a small number of flaps in place than it is to cut a custom net or sling from a flat blade, and then sew. la into the mesh cavity of the appropriate size and shape for the given implant and soft tissue deficit.
    [009] Various embodiments of the mesh pocket include one or more stretch cords around an opening, which can be pulled to close the opening. Using a stretch cord design allows the mesh pocket walls to fit flush against an implant. This design helps eliminate pooled material and resulting air cavities that can cause bacterial infection and swelling.
    [0010] The mesh pouch embodiments described herein have no resorbable coating. Rather, the embodiments described herein are constructed completely of a bioabsorbable material. Having the entire device constructed from a bioabsorbable material can reduce the complications and infections commonly seen from a non-bioabsorbable mesh implant.
    [0011] The various modalities described here provide patients with longer results in breast augmentation or reconstruction, which reduces the need for subsequent revision surgeries.
    [0012] Turning to Figures 1 to 4, a mesh pocket according to an embodiment is illustrated. The mesh pocket, generally labeled 100, includes a mesh wall 102 that surrounds and defines an enclosure 104. Mesh wall 102 is spheroidal in shape when fully expanded, but is configured to conform to the shape of an implant when expanded. use. Mesh wall 102 has an opening 106 at one end 108, through which an implant (such as a breast implant or other breast prosthesis, such as a tissue expander) can be inserted.
    [0013] In one embodiment, mesh wall 102 is comprised of a first series of circular cords 110 that encircle a longitudinal axis A of mesh pocket 100, and which are smaller in circumference at opposite ends 108 and 112 of the mesh pocket. mesh 100 and larger in circumference around the center 114 of mesh pocket 100. Mesh wall 102 is further comprised of a second series of circular strands 116, which are oriented in planes that are perpendicular to the orientation planes of the first series of circular chords 110. Mesh wall 102 is still further comprised of a third series of circular chords 118, which are oriented in planes that are perpendicular to the orientation planes of both the first set of circular chords 110 and the second series of circular chords 116 The second and third series of circular chords 116 and 118 are discontinuous at places where aperture 106 interrupts them.
    [0014] In one embodiment, the mesh wall 102 comprises a porous material such as woven surgical mesh. It is configured to maintain a three-dimensional configuration, such as a breast shape or a spherical shape, regardless of the presence of a surgically implanted device. It can be made of a stretchable material that allows opening 106 to expand and subsequently contract opening 106 to or near its original size. Mesh wall 102 can be made of a bioabsorbable material such as poly-(p)-dioxanone, poly-trimethylene carbonate, polyglycolide, etc. It can also be composed of a biological material, including complex extracellular matrices and simple polymers such as P4HB, fibroin, etc.
    [0015] According to one embodiment, next to and surrounding opening 106 is a stretch cord 120 which, when pulled away from mesh wall 102, closes opening 106 sufficiently to prevent an implant from exiting enclosure 106. Figure 2, the draw cord 120 is secured to the mesh wall 102 by a sleeve 122 (which may be made of solid material or may be made of a series of threaded loops). The draw cord 120 has a first free portion 124 and a second free portion 126, each of which is free from the sleeve 122. To close the opening 106, one or both of the free portions 124 and 126 are pulled away from the mesh wall 102. Instead of a sleeve 122, the stretch cord 120 may be affixed to the mesh wall 102 through one or more openings along the edge of the opening 106 (e.g., in a sufficiently dimensioned manner such that a rope or cord can be passed through and pulled to close the pouch opening in the same way as a drawstring or tobacco pouch).
    [0016] In one embodiment, the material around opening 106 has elastic properties imparted by the textile characteristics of mesh wall 102 (e.g., in the opening rim) so that a surgical implant can be placed in enclosure 106 by an opening of forced enlargement and insertion of the implant. The implant is then trapped by retracting the opening. This embodiment may or may not include a draw cord.
    [0017] As shown in Figures 1 to 4, in one embodiment, the mesh pocket 100 includes one or more extensions, shown in the figures as a first mesh flap 128 and a second mesh flap 130. The mesh flaps 128 and 130 are affixed to mesh wall 102 on opposite sides of the widest point of mesh pocket 100. Mesh tabs 128 and 130 provide surfaces for suturing mesh pocket 100 to inner portions (eg, inner fabric) of a patient. Mesh flap pore sizes and patterns may vary depending on modality. Two mesh tabs are shown in the drawings, but additional mesh tabs are possible in other modalities. In this embodiment, mesh flaps 128 and 130 are placed in the same plane midway (or approximately midway) across the spheroid shape cross of mesh pocket 100. Other embodiments may have mesh flaps placed in different planes or in different cross-sectional lengths along the diameter of the mesh bag.
    [0018] In one embodiment, mesh pocket 100 includes an integrated wire 132 affixed to mesh wall 102. Wire 132 has a needle 134 affixed to its terminal. Thread 132 can be used to suture from mesh pocket 100 to an interior portion of a patient. According to one embodiment, yarn 132 is connected to one or more of the strands of mesh wall 102 (either with a glove configuration such as draw cord 120 or without a glove) so as to pull yarn 132 (by example, during suturing using the thread) has the effect of making the enclosure 104 smaller so that the mesh wall 102 fits more comfortably over an implant. The mesh bag 100 can have multiples of these threads integrated with needles.
    [0019] Turning to Figure 5 and Figure 6, an example of how the 100 mesh pouch is used will now be described. A medical device, such as a breast implant, is inserted into mesh pocket 100 through opening 106. After the medical device is inserted, it will be completely encased within mesh wall 104. Drawstring 120 is pulled from so that the opening 106 becomes smaller and smaller as the draw cord 120 is pulled tighter until it becomes tight. The draw cord 120 is then girded. The implant can be held within the mesh pocket 100 due to the elastic recoil of the mesh wall 102, or more securely by closing the opening 106 with the stretch cord 120. The rest shape of the mesh wall 102 can force a round implant wrapped in this mode to assume a more natural breast shape.
    [0020] The implant within the 100 mesh bag can then be placed in the proper position and in the appropriate tissue plane, as it would be without the 100 mesh bag (between the skin and the pectoral/fascia in the reconstruction scenario pre-pectoral breast, for example). However, after placement, the integrated mesh flaps 128 and 130 can be sutured directly to the soft tissue (an interior of the chest wall or other tissue such as the pectoral fascia, for example) to maintain their position during the process. healing. Suturing the 100 mesh pocket to the chest wall provides a way to locate the implant without having to rely on soft tissue manipulation, and the position of the flaps away from the breast implant minimizes the risk of accidental damage to the breast implant during this process. Positioning and shaping can be further facilitated by using the integrated needle 134 (or needles, if there are multiple) to suture to the chest wall, which (if integrated with mesh wall 102 as described above) is also girded down or sews the 100 mesh pouch as desired by squeezing threads (e.g., embedded fibers) to which the embedded needles are attached. Finally, the overlying layers (skin and subcutaneous tissue, for example) are closed. The weight of the implant is supported by the 100-mesh bag and the soft tissue to which it is sutured, rather than the envelope of skin covering it.
    [0021] According to an embodiment, the mesh pocket 100 is formed as follows: 1) a mesh sheet is formed by warp knitting, electrospinning or other textile technique. 2) A thermally conductive mold or mandrel is formed into a desired spheroid or breast shape. 3) The mesh is wrapped around and annealed into the mold or mandrel to the desired spheroid or breast shape.
    [0022] The 100 mesh bag can have uses in multiple domains of breast surgery, such as direct implant pre-pectoral breast reconstruction for a mastectomy defect. In this scenario, recreating a breast mound is accomplished by placing a prosthetic breast implant in the plane between the pectoral muscle and the overlying skin, in the space where the breast tissue used to reside before the mastectomy. For example, in Figure 5, an implant in the form of a mesh pouch 500 (configured in accordance with one or more of the modalities described above) disposed IN SITU in a human breast, with a retractor 502 also shown, is graphically depicted. In Figure 6, a 600 mesh pouch-shaped implant (configured in accordance with one or more of the modalities described above) disposed IN SITU in a human breast with a 602 mesh flap sutured in place is shown. The various tissues shown in Figure 6 include skin and subcutaneous tissue 604, pectoral 606, ribs 608, and intercostals 610.
    [0023] It should be understood that the modalities described herein are to be considered only in the descriptive sense and not for limiting purposes. Descriptions of features or features within each modality should be considered available for other similar features or features in other modalities. It will be understood by those skilled in the art that various changes in form and detail can be made without abandoning its spirit and scope.
    权利要求:
    Claims (15)
    [0001]
    1. Mesh bag (100) for containing a surgical implant within a patient's body, the mesh bag (100) characterized in that it comprises: a mesh wall (102) defining an enclosure (104) having a opening (106) at one end (108) of the enclosure (104); a stretch cord (120) configured to close the opening (106) when stretched so as to prevent the surgical implant from exiting the enclosure (104); and a mesh flap (128) extending from the mesh wall (102), the mesh flap (128) providing a surface for suturing the mesh pocket (100) to an inner surface of the patient's body.
    [0002]
    2. Mesh pocket (100) according to claim 1, characterized in that it further comprises a thread (132) extending from the mesh wall (102).
    [0003]
    3. Mesh bag (100) according to claim 2, characterized in that it further comprises a needle (134) affixed to a thread terminal (132).
    [0004]
    4. Mesh pocket (100) according to claim 1, characterized in that it further comprises one or more strands (132) extending from the mesh wall (102), wherein each of the one or more wires (132) is configured to tighten the mesh wall (102) around the surgical implant when pulled.
    [0005]
    5. Mesh pocket (100) according to claim 1, characterized in that the mesh wall (102) comprises a series of circular cords (110) surrounding a longitudinal geometric axis of the mesh pocket.
    [0006]
    6. Mesh pocket (100) according to claim 5, characterized in that the mesh wall (102) further comprises a second series of circular cords (116) oriented in planes that are perpendicular to the orientation planes of the series. of circular strings (110).
    [0007]
    7. Mesh bag (100) according to claim 1, characterized in that the enclosure (104) is spherical in shape when the mesh wall (102) is fully expanded.
    [0008]
    8. Mesh bag (100) according to claim 1, characterized in that the mesh wall (102) is made of a stretchable material that allows expansion and contraction of the opening (106).
    [0009]
    9. Mesh bag (100) according to claim 1, characterized in that the mesh wall (102) is made of a material selected from the group consisting of poly-(p)-dioxanone, poly-trimethylene -carbonate, polyglycolide, P4HB and fibroin.
    [0010]
    10. Mesh bag (100) for containing a surgical implant within a patient's body, the mesh bag (100) characterized in that it comprises: a mesh wall (102) defining an enclosure (104) having a opening (106) at one end (108) of the enclosure (104); a stretch cord (120) surrounding a rim of the opening (106) and configured to close the opening (106) when stretched so as to prevent the surgical implant from exit the enclosure (104); a wire (132) extending from the mesh wall (102); and a needle (134) affixed to a terminal of the thread (132).
    [0011]
    11. Mesh pocket (100) according to claim 10, characterized in that the mesh wall (102) comprises a series of circular cords (110) surrounding a longitudinal geometric axis of the mesh pocket (100).
    [0012]
    12. Mesh pocket (100) according to claim 11, characterized in that the mesh wall (102) further comprises a second series of circular cords (116) oriented in planes that are perpendicular to the orientation planes of the series of circular strings (110).
    [0013]
    13. Mesh bag (100) according to claim 10, characterized in that the enclosure (104) is spherical in shape when the mesh wall (102) is fully expanded.
    [0014]
    14. Mesh bag (100) according to claim 10, characterized in that the mesh wall (102) is made of a stretchable material that allows expansion and contraction of the opening (106).
    [0015]
    15. The mesh bag (100) according to claim 10, characterized in that the mesh wall (102) is made of a material selected from the group consisting of poly-(p)-dioxanone, poly-trimethylene -carbonate, polyglycolide, P4HB and fibroin.
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    法律状态:
    2021-01-05| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-04-20| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/11/2018, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201762585402P| true| 2017-11-13|2017-11-13|
    US62/585,402|2017-11-13|
    PCT/US2018/060281|WO2019094861A1|2017-11-13|2018-11-12|Mesh pouch for medical implant and method for using same|
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