WO2024243574A2 - Bordure absorbable pour maillage herniaire - Google Patents

Bordure absorbable pour maillage herniaire Download PDF

Info

Publication number
WO2024243574A2
WO2024243574A2 PCT/US2024/031144 US2024031144W WO2024243574A2 WO 2024243574 A2 WO2024243574 A2 WO 2024243574A2 US 2024031144 W US2024031144 W US 2024031144W WO 2024243574 A2 WO2024243574 A2 WO 2024243574A2
Authority
WO
WIPO (PCT)
Prior art keywords
mesh
border
edge
poly
location
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2024/031144
Other languages
English (en)
Other versions
WO2024243574A3 (fr
Inventor
Shirin TOWFIGH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hexagon Health Inc
Original Assignee
Hexagon Health Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hexagon Health Inc filed Critical Hexagon Health Inc
Priority to EP24812025.5A priority Critical patent/EP4719265A2/fr
Publication of WO2024243574A2 publication Critical patent/WO2024243574A2/fr
Publication of WO2024243574A3 publication Critical patent/WO2024243574A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body

Definitions

  • Hernia occurs when there is a weakness or hole in the muscular wall. Such hole allows organs and tissues to push through, or herniate, producing a bulge.
  • an inguinal hernia which is a protrusion of the abdominal-cavity contents through the inguinal canal or other defects within the groin region. Inguinal hernia is common in men. Inguinal hernia repair with mesh is one of the most frequently performed operations.
  • the implant comprises, a mesh comprising a fabric layer configured to adhere to a tissue upon implantation of the mesh in the subject, the mesh configured to cover at least a portion of a hernia, and a border composed of a bioabsorbable material, the border coupled to a portion of an edge of the mesh and extending at a non-zero angle therefrom, wherein the border is configured to be absorbed within a target amount of time after implantation.
  • the target amount of time is greater than an adhesion time for the mesh to at least partially adhere to the tissue surrounding the hernia.
  • the target amount of time is at least about 1 week, at least about 2 weeks, at least about 1 month, at least about 2 months, at least about 3 months, at least about 4 months, at least about 6 months, at least about 1 year, or at least about 2 years.
  • the border extends from an inferior edge of the mesh, a lateral edge of the mesh, a medial edge of the mesh, a superior edge of the mesh, or a combination of two or more thereof. In some embodiments, the border extends from the edge by at least about 1 mm, at least about 2 mm, at least about 5 mm. at least about 1 cm, at least about 2 cm, at least about 3 cm, at least about 5 cm, or at least about 10 cm.
  • the border extends outward from a first edge location of the edge of the mesh to form a first border width, wherein the border extends outward from a second edge location of the edge of the mesh spaced apart from the first location to form a second border width, and wherein a length of the border extends betw een the first border width and the second border width.
  • the border extends from the edge of the mesh at a non-zero angle relative to the mesh at a first edge location to form a first border width generally along a lateral edge of the border, and wherein the border extends from the edge of the mesh at a non-zero angle relative to the mesh at a second edge location to form a second border width generally along a medial edge of the border, and wherein a length of the border extends between the first border width and the second border width.
  • the first border width is longer than the second border width.
  • the first border width is the same length as the second border width.
  • the length forms a smooth gradation in extension from the mesh edge betw een the first border width and the second border width.
  • the border comprises alginate, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), chitosan, collagen, dioxanones (e.g..
  • poly(ethylene adipate) PEA
  • poly(ethylene oxide-co-caprolactone) PEOCL
  • polyethylene oxide-co-lactide) PELA
  • poly(ethylene oxide-co-propylene oxide) PEOPO
  • poly(ethylene oxide terephthalate) PEOT
  • poly(ethylene succinate) PES
  • poly(ethylene terephthalate) PET
  • poly(ester-amide) PEA
  • poly(ester-anhydride) PEAN
  • poly(ester carbonate urethane) PECU
  • poly(ester-ether-ester) PEE
  • poly(glycolic acid-co-caprolactone) PGACL
  • poly(gly colic acid-co-trimethylene carbonate) PGATMC
  • poly(gly colic acid-co- caprolactone) PGACL
  • poly(glycolic acid-co-trimethylene carbonate) PGATMC
  • poly(glycerol sebacate) PS)
  • the border comprises only absorbable materials, such that the border is fully absorbable.
  • the border is coupled to the mesh via glue, sewing, grips, sutures, staples, or a combination of two or more thereof.
  • the mesh is configured as an inguinal mesh, an open mesh, a lap mesh, a robotic mesh, an onlay mesh, a sublay mesh, an underlay mesh, or a combination of two or more thereof.
  • the mesh is configured to implanted at least partially within an abdomen of the subject, a flank of the subject, or other areas where hernias occur and need treatment with a hernia mesh.
  • the mesh further comprises a single fin having a fin edge extending at least partially inferiorly from the fabric layer.
  • the border comprises a medial edge extending from the mesh at the first edge location, lateral edge extending from the mesh at the second edge location, and a free edge therebetween, wherein the free edge is longer than the edge of the border coupled to the mesh from the first edge location to the second edge location.
  • the border comprises a medial edge extending from the mesh at the first edge location, lateral edge extending from the mesh at the second edge location, and a free edge therebetween, wherein the free edge is shorter than the edge of the border coupled to the mesh from the first edge location to the second edge location.
  • the border comprises a medial edge extending from the mesh at the first edge location, lateral edge extending from the mesh at the second edge location, and a free edge therebetween, wherein the free edge is about equal than the edge of the border coupled to the mesh from the first edge location to the second edge location.
  • at least one of the medial edge, the lateral edge, and the free edge of the border are a straight edge when flattened.
  • at least one of the medial edge, the lateral edge, and the free edge of the border form a curve when flattened.
  • at least one of the medial edge, the lateral edge, and the free edge of the border form an arc when flattened.
  • the border extends from the mesh only on the lateral half of the mesh. In some embodiments, the border extends from the mesh only on the medial half of the mesh. In some embodiments, the border extends from the mesh at least on the lateral half of the mesh. In some embodiments, the border extends from the mesh at least on the medial half of the mesh. In some embodiments, the first border width and the second border width are about equal. In some embodiments, the first border width and the second border width are each about 1 mm. at least about 2 mm, at least about 5 mm, at least about 1 cm, at least about 2 cm, at least about 3 cm, at least about 5 cm, or at least about 10 cm. In some embodiments, the first border width and the second border width are different.
  • a free edge border from the first location to the second location has a free edge border width that varies in width.
  • the free edge border width varies in width along its length about 1 mm, about 5 mm, about 1 cm, about 2 cm, about 3 cm, about 5 cm, about 10 cm, at least about 1 mm, at least about 2 mm, at least about 5 mm, at least about 1 cm, at least about 2 cm, at least about 3 cm, at least about 5 cm, or at least about 10 cm, from 1 cm to 10 cm, from 1 cm to 5 cm. from 2 cm to 5 cm, or from 1 cm to 3 cm.
  • the free edge border width along its length from the first location to the second location is about 1 mm, about 5 mm, about 1 cm, about 2 cm, about 3 cm, about 5 cm, about 10 cm, 1 mm to 10 cm, about 1 cm to about 10 cm, about 2 cm to about 10 cm, about 1 cm to about 5 cm, about 2 cm to about 5 cm, at least about 1 mm, at least about 2 mm. at least about 5 mm, at least about 1 cm, at least about 2 cm, at least about 3 cm, at least about 5 cm, at least about 10 cm, from 1 cm to 10 cm, from 1 cm to 5 cm, from 2 cm to 5 cm, from 1 cm to 3 cm, at least 1 mm, at least 2 mm. at least 5 mm, at least 1 cm, at least 2 cm, at least 3 cm, at least 5 cm, or at least 10 cm.
  • Fig. 1A illustrates an exemplary sublay left inguinal hernia mesh having an absorbable border that extends the inferior edge of the mesh, according to embodiments described herein.
  • Fig. IB illustrates an example of the sublay left inguinal hernia mesh having an absorbable border that extends partially along and outwards from the inferior edge of the mesh, according to embodiments described herein.
  • Fig. 2A illustrates an exemplary left inguinal mesh, sublay position, having an absorbable border extending outwards from the inferior border of the original mesh, according to embodiments described herein.
  • Fig. 2B illustrates an example of the left inguinal mesh having an absorbable border that extends partially along and outwards or at a non-zero angle from the inferior edge of the mesh, according to embodiments described herein.
  • FIG. 3A illustrates a left onlay mesh with a fin for femoral hernia and inguinal repair, having an absorbable border extending along and outwards or at a non-zero angle from the inferior edge of the mesh, according to embodiments described herein.
  • Fig. 3B illustrates an example of the left onlay mesh with a fin for femoral hernia and inguinal repair having an absorbable border that extends partially along and outwards (or at a non-zero angle) from the inferior edge of the mesh, according to embodiments described herein.
  • Fig. 4A illustrates an example of a mesh for inguinal hernia repair having an absorbable border extending along and outwards (or at a non-zero angle) from the inferior edge, according to embodiments described herein.
  • Fig 4B illustrates an example of the mesh for inguinal hernia repair having an absorbable border that extends partially along and outwards (or at a non-zero angle) from the inferior edge of the mesh, according to embodiments described herein.
  • reference to a range of 1-5,000-fold includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20-fold, etc., as well as 1.1, 1.2, 1.3, 1.4, 1.5-fold, etc., 2.1, 2.2, 2.3, 2.4, 2.5-fold, etc., and so forth.
  • the terms “3D” and “three-dimensional” refer to the shape a mesh and/or a border of a mesh conforms to.
  • the mesh and border described herein are planar, flexible materials (e.g., having a fabric-like characteristics).
  • the mesh and border of the mesh may be placed over a sphere where the mesh will take the shape and curvature of a sphere while remaining a planar material.
  • the mesh portion would take on the shape of a sphere, while the border would extend in a different direction from the sphere.
  • hernias There are various types of hernias known, some of which are location specific, and/or some of which are gender specific. For example, inguinal hernias are defects within the muscle and fascia planes of the groin region, wherein men are considered to be more prone to inguinal hernias due to the narrower and deeper male pelvis.
  • At least one method for hernia repair includes implanting a mesh about the defect, so as to contain the resulting bulge.
  • the gold standard for hernia repair involves use of a mesh to patch the hernia defect in a tension-free manner.
  • hernia repair is performed using open, laparoscopic, or robotic-assisted techniques.
  • the implantation of mesh has shown to be superior to non-mesh techniques due to the significantly lower risk of hernia recurrence when such a tension-free repair is performed.
  • mesh brands, sizes, and surgical techniques for mesh implantation can include purely non-absorbable material, purely absorbable material, or a hybrid of absorbable and non -absorbable material
  • the mesh can migrate, erode, fold, buckle, break, tear, disintegrate, or cause an autoimmune or inflammatory reaction.
  • This folding of the mesh is referred to as a “meshoma.” This can cause hernia recurrence or chronic pain in various forms.
  • Folding or buckling of the mesh is especially a problem with sublay or underlay positioning of the mesh deep to the inguinal floor muscle. This is commonly performed with the laparoscopic or robotic-assisted approaches. Such buckling or folding has been referred to as “taco-ing” or “clam shelling 7 ’ of the mesh.
  • Techniques related to the placement of the mesh can help reduce risks of movement, buckling, or folding of the mesh.
  • One technique is to maximize the dissection of tissue in the retromuscular plane prior to mesh placement. Another is to allow for wider overlap of the mesh over normal healthy tissues.
  • the meshes described herein include a border extending thereof that is implanted with the mesh and at least partially secures the mesh to the desired tissue, wherein at least a portion of the border is absorbable to the surrounding tissue, such that said absorbable portion is thereby removed from the mesh.
  • devices comprising mesh coupled to biodegradable borders that address the issue of mesh folding or buckling in patients who undergo mesh implantation for inguinal hernia repair.
  • Mesh-related complications in the inguinal region may be a result of mesh folding, migration, and/or abnormal adherence or erosion into nearby structures. This can result in a hernia recurrence and/or may affect the nerves, vessels, vas deferens (in males), and/or bladder by inciting an abnormal interaction between the folded mesh and these nearby structures.
  • the meshes and methods disclosed herein are intended to help reduce mesh folding or migration from its original position by adding an absorbable or mostly absorbable component (e.g., a border as described herein) that will protect the mesh from folding during the initial stages of its integration with normal tissues.
  • an absorbable or mostly absorbable component e.g., a border as described herein
  • bioabsorbable and absorbable are used interchangeably, and are intended to mean that such portion of the device is capable of being absorbed by the subject’s body and/or degraded into smaller portions that are then removed from the body, and/or chemically and physically altered or broken down and cleared from the physiological environment by any means without outside intervention to do so.
  • the absorbable component is intended to remain active during the healing stages after the operation, and while the mesh is integrating into the normal tissues. Once the mesh is fully integrated and can no longer move, the absorbable component may start disintegrating.
  • the absorbable or mostly absorbable component may be synthetic, biologic, or a combination of both.
  • the meshes and methods disclosed herein may be used to reduce one or more selected from: chronic pain, functional impairment, and sexual dysfunction due to mesh folding.
  • the absorbable component of the inguinal hernia mesh may be used to reduce hernia recurrence and/or its severity.
  • the devices disclosed herein may be applicable to various mesh placement techniques and surgical techniques. As non-limiting examples, these techniques include onlay mesh placement, sublay mesh placement, mesh-plug placement, retroperitoneal mesh placement, open mesh techniques, laparoscopic techniques, robotic techniques, or a combination thereof.
  • the terms “absorbed” and “absorption rate” when used to describe the border of the mesh refers to when the material of the border which has dissolved or degraded a target percentage within a target time period when tested ex vivo in solution.
  • the target percentage is 99%. In some embodiments, the target percentage is 95%. In some embodiments, the target percentage is 90%. In some embodiments, the target percentage is 85%. In some embodiments, the target percentage is 80%. In some embodiments, the target percentage is 75%. In some embodiments, the target percentage is 70%. In some embodiments, the target percentage is 65%. In some embodiments, the target percentage is 60%. In some embodiments, the target percentage is 55%.
  • the target percentage is 50%. In some embodiments, the target percentage is 45%. In some embodiments, the target percentage is 40%. In some embodiments, the target percentage is 35%. In some embodiments, the target percentage is 30%. In some embodiments, the target percentage is 25%. In some embodiments, the target percentage is 20%. In some embodiments, the target percentage is 15%. In some embodiments, the target percentage is 10%. In some embodiments, the target percentage is 5%.
  • the absorption rate of the border is controlled by selecting a material of a desired thickness.
  • a thicker border may absorb at a slower rate than a thinner border.
  • the border thickness is between 0. 1-0.5, 0.5- 1.0, 1.0-1.5, 1.5-2.0, 2.0-2.5, 2.5-3.0, 3.0-3.5, 3.5-4.0, 4.0-4.5, 4.5-5.0, 5.0-5.5 millimeters.
  • the absorption rate of the border is controlled by altering the composition of polymers making up the border.
  • the absorption rate is controlled by the density of the border. For example, a porous border may be used for a faster absorption rate while a solid border may be used for a slower absorption rate.
  • the absorption rate of the border is selected to substantially match the tissue integration rate into the mesh around the hernia so as to maintain adherence between the mesh and the tissue.
  • the border is selected to substantially match the tissue integration rate into the entire mesh so as to maintain adherence between the mesh and the tissue and prevent a portion or the entire mesh from curling within the patient.
  • an implant for hernia repair in a subject comprising: a mesh comprising a fabric layer comprising a plurality of pores configured to enable tissue adhesion to the mesh upon implantation of the mesh in the subject, the mesh configured to cover at least a portion of the hernia; and a border extending from the mesh, the border configured to be at least partially absorbable into the subject after a target amount of time after implantation into the subject.
  • the target amount of time corresponds to the mesh at least partially adhering to the subject about the portion of the hernia. In some embodiments, the target amount of time is at least about 1 week, at least about 2 weeks, at least about 1 month, at least about 2 months, at least about 3 months, at least about 4 months, at least about 6 months, at least about 1 year, or at least about 2 years.
  • the border extends from any edge defining the mesh. In some embodiments, the border extends from a inferior edge of the mesh, a lateral edge of the mesh, a medial edge of the mesh, a superior edge of the mesh, or any combination thereof. In some embodiments, the border extends from at least a portion of the mesh by at least about 1 mm, at least about 2 mm, at least about 5 mm, at least about 1 cm, at least about 2 cm. at least about 3 cm, at least about 5 cm, or at least about 10 cm. In some embodiments, the border comprises one or more absorbable materials. In some embodiments, the border comprises only absorbable materials, such that the border is fully absorbable.
  • the border is coupled to the mesh via glue, sowing, grips, sutures, staples, or any combination thereof.
  • the mesh is configured as an inguinal mesh, an open mesh, a lap mesh, a robotic mesh, an onlay mesh, a sublay mesh, an underlay mesh, or any combination thereof.
  • the mesh is configured to implanted about an abdomen of the subject, a flank of the subject, or other areas thereabout.
  • the mesh further comprises a single fin having a fin edge extending at least partially inferiorly from the fabric layer.
  • the present invention relates to implants used for repairing a hernia.
  • repairing a hernia comprises implanting a mesh to overlay the hernia defect and optionally surrounding area.
  • any type of hernia mesh can be used, such as inguinal, abdominal/ventral, or any combination thereof.
  • inguinal hernias include all hernias of the groin.
  • inguinal hernia includes but is not limited to indirect and directs inguinal hernias, femoral hernias, and obturator hernias.
  • implantable mesh generally sheets of mesh having two flat sides adheres to the subject's tissue on both flat sides following and/or during an inflammatory response to the implantation of the device.
  • the goal of hernia repair is for this adhesion to occur on both flat sides of a mesh, however, depending on mesh design and surgical technique, the mesh may migrate or may not lay flat and may fold or buckle during the initial adhesion process. This can cause functional deterioration, pain, and other effects which are difficult to treat and can cause life-long debility.
  • an optimal mesh repair e.g., of an inguinal hernia is to have adhesion of the mesh onto the abdominal and pelvic floor structures along its entire perimeter.
  • the mesh may lift off from the intended area of adherence, resulting in folding, buckling, or balling up of the mesh.
  • this additional component can help reduce the risk of mesh lifting off at its edges.
  • implantable meshes for hernia repair that include a border extending from an edge of the mesh, wherein the border is at least partially absorbable.
  • the border is configured to further secure the mesh to the subject, and configured to be absorbed in the tissue after a certain amount of time, wherein such amount of time may correspond to an amount of time for the mesh to sufficiently adhere to the tissue about the hernia defect (e.g., via tissue integration or tissue adhesion).
  • the border improves the adherence and long term efficacy of the original mesh piece by optimizing the initial healing process. In some cases, by having the absorbable border, the overall need for mesh in the long term is reduced (compared to traditional mesh implants) and only have it for the short term.
  • the mesh, scaffold, or other implant whether synthetic or nonsynthetic, used for the intention of inguinal hernia repair are herein referred as a group termed "‘mesh/’
  • implants as disclosed herein include but are not limited to meshes, biologies, allografts, xenografts, scaffolds, bioactive synthetic meshes, absorbable meshes, non-absorbable meshes, hybrid products, and implants made of other biomaterials.
  • “mesh” is equivalent to “implant’' as disclosed herein.
  • an optimal mesh repair of an inguinal hernia is to have selective adhesion of the mesh onto the abdominal and pelvic floor structures that support the hernia defect which includes but are not limited to nearby muscles, fascias, and ligaments, without adhesion to critical structures including but not limited to nerves (including a genital nerve) and optionally the round ligament in female and the spermatic cord and its content and nerves (including a genital nerve) in males.
  • nerves including a genital nerve
  • implants as disclosed herein include one or more selected from: a synthetic implant, a partially synthetic implant, and a non-synthetic implant.
  • implants as disclosed herein include but are not limited to meshes, biologies, allografts, xenografts, scaffolds, bioactive synthetic meshes, absorbable meshes, non-absorbable meshes, hybrid products, and implants made of other biomaterials.
  • the devices and methods disclosed herein may include mesh for implantation during different surgical procedures, for non-limiting examples, open inguinal surgery, laparoscopic surgery, or robotic-assisted surgery.
  • the devices and methods disclosed herein may include mesh for implantation at different location, for non-limiting example, left or right of the midline of the body, on top of muscle, and/or behind the muscle.
  • the technique for mesh implantation may be open, laparoscopic, or robotic-assisted, and this does not vary greatly between males and females.
  • the onlay, sublay, or hybrid techniques may not be significantly variable between males and females.
  • the devices disclosed herein, with or without a border may have an initial inflammatory stage in which the device may adhere to ty pically but not limited to muscle, ligament, or fascia, as possible, and may have relatively rapid and relatively strong tissue ingrowth from as much normal healthy vascular tissue.
  • these structures include but are not limited to the spermatic cord and its contents as well as nearby nerves.
  • Non-limiting example of these structures includes the genital branch of the genitofemoral nerve and the nerves along the vas deferens, which runs within the spermatic cord.
  • adherence of the mesh to undesired tissues or regions occurs with both flat and three- dimensional mesh designs. In some cases, such undesired adherence causes chronic groin pain, pelvic pain, and/or pain with sexual intercourse and orgasm. Males may also suffer from testicular pain and infertility.
  • the border helps alleviate said risk of the initial inflammatory stage by providing additional security of the mesh to the surroundings.
  • the border is adapted to prevent separation and/or curling of a portion of the mesh away from the wall of a user.
  • the border may be adapted to provide additional adhesion over the bottom of the mesh.
  • the border is adapted to at least partially cover the peritoneal nerves.
  • the border is adapted to at least partially cover the spermatic chord. Covering nerves and/or the spermatic chord at least partially with the border may prevent pulling of the mesh on the nerve by the patient causing pain while maintaining adhesion betw een the mesh and the border.
  • Maintaining adherence of the mesh to the tissue initially while the mesh adheres to the tissue about or around the hernia is important to ensure repair of the hernia.
  • the curling of an inguinal hernia mesh may occur as a result from a combination of factors related to the mesh material, surgical technique, and patient-specific issues.
  • Mesh used for hernia repairs must be lightweight and flexible for placement, but this also may cause the mesh to be prone to curling under tension and/or after being placed in the body. Further, insufficient fixation of the mesh to the tissue of the patient surrounding the hernia can cause the mesh to curl away from the tissue wall.
  • postoperative body movements, the healing process, and environmental factors like temperature changes can influence the mesh's stability and shape. Postoperative movements such as.
  • coughing or straining can place stress on the mesh, potentially causing it to shift and curl away from the tissue wall. Additionally, the body's healing response such as an inflammatory response to the material and/or the formation of scar tissue during tissue ingrow th, can influence the position and shape of the mesh.
  • an inguinal hernia mesh curls, it increases the risk of decreased effectiveness of the hernia repair.
  • a curled mesh may fail to adequately cover the defect in the abdominal wall, leading to incomplete or unstable repair, which significantly increases the risk of the hernia recurring.
  • the mesh may irritate surrounding nen es, causing chronic pain, and potentially damage nearby tissues and organs. This irritation and damage not only result in discomfort but can also complicate post-surgical recovery and diminish the overall success of the hernia repair.
  • a curled hernia mesh may increase the risk of infection and other complications.
  • the undesirable positioning may create spaces where fluids accumulate, fostering an environment for infections, which are serious complications that might necessitate removal of the mesh.
  • adhesions may form if the mesh adheres to other adjacent tissues and/or organs, leading to chronic pain and potentially causing bow el obstruction.
  • curling would likely result in poor integration of the mesh into the tissue and impede proper healing, diminishing the overall effectiveness of the repair.
  • the mesh comprises of a fabric layer (as described herein, and as described in PCT application PCT/US2016/024090, which is incorporated herein by reference in its entirety).
  • the implantable mesh for inguinal hernia repair disclosed herein is synthetic.
  • the fabric layer, the anti-adhesive barrier, or both the fabric layer and the anti-adhesive barrier are synthetic.
  • the synthetic mesh is made of one or more synthetic materials selected from but not limited to: polypropylene, polyester, expanded polytetrafluoroethylene (ePTFE), and copolymer, block copolymers, homopolymers, blends, and combinations of any two or more thereof and polymer suitable for inguinal floor reconstruction.
  • the fabric layer comprises an interlaced structure defining a plurality of interstitial openings (alternatively called interstices herein).
  • the border is composed of one or more bioabsorbable materials.
  • the synthetic mesh is made of one or more bioabsorbable materials selected from one or more selected from but not limited to: alginate, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), chitosan, collagen, dioxanones (e.g..
  • PHBV poly(3-hydroxybutyrate-co-3-hydroxyvalerate)
  • polyethylene adipate) PEA
  • poly(ethylene oxide-co-caprolactone) PEOCL
  • polyethylene oxide-co-lactide) PELA
  • poly(ethylene oxide-co-propylene oxide) PEOPO
  • poly(ethylene oxide terephthalate) PET
  • poly(ethylene succinate) PES
  • PET poly(ethylene terephthalate)
  • PEAN poly(ester carbonate urethane)
  • poly(ester-ether-ester) PEE
  • poly(glycolic acid-co-caprolactone) PGACL
  • poly(gly colic acid-co-trimethylene carbonate) PGATMC
  • poly(gly colic acid-co- caprolactone) PGACL
  • poly(glycolic acid-co-trimethylene carbonate) PGATMC
  • poly(glycerol sebacate) PES
  • poly(L- lactide-co-D.L-lactide)/polylactic acid poly(lactic acid-co-caprolactone) (PLACE), poly(lactic-co-gly colic acid) (PLGA), polypropylene carbonate) (PPC), poly (propylene fumarate) (PPF), polypropylene glycol) (PPG), poly(trimethylene carbonate) (PTMC), poly(vinyl pyrrolidone) (PVP), polyethylene glycol (PEG
  • the implantable mesh for hernia repair (any type of hernia repair, including inguinal hernia repair) disclosed herein is a hybrid mesh.
  • a hybrid mesh includes at least one synthetic material and at least one biological material.
  • the fabric layer, the anti-adhesive barrier, or both the fabric layer and the anti-adhesive barrier are hybrid.
  • the fabric layer is synthetic, biological or hybrid.
  • the fabric layer is hybrid, and the anti- adhesive barrier is biological, or hybrid, or synthetic.
  • the biological material is absorbable over a pre-determined period of time by the human body.
  • the implantable mesh for inguinal hernia repair disclosed herein is a biological mesh. In some embodiments, the implantable mesh for inguinal hernia repair disclosed herein is a hybrid mesh combining at least a biological and a synthetic material in either the fabric layer, the barrier, or both the fabric layer and the barrier. In some embodiments, the implantable mesh for inguinal hernia repair disclosed herein is a hybrid mesh combining at least an absorbable material and a synthetic material in either the fabric layer, a barrier, the attachment means of the barrier, both the fabric layer and the barrier, both the barrier and the attachment means, or all three of the fabric layer, the barrier, and the attachment means.
  • the mesh as described herein may be any shape that has a curved medial edge or a flat medial edge.
  • the tip or peak of the medial curve may be pointing outward.
  • the mesh may be any shape that has a substantially straight lateral edge or a curved lateral edge.
  • the mesh may be any shape that has a straight or curved inferior edge.
  • the mesh may be any shape that has a straight or curved superior edge.
  • the mesh may be any shape that has at least one smooth edge.
  • the mesh edges do not have any abrupt shape changes or transitions.
  • the mesh has a shape of a square, a rectangle, a diamond, an oval, a trapezoid, a parallelogram, a round, a diamond, a u-shape. a bell-shape, a fan shape, a hexagon, a pentagon, or the like.
  • any mesh disclosed or as used herein includes at least one fabric layer.
  • the meshes as disclosed herein may only comprise a single fabric layer.
  • the single fabric layer of a 2-dimensional mesh may comprise a surface area on one side of the fabric layer.
  • the one side may be an anterior side, or a posterior side.
  • the surface area on the anterior side and the surface area on the posterior side may be identical.
  • the single fabric layer of a 3-dimensional mesh may comprise a surface are on multiple sides of the fabric layer. The sides may be an anterior, posterior, medial, and/or lateral side.
  • the surface area of the fabnc layer may be the maximal area restricted by the edges of the fabric layer.
  • the single fabric layer may have variation in its weave pattern, pore size, weight, density, and/or other physical features.
  • the fabric layer may be adhesive to surrounding tissues.
  • the fabric layer may be selectively anti-adhesive to spermatic cords, contents and/or critical nerves in the area.
  • the fabric layer may be flat, folded, curved, or other 3-dimensional shape.
  • the flat fabric layer may be folded, curved or bent under force.
  • the flat fabric layer may be resiliency curved or bent.
  • the fabric layer may be resiliently reshaped to different degrees from a flat fabric layer to accommodate the anatomy of different patients.
  • the fabric layer may have a pre-determined resistance to reshaping in certain directions in order to hold the herniated tissue back from bulging.
  • the fabric layer may include a grid, a braid, a weave, an interlaced structure, or the like that defines a plurality of interstitial pores (e.g., 101, 201, 301 in PCT/US2016/024090).
  • the pores may have a maximal dimension on the surface area that.
  • the maximal dimension being a width, a length, a diameter, a long axis, or a diagonal.
  • the maximal dimension may be no less than 5 mm, 4mm, 3 mm, 2mm, or 1 mm.
  • the fabric layer may be sheet without any visible weave or any visible pores to naked eyes.
  • the fabric layer may allow tissue adhesion to the mesh with tissue that is directly contacting one side or both side of the fabric layer.
  • Such tissue adhesion may be nonselective.
  • the grid, braid, weave of the fabric layer may enable tailoring of a keyhole and a slit to accommodate critical structures of the male or female patients without disruption or damage to the rest of the fabric layer and its physical properties.
  • the fabric layer may include a horizontal centerline.
  • the horizontal centerline is at exactly 50% of mesh height, the mesh height being in the superior-to-inferior direction, or the longitudinal direction of the mesh or of the patient upon implantation.
  • the horizontal centerline may be at about 50% of mesh height, the mesh height being in the superior-to-inferior direction, or the longitudinal direction.
  • the fabric layer may include a vertical centerline.
  • the vertical centerline is at exactly 50% of mesh width, the mesh height being in the medial-to-lateral direction, or the transverse direction of the mesh or of the patient upon implantation.
  • the vertical centerline may be at about 50% of mesh width, the mesh width being in the medial-to-lateral direction, or the transverse direction.
  • the mesh height may be the maximal distance between a superior edge and an inferior edge in the longitudinal direction.
  • the mesh width may be the maximal distance between a medial edge and a lateral edge in the transverse direction.
  • the meshes as disclosed herein may include a fin.
  • a fin as disclosed herein may be added to the meshes as disclosed herein either during manufacturing or by a surgeon. If needed, the new mesh combining a mesh as disclosed herein and a fin as disclosed herein may be tailored to properly fit into various patients.
  • the mesh may have any shape or size that is suitable for onlay or sublay implantation for inguinal hernia.
  • the maximal horizontal width of the mesh in the lateral-to-medial direction may be about 0. 1 inch to about 15 inches.
  • the maximal vertical height of the mesh in the superior-to-inferior direction may be about 0.5 inch to about 15 inches.
  • Nonlimiting example of mesh sizes include about 1 inch by about 4 inches, about 2 inches by about 4 inches, about 3 inch by about 6 inches, about 4 inch by about 6 inches, about 3 inch by about 5 inches, about 5 inch by about 7 inches, about 1 inch by about 3 inches, about 2.5 inch by about 4.5 inches, or about 3.5 inch by about 5.5 inches.
  • the mesh includes one or more selected from non-limiting list: a plug, a Prolene Hernia System® mesh, a Kugel mesh hernia patch °, and a Progeria mesh system ®.
  • the mesh does not include a keyhole-like feature.
  • the barrier covers the contact area between the tube-like structure and the mesh.
  • the border is configured to be attached to any mesh described herein at an inferior side, a superior side, a lateral side, a medial side, or a combination of two or more thereof.
  • FIGs. 1 to 4 depict exemplary meshes (100, 200, 300, and 400, respectively) having a border ( 1 10, 210, 310, and 410, respectively) attached thereto at an inferior portion of the mesh.
  • FIG. 1A depicts a sublay left inguinal hernia mesh 100 having an absorbable border 110 that extends the inferior edge of the mesh.
  • FIG. 2A depicts a left inguinal mesh 200 having an absorbable border 210 extending beyond the inferior border of the original mesh.
  • FIG. 3 A depicts a left onlay mesh 300 with a fin for femoral hernia and inguinal repair having an absorbable border 310 extending from the inferior edge of the mesh.
  • Fig. 4A illustrates an example of an inguinal hernia repair mesh 400 for inguinal hernia repair having an absorbable border 410 extending along and outwards from the inferior edge 405.
  • any of the borders 120, 220, 230, and 420 extend around between 10-20%, 20-30%, 30-40%, 40-50%, 50-60%, 60-70%, 70-80%, 80-90%, 90-100% of the outer edge of the respective meshes 100, 200, 300, and 400.
  • Fig. IB, Fig 2B, Fig. 3B, and Fig. 4B illustrate exemplary embodiments where the border extends partially along a side of edge of the mesh. In some embodiments, the border extends from a portion of the edge of the mesh most likely to curl away from the tissue within the patient.
  • Fig. IB illustrates an example of a border 120 extending outwards from the edge of the sublay left inguinal hernia mesh 100 and partially along the edge of the sublay left inguinal hernia mesh 100.
  • Fig. 2B illustrates an example of a border 220 extending outwards from the edge of the left inguinal mesh 200 and partially along the edge of the left inguinal mesh 200.
  • Fig. IB illustrates an example of a border 120 extending outwards from the edge of the sublay left inguinal hernia mesh 100 and partially along the edge of the sublay left inguinal hernia mesh 100.
  • Fig. 2B illustrates an example of a border 2
  • a border 320 extending outwards from the edge left onlay mesh 300 and partially along the edge of the left onlay mesh 300.
  • a border 420 extending outwards from the inferior edge 405 of the inguinal hernia repair mesh 400 and partially along the edge of the inguinal hernia repair mesh 400.
  • the border (110, 210, 310, and 410, respectively) comprises a medial edge (102, 202, 302, and 402, respectively) extending from the mesh at the first edge location, lateral edge (104, 204, 304, and 404, respectively) extending from the mesh at the second edge location, and a free edge (106, 206, 306 and 406, respectively) therebetween, wherein the free edge (106, 206, 306 and 406. respectively) is longer than the edge of the border coupled to the mesh from the first edge location to the second edge location.
  • the border comprises a medial edge (102, 202, 302, and 402, respectively) extending from the mesh at the first edge location, lateral edge (104, 204, 304, and 404, respectively) extending from the mesh at the second edge location, and a free edge (106, 206, 306 and 406. respectively) therebetween, wherein the free edge (106. 206, 306 and 406, respectively) is shorter than the edge of the border coupled to the mesh from the first edge location to the second edge location.
  • the border comprises a medial edge (102, 202, 302, and 402, respectively) extending from the mesh at the first edge location, lateral edge (104. 204, 304, and 404.
  • the free edge (106, 206, 306 and 406, respectively) is about equal than the edge of the border coupled to the mesh from the first edge location to the second edge location.
  • at least one of the medial edge (102, 202. 302, and 402, respectively), the lateral edge (104, 204, 304, and 404, respectively), and the free edge (106, 206. 306 and 406. respectively) of the border are a straight edge when flattened.
  • At least one of the medial edge (102, 202, 302, and 402, respectively), the lateral edge (104, 204, 304, and 404, respectively), and the free edge (106, 206, 306 and 406, respectively) of the border form a curve when flattened.
  • at least one of the medial edge (102. 202, 302, and 402. respectively), the lateral edge (104. 204, 304, and 404, respectively), and the free edge (106, 206. 306 and 406, respectively) of the border form an arc when flattened.
  • the border is configured to be attached to the mesh by any attachment means known in the art, such as through stitching, sewing, weaving, gluing, spraying, other manufacturing methods for attachment, or any combination thereof.
  • the border extends from the mesh (e.g.. at any edge of the mesh) at least about 0. 1 cm to at least about 5 cm (relative to any portion of the mesh).
  • the border extends from the mesh at least about 0.5 cm, at least about 1 cm, at least about 1.5 cm, at least about 2 cm, at least about 2.5 cm, at least about 3 cm, at least about 4 cm, or at least about 5 cm.
  • the border extends a variable distance from the mesh along the edge of the mesh.
  • the border may extend from a first location of the mesh to a first distance and extend along the edge of the mesh to a second location having a second distance from the mesh, wherein the first distance is greater that the second distance.
  • the distance of the border from the mesh at the first location may be a gradation in distance to the second location.
  • the distance in the width of the border between the first location and the second location is 0. 1-0.5, 0.5-1, 1-1.5, 1.5-2, 2-2.5, 2.5-3, 3-3.5, 3.5-4, 4-4.5, or 4.5-5 mm.
  • the border is configured to be secured to the subject (at and/or surrounding the hernia defect for example) via any means known in the art.
  • the border is secured to the subject using one or more grips, a biocompatible adhesive, or comprises other material configured to be secured to the subject.
  • by being secured to the subject, and thereby securing and/or further securing the mesh about the hernia defect helps reduce the recurrence of a hernia as described herein (e.g., due to folding up of the mesh, thereby exposing the hernia defect).
  • an absorbable border or partially absorbable border may be included about an inner edge of a keyhole for a mesh (e g., for any keyhole described in a mesh in PCT/US2016/024090. including parastomal hernia mesh designs).
  • the border is at least partially absorbable, such that at least a portion of the border is absorbed (e g., by the tissue surrounding the hernia defect) and thereby removed from the mesh.
  • the border is configured to be at least partially absorbed after a minimum length of time after being implanted into the subject.
  • the border is configured to be at least partially absorbed after at least about 1 day to about 1 year after implantation, at least about 1 week to about 6 months after implantation, at least about 2 weeks to about 4 months after implantation, or at least about 1 month to about 3 months after implantation.
  • the border is configured to be at least partially absorbed after at least about 1 week, at least about 2 weeks, at least about 1 month, at least about 2 months, at least about 3 months, at least about 4 months, or at least about 6 months after implantation.
  • the mesh is configured to be secured to the surrounding tissue (e.g.. via tissue integration or tissue adhesion as described herein) by the time the border has been partially or fully absorbed, such that said border is no longer needed to keep the mesh in place and/or help prevent the mesh from folding up.
  • the border by configuring the border to be at least partially absorbed (e.g., by the surrounding tissue about the hernia defect), the amount of mesh required to be secured for the hernia repair can be reduced.
  • the mesh can be sized to cover only the hernia defect, and/or a reduced portion thereabout (as compared to other traditional meshes), wherein the border will cover further portions of the surrounding tissue about the hernia.
  • the remaining mesh may be tailored to ensure coverage of the hernia defect.
  • Such reduction in the total area covered by mesh may be beneficial for the subject, particularly in helping reduce the onset of post-implantation complications.
  • the border is configured to be absorbed by comprising one or more absorbable materials (e.g., any absorbable material known in the art).
  • the border comprises only absorbable materials.
  • the border comprises a hybrid of one or more absorbable materials and one or more nonabsorbable materials.
  • the term “about.” and “approximately” refers to variations of less than or equal to +/- 1%, +/- 2%, +/- 3%, +/- 4%, +/- 5%, +/- 6%, +/- 7%, +/-'8%, +/- 9%, +/- 10%, +/- 11%, +/- 12%, +/- 14%, or +/- 15%, depending on the embodiment.
  • about 100 meters represents a range of 95 meters to 105 meters, 90 meters to 110 meters, or 85 meters to 115 meters depending on the embodiments.
  • substantially refers to less than or equal to +/- 1%, +/- 2%, +/- 3%, +/- 4%. +/- 5%, +/- 6%, +/- 7%, +/- 8%, +/- 9%. +/- 10%, +/- 11%, +/- 12%, +/- 14%, or +/- 15% variation.
  • substantially parallel represents a range of -1 to 1 degree difference, -5 to 5 degree difference, or -15 degrees to 15 degrees of difference from being parallel, depending on the embodiments.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Sont divulgués des maillages implantables pour une réparation de hernie inguinale chez un patient, comprenant une bordure absorbable conçue pour s'étendre à partir des bords d'un maillage herniaire. Dans certains modes de réalisation, l'implant comprend un maillage comprenant une couche de tissu conçue pour adhérer à un tissu lors de l'implantation du maillage dans le sujet, le maillage est conçu pour recouvrir au moins une partie d'une hernie, et une bordure composée d'un matériau bioabsorbable, la bordure étant couplée à une partie d'un bord du maillage et s'étendant à un angle non nul à partir de celle-ci, la bordure étant conçue pour être absorbée dans une quantité de temps cible après l'implantation.
PCT/US2024/031144 2023-05-25 2024-05-24 Bordure absorbable pour maillage herniaire Ceased WO2024243574A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24812025.5A EP4719265A2 (fr) 2023-05-25 2024-05-24 Bordure absorbable pour maillage herniaire

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363504437P 2023-05-25 2023-05-25
US63/504,437 2023-05-25

Publications (2)

Publication Number Publication Date
WO2024243574A2 true WO2024243574A2 (fr) 2024-11-28
WO2024243574A3 WO2024243574A3 (fr) 2024-12-26

Family

ID=93590339

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/031144 Ceased WO2024243574A2 (fr) 2023-05-25 2024-05-24 Bordure absorbable pour maillage herniaire

Country Status (2)

Country Link
EP (1) EP4719265A2 (fr)
WO (1) WO2024243574A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12496178B2 (en) 2017-05-02 2025-12-16 Sofradim Production Prosthesis for inguinal hernia repair

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8562633B2 (en) * 2004-08-02 2013-10-22 W. L. Gore & Associates, Inc. Tissue repair device with a bioabsorbable support member
CA2789758C (fr) * 2010-02-16 2018-06-19 Ams Research Corporation Maille bioabsorbable pour implants chirurgicaux
CN110934660B (zh) * 2015-03-24 2022-06-07 海克斯工健康公司 用于腹股沟疝修补术的具有屏障的性别特定网状植入物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12496178B2 (en) 2017-05-02 2025-12-16 Sofradim Production Prosthesis for inguinal hernia repair

Also Published As

Publication number Publication date
WO2024243574A3 (fr) 2024-12-26
EP4719265A2 (fr) 2026-04-08

Similar Documents

Publication Publication Date Title
US12594153B2 (en) Gender-specific mesh implant with barrier for inguinal hernia repair
AU2017318580B2 (en) Breast treatment device
US10820980B2 (en) Combination three-dimensional surgical implant
US8728159B2 (en) Prosthetic breast support
US20090204129A1 (en) Bioactive wide-weave mesh
US9636203B2 (en) Method and apparatus of tension free inguinal hernia repair reconstructing physiology using inguinal hernia prosthetic having lateral non-encircling cord locating structure
EP2760370A1 (fr) Prothèse herniaire implantable comportant un anneau d'un seul tenant
WO2024243574A2 (fr) Bordure absorbable pour maillage herniaire
WO2007021875A1 (fr) Systemes, procedes et dispositifs se rapportant a une gaine amovible destinee a une attele implantable
JP2017538547A (ja) 軟組織修復のための埋め込み型プロテーゼ
EP3324881A1 (fr) Prothèses de réparation de hernies
HK40081927A (en) Gender-specific mesh implant with barrier for inguinal hernia repair
US12064330B2 (en) Implantable prothesis for minimally invasive hernia repair
HK40005541B (en) Gender-specific mesh implant with barrier for inguinal hernia repair
HK40005541A (en) Gender-specific mesh implant with barrier for inguinal hernia repair

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24812025

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase

Ref country code: DE

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24812025

Country of ref document: EP

Kind code of ref document: A2

WWE Wipo information: entry into national phase

Ref document number: 2024812025

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2024812025

Country of ref document: EP

Effective date: 20260102

ENP Entry into the national phase

Ref document number: 2024812025

Country of ref document: EP

Effective date: 20260102

ENP Entry into the national phase

Ref document number: 2024812025

Country of ref document: EP

Effective date: 20260102

ENP Entry into the national phase

Ref document number: 2024812025

Country of ref document: EP

Effective date: 20260102

ENP Entry into the national phase

Ref document number: 2024812025

Country of ref document: EP

Effective date: 20260102

ENP Entry into the national phase

Ref document number: 2024812025

Country of ref document: EP

Effective date: 20260102

WWP Wipo information: published in national office

Ref document number: 2024812025

Country of ref document: EP