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WO2023081216A2 - Implant médical auto-adhérent et son procédé d'utilisation - Google Patents

Implant médical auto-adhérent et son procédé d'utilisation Download PDF

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Publication number
WO2023081216A2
WO2023081216A2 PCT/US2022/048709 US2022048709W WO2023081216A2 WO 2023081216 A2 WO2023081216 A2 WO 2023081216A2 US 2022048709 W US2022048709 W US 2022048709W WO 2023081216 A2 WO2023081216 A2 WO 2023081216A2
Authority
WO
WIPO (PCT)
Prior art keywords
bio
implant
adhesive
dehydrated
compatible
Prior art date
Application number
PCT/US2022/048709
Other languages
English (en)
Other versions
WO2023081216A3 (fr
Inventor
Allison M. STAUFFER
Nehal N. PATEL
Timothy Young
Original Assignee
Smith & Nephew, Inc.
Smith & Nephew Orthopaedics Ag
Smith & Nephew Asia Pacific Pte. Limited
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 Smith & Nephew, Inc., Smith & Nephew Orthopaedics Ag, Smith & Nephew Asia Pacific Pte. Limited filed Critical Smith & Nephew, Inc.
Publication of WO2023081216A2 publication Critical patent/WO2023081216A2/fr
Publication of WO2023081216A3 publication Critical patent/WO2023081216A3/fr

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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3616—Blood, e.g. platelet-rich plasma
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments

Definitions

  • the present disclosure pertains generally, but not by way of limitation, to orthopedic implants and methods of treatment. More particularly, the present disclosure relates to a tendon repair implant, such as one that is engineered for arthroscopic placement over or in the area of a full or partial thickness tear of the supraspinatus tendon of the shoulder
  • This disclosure provides design, material, manufacturing method, and use alternatives for implants used for soft tissue repairs such as but not limited to rotator cuff repairs.
  • An example implant includes a bio-compatible implant adapted for use in repairing soft tissue damage, the bio-compatible implant includes a dehydrated collagen scaffold, and a bio- absorbable anchoring mechanism that is secured relative to the dehydrated collagen scaffold, the bio-absorbable anchoring mechanism adapted to secure the bio-compatible implant in place at a treatment site upon implantation.
  • the bio-absorbable anchoring mechanism may include a bio-adhesive layer.
  • the bio-compatible implant may further include a peel layer disposed on the bio-adhesive layer.
  • the bio-absorbable anchoring mechanism may include a plurality of microhooks that are adapted to penetrate into tissue at the treatment site.
  • Another example implant includes a bio-compatible implant adapted for use in repairing soft tissue damage.
  • the bio-compatible implant includes a dehydrated collagen scaffold including an active side and a nonactive side.
  • a dehydrated bio-adhesive is dispersed relative to the active side.
  • the dehydrated bio-adhesive includes a plurality of isolated and purified bloodborne components disposed within the bio-adhesive.
  • One of the plurality of isolated and purified blood borne components includes a zymogen.
  • the zymogen comprises Factor XIII.
  • another one of the plurality of isolated and purified blood-borne components includes isolated and purified fibrinogen.
  • another one of the plurality’ of isolated and purified blood-borne components includes isolated and purified thrombin.
  • the dehydrated bio-adhesive includes 1 to 50 Ill/cm 2 isolated and purified fibrinogen, 4 to 15 mg/cm 2 isolated and purified thrombin, and 10 to 400 lU/ml isolated and purified Factor XIII.
  • the dehydrated bio-adhesive comprises a coating on the active side of the dehydrated collagen scaffold.
  • the dehydrated bio-adhesive penetrates into an interior of the dehydrated collagen scaffold.
  • the dehydrated collagen scaffold has a porosity of 70 to 90 percent.
  • the dehydrated collagen scaffold has an average pore size in a range of 100 to 300 microns.
  • the bio-compatible implant includes an active layer including a first collagen layer adapted to have a first rate of contraction when dehydrated, a bio-adhesive dispersed relative to the first collagen layer, and a non-active layer disposed relative to the active layer.
  • the bioadhesive includes plurality’ of isolated and purified blood-borne components disposed within the bio-adhesive.
  • the non-active layer includes a second collagen layer adapted to have a second rate of contraction when dehydrated. The second rate of contraction is different from the first rate of contraction when dehydrated. The different first and second rates of contraction when dehydrated cause the bio-compatible implant to roll up when dehydrated.
  • the rolled-up bio-compatible implant is configured to flatten out when rehydrated.
  • the first collagen layer further comprises a plurality of microstructures extending from the first collagen layer, thereby increasing surface area of the first collagen layer.
  • the plurality of microstructures extending from the first collagen layer comprise one or more of random fibers, fleece, microhooks or a sponge.
  • the bio-adhesive includes 300 to 600 lU/ml isolated and purified fibrinogen, 40 to 115 mghnl isolated and purified thrombin, and 60 to 120 lU/ml isolated and purified Factor XIII.
  • Another example is a method of repairing soft tissue damage, the method includes creating a cavity proximate a site of the soft tissue damage and inserting a delivery' device including an implant into the cavity'.
  • the delivery' device includes an implant rolled up within the deliverydevice.
  • the implant includes a dehydrated collagen scaffold including an active side and a nonactive side, and a dehydrated bio-adhesive dispersed relative to the active side.
  • the dehydrated bio-adhesive includes a plurality of isolated and purified blood-borne components disposed within the bio-adhesive.
  • One of the plurality of isolated and purified blood-borne components includes a zymogen.
  • the method further includes rehydrating the implant while in the delivery device by exposing the implant to saline within the cavity. Thereafter, the rehydrated implant is deployed from the delivery' device and the implant is held in place over the site of the soft tissue damage with pressure for a period of time until the dehydrated bio-adhesive rehydrates and adheres to anatomy at the site of the soft tissue damage.
  • the method further includes releasing the implant and withdrawing the delivery’ device.
  • the period of time comprises about three minutes.
  • Another example implant is a bio-compatible implant adapted for use in repairing soft tissue damage.
  • the bio-compatible implant includes a dehydrated collagen scaffold, a bioadhesive layer disposed relative on the dehydrated collagen scaffold, and a removable peel layer disposed over the bio-adhesive layer.
  • the bio-adhesive includes one or more of fibrin glue, GRFG (gelatin-resorcinol-formaldehyde /glutaraldehyde) glue, cyanoacrylate glue, a polysaccharide adhesive, a polypeptide adhesive, a polymeric adhesive, or a PEG (poly ethylene glycol) based adhesive.
  • fibrin glue GRFG (gelatin-resorcinol-formaldehyde /glutaraldehyde) glue
  • cyanoacrylate glue a polysaccharide adhesive
  • a polypeptide adhesive a polypeptide adhesive
  • polymeric adhesive a polymeric adhesive
  • PEG poly ethylene glycol
  • the removable peel layer includes a flexible polymeric layer.
  • the removable peel layer includes polyethylene or polyester.
  • the removable peel layer includes a geometry’ that facilitates removal of the removable peel layer subsequent to implantation.
  • Another example implant is a bio-compatible implant adapted for use in repairing soft tissue damage, ’
  • the bio-compatible implant includes a dehydrated collagen scaffold, and a plurality of microhooks extending away from the dehydrated collagen scaffold, the plurality' of microhooks adapted to penetrate into tissue at the treatment site.
  • At least some of the plurality of microhooks are disposed within and extend out of the dehydrated collagen substrate.
  • at least some of the plurality of microhooks extend all the way’ through the dehydrated collagen substrate, with a first portion on a first side of the dehydrated collagen substrate and a hook-shaped second portion extending out of an opposing second side of the dehydrated collagen substrate.
  • At least some of the plurality' of microhooks are secured together in a layer that is secured relative to the dehydrated collagen substrate.
  • At least some of the microhooks are formed of poly lactic acid.
  • Figure 1 illustrates a cross-section of an anterior view of a shoulder of a patient
  • Figure 2 illustrates a shoulder including a head of the humerus mating with the glenoid fossa of the scapula at a glenohumeral joint and an implant affixed to a tendon;
  • Figure 3A illustrates an example implant delivery device attached to an implant
  • Figure 3B illustrates an example delivery' device attached to an implant
  • Figure 3C illustrates an example delivery' device attached to an implant
  • Figure 4 illustrates an example implant delivery’ device attached to an implant
  • FIG. 5 is a schematic diagram showing an example implant
  • Figure 6 is a schematic diagram showing an example implant
  • Figure 7A is a schematic diagram showing an example implant
  • Figure 7B is a schematic diagram of the example implant of Figure 7 A, showing the implant curling in a first direction;
  • Figure 7C is a schematic diagram of the example implant of Figure 7 A, showing the implant curling in a second direction;
  • Figure 8 is a perspective diagram of an example implant
  • Figure 9 A is a perspective diagram of an example implant
  • Figures 9B through 9E are enlarged view of a portion of the example implant of Figure
  • Figure 10 is a flow diagram showing an example method of making a soft tissue repair
  • Figure 11 is a perspective diagram of an example implant
  • Figures 12A through 12F are schematic diagrams of example peel layers usable with the example implant of Figure 11;
  • Figure 13 is an exploded side view’ of an example implant
  • Figure 14A is a perspective diagram of an example implant
  • Figure 14B is a side view' of a portion of the example implan t of Figure 14 A;
  • Figures 15A through 15C are schematic cross-sections of the example implant of
  • Figure 14 A showing ways of securing a plurality of microhooks
  • Figure 16A is a perspective diagram of a layer of microhooks.
  • Figure 16B is a schematic side view" of an example implant including the layer of microhooks of Figure 16A.
  • references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc. indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, s comptures, and/or characteristics may also be used connection wi th other embodiments whether or not explicitly described unless clearly stated to the contrary'.
  • An accepted treatment for rotator cuff tears may include reattaching the tom tendon to the humeral head using sutures. Additionally, in treating rotator cuff tears, an accepted practice may also include the placement of a scaffold over the repaired tendon to mechanically reinforce the repaired tendon. Therefore, there is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body.
  • Figure 1 shows a cross-sectional view of a shoulder 10 including an example implant 12.
  • Shoulder 10 further shows ahead 14 of a humerus 16 mating with a glenoid fossa 18 of scapula 20.
  • the glenoid fossa 18 comprises a shallow depression in scapula 20.
  • a supraspinatus tendon 22 is also shown. These muscles (along with others) control the movement of the humerus 16 relative to the scapula 20.
  • a distal tendon 24 of the supraspinatus tendon 22 meets the humerus 16 at an insertion point 26.
  • the distal tendon 24 includes a damaged portion 28 located near die insertion point 26.
  • the damaged portion 28 includes a tear 30 extending partially through the distal tendon 24.
  • the tear 30 may be referred to as a partial thickness tear.
  • the depicted partial thickness tear 30 is on the bursal side of the tendon, however, the tear may also be on the opposite or articular side of the distal tendon 24 and/or may include internal tears to the distal tendon 24 not visible on either surface. In other instances the tear 30 may be a full thickness tear.
  • Figure 1 further illustrates that the tendon repair implant 12 has been placed over the partial thickness tear 30,
  • the tendon repair implant 12 is placed on the bursal side of the tendon regardless of whether the tear is on the bursal side, articular side or within the tendon. Further, the tendon repair implant 12 may overlay multiple tears.
  • the implant 12 may be used at a variety’ of different treatment sites, such as the hip, knee, ankle, et.
  • the implant 12 may be used for any of a variety of soft tissue repairs, such as but not limited to the Gluteus Medius, which is a large fan-shaped muscle located in the posterior hip, the Hip Capsule, which is also in the hip.
  • the implant 12 may be used in treating soft tissue injuries in the knee, such as but not limited to ligaments such as the ACL (anterior cruciate ligament), MCL (medial collateral ligament) and the PCL (posterior cruciate ligament) and tendons such as the hamstring tendons, the quadriceps tendon and the patellar tendon.
  • the implant 12 may be used in treating soft tissue injuries in the Achilles tendon.
  • the implant 12 may be used in treating soft tissue injuries for any areas of the body that will accommodate the implant 12.
  • delivery of an implant 12 may require a physician to create an incision in the patient sufficient to access the target implant site.
  • the physician may insert an implant delivery’ system through the access site and position the distal end of the implant delivery system adjacent the target implant site. The physician may then manipulate the implant delivery system to deploy an implant out of a delivery' sheath adjacent the target implant site.
  • Figure 2 provides a perspective view of an implant delivery system 40 extending through the shoulder 10 of a patient.
  • Figure 2 the shows implant delivery' system 40 deployed adjacent a target site (e.g., a tear in the supraspinatus tendon).
  • the implant delivery system 40 includes a sheath member 42 (e.g., a cannula) including a proximal portion (not shown), a distal portion 48 and a lumen extending within at least a portion of the cannula 42.
  • the implant delivery' system 40 may include a delivery' shaft 44 extending within the lumen of the sheath member 42 and longitudinally movable relative thereto.
  • the delivery' shaft 44 may include a proximal portion (not shown) extending out of the proximal portion of the sheath member 42 and/or otherwise manipulatable relative to the sheath member 42 by a user. Additionally, in some examples the proximal portion of the delivery- shaft 44 and/or the sheath member 44 may be coupled to a handle member (not shown).
  • the handle member may be utilized to manipulate the delivery shaft 44, For example, the handle member may be utilized to impart a rotational force to the delivery’ shaft 44.
  • the delivery' shaft 44 may include a distal portion 50 extending out of the distal portion 48 of the sheath member 42. Further, the delivery shaft 44 may include a lumen extending therein. The lumen of the delivery shaft 44 may extend along a portion or the entire length of the delivery shaft 44 (e.g., from the distal portion 50 to the proximal portion of the delivery' shaft 44).
  • the delivery’ system 40 may further include a detachable frame member 46 attached to the distal portion 50 of the delivery shaft 44.
  • the detachable frame 46 may be attached to an implant 12 (e.g., a sheet-like implant).
  • an implant 12 e.g., a sheet-like implant.
  • the combined structure including the frame 46 and the implant 12 may be defined as having a proximal end 52 and a distal end 54 as illustrated in Figure 2.
  • a clinician may orient the frame 46 and the implant 12 (for example, via a handle member attached to a proximal portion of the delivery shaft 44) such that the proximal portion 52 may be adjacent (e.g., overlaid) on a portion of the humerus (e.g., on the bone), while the distal portion 54 of the frame 46 and the implant 12 may overlay the distal tendon 24.
  • delivery of implant delivery system 40 may include the insertion of delivery’ sheath 42 through an access site (e.g., incision) and advancement to a target site.
  • a clinician may deploy the detachable frame 46 in combination with the implant 12 out of the lumen located within and along the distal portion 48 of the delivery sheath 42, such as by retracting the delivery sheath 42 relative to the delivery' shaft 44 and the frame 46, and positioning the implant 12 and the frame 46 over the target site.
  • the detachable frame 46 and the implant 12 combination may be contained (e.g., housed) within the lumen of the delivery’ sheath 42 for subsequent deployment distally out distal opening of the delivery sheath 42.
  • the combination of the detachable frame 46 and the implant 12 may wrap and/or fold upon itself such that it may be positioned within the lumen of the delivery sheath 42.
  • the detachable frame 46 and the implant 12 may warp and/or fold around the implant delivery shaft 44 while disposed within the delivery' sheath 42.
  • the detachable frame 46 may be formed as a monolithic structure by being formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structure from a single piece of material. It is contemplated that detachable frame 46 may be constructed using alternati ve materials and/or manufacturing methodologies. For example, the frame 46, or portions thereof, may be constructed from a polymeric material, a ceramic material and/or other various materials. Additionally, the frame 46 may be manufactured via an injection molding or alternative polymer manufacturing methodologies. Alternatively, the frame 46 may be formed through a 3- D printing process, if desired. Further, different portions of the frame 46 may be made from a variety of materials and combined using alternative methodologies. Variations of combining different materials with different portions of the frame 46 are contemplated.
  • the frame 46 when combined with an example implant 12, the frame 46 may be defined as having a first surface that faces away from the implant 12 when the implant 12 is attached to the frame 46 (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant 12 (e.g., a second surface that faces a target site in the body).
  • attachment apertures 70 may extend from the first surface to the second surface.
  • attachment apertures 70 may be defined as holes and/or openings that extend through the thickness of the frame 46 from the first surface of the frame 46 that faces away from the implant. 12 to the second surface of the frame 46 that faces toward the implant. 12.
  • Attachment apertures 70 may be utilized to attach and/or couple frame 46 to an example implant 12.
  • Figure 3A shows an example frame 46 attached to an example implant 12. Further, Figure 3 shows example frame 46 attached to example implant 12 at the distal or free end of each of four attachment arms 64, respectively. Attachment of free distal ends of attachment arms 64 to implant 12. may be made by any desired attachment mechanism.
  • Figure 3B shows a detailed view' of a portion of the proximal portion 54 of a frame 46 atached to an implant 12. Further, Figure 3B show's example atachment arm 64 including a distal portion 68. Three attachment apertures 70 are positioned along the distal portion 68 of the atachment arm 64. Additionally, Figure 3B shows an example attachment member (e.g. ware) 76 extending between and through one or more of the attachment apertures 70 located on the distal portion 68 of the attachment aims 64.
  • an example attachment member e.g. ware
  • the atachment members 76 may be one of several structures and/or techniques contemplated to attach the example frame 46 to the example implant 12. As shows in Figure 3B, the attachment member 76 may be positioned, looped, wound and/or threaded through one or more atachment apertures 70 such that the attachment member 76 is prevented from being pulled away from the distal portion 68 of the attachment arm 64. In other words, winding the attachment member 76 through one or more of the atachment apertures 70 may effectively affix the atachment member 76 onto the attachment arm 64.
  • the atachment member 76 may be affixed to the distal portion 68 of the attachment arms 64 (via attachment apertures 70, for example) without having either end of the attachment member 76 directly attached (e.g., welded, tied, etc.) to any structure (e.g., frame 46).
  • the attachment member 76 may be wrapped and/or looped through the attachment apertures 70 one or more times to provide a friction fit and/or resistive tension to unraveling or unwinding as a withdrawal force is applied to the attachment member 76.
  • the implant may be attached to the attachment arms 64 in another fashion, such as with other atachment members attached to and/or extending from the attachment arms 64.
  • Figure 3B show's a single attachment member 76 extending between two attachment apertures 70, it is contemplated that the attachment member 76 may extend and/or wrap between two or more of the attachment apertures 70.
  • the attachment member 76 may be w'oven (e.g., over-and-under) through three apertures 70 in order to lock the attachment member 76 to the distal end 68 of the attachment arm 64.
  • an attachment member e.g., wire, thread, cable, etc.
  • an attachment member e.g., wire, thread, cable, etc.
  • adhesives may be used alone or in combination with another attachment mechanism to attach the frame 46 to the implant 12.
  • a variety'’ of injection molding techniques may be employed to attach the frame 46 to the implant 12.
  • combinations of the disclosed techniques may be used to attach the frame 46 to the implant 12.
  • an attachment member 76 may be used in conjunction with an adhesive to attach the frame 46 to the implant 12 without having to wind the attachment member 76 through the attachment apertures 70.
  • the frame 46 may be able to be “detached” from the implant 12.
  • the frame 46 may be configured to detach from the implant 12 after the implant 12 has been affixed to a target site in the body. Therefore, it can be appreciated that in some examples disclosed herein, the frame member 46 may be temporarily attached to the implant 12.
  • the frame member 46 may be coupled, affixed or attached to the implant 12 while positioned within the delivery' sheath 42, deployed out of the delivery’ sheath 42 and maneuvered into position relative to a target site.
  • the implant 12 may be affixed to the target site via bio-adhesives with or without the use of tissue anchors and/or sutures, as will be discussed.
  • the frame 46 may be pulled aw'ay (e.g., detached) from the implant 12 and removed from the body.
  • Figure 3B show's an example attachment configuration which may allow the frame 46 to detach from the implant 12.
  • Figure 5B show's attachment member 76 wound in a spiral pattern 80 along the surface of implant 12 facing a target site.
  • attachment member 76 may form a spiral pattern 80 that remains in a plane substantially parallel to the plane of the surface of implant 12 which faces a target site.
  • attachment member 76 may extend from the side of attachment arm 64 facing away from implant 12, through the combined thickness of the attachment arm 64 and implant 12, eventually exiting implant 12 on the surface of implant 12. facing a target site.
  • the spiral pattern 80 shown in Figure 5B is one of a variety’ of configurations for which attachment member 76 may' be w ound m order to prevent frame 46 from prematurely releasing from implant 12.
  • Attachment member 76 may have a first end secured to a free distal end of attachment arm 64 positioned on a first side of implant 12 and have a second end positioned on a second, opposite side of implant 12. In some instances, attachment member 76 may extend through implant 12 from the first side of implant 12 to the second side of implant 12. However, in other instances, attachment member 76 may extend around an edge of implant 12 from the first side of implant 12 to the second side of implant 12.
  • the attachment member 76 may be configured to be detached from implant 12 upon application of a threshold level of force.
  • the spiral pattern 80 shown in Figure 3B may provide the frame 46 the ability to detach from the implant 12 when a threshold “pull-aw'ay force” is applied to the frame 46.
  • a clinician may apply a force to the frame 46 (via a tether, for example) such that the frame 46 is pulled away from the implant 12.
  • the atachment members 76 e.g., spiral portion 80 of the atachment member 76 shown in Figures 3B
  • the body e.g., thickness
  • Figure 3C shows another example method to attach the frame 46 to an example implant 12.
  • the attachment member 76 may include a spiral 81 positioned on the surface of the implant 12 which faces away from a target site (similar to the spiral 80 shown in Figure 3B). Additionally, Figure 3C show's that the attachment member 76 may include a second spiral 82 positioned on the surface of an attachment arm 68 that faces away from the implant 12.
  • Figure 3C show's two spirals 81/82 formed at opposite ends of the attachment member 76 and positioned on both the attachment arm 64 facing away from the implant 12 (e.g., spiral 82 of Figure 5C) and on the side of the implant 12 lying along a treatment site (e.g., spiral 81 of Figure 3C).
  • the configuration of spirals 81/82 may provide a frame 46 with a “releasable” connection to the implant 12 similar to that discussed with respect to Figure 3B.
  • Figure 4 shows an example frame 46 coupled to an example implant 12 via the attachment members 76 as described above. Further, Figure 4 shows the frame 46 in combination with the implant 12 coupled to an example implant delivery system 40. Similar to that discussed with respect to Figure 2, the implant delivery system 40 includes implant delivery' shaft 44 extending through an example lumen 84 of an example delivery' sheath 42.
  • Figure 4 shows the delivery shaft 44 coupled to the frame 46 via a connection assembly 88.
  • the connection assembly 88 may include a first connection member 90 attached to the head portion 58 of the frame 46 and a second connection member 92. attached to the distal end 50 of the delivery shaft 44. While Figure 4 does not directly show the first connection member 90 attached directly to the second connection member 92, it can be appreciated that the first and second connection members 90/92 of connection assembly 88 may form a mating connection.
  • the first connection member 90 may form a male connection member while the second connection member 92 may form a mating female connection member.
  • the second connection member 92 may include a cavity which is configured to extend over and allow' the first connection member 90 to be inserted therein.
  • the first connection member 90 may be a female connection member, while the second connection member 92 may be a mating male connection member.
  • second connection member 92 may disengage or decouple from the first connection member 90.
  • the connection assembly' 88 including first and second connection members 90/92
  • first and second connection members 90/92 may be defined as a “quick release” connection assembly, or otherwise decoupling connection assembly.
  • a variety of design configurations may be employed to engage/ disengage (i.e., couple/decouple) the first and second connection members 90/92 from one another.
  • the first, and second connection members 90/92 may be coupled via a threaded connection, friction fit, spring loaded connection, bayonet connection, movable collar or another actuation mechanism, or the like.
  • the connection member 90/92 may be engaged/disengaged by an operator of the device.
  • the delivery shaft 44 may be atached (via the connection assembly 88, for example) to the head portion 58 of the frame member 46.
  • the first connection member 90 of the connection assembly 88 may attach to head portion 58 via an aperture 60 (not shown).
  • the first connection member 90 may be attached to the head portion 58 of the frame member 46 via a variety of mechanical fastening means (e.g., injection molding, encapsulation, bonding, etc.)
  • a physician may insert the implant delivery system 40 (including the delivery sheath 42, the deliver ⁇ ' shaft 44, the frame 46 and the implant 12) through an incision and position the distal end of the implant deliver ⁇ ' system 40 adjacent a target implant site (e.g., tom tendon).
  • a target implant site e.g., tom tendon
  • the physician may manipulate the implant deliver ⁇ ' shaft 44 to advance the implant 12 (while attached to the detachable frame 46) out of the delivery sheath 42 adjacent the target implant site.
  • the physician may retract the delivery sheath 42 proximally relative to the delivery shaft 44 and the frame 46 and/or may advance the delivery shaft 44 and the frame 46 distally relative to the deliver ⁇ ' sheath 42.
  • FIG. 4 shows the frame 46 and the implant 12 deployed from the distal portion 48 of the delivery sheath 42.
  • the frame 46 and the implant 12 may have a substantially concave shape with respect to the deliver ⁇ ' sheath 42. It can be appreciated that the concave shape of the frame member 46 and the implant 12 may facilitate positioning the implant 12 along the generally rounded shape of the human shoulder.
  • the frame 46 and the implant 12 may be wrapped around the delivery shaft 44 in a convex configuration. Therefore, the frame 46 and the implant 12 may shift from a first convex configuration (while wrapped tightly around the deliver ⁇ ' shaft 44 within the lumen 84 of the deliver ⁇ ' sheath 42) to a second concave configuration when advanced (e.g., deployed) out of the sheath 42.
  • the frame 46 and the implant 12 may be attached to the deliver shaft 44 via the connection assembly 88 when positioned within the lumen 84 of the delivery sheath 42.
  • the frame 46 and implant 12 may wrap, or extend around, the delivery shaft 44.
  • the position of the frame 46 and implant 12 maybe in a convex configuration with respect to the distal end 50 of the delivery shaft 44.
  • the frame 46 and implant 12 may “shift” from a convex configuration to a concave configuration (as viewed with respect to the distal end 50 of deliver ⁇ ' shaft 44), Additional details regarding the frame 46 and the implant delivery’ system 40 may be found in US Patent No. 10,314,689, which is incorporated by reference herein in its entirety.
  • FIG. 5 is a schematic diagram of an exampie bio-compatible implant 100.
  • the biocompatible implant 100 may be used for any of a variety of soft tissue repairs, such as but not limited to the Gluteus Medius, which is a large fan-shaped muscle located in the posterior hip, the Hip Capsule, which is also in the hip.
  • the bio-compatible implant 100 may be used in treating soft tissue injuries in the knee, such as but not limited to ligaments such as the ACL (anterior cruciate ligament), MCL (medial collateral ligament) and the PCL (posterior cruciate ligament) and tendons such as the hamstring tendons, the quadriceps tendon and the patellar tendon.
  • the bio-compatible implant 100 may be used in treating soft tissue injuries in the Achilles tendon.
  • the bio-compatible implant 100 may be used in treating soft tissue injuries for any areas of the body that will accommodate the bio-compatibie implant 100.
  • the bio-compatible implant 100 will be described herein ⁇ with respect to rotator cuff repairs.
  • the bio-compatible implant 100 may be considered as being an example of the implant 12 discussed with respect to Figures 1-2, 3A-3C and 4.
  • the biocompatible implant 100 may be considered as including a scaffold 102 and a bio-adhesive 104 that is dispersed on the scaffold 102.
  • the scaffold 102 may be a collagen scaffold, although other materials are contemplated.
  • the scaffold 102 is formed of collagen that has been dehydrated.
  • the scaffold 102 may be formed as a fibrous collection of collagen fibers that define a porous scaffold with a large number of void spaces.
  • the collagen used to form the scaffold 102 may come from any of a variety of different sources.
  • Collagen is a main structural protein in the extracellular matrix found in various connective tissues and thus can be obtained from various animals.
  • the collagen used to form the scaffold 102 may be bovine-based, i.e., from cows.
  • the collagen used to form the scaffold 102 may come from bovine tendon material.
  • bovine Achilles tendon is digested down to highly purified collagen, and is reconstituted into a sheet by spinning the fibers around a mandrel.
  • the scaffold 102 may be formed of collagen that has been obtained in other methods as well.
  • the scaffold 102 may be formed having a variety of different porosity levels (defined as relative amount of void space to solid material), in some cases the scaffold 102 may have a porosity of at least 50 percent or more, at least 60 percent or more, at least 70 percent or more, or at least 80 percent or more. In some cases, the scaffold 102 may have a porosity of 60 percent to 90 percent, 70 percent to 90 percent, 80 percent to 90 percent, or 85 percent to 90 percent.
  • Pore size refers to a diameter of voids, or empty spaces, formed within the scaffold 102.
  • Average pore size accordingly, refers to an average diameter of these voids.
  • the scaffold 102 may have an average pore size of 20 microns or greater, or 30 microns or greater, or 40 microns or greater, or 50 microns or greater, or 60 microns or greater, or 70 microns or greater, or 80 microns or greater, or 90 microns or greater.
  • the scaffold 102 may have an average pore size that is in a range of 100 microns to 500 microns, 100 microns to 400 microns, 100 microns to 300 microns, 100 microns to 150 microns, or 200 microns to 400 microns, for example.
  • the bio-adhesive 104 may 7 additionally’ or alternatively 7 be disposed at least partially within the scaffold 102.
  • the bioadhesive 104 may 7 be present on and/or in the scaffold 102 in a dehydrated form.
  • the bio-adhesive 104 may be dipped, sprayed or otherwise applied to the scaffold 102 in a liquid form, prior to being dehydrated.
  • the bio-adhesive 104 once hydrated upon implantation, can adhere to both tissue and bone, even in the absence of any blood present around the bio-compatible implant 100.
  • the bio-adhesive 104 includes a plurality of isolated and purified blood-borne components that are disposed within the bio-adhesive 104.
  • One of the plurality of isolated and purified blood-borne components may include a zymogen,
  • a zymogen is an inactive substance that can be converted into an enzyme when activated by another enzyme.
  • the zymogen may be Factor XIII, which is a fibrin-stabilizing factor found in human blood.
  • Addi ti onal i solated and purifi ed blood-borne components that may form part of the bioadhesive 104 include fibrinogen and thrombin.
  • Fibrinogen is a soluble protein that is present in blood plasma.
  • Thrombin is an enzyme found in blood plasma that causes blood clotting by converting fibrinogen to fibrin.
  • Fibrin is an insoluble protein that forms a fibrous mesh that impedes the flow of blood and thus causes blood clotting.
  • the thrombin enzyme cleaves peptides from fibrinogen to produce fibrin monomers. The fibrin monomers then polymerize to produce insoluble fibrin.
  • thrombin In the presence of calcium, thrombin also activates factor XIII, an enzyme that catalyzes covalent bond formation between the fibrm molecules to form a crosslinked clot resistant to dissolution.
  • factor XIII an enzyme that catalyzes covalent bond formation between the fibrm molecules to form a crosslinked clot resistant to dissolution.
  • the crosslinked fibrin polymer further crosslinks with glycoproteins, collagen, and plasma to anchor to the tissue site. In some cases, maximum adhesive strength occurs after 3 minutes.
  • the bio-adhesive 104 may include thrombin present in amounts ranging from 1 to 50 International Units per square centimeter (IU/cm 2 ) or 300 to 600 lU/milliliter (lU/ml).
  • the bio-adhesive 104 may include fibrinogen present in amounts ranging from 4 to 15 milligrams per square centimeter (mg/cm 2 ) or 40 to 115 mg/ml.
  • the bio-adhesive 104 may include Factor XIII present in amounts ranging from 10 to 400 lU/ml, or in some cases ranging from 60 to 120 lU/ml.
  • the bio-adhesive 104 may include additional components that aid in the functionality of the primary components.
  • the bio-adhesive 104 may include calcium chloride present in an amount of about 0.04 millimoles per ml (mmol/ml). In some cases, calcium chloride can help thrombin activate Factor XIII.
  • the bioadhesive 104 may include aprotinin present in an amount ranging from 1000 to 3000 kilo International Units per ml (KlU/ml). Aprotinin is a small protein bovine pancreatic trypsin inhibitor that slows fibrin clot degradation or fibrinolysis. In some cases, a synthetic fibrinolytic inhibitor may be used instead.
  • increasing the relative thrombin content can result in faster bonding.
  • increasing the relative fibrinogen content can result in stronger adhesion.
  • adding Factor XIII can help with tissue adhesion even in the absence of blood.
  • Increasing the relative Factor .XIII content can increase fibrin cross-linking, for example.
  • inclusion of Factor XIII can mean that the bio-adhesive 104 will adhere to tissue such as tendon and bone, such as the humeral head, even if there is no blood present at the implantation site.
  • FIG. 6 is a schematic diagram of an example bio-compatible implant 106.
  • the biocompatible implant 106 may be considered as being an example of the implant 12 discussed with respect to Figures 1-2, 3A-3C and 4.
  • the bio-compatible implant 106 may be used for any of a variety of soft tissue repairs, such as but not limited to rotator cuff repairs.
  • the bio-compatible implant 106 may be used for tendon repairs in other parts of the human body, for example.
  • the bio-compatible implant 106 is similar to the bio-compatible implant 100 shown in Figure 5, but includes a dissolvable coating 108 that is disposed over the bio-adhesive 104 in order to protect and isolate the bio-adhesive layer 104.
  • the dissolvable coating 108 may be formed of any suitable material that is bio-compatible, meaning that it does not generate a negative reaction by the body when implanted within the body, and that can dissolve within a period of several minutes when exposed to blood or to saline.
  • suitable materials include water soluble polymers, such as polyvinyl alcohol, polyethylene oxide, polyethylene glycol, high molecular weight carbohydrates and starches, etc.
  • adding the dissolvable coating 108 helps to keep the bio-adhesive 104 dry until it is time to rehydrate the bio-adhesive 104.
  • the dissolvable coating 108 may, for example, permit rolling up the bio-compatible implant 106 for implantation.
  • FIG. 7A is a schematic diagram of an example bio-compatible implant 110 that may be used for soft tissue repairs.
  • the bio-compatible implant 110 may be used for any of a variety of soft tissue repairs, such as but not limited to rotator cuff repairs.
  • the bio-compatible implant 110 may be used for tendon repairs in other parts of the human body, for example.
  • the biocompatible implant 110 includes a non-active layer 112 and an active layer 114.
  • the non-active layer 112. and the active layer 114 may each be considered as being part of a scaffold such as a collagen scaffold, with the non-active layer 112 being a first layer of collagen within the collagen scaffold and the active layer 114 being a second layer of collagen within the collagen scaffold.
  • the active layer 114 has a first rate of contraction when dehydrated and the non-active layer 112 has a second rate of contraction when dehydrated that is different from the first rate of contraction when dehydrated.
  • a collagen scaffold may be dried by drying the non-active layer 112 at a first drying rate and drying the active layer 114 at a different drying rate, thereby causing the scaffold to preferentially curl in one direction.
  • the scaffold may have two or more layers with differing fiber orientation, i.e., the non-active layer 112 is formed of fibers oriented in a first direction and the active layer 114 is formed of fibers that are oriented in a second, different, direction. This may cause the scaffold to curl preferentially in one direction when dried.
  • the different first and second rates of contraction when dehydrated may cause the biocompatible implant 110 to roll up when dehydrated. This can aid in preparing the bio-compatible implant 110 for implantation by making the bio-compatible implant 110 fit better into or onto a deployment device.
  • the bio-compatible implant 110 is configured to flatten out when rehydrated upon implantation and exposure to blood or perhaps saline that may be present at the treatment site.
  • the active layer 114 also includes a bio-adhesive dispersed relative to the scaffold, the bio-adhesive including plurality of isolated and purified blood-borne components that are disposed within the bio-adhesive.
  • the bio-adhesive may include a plurality of isolated and purified blood-borne components.
  • One of the plurality of isolated and purified blood-borne components may include a zymogen such as Factor XIII, which is a fibrin-stabilizing factor found in human blood.
  • Additional isolated and purified blood-borne components that may form part of the bio-adhesive include fibrinogen and thrombin.
  • the bioadhesive may include additional components as w r ell.
  • the non-active layer 112 may have a greater rate of contraction upon dehydration than the active layer 114.
  • Figure 7C shows the bio-compatible implant 110 in which the non-active layer 112 has a relatively greater rate of contraction upon dehydration, as each of the layers are shown in phantom, labeled as 112’, 114’ and 116’, curling upwards.
  • the bio-compatible implant 110 would be rolled up with the dissolvable coating 116 on the outside.
  • FIG. 7D shows the bio-compatible implant 110 in which the active layer 114 has a relatively greater rate of contraction upon dehydration, as each of the layers are shown in phantom, labeled as 112’, 114’ and 116’, curling downwards.
  • the bio-compatible implant 110 would be rolled up with the non-active layer 114 on the outside.
  • FIG 8 is a perspective view of an example bio-compatible implant 120.
  • the biocompatible implant 120 may be considered as being an example of the bio-compatible implant 100 shown in Figure 5.
  • the bio-compatible implant 120 may be used for any of a variety of soft tissue repairs, such as but not limited to rotator cuff repairs.
  • the bio-compatible implant 120 may be used for tendon repairs in other pails of the human body, for example. While the bio-compatible implant 120 is shown as being rectilineal', this is merely illustrative.
  • the bio-compatible implant 120 may take any desired shape, such as a round shape, an ovoid shape, or other shapes, as long as the bio-compatible implant 120 retains the overall dimensions appropriate for its intended treatment site and retains an active surface that can adhere itself to tissue (such as soft tissue and/or bone) at the intended treatment site.
  • the bio-compatible implant 120 includes a collagen scaffold 122.
  • the collagen scaffold 122 may instead be formed of or include other materials as well.
  • a bio-adhesive may be disposed within the collagen scaffold.
  • the bio-adhesive includes fibrinogen molecules, schematically shown as circles 124; thrombin molecules, schematically shown as hexagons 126; and Factor XIII molecules, schematically shown as dots 128. It will be appreciated that this is merely illustrative, as the individual molecules that will interact to form a bio-adhesive once hydrated wall be coated onto individual fibers within the collagen scaffold 122.
  • the bio-adhesive may' include a plurality'- of isolated and purified blood-borne components.
  • One of the plurality' of isolated and purified blood-borne components may include a zymogen such as Factor XIII, which is a fibrin-stabilizing factor found in human blood.
  • Additional isolated and purified blood-borne components that may form part of the bio-adhesive include fibrinogen and thrombin.
  • the bio-adhesive may include thrombin present in amounts ranging from
  • the bio-adhesive may include fibrinogen present in amounts ranging from 4 to 15 mg/cm 2 or 40 to 1 15 mg/ml.
  • the bio-adhesive may include Factor XIII present in amounts ranging from 10 to 400 lU/ml, or in some cases ranging from 60 to 120 lU/ml.
  • the bio-adhesive 104 may include additional components that aid in the functionality' of the primary' components.
  • the bio-adhesive may include calcium chloride present in an amount of about 0.04 mmol/ml. In some cases, calcium chloride can help thrombin activate Factor XIII.
  • the bio-adhesive may include aprotinin present in an amount ranging from 1000 to 3000 KIU/ml.
  • an upper surface (with respect to the illustrated orientation) 130 of the collagen scaffold 122 may be dyed a particular color in order to easily and visually provide a “this side up” indication which indicated to a surgeon or other medical professional the desired orientation for positioning the bio-compatible implant 120 at a particular treatment site.
  • FIG 9A is a perspective view of air example bio-compatible implant 140.
  • the biocompatible implant 140 may be considered as being an example of the bio-compatible implant 110 shown in Figures 7A-7C.
  • the bio-compatible implant 140 may be used for any of a variety of soft tissue repairs, such as but not limited to rotator cuff repairs.
  • the bio-compatible implant 140 may be used for tendon repairs in other parts of the human body, for example. While the bio-compatible implant 140 is shown as being rectilinear, this is merely illustrative.
  • the bio-compatible implant 140 may take any desired shape, such as a round shape, an ovoid shape, or other shapes, as long as the bio-compatible implant 140 retains the overall dimensions appropriate for its intended treatment site and retains an active surface that can adhere itself to tissue (such as soft tissue and/or bone) at the intended treatment site.
  • the bio-compatible implant 140 has a bilayer construction including a nonactive layer 142 and an active layer 144.
  • the nonactive layer 142 may include a first collagen scaffold having a first rate of contraction when dehydrated and the active layer 144 may include a second collagen scaffold having a second rate of contraction when dehydrated that is different from the first rate of contraction when dehydrated.
  • the different first and second rates of contraction when dehydrated may cause the bio-compatible implant 140 to roll up when dehydrated. This can aid in preparing the bio-compatible implant 140 for implantation by making the bio-compatible implant 140 fit better into or onto a deployment device.
  • the bio-compatible implant 140 is configured to flatten out when rehydrated upon implantation and exposure to blood or perhaps saline that may be present at the treatment site.
  • the nonactive layer 142 includes an upper surface 130 that may be dyed a particular color in order to easily and visually provide a “this side up” indication which indicated to a surgeon or other medical professional the desired orientation for positioning the bio-compatible implant 140 at a particular treatment site.
  • the active layer 144 includes a collagen scaffold, although other materials may also be used.
  • the active layer 144 also includes a bio-adhesive disposed within the collagen scaffold.
  • the bio-adhesive includes a plurality of isolated and purified blood-bome components.
  • One of the plurality of isolated and purified blood-borne components may include a zymogen such as Factor XIII, which is a fibnn-stabiiizing factor found in human blood.
  • Additional isolated and purified blood-bome components that may form part of the bio-adhesive include fibrinogen and thrombin.
  • the bio-adhesive may include thrombin present in amounts ranging from 1 to 50 IU/cm 2 or 300 to 600 lU/ml.
  • the bio-adhesive may include fibrinogen present in amounts ranging from 4 to 15 mg/cm 2 or 40 to 115 mg/ml.
  • the bio-adhesive may include Factor .XIII present in amounts ranging from 10 to 400 IU/ml, or in some cases ranging from 60 to 120 lU/ml.
  • the bio-adhesive 104 may include additional components that aid in the functionality of the primary components.
  • the bio-adhesive may include calcium chloride present in an amount of about 0.04 mmol/ml.
  • calcium chloride can help thrombin activate Factor XIII.
  • the bio-adhesive may include aprotinin present in an amount ranging from 1000 to 3000 KlU/ml.
  • the fibrinogen molecules are schematically shown as circles 124, the thrombin molecules are schematically shown as hexagons 126. and the Factor XIII molecule are, schematically shown as dots 128. It will be appreciated that this is merely illustrative, as the individual molecules that will interact to form a bio-adhesive once hydrated will be coated onto individual fibers within the collagen scaffold.
  • the active layer 144 may include additional structure that provides the active layer 144 with additional surface area.
  • Figures 9B through 9E provide illustrative but nonlimiting examples of this.
  • the active layer 144 includes a number of random fibers 150, with the fibrinogen molecules 124, the thrombin molecules 126 and the Factor XIII molecules 128 dispersed within the random fibers 150.
  • the random fibers 150 form part of the active layer 144.
  • the random fibers 150 extend from the active layer 144.
  • the random fibers 150 may be formed of collagen or any other suitable material.
  • the active layer 144 includes a fleece 152, with the fibrinogen molecules 124, the thrombin molecules 126 and the Factor XIII molecules 12.8 dispersed within the fleece 152.
  • the fleece 152 forms part of the active layer 144.
  • the fleece 152 extends from the active layer 144.
  • the fleece 152 may be formed of collagen or any other suitable material.
  • the active layer 144 includes a sponge 154, with the fibrinogen molecules 124, the thrombin molecules 126 and the Factor XIII molecules 128 dispersed within the sponge 154.
  • the sponge 154 forms part of the active layer 144.
  • the sponge 154 extends from the active layer 144.
  • the fleece 152 may be formed of collagen or any other suitable material,
  • the active layer 144 includes a plurality of micro hooks 156, with the fibrinogen molecules 124, the thrombin molecules 126 and the Factor XIII molecules 128 dispersed within the plurality of micro hooks 156.
  • the plurality of micro hooks 156 may be considered as being equivalent to the hooks commonly known as being part of VelcroTM, for example.
  • the plurality of micro hooks 156 form part of the acti ve layer 144.
  • the plurality of micro hooks 156 extend from the active layer 144.
  • the plurality’ of micro hooks 156 may’ be formed of collagen or any’ other suitable material.
  • FIG 10 is a flow diagram showing an example method 160 of repairing soft tissue damage using an implant such as the bio-compatible implant 100, the bio-compatible implant 110, the bio-compatible implant 120 or the bio-compatible implant.
  • Tire method 160 includes creating a cavity proximate a site of the soft tissue damage, as indicated at block 162, A delivery device including an implant rolled up, folded, or otherwise disposed within the delivery device is inserted into the cavity, as indicated at block 164.
  • the implant includes a dehydrated collagen scaffold including an active side and a nonactive side, as indicated at block 164a as well as a dehydrated bio-adhesive that is dispersed relative to the active side, the dehydrated bio-adhesive including a plurality' of isolated and purified blood-borne components disposed within the bio-adhesive, one of the plurality’ of isolated and purified blood-borne components including a zymogen (e.g., Factor XIII), as indicated at block 164b.
  • the implant is rehydrated while in the delivery' device byexposing the implant to saline within the cavity, as indicated at block 166. In some cases, rehydrating the implant causes the implant to unroll.
  • the rehydrated implant is deployed from the deliver ⁇ - device, as indicated at block 168.
  • the implant may be passed into the joint space and placed using standard arthroscopic graspers.
  • standard arthroscopic graspers may be considered as being a delivery device.
  • the implant is held in place over the site of the soft tissue damage while applying pressure for a period of time until the dehydrated bio-adhesive rehydrates and adheres to anatomy at the site of the soft tissue damage, as indicated at block 170.
  • the period of time corresponds to about a total of three minutes before the implant is released.
  • the implant is then released and the delivery' device is withdrawn, as indicated at block 172,
  • FIG. 1 I is a perspective view 7 of an example bio-compatible implant 180.
  • the bio-compatible implant 1 80 will be described herein with respect to rotator cuff repairs.
  • the bio-compatible implant 180 may be considered as being an example of the implant 12 discussed with respect to Figures 1-2, 3A-3C and 4.
  • the bio-compatible implant 180 may be considered as including the collagen scaffold 102, which as noted above may be formed as a fibrous collection of collagen fibers that define a porous scaffold with a large number of void spaces.
  • the bio-compatible implant 180 includes a bio-absorbable anchoring mechanism.
  • the bio-compatible implant 180 includes a bio-adhesive layer 182 that is disposed relative to the collagen scaffold 102 and a removable peel layer 184 that is disposed relative to the bio-adhesive layer 182.
  • the removable peel layer 184 may cover the bioadhesive layer 182 until the removable peel layer 184 is selectively removed to expose the bioadhesive layer 182.
  • the bio-adhesive layer 182 may be located between the collagen scaffold 102 and the removable peel layer 184. It will be appreciated that the peel layer 184 protects the bio-adhesive layer 182, and helps to prevent the bio-adhesive layer 182 from accidently sticking to something before adhesion is desired.
  • the bio-adhesive layer 182 may be configured to adhere to soft tissue and/or bone, in order to help hold the bio-compatible implant 180 in position at a treatment site. In some cases, the bio-adhesive layer 182 may provide sufficient holding power, prior to any subsequent tissue ingrowth, that other anchoring mechanisms such as but not limited to sutures, are not needed, or can be used in a reduced quantity’.
  • the bio-adhesive layer 182 may be formed of any suitable adhesive material that will adhere to soft tissue and bone, and that is safe for use within the body.
  • the bio- adhesive layer 182 may include isolated and purified blood-borne components such as fibrinogen, thrombin and Factor XIII, much like the bio-adhesrve 104 described above. In some cases, other materials may be used.
  • the bio-adhesive layer 182 may include fibrin glue.
  • the bioadhesive layer 182 may include GRFG, or gelatin-resorcmol-formaldehyde/glutaraldehyde. Cyanoacrylate glues may be used.
  • polymeric adhesives including but not limited to polysaccharides and polypeptides may be used in the bio-adhesive layer 182.
  • PEG polyethylene glycol
  • hydrogels may be used in the bio-adhesive layer 182.
  • Naturally- derived materials such as mussel-inspired adhesives may be used in the bio-adhesive layer 182.
  • Other adhesives may also be used, provided that they are safe for use within the body, and optionally that they are bio-absorbable over time.
  • the peel layer 184 may be formed of any of a variety of different materials.
  • the peel layer 184 may be formed of a flexible polymeric material. Examples include but are not limited to polyethylene and polyester. Other flexible polymeric materials may also be used, particularly if the particular flexible polymeric material is able to be lightly adhered to the bioadhesive layer 182 prior to implantation, but are able to release from the bio-adhesive layer 182 when it is desired to remove the peel layer 184 from the bio-adhesive layer 182 in order to expose the bio-adhesive layer 182, In some cases, the force needed to remove the peel layer 184 from the bio-adhesive layer 1 82 should be lower than the force needed to dislodge the adhered biocompatible implant 180 by causing the bio-adhesive layer 182 to release from the tendon.
  • the removal force of the peel layer 184 may be less than 1 Ibf, such as between 0.1 Ibf and .95 Ibf or between 0.1 Ibf and 1.9 Ibf. .
  • the peel layer 184 may have any of a variety of different geometries.
  • the peel layer 184 may be rectangular, or at least substantially rectangular in order to match the geometry’ of the bio-adhesive layer 182. and the collagen substrate 102 itself.
  • substantially rectangular refers to a geometry in which each of the comers are close to 90 degrees, such as between 75 and 105 degrees.
  • the peel layer 184 may have a geometry that facilitates grasping and removing the peel layer 184 from the bio-adhesive layer 182.
  • Figures 12 A through 12F provide illustrative but non-limiting examples of possible geometries for the peel layer 184 that should each help to facilitate grasping and removing of the peel layer 182.
  • a strip of the peel layer 184 may extend from the implant a distance sufficient to allow the strip of the peel layer 184 to be reachable from outside of the joint. This would allow a user to remove the peel layer 184 from outside of the joint without any additional instrumentation.
  • the peel layer 184 covers at least an entirety of the bio-adhesive layer 182 and the bioadhesive layer 182 covers an entirety of the bio-compatible implant 180.
  • FIG. 12 A schematically shows a peel layer 184a having a largely rectilinear main portion 186 and a tab portion 188.
  • a dashed line 190 indicates part of a perimeter of the bioadhesive layer 182, It will be appreciated that because the tab portion 188 extends beyond the perimeter of the bio-adhesive layer 182, it will be easy to grasp the tab portion 188 and thus remove the peel layer 184a when removal of the peel layer 184a from the bio-adhesive layer 182 is desired.
  • Figure 12B schematically shows a peel layer 184b having a largely rectilinear main portion 186 and an angled extension portion 192.
  • the dashed line 190 indicates part of the perimeter of the bio-adhesive layer 182. It will be appreciated that because the angled extension portion 192 extends beyond the perimeter of the bio-adhesive layer 182, it will be easy to grasp the angled extension portion 192 and thus remove the peel layer 184b when removal of the peel layer 184b from the bio-adhesive layer 182 is desired.
  • angled extension portion 192 is shown as extending such that a first side 186a of the peel layer 184b is shorter than a second side 186b of the peel layer 184b, this is merely illustrative.
  • the angled extension portion 192 may be formed such that the first side 186a of the peel layer 184b is longer than the second side 186b of the peel layer 184b.
  • FIG. 12C schematically shows a peel layer 184c having a largely rectilinear main portion 186 and a rectilinear extension portion 194.
  • the dashed line 190 indicates part of the perimeter of the bio-adhesive layer 182. It will be appreciated that because the rectilinear extension portion 194 extends beyond the perimeter of the bio-adhesive layer 182, it will be easy to grasp the rectilinear extension portion 194 and thus remove the peel layer 184b when removal of the peel layer 184c from the bio-adhesive layer 182 is desired.
  • the rectilinear extension portion 194 is shown as extending such that the first side 186a of the peel layer 184b is the same length as the second side 186b of the peel layer 184c, this is merely illustrative. In some cases, the rectilinear’ extension portion 194 may be formed such that the first side 186a of the peel layer 184c is a different length from the second side 186b of the peel layer 184c.
  • the peel layer 184 may be configured to fit around components of the deliver ⁇ ' device used to deliver the bio-compatible implant 180.
  • the peel layer 184 may be configured to fit around the attachment arms 64 of the frame 46, as seen for example in Figure 4.
  • Figure 12D schematically shows a peel layer 184d that is configured to fit around the atachment arms 64.
  • the peel layer 184d includes a main portion 198 and a number of cutouts 200, individually labeled as 200a, 200b, 200c and 200d.
  • the bio-compatible implant 180 may be atached to the attachment arms 64 of the frame 46 of the implant delivery device in the cutouts 200, such that removal of the peel layer 184 does not interfere with the attachment of the biocompatible implant 180 with delivery’ frame 46 and/or such that the connection between the biocompatible implant 180 and the delivery frame 46 does not interfere with removal of the peel layer 184.
  • the bio-adhesive layer 182 is illustrated (via the dashed line 190) as being rectilinear, in some cases the bio-adhesive layer 182 may have an overall shape that matches that of the peel layer 184d. While not show, the peel layer 184d may include one or more tabs or extensions to facilitate grasping and removing the peel layer 184d at an appropriate time.
  • Figure 12E schematically show's a peel layer 184e having a largely triangular mam portion 202.
  • the dashed line 190 indicates part of the perimeter of the bio-adhesive layer 182, It will be appreciated that the triangular main portion 202 includes tabs 204, individually labeled as
  • Figure 12F schematically show's a peel layer 184f having a largely trapezoidal main portion 2.06.
  • the dashed line 190 indicates part of the perimeter of the bio-adhesive layer 182.
  • the trapezoidal main portion 202 includes tabs 208, individually labeled as 208a and 208b, that extend beyond the perimeter of the bio-adhesive layer 182, it will be easy to grasp one or more of the tabs 208 and thus remove the peel layer 184f when removal of the peel layer 184f from the bio-adhesive layer 182 is desired.
  • FIG. 13 is an exploded end view of an example bio-compatible implant 180a.
  • the bio-compatible implant 180a is similar to the bio-compatible implant 180, but includes a bio- adhesive layer 182a that is smaller than the peel layer 184 yet still covers the bio-compatible implant 180a up to the edges of the bio-compatible implant 180a such that all of the surface area of the bio-compatible implant 180a can be adhered to the tendon.
  • the peel layer 184 is larger than the bio-adhesive layer 182a, it may be easy to grasp the peel layer 184 anywhere around a perimeter of the peel layer 1 84 in order to remove the peel layer 184 at a desired time. In other w'ords, medical personnel may grasp the portion of the peel layer 184 extending beyond the perimeter of the bio-adhesive layer 182a to remove the peel layer 184 from the bio-compatible implant 180a.
  • FIG 14A is a perspective view of an example bio-compatible implant 210.
  • the bio-compatible implant 210 will be described herein with respect to rotator cuff repairs.
  • the bio-compatible implant 210 may be considered as being an example of the implant 12 discussed with respect to Figures 1-2, 3A-3C and 4.
  • the bio-compatible implant 210 may be considered as including the collagen scaffold 102, which as noted above may be formed as a fibrous collection of collagen fibers that define a porous scaffold with a large number of void spaces.
  • the bio-compatible implant 210 includes a bio-absorbable anchoring mechanism.
  • the bio-compatible implant 210 may include a non- bioabsorbable anchoring mechanism.
  • the bio-compatible implant 210 includes a plurality of micro-features, such as microhooks 212 extending from a lower surface of the collagen scaffold 102. Tn some cases, at least some of the microhooks 212 may have a curved or barbed shape.
  • the microhooks 212 may be adapted to be able to penetrate soft tissue in order to help secure the bio-compatible implant 210 in place relative to the soft tissue prior to tissue ingrowth.
  • the microhooks 212 may provide sufficient initial holding power such that additional anchoring such as sutures may not be necessary', or may be used in a reduced number.
  • the micro-features may be micro-protrusions or micro-pillars extending from a lower surface of the collagen scaffold 102.
  • the microhooks 212 may be formed of any suitable material. In some cases, the microhooks 212 may be formed of a bio-absorbable material. In some cases, the microhooks 212 may be formed of an absorbable polymer such as poly lactic acid, which is formed by polymerizing lactide. Because lactide is a chiral molecule, there are stereoisomers, including poly-L-lactic acid (PLLA) and PLDL (a mixture of L and D monomers). The microhooks 212 may be formed of PLAA-HA, which is a hybrid of PLLA and hydroxyapatite.
  • REGENESORB which is an advanced biocomposite material commercially available from Smith-Nephew, may also be used to form the microhooks 212.
  • the microhooks 212 may degrade in a desired time frame, such as a time frame of five weeks to two years, a time frame of five weeks to one year, a time frame of five weeks to nine months, a time frame of five weeks to six months, a time frame of three months to one year, a time frame of three months to nine months, or a time frame of three months to six months, for example.
  • the microhooks 212 may be formed having any desired dimensions. As an example, at least some of the microhooks 212 may have an overall length (extending out of the collagen substrate 102) in a range of 0.13 inches to 0.5 inches and a width in a range of 0.020 inches to 0. inches. In some cases, the microhooks 212 may have a length of about 0.26 inches and an average width of 0.075 inches. In some cases, these dimensions may refer to average lengths and widths, with of course some microhooks 212 being smaller than average and some microhooks 212 being larger than average. In some cases, the microhooks 212 may be considered as forming part of a hook and loop securement mechanism such as that known commercially under the Velcro name.
  • the microhooks 212 may include a distal piercing section 212a that is adapted to pierce into tissue such as a tendon.
  • the distal piercing section 212a may have a pointed distal tip.
  • a hook or barb section 212b is adapted to help prevent the microhooks 212 from retracting from the tissue.
  • the hook or barb section 2.12b may include a barb extending outward from the shank 212c of the microhook 212.
  • the elongate portion or shank 212c may be dimensioned to allow the distal piercing section 212a and the hook section 212b to penetrate the tissue.
  • each microhook 212 may- be seen as having a curved or barbed portion 214 and a straight portion 216.
  • the microhooks 212 may be secured relative to the bio-compatible implant 210 by pushing the straight base portion 216 of each microhook 212 directly into the collagen substrate 212, with the curved or barbed portion 214 extending beyond a lower (wdth respect to the illustrated orientation) surface 102a of the collagen substrate 102.
  • each microhook 212 includes an anchor portion 218 at a base of the microhook 212. as well as the aforementioned curved or barbed portion 214.
  • the anchor portion 218 helps to secure the microhook 212 in position relative to the collagen substrate 212 with the curved or barbed portions 214 extending beyond the lower surface 102a of the collagen substrate 102.
  • the anchor portion 218 may be embedded within the collagen substrate 102, but not extend entirely through the thickness of the collagen substrate 102.
  • the collagen substrate 212 may be formed around a number of previously positioned microhooks 212, Figure 15C is similar, but shows that the anchor portion 218 of each microhook 212 extends entirely through the thickness of the collagen substrate 102 while the curved or barbed portions 214 extend from the lower surface 102a of the collagen substrate 102.
  • the anchor portion 218 may extend beyond an upper (with respect to the illustrated orientation) surface 102b while the curved or barbed portions 214 extend beyond the lower surface 102a of the collagen substrate 102.
  • the microhooks 212 may be covered with a covering or some other mechanism that prevents premature attachment of the microhooks 212 before attachment is appropriate.
  • a peel layer may be used to cover the microhooks 212, and the peel layer may be removed when appropriate.
  • the microhooks 212 may be integrated into the collagen substrate 102 as part of the manufacturing process. In some cases, the microhooks 212 may be added as part of a secondary manufacturing process that is subsequent to formation of the collagen substrate 102. In some cases, the microhooks 212 may be added by a user using an assembly tool, for example.
  • Figure 16A is a perspective diagram of an example microhook assembly 220 that includes a collection of fibers 222 that are woven or braided together.
  • the microhook assembly 220 may be a textile mat or sheet formed of a plurality of fibers 222 such as woven or braided fibers, in which some of the fibers 222 include end regions extending from the mat or sheet to form microhooks 224. For instance, as shown in Figure 16A, some of the ends of the fibers 222 extend outwardly from the microhook assembly 220 to form a number of microhooks 224. It will be appreciated that after the microhook assembly 220 is formed, the microhook assembly 220 may be secured to a collagen substrate 102 in any suitable manner, including sutures and adhesives.
  • Figure 16B shows an example bio-compatible implant 228 in which the microhook assembly 220 is secured to the collagen substrate 102 via an adhesive layer 226. Any suitable adhesive may be used as the adhesive layer 226, including those discussed herein with respect to the bio-adhesive layer 182.

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Abstract

Un implant biocompatible est conçu pour être utilisé dans la réparation de lésions des tissus mous telles que, mais sans y être limitées, la réparation de la coiffe des rotateurs. L'insert biocompatible comprend un échafaudage de collagène déshydraté et un mécanisme d'ancrage biorésorbable qui est fixé par rapport à l'échafaudage de collagène déshydraté. Le mécanisme d'ancrage bio-absorbable est conçu pour fixer l'implant biocompatible en place au niveau d'un site de traitement lors de l'implantation. Le mécanisme d'ancrage biorésorbable peut comprendre un bio-adhésif. Le mécanisme d'ancrage bio-absorbable peut comprendre un mécanisme d'ancrage mécanique tel qu'une pluralité de microcrochets. Le bio-adhésif déshydraté peut comprendre une pluralité de composants transmissibles par le sang isolés et purifiés disposés, à l'intérieur du bio-adhésif, l'un de la pluralité de composants sanguins isolés et purifiés comprenant un zymogène. Le bio-adhésif peut également comprendre d'autres composants transmissibles par le sang isolés et purifiés tels que le fibrinogène et la thrombine. L'invention concerne également d'autres bio-adhésifs.
PCT/US2022/048709 2021-11-03 2022-11-02 Implant médical auto-adhérent et son procédé d'utilisation WO2023081216A2 (fr)

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US10314689B2 (en) 2015-12-31 2019-06-11 Rotation Medical, Inc. Medical implant delivery system and related methods

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US10314689B2 (en) 2015-12-31 2019-06-11 Rotation Medical, Inc. Medical implant delivery system and related methods

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