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WO2018201116A1 - Couverture implantable en cordon ombilical et procédé de fabrication - Google Patents

Couverture implantable en cordon ombilical et procédé de fabrication Download PDF

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Publication number
WO2018201116A1
WO2018201116A1 PCT/US2018/030066 US2018030066W WO2018201116A1 WO 2018201116 A1 WO2018201116 A1 WO 2018201116A1 US 2018030066 W US2018030066 W US 2018030066W WO 2018201116 A1 WO2018201116 A1 WO 2018201116A1
Authority
WO
WIPO (PCT)
Prior art keywords
cover
implantable
umbilical cord
implantable cover
forming
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/US2018/030066
Other languages
English (en)
Inventor
Christian Beaudry
Grant Dakota SENNER
Merrill B. STROMER
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.)
Aluta Biosciences LLC
Original Assignee
Aluta Biosciences LLC
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 Aluta Biosciences LLC filed Critical Aluta Biosciences LLC
Publication of WO2018201116A1 publication Critical patent/WO2018201116A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L31/005—Ingredients of undetermined constitution or reaction products thereof
    • 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
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/64—Animal cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37512—Pacemakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Definitions

  • This application relates to covers derived from umbilical cord tissue for use with implantable devices, such as a cardiac pacemaker, implantable cardioverter defibrillator (ICD) or implantable neurostimulator.
  • implantable devices such as a cardiac pacemaker, implantable cardioverter defibrillator (ICD) or implantable neurostimulator.
  • ICD implantable cardioverter defibrillator
  • neurostimulator implantable neurostimulator
  • Implantation of medical devices are often associated with inflammation of the surrounding tissue, infections at the site of implant, and fibrotic tissue formation surrounding the implant. Additionally, implantable devices often require replacement and/or repair or alteration and can become enveloped with tissue, including fibrotic tissue making removal of the device and leads difficult.
  • Use of a cover or pouch derived from umbilical cord tissue containing intrinsic anti-inflammatory, anti-bacterial, and anti-fibrotic properties for use with the implantable device may reduce inflammation at the time of implant, reduce infections, reduce the formation of fibrotic tissue, and deliver additional therapeutic benefits.
  • the invention is directed to an umbilical cord cover for use with an implantable article, such as an electronic medical device.
  • An exemplary umbilical cord cover comprises a portion of an umbilical cord having a conduit extending along the length that forms an envelope for receiving an implantable article.
  • An exemplary umbilical cord cover is biologically active.
  • An exemplary umbilical cord cover may have a single opening and be in the form of a pouch for receiving an implantable article.
  • a portion of an umbilical cord is used to form an umbilical cord cover and one end is attached together to form a pouch.
  • the attached end of the umbilical cord may be attached by a stitch or suture, by adhesive, or the tissue may be directly attached, wherein tissue in attached directly together by application of pressure over a period of time.
  • the tissue may be welded or laminated together as well.
  • a separate material, an end-cover is used to seal off one end of the umbilical cord to form a pouch.
  • the end-cover may comprise, consists essentially of or consist of umbilical cord material and may be attached to the umbilical cord by an attachment, as described.
  • a sheet of umbilical cord may be prepared by cutting the umbilical cord along the length and splaying the umbilical cord to form a sheet.
  • the sheet may be folded and attached along a portion of the perimeter to form an envelope or a pouch.
  • two or more sheets of umbilical cord are layered and attached along a portion of the perimeter to form an envelope or a pouch.
  • the inside surface of the umbilical cord may form the inside surface of the umbilical cord cover or the outside surface of the umbilical cord cover.
  • the outside surface of the umbilical cord may form the outside surface or inside surface of the umbilical cord cover.
  • a biologically active material such as an implantable cover is defined as a material that is able to elicit cells and tissues responses and that comprises biologically active components including but not limited to proteins, growth factors, cytokines and in some cases cells that may be live active cells.
  • An implantable cover may consist essentially of or consist of a biologically active material derived from umbilical cord tissue.
  • An implantable cover that consists essentially of biologically active material comprises a cover material that is a biologically active, such as umbilical cord tissue and may include non-biologically active attachments, such as a stitch or adhesive and may also include an anti-microbial agent, an antifibrotic agent, a pharmacological agent, anti-inflammatory agents, medicant agents and saline, for example.
  • a biologically active material may be determined to be bioactive through functional-assays demonstrating anti-microbial properties, anti-fibrotic properties, anti-inflammatory properties and other biological and physiological properties including among others modulation of cell migration, cell differentiation, cell proliferation, protein biosynthesis.
  • An exemplary biologically active umbilical cord cover is in the form of an envelope and has an inner surface, an outer surface, a first end and a second end that opposes the first end.
  • the envelope may be configured around opposing surfaces of an implantable article and is a one-piece unit.
  • An envelope may be a piece of umbilical cord and be in the form of tube having a continuous wall that extends around the radius of the conduit.
  • An exemplary envelope extends around two opposing sides of an implantable article and is a contiguous piece of material.
  • an envelope umbilical cord cover is a folded piece of umbilical cord sheet material and the extended or cut ends may be attached to form a conduit for receiving an implantable article.
  • an envelope umbilical cord comprises two or more sheets of umbilical cord material that is attached to form a conduit for receiving an implantable article.
  • An exemplary umbilical cord cover is a pouch that forms an enclosure for receiving an implantable article.
  • the pouch enclosure may be a portion of the length of an umbilical cord that is attached on one end.
  • An umbilical cord tube may have one end of the tube attached by stitched suture, adhesive or a direct attachment.
  • An end-cover may be attached to one end of an umbilical cord tube to form a pouch.
  • a pouch is formed from a folded piece of umbilical cord sheet material and the perimeter is attached to form a pouch.
  • a pouch is formed from two or more layers of umbilical cord sheet material that are attached together along the perimeter to form a pouch.
  • the end-cover material may be umbilical cord sheet material.
  • Natural umbilical cord comprises an outer layer of amnion which is the extension of the amniotic membrane covering the placenta and Wharton's Jelly.
  • the umbilical cord further comprises an allantoic duct, two arteries and one vein buried within the Wharton's Jelly.
  • the amniotic membrane is a translucent membrane and has multiple layers; an epithelial layer; a basement membrane layer; a compact layer; a fibroblast layer; and a spongy layer.
  • the amniotic membrane lacks the immunogenic antigens HLA-A, B, or DR, reducing the risk of graft-versus-host reaction.
  • the amniotic membrane is rich in biologically active molecules, including TIMP-1, TIMP-2, IL-lra, EGF, bFGF, TFG- ⁇ , IGF-1, PDGF-AA, and PDGF-BB among others.
  • the amniotic membrane contains cells including epithelial cells and mesenchymal stem cells.
  • the amniotic membrane also contains hyaluronic acid and anti-microbial peptides including Pentraxin-3 and S100-A8.
  • the antimicrobial peptides Pentraxin-3 and S100-A8 are known to play an important role against bacterial infection caused by Staphylococcus aureus, Staphylococcus epidermis,
  • the Wharton's Jelly contains mesenchymal stem cells, growth factors and a large amounts of extracellular matrix proteins including collagen, hyaluronate and proteoglycans.
  • the amniotic membrane and Wharton's Jelly possess several intrinsic regenerative properties including cellular proliferation, cellular migration, cellular differentiation, modulation of inflammation, reduction of fibrosis, reduction of adhesion among others.
  • Umbilical cord tissue has a wall thickness that is much greater than placental tissue layers, on order of eight times to ten or more times greater. This increased tensile strength provides for a more robust implantable cover.
  • One or more components of the umbilical cord may be removed before, during, or after making an umbilical cord cover.
  • the Wharton's Jelly portion of the umbilical cord may be partially, substantially, or completely removed from the umbilical cord material.
  • the smooth musculature may be partially or substantially removed.
  • Portions of the umbilical cord may be removed physically or with chemical agents.
  • Umbilical cord material also comprises growth factors, cytokines, extracellular matrix proteins, hyaluronic acid, proteoglycans, and anti-microbial peptides. These materials are known to provide improved healing and other beneficial therapeutic effects.
  • the umbilical cord, implantable envelope, pouch or cover sheet may be soaked in agents to increase or enrich agents.
  • an implantable pouch consisting of umbilical cord tissue may be soaked in an anti-microbial agent, an antifibrotic agent, a pharmacological agent, a solution containing cells, a solution containing growth factors, a solution containing cytokines, a solution containing extracellular matrix proteins and the like.
  • An exemplary implantable cover consists essentially of umbilical cord tissue and may include attachments, such as a stitch or adhesive.
  • An exemplary implantable cover may consist of umbilical cord tissue and comprise a conduit formed in the umbilical cord to form a tube or may comprise a folded cover sheet of umbilical cord tissue that forms an envelope and may comprise a direct attachment, wherein the umbilical cord tissue is bonded or attached to itself directly without any additional stitching or adhesive.
  • An implantable cover may consist of umbilical cord tissue when an enlarged cover sheet is utilized having a direct attachment.
  • a release layer or a sheet of material that prevents direct attachment, such as a low surface energy material such as fluoropolymer or polyurethane, may be used to prevent the formation of a direct attachment when pressure is applied to two layered umbilical cord sheets.
  • a release layer may have a release tab that creates a secondary opening in a pouch or envelope.
  • An exemplary implantable cover, umbilical cord cover layer or umbilical cover sheet may be bioerodible or biodegradable.
  • a bioerodible material as used herein, may comprises bioerodible additives to enable the material to breakdown more quickly after being implanted.
  • a bioerodible additive may be a bioresorbable material or biodegradable material.
  • a biodegradable material is susceptible of breakdown into simpler components by biological processes, as by bacterial or other enzymatic action.
  • Figure 1 shows a diagram of a fetus coupled to the placenta by the umbilical cord.
  • Figure 2 shows a diagram of a fetus coupled to the placenta by the umbilical cord.
  • Figure 3 shows a cross-sectional micrograph of an umbilical cord.
  • Figure 4 shows a side view of an exemplary umbilical cord that has a length from a placental end to a fetus end and a conduit therethrough.
  • Figure 5 shows a placental-end view of an exemplary umbilical cord tube, wherein a portion of the interior of the umbilical cord has been removed to form an implantable tube.
  • Figure 6 shows a fetus-end view the exemplary implantable tube shown in Figure. 4.
  • Figure 7 shows a front perspective view of an exemplary umbilical cord tube cover comprising a portion of an umbilical cord that forms an envelope and an attachment on one end to form a pouch.
  • Figure 8 shows a side perspective view of an exemplary umbilical cord tube cover comprising a portion of an umbilical cord that forms an envelope and an attachment on one end to form a pouch.
  • Figures 9 and 10 show perspective views of an exemplary umbilical cord tube cover comprising a portion of an umbilical cord that forms an envelope and an end-cover attached to one end to form a pouch.
  • Figure 1 1 shows a perspective view of an end-cover comprising umbilical cord tissue in a sheet form.
  • Figure 12 shows a front perspective view of an exemplary umbilical cord cover comprising a portion of an umbilical cord that forms an envelope and an attachment on one end to form a pouch.
  • Figure 13 shows a side perspective view of an exemplary umbilical cord tube cover comprising a portion of an umbilical cord that forms an envelope and an attachment on one end to form a pouch.
  • Figures 14 and 15 show perspective views of an exemplary umbilical cord tube cover comprising a portion of an umbilical cord that forms an envelope and an end-cover attached to one end to form a pouch.
  • Figure 16 shows a perspective view of a portion of an umbilical cord tube with a cut through the umbilical cord tube along the length to form a sheet, as shown in FIG. 16.
  • Figure 17 shows a perspective view of an umbilical cord sheet formed from a cut section of umbilical cord.
  • Figure 18 shows a perspective view of a section of an umbilical cord having a slit to allow the umbilical cord to be open to produce a cover sheet.
  • Figures 19 to 21 show two cover sheets formed from an umbilical cord being attached along a portion of the perimeter to form an enlarged implantable cover sheet.
  • Figure 22 shows a perspective view of an umbilical cord sheet folded to form an envelope.
  • Figure 23 shows a perspective view of an umbilical cord sheet folded to form an envelope and an attachment around a portion of the perimeter to form a pouch.
  • Figure 24 shows a perspective view of two umbilical cord sheets attached around a portion of their perimeters for form a pouch.
  • Figure 25 shows a perspective view of two umbilical cord sheets layered one atop the other with a release layer between them and pressure being applied to form a direct attachment.
  • Figure 26 shows a perspective view of an implantable pouch having a direct attachment around the perimeter and an opening.
  • Figure 27 shows a perspective view of two umbilical cord sheets and a release layer place on one of the sheets having a tab to create a secondary opening when the two layers are attached to form direct attachment around the perimeter.
  • Figure 28 shows a perspective view of an exemplary pouch having a secondary opening.
  • Figure 29 show a perspective view of the exemplary pouch shown in FIG. 28 with an implantable article inserted into the pouch with leads from the implantable article extending through the secondary opening in the perimeter of the pouch.
  • Figure 30 shows a perspective view of an envelope formed from an implantable cover sheet having a release layer inserted into the envelope to allow direct attachment of the two sides to form a pouch.
  • Figure 31 shows an exemplary umbilical cord cover.
  • Figure 32 shows a front view of an exemplary implantable article, a pacemaker.
  • Figure 33 shows a front view of the pacemaker shown in FIG. 32 with the umbilical cord cover shown in FIG. 31 partially configured therearound.
  • Figure 34 shows a front view of the pacemaker shown in FIG. 32 with the umbilical cord cover shown in FIG. 31 partially configured therearound.
  • Figure 35 shows a front view of the umbilical cord cover shown in FIG. 20 configured completely around the pacemaker shown in FIG. 32.
  • Figure 36 shows a bar graph of the total proteins for three different samples from an umbilical cord containing different amounts of the Wharton's Jelly.
  • Figure 37 shows a graph of protein release from a sample taken from an umbilical cord versus time.
  • Figure 38 shows a bar graph of the hyaluronic acid for two different samples from an umbilical cord containing different amounts of the Wharton's Jelly.
  • Figure 39 shows a flow diagram of a method to form an implantable cover from umbilical cord cover sheet derived from an umbilical cord.
  • Figure 40 shows a flow diagram of a method to form an implantable pouch from an umbilical cord cover sheet derived from an umbilical cord by folding and forming a direct attachment.
  • Figure 41 shows a flow diagram of a method to form an implantable cover from umbilical cord cover sheet derived from an umbilical cord.
  • Figure 42 shows a flow diagram of a method of forming an implantable cover by removing a portion of the interior of a section of an umbilical cord.
  • Figure 43 shows a flow diagram of a method of forming an implantable cover by removing a portion of the interior of a section of an umbilical cord and attached an end-cover to one of the open ends to form an implantable pouch.
  • the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion.
  • a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
  • use of "a” or “an” are employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.
  • a fetus 34 is coupled to the placenta 32 by the umbilical cord 20.
  • the umbilical cord has a placenta end 22 that connects the umbilical cord to the placenta and a fetus end 34 that connects the umbilical cord to the fetus.
  • the fetus and placenta are within the amniotic sack 30 comprising amnion tissue 31.
  • an umbilical cord 20 comprises a cord lining comprising amnion 82, Wharton's Jelly, allantoic duct, umbilical vein, and two umbilical arteries.
  • an exemplary umbilical cord 20 has a length 23 from a placenta end 22 to the fetus end 24 and has a conduit 21 therethrough.
  • the umbilical cord may have an interior portion removed to form an umbilical tube cover 18 that has an inside surface 29 and an outside surface 27.
  • Figure 4 shows a placental end 22 of an exemplary umbilical tube cover 18.
  • the inner diameter 25 of the umbilical cord conduit 21 is shown as well as the wall thickness 28 of the umbilical cord.
  • Figure 5 shows a fetus end 24 of an exemplary umbilical tube cover 18.
  • the outer diameter 26 of the umbilical cord is shown.
  • an exemplary umbilical cord cover 15 comprises a portion of an umbilical cord 20 having an interior portion removed to make an umbilical tube cover 18 that forms an envelope 17 and an attachment 56 on one end to form a pouch 50.
  • the attached end 54 of the umbilical tube cover comprises a stitch closes the open end of the conduit 21 by securing the cover wall 52 together.
  • the cover opening 51 allows an implantable article to be placed therein.
  • the inside surface 29 of the umbilical tube cover is the inside surface of the umbilical cord cover and the outside surface 27 of the umbilical cord is the outside surface of the umbilical cord cover.
  • an exemplary umbilical cord cover 15 comprises a portion of an umbilical cord 20 having a portion of the interior remove that forms an envelope 17 and an end cover 40 that is attached to the umbilical tube cover to form pouch 50.
  • the end-cover is attached to the umbilical cord 20 by an attachment 56 to form an attached end 54, or closed end of the pouch.
  • the end-cover is a sheet of umbilical cord 42 comprising umbilical cord tissue 43.
  • the end-cover prepared by cutting open a section of an umbilical cord to form a sheet of material.
  • the cover opening 51 allows an implantable article to be placed therein.
  • the inside surface 29 of the umbilical cord is the inside surface of the umbilical cord cover and the outside surface 27 of the umbilical cord is the outside surface of the umbilical cord cover.
  • an exemplary umbilical cord cover 15 comprises a portion of an umbilical cord 20 having an interior portion removed to form a tube that has been inverted such that the inside surface 29 of the umbilical cord forms the outside surface 55 of the umbilical tube cover 18 and the outside surface 27 of the umbilical cord is configured on the inside surface 59 of the umbilical tube cover or cord cover 15.
  • the attached end 54 of the cover is attached by an attachment 56, a stitch 57.
  • an exemplary umbilical cord cover 15 comprises a portion of an umbilical cord 20 having an interior portion removed to form a tube that has been inverted such that the inside surface 29 of the umbilical cord forms the outside surface 55 of the umbilical cord cover and the outside surface 27 of the umbilical cord is configured on the inside surface 59 of the umbilical cord cover 15.
  • the attached end 54, or closed end, of the cover comprises an end-cover 40 attached to the umbilical cord by an attachment 56, a stitch 57.
  • the end-cover may be a piece of umbilical cord and may be configured with the inside surface of the umbilical cord facing into the cover or forming an outside surface of the cover.
  • an umbilical cord 20, with an interior portion removed to from an umbilical tube cover 18, is cut along the length to form an umbilical cord sheet 42, as shown in FIG. 17.
  • the cut along the length of the umbilical cord tube creates a first cut edge 76 and a second cut edge 78.
  • the umbilical cord is opened and flattened out it forms the umbilical cord sheet 42 shown in FIG. 17 having a length 45 from a first end 44 to a second end 46 and a width 48 from a first side 47 to a second side 49.
  • the sides are the first and second cut edges as shown in FIG. 16.
  • the umbilical cord tissue 43 may comprise amniotic membrane, Wharton's jelly, and/or smooth musculature. Layers of the umbilical cord tissue may be removed as required for the application of use.
  • Figure 18 shows a perspective view of a section of an umbilical cord 20 having a slit to allow the umbilical cord to be open to produce a cover sheet.
  • the slit umbilical cord may be opened or flattened out to form a cover sheet.
  • the slit cord may have additional material removed to form a substantially flat sheet, such as some of the Wharton's Jelly, veins and/or artery.
  • the cover sheet may be rolled or placed under pressure to enlarge the sheet dimension size of the cover sheet.
  • FIGS 19 to 21 show two cover sheets 42, 42 formed from an umbilical cord being attached along a portion of the perimeter to form an enlarged implantable cover sheet 41.
  • the attachment 56 is a stitch 47 along the perimeter.
  • the attachment 56 is an adhesive 58.
  • the attachment 56 is a direct attachment 69, wherein the two cover sheets bond directly together through application of pressure over a period of time wherein the umbilical cord tissue may dry and form a direct bond. The sheets will bond and attach with application of pressure.
  • an umbilical cord sheet 42 is folded to form an envelope and then a portion of the perimeter is attached to form a pouch 50.
  • the umbilical cord sheet is folded about a fold 60 with the first and second cut edges, 76, 78 aligned on the extended ends 62 of the folded sheet material.
  • the inside surface 29 of the umbilical cord 20 is facing out on the pouch 50, or forms the outside surface.
  • some layers of the umbilical cord may be removed prior to or after forming the umbilical cord cover 15.
  • a portion of the perimeter of the folded sheet are attached together by an attachment 56, an adhesive 58, leaving an opening 51 for receiving an implantable article.
  • the umbilical cord cover 15 has the outside surface 27 of the umbilical cord tissue 43 forming the outside surface of the 55 of the umbilical cord cover 15.
  • two umbilical cord sheets 42, 42' are layered one atop the other with a release layer 67 between them. Pressure is applied, as indicated by the large bold arrows to form a direct attachment 69 or bond. The pressure is applied at least around the perimeter to cause the two umbilical cord sheets to bond together as they dry in contact with each other under pressure. The release sheet can be removed after the direct bond is formed and prevents the middle portion of the two umbilical cord sheets from bonding, thereby forming a pouch.
  • an exemplary implantable pouch 50 has a direct attachment around the perimeter and a cover opening 51 to receive an implantable article.
  • the pouch consists of umbilical cord tissue 43.
  • a first umbilical cord sheet 42 has a release layer 67 with a release tab 68 configured thereon.
  • a second umbilical cord sheet 42' may then be place over the first sheet and release layer and pressure may be applied to form a direct attachment around the perimeter, where the release layer and release tab do not interfere with direct contact between the two umbilical cord sheets.
  • the release layer is removed to form an implantable pouch 50 having a cover opening 51 for receiving an implantable article 120, and a secondary opening 66 for extending a lead 65 therethrough.
  • the secondary opening may be configured in any location around the perimeter of the pouch including proximal with the cover opening 51.
  • the secondary opening may extend down from the cover opening along one of the sides.
  • An implantable article, such as an electronic device is configured within the pouch 50 with a lead 65 extending through the secondary opening in FIG. 29.
  • an envelope 17 is formed from an implantable cover sheet 42 and a release layer 67 is inserted into the envelope to allow direct attachment of the two envelope sides 1 10 and 1 12, to form a pouch.
  • an exemplary umbilical cord cover 15 is configured for placement at least partially over and implantable article 120, such as an electronic device 122.
  • the pacemaker 124 has an irregular shape that is covered, at least in part, by umbilical cord cover 15.
  • the opening 51 of the cover is extended over the implantable article.
  • the umbilical cord cover is partially extended over the implantable article and in FIG. 35 the implantable cover 15 substantially covers the implantable article 120.
  • HA hyaluronic acid
  • WJ hyaluronic acid
  • Figure 39 shows a flow diagram of a method to form an implantable cover, in the form of an envelope or pouch, form a folded umbilical cord cover sheet.
  • Figure 40 shows a flow diagram of a method to form an implantable pouch from an umbilical cord cover sheet derived from an umbilical cord by folding and forming a direct attachment. Note that two or more umbilical cover sheets may be attached to form an enlarged cover sheet before it is folded and bonded to form the pouch as described in this method diagram.
  • Figure 41 shows a flow diagram of a method to form an implantable cover, in the form of an envelope or pouch, form a two layered and attached umbilical cord cover sheets.
  • Figure 42 shows a flow diagram of a method of forming an implantable cover by removing a portion of the interior of a section of an umbilical cord.
  • Figure 43 shows a flow diagram of a method of forming an implantable cover by removing a portion of the interior of a section of an umbilical cord and attached an end-cover to one of the open ends to form an implantable pouch.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une couverturee implantable pour un article implantable, tel qu'un stimulateur cardiaque, qui utilise un tissu de cordon ombilical pour former une enveloppe d'air autour d'au moins deux côtés opposés de l'article. Une poche peut être formée dans du tissu de cordon ombilical ayant une ouverture unique pour recevoir l'article implantable. Une enveloppe peut être formée en retirant la partie intérieure du cordon ombilical pour former un tube ayant deux extrémités ouvertes ou en formant une feuille de couverture dans le cordon ombilical, puis en pliant la feuille de couverture pour former l'enveloppe. Une poche peut être formée par fixation de côtés d'une enveloppe, tels que l'un ou les deux côtés s'étendant à partir du pli de l'enveloppe et/ou des extrémités étendues de l'enveloppe. La couverture implantable dérivée du cordon ombilical peut avoir une certaine épaisseur de gelée de Wharton et/ou de membrane amniotique. La couverture implantable dérivé de cordon ombilical peut être biologiquement active.
PCT/US2018/030066 2017-04-29 2018-04-28 Couverture implantable en cordon ombilical et procédé de fabrication Ceased WO2018201116A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762492176P 2017-04-29 2017-04-29
US62/492,176 2017-04-29

Publications (1)

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WO2018201116A1 true WO2018201116A1 (fr) 2018-11-01

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080069895A1 (en) * 2006-08-15 2008-03-20 Qing Liu Umbilical cord biomaterial for medical use
WO2011031489A2 (fr) * 2009-08-25 2011-03-17 Tissuetech, Inc. Produits de membrane amniotique du cordon ombilical
US8685732B2 (en) * 2008-10-10 2014-04-01 Histocell, S.L. Biomaterial based on Wharton's jelly from the human umbilical cord
US20170049553A1 (en) * 2015-08-17 2017-02-23 Vivex Biomedical, Inc. Shaped umbilical cord transplant product
US9585983B1 (en) * 2011-10-12 2017-03-07 BioDlogics, LLC Wound covering and method of preparation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080069895A1 (en) * 2006-08-15 2008-03-20 Qing Liu Umbilical cord biomaterial for medical use
US8685732B2 (en) * 2008-10-10 2014-04-01 Histocell, S.L. Biomaterial based on Wharton's jelly from the human umbilical cord
WO2011031489A2 (fr) * 2009-08-25 2011-03-17 Tissuetech, Inc. Produits de membrane amniotique du cordon ombilical
US9585983B1 (en) * 2011-10-12 2017-03-07 BioDlogics, LLC Wound covering and method of preparation
US20170049553A1 (en) * 2015-08-17 2017-02-23 Vivex Biomedical, Inc. Shaped umbilical cord transplant product

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