WO2023091098A1 - An implantable patch for vascular injuries with a blood perfusion system - Google Patents

An implantable patch for vascular injuries with a blood perfusion system Download PDF

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Publication number
WO2023091098A1
WO2023091098A1 PCT/TR2021/051267 TR2021051267W WO2023091098A1 WO 2023091098 A1 WO2023091098 A1 WO 2023091098A1 TR 2021051267 W TR2021051267 W TR 2021051267W WO 2023091098 A1 WO2023091098 A1 WO 2023091098A1
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WO
WIPO (PCT)
Prior art keywords
membrane
implantable patch
patch
adhesive
implantable
Prior art date
Application number
PCT/TR2021/051267
Other languages
French (fr)
Inventor
Mehmet Hakan Akpinar
Ibrahim Faruk AKTURK
Original Assignee
Mehmet Hakan Akpinar
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 Mehmet Hakan Akpinar filed Critical Mehmet Hakan Akpinar
Priority to PCT/TR2021/051267 priority Critical patent/WO2023091098A1/en
Publication of WO2023091098A1 publication Critical patent/WO2023091098A1/en

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Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483—Barbs
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0007—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to an implantable patch for vascular injuries with a blood perfusion system that allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through an implantable patch.
  • Emergency Surgery can be defined as surgery required to deal with an acute threat to life, organ, limb, or tissue caused by external trauma, acute disease process, acute exacerbation of a chronic disease process, or complication of a surgical or other interventional procedure.
  • Emergency access is a technique of rapid surgical exposure of a superficial vein to allow rapid catheterization.
  • a short defined time limit ⁇ 5 minutes
  • vascular access is not achieved within that time limit, it should proceed directly to an emergency cutdown.
  • vascular injuries cause a significant burden of mortality and disability. Patients with vascular injuries represent a significant clinical challenge to all kinds of health centers. Most injuries are detected with computed tomography angiography and managed with either antiplatelet medications or anticoagulation. The stages to diagnosis and management of peripheral vascular injury include early recognition of the injury; hemorrhage control with direct pressure, packing, or tourniquets; and urgent surgical consultation. During the closure of a dissected, ruptured or injured, ensuring blood flow in the damaged area is vital for the procedure's success.
  • the pericardium patches are commonly used in vascular surgery, correction of congenital, and acquired heart diseases.
  • the bovine pericardial patches are alternative for a broad spectrum of clinical uses due to their characteristics such as easy handling, suturability, and hemostasis compared with synthetic patches. Also, their superior biocompatibility enables excellent host tissue incorporation without the need for special sutures or needles.
  • Bovine pericardial patches are cross-linked with glutaraldehyde in a controlled environment preserving its natural collagen structures. This procedure enhances the mechanical strength of the tissue while maintaining its superior flexibility.
  • Another treatment method for providing hemostasis is using the fibrin sealants, or fibrin glues as a source of fibrinogen and thrombin. They are used as topical hemostatic agents and improve hemostasis where standard surgical techniques are insufficient or impractical. Fibrin sealants provide adequate tissue adhesion in many clinical situations.
  • the present invention relates to an implantable patch with a blood perfusion system that provides treatment for vascular injuries allowing prolonged dilatation avoiding the high risks of blood stricture during balloon inflation, and a method for manufacturing such an implantable patch.
  • Fig. 1 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention having component details such as a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, an inner lumen (102) for the balloon catheter system used as a guidewire lumen, a radiopaque marker band (103) to visualize the balloon location under fluoroscopy, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising adhesive or coagulant agent (106) between the internal membrane (105a) and external membrane (105b), the anchoring wires (107) to hold the multi-layered implantable patch (105) steady, a kink-resistant inflation lumen (108) for the balloon catheter, the connecting strut (109) of the self/mechanically expandable stent frame (101 ) to the external surface of the inner lumen (102), the balloon catheter main shaft (110) to push and pull the total system (The detail A in the preferred embodiment of
  • Fig. 2 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention having component details such as a multilayered implantable patch (105) comprising adhesive or coagulant agent(106) between the internal membrane (105a) and external membrane (105b) and the anchoring wires (107) to hold the multi-layered implantable patch (105) steady.
  • Fig. 3a is a top view schematic illustration of a preferred embodiment of the implantable patch showing an intermediate membrane (105c) between internal membrane (105a) and adhesive or coagulant agent (106) to provide antithrombogenic effect and rapid endothelization.
  • Fig. 3b is a top view schematic illustration of a preferred embodiment of the implantable patch showing an intermediate membrane (105c) between external membrane (105b) and adhesive or coagulant agent (106) to provide controlled adhesive or coagulant agent (106) release.
  • Fig. 4 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention having component details such as valve located in internal lumen (111 ).
  • the detail C in the preferred embodiment of the implantable patch according to the invention presents the valve located in internal lumen (111 ) indicating the diameter (D1 ).
  • Fig. 5 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the implantable patch comprising a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising of an adhesive or coagulant agent (106) between the internal membrane (105a) and external membrane (105b), a one sided folding hood (113) located in side branch access part (112) corresponding the first side branches of aortic arch through the first inflation lumen(114).
  • the implantable patch comprising a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising of an adhesive or coagulant agent (106) between the internal membrane (105
  • Fig. 6 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the implantable patch comprising a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising of an adhesive or coagulant agent (106) between the internal membrane (105a) and external membrane (105b), a one sided folding hood (113) located in side branch access part (112) corresponding the three side branches of aortic arch through first inflation lumen (114), second inflation lumen (115) and third inflation lumen (116) respectively.
  • the implantable patch comprising a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising
  • Fig. 7 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the extension of the two-sided folding hood (113) located in side branch access part (112) corresponding the side branches first inflation lumen (114), second inflation lumen (115) and third inflation lumen (116) after pulling the guidewire to center the side branches (Detail D in the preferred embodiment of the implantable patch according to the invention presents the two-sided folding hold (113) as unstreched position (L1 ) and detail E presents the two-sided folding hood (113) as stretched position extending from L1 to L2.).
  • Fig. 8 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the extension of the one-sided folding hood (113) located in side branch access part (112) corresponding the side branches first inflation lumen (114), second inflation lumen (115) and third inflation lumen (116) after pulling the guidewire to center the side branches (Detail F in the preferred embodiment of the implantable patch according to the invention presents the one-sided folding hold (113) as unstreched position (L1 ) and detail G presents the one-sided folding hood (113) as stretched position extending from L1 to L2.).
  • the present invention relates to an implantable patch for vascular injuries with a blood perfusion system that allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through the implantable patch.
  • the implantable patch of the invention has either an internal surface or between the balloon surface, a metallic structure which either self or mechanically expands to create the large internal lumen to create sufficient blood perfusion through the balloon catheter lumen. Afterward, the balloon is inflated to a nominal pressure to perform an emergency intervention to control hemorrage caused by a vessel dissection, rupture, perforation or injury for a certain time providing sufficient blood flow for the distal tissues and vessels.
  • the implantable patch for vascular injuries with a blood perfusion system which allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through an implantable patch, comprises:
  • a multi-layered implantable patch (105) comprising of an internal membrane (105a), an external membrane (105b), an intermediate membrane (105c) and the adhesive or coagulant agents (106) that promote clotting, gluing, coagulation between the internal membrane (105a), - an external membrane (105b) which bursts/perforates/releases internal substance such as the adhesive or coagulant agents (106) that promote clotting, gluing or coagulation of the dissected, ruptured or damaged tissue made of a constant or bioabsorbable polymeric material such as polycaprolactone, polylactic acid, polylactic-co-glycolic acid which can be triggered with pressure, temperature change, chemical reaction or any combination of these,
  • a constant or bioabsorbable polymer such as PET, dacron, PTFE, pericardium patch which will be bonded/funded/absorbed to an external membrane (105b) for housing adhesive or coagulant agents (106)
  • an intermediate membrane (105c) made of a bioabsorbable material such as polycaprolactone, polylactide acid or copolymers thereof to enhance anti-thrombogenicity, rapid endothelization or controlled material release,
  • - valve located in internal lumen (111 ) made of a flexible and soft polymer alloys to pulsative perfusion during the balloon inflation, two or more radiopaque marker bands (103) located in the side branch access parts of the implantable patch to monitor actual location of the implantable patch under fluoroscopy.
  • the implantable patch comprises a multilayered implantable patch (105) which comprises an internal membrane (105a) as the main patch made of a constant or bioabsorbable polymer, an external membrane (105b) as a bioabsorbable layer made of a constant or bioabsorbable layer and an intermediate layer (105c) between the internal membrane (105a) and adhesive or coagulant agent (106) and/or external membrane (105b) and adhesive or coagulant agent (106).
  • a multilayered implantable patch (105) which comprises an internal membrane (105a) as the main patch made of a constant or bioabsorbable polymer, an external membrane (105b) as a bioabsorbable layer made of a constant or bioabsorbable layer and an intermediate layer (105c) between the internal membrane (105a) and adhesive or coagulant agent (106) and/or external membrane (105b) and adhesive or coagulant agent (106).
  • the implantable patch comprises adhesive or coagulant agent (106) between the said multi-layered implantable patch (105) to promote clotting, adhesion or coagulant of the dissected, ruptured or damaged tissue.
  • the external membrane (105b) contacts to dissected, ruptured or damaged tissue intended and the adhesive or coagulant agents (106) that promote clotting, adhesion or coagulation are released after the external membrane (105b) is burst by applied pressure arising the balloon inflation, temperature change, chemical reaction or any combination of these.
  • the internal membrane (105a) is adhered to the dissected, ruptured or damaged tissue surface through adhesive or coagulant agents (106) and closes the dissection, rupture or injury without any additional layers.
  • the adhesive or coagulant agent (106) is filled between the internal membrane (105a) and the intermediate membrane (105c) to provide controlled release where needed.
  • the external membrane (105b) is burst by pressure created on the external membrane (105b) surface
  • the intermediate membrane (105c) fused into the external membrane (105b) holds the adhesive and coagulant agent to provide a controlled adhesive or coagulant agent release on the tissue intended.
  • the dissected, ruptured or damaged tissue is filled by adhesive and coagulant agent, the internal membrane contacts to the tissue intended to close it.
  • the implantable patch comprises the adhesive or coagulant agent (106) between the external membrane (105b) and the intermediate membrane (105c) to enhance anti- thrombogenic process and rapid endothelization.
  • the adhesive or coagulant agent (106) is filled inside of the dissected, ruptured or damaged tissue and the intermediate membrane (105c) fused into the internal membrane (105a) holds the adhesive and coagulant agent to enhance anti- thrombogenic process and rapid endothelization.
  • the internal membrane (105a) functions after the intermediate membrane (105c) contacts to the tissue increment of pressure applied to close the dissected, ruptured or damaged tissue permanently.
  • the adhesive or coagulant agent (106) is filled inside of the cavities of the external membrane (105b).
  • the external membrane (105b) filled with adhesive or coagulant agent (106) is covered/fused with internal membrane (105a) to create a multi-layered implantable patch (105).
  • the implantable patch comprises an adhesive and coagulant agent (106) that is filled inside of the cavities of the intermediate layer (105c) fused with external membrane (105b) and covered/fused with internal membrane (105a) to create a multi-layered implantable patch (105).
  • the adhesive or coagulant agent (106) is filled inside of the cavities of the external membrane (105b) and covered/fused with an intermediate membrane (105c) combined to an internal membrane (105a) to create a multi-layered implantable patch (105).
  • the repair of a dissected, ruptured or injured vessels can be done by either the multi-layered implantable patch (105) only or the multi-layered implantable patch (105) containing adhesive and coagulant agents (106) that promote clotting, gluing or coagulation of the dissected, ruptured or damaged tissue between internal membrane (105a) and external membrane (105b).
  • the implantable patch comprises an internal membrane (105b) made of a constant or bioabsorbable polymer such as PET, dacron, PTFE or pericardium patch which will be bonded/funded/absorbed to a constant or bioabsorbable polymer to create an external layer for housing agents that promote clotting, glueing and coagulation of the dissected, ruptured or damaged tissue.
  • a constant or bioabsorbable polymer such as PET, dacron, PTFE or pericardium patch
  • One embodiment of the implantable patch includes anchoring wires (107) made of nitinol or similar materials to hold the double-layered membrane patch (105) steady.
  • One embodiment of the invention includes two or more radiopaque marker bands (103) located in side branch access parts corresponding to aortic branches to monitor actual location of the implantable patch.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to an implantable patch for vascular injuries with a blood perfusion system that allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through an implantable patch.

Description

AN IMPLANTABLE PATCH FOR VASCULAR INJURIES WITH A BLOOD PERFUSION SYSTEM
Technical Field of the Invention
The present invention relates to an implantable patch for vascular injuries with a blood perfusion system that allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through an implantable patch.
Background of the Invention (Prior Art)
In the prior art, emergency surgery and cutdown techniques are commonly used to treat vascular injuries. The treatment is provided by the inside of the damaged area using the sutures. Venous cutdown is an emergency procedure in which the vein is exposed surgically. Then a cannula is inserted into the vein under direct vision. This procedure is used to get vascular access in trauma and hypovolemic shock patients when peripheral cannulation is difficult or impossible.
Emergency Surgery can be defined as surgery required to deal with an acute threat to life, organ, limb, or tissue caused by external trauma, acute disease process, acute exacerbation of a chronic disease process, or complication of a surgical or other interventional procedure.
Emergency access is a technique of rapid surgical exposure of a superficial vein to allow rapid catheterization. For most patients in need of immediate vascular access, a short defined time limit (< 5 minutes) should be set on any attempt at percutaneous catheterization. If vascular access is not achieved within that time limit, it should proceed directly to an emergency cutdown.
Vascular injuries cause a significant burden of mortality and disability. Patients with vascular injuries represent a significant clinical challenge to all kinds of health centers. Most injuries are detected with computed tomography angiography and managed with either antiplatelet medications or anticoagulation. The stages to diagnosis and management of peripheral vascular injury include early recognition of the injury; hemorrhage control with direct pressure, packing, or tourniquets; and urgent surgical consultation. During the closure of a dissected, ruptured or injured, ensuring blood flow in the damaged area is vital for the procedure's success.
The pericardium patches are commonly used in vascular surgery, correction of congenital, and acquired heart diseases. The bovine pericardial patches are alternative for a broad spectrum of clinical uses due to their characteristics such as easy handling, suturability, and hemostasis compared with synthetic patches. Also, their superior biocompatibility enables excellent host tissue incorporation without the need for special sutures or needles. Bovine pericardial patches are cross-linked with glutaraldehyde in a controlled environment preserving its natural collagen structures. This procedure enhances the mechanical strength of the tissue while maintaining its superior flexibility. Another treatment method for providing hemostasis is using the fibrin sealants, or fibrin glues as a source of fibrinogen and thrombin. They are used as topical hemostatic agents and improve hemostasis where standard surgical techniques are insufficient or impractical. Fibrin sealants provide adequate tissue adhesion in many clinical situations.
Currently, no dedicated device is available in the market to treat vascular injuries through percutaneous interventions providing sutureless treatment of the damaged area. Thus, there is a need for an alternative treatment for vascular injuries with a blood perfusion system to provide more effective and successful treatment results. Treatment of a dissected, ruptured or injured vessel with minimally invasive methods without the need for sutures with more biocompatible components by providing hemorrhage will significantly relieve the burden of vascular injuries and achieve rapid and successful results. Summary of the Invention
The present invention relates to an implantable patch with a blood perfusion system that provides treatment for vascular injuries allowing prolonged dilatation avoiding the high risks of blood stricture during balloon inflation, and a method for manufacturing such an implantable patch.
Brief Description of the Drawings
Fig. 1 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention having component details such as a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, an inner lumen (102) for the balloon catheter system used as a guidewire lumen, a radiopaque marker band (103) to visualize the balloon location under fluoroscopy, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising adhesive or coagulant agent (106) between the internal membrane (105a) and external membrane (105b), the anchoring wires (107) to hold the multi-layered implantable patch (105) steady, a kink-resistant inflation lumen (108) for the balloon catheter, the connecting strut (109) of the self/mechanically expandable stent frame (101 ) to the external surface of the inner lumen (102), the balloon catheter main shaft (110) to push and pull the total system (The detail A in the preferred embodiment of the implantable patch according to the invention presents the anchoring wire (107) to the tissue surface. The detail B presents a vesicle containing the adhesive or coagulant agent (106).).
Fig. 2 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention having component details such as a multilayered implantable patch (105) comprising adhesive or coagulant agent(106) between the internal membrane (105a) and external membrane (105b) and the anchoring wires (107) to hold the multi-layered implantable patch (105) steady. Fig. 3a is a top view schematic illustration of a preferred embodiment of the implantable patch showing an intermediate membrane (105c) between internal membrane (105a) and adhesive or coagulant agent (106) to provide antithrombogenic effect and rapid endothelization.
Fig. 3b is a top view schematic illustration of a preferred embodiment of the implantable patch showing an intermediate membrane (105c) between external membrane (105b) and adhesive or coagulant agent (106) to provide controlled adhesive or coagulant agent (106) release.
Fig. 4 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention having component details such as valve located in internal lumen (111 ). The detail C in the preferred embodiment of the implantable patch according to the invention presents the valve located in internal lumen (111 ) indicating the diameter (D1 ).
Fig. 5 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the implantable patch comprising a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising of an adhesive or coagulant agent (106) between the internal membrane (105a) and external membrane (105b), a one sided folding hood (113) located in side branch access part (112) corresponding the first side branches of aortic arch through the first inflation lumen(114).
Fig. 6 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the implantable patch comprising a self/mechanically expandable stent frame (101 ) as the skeleton of the enlarged internal lumen, a balloon (104) attached to the external surface of the self/mechanically expandable stent frame (101 ), a multi-layered implantable patch (105) comprising of an adhesive or coagulant agent (106) between the internal membrane (105a) and external membrane (105b), a one sided folding hood (113) located in side branch access part (112) corresponding the three side branches of aortic arch through first inflation lumen (114), second inflation lumen (115) and third inflation lumen (116) respectively.
Fig. 7 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the extension of the two-sided folding hood (113) located in side branch access part (112) corresponding the side branches first inflation lumen (114), second inflation lumen (115) and third inflation lumen (116) after pulling the guidewire to center the side branches (Detail D in the preferred embodiment of the implantable patch according to the invention presents the two-sided folding hold (113) as unstreched position (L1 ) and detail E presents the two-sided folding hood (113) as stretched position extending from L1 to L2.).
Fig. 8 is a schematic illustration of a preferred embodiment of the implantable patch according to the invention showing the extension of the one-sided folding hood (113) located in side branch access part (112) corresponding the side branches first inflation lumen (114), second inflation lumen (115) and third inflation lumen (116) after pulling the guidewire to center the side branches (Detail F in the preferred embodiment of the implantable patch according to the invention presents the one-sided folding hold (113) as unstreched position (L1 ) and detail G presents the one-sided folding hood (113) as stretched position extending from L1 to L2.).
Description of References in Drawings
101 - self/mechanically expandable stent frame
102- inner lumen
103- a radiopaque marker band
104- balloon 105- a multi-layered implantable patch
105a- internal membrane
105b- external membrane
105c- intermediate membrane
106- adhesive or coagulant agent
107- anchoring wires
108- kink-resistant inflation lumen
109- connecting strut
110- balloon catheter main shaft
111 - valve located in internal lumen
112- side branch access part
113- folding hood
114- first inflation lumen
115- second inflation lumen
116-third inflation lumen
A- Anchoring wire (107) to the tissue surface
B- Vesicle containing the adhesive or coagulant agent (106)
C- Valve located in internal lumen (111 )
D- Two-sided folding hold (113) as unstreched position
E- Two-sided folding hood (113) as stretched position extending from L1 to
L2
F- One-sided folding hold (113) as unstreched position
G- One-sided folding hood (113) as stretched position extending from L1 to
L2 D1 : Diameter of the valve located in internal lumen (111 )
L1 : Unstrected position of the folding hood (113)
L2: Stretched length of the folding hood (113)
Detailed Description of the Invention
The present invention relates to an implantable patch for vascular injuries with a blood perfusion system that allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through the implantable patch.
The implantable patch of the invention has either an internal surface or between the balloon surface, a metallic structure which either self or mechanically expands to create the large internal lumen to create sufficient blood perfusion through the balloon catheter lumen. Afterward, the balloon is inflated to a nominal pressure to perform an emergency intervention to control hemorrage caused by a vessel dissection, rupture, perforation or injury for a certain time providing sufficient blood flow for the distal tissues and vessels.
According to the present invention, the implantable patch for vascular injuries with a blood perfusion system which allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through an implantable patch, comprises:
- a multi-layered implantable patch (105) comprising of an internal membrane (105a), an external membrane (105b), an intermediate membrane (105c) and the adhesive or coagulant agents (106) that promote clotting, gluing, coagulation between the internal membrane (105a), - an external membrane (105b) which bursts/perforates/releases internal substance such as the adhesive or coagulant agents (106) that promote clotting, gluing or coagulation of the dissected, ruptured or damaged tissue made of a constant or bioabsorbable polymeric material such as polycaprolactone, polylactic acid, polylactic-co-glycolic acid which can be triggered with pressure, temperature change, chemical reaction or any combination of these,
- an internal membrane (105a) made of a constant or bioabsorbable polymer such as PET, dacron, PTFE, pericardium patch which will be bonded/funded/absorbed to an external membrane (105b) for housing adhesive or coagulant agents (106),
- an intermediate membrane (105c) made of a bioabsorbable material such as polycaprolactone, polylactide acid or copolymers thereof to enhance anti-thrombogenicity, rapid endothelization or controlled material release,
- an adhesive or coagulant agent (106) that promote clotting, glueing or coagulation adhering an internal membrane (105a) into the tissue surface and repair the injury ,
- anchoring wires (107) made of shape memory and self-expandable alloys to hold the multi-layered implantable patch (105) steady,
- valve located in internal lumen (111 ) made of a flexible and soft polymer alloys to pulsative perfusion during the balloon inflation, two or more radiopaque marker bands (103) located in the side branch access parts of the implantable patch to monitor actual location of the implantable patch under fluoroscopy. In one embodiment of the invention, the implantable patch comprises a multilayered implantable patch (105) which comprises an internal membrane (105a) as the main patch made of a constant or bioabsorbable polymer, an external membrane (105b) as a bioabsorbable layer made of a constant or bioabsorbable layer and an intermediate layer (105c) between the internal membrane (105a) and adhesive or coagulant agent (106) and/or external membrane (105b) and adhesive or coagulant agent (106).
In one embodiment of the invention, the implantable patch comprises adhesive or coagulant agent (106) between the said multi-layered implantable patch (105) to promote clotting, adhesion or coagulant of the dissected, ruptured or damaged tissue. The external membrane (105b) contacts to dissected, ruptured or damaged tissue intended and the adhesive or coagulant agents (106) that promote clotting, adhesion or coagulation are released after the external membrane (105b) is burst by applied pressure arising the balloon inflation, temperature change, chemical reaction or any combination of these.
In one embodiment of the implantable patch, the internal membrane (105a) is adhered to the dissected, ruptured or damaged tissue surface through adhesive or coagulant agents (106) and closes the dissection, rupture or injury without any additional layers.
In one embodiment of the implantable patch, the adhesive or coagulant agent (106) is filled between the internal membrane (105a) and the intermediate membrane (105c) to provide controlled release where needed. After the external membrane (105b) is burst by pressure created on the external membrane (105b) surface, first the intermediate membrane (105c) fused into the external membrane (105b) holds the adhesive and coagulant agent to provide a controlled adhesive or coagulant agent release on the tissue intended. After the dissected, ruptured or damaged tissue is filled by adhesive and coagulant agent, the internal membrane contacts to the tissue intended to close it.
Another embodiment of the In one embodiment of the implantable patch comprises the adhesive or coagulant agent (106) between the external membrane (105b) and the intermediate membrane (105c) to enhance anti- thrombogenic process and rapid endothelization. After the external membrane (105b) is burst by pressure created on the external membrane (105b) surface, the adhesive or coagulant agent (106) is filled inside of the dissected, ruptured or damaged tissue and the intermediate membrane (105c) fused into the internal membrane (105a) holds the adhesive and coagulant agent to enhance anti- thrombogenic process and rapid endothelization. The internal membrane (105a) functions after the intermediate membrane (105c) contacts to the tissue increment of pressure applied to close the dissected, ruptured or damaged tissue permanently.
In one embodiment of the invention, the adhesive or coagulant agent (106) is filled inside of the cavities of the external membrane (105b). The external membrane (105b) filled with adhesive or coagulant agent (106) is covered/fused with internal membrane (105a) to create a multi-layered implantable patch (105).
In another embodiment of the invention, the implantable patch comprises an adhesive and coagulant agent (106) that is filled inside of the cavities of the intermediate layer (105c) fused with external membrane (105b) and covered/fused with internal membrane (105a) to create a multi-layered implantable patch (105). In another embodiment of the invention, the adhesive or coagulant agent (106) is filled inside of the cavities of the external membrane (105b) and covered/fused with an intermediate membrane (105c) combined to an internal membrane (105a) to create a multi-layered implantable patch (105).
The repair of a dissected, ruptured or injured vessels can be done by either the multi-layered implantable patch (105) only or the multi-layered implantable patch (105) containing adhesive and coagulant agents (106) that promote clotting, gluing or coagulation of the dissected, ruptured or damaged tissue between internal membrane (105a) and external membrane (105b).
In one embodiment of the invention, the implantable patch comprises an internal membrane (105b) made of a constant or bioabsorbable polymer such as PET, dacron, PTFE or pericardium patch which will be bonded/funded/absorbed to a constant or bioabsorbable polymer to create an external layer for housing agents that promote clotting, glueing and coagulation of the dissected, ruptured or damaged tissue.
One embodiment of the implantable patch includes anchoring wires (107) made of nitinol or similar materials to hold the double-layered membrane patch (105) steady.
One embodiment of the invention includes two or more radiopaque marker bands (103) located in side branch access parts corresponding to aortic branches to monitor actual location of the implantable patch.

Claims

CLAIMS An implantable patch for vascular injuries with a blood perfusion system which allows a continuous flow through a blood perfusion system during the treatment of the vascular injuries through an implantable patch, characterized by comprising;
- a multi-layered implantable patch (105) comprising of an internal membrane (105a), an external membrane (105b), an intermediate membrane (105c) and adhesive or coagulant agents (106) that promote clotting, gluing, coagulation between the internal membrane (105a),
- an external membrane (105b) which bursts/perforates/releases internal substance which is the adhesive or coagulant agents (106) that promote clotting, gluing or coagulation of the dissected, ruptured or damaged tissue made of a constant or bioabsorbable polymeric material which is chosen from polycaprolactone, polylactic acid or polylactic-co-glycolic acid which can be triggered with pressure, temperature change, chemical reaction or any combination of these,
- an internal membrane (105a) made of a constant or bioabsorbable polymer which is PET, dacron, PTFE or pericardium patch which will be bonded/funded/absorbed to an external membrane (105b) for housing the adhesive or coagulant agents (106),
- an intermediate membrane (105c) made of a bioabsorbable material to enhance anti-thrombogenicity, rapid endothelization or controlled material release, an adhesive or coagulant agent (106) that promote clotting, gluing or coagulation adhering an internal membrane (105a) into the tissue surface and repair the injury ,
- anchoring wires (107) made of shape memory and self-expandable alloys to hold the multi-layered implantable patch (105) steady,
- valve located in internal lumen (111) made of a flexible and soft polymer alloys to pulsative perfusion during the balloon inflation,
- two or more radiopaque marker bands (103) located in the side branch access parts of the implantable patch to monitor actual location of the implantable patch under fluoroscopy. An implantable patch for vascular injuries with a blood perfusion system according to Claim 1 , characterized by comprising anchoring wires (107) which hold the multi-layered implantable patch (105) during and after balloon inflation is performed and stabilize the multi-layered implantable patch (105) to the target tissue. An implantable patch for vascular injuries with a blood perfusion system according to Claim 1 , wherein adhesive or coagulant agents (106) that promote clotting, adhesion or coagulation can comprise different shape and sizes of vesicles or laminated layer to provide multi-layered implantable patch (105) adhesion into the intended tissue. An implantable patch for vascular injuries with a blood perfusion system according to Claim 1 , wherein an internal membrane (105a), external membrane (105b) and intermediate membrane (105c) as components of the multi-layered implantable patch (105) can made of same or different materials varying material thickness and mechanical properties. An implantable patch for vascular injuries with a blood perfusion system according to Claim 1 , characterized in that the bioabsorbable material wherein an intermediate membrane (105c) is made of is chosen from polycaprolactone, polylactide acid or copolymers thereof.
14
PCT/TR2021/051267 2021-11-22 2021-11-22 An implantable patch for vascular injuries with a blood perfusion system WO2023091098A1 (en)

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Application Number Priority Date Filing Date Title
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040024419A1 (en) * 1988-08-24 2004-02-05 Endoluminal Therapeutics, Inc. Biodegradable polymeric endoluminal sealing process, apparatus and polymeric products for use therein
US20040059406A1 (en) * 2002-09-20 2004-03-25 Cully Edward H. Medical device amenable to fenestration
EP1779816A2 (en) * 2005-11-01 2007-05-02 Nitinol Development Corporation Stent with thin drug-eluting film

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040024419A1 (en) * 1988-08-24 2004-02-05 Endoluminal Therapeutics, Inc. Biodegradable polymeric endoluminal sealing process, apparatus and polymeric products for use therein
US20040059406A1 (en) * 2002-09-20 2004-03-25 Cully Edward H. Medical device amenable to fenestration
EP1779816A2 (en) * 2005-11-01 2007-05-02 Nitinol Development Corporation Stent with thin drug-eluting film

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