WO2020131560A1 - Vascular shunt - Google Patents

Vascular shunt Download PDF

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Publication number
WO2020131560A1
WO2020131560A1 PCT/US2019/065931 US2019065931W WO2020131560A1 WO 2020131560 A1 WO2020131560 A1 WO 2020131560A1 US 2019065931 W US2019065931 W US 2019065931W WO 2020131560 A1 WO2020131560 A1 WO 2020131560A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
blood vessel
distal end
vascular graft
tube
Prior art date
Application number
PCT/US2019/065931
Other languages
French (fr)
Inventor
Ignacio RUA
Original Assignee
Baptist Health South Florida, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baptist Health South Florida, Inc. filed Critical Baptist Health South Florida, Inc.
Publication of WO2020131560A1 publication Critical patent/WO2020131560A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12036Type of occlusion partial occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069Sealing means

Definitions

  • This disclosure relates to a vascular shunt, and more particularly relates to a renal artery shunt.
  • AAA abdominal aortic aneurysms
  • a vascular perfusion apparatus includes a vascular graft and a plurality of balloon shunts fluidly coupled to the vascular graft.
  • the vascular graft extends from a proximal end to a distal end.
  • the graft defines a lumen extending from the proximal end to the distal end.
  • the proximal end is configured to be coupled to a source blood vessel by an anastomosis.
  • the plurality of balloon shunts are fluidly coupled to the distal end of the vascular graft.
  • Each shunt includes a tube that has a proximal end fixed relative to the distal end of the vascular graft, and has a distal end configured for insertion into a receiving blood vessel (e.g., via a small incision made in the blood vessel).
  • Each balloon shunt also includes a balloon surrounding the tube near the distal end of the tube, and an inflation tube extending from a valve to the balloon.
  • fluid such as saline, water, or air may be used to inflate the balloon via injection into the tube and to deflate the balloon by withdrawal of the fluid.
  • the balloon is configured for expansion to seal within and with the receiving blood vessel while permitting blood flow from the tube surrounded by the balloon into the blood vessel.
  • the vascular perfusion apparatus When surgically connected to a patient, the vascular perfusion apparatus allows for renal perfusion during cases that require suprarenal clamping, such as abdominal aortic aneurysms. This can allow a surgeon to protect the kidneys and decrease or eliminate post operative renal failure due to lack of blood supply during procedures.
  • the proximal ends of the tubes of the balloon shunt are integrally formed with the distal end of the vascular graft.
  • the vascular graft includes a cap that seals with the distal end of the vascular graft, and the cap is fluidly coupled to the proximal ends of the tubes.
  • the vascular graft is formed of one of polytetrafluoroethylene (PTFE) (e.g., Teflon®, E.I. du Pont de Nemours and Company, Wilmington, Delaware) and polyethylene terephthalate (PETE, also referred to as PET) (e.g., Dacron®, E.I. du Pont de Nemours and Company, Wilmington, Delaware).
  • PTFE polytetrafluoroethylene
  • PET polyethylene terephthalate
  • the balloon shunts are formed of one of PTFE and blood- compatible plastic (e.g., Silastic® plastic, Dow Coming Corporation, Midland, Michigan).
  • a length of the vascular shunt is between 60 cm and 80 cm
  • the diameters of the tubes of the balloon shunt are between 2mm and 3mm
  • the lengths of the tubes of the balloon shunts are between 5 cm and 6 cm, with the balloons covering about 1 ⁇ 2 cm to 1 cm of the length of the tubes at or near the end of the tubes.
  • a perfusion method includes providing a vascular perfusion apparatus, such as any of those embodiments described above, fluidly coupling the proximal end of the vascular graft to the source blood vessel by an anastomosis, and fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel.
  • fluidly coupling each distal end of the tube of the balloon shunts to a respective blood vessel includes forming an incision in each receiving blood vessel, introducing the distal end of the tube and the balloon into the incision, and inflating the balloon to expand the balloon against the interior wall of the blood vessel to seal the incision.
  • the method includes clamping the vascular graft prior to fluid coupling the proximal end of the vascular graft to the source blood vessel.
  • the method may further include unclamping the vascular graft after the proximal end of the vascular graft is coupled to the source blood vessel, and before fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel, to begin flowing blood from the source blood vessel through the vascular graft and the balloon shunts.
  • the method may include clamping the vascular graft to stop the flow of blood through the vascular graft and the balloon shunts after blood flows to the distal ends of the tubes.
  • the method may include unclamping the vascular graft after fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel to restart the flow of blood through the vascular apparatus.
  • a surgeon may wish to sequentially relocate the distal ends of the tube to perfuse other areas of the body. For example, after perfusion of the kidneys for a period of time, a surgeon may clamp the vascular graft to stop the flow of blood therethrough and then deflate the balloons by opening the inflation valves and withdrawing fluid from the balloons using a syringe and the tubing. Once the balloons are sufficiently deflated, the distal ends of the tubes and the balloons are withdrawn from the renal arteries through the incisions, which can then be surgically closed by any suitable means.
  • the surgeon may then form incisions in other receiving blood vessels, such as the superior mesenteric artery and/or celiac artery, in the same manner as described above, and the distal ends of the tubes and their corresponding balloons can be inserted through the incisions and inflated to seal with the other receiving blood vessels. Then, the vascular graft can be unclamped to restart blood flow through the apparatus into those arteries.
  • other receiving blood vessels such as the superior mesenteric artery and/or celiac artery
  • the vascular graft is clamped and the distal ends of the tube and the balloons are removed from the receiving blood vessels as described above, and any incisions therein are surgically closed. Then, the proximal end of the vascular graft may be disconnected from the source blood vessel by removing the anastomosis and surgically closing the incision in the source blood vessel.
  • FIG. 1 shows an embodiment of a vascular apparatus in accordance with an aspect of the disclosure.
  • FIG. 2 shows an alternative coupling between a vascular graft and tubular balloon shunts.
  • FIG. 3 shows another embodiment of a vascular apparatus.
  • Fig. 1 shows an embodiment of a vascular apparatus 100 in accordance with an aspect of the disclosure.
  • the term“source” refers to a blood vessel that is a source of blood to be transported
  • the term“recipient” or“receiving” refers to a blood vessel that receives the transported blood from the source.
  • “proximal” and“distal” refer to the direction of blood flow through the vascular apparatus, i.e., from a proximal location (e.g., proximal end) to a distal location (distal end).
  • the apparatus 100 includes a tubular vascular graft 102 and a plurality of tubular balloon shunts 104.
  • the vascular graft has a proximal end 102a and a distal end 102b, and defines an inner lumen 102c that extends from the proximal end 102a to the distal end 102b.
  • the balloon shunts 104 are fluidly coupled to the distal end 102b of the vascular graft 102. Although two balloon shunts 104 are shown in Fig. 1, it will be appreciated that more than two shunts 104 may be included.
  • the proximal end 102a of the vascular graft is configured to be connected to a source blood vessel 200, such as the aorta or axillary artery, by an anastomosis 202.
  • an incision 204 is made in the source blood vessel 200 and the proximal end 102a of the vascular graft 102 is placed in fluid communication with the source blood vessel 200 by connecting the proximal end 102a to the source blood vessel 200 with the anastomosis 202 around the incision site 204. Accordingly, blood from the source vessel 200 can be transported through the inner lumen 102c of the vascular graft 102 to the balloon shunts 104.
  • Each tubular balloon shunt 104 includes a tube 106 and an annular balloon 108 coupled to the tube 106.
  • Each tube 106 extends from a proximal end 106a to a distal end 106b.
  • Each tube 106 defines an inner lumen 106c that extends from the proximal end 106a to the distal end 106b of the tube 106.
  • the lumens 106c of the tubes 106 are in fluid communication with the lumen 102c of the vascular graft 102.
  • the lumens 106c are configured to carry blood from the proximal end 106a to the distal end 106b of the tubes 106.
  • the annular balloons 108 are located at or near the distal ends 106b of the tubes 106.
  • Each balloon 108 is expandable and is fluidly connected to a corresponding inflation syringe 110 by an inflation tube 112 and valve 114 for inflation and deflation of the balloon 108.
  • the syringe 110 may be filled with saline, water, or air, which can be introduced into the balloon 108 through the tubing 112 and the valve 114 to inflate the balloon 108 and expand it into the configuration of the balloon 108 shown in dotted lines in Fig. 1.
  • the syringe 110 can be used to withdraw fluid from the balloon 108 through the tubing 112 and the valve 114 to partially or fully deflate the balloon 108 and contract it into the configuration of the balloon 108 shown in thick solid lines in Fig. 1.
  • the distal ends 106b of the tubes 106 and the balloons 108 are configured to be introduced into and withdrawn from receiving blood vessels 300 through respective incisions 304 formed therein when the balloons 108 are sufficiently deflated. Once the distal ends 106b of the tubes 106 and the deflated balloons 108 are inside the receiving blood vessels 300, the balloons 108 can be inflated to expand against the inside of the receiving bloods vessel 300 to seal therewith. Blood from the source blood vessel 200 can be delivered into the receiving blood vessels 300 through the tubes 106 to perfuse targeted organs (e.g., kidneys) or tissues.
  • the distal ends 106b may be capped with a removable cap 116 to temporarily stop the flow of blood through the distal ends 106b.
  • the proximal ends 106a of the tubes 106 are fluidly connected in a fluid-tight manner to the distal end 102b of the vascular graft 102.
  • the proximal ends such as by molding or otherwise bonding them together as a unitary piece.
  • the proximal ends 106a of the tubes 106 may be fluidly coupled to an intermediate cap or plug 120 that is connected and sealed to the distal end 102b of the vascular graft 102.
  • the cap or plug 120 has openings or ports 122 that receive the proximal ends 106a of tubes 106.
  • the openings or ports 122 are sized such that they are fluid-tight with the tubes thereby facilitating blood flow from the lumen 102c of vascular graft 102 to and through the lumens 106c of tubes 106.
  • the cap or plug 120 may be formed from or coated with materials biocompatible with blood, such as any of those described hereinafter.
  • the vascular graft 102 and the balloon shunts 104 are formed of materials that are biocompatible with blood.
  • the vascular graft 102 is formed of a material suitable for anastomosis with a source blood vessel such as the aorta or axillary artery.
  • the vascular graft 102 may be formed of polytetrafluoroethylene (PTFE) (e.g., Teflon®, E.I. du Pont de Nemours and Company, Wilmington, Delaware) or polyethylene terephthalate (PETE, also referred to as PET) (e.g., Dacron®, E.I. du Pont de Nemours and Company, Wilmington, Delaware).
  • PTFE polytetrafluoroethylene
  • PET polyethylene terephthalate
  • PTFE is advantageous because it has relatively high tensile strength in comparison to the above-noted examples, and is mechanically tough. PET has similar mechanical properties to PTFE, but also can be heat shrunk.
  • the tubes 106 of the balloon shunts 104 may be formed of PTFE, polyurethane, or a blood-compatible plastic such as Silastic® (Dow Corning Corporation, Midland, Michigan).
  • the vascular graft 102 may have a length of between 60 cm and 80 cm, e.g., 70 centimeters, between the proximal end 102a and the distal end 102b.
  • each tube 106 of the balloon shunts 104 may have a length between 4 cm and 6 cm.
  • Each balloon 108 may have a length between 1 ⁇ 2 cm to 1 cm covering a corresponding tube 106 at or near its distal end 106b.
  • the outer diameter of the tubes 106 may be between 2 mm and 3 mm.
  • the inner diameter of the tubes 106 may be as large as possible without compromising wall integrity.
  • the outer diameter of vascular graft 102 may be between 7 mm and 8 mm, and the inner diameter of the graft 102 may be as large as possible without compromising wall integrity.
  • the transition of the vascular graft 102 to the tubes 106 of the balloon shunts 104 can be gradual, in the sense that that the graft or the balloon shunt tubes may taper to maintain laminar flow.
  • the apparatus 100 may be used as follows for perfusion of the kidneys. Initially the apparatus 100 is provided in a sterilized condition, free of any blood and the vascular graft 102 is clamped at a location between the proximal end 102a and the distal end 102b.
  • the incision 204 is formed in the source blood vessel 200 (e.g., aorta or axillary artery) and the proximal end 102a of the vascular graft 102 is placed in fluid communication with the incision 204.
  • the vascular graft 102 is connected to the source blood vessel 200 around the incision 204 by the anastomosis 202.
  • the vascular graft 102 can be unclamped to permit the introduction of blood from the source vessel 200 through the vascular graft 102 to remove any air trapped in vascular graft 102 or the tubes 106 of the balloon shunts 104.
  • the blood is allowed to flow to the distal ends 106b of the tubes 106 to remove any air trapped in the apparatus 100 before the distal ends 106b of the tubes 106 are inserted into the receiving blood vessels 300 (e.g., renal arteries).
  • the vascular graft 102 is clamped again to stop the flow of blood through the distal ends 106b.
  • the aforementioned removable caps 116 may be attached to the distal ends 106b to stop the flow of blood therefrom.
  • the incisions 304 can be formed in each renal artery 300, and the distal ends 106b of the tubes 106 and their corresponding deflated balloons 108 are introduced (after removing any cap 116 on the distal ends 106b) through the respective incisions 304 into the renal arteries 300.
  • the balloons 108 can then be inflated by introducing fluid from the syringes 110 through the inflation tubes 112 and valves 114 into the balloons 108 to expand the balloons 108 to seal the balloons 108 with and within the renal arteries 300. Once the balloons 108 are inflated, the inflation valves 114 can be closed to prevent deflation of the balloons 108. Then, the vascular graft 102 can be unclamped to restart blood flow through the apparatus 100 to perfuse the kidneys through the renal arteries 300.
  • a surgeon may wish to sequentially relocate the distal ends 106b to perfuse other areas of the body. For example, after perfusion of the kidneys for a period of time, a surgeon may clamp the vascular graft 102 to stop the flow of blood therethrough and then deflate the balloons 108 by opening the inflation valves 114 and withdrawing fluid from the balloons 108 using the syringe 110 and tubing 112. Once the balloons 108 are sufficiently deflated to fit through the incisions 304 in the renal arteries 300, the distal ends 106b of the tubes 106 and the balloons 108 are withdrawn from the renal arteries 300 through the incisions 304, which can then be surgically closed by any suitable means.
  • the surgeon may then form incisions in the superior mesenteric artery and/or the celiac artery in the same manner as described above for the renal arteries 300, and the distal ends 106b and balloons 108 can be inserted through the incisions and inflated to seal with the superior mesenteric artery and/or the celiac artery. Then, the vascular graft 102 can be unclamped to restart blood flow through the apparatus 100 into the superior mesenteric artery and/or the celiac artery. After the blood flows into the superior mesenteric artery and/or the celiac artery for a period of time, the surgeon can stop the flow of blood by clamping on the vascular graft 102.
  • the balloons 108 can be deflated prior to withdrawal of the distal ends 106b of the tubes 106 from the superior mesenteric artery and/or celiac artery, as described above for the renal arteries. Then the incisions that were formed in the superior mesenteric artery and/or celiac artery can be surgically closed by any suitable means. If used only for perfusion of the superior mesenteric artery, the above procedure for perfusion of the superior mesenteric artery can be repeated for the celiac artery. Moreover, the perfusion of one or more of the foregoing arteries can continue cyclically as needed to perfuse the various portions of the body.
  • the vascular graft 102 is clamped and the distal ends 106b of the tubes 106 and the balloons 108 are removed from the receiving blood vessels as described above, and any incisions therein are surgically closed. Then, the proximal end 102a of the vascular graft 102 may be disconnected from the source blood vessel 200 by removing the anastomosis 202 and surgically closing the incision 204 in the source blood vessel 200. Any remaining incisions in the receiving blood vessels which are still open are also surgically closed.
  • Apparatus 400 comprises a tubular vascular graft 402 having a proximal end 402a, a bifurcated distal end 402b with legs 403a and 403b, and an inner lumen 402c that extends from the proximal end 402a to the distal end 402b.
  • Leg 403a in turn is coupled to two tubular balloon shunts 404 which are fluidly coupled to the distal end of graft leg 403a.
  • two balloon shunts 404 are shown in Fig. 3, it will be appreciated that more than two shunts 404 may be included.
  • Each tubular balloon shunt 404 includes a tube 406 and an annular balloon 408 coupled to the tube 406.
  • Each tube 406 extends from a proximal end 406a to a distal end 406b.
  • Each tube 406 defines an inner lumen 406c that extends from the proximal end 406a to the distal end 406b of the tube 406.
  • the lumens 406c of the tubes 406 are in fluid communication with the lumen 402c of the vascular graft 402.
  • the lumens 406c are configured to carry blood from the proximal end 406a to the distal end 406b of the tubes 406.
  • leg 403b of graft 402 may be clamped or may be used by the surgeon as needed.
  • leg 403b may be sutured to a lower distal artery such as the left common iliac.
  • the vascular graft may have a length of between 40 cm and 120 cm, although in other embodiments other lengths may be utilized, and in certain embodiments a length of between 60 cm and 80 cm is preferred and/or critical.
  • the vascular graft may be formed of any material compatible with grafting onto a blood vessel, although in certain embodiments PTFE or PETE is preferred and/or critical.
  • the balloon shunts may have tubes having any diameter suitable for insertion into a receiving vessel, although in certain embodiments, tubes having diameters of between 2 mm and 3mm are preferred and/or critical.
  • the tubes of the balloon shunts may have a length of between 2 cm and 50 cm, although in other embodiments other lengths may be utilized, and in certain embodiments, balloon shunts with tubes having a length of between 4 cm and 6 cm are preferred and/or critical.
  • the apparatus with the vascular graft and the plurality of balloon shunts is used to provide blood to any organ whose blood supply is shut off or reduced due to clamping of any artery, although in certain embodiments the coupling of the graft of the apparatus to the aorta or axillary artery and the insertion of the tubes of the balloon shunts of the apparatus into the renal, superior mesenteric, or celiac arteries is preferred and/or critical.

Abstract

A vascular apparatus includes a vascular graft and a plurality of balloon shunts. The vascular graft includes proximal and distal ends and defines a lumen. The proximal end of the graft is configured to be coupled to a source blood vessel by an anastomosis. The balloon shunts are fluidly coupled to the lumen at the distal end of the vascular graft. Each shunt includes a tube having a proximal end fixed to the distal end of the vascular graft and having a distal end configured for insertion into a receiving blood vessel, and a balloon surrounding the tube at or near the distal end of the tube. The balloons are expand to seal with the receiving blood vessel. When surgically placed, the apparatus carries blood from the source blood vessel such as the aorta or axillary artery to the receiving blood vessels such as the renal arteries.

Description

VASCULAR SHUNT
BACKGROUND
1. Field
[0001] This disclosure relates to a vascular shunt, and more particularly relates to a renal artery shunt.
2. State of the Art
[0002] One method of surgical repair for abdominal aortic aneurysms (AAA) involves open access to the aorta, the application of vascular clamps, and the replacement of the aneurysmal segment by a synthetic graft. The synthetic graft is typically made from Dacron®
(polyethylene terephthalate - PETE) and is sutured into place. Clamps are commonly required to place the graft and may impede renal blood flow during the procedure if the aneurysm is situated above or at the level of the renal arteries.
[0003] Suprarenal clamping in abdominal aortic surgery is associated with a significant risk of post-operative renal failure, general morbidity, and mortality. Post-operative renal failure is common following aortic aneurysm surgery and is associated with a poor clinical outcome. In addition, pre-existing renal failure and renal artery stenosis due to aortic atheroma may increase the incidence of renal failure associated with open surgical repair.
SUMMARY
[0004] According to one aspect of the disclosure, further details of which are described herein, a vascular perfusion apparatus includes a vascular graft and a plurality of balloon shunts fluidly coupled to the vascular graft. The vascular graft extends from a proximal end to a distal end. The graft defines a lumen extending from the proximal end to the distal end. The proximal end is configured to be coupled to a source blood vessel by an anastomosis.
[0005] The plurality of balloon shunts are fluidly coupled to the distal end of the vascular graft. Each shunt includes a tube that has a proximal end fixed relative to the distal end of the vascular graft, and has a distal end configured for insertion into a receiving blood vessel (e.g., via a small incision made in the blood vessel). Each balloon shunt also includes a balloon surrounding the tube near the distal end of the tube, and an inflation tube extending from a valve to the balloon. In this manner, fluid such as saline, water, or air may be used to inflate the balloon via injection into the tube and to deflate the balloon by withdrawal of the fluid. The balloon is configured for expansion to seal within and with the receiving blood vessel while permitting blood flow from the tube surrounded by the balloon into the blood vessel.
[0006] When surgically connected to a patient, the vascular perfusion apparatus allows for renal perfusion during cases that require suprarenal clamping, such as abdominal aortic aneurysms. This can allow a surgeon to protect the kidneys and decrease or eliminate post operative renal failure due to lack of blood supply during procedures.
[0007] In embodiments, the proximal ends of the tubes of the balloon shunt are integrally formed with the distal end of the vascular graft. Also, in embodiments, the vascular graft includes a cap that seals with the distal end of the vascular graft, and the cap is fluidly coupled to the proximal ends of the tubes.
[0008] In embodiments, the vascular graft is formed of one of polytetrafluoroethylene (PTFE) (e.g., Teflon®, E.I. du Pont de Nemours and Company, Wilmington, Delaware) and polyethylene terephthalate (PETE, also referred to as PET) (e.g., Dacron®, E.I. du Pont de Nemours and Company, Wilmington, Delaware).
[0009] Also, in embodiments, the balloon shunts are formed of one of PTFE and blood- compatible plastic (e.g., Silastic® plastic, Dow Coming Corporation, Midland, Michigan). In embodiments, a length of the vascular shunt is between 60 cm and 80 cm, the diameters of the tubes of the balloon shunt are between 2mm and 3mm, and the lengths of the tubes of the balloon shunts are between 5 cm and 6 cm, with the balloons covering about ½ cm to 1 cm of the length of the tubes at or near the end of the tubes.
[0010] According to another aspect of the disclosure, a perfusion method includes providing a vascular perfusion apparatus, such as any of those embodiments described above, fluidly coupling the proximal end of the vascular graft to the source blood vessel by an anastomosis, and fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel. [0011] In embodiments, fluidly coupling each distal end of the tube of the balloon shunts to a respective blood vessel includes forming an incision in each receiving blood vessel, introducing the distal end of the tube and the balloon into the incision, and inflating the balloon to expand the balloon against the interior wall of the blood vessel to seal the incision.
[0012] Also, in embodiments, the method includes clamping the vascular graft prior to fluid coupling the proximal end of the vascular graft to the source blood vessel. The method may further include unclamping the vascular graft after the proximal end of the vascular graft is coupled to the source blood vessel, and before fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel, to begin flowing blood from the source blood vessel through the vascular graft and the balloon shunts. In addition, the method may include clamping the vascular graft to stop the flow of blood through the vascular graft and the balloon shunts after blood flows to the distal ends of the tubes. Also, the method may include unclamping the vascular graft after fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel to restart the flow of blood through the vascular apparatus.
[0013] After the one organ is perfused, a surgeon may wish to sequentially relocate the distal ends of the tube to perfuse other areas of the body. For example, after perfusion of the kidneys for a period of time, a surgeon may clamp the vascular graft to stop the flow of blood therethrough and then deflate the balloons by opening the inflation valves and withdrawing fluid from the balloons using a syringe and the tubing. Once the balloons are sufficiently deflated, the distal ends of the tubes and the balloons are withdrawn from the renal arteries through the incisions, which can then be surgically closed by any suitable means.
[0014] The surgeon may then form incisions in other receiving blood vessels, such as the superior mesenteric artery and/or celiac artery, in the same manner as described above, and the distal ends of the tubes and their corresponding balloons can be inserted through the incisions and inflated to seal with the other receiving blood vessels. Then, the vascular graft can be unclamped to restart blood flow through the apparatus into those arteries.
[0015] When the surgeon is finished using the vascular apparatus, the vascular graft is clamped and the distal ends of the tube and the balloons are removed from the receiving blood vessels as described above, and any incisions therein are surgically closed. Then, the proximal end of the vascular graft may be disconnected from the source blood vessel by removing the anastomosis and surgically closing the incision in the source blood vessel.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Fig. 1 shows an embodiment of a vascular apparatus in accordance with an aspect of the disclosure.
[0017] Fig. 2 shows an alternative coupling between a vascular graft and tubular balloon shunts.
[0018] Fig. 3 shows another embodiment of a vascular apparatus.
DETAILED DESCRIPTION
[0019] Fig. 1 shows an embodiment of a vascular apparatus 100 in accordance with an aspect of the disclosure. As used herein, the term“source” refers to a blood vessel that is a source of blood to be transported, and the term“recipient” or“receiving” refers to a blood vessel that receives the transported blood from the source. Also, as used herein,“proximal” and“distal” refer to the direction of blood flow through the vascular apparatus, i.e., from a proximal location (e.g., proximal end) to a distal location (distal end).
[0020] The apparatus 100 includes a tubular vascular graft 102 and a plurality of tubular balloon shunts 104. The vascular graft has a proximal end 102a and a distal end 102b, and defines an inner lumen 102c that extends from the proximal end 102a to the distal end 102b.
The balloon shunts 104 are fluidly coupled to the distal end 102b of the vascular graft 102. Although two balloon shunts 104 are shown in Fig. 1, it will be appreciated that more than two shunts 104 may be included.
[0021] The proximal end 102a of the vascular graft is configured to be connected to a source blood vessel 200, such as the aorta or axillary artery, by an anastomosis 202.
Specifically, as shown in Fig. 1, an incision 204 is made in the source blood vessel 200 and the proximal end 102a of the vascular graft 102 is placed in fluid communication with the source blood vessel 200 by connecting the proximal end 102a to the source blood vessel 200 with the anastomosis 202 around the incision site 204. Accordingly, blood from the source vessel 200 can be transported through the inner lumen 102c of the vascular graft 102 to the balloon shunts 104.
[0022] Each tubular balloon shunt 104 includes a tube 106 and an annular balloon 108 coupled to the tube 106. Each tube 106 extends from a proximal end 106a to a distal end 106b. Each tube 106 defines an inner lumen 106c that extends from the proximal end 106a to the distal end 106b of the tube 106. The lumens 106c of the tubes 106 are in fluid communication with the lumen 102c of the vascular graft 102. The lumens 106c are configured to carry blood from the proximal end 106a to the distal end 106b of the tubes 106.
[0023] The annular balloons 108 (shown in Fig. 1 in a deflated condition in solid lines, and in an inflated condition in dotted lines) are located at or near the distal ends 106b of the tubes 106. Each balloon 108 is expandable and is fluidly connected to a corresponding inflation syringe 110 by an inflation tube 112 and valve 114 for inflation and deflation of the balloon 108. The syringe 110 may be filled with saline, water, or air, which can be introduced into the balloon 108 through the tubing 112 and the valve 114 to inflate the balloon 108 and expand it into the configuration of the balloon 108 shown in dotted lines in Fig. 1. Alternatively, the syringe 110 can be used to withdraw fluid from the balloon 108 through the tubing 112 and the valve 114 to partially or fully deflate the balloon 108 and contract it into the configuration of the balloon 108 shown in thick solid lines in Fig. 1.
[0024] The distal ends 106b of the tubes 106 and the balloons 108 are configured to be introduced into and withdrawn from receiving blood vessels 300 through respective incisions 304 formed therein when the balloons 108 are sufficiently deflated. Once the distal ends 106b of the tubes 106 and the deflated balloons 108 are inside the receiving blood vessels 300, the balloons 108 can be inflated to expand against the inside of the receiving bloods vessel 300 to seal therewith. Blood from the source blood vessel 200 can be delivered into the receiving blood vessels 300 through the tubes 106 to perfuse targeted organs (e.g., kidneys) or tissues. The distal ends 106b may be capped with a removable cap 116 to temporarily stop the flow of blood through the distal ends 106b.
[0025] The proximal ends 106a of the tubes 106 are fluidly connected in a fluid-tight manner to the distal end 102b of the vascular graft 102. In embodiments, the proximal ends such as by molding or otherwise bonding them together as a unitary piece. Alternatively, as shown in Fig. 2, the proximal ends 106a of the tubes 106 may be fluidly coupled to an intermediate cap or plug 120 that is connected and sealed to the distal end 102b of the vascular graft 102. The cap or plug 120 has openings or ports 122 that receive the proximal ends 106a of tubes 106. The openings or ports 122 are sized such that they are fluid-tight with the tubes thereby facilitating blood flow from the lumen 102c of vascular graft 102 to and through the lumens 106c of tubes 106. The cap or plug 120 may be formed from or coated with materials biocompatible with blood, such as any of those described hereinafter.
[0026] The vascular graft 102 and the balloon shunts 104 are formed of materials that are biocompatible with blood. In addition, the vascular graft 102 is formed of a material suitable for anastomosis with a source blood vessel such as the aorta or axillary artery. Thus, the vascular graft 102 may be formed of polytetrafluoroethylene (PTFE) (e.g., Teflon®, E.I. du Pont de Nemours and Company, Wilmington, Delaware) or polyethylene terephthalate (PETE, also referred to as PET) (e.g., Dacron®, E.I. du Pont de Nemours and Company, Wilmington, Delaware). PTFE is advantageous because it has relatively high tensile strength in comparison to the above-noted examples, and is mechanically tough. PET has similar mechanical properties to PTFE, but also can be heat shrunk. The tubes 106 of the balloon shunts 104 may be formed of PTFE, polyurethane, or a blood-compatible plastic such as Silastic® (Dow Corning Corporation, Midland, Michigan).
[0027] According to embodiments, the vascular graft 102 may have a length of between 60 cm and 80 cm, e.g., 70 centimeters, between the proximal end 102a and the distal end 102b. Also, each tube 106 of the balloon shunts 104 may have a length between 4 cm and 6 cm. Each balloon 108 may have a length between ½ cm to 1 cm covering a corresponding tube 106 at or near its distal end 106b. The outer diameter of the tubes 106 may be between 2 mm and 3 mm. The inner diameter of the tubes 106 may be as large as possible without compromising wall integrity. The outer diameter of vascular graft 102 may be between 7 mm and 8 mm, and the inner diameter of the graft 102 may be as large as possible without compromising wall integrity.
[0028] According to embodiments, the transition of the vascular graft 102 to the tubes 106 of the balloon shunts 104 can be gradual, in the sense that that the graft or the balloon shunt tubes may taper to maintain laminar flow.
[0029] The apparatus 100 may be used as follows for perfusion of the kidneys. Initially the apparatus 100 is provided in a sterilized condition, free of any blood and the vascular graft 102 is clamped at a location between the proximal end 102a and the distal end 102b. The incision 204 is formed in the source blood vessel 200 (e.g., aorta or axillary artery) and the proximal end 102a of the vascular graft 102 is placed in fluid communication with the incision 204. The vascular graft 102 is connected to the source blood vessel 200 around the incision 204 by the anastomosis 202. The vascular graft 102 can be unclamped to permit the introduction of blood from the source vessel 200 through the vascular graft 102 to remove any air trapped in vascular graft 102 or the tubes 106 of the balloon shunts 104. The blood is allowed to flow to the distal ends 106b of the tubes 106 to remove any air trapped in the apparatus 100 before the distal ends 106b of the tubes 106 are inserted into the receiving blood vessels 300 (e.g., renal arteries).
Once the blood flows at least to the distal ends 106b, the vascular graft 102 is clamped again to stop the flow of blood through the distal ends 106b. Alternatively, the aforementioned removable caps 116 may be attached to the distal ends 106b to stop the flow of blood therefrom. Then, the incisions 304 can be formed in each renal artery 300, and the distal ends 106b of the tubes 106 and their corresponding deflated balloons 108 are introduced (after removing any cap 116 on the distal ends 106b) through the respective incisions 304 into the renal arteries 300. The balloons 108 can then be inflated by introducing fluid from the syringes 110 through the inflation tubes 112 and valves 114 into the balloons 108 to expand the balloons 108 to seal the balloons 108 with and within the renal arteries 300. Once the balloons 108 are inflated, the inflation valves 114 can be closed to prevent deflation of the balloons 108. Then, the vascular graft 102 can be unclamped to restart blood flow through the apparatus 100 to perfuse the kidneys through the renal arteries 300.
[0030] At some time during the surgery, a surgeon may wish to sequentially relocate the distal ends 106b to perfuse other areas of the body. For example, after perfusion of the kidneys for a period of time, a surgeon may clamp the vascular graft 102 to stop the flow of blood therethrough and then deflate the balloons 108 by opening the inflation valves 114 and withdrawing fluid from the balloons 108 using the syringe 110 and tubing 112. Once the balloons 108 are sufficiently deflated to fit through the incisions 304 in the renal arteries 300, the distal ends 106b of the tubes 106 and the balloons 108 are withdrawn from the renal arteries 300 through the incisions 304, which can then be surgically closed by any suitable means.
[0031] The surgeon may then form incisions in the superior mesenteric artery and/or the celiac artery in the same manner as described above for the renal arteries 300, and the distal ends 106b and balloons 108 can be inserted through the incisions and inflated to seal with the superior mesenteric artery and/or the celiac artery. Then, the vascular graft 102 can be unclamped to restart blood flow through the apparatus 100 into the superior mesenteric artery and/or the celiac artery. After the blood flows into the superior mesenteric artery and/or the celiac artery for a period of time, the surgeon can stop the flow of blood by clamping on the vascular graft 102. The balloons 108 can be deflated prior to withdrawal of the distal ends 106b of the tubes 106 from the superior mesenteric artery and/or celiac artery, as described above for the renal arteries. Then the incisions that were formed in the superior mesenteric artery and/or celiac artery can be surgically closed by any suitable means. If used only for perfusion of the superior mesenteric artery, the above procedure for perfusion of the superior mesenteric artery can be repeated for the celiac artery. Moreover, the perfusion of one or more of the foregoing arteries can continue cyclically as needed to perfuse the various portions of the body.
[0032] When the surgeon is finished using the vascular apparatus 100, the vascular graft 102 is clamped and the distal ends 106b of the tubes 106 and the balloons 108 are removed from the receiving blood vessels as described above, and any incisions therein are surgically closed. Then, the proximal end 102a of the vascular graft 102 may be disconnected from the source blood vessel 200 by removing the anastomosis 202 and surgically closing the incision 204 in the source blood vessel 200. Any remaining incisions in the receiving blood vessels which are still open are also surgically closed.
[0033] Turning to Fig. 3, another vascular apparatus 400 is seen. Apparatus 400 comprises a tubular vascular graft 402 having a proximal end 402a, a bifurcated distal end 402b with legs 403a and 403b, and an inner lumen 402c that extends from the proximal end 402a to the distal end 402b. Leg 403a in turn is coupled to two tubular balloon shunts 404 which are fluidly coupled to the distal end of graft leg 403a. Although two balloon shunts 404 are shown in Fig. 3, it will be appreciated that more than two shunts 404 may be included. Each tubular balloon shunt 404 includes a tube 406 and an annular balloon 408 coupled to the tube 406. Each tube 406 extends from a proximal end 406a to a distal end 406b. Each tube 406 defines an inner lumen 406c that extends from the proximal end 406a to the distal end 406b of the tube 406.
The lumens 406c of the tubes 406 are in fluid communication with the lumen 402c of the vascular graft 402. The lumens 406c are configured to carry blood from the proximal end 406a to the distal end 406b of the tubes 406.
[0034] It will be appreciated that leg 403b of graft 402 may be clamped or may be used by the surgeon as needed. For example, leg 403b may be sutured to a lower distal artery such as the left common iliac.
[0035] In embodiments, the vascular graft may have a length of between 40 cm and 120 cm, although in other embodiments other lengths may be utilized, and in certain embodiments a length of between 60 cm and 80 cm is preferred and/or critical. In embodiments, the vascular graft may be formed of any material compatible with grafting onto a blood vessel, although in certain embodiments PTFE or PETE is preferred and/or critical. In embodiments, the balloon shunts may have tubes having any diameter suitable for insertion into a receiving vessel, although in certain embodiments, tubes having diameters of between 2 mm and 3mm are preferred and/or critical. In embodiments, the tubes of the balloon shunts may have a length of between 2 cm and 50 cm, although in other embodiments other lengths may be utilized, and in certain embodiments, balloon shunts with tubes having a length of between 4 cm and 6 cm are preferred and/or critical. In embodiments, the apparatus with the vascular graft and the plurality of balloon shunts is used to provide blood to any organ whose blood supply is shut off or reduced due to clamping of any artery, although in certain embodiments the coupling of the graft of the apparatus to the aorta or axillary artery and the insertion of the tubes of the balloon shunts of the apparatus into the renal, superior mesenteric, or celiac arteries is preferred and/or critical.
[0036] There have been described and illustrated herein several embodiments of a vascular apparatus and a method of use. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular types of biocompatible materials have been disclosed, it will be understood that other suitable biocompatible materials can be used. Moreover, while particular configurations have been disclosed that have two balloon shunts, it will be appreciated that other embodiments may include more than two balloon shunts, which may permit the simultaneous perfusion of the renal arteries, the superior mesenteric artery, and the celiac artery, for example. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims

WHAT IS CLAIMED IS:
1. A vascular perfusion apparatus comprising:
a vascular graft formed of one of PTFE and PETE extending from a proximal end to a distal end, the graft defining a lumen extending from the proximal end to the distal end, the proximal end configured to be coupled to a source blood vessel by an anastomosis, wherein a length of the vascular shunt is between 60 and 80 cm; and
a plurality of balloon shunts formed of one of PTFE and a blood-compatible plastic fluidly coupled to the distal end of the vascular graft, each shunt including a tube having a proximal end fixed to the distal end of the vascular graft and having a distal end configured for insertion into a receiving blood vessel, each shunt including a balloon surrounding the tube near or at the distal end of the tube, the balloon configured for expansion to seal with the receiving blood vessel, wherein the diameters of the tubes of the balloon shunts are between 2 mm and 3 mm.
2. The apparatus according to claim 1, wherein:
the proximal ends of the tubes are integrally formed with the distal end of the vascular graft.
3. The apparatus according to claim 1, wherein:
the vascular graft is coupled to the proximal ends of the tubes via an intermediate cap that seals the distal end of the vascular graft.
4. The apparatus according to claim 1, further comprising:
for each of said plurality of balloon shunts, an inflation tube fluidly coupled to the balloon, and a syringe configured to introduce or withdraw fluid via the inflation tube to or from the balloon to respectively inflate or deflate the balloon.
5. The apparatus according to claim 1, wherein:
the lengths of the tubes of the balloon shunts are between 4 cm and 6 cm.
6. A perfusion method comprising:
(a) providing a vascular perfusion apparatus comprising:
(1) a vascular graft formed of one of PTFE and PETE extending from a proximal end to a distal end, the graft defining a lumen extending from the proximal end to the distal end, the proximal end configured to be coupled to a source blood vessel by an anastomosis, wherein a length of the vascular shunt is between 60 and 80 cm; and
(2) a plurality of balloon shunts formed of one of PTFE and blood-compatible plastic fluidly coupled to the distal end of the vascular graft, each shunt including a tube having a proximal end fixed to the distal end of the vascular graft and having a distal end configured for insertion into a receiving blood vessel, each shunt including a balloon surrounding the tube near or at the distal end of the tube, the balloon configured for expansion to seal with the receiving blood vessel, wherein the diameter of the tubes of the balloon shunts are between 2 mm and 3 mm;
(b) fluidly coupling the proximal end of the vascular graft to the source blood vessel by an anastomosis; and
(c) fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel by forming an incision in each respective receiving blood vessel, introducing the distal end of the tube and the balloon into the incision, and inflating the balloon to expand the balloon against the interior wall of the blood vessel to seal the incision.
7. The method according to claim 6, further comprising:
clamping the vascular graft prior to fluid coupling the proximal end of the vascular graft to the source blood vessel.
8. The method according to claim 7, further comprising:
unclamping the vascular graft after the proximal end of the vascular graft is coupled to the source blood vessel, and before fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel, to begin flowing blood from the source blood vessel through the vascular graft and the balloon shunts; and
after blood flows to the distal ends of the tubes, clamping the vascular graft to stop the flow of blood through the vascular graft and the balloon shunts.
9. The method according to claim 8, further comprising:
unclamping the vascular graft after fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel to permit blood from the source blood vessel through distal end of the balloon shunt into the receiving blood vessel.
10. The method according to claim 9, further comprising:
removing the distal end of the balloon shunt from the receiving blood vessel by:
clamping the vascular shunt to stop the flow of blood therethrough, deflating the balloon by withdrawing fluid from the balloon, and when the balloon is sufficiently deflated to fit through the incision in the receiving blood vessel, withdrawing the balloon and the distal end of the balloon shunt from the receiving blood vessel.
11. The method according to claim 10, further comprising:
after said withdrawing, forming an incision in another receiving blood vessel, moving the distal end of at least one of said plurality of balloon shunts to said another receiving blood vessel introducing the distal end of the tube and the balloon of the said at least one of said plurality of balloon shunts into the incision in the another receiving blood vessel, inflating the balloon of the at least one of said plurality of balloon shunts in the another receiving blood vessel to expand the balloon against the interior wall of the another receiving blood vessel to seal the incision in the another receiving blood vessel, and permitting blood to flow from source blood vessel into said another receiving blood vessel.
12. The method according to claim 6, wherein said respective receiving blood vessels are renal arteries, and said source blood vessel is an aorta or axillary artery.
13. The method of claim 12, wherein said respective receiving blood vessels are renal arteries, said source blood vessel is an aorta or axillary artery, and said another receiving blood vessel is at least one of a superior mesenteric artery and a celiac artery.
14. A vascular perfusion apparatus comprising:
a vascular graft having a proximal end and a distal end and defining a lumen extending from the proximal end to the distal end, the vascular graft made of a material compatible for coupling to a source blood vessel, and the proximal end configured to be coupled to a source blood vessel by an anastomosis; and
a plurality of balloon shunts formed of a blood-compatible material fluidly coupled to the distal end of the vascular graft, each shunt including a tube having a proximal end fixed to the distal end of the vascular graft and having a distal end configured for insertion into a receiving blood vessel, each shunt including a balloon surrounding the tube near or at the distal end of the tube, the balloon configured for expansion to seal with the receiving blood vessel.
15. A method, comprising:
(a) providing a vascular perfusion apparatus comprising
(1) a vascular graft having a proximal end and a distal end and defining a lumen extending from the proximal end to the distal end, the vascular graft made of a material compatible for coupling to a source blood vessel, and the proximal end configured to be coupled to a source blood vessel by an anastomosis, and
(2) a plurality of balloon shunts formed of a blood-compatible material fluidly coupled to the distal end of the vascular graft, each shunt including a tube having a proximal end fixed to the distal end of the vascular graft and having a distal end configured for insertion into a receiving blood vessel, each shunt including a balloon surrounding the tube near or at the distal end of the tube, the balloon configured for expansion to seal with the receiving blood vessel;
(b) fluidly coupling the proximal end of the vascular graft to the source blood vessel by an anastomosis; and
(c) fluidly coupling each distal end of the tube of the balloon shunts to a respective receiving blood vessel by forming an incision in each respective receiving blood vessel, introducing the distal end of the tube and the balloon into the incision, and inflating the balloon to expand the balloon against the interior wall of the blood vessel to seal the incision.
PCT/US2019/065931 2018-12-17 2019-12-12 Vascular shunt WO2020131560A1 (en)

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