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
  • A61F2/02—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
  • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
• • 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
  • A61F2/856—Single tubular stent with a side portal passage
• • 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
  • A61F2/0095—Packages or dispensers for prostheses or other implants

Definitions

• the invention relates to implantable medical devices known as DMI, and in particular such devices for creating vascular anastomoses through a prosthesis. Implantation of a prosthesis to form a vascular anastomosis is known for various medical indications.
• a known prosthetic structure for anastomosis includes a main tube with a sealed wall and a stent, and a secondary tube with a sealed wall.
• the secondary tube is connected to an intermediate position of the main tube, to form a branch with this main tube.
• the stent of the main tube of the prosthesis is unfolded, so that the main tube is wedged to the wall of the aorta and ensures blood circulation through it.
• the secondary tube is held outside the aorta.
• An aortic anastomosis is thus formed through the aortic orifice released by removal of the introducer. The implantation of such a prosthesis is possible without interrupting the aortic blood circulation during the procedure.
• WO2008 / 1 12270 discloses a vascular prosthesis for the formation of anasthomosis.
• a first tube comprises a sealed wall with a stent integral with the sealed wall.
• a lateral orifice is formed in the sealed wall.
• a second tube is fixed around the lateral orifice.
• a flow can be established through the second tube, thereby forming a bypass of the first tube at the side port.
• WO2007 / 047023 discloses a vascular prosthesis comprising a section which splits into two branches. The vascular prosthesis is kept compressed in a sleeve before use. Stents keep the openings of the prosthesis open after deployment.
• the invention aims to solve one or more of these disadvantages.
• the invention thus relates to a vascular prosthesis for forming an anastomosis, as defined in appended claim 1.
• the invention also relates to the subject of the appended dependent claims.
• the various features of the dependent claims may also be independently combined with the features of claim 1, without constituting an intermediate generalization.
• the invention also relates to a method as defined in the appended claims.
• FIG 1 is a perspective view of an example of prosthesis according to the invention after deployment of a bifurcation tube through an incision in a recipient vessel;
• FIG 2 is a perspective view of the prosthesis of Figure 1 after opening an end of the bifurcation tube;
• FIG. 3 is a perspective view of the prosthesis of FIG. 1 after connection of an external conduit to the bifurcation tube;
• FIGS. 4 and 5 are perspective views of steps of an exemplary method of manufacturing the prosthesis of FIG. 1;
• FIG. 6 is a longitudinal sectional view of the prosthesis at the stage of manufacture of FIG. 5;
• FIGS. 7 to 15 are perspective views of other steps of the manufacturing method of the prosthesis of FIG. 1;
• FIGS. 16 to 24 are perspective views of different stages of placement of the prosthesis of FIG. 1 and formation of an anastomosis;
• FIG. 25 diagrammatically illustrates an application of the aortic anastomosis for a left ventricular assist device
• FIG. 26 schematically illustrates an application of the anastomosis to the iliac artery for a renal transplant.
• the invention proposes a vascular prosthesis for the formation of an anastomosis, for a placement without interruption of the blood circulation of the recipient vessel and without bleeding, with a lower risk of injury to the recipient vessel.
• Anastomosis is a connection between two structures, organs or spaces, for example between blood vessels.
• Figure 1 is a perspective view of a vascular prosthesis 1 placed to form an anastomosis at a vessel 91.
• the prosthesis 1 has here been deployed at the level of the vessel 91.
• the prosthesis 1 comprises a main tube 2, here positioned to fit at least locally the inner wall of the vessel 91.
• the main tube 2 is intended to ensure the continuity of blood flow through the vessel 91 and prevent blood circulation to its periphery.
• the main tube 2 has first and second orifices 23 and 24 at its longitudinal ends.
• the prosthesis 1 further comprises a secondary tube 3.
• the secondary tube 3 has first and second ends 33 and 34.
• the secondary tube 3 is fixed to the main tube 2 in a sealed manner by its end 33 around a lateral orifice of this tube 2, detailed later.
• the secondary tube 3 and the main tube 2 thus communicate at this orifice.
• the end 34 of the secondary tube 3 is in a closed state, clogged or closed, that is to say forming a shutter.
• the end 34 of the secondary tube 3 is thus non-emergent and blocks any flow.
• the closed state of the end 34 is here made by sutures 35.
• a traction element 32 for example a wire, is fixed to the end 34 of the secondary tube 3.
• An incision 91 1 is here formed through a vessel wall 91.
• the incision 91 1 is traversed by the secondary tube 3.
• the main tube 2 guarantees the blood circulation through the vessel 91, and the closure of the secondary tube 3 prevents bleeding bypassing through the tube 3.
• the main tube 2 marries the vessel 91 so as to avoid blood circulation between them, and thus to prevent blood circulation through the orifice 91 1 at the periphery of the secondary tube 3.
• a clamp 71 (commonly referred to as a clamp) is placed on the secondary tube 3 to block blood flow through this tube 3.
• An opening 38 is provided at the end 34 of the tube 3. The opening 38 is for example made by cutting the secondary tube 3 at the end 34, or by removing the sutures 35.
• FIG. 3 a duct 92 (for example a vessel or a tube) is sealed to the secondary tube 3.
• the connection of the duct 92 is for example made by a suture 42 between the secondary tube 3 and the duct 92. Anastomosis between the conduits 91 and 92 is thus formed.
• the clip 71 is then removed to release the blood flow through the tube 3.
• a blood flow can then be established between the conduits 91 and 92.
• Figures 4 to 23 illustrate a method of manufacture and the structure of an exemplary vascular prosthesis 1 according to one embodiment of the invention.
• FIG. 4 there is a main tube 2 comprising a sealed wall 21.
• the sealed wall 21 forms a flow conduit between longitudinal orifices 23 and 24.
• a stent is integral with the sealed wall 21.
• the stent is here present inside the sealed wall 21, but can also be fixed outside this sealed wall 21.
• the stent may be secured to the sealed wall 21 by any appropriate means, for example by sutures.
• a lateral orifice 25 is formed in an intermediate position of the sealed wall 21.
• the lateral orifice 25 is for example positioned at a distance between 0.4 * L and 0.6 * L of said orifice 23, with L the length of the main tube 2.
• the lateral orifice 25 is advantageously positioned at a distance of at least 15 mm with respect to the orifices 23 and 24. Such a positioning of the lateral orifice 25 makes it possible to have optimal bearing surfaces for the main tube 2 on the inner wall of the vessel 91, on either side of this orifice 25.
• Figure 6 is a longitudinal sectional view of the main tube 2 at this stage of the manufacturing process.
• the stent 22 secured to the sealed wall 21 is visible here.
• the stent 22 comprises a plurality of rings distributed longitudinally between the orifices 23 and 24.
• the lateral orifice 25 is advantageously formed between two rings of the stent 22.
• radiopaque markers 26 are fixed around the lateral orifice 25, in order to allow the location of the lateral orifice 25 during the implantation of the prosthesis 1.
• the markers 26 have a structure known per se to allow their location by the practitioner.
• the markers 26 can be fixed to the leaktight wall 21 in a manner known per se by means of sutures.
• the markers 26 may also be attached to the impervious wall 21 at earlier or later stages of the manufacturing process.
• the end 33 of a secondary tube 3 is secured to the main tube 2.
• the secondary tube 3 is fixed to the main tube 2 in a sealed manner around or at the edge of the lateral orifice 25.
• the tubes 2 and 3 are then in communication via the lateral orifice 25.
• the closed tube 3 prevents blood flow therethrough.
• the attachment of the secondary tube 3 to the main tube 2 is here carried out by means of sutures 41, for example made of polypropylene monofilament and / or braided polyester.
• the sutures 41 may be provided at the edge of the lateral opening 25. Alternatively or alternatively to the markers 26, the sutures 41 may be radiopaque to promote the location of the lateral opening 25.
• the secondary tube 3 comprises a sealing wall 31 extending from the end 33 to a free end 34. An opening 39 is formed at the free end 34.
• the tube secondary 3 extends here in a direction perpendicular to the longitudinal axis of the main tube 2. Such an arrangement is preferred when the blood flow provided through the tube 2 is bidirectional, but this provision is also possible for a unidirectional blood circulation.
• the secondary tube 3 may however extend along an axis inclined relative to a perpendicular to the axis of the main tube 2, depending on the applications.
• Tubes 2 and 3 are cylindrical here, but it is also possible to envisage using tubes 2 and 3 having curved shapes at rest or after placement in the recipient vessel.
• a traction element 32 is fixed to the end 34 of the tube 3.
• the fixing of the traction element 32 can be carried out by any appropriate means, for example by means of sutures by means of a gluing.
• the traction element 32 may for example be in the form of a flexible wire.
• the traction element 32 is advantageously radiopaque or is integral with a radio-opaque component, to facilitate its location by the practitioner. Those skilled in the art will understand that the steps illustrated in Figures 8 to 10 can of course be easily reversed.
• the secondary tube 3 is introduced inside the main tube 2 through the lateral orifice 25.
• the tubes 2 and 3 then extend in the same direction.
• the traction element 32 has a length greater than that of the secondary tube 3, to allow its gripping from outside the main tube 2 in the illustrated configuration.
• a free end of the traction member 32 is projecting out of the main tube 2 through the lateral orifice 25, to allow subsequent gripping by the practitioner.
• the free end of the traction element 32 is here clearly visible and accessible through the lateral orifice 25.
• FIG. 12 illustrates a variant in which the secondary tube 3 is also introduced inside the main tube 2 through the lateral orifice 25 and in which the traction element 32 has a length greater than that of the secondary tube 3.
• the traction element 32 is secured to a border of the lateral orifice 25. This ensures that the end of the traction element 32 is always accessible by the practitioner at the lateral orifice 25.
• one end of the traction element 32 is for example fixed to the edge of the orifice 25 via a suture 43.
• the traction element 32 passes through the orifice 25 from side to side, which facilitates its grip by the practitioner.
• the traction element 32 passes through the orifice 25 along the longitudinal axis of the tube 2.
• the tube 3 is thus partially housed in the tube 2, which corresponds to the configuration of the prosthesis 1 prior to its introduction.
• the prosthesis 1 is then in a compact configuration in which the tube 3 is accessible, and in a perfectly defined position.
• the end 34 of the tube 3 protrudes out of the orifice 24. It can however be provided that the tube 3 remains inside the tube 2, set back with respect to the orifice 24.
• the prosthesis 1 is completed with components intended to allow it to be placed in the recipient vessel.
• a tube 6 is introduced into the tube 2 and passes through from one side. This tube 6 is open at its ends and is intended to allow the sliding of a guide wire.
• the tube 6 comprises in particular an orifice 61 near the orifice 24.
• a sleeve 5 also surrounds the tubes 2 and 3.
• the sleeve 5 holds the tube 2 in a retracted configuration.
• the stent 22 of the tube 2 is elastically deformed and kept compressed around the tube 6.
• the sleeve 5 is slidably mounted around the tube 2.
• the sleeve 5 extends for example over the entire length of the tube 6.
• the sleeve 5 has an opening 51 for allowing the passage of the guide wire.
• the sleeve 5 is intended to slide relative to the tube 2 to disengage.
• the prosthesis 1 may have a particularly small diameter, which allows its implementation without interrupting the blood flow through the recipient vessel.
• the prosthesis 1 provided with the sleeve 5 and the tube 6 is housed in a sealed package 8, sterile.
• a more rigid sleeve 5 and a tube 6 may be in a rectilinear shape, inside an elongated sealed package 8.
• the prosthesis 1 is then ready to be extracted from the package 8 to be positioned on a guide wire and on a delivery system or launcher not shown.
• Other variants of the method of manufacturing a prosthesis 1 according to the invention are of course conceivable.
• the wall 21 is typically formed of a sealed sleeve, for example example in woven polyester, or formed of PTFE.
• the wall 21 may be formed of a sealed sleeve of materials distributed under the trade references Dacron or GoreTex for example.
• the stent 22 may be made of a metal alloy such as that distributed under the trade name Nitinol or steel.
• the stent 22 can be self-expanding type.
• the stent 22, maintained initially compressed by a removable sleeve, can expand by the withdrawal (typically by sliding) of the removable sleeve as detailed later.
• the tube 2 typically has an inside diameter of between 6 and 35 mm, in the absence of stress on it (such as radial compression).
• the tube 2 may also typically have a length of between 60 and 200 mm.
• the wall 31 is typically formed of a waterproof sleeve, for example woven polyester, or formed of PTFE.
• the wall 31 may be formed of a sealed sleeve of materials distributed under the trade references Dacron or GoreTex for example.
• the tube 3 is advantageously devoid of a stent, in order to facilitate its deformation and its deployment through the lateral orifice 25 with reasonable efforts, and to prevent the positioning of the secondary tube 3 inside the tube 2 poses a problem for setting up a drop system.
• the tube 3 typically has an inside diameter of between 6 and 20 mm, in the absence of stress on it (such as radial compression).
• the tube 3 may also typically have a length of between 60 and 150 mm.
• the tube 3 has a lower section than the tube 2, and a shorter length than the tube 2.
• Figures 16 to 23 illustrate an example of formation of a vascular anastomosis through an example of prosthesis 1 according to the invention.
• the prosthesis 1 is initially extracted from the package 8 as illustrated in FIG. 15, then positioned on a delivery system.
• an introducer is positioned on the recipient vessel or another vessel connected thereto, away from the place where it is desired to perform the anastomosis.
• a relatively rigid guidewire is then introduced into the vessel via the introducer.
• the prosthesis 1 is then guided to the place of its introduction into the recipient vessel 91 via this guide wire.
• the prosthesis 1 can then be in a configuration as shown schematically in FIG. 16.
• the sleeve 5 here holds the prosthesis 1 in a retracted configuration, the tube 2 then being kept compressed. In this retracted configuration, the blood circulation is maintained.
• the sleeve 5 is slid with respect to the tube 6 and the tube 2, which gradually discovers the tube 2.
• a release system is known per se to be able to drive the sleeve 5 in sliding.
• the deployment of the prosthesis 1 in the recipient vessel 91 has been completed.
• the stent 22 of the tube 2 resiliently recalls the tube 2 to an expanded configuration, in which this tube 2 matches the inner wall of the vessel 91.
• the tube 2 then sufficiently marries the inner wall of the vessel 91 to prevent blood flow to the periphery of the tube 2.
• the practitioner has identified the position of the lateral orifice 25 and the traction element 32, through the radiopaque means. The practitioner then makes an incision 91 1 in the vessel 91, so as to discover the lateral orifice 25 and the traction element 32. Due to the deployment of the tube 2 and the closure of the tube 3, no blood flow can occur. 'intervenes through the incision 91 1. The tube 3 is still housed in the tube 2 at this stage, and thus protected.
• the practitioner grasps the traction element 32, has made it pass through the incision 91 1.
• the practitioner pulls on the end 34 of the tube 3.
• the practitioner then progressively exits the tube 3 through the orifice 25 and the incision 91 1.
• the tube 3 is then in the configuration of FIG. 19, in which its major part is projecting through the incision 91 1.
• the tube 3 is always closed at this stage.
• the practitioner has placed a clamp 71 on the tube 3, near the end 33 or at an intermediate position of the tube 3.
• the clamp guarantees an absence of blood flow through the tube 3.
• the practitioner removes the traction element 32 and cleans an opening 38 at the end 34. Due to the presence of the clamp 71, no blood circulation intervenes through the opening 38.
• the removal of the element 32 and the formation of the opening 38 are here made by cutting the tube 3 at the end 34.
• the removal of the element 32 and the formation of the opening 38 can also be made by removing the sutures 35 and 41 at the end 34.
• a conduit 92 is sealingly connected to the end 34 of the tube 3. This connection can be made in a manner known per se, for example by sutures 42 between the conduit 92 and the tube 3.
• the conduit 92 may be a synthetic conduit or other vessel, depending on medical applications. The conduit 92 and the tube 3 are now in communication.
• FIG 25 schematically illustrates a first medical application of the anastomosis implementing a vascular prosthesis 1 according to the invention.
• the anastomosis is here intended to connect the aorta 91 to an assistance device 93 implanted in the heart of the patient.
• the vascular implant 1 is thus put in place in the aorta, the tube 3 being protruding into the left thorax out of this aorta 91.
• the tube 3 is connected to a conduit 92 from the blood circulation aid 93.
• the vascular implant 1 can be placed in the descending thoracic aorta trans-femorally.
• the deployment of the tube 3 through the incision 91 1 is made through a left thoracotomy or thoracoscopy. .
• FIG 26 schematically illustrates a second medical application of the anastomosis implementing a vascular prosthesis 1 according to the invention.
• the anastomosis is here intended to connect an iliac artery 91 to a renal artery 94 of a renal graft 95 to be grafted.
• the diseased kidneys 96 of the patient are here illustrated on the aorta of the recipient.
• the kidney 95 is grafted here on the external iliac artery 91.

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

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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Citations (4)

• 2015
  • 2015-10-15 FR FR1559822A patent/FR3042403B1/fr active Active
• 2016
  • 2016-10-10 WO PCT/FR2016/052620 patent/WO2017064406A1/fr active Application Filing

Patent Citations (4)

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