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WO2015190928A1 - Prothèse vasculaire et procédé - Google Patents

Prothèse vasculaire et procédé Download PDF

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Publication number
WO2015190928A1
WO2015190928A1 PCT/NL2015/050433 NL2015050433W WO2015190928A1 WO 2015190928 A1 WO2015190928 A1 WO 2015190928A1 NL 2015050433 W NL2015050433 W NL 2015050433W WO 2015190928 A1 WO2015190928 A1 WO 2015190928A1
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WO
WIPO (PCT)
Prior art keywords
prosthesis
blood vessel
outer end
placing device
bypass
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/NL2015/050433
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English (en)
Inventor
Adri Marinus Blomme
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2015190928A1 publication Critical patent/WO2015190928A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/02—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
    • A61F2002/065—Y-shaped blood vessels

Definitions

  • the present invention relates to a vascular prosthesis system for intraluminal connection of a vascular prosthesis in a blood vessel of the human or animal body, comprising:
  • vascular prosthesis comprises an at least substantially tubular prosthesis body provided at an outer end with suturing means, which suturing means comprise at least one suturing member for an intraluminal anchoring in a vessel wall of the blood vessel, wherein at least the outer end of the prosthesis body of the vascular prosthesis is deformable from an at least partially compressed first state, in which the vascular prosthesis is introduced into the blood vessel, and a radially expanded second state in which at least one suturing member extends radially therefrom and penetrates the vessel wall;
  • a fixation body provided externally of the vessel wall for the purpose, in the expanded second state of the outer end of the prosthesis body of the vascular prosthesis, of receiving and fixing therein a free outer end of the at least one suturing member;
  • a introducing system for introducing the vascular prosthesis with at least the outer end intraluminally into the blood vessel, which introducing system is able and configured to bring at least the outer end of the prosthesis body from an at least partially compressed first state to the expanded second state and therein force the at least one suturing member into the fixation body.
  • Such a system can be applied for treatment of vascular disorders of varying nature, particularly in the peripheral blood vessels of the human body.
  • a very common treatment is for instance the treatment of an abdominal aortic aneurysm. This is a local widening of the blood vessel which manifests itself as a blood-filled swelling or bulge and which is the result of a degenerative development of the vessel wall. In order to prevent spontaneous rupture of such an AAA-aneurysm it has to be treated as early as possible.
  • a CT scan with contrast shows exactly what the arterial tree around the aorta looks like. This also determines whether an operation will take place laparotomically, via an opened abdominal cavity, or endovascularly, from the vessels after approach in the femoral artery.
  • aortic bifurcation prosthesis also referred to as aortic bifurcation graft
  • aortic bifurcation graft or a made-to-measure endoprosthesis such as an endovascular stent/graft.
  • This latter procedure is also referred to as EVAR; Endovascular Aneurysm Repair.
  • a vascular prosthesis is introduced intraluminally in the form of a prosthesis body, opposite outer ends of which connect respectively upstream and downstream of the aneurysm to as still healthy parts of the blood vessel. Particularly upstream this connection has to be leak-tight.
  • European patent application EP 1.075.231 proposes a vascular prosthesis system which at least significantly obviates the above stated drawbacks of both the endovascular (EVAR) and the classical treatment.
  • This known vascular prosthesis comprises a prosthesis body which is provided on an expandable outer end with an expandable annular body from which sharp suturing members extend radially.
  • Introduction of such a vascular prosthesis requires only a minimally invasive procedure, wherein a relatively small percutaneous incision is made at the position of a part of the blood vessel to be treated so as to expose this part.
  • the vessel wall is opened to minimal extent so as to enable the prosthesis body to be introduced via the thus created vessel wall opening and to be manoeuvred with the proximal outer end to a still healthy part of the blood vessel.
  • the annular body is brought into a radially expanded state, wherein the suturing members penetrate through the vessel wall and are received in a fixation body which has been arranged around the blood vessel at this position.
  • a particularly reliable suturing can thus be realized in that the vessel wall can be firmly clamped at this position between the internal anchoring body and the external fixation body. This prevents a danger of transluminal migration and reduces the chance of endoleakage occurring later.
  • the proposed suturing technique moreover requires no special skills or aptitude on the part of the surgeon.
  • the present invention has for its object, among others, to provide a vascular prosthesis system and method with which the necessary clamping time during a treatment to be performed therewith can be significantly limited, particularly in the direction toward vital organs when performing an anastomosis in the aorta.
  • a vascular prosthesis system of the type described in the preamble has the feature according to the invention that the introducing system comprises a first placing device for placing and temporarily holding the fixation body outside the blood vessel in mutual co-action with a second placing device for placing and expanding in situ at least the outer end of the vascular prosthesis in the blood vessel, and that the first placing device and the second placing device are provided with registering means which give an indication detectable externally of the blood vessel of a correct mutual alignment of the deformable outer end of the prosthesis body of the vascular prosthesis with the suturing means in the blood vessel relative to the fixation body outside the blood vessel.
  • the vascular prosthesis and the fixation body can here already be provided on the associated placing device and sterilized prior to the procedure, or even be supplied seated on the associated placing device as prepared assembly (kit) in a sterile packaging.
  • a limited incision in the vessel wall at the intended location will suffice to enable intraluminal introduction of the prosthesis via this incision using the second placing device.
  • the fixation body is arranged outside the blood vessel by means of the first placing device at the position where the suturing has to be performed.
  • the registering means now provide a direct indication and feedback for a correct alignment of the outer end of the vascular prosthesis and the fixation body relative to each other.
  • the vascular prosthesis is now guided intraluminally into the blood vessel over exactly the correct distance, i.e. sufficiently far but not too far.
  • the outer end of the vascular prosthesis which is provided with at least one suturing member, is expanded in order to bring about a faultless penetration and suturing of the suturing member in the fixation body.
  • a distal connection of the vascular prosthesis can optionally be realized by means of a rapid-action coupling which has been pre-prepared.
  • the prosthesis system according to the invention has the feature that the registering means comprise a stop which extends from a one of the first and the second placing device and on which, in the case of a correct mutual alignment of the outer end of the prosthesis body of the vascular prosthesis in the blood vessel with the fixation body outside the blood vessel, abuts a shoulder provided on another of the first and the second placing device.
  • a correct alignment of the vascular prosthesis and the fixation body can thus be achieved easily and quickly by bringing together the stop and shoulder.
  • the second placing device will in that case be carried partially into the blood vessel, the stop or the shoulder formed thereon remains outside the blood vessel so that a direct detection of a correct registering is possible.
  • a further particular embodiment of the prosthesis system according to the invention is characterized in that the stop extends from a receiving cavity in the one placing device and the shoulder is provided on a member which is receivable in the receiving cavity and which extends from the other placing device and is received at least substantially fittingly in the receiving cavity.
  • the registering means thus provide not only a visual but also a tangible indication of a correct alignment of the fixation body and the suturing means to be received therein.
  • a further preferred embodiment of the prosthesis system according to the invention is characterized in that manually releasable coupling means are provided between the receivable member and the receiving cavity for the purpose of a temporary mutual connection.
  • This is particularly a snap or click connection which is made between the two components and which holds the two placing devices in a correct mutual relation while the outer end of the vascular prosthesis is expanded.
  • a further particular embodiment of the prosthesis system is characterized according to the invention in that the first placing device comprises a basic part and a closing part which together enclose a continuous cavity, and that the cavity comprises a guide in a wall thereof for the purpose of receiving the fixation body in strip-like state therein and carrying it all around the cavity, and that the closing part can be coupled to and uncoupled from the basic part in order to respectively at least substantially close and open the wall of the cavity.
  • the prosthesis system according to the invention is advantageously further characterized here in that the registering means are provided at least partly on the basic part of the first placing device.
  • the cavity is thus divisible so that, in the removed or at least uncoupled state of the closing part, the blood vessel can be carried laterally into the cavity in the basic part, after which the cavity is closed by coupling the closing part to the basic part.
  • the fixation body can then be carried around the blood vessel by carrying the fixation body into the guide in strip-like, flat state and guiding it around the blood vessel.
  • Use is made here of a fixation body which is sufficiently flexible to be able to follow a radius of the blood vessel. This can all be already fully prepared before interrupting a blood flow through the blood vessel. This does not therefore add to the clamping time of the operation.
  • a further particular embodiment of the prosthesis system has the feature that opposite outer ends of the fixation body lie together and are mutually connected in order to close the fixation body round the blood vessel, and more particularly that the striplike fixation body comprises axially adjustable closing means between the outer ends, in particular axially adjustable snap means.
  • the axial adjustability thus allows a range of blood vessel diameters to be accommodated.
  • the fixation body is formed at least substantially from a biocompatible plastic.
  • a particularly practical embodiment of the prosthesis system according to the invention is characterized in that the second placing device comprises a first shaft part intended and configured to receive the vascular prosthesis thereover, and a second shaft part running at least substantially parallel to the first shaft part, wherein the first shaft part comprises fixation means for holding the vascular prosthesis and the second shaft part comprises at least a part of the registering means.
  • the fixation means for the vascular prosthesis thus hold the vascular prosthesis in a precisely defined state and position relative to the placing device.
  • the prosthesis system has the feature that the second placing device comprises close to a distal outer end of the first shaft part an inflatable balloon body with a body cavity which is in open communication with an inflation channel extending proximally from the balloon body, wherein the deformable outer end of the prosthesis body of the vascular prosthesis lies with the suturing means on the balloon body.
  • the outer end of the vascular prosthesis can thus be expanded in vivo by inflating the balloon body via the inflation channel. For this expansion, and thereby suturing of the vascular prosthesis, it is thus not necessary to introduce additional means, which could otherwise result in loss of time.
  • the system is hereby precise as well as being quick and simple.
  • a further preferred embodiment of the prosthesis system has the feature here according to the invention that the first shaft part comprises a longitudinal guide cavity which continues in the first shaft part and opens both proximally and distally so as to receive a catheter shaft of a balloon catheter for axial movement therethrough.
  • the second placing device with the balloon body with which the outer end of the vascular prosthesis can be expanded can thus be guided over the shaft of a balloon catheter.
  • This balloon catheter comprises a further balloon body which is thus positioned upstream and can be inflated in order to fully close the blood vessel to be treated immediately upstream of the vascular prosthesis to be arranged.
  • a further preferred embodiment of the prosthesis system has the feature that the balloon catheter is provided with indicator means and that the first placing device comprises detection means which are able and configured to detect and indicate a passage of the balloon catheter through the cavity on the basis of the indicator means. Because the first placing device also comprises a registering of the outer end of the vascular prosthesis, the first placing device thus provides a correlation of this outer end and the positioning of the balloon catheter, which must be located beyond this point with the balloon provided thereon. A visually and/or otherwise externally detectable indication from the first placing device thus shows that the balloon catheter is positioned correctly, so that the balloon thereof will be inflated at a correct location.
  • vascular prosthesis comprises on the deformable outer end an expandable body which is at least substantially annular in expanded state
  • suturing means comprise a series of suturing members which, at least in expanded state, extend radially from a periphery of the annular body and are distributed at a regular pitch over this periphery, and more particularly that the expandable body comprises a form-closed metal body.
  • annular body preferably of metal, connects optimally to the natural anatomy of the blood vessel, which limits the chance of endoleakage.
  • the regular pitch of the suturing members moreover contributes toward a uniform clamping of the vessel wall between the expanded, internal suturing body and the external fixation body in which the suturing members are received.
  • the present invention also provides a method for treating a blood vessel in a human or animal body, wherein use is made of an above described vascular prosthesis system according to the invention and wherein, in the sequence indicated:
  • a fixation body is arranged round the blood vessel upstream of a treatment location with a first placing device
  • a blood flow through the blood vessel is interrupted upstream of the fixation body
  • c. at least a deformable outer end of a vascular prosthesis is introduced intraluminally into the blood vessel via an incision in the vessel wall with a second placing device and is placed in the blood vessel upstream of the treatment location
  • the deformable outer end of the vascular prosthesis is brought into the radially expanded, second state in order to press suturing means provided on the outer end through a vessel wall of the blood vessel and into the fixation body.
  • a preferred embodiment of the method according to the invention has in this respect the feature that, before the blood flow through the blood vessel is interrupted upstream of the fixation body, a bypass prosthesis is connected to optionally the same blood vessel downstream of the treatment location, this bypass prosthesis comprising a primary prosthesis body with opposite open outer ends between which a primary body cavity extends, which outer ends are each sutured intraluminally to a vessel wall of the blood vessel, wherein a secondary prosthesis body extends with a secondary body cavity laterally from the primary prosthesis body between the outer ends of the primary prosthesis body, which body cavity is in open communication with the primary body cavity in the primary prosthesis body, that a free outer end of the secondary prosthesis body is coupled to a free outer end of the vascular prosthesis, and that after the deformable outer end of the vascular prosthesis has been brought into radially expanded second state the blood circulation along the treatment location is resumed as soon as the free outer end of the secondary prosthesis body and a free outer end of the vascular prosthesis have been coupled in leak-tight manner
  • a particular embodiment of the method has for this purpose the feature that the outer ends of the primary prosthesis body are each provided with suturing means with suturing members and are radially deformable from a compressed first state to an expanded second state, that the primary prosthesis body of the bypass prosthesis in the compressed first state of the outer ends is introduced intraluminally into the blood vessel via an incision in the vessel wall, and that the two outer ends of the primary prosthesis body of the bypass prosthesis are brought in situ from the compressed first state to the radially expanded second state, wherein the suturing members protrude radially and penetrate the vessel wall.
  • the method according to the invention has the feature in a further preferred embodiment that the free outer ends of respectively the vascular prosthesis and the bypass prosthesis are provided with mutually co-acting rapid-action coupling means which realize and maintain the leak-tight connection therebetween.
  • these rapid-action coupling means have been mutually coupled, for instance by means of a screw, bayonet, snap or click connection, the blood flow can be fully resumed via the primary prosthesis and the bypass prosthesis, whereby a significant time-saving can be achieved.
  • the invention also relates to a further method for realizing a bypass for a blood vessel, wherein such a bypass prosthesis is likewise applied for the prosthesis located upstream.
  • a bypass prosthesis is likewise applied for the prosthesis located upstream.
  • an occlusion in a blood vessel can thus also be treated as well as an aneurysm by providing such a bypass prosthesis in optionally the same blood vessel on either side of the occlusion.
  • such a method has for this purpose the feature that downstream of a bypass location a first bypass prosthesis and upstream of the bypass location a similar further bypass prosthesis is connected to optionally the same blood vessel, wherein at least one outer end of at least one of the first and the further bypass prosthesis is sutured intraluminally to a vessel wall of the relevant blood vessel by making use of the prosthesis system according to the invention, which first and further bypass prosthesis each comprise a primary prosthesis body with opposite open outer ends between which a primary body cavity extends and at least one outer end of which is sutured intraluminally to a vessel wall of the relevant blood vessel, wherein a secondary prosthesis body extends with a secondary body cavity laterally from the primary prosthesis body between the outer ends of the primary prosthesis body of each of the bypass prostheses, which body cavity is in open communication with the primary body cavity in the primary prosthesis body, that a free outer end of the secondary prosthesis body of the first bypass prosthesis is coupled to a free outer end of the secondary prosthesis
  • a particular embodiment of this method has the feature here that the at least the one outer end of the primary prosthesis body of each of the bypass prostheses is provided with suturing means with suturing members and is radially deformable from a compressed first state to an expanded second state, that the primary prosthesis body of each of the bypass prostheses in the compressed first state of the outer ends is introduced intraluminally into the blood vessel via an incision in the vessel wall of optionally the same blood vessel, and that at least the one outer end of the primary prosthesis body of each of the bypass prostheses are brought in situ from a compressed first state to the radially expanded second state in which the suturing members protrude radially and penetrate the vessel wall, wherein the free outer ends of the secondary prosthesis bodies of the two bypass prostheses are more particularly provided with mutually co-acting rapid-action coupling means which realize and maintain the leak-tight connection therebetween.
  • figures 1-17 show a method according to the invention at successive stages for realizing an anastomosis making use of inter alia an exemplary embodiment of the prosthesis system according to the invention with an exemplary embodiment of each of the placing devices involved therein;
  • figure 18 shows a result of a method according to the invention for making a bypass beyond an occlusion in a blood vessel making use of an exemplary embodiment of the prosthesis system according to the invention with an exemplary embodiment of each of the placing devices involved therein.
  • Figure 1 shows a schematic view of the human body with a very common location for an abdominal aneurysm 15 in the aorta descendens 10. This location is typically between the renal arteries 1 1, 12 to the kidneys and the bifurcation 20 to the iliac arteries. This area is further elucidated in figure 2.
  • a bypass prosthesis 30 is first of all arranged in each of the iliac veins 21, 22. An example of such a prosthesis is shown in figure 3.
  • the prosthesis comprises a primary prosthesis body 1 with a body cavity open at both outer ends and provided about halfway along with a secondary prosthesis body 32 which is in open communication with the body cavity of the primary tubular body via an opening in the side wall of the primary tube.
  • Both parts 31, 32 of prosthesis 30 are formed from a liquid-tight, biocompatible flexible textile, such as for instance woven CoreTex, and transpose at least substantially seamlessly into each other.
  • Primary prosthesis body 31 comprises at both free outer ends suturing means 33, 34 in the form of an expandable ring on which suturing members 35 are provided which, after expansion of the ring, will penetrate the vessel wall and thus anchor the prosthesis thereto.
  • These suturing members 35 comprise here spikes or other protrusions which are forced radially outward during expansion of the ring and will here penetrate the vessel wall.
  • the prosthesis comprises for this purpose a balloon catheter 40 with an inflatable balloon body 43, 44 inside each of the annular bodies 33, 34. Via a common inflation channel running through a shaft of the catheter balloons 43, 44 are in open communication with a proximal outer end of the catheter, where a coupling can be made to conventional inflation means.
  • the balloon bodies can hereby be inflated and evacuated under pressure making use of a suitable inflation medium such as a physiological saline solution.
  • the relevant blood vessel 21 is clamped upstream and downstream for a short time using conventional clamping means Kl, and a small incision XI in the order of 1 to 2 centimetres is made therebetween in the vessel wall.
  • a small incision XI in the order of 1 to 2 centimetres is made therebetween in the vessel wall.
  • the primary prosthesis body 31 of the prosthesis is introduced in compressed state together with the balloon catheter 40 enveloped therein, after which balloon bodies 43, 44 are inflated in a short time so as to expand the two annular bodies 33, 34 at the intended location.
  • Suturing members 35 now penetrate the vessel wall and the primary prosthesis body 31 thus lies anchored intraluminally in the relevant blood vessel 21 , see figure 4.
  • the two balloon bodies 43, 44 are then evacuated and removed with catheter 40.
  • the free outer end of the secondary prosthesis body 32 is now provided with a clamp K2 for liquid- tight closure thereof, after which the blood flow through the blood vessel can be resumed by removing the clamping means Kl provided thereon.
  • the described procedure is repeated at the other iliac artery 22, whereby the situation of figure 5 is obtained. All in all, the blood circulation has not been interrupted, or hardly so, particularly because use was made here of a bypass prosthesis according to the invention which can be sutured exceptionally quickly and is pre-prepared therefor.
  • a fixation body 60 is arranged externally of the primary blood vessel 10 using a first placing device 50.
  • the first placing device 50 comprises a holder of plastic with a continuous cavity 53 in which blood vessel 10 is co-axially received. Holder 50 is constructed from a basic part 51 and a closing part 52, see also figure 6B, which together enclose cavity 53 when assembled.
  • Closing part 52 can be coupled for this purpose to basic part 51, for instance by being slid therein as indicated with an arrow in figure 6B, after basic part 51 has been placed round blood vessel 10 at the desired location.
  • a guide (not further shown), for instance in the form of opposite grooves, in which a fixation body 60 is received in strip form, see figure 6A, and guided therein around the blood vessel to form a round shape, see figure 6B.
  • Fixation body 60 is flexible for this purpose, and for instance formed from a biocompatible plastic.
  • holder 50 is closed with closing part 52 and the annular fixation body 60 lies retained against the wall of cavity 53 so as to receive support therefrom.
  • Free outer ends of the fixation body can optionally be connected to each other.
  • the dimensions and specific embodiment of cavity 53 are selected such that fixation body 60 now lies externally relatively firmly on the vessel wall.
  • Exchangeable inserts can optionally be used for this purpose as fitting parts in order to adjust the size of the cavity more or less precisely to that of blood vessel 10, or holders of different dimensions can be applied.
  • aneurysm 15 is punctured with an infusion needle 88, see figure 7, through which can be guided a catheter 80 having on an outer end a balloon body 85 which is guided intraluminally into blood vessel 10 to a position beyond the first placing device 50.
  • a catheter 80 having on an outer end a balloon body 85 which is guided intraluminally into blood vessel 10 to a position beyond the first placing device 50.
  • Use can be made here of a more or less standard dilatation catheter.
  • an indicator for instance a gold tape, which is recognized by the first placing device and detected as soon as it passes through cavity 53.
  • a proximal outer end catheter 80 is coupled to inflation means with which balloon 85 is inflated via an inflation channel running in the shaft of the catheter for this purpose, see figure 8.
  • inflation means with which balloon 85 is inflated via an inflation channel running in the shaft of the catheter for this purpose, see figure 8.
  • the blood flow through the primary blood vessel 10 is now closed and, in the shown case, the same likewise applies to the blood circulation through the renal arteries
  • an incision X2 is then made in aneurysm 15 in order to open blood vessel 10 there.
  • a second placing device 90 of the prosthesis system according to the invention with a vascular prosthesis 100 thereon is guided into blood vessel 10, see figure 9.
  • the second placing device 90 comprises a first rod-like shaft part 91 , over which prosthesis 100 is received in order to be guided together therewith into the blood vessel, in combination with a second rod-like shaft part 92 which remains external of blood vessel 10 and runs at least substantially parallel to first shaft part 91.
  • Extending longitudinally in first shaft part 91 is a body cavity 93 accessible on either side, see figure 10A.
  • first shaft part 91 the second placing device carries an inflatable balloon body 75 which extends all the way round.
  • first shaft part comprises an inflation channel 77 for this balloon body 75.
  • This inflation channel continues into a tubular outer end 70 which can be connected proximally to usual inflation means with which a suitable inflation medium, i.e. a physiological fluid, can be introduced into the balloon body and evacuated therefrom.
  • Balloon body 75 can thus be brought in controlled manner from an initial contracted state to a radially expanded state and subsequently be deflated. Balloon body 75 remains precisely fixed relative to first shaft part 91 here, and the same applies for vascular prosthesis 100, see figure 10B, which is arranged over first shaft part 91 and lies with a distal outer end over balloon body 75.
  • Vascular prosthesis 100 comprises a tubular body 103 which is provided on a free outer end with suturing means in the form of a radially expandable annular body 1 10 from which a number of suturing members 1 15 extend radially.
  • This annular body 1 10 is brought into a radially compressed state on balloon body 75 and thereby fixed thereon. This position is hereby precisely matched and aligned with a free outer end 95 of second shaft body 92 of the second placing device 90.
  • the prosthesis 100 comprises two separate legs 101 , 1 02.
  • the prosthesis is woven from a flexible liquid-tight textile, wherein the separate parts 101 , 102, 103 transpose seamlessly, or at least in leak-tight manner, into each other.
  • First shaft part 91 extends here through one of the two legs of prosthesis 100.
  • a releasable rapid-action coupling 120 between this leg 102 of prosthesis 100 and first shaft part 91 provides here for a leak-tight connection and further fixation of the prosthesis on the second placing device 90.
  • the second placing device can be guided easily and quickly into the blood vessel by using catheter shaft 82 of balloon catheter 80 as guide.
  • the catheter shaft is carried beforehand through body cavity 93 of first shaft part 91 so that the placing device can now be guided with first shaft part 91 over catheter shaft 82 of dilatation catheter 80 inside blood vessel 10, while both catheter shaft 82 and inflation/deflation tube 70 for balloon body 75 run proximally outward from the distal outer end of first shaft part 91 via body cavity 93, see figure 1 1.
  • Second shaft part 92 of the second placing device 90 remains at all times outside the blood vessel and is placed with the free outer end 95 thereof inside a cavity 55 provided for the purpose on the first placing device 50, see also figure 6A.
  • This outer end 95 carries a radial groove 94 in its periphery in which snap means (not further shown), for instance protrusions extending from a wall of cavity 55, engage under spring tension.
  • the protrusions thus form a defined stop against which outer end 95 is received with a shoulder, which shoulder extends from an edge of the groove formed in outer end 95.
  • Free outer end 95 snaps fixedly here into cavity 55, and the second placing device 90 is locked into the first placing device 50. Because the free outer end 95 and the location of balloon body 75 with suturing means 1 10, 1 15 thereon are precisely adjusted relative to each other, this locking brings about a precise, quick and faultless register between on the one hand the balloon body 75 with suturing means 1 10, 1 15 thereon and on the other the cavity 53 having therein the fixation body 60 of the first placing device 50.
  • Balloon body 75 can be inflated as soon as this locking has been effected.
  • the expandable outer end of the vascular prosthesis with annular body 1 10 connected thereto is hereby brought from its compressed state to a radially expanded state.
  • Suturing members 1 15 penetrate through the vessel wall here and are tightly received in fixation body 60, which here lies externally round the vessel wall and is supported by the wall of cavity 55 of the first placing device 50. An exceptionally reliable suturing can thus be realized between the internal annular body 110 and the external fixation body 60 with leak-tight enclosing of the vessel wall of blood vessel 10.
  • Balloon catheter 80 is now pulled with the balloon body a little into cavity 93 of first shaft part 91 and now seals cavity 93 in leak-tight manner.
  • a plug body can optionally be provided for this purpose on and around catheter shaft 82, and is received fittingly in cavity 93.
  • This leak-tight fit of catheter shaft 82 in central cavity 93 of first shaft part 91 thus maintains an effective interruption of the blood flow in the treated blood vessel 10.
  • the free leg 101 of prosthesis 100 is coupled to the free outer end of one of the two bypass prostheses 31 by means of a leak-tight rapid-action coupling 130, see figure 13.
  • Balloon body 75 is then deflated, see figure 14, whereby the blood circulation is already resumed via the just arranged coupling 130 to one of the two bypass prostheses 30.
  • the clamp K2 provided earlier on bypass prosthesis 30 is removed for this purpose just before or after deflating of balloon body 75, wherein a rapid-action coupling 120 provides for a leak-tight closure of the other leg 102.
  • unlocking means provided for the purpose. These comprise a resilient slide 56 on basic part 51 of the first placing device 50, see figure 6A. Forcing this slide 56 from its rest position causes action on the snap protrusions in the wall of cavity 55 so that they are forced out of the peripheral groove in outer end 95 and second shaft part 92 is hereby released.
  • First shaft part 91 of the second placing device 90 is then wholly removed together with balloon catheter 80, 85 and the meanwhile deflated balloon body 75 via the other leg 102 of vascular prosthesis 100.
  • This leg 102 of the vascular prosthesis is still clamped for a short time with a clamp K3 provided for the purpose, see figure 15, until a leak-tight rapid- action coupling has also been effected here to the secondary prosthesis body 32 of the as yet unconnected bypass prosthesis 30.
  • This coupling takes place in similar manner as that between the other leg 101 and the other bypass prosthesis, as shown in figure 16.
  • the two remaining clamps K2,K3 can now be removed, whereby the blood circulation is fully restored again, see figure 17.
  • the closing means S1 ,S2 are retained in order to permanently isolate the aneurysm.
  • the first placing device 50 is now also removed.
  • Closing part 52 is for this purpose taken out of basic part 51 of the first placing device in order to leave the blood vessel clear.
  • Fixation body 60 remains behind around blood vessel 10 in order to ensure a permanent anchoring of the vascular prosthesis.
  • the incision X2 can now be sutured and the abdominal cavity of the patient closed.
  • the critical clamping time during which the blood circulation has actually been blocked is thus limited to the order of only several minutes, which entails a considerable improvement relative to a traditional suturing of an aortic bifurcation prosthesis.
  • EVAR still provides a slight advantage in this respect, a considerably more reliable prosthesis is on the other hand provided according to the invention which more than fully compensates for this apparent advantage.
  • the invention is otherwise not only suitable for treating an aneurysm, it also has other fields of application.
  • An example hereof is shown in figure 18.
  • a bypass 30,200,30 of a blood vessel around an occlusion 16 present therein is realized here in similar manner as described above.
  • a first bypass prosthesis 30 is arranged intraluminally in the blood vessel and fixed with a fixation body 60 arranged externally of the blood vessel.
  • a quick and correct alignment of the anchoring means in the form of an annular body with radially extending suturing members, which extend internally from the prosthesis, with the external fixation body 60 is here also possible using the placing device. It suffices to provide such a fixation only on an upstream side of the bypass prosthesis.
  • a second bypass prosthesis 30 is arranged beyond, i.e. downstream of, occlusion 16 in similar manner, wherein a fixation with an external fixation body can be wholly dispensed with if desired, as also shown in the figure.
  • An anchoring of the anchoring means in the vessel wall suffices here on both opposite sides of the primary tube body of the bypass prosthesis.
  • a leak-tight connection is brought about between the two secondary tube bodies of the two bypass prostheses by means of a leakage-free rapid-action coupling 140 and a hollow connecting piece 200.
  • a leakage-free rapid-action coupling 140 and a hollow connecting piece 200.
  • use can otherwise also be made here of a male-female coupling, as between the primary prosthesis and the bypass prosthesis in the first exemplary embodiment, wherein such a connecting piece 200 is not necessary. All in all, a blood vessel can thus be diverted past an occlusion in quick and simple manner.
  • vascular prosthesis system according to the invention is thus described on the basis of an application for a bifurcation prosthesis, but the system can be utilized just as advantageously for a vascular prosthesis with a straight, single prosthesis body.

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

Abstract

L'invention concerne un système de prothèse vasculaire, qui comprend un système d'introduction pour introduire une prothèse vasculaire (100) par voie intraluminale dans un vaisseau sanguin (10), et étendre son extrémité externe in situ. Le système d'introduction comprend un premier dispositif de placement (5) pour placer et maintenir temporairement un corps de fixation externe (60) à l'extérieur du vaisseau sanguin. Le système d'introduction comprend également un second dispositif de placement (90) pour placer et étendre in situ la prothèse vasculaire (100) dans le vaisseau sanguin. Les premier et second dispositifs de placement (50, 90) comprennent des moyens d'alignement à action mutuellement conjointe, qui donnent une indication pouvant être détectée à l'extérieur du vaisseau sanguin d'un alignement correct de l'extrémité externe extensible (110) de la prothèse vasculaire (100) dans le vaisseau sanguin par rapport au corps de fixation (60) à l'extérieur du vaisseau sanguin.
PCT/NL2015/050433 2014-06-12 2015-06-11 Prothèse vasculaire et procédé Ceased WO2015190928A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL2012995A NL2012995B1 (nl) 2014-06-12 2014-06-12 Vaatprothese-systeem en werkwijzen.
NL2012995 2014-06-12

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WO2015190928A1 true WO2015190928A1 (fr) 2015-12-17

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3528754A4 (fr) * 2016-10-19 2020-06-10 Merit Medical Systems, Inc. Ensembles d'accès vasculaire sous-cutané et dispositifs et procédés associés
US12257377B1 (en) * 2020-08-11 2025-03-25 Simon B. Rayhanabad Method of performing a minimally invasive bypass

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999055254A1 (fr) * 1998-04-28 1999-11-04 Adri Marinus Blomme Moyen de suture pour raccorder une prothese vasculaire tubulaire a un vaisseau sanguin du corps et moyen de ramification, prothese vasculaire, dispositif d'insertion et de suture d'une prothese vasculaire dans le corps et systeme de prothese vasculaire
US20040034377A1 (en) * 2000-04-29 2004-02-19 Ventrica, Inc. Components, systems and methods for forming anastomoses using magnetism or other coupling means
WO2008152620A2 (fr) * 2007-06-13 2008-12-18 Edo Kaluski Système de distribution à ballonnet bifurqué et stent

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999055254A1 (fr) * 1998-04-28 1999-11-04 Adri Marinus Blomme Moyen de suture pour raccorder une prothese vasculaire tubulaire a un vaisseau sanguin du corps et moyen de ramification, prothese vasculaire, dispositif d'insertion et de suture d'une prothese vasculaire dans le corps et systeme de prothese vasculaire
US20040034377A1 (en) * 2000-04-29 2004-02-19 Ventrica, Inc. Components, systems and methods for forming anastomoses using magnetism or other coupling means
WO2008152620A2 (fr) * 2007-06-13 2008-12-18 Edo Kaluski Système de distribution à ballonnet bifurqué et stent

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3528754A4 (fr) * 2016-10-19 2020-06-10 Merit Medical Systems, Inc. Ensembles d'accès vasculaire sous-cutané et dispositifs et procédés associés
US11027107B2 (en) 2016-10-19 2021-06-08 Merit Medical Systems, Inc. Subcutaneous vascular access assemblies and related devices and methods
US12257377B1 (en) * 2020-08-11 2025-03-25 Simon B. Rayhanabad Method of performing a minimally invasive bypass

Also Published As

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