(19)
(11)EP 1 389 976 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
06.05.2020 Bulletin 2020/19

(21)Application number: 02733916.7

(22)Date of filing:  27.03.2002
(51)Int. Cl.: 
A61F 2/06  (2013.01)
(86)International application number:
PCT/US2002/009874
(87)International publication number:
WO 2002/091949 (21.11.2002 Gazette  2002/47)

(54)

APPARATUS AND TECHNIQUE FOR UNIFORM LOADING OF ENDOLUMINAL PROSTHESES

VORRICHTUNG UND VERFAHREN ZUR GLEICHMÄSSIGEN BELASTUNG VON ENDOLUMINALEN PROTHESEN

DISPOSITIF ET TECHNIQUE POUR LE CHARGEMENT UNIFORME DE PROTHESES ENDOLUMINALES


(84)Designated Contracting States:
AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

(30)Priority: 04.04.2001 US 826267

(43)Date of publication of application:
25.02.2004 Bulletin 2004/09

(73)Proprietor: Bard Peripheral Vascular, Inc.
Tempe, AZ 85280 (US)

(72)Inventors:
  • PLETZER, Scott
    Gilbert, AZ 85296 (US)
  • MERRILL, Scott
    Tempe, AZ 85282 (US)

(74)Representative: Hoffmann Eitle 
Patent- und Rechtsanwälte PartmbB Arabellastraße 30
81925 München
81925 München (DE)


(56)References cited: : 
US-A- 5 810 870
US-A- 6 139 573
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND OF THE INVENTION


    1. Field of the Invention:



    [0001] The present invention relates generally to a device and method for aiding the process of loading endoluminal devices into a delivery apparatus. More particularly, the present invention is directed to a device and method to facilitate the collapse of a prosthesis.

    2. Description of Prior Art:



    [0002] Endoluminal prostheses such as stents, stent-grafts and other related devices are used to treat vessels that have become weakened or diseased. These prostheses are used in a variety of circumstances to provide a remedy for the damaged vessels. The remedy can come in the form, for example, of added support for a vessel that has become weakened as a result of an aneurysm, or to reopen a vessel in which flow has been restricted due to diseases such as arteriosclerosis.

    [0003] In order to effectively deliver a prosthesis to the problematic site in the vasculature of the patient, the prosthesis must first be placed within a delivery apparatus, generally including a restrictive sheath or catheter. For example, U.S. Patent No. 6,096,027, describes a loading device to compress and load prostheses onto or into a catheter. This is accomplished by placing a stent device into a flexible sleeve or bag, and pulling the bagged stent device through a funnel shaped apparatus. At the end of the funnel taper, a catheter is positioned either to receive the stent device therein, or to accept the stent device thereon. The use of the bag or sleeve to pull the stent device through a funnel-shaped loading apparatus acts to minimize frictional forces inherent in collapsing a stent device from its full diameter, as well as avoiding the longitudinally applied forces associated with pushing a stent device through a loading mechanism.

    [0004] The loading process described above can be additionally facilitated, particularly for large diameter stent and stent-grafts, by providing further methods to reduce the loading forces. Thus, it is desirable to provide devices and methods for preparing endoluminal prostheses in order to diminish frictional forces acting on the prostheses during the loading thereof into a delivery apparatus.

    [0005] US 6,139,573 discloses a stent having a plurality of openings and surrounded by ePTFE cover. The stent and cover may be positioned on a mandrel and surrounded by a sleeve. The sleeve is contracted such that the cover is formed through the openings in the stent.

    [0006] WO0045739 and WO0047135 further disclose devices and methods for manipulating endoluminal endoprosthesis.

    SUMMARY OF THE INVENTION



    [0007] According to a first aspect of the present invention there is provided a device according to Claim 1.

    [0008] According to a second present aspect of the invention there is provided a method according to Claim 12.

    [0009] The present invention relates to devices and methods to facilitate the loading of a prosthesis into a delivery apparatus. More particularly, the present invention is related to devices and methods for forming alterations in the prosthesis to make collapsing of the prosthesis easier by reducing frictional forces acting thereon during the process of loading the prosthesis into a delivery apparatus. Advantageously, creation of alterations in the prosthesis enables a more compact collapse, leading to a smaller insertion profile. This is beneficial to both the physician and patient as complications inherent with the insertion of prostheses are largely reduced. In the present invention, a device to create alterations in a prosthesis includes a grooved mandrel and a pressing comb.

    [0010] The grooved mandrel is preferably a tubular object made from a hard substance, such as stainless steel, with grooves running longitudinally down its length. The grooves are spaced around the circumference of the mandrel, creating two distinct diameters, one for the grooved areas and another for the non-grooved or raised areas. Such a device is also known as a"splined"mandrel to those of skill in the art. The pressing comb is preferably a long hard structure also preferably made of stainless steel, having teeth to create an alteration in a prosthesis without puncturing a layer thereof. The teeth of the comb are therefore extremely short in comparison to a conventional comb. In the present invention, this device additionally includes a coupling apparatus, which not only connects the mandrel and the comb, but also coordinates their actions with respect to one another, mechanically controlling the alteration process.

    [0011] In the method of utilizing the above-described present invention, the grooved mandrel is placed into the prosthesis, preferably such that a tight fit between the two is achieved, and mounted on a receiving rack. The receiving rack is attached to the coupling apparatus, which is in turn attached to the pressing comb. When the coupling apparatus is activated (i.e., by using a pneumatic control box), the pressing comb is moved a pre-determined distance downward, making contact with the prosthesis (the underlying mandrel being positioned such that a grooved section is facing the comb), until a longitudinal set of alterations is created. The mandrel is then axially rotated until the adjacent grooved section is facing upward and another set of alterations is fashioned. This process is continued until a desired number of sets of alterations are produced.

    [0012] In other preferred embodiments of the present invention, a device to create alterations in a prosthesis includes a grooved mandrel, a marking wheel and a shaft. The marking wheel can have teeth spaced around its circumference to effectuate an alteration on a prosthesis when the wheel runs along its periphery. In practice, the grooved mandrel is placed within the prosthesis and the shaft is placed through the middle of the marking wheel. The shaft is then used to move the wheel longitudinally down the outside of the prosthesis, forming alterations thereon. Of course, as in the embodiment described above, it would be advantageous to utilize a coupling apparatus to coordinate the formation of the alterations on the desired portion of the prosthesis.

    [0013] These and other features and advantages of the present invention will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the preferred embodiments of the invention and the accompanying drawings.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0014] 

    Fig. 1 depicts a longitudinal view of a grooved mandrel of the present invention.

    Fig. 2 depicts a cross-sectional view of a grooved mandrel of the present invention.

    Fig. 3 depicts a close-up view of a pressed comb of the present invention acting on an esophageal stent with a grooved mandrel inserted therethrough.

    Fig. 4 depicts a frontal view of a preferred embodiment of the present invention, showing a fully assembled pressed comb apparatus.

    Fig. 5 depicts a side view of Fig. 4.

    Fig. 6 depicts an overhead view of Fig. 4.

    Fig. 7 depicts a marking wheel of the present invention acting on an esophageal stent.

    Fig. 8 depicts a micrograph view of a cross-section of an esophageal stent following alteration processing but prior to loading.

    Fig. 9 depicts a micrograph view of a cross-section of the esophageal stent of Fig. 8 after it has been loaded into a delivery apparatus.

    Fig. 10 depicts a micrograph view of a cross-section of an esophageal stent loaded into a delivery apparatus without undergoing an alteration processing.


    DESCRIPTION OF THE PREFERRED EMBODIMENTS



    [0015] Turning now to the drawings, the present invention relates to devices and methods used to create alterations in a layer of biocompatible material covering or encapsulating a stent. The preferred biocompatible material utilized to cover and encapsulate stents for the present invention is expanded polytetrafluoroethylene (ePTFE), although a number of different materials are certainly within the scope of this invention, including polytetrafluoroethylene, polyesters, polyurethanes and other covering materials that would be, at a minimum, temporarily deformed from an alteration process such as the one described in the present invention. The term alteration as used herein means a small indentation, crease, dimple or differential density created in the surface of the ePTFE or other biocompatible material.

    [0016] Referring to Figs. 1 and 2, a grooved mandrel 10 is illustrated. Grooved mandrel 10 is tubular with two distinct diameters, which successively alternate about its circumference. This can best be seen in the cross-sectional view of Fig. 2, where each grooved section 14 set at a first diameter is immediately followed by a raised section 12 set at a second diameter. The importance of the two distinct sections 12 and 14 on the grooved mandrel 10 will be appreciated to one of skill in the art with respect to the creation of the alterations in the covered stents, described in more detail below.

    [0017] Fig. 3 illustrates a close-up view of the creation of alterations 122 in the ePTFE covering 120 of an esophageal stent-graft 100. The esophageal stent-graft 100 has a stent 110 that is encapsulated by an ePTFE covering 120. The term encapsulated as used herein means at least one layer of biocompatible material, in this case ePTFE, covering each of the luminal and abluminal layers of the stent and adhered to one another through the walls of the stent. Ends 104 of the esophageal stent-graft 100 can be left uncovered and flared outward from a central axis of the stent 100 as shown. In a preferred embodiment of the present invention, the esophageal stent-graft 100 is mounted on the grooved mandrel 10 (see Figs. 4-6 for more detail). Pressing comb 20 is positioned to contact the ePTFE covering 120 of the esophageal stent-graft 100 at measured equidistant intervals longitudinally along the length of the stent-graft 100. The grooved mandrel 10 is positioned within the stent-graft 100 such that the grooves 12 of the mandrel 10 are underneath each set of alterations to be fashioned. When contact is made between teeth 24 of the pressing comb 20 and the ePTFE covering 120 at each groove 12 of the mandrel 10, an alteration 122 is created in the ePTFE covering 120.

    [0018] The devices and methods to create alterations in biocompatible layers according to the present invention are especially advantageous to large diameter prostheses such as the esophageal stent-graft 100 illustrated herein. This is due to the presence of increased loading forces acting on a larger diameter prosthesis (compared to a smaller diameter prosthesis) when collapsing for loading into a delivery apparatus. However, it should be appreciated that the devices and methods presented herein are equally applicable to biliary stents and other small diameter covered stents as well as grafts or sheaths or other endoluminal prostheses.

    [0019] Ideally, the alterations 122 will be created in the ePTFE covering 120 at a mid-point 112 between successive longitudinal articulations 114 in the stent 110. The term articulation as used herein means a tip or point of a diamond shape in the stent wall. The creation of an alteration 122 at the mid-point 112 between successive longitudinal articulations 114 is accomplished through spacing of the teeth 24 of comb 20 and pre-positioning of the comb 20 prior to the creation of the alterations 122 in accordance with the articulation 114 spacing, so that the teeth 24 correspond to the mid-points 112. When the comb 20 comes into contact with the ePTFE covering 120, a set of alterations 122 will simultaneously be produced along a longitudinal axis of the esophageal stent-graft 100.

    [0020] Turning now to Figs. 4-6, a preferred embodiment of the present invention is illustrated. Fig. 4 shows a front view of a pressing comb device 40 with esophageal stent-graft 100 mounted thereon. As partially shown in Fig. 3, the grooved mandrel 10 is inserted through the center of esophageal stent-graft 100. This enables the mounting and stabilization of the esophageal stent-graft 100 for creation of alterations 122 in the ePTFE covering 120. The mandrel 10 is coupled to a main support structure 42 by support pins 54, which are inserted into the center of the mandrel 10 whereby the mandrel 10 with the esophageal stent-graft 100 mounted is fully rotatable. A stop disk 60 abuts one end of the esophageal stent-graft 100 to prevent the esophageal stent-graft 100 from migrating, and a detent disk 50 is coupled to the mandrel 10 via one of the pins 54 to control the rotation of the esophageal stent-graft 100. The control of the esophageal stent-graft 100 is further accomplished through the use of a locking pin 52, which is utilized to lock the detent disk 50 in each axial position for creation of alterations on the esophageal stent-graft 100. The locking action of pin 52 can best be seen in Fig. 5, where an end view of the pressing comb device 40 is shown. The detent disk 50 has several pin holes 56 therein, each associated with an axial position of the esophageal stent-graft 100 where a set of alterations is desired. Certainly, depending on the prosthesis or material to be manipulated by the pressing comb device 40, these pin holes 56 can be more or less numerous.

    [0021] A linear slide 30 is mounted atop the main support 42. The linear slide 30 is controlled mechanically to move in a vertical direction a desired predetermined distance. Pressing comb 20 is attached to the base of the linear slide 30 via screws 28 that slide into a pressing comb body 22 through a comb mounting plate 26. The features of the pressing comb device 40 can alternatively be viewed from above in Fig. 6. From this overhead view the esophageal stent-graft 100 can be seen more clearly. Once completely mounted on the pressing comb device 40, the esophageal stent-graft 100 can be acted on by the pressing comb 20, where each pass of the pressing comb 20 downward, contacting the esophageal stent-graft 100, creates a longitudinal set of alterations 122 along the ePTFE covering 120 of the esophageal stent 100.

    [0022] Referring now to Fig. 7, an alternate preferred embodiment is depicted. In this embodiment, the alterations are created in the ePTFE covering 120 of the esophageal stent-graft 100 through the use of a marking wheel device 90. The marking wheel device 90 includes a marking wheel 92 and a shaft 96. The shaft 96 is positioned through the center of the marking wheel 92 for smooth and steady movement thereof. The marking wheel device 90 may have teeth around the circumference of the marking wheel 92 to produce alternating dimples in the ePTFE covering 120. In the absence of teeth, alterations can be formed by the wheel 92 itself in the form of grooves along the length of the ePTFE covering 120. In preferred embodiments, a coupling apparatus will be attached to the shaft 96 to ensure uniform movement and pressure of the wheel 92 along the ePTFE covering 120.

    [0023] In alternate preferred embodiments of the present invention, rather than a set of alterations being created along a longitudinal axis of a prosthesis as described above, different sets of alterations or a series of single alterations could be produced. For example, a circumferential set of alterations could be produced along a circumferential axis of the prosthesis by a disc-like device fashioned to fit around the circumference of the prosthesis. Teeth or other alteration-forming units could be on the inside of the disc-like device and the disc could contract at once or in intervals to cause alterations on the outside of the prosthesis. Similarly, the teeth on the disc-like device could be placed around the outside of the disc, similar to the marking wheel 92 in Fig. 7, and the device could be placed within the prosthesis to be expanded outward to cause alterations on the inside of the prosthesis along a circumferential axis. In addition, circumferential alterations and longitudinal alterations could be made in concert by different types of devices, or sets of alterations could be made on different axes simultaneously.

    [0024] It should also be noted that while examples have been provided herein with regard to collapse of prostheses from a large to a small diameter, the scope of the present invention extends to the creation of alterations in the prosthesis to effectuate other forms of collapse as well. Thus, for example, alterations could be produced in a prosthesis to facilitate an accordion-like collapse thereof.

    [0025] Finally, many modifications may be made by those having ordinary skill in the art without departing from the scope of the present invention. In particular, it should be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment details and procedures, can be accomplished without departing from the scope of the invention.


    Claims

    1. A device to create alterations in an endoluminal prosthesis, wherein the endoluminal prosthesis (100) comprises at least one layer of biocompatible material (120), comprising:

    a means (10) to stabilize the endoluminal prosthesis, wherein the endoluminal prosthesis can be incrementally axially rotated, wherein the stabilizing means comprises a grooved mandrel suitable for receiving the endoluminal prosthesis; the mandrel including a plurality of grooves (12) running longitudinally down its length, the grooves being spaced around the circumference of the mandrel; and

    a means (20, 92) to manipulate the layer of biocompatible material at at least one distinct point on the endoluminal prosthesis to produce an alteration (122) on the surface thereof,

    characterised in that the manipulating means comprising spaced apart teeth (24) to create the alteration,

    wherein the device further comprises a means to couple (54) the stabilizing means with the manipulating means, wherein the coupling means is adapted to rotate the stabilizing means following the formation of at least one alteration (122) on the surface of the endoluminal prosthesis, wherein the coupling means comprises a main support structure (42), wherein the grooved mandrel (10) is coupled to the main support structure by support pins (54) which are inserted into the center of the mandrel, and wherein a stop disk is configured to abut one end of the endoluminal prosthesis to prevent the endoluminal prosthesis from migrating


     
    2. A device according to claim 1, further comprising a force means coupled to the manipulating means to produce energy for use thereof in producing the alteration (122).
     
    3. A device according to claim 2, wherein the force means is selected from the group consisting of pneumatic, hydraulic and mechanical.
     
    4. A device according to claim 1, wherein the at least one alteration (122) comprises a set of alterations that are simultaneously produced along at least one axis of the endoluminal prosthesis (100).
     
    5. A device according to claim 4, wherein the set of alterations (122) is produced along a longitudinal axis of the endoluminal prosthesis (100).
     
    6. A device according to claim 4, wherein the set of alterations (122) is produced along a circumferential axis of the endoluminal prosthesis (100).
     
    7. A device according to claim 4, wherein the set of alterations (122) is produced along more than one axis of the endoluminal prosthesis (100).
     
    8. A device according to claim 4, wherein the set of alterations (122) is produced on both surfaces of the layer of biocompatible material.
     
    9. A device according to claim 1, wherein the grooved mandrel has a diameter approximately equal to but less than an inside diameter of the endoluminal prosthesis to establish an interference fit when positioned therein.
     
    10. A device according to claim 1, wherein the manipulating means (20) comprises a pressing comb.
     
    11. A device according to claim 1, wherein the manipulating means comprises a marking wheel (92) and a shaft (90) combined therewith.
     
    12. 12. A method for preparing an implantable endoluminal prosthesis for loading into a delivery sheath using the device of any of Claims 1 to 11, wherein the endoluminal prosthesis (100) comprises a stent (110) with at least one layer of biocompatible material (120) attached thereto, comprising the steps of:

    stabilizing the endoluminal prosthesis;

    forming an alteration (122) on the surface of said biocompatible layer;

    rotating the endoluminal prosthesis axially in an incremental fashion; and

    collapsing the endoluminal prosthesis for loading into the delivery sheath.


     
    13. A method according to claim 12, wherein the step of stabilizing comprises inserting a grooved mandrel (10) of appropriate diameter into the endoluminal prosthesis (100), wherein an interference fit between the mandrel and the endoluminal prosthesis is established.
     
    14. A method according to claim 13, removing the endoluminal prosthesis from the mandrel wherein said forming step comprises forming a first set of alterations (122) in the biocompatible layer along a longitudinal axis of the endoluminal prosthesis at a first axial position aligned with a first groove in the mandrel; and
    Wherein after rotating the endoluminal prosthesis axially in an incremental fashion, subsequent sets of creases are created along the longitudinal axis of the endoluminal prosthesis at a plurality of axial positions, each aligned with grooves in the mandrel, until the endoluminal prosthesis has been rotated 360° from the first axial position.
     
    15. A method according to claim 12, wherein said forming step further comprises contacting the endoluminal prosthesis (100) with a pressing comb (20).
     
    16. A method according to claim 15, wherein the endoluminal prosthesis (100) further comprises a stent (110) having a plurality of articulations (122) arranged longitudinally in rows about its circumference, wherein the pressing comb (20) has teeth spaced a distance corresponding to the distance between successive longitudinal articulations and wherein the teeth are adapted to create an alteration in the biocompatible layer between each successive longitudinal articulation.
     
    17. A method according to claim 12, wherein the altering step further comprises contacting the endoluminal prosthesis (100) with a marking wheel (92).
     


    Ansprüche

    1. Vorrichtung zum Erzeugen von Änderungen in einer endoluminalen Prothese, wobei die endoluminale Prothese (100) mindestens eine Schicht aus biokompatiblem Material (120) umfasst, umfassend:

    ein Mittel (10) zum Stabilisieren der endoluminalen Prothese, wobei die endoluminale Prothese inkrementell axial gedreht werden kann, wobei das Stabilisierungsmittel einen genuteten Mandrin umfasst, der zum Aufnehmen der endoluminalen Prothese geeignet ist; wobei der Mandrin eine Vielzahl von Nuten (12) einschließt, die in Längsrichtung über seine Länge verlaufen, wobei die Nuten um den Umfang des Mandrins herum beabstandet sind; und

    ein Mittel (20, 92) zum Manipulieren der Schicht aus biokompatiblem Material an mindestens einem eindeutigen Punkt auf der endoluminalen Prothese, um eine Änderung (122) auf der Oberfläche davon hervorzubringen, dadurch gekennzeichnet, dass das Manipulationsmittel beabstandete Zähne (24) umfasst, um die Änderung zu erzeugen, wobei

    die Vorrichtung weiter ein Mittel zum Koppeln (54) des Stabilisierungsmittels mit dem Manipulationsmittel umfasst, wobei das Kopplungsmittel angepasst ist, um das Stabilisierungsmittel der Bildung von mindestens einer Änderung (122) auf der Oberfläche der endoluminalen Prothese folgend zu drehen, wobei das Kopplungsmittel eine Hauptstützstruktur (42) umfasst, wobei der genutete Mandrin (10) mit der Hauptstützstruktur durch Stützstifte (54) gekoppelt ist, die in die Mitte des Mandrins eingeführt sind, und wobei eine Anschlagscheibe konfiguriert ist, um an einem Ende der endoluminalen Prothese anzuliegen, um Migrieren der endoluminalen Prothese zu verhindern.


     
    2. Vorrichtung nach Anspruch 1, weiter umfassend ein Kraftmittel, das mit dem Manipulationsmittel gekoppelt ist, um Energie zur Verwendung beim Hervorbringen der Änderung (122) hervorzubringen.
     
    3. Vorrichtung nach Anspruch 2, wobei das Kraftmittel ausgewählt ist aus der Gruppe, bestehend aus pneumatisch, hydraulisch und mechanisch.
     
    4. Vorrichtung nach Anspruch 1, wobei die mindestens eine Änderung (122) einen Satz von Änderungen umfasst, die gleichzeitig entlang mindestens einer Achse der endoluminalen Prothese (100) hervorgebracht werden.
     
    5. Vorrichtung nach Anspruch 4, wobei der Satz von Änderungen (122) entlang einer Längsachse der endoluminalen Prothese (100) hervorgebracht wird.
     
    6. Vorrichtung nach Anspruch 4, wobei der Satz von Änderungen (122) entlang einer Umfangsachse der endoluminalen Prothese (100) hervorgebracht wird.
     
    7. Vorrichtung nach Anspruch 4, wobei der Satz von Änderungen (122) entlang mehr als einer Achse der endoluminalen Prothese (100) hervorgebracht wird.
     
    8. Vorrichtung nach Anspruch 4, wobei der Satz von Änderungen (122) auf beiden Oberflächen der Schicht aus biokompatiblem Material hervorgebracht wird.
     
    9. Vorrichtung nach Anspruch 1, wobei der genutete Mandrin einen Durchmesser aufweist, der ungefähr gleich, aber kleiner als ein Innendurchmesser der endoluminalen Prothese ist, um eine Presspassung zu etablieren, wenn er darin positioniert wird.
     
    10. Vorrichtung nach Anspruch 1, wobei das Manipulationsmittel (20) einen Presskamm umfasst.
     
    11. Vorrichtung nach Anspruch 1, wobei das Manipulationsmittel ein Signierrad (92) und eine damit kombinierte Welle (90) umfasst.
     
    12. Verfahren zum Herstellen einer implantierbaren endoluminalen Prothese zum Laden in eine Einführhülse unter Verwendung der Vorrichtung nach einem der Ansprüche 1 bis 11, wobei die endoluminale Prothese (100) einen Stent (110) mit mindestens einer daran befestigten Schicht aus biokompatiblem Material (120) umfasst, umfassend die Schritte:

    Stabilisieren der endoluminalen Prothese;

    Bilden einer Änderung (122) auf der Oberfläche der biokompatiblen Schicht;

    axiales Drehen der endoluminalen Prothese auf eine inkrementelle Weise; und

    Einklappen der endoluminalen Prothese zum Laden in die Einführhülse.


     
    13. Verfahren nach Anspruch 12, wobei der Schritt des Stabilisierens das Einsetzen eines genuteten Mandrins (10) von geeignetem Durchmesser in die endoluminale Prothese (100) umfasst, wobei eine Presspassung zwischen dem Mandrin und der endoluminalen Prothese etabliert wird.
     
    14. Verfahren nach Anspruch 13, Entfernen der endoluminalen Prothese von dem Mandrin, wobei der Schritt des Bildens das Bilden eines ersten Satzes von Änderungen (122) in der biokompatiblen Schicht entlang einer Längsachse der endoluminalen Prothese an einer ersten axialen Position umfasst, die mit einer ersten Nut in dem Mandrin ausgerichtet ist; und
    wobei nach axialem Drehen der endoluminalen Prothese auf eine inkrementelle Weise entlang der Längsachse der endoluminalen Prothese an einer Vielzahl von axialen Positionen, die jeweils mit Nuten im Mandrin ausgerichtet sind, aufeinanderfolgende Sätze von Falten erzeugt werden, bis die endoluminale Prothese um 360° ab der ersten axialen Position gedreht wurde.
     
    15. Verfahren nach Anspruch 12, wobei der Schritt des Bildens weiter das In-Kontakt-Bringen der endoluminalen Prothese (100) mit einem Presskamm (20) umfasst.
     
    16. Verfahren nach Anspruch 15, wobei die endoluminale Prothese (100) weiter einen Stent (110) mit einer Vielzahl von Gelenken (122) umfasst, die in Längsrichtung in Reihen um seinen Umfang herum angeordnet sind, wobei der Presskamm (20) Zähne aufweist, die in einem Abstand beabstandet sind, der dem Abstand zwischen sukzessiven Längsgelenken entspricht, und wobei die Zähne angepasst sind, um eine Änderung in der biokompatiblen Schicht zwischen jedem sukzessiven Längsgelenk zu erzeugen.
     
    17. Verfahren nach Anspruch 12, wobei der Änderungsschritt weiter das In-Kontakt-Bringen der endoluminalen Prothese (100) mit einem Signierrad (92) umfasst.
     


    Revendications

    1. Dispositif pour créer des altérations dans une prothèse endoluminale, dans lequel la prothèse endoluminale (100) comprend au moins une couche de matériau biocompatible (120), comprenant :

    un moyen (10) pour stabiliser la prothèse endoluminale, dans lequel la prothèse endoluminale peut être tournée axialement de manière progressive, dans lequel le moyen de stabilisation comprend un mandrin rainuré fait pour recevoir la prothèse endoluminale; le mandrin incluant une pluralité de rainures (12) s'étendant longitudinalement sur sa longueur, les rainures étant espacées autour de la circonférence du mandrin ; et

    un moyen (20, 92) pour manipuler la couche de matériau biocompatible au niveau d'au moins un point distinct sur la prothèse endoluminale pour produire une altération (122) sur la surface de celle-ci,

    caractérisé en ce que le moyen de manipulation comprenant des dents espacées (24) pour créer l'altération, dans lequel le dispositif comprend en outre un moyen pour accoupler (54) le moyen de stabilisation au moyen de manipulation, dans lequel le moyen d'accouplement est adapté pour faire tourner le moyen de stabilisation suite à la formation d'au moins une altération (122) sur la surface de la prothèse endoluminale, dans lequel le moyen d'accouplement comprend une structure de support principale (42), dans lequel le mandrin rainuré (10) est accouplé à la structure de support principale par des tiges de support (54) qui sont insérées dans le centre du mandrin, et dans lequel un disque d'arrêt est configuré pour venir buter contre une extrémité de la prothèse endoluminale pour empêcher la prothèse endoluminale de migrer.


     
    2. Dispositif selon la revendication 1, comprenant en outre un moyen de force accouplé au moyen de manipulation pour produire de l'énergie pour une utilisation de celle-ci dans une production de l'altération (122).
     
    3. Dispositif selon la revendication 2, dans lequel le moyen de force est choisi dans le groupe comprenant pneumatique, hydraulique et mécanique.
     
    4. Dispositif selon la revendication 1, dans lequel la au moins une altération (122) comprend un ensemble d'altérations qui sont produites simultanément le long d'au moins un axe de la prothèse endoluminale (100).
     
    5. Dispositif selon la revendication 4, dans lequel l'ensemble d'altérations (122) est produit le long d'un axe longitudinal de la prothèse endoluminale (100).
     
    6. Dispositif selon la revendication 4, dans lequel l'ensemble d'altérations (122) est produit le long d'un axe circonférentiel de la prothèse endoluminale (100).
     
    7. Dispositif selon la revendication 4, dans lequel l'ensemble d'altérations (122) est produit le long de plus d'un axe de la prothèse endoluminale (100).
     
    8. Dispositif selon la revendication 4, dans lequel l'ensemble d'altérations (122) est produit sur les deux surfaces de la couche de matériau biocompatible.
     
    9. Dispositif selon la revendication 1, dans lequel le mandrin rainuré présente un diamètre à peu près égal à mais inférieur à un diamètre intérieur de la prothèse endoluminale pour établir un ajustement avec serrage lorsqu'il est positionné à l'intérieur de celle-ci.
     
    10. Dispositif selon la revendication 1, dans lequel le moyen de manipulation (20) comprend un peigne de pression.
     
    11. Dispositif selon la revendication 1, dans lequel le moyen de manipulation comprend une roue de marquage (92) et un arbre (90) combiné avec celle-ci.
     
    12. Procédé de préparation d'une prothèse endoluminale implantable pour un chargement dans une gaine de mise en place à l'aide du dispositif selon l'une quelconque des revendications 1 à 11, dans lequel la prothèse endoluminale (100) comprend un stent (110) avec au moins une couche de matériau biocompatible (120) attachée à celui-ci, comprenant les étapes :

    de stabilisation de la prothèse endoluminale ;

    de formation d'une altération (122) sur la surface de ladite couche biocompatible ;

    de rotation de la prothèse endoluminale axialement d'une façon progressive ; et

    de rétraction de la prothèse endoluminale pour un chargement dans la gaine de mise en place.


     
    13. Procédé selon la revendication 12, dans lequel l'étape de stabilisation comprend une insertion d'un mandrin rainuré (10) d'un diamètre approprié dans la prothèse endoluminale (100), dans lequel un ajustement avec serrage entre le mandrin et la prothèse endoluminale est établi.
     
    14. Procédé selon la revendication 13, un retrait de la prothèse endoluminale hors du mandrin dans lequel ladite étape de formation comprend une formation d'un premier ensemble d'altérations (122) dans la couche biocompatible le long d'un axe longitudinal de la prothèse endoluminale au niveau d'une première position axiale alignée sur une première rainure dans le mandrin ; et
    dans lequel après une rotation de la prothèse endoluminale axialement d'une façon progressive, des ensembles de plis ultérieurs sont créés le long de l'axe longitudinal de la prothèse endoluminale au niveau d'une pluralité de positions axiales, chacun étant aligné sur des rainures dans le mandrin, jusqu'à ce que la prothèse endoluminale ait été tournée à 360° par rapport à la première position axiale.
     
    15. Procédé selon la revendication 12, dans lequel ladite étape de formation comprend en outre une entrée en contact de la prothèse endoluminale (100) avec un peigne de pression (20).
     
    16. Procédé selon la revendication 15, dans lequel la prothèse endoluminale (100) comprend en outre un stent (110) présentant une pluralité d'articulations (122) agencées longitudinalement en rangées autour de sa circonférence, dans lequel le peigne de pression (20) présente des dents espacées d'une distance correspondant à la distance entre des articulations longitudinales successives et dans lequel les dents sont adaptées pour créer une altération dans la couche biocompatible entre chaque articulation longitudinale successive.
     
    17. Procédé selon la revendication 12, dans lequel l'étape d'altération comprend en outre une entrée en contact de la prothèse endoluminale (100) avec une roue de marquage (92).
     




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    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description