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
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
  • A61F2/9524—Iris-type crimpers
• • 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
  • A61F2/958—Inflatable balloons for placing stents or 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
  • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
  • B25B—TOOLS OR BENCH DEVICES NOT OTHERWISE PROVIDED FOR, FOR FASTENING, CONNECTING, DISENGAGING OR HOLDING
  • B25B27/00—Hand tools, specially adapted for fitting together or separating parts or objects whether or not involving some deformation, not otherwise provided for
  • B25B27/14—Hand tools, specially adapted for fitting together or separating parts or objects whether or not involving some deformation, not otherwise provided for for assembling objects other than by press fit or detaching same
  • B25B27/146—Clip clamping hand tools

Definitions

• the invention relates to a device for crimping a stent onto a catheter delivery system which comprises :
• the four spaced longitudinal elements are moved back and forth in the direction of the longitudinal axis in order to compress the stent on the catheter delivery system by means of actuators including elastic rod means whereby each segment is moved as a whole.
• actuators including elastic rod means whereby each segment is moved as a whole.
• a device for crimping a stent onto a catheter delivery system wtiich comprises :
• - a generally tubular channel having a longitudinal axis and having a circumferential wall formed by four spaced longitudinal elements; - entrance means at one end of said generally tubular channel for allowing a delivery system to be inserted into said generally tubular channel and be positioned at a predetermined position relative thereto;
• each longitudinal element as seen along the longitudinal direction of the tubular channel is composed of a number of individual segments, each segment being movable by said pressure application means and said releasing means independently from each other segment within the same element.
• each longitudinal element is composed of the same number of segments, each segment having a plate-like shape with two parallel side wails, each side wall being in contact with the side wall of its neighbouring segment in the same element, the side walls being positioned perpendicularly to the longitudinal axis and the side walls of the segments with the same serial number in each element being positioned in the same plane.
• each segment has a curved surface edge directed towards the longitudinal axis of the tubular channel so that the edge of each segment engaging the stent is optimized in shaped.
• the curved surface of each segment is limited by two stop edges, which are perpendicular with respect to each other, and in a closed position in which all segements are as close as possible to the longitudinal axis of the tubular channel, each stop edge abuts upon a stop edge of a segment of an adjacent element. In this way movement of the segment towards the longitudinal axis is stopped by engagement of the stop edges of two adjacent elements, thereby limiting the compression of the stent on the catheter delivery system.
• each segment is provided with guiding edges co-operating with guiding surfaces in a housing, the general guiding direction being under an angle of 45° with respect to the stop edges and directed towards the longitudinal axis of the tubular channel.
• the border line between the adjacent stop edges of the segments in two adjacent elements and the curved edges becomes a straight line.
• the stent may be squeezed between the stop edges, and thereby be deformed, so that a useless catheter delivery system might be obtained.
• segments can be used with respect to the position of their stop edges in such a way that the sequence of the segments in each element is such that in the closed position the border line between the adjacent stop edges and the curved edge, is a broken line at each transition of one segment to the next segment in the same element.
• the segments are all identical and such that in the closed position, the stop edge of a segment is positioned in such a way that the longitudinal axis is not lying in the extension of the stop edges and all segments are identical and, each segment in an element is inversed with respect to its adjacent segment thereby forming a broken edge line between the adjacent stop edges and the curved edges.
• distance elements are placed between the adjacent segments.
• each segment is provided with means cooperating with the adjacent segments in the two adjacent elements, whereby a movement of a segment is transferred in a corresponding movement of its adjacent segments.
• Fig. 1 is a cross-section view of a device for crimping a stent onto a catheter delivery system according to the invention
• Fig. 2 is a partially exploded view of the core part of the system of Fig. 1 .
• Fig. 3 is a top view of a segment used to form the core part shown in Fig. 2
• F Fiigg.. 44AA - - ⁇ 44BB are schematic representations of the core part of the systems before starting the crimping.
• Fig. 5A ⁇ ⁇ 5B are schematic representations according to Figures 4A - 4B in an intermediate position
• Fig. 6A ⁇ ⁇ 6B are schematic representations according to Figures. 4A - 4B in the most compressed position.
• a device 10 for crimping a stent onto a catheter deliver system comprises a housing 20, having a generally octogenal cross-section and provided with a longitudinal bore 21 having a cross-shaped cross-section for housing the moving parts of the compressing systems. Both ends of the housing 20 are closed by means of one or more removable end plates which provides support and access to the several parts to be described below.
• the housing 20 is provided with a number of bores 30 e.g. eight in the embodiment shown, which are used to accommodate tie rods, by means of which the end plates can be fitted to the housing 20 and which at the same time increase the strength of the whole construction.
• Each element 25 consists in fact of plate like segments 26 having two parallel flat side walls which are stacked on top of each other and together form each time one of four elements 25.
• the segments 26 are positioned in such a way within the elements 25 that each time four segments within the four elements are exactly within the same plane, i.e. these side walls are aligned with respect to each other.
• Each segment has a curved edge 40, directed towards a substantially cylindrical longitudinal channel 27 having a longitudinal axis, the four curved edges 40 of four coplanar segments 26 being capable to form together a closed circular edge, of a circle circumference.
• each segment 26 is limited by two stop edges 41 , 42 which are positioned under an angle of 90° with respect ot each other, and which serve to engage corresponding stop edges 41 , 42 of coplanar segments 25.
• Edge 44 forms part of a rectangular notch 47, which is limited by edges 48, 49, edge 48 being parallel to edge 44 and edge 49 being perpendicular thereto.
• Edge 45 forms part of a rectangular notch 50, which is further limited by edges 51, 52, edge 51 being parallel to edge 45 and edge 52 being perpendicular thereto.
• the segment 26 is provided with a substantially rectangular notch 53, formed by longitudinal edges 54, 55 and a top edge 56 have a concave curvature.
• the edges 54, 55 are parallel to stop edge 41 and therefor perpendicular with respect to stop edge 42.
• Edge 54 is part of a recess 57 which is further limited by edges 58, 59 and 60, edge 58 being perpendicular with respect to edge 57, edge 59 being parallel to edge 54 and edge 60 extending under an angle of e.g. 45° with respect to edge 59 and connecting the same to teh stop edge 42.
• the width of the notch 53 is such that is equal to the width of the reces 43. Furthermore the design is made such that the concave edge 56 is almost aligned with the stop edge 42, whereas the length of the edge 54 is almost equal to the length of the edge 48.
• Edge 55 is further limited by an edge 61 which is aligned with edge 58, thereby providing an edge 55 with the same length as edge 54.
• edges 62, 63 are joined to the edge 51 , and 61 respectively, the edges 62, 63 being parallel to each other and extending under an angle of 45° with respect to the main direction of the edges 51 , 61.
• the contour of the segment 26 is mainly oriented in a direction perpendicular with respect to the edges 62, 63.
• the segment 26 is further provided with two bores 65, 66 which are used to slide the segment 26 on rods 67, in order to stack a number of segments so as to obtain an element 25.
• the diameter of the rods is slightly smaller than the diameter of the bores 65, 66 thereby providing some freedom of movement.
• each segment 26 is identical and the whole of the crimping device is obtained by sliding each time four coplanar segments 26 over the rods 67 the four coplanar segments being positioned with respect to each other as shown in Figure 1 and 2.
• This means that the notch 53 of each segment 26 is fitting into the recess of its adjacent coplanar segment 26.
• each segment 26 is able to slide in these cross-arms which serve as a guide therefor.
• each coplanar set of segments 26 is able to move through and fro in the direction of the central axis 27, thereby guided by the edges 62, 63 along the respective cross-arms, which movement is possible because of the clearance between the rod 67 and the bore 66.
• the through and fro movement of each segment is coordinated with the movement of the other coplanar segments because of the coupling between, the coplanar segments by means of the notches 53 and recesses 43. Otherwise the movement of each coplanar set of segments is completely independent of the movement of its adjacent coplanar set of segments. This independency of adjacent sets of coplanar segments is even improved by providing distance elements, such as distance rings 70 between adjacent segments of the same element.
• the movement of the segments 26 is obtained by means of inflatable hoses.
• four inflatable hoses 75 have been provided between the concave edges 64 of the segments 26 of each element 25 and the end portion of the cross-arms of the bore 21.
• one hoses75 is present for each element 25, the four hoses 75 being connectable to the same source of pressurized air, and therefor being maintained under the same pressure.
• all segments 26 are pressed with the same force towards the central channel, but the movement of each coplanar set of segments is within defined limits, independent from the movement of its adjacent coplanar set of segments there allowing adjustment for small irregularities.
• inflotable hoses In order to move the segments away from the central axis 27, four inflotable hoses have been provide, each in each longitudinal space provided between the edges 46 of the recesses 43 of all segments of one element and between the edges 56 of the notches 53 of all segments of its adjacent element.
• each curved edge 40 can be shaped as one fourth of a circle circumference. This means that after full movement of the four segments of each coplanar set of segments a full circle circumference is obtained around the central channel 27. If the diameter of the circle corresponds substantially to the diameter of the catheter delivery system inserted into the central channel 27 a good crimping of the stent can be obtained.
• the first problem can be overcome by using a quarter part of a circle circumference for the curved edge 40 which is positioned in such a way with respect ot he stop edges 41 , 42 that the angle between the edge 41 , 42 and the curved edge 40 is different from 90°. This can be done because the movement fo the segment 26 is under an angle of 45° with respect to the edges 41 , 42, so that after engagement of the stop edges 41 , 42 a complete circle circumference is obtained.
• fig. 4B there is shown the relative position of a number of segments with their curved edge 40 and their stop edges 41 , 42.
• two adjacent segments of each element are shown.
• a first segment is shown comprising the stop edges 41a, 42a and the intermediate curved edge 40a and a second segment is shown comprisiong the stop edges 41 b, 42b and the intermediate curved edge 40b.
• a second segment is shown comprisiong the stop edges 41 b, 42b and the intermediate curved edge 40b.
• the catheter delivery system and its stent used have a diameter smaller than the average diameter shown in Fig. 5A, there is no danger that the stent becomes squeezed between two adjacent elements. From this position on the stent may be compressed. The compression can be prosecuted until the position as shown in Fig. 6A and 6B has been reached in which there is complete abutment of the stop edges. As the central channel 27 remains substantially cylindrical during the transition from the situation shown in Fig. 5B up til the situation shown in Fig. 6A, it becomes possible to use catheter delivery systems having any diameter between the average diameter of the central channel 27 in Fig. 5A and the diameter of the central channel 27 in Fig. 6B.
• the diameter of the central channel 27 as shown in Fig. B is slightly larger than the diameter of the catheter delivery system, so that the stent is smoothly compressed on the catheter delivery system, the deformation of the stent being restricted and defined by the ultimate diameter of the channel 27.
• an ultimate diameter of the central channel 27 as shown in Fig. 6B is used whcih is smaller than the diameter of the catheter delivery device, so that the deformation of the stent is governed by the force exerted by the pressure devices 75.

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• 2000
  • 2000-08-03 AU AU2000267004A patent/AU2000267004A1/en not_active Abandoned
  • 2000-08-03 WO PCT/EP2000/007695 patent/WO2002011646A1/en not_active Application Discontinuation
  • 2000-08-03 EP EP00954606A patent/EP1318767A1/de not_active Withdrawn

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