Method for mechanical pre-crimping of stents, especially drug-coated stents

Abstract

The present invention relates to a method for arranging a stent, in particular a drug-coated stent, on a balloon of a balloon catheter. At the stent implantation site (e.g., during an angioplasty procedure), the balloon of the balloon catheter acts to radially expand the stent so that the stent, for example, opens a vascular stenosis and is firmly fixed to the vessel wall.

Description

Technical Field

[0001] The present invention relates to a method for arranging a stent, in particular a drug-coated stent, on a balloon of a balloon catheter. The balloon of the balloon catheter acts to radially expand the stent at the stent implantation site (e.g., during an angioplasty procedure), so that the stent, for example, opens a vascular stenosis and is firmly fixed to the vessel wall. Background Art

[0002] In an automated system for producing such a stent system, it is advantageous to transport the stent by machine between individual processing steps, for example, from a stent magazine to the processing step of stent deployment or assembly on a balloon catheter.

[0003] On the one hand, this can be done by a mechanical gripper, or by utilizing gravity in a sliding system or by utilizing other forces, such as, for example, magnetic forces or deflections due to compressed air or the like.

[0004] In all cases, cross contamination of stents, in particular of drug-coated stents (i.e., stents coated with at least one drug), needs to be prevented during delivery and also during assembly on a balloon catheter. This can be ensured, for example, by cleaning the assembly system or the delivery system after each individual production run, by replacing contaminated components, or by avoiding direct contact points.

[0005] However, in automated systems that process a large number of items, implementing the first two methods mentioned (cleaning the assembly system or conveying system or replacing contaminated components) is very laborious and cost-intensive.

[0006] US2002 / 0116045 discloses a protective sheath for a catheter arrangement having a tubular element. US6,152,944 also discloses a removable stent protector comprising a first removable sleeve having a variable inner diameter to facilitate sliding of the first sleeve over a balloon and a stent, the stent protector being removed prior to use of the stent delivery system. US8,003,157 also describes a system for coating a stent having a device for weighing the stent, a device for aligning the stent with a stent support, and a device for coating the stent, as well as a device for drying the stent and inspecting the stent. Finally, US8,430,057 discloses a fixture shaped to minimize the contact surface of the stent end. Summary of the invention

[0007] Starting from this prior art, the present invention has the object of providing a method for arranging a stent, in particular a drug-coated stent, on a balloon catheter which makes it easy to prevent cross-contamination of the stents.

[0008] This is achieved by a method having the features of claim 1. Advantageous embodiments of the invention are indicated in the dependent claims and described below.

[0009] Claim 1 discloses a method for placing a stent on a balloon of a balloon catheter, the method comprising the following steps:

[0010] a) providing a stent having a wall structure, the wall structure surrounding in a peripheral direction and extending along a longitudinal axis and surrounding an interior of the stent extending along the longitudinal axis, the wall structure having an inner surface facing the interior and an outer surface facing away from the inner surface;

[0011] b) provide protection to avoid contamination of the stent;

[0012] c) inserting the stent in an insertion direction into a region between a plurality of movable pressure plates of a crimping tool (also referred to as a crimping head) such that the movement of the stent in the insertion direction is limited by, for example, a retractable stop (for example in the insertion device);

[0013] d) moving the pressure plate in a direction toward the outer surface of the bracket so that the bracket is retained by the pressure plate and optionally retracting the stopper;

[0014] e) inserting a balloon catheter into the interior of the stent so that the wall structure of the stent surrounds the balloon of the balloon catheter;

[0015] f) moving the pressure plate in a direction towards the outer surface of the stent so that the pressure plate crimps the stent onto the balloon, in particular, so that the inner surface of the wall structure abuts against the outer surface of the balloon; and

[0016] g) opening the pressure plates and retracting the balloon catheter (eg, in a direction opposite to the direction of insertion) out of the area between the pressure plates with the stent crimped onto the balloon.

[0017] The present invention now provides that the stent is inserted into the aforementioned region according to step c) so that

[0018] - at least a first portion of the protective device prevents contact between a face of the support and the stop;

[0019] and / or

[0020] -When the pressure plate is pressed against the outer surface of the stent with the second part of the protective device between the two, at least the second part of the protective device is located between the outer surface of the wall structure of the stent and the pressure plate, the stent is held by the pressure plate in step d) with the second part of the protective device between the two, and the pressure plate curls the stent onto the balloon in step f) with the second part of the protective device between the two.

[0021] The stop in step c) may be a retractable stop, so that the stop can still be retracted in step d) (if the bracket is held by a pressure plate).

[0022] In one embodiment, the stopper also has a hole through which the balloon catheter can be pushed. In this case, the stopper does not need to be retracted. In addition, in this case, the stopper can also be integrated into the pressure plate.

[0023] For the case where only the first part or only the second part of the protective device is used, the distinction between the first part and the second part of the protective device is of course not applicable. The reason is that there is at least a part of the protective device that prevents contact between the face and the stopper, or there is at least a part of the protective device that is located between the outer surface of the wall structure of the support and the pressure plate.

[0024] Stents, especially drug-coated stents, are therefore very important to avoid cross contamination of stents.

[0025] A preferred embodiment of the method provides that the pressure plate is movable in a horizontal direction, the insertion direction preferably pointing vertically downwards.

[0026] One embodiment of the method also provides that the support is arranged in the aforementioned region between the pressure plates, in particular by gravity, so that the longitudinal axis of the support runs vertically and the support is supported on a stop by a first part of the protection device, the stop being arranged vertically below the support. Following the vertical solution of the embodiment with the benefit of gravity has the advantage that a device configured to expand vertically can be used. Thus, when space in a building is very expensive, such a device uses the space in the room that expands to the ceiling, which is very efficient.

[0027] One embodiment of the method also provides that the protective device or the first part and the second part of the protective device are formed by a bladder having at least one elastically deformable wall, and the stent is arranged in the bladder before being arranged in the aforementioned area (between the pressure plates) so that the at least one wall surrounds at least a section of the outer surface of the wall structure of the stent (in particular, the outer surface of the wall structure of the stent, except for the gap). This is particularly advantageous when the bladder is formed by an elastic material, because on the one hand the elastic material can keep the stent in place by tightening the stent to the catheter. On the other hand, the bladder will widen again after curling, thereby facilitating the release of the curled stent from the bladder on the catheter. Therefore, the bladder can be formed by any suitable elastic material, ranging from polymer-based materials to metals. In addition, carbon fiber-based bladders can also be used. Related materials such as aviation graphite or aviation graphene are also suitable as bladder materials.

[0028] In particular, this involves arranging the bladder together with the bracket in the aforementioned region between the pressure plates such that the bladder contacts the stop and a face of the bracket is spaced apart from the stop.

[0029] One embodiment of the method also provides that the wall has a continuous gap extending in the axial direction, which gap allows or simplifies the compression of the wall in the radial direction. An alternative embodiment provides that the wall has two edges that overlap each other in the peripheral direction. This allows the edges to move towards each other when the wall of the bladder is subjected to radial compression or deformation.

[0030] Another embodiment of the method provides that the bladder has a further wall which surrounds at least one wall, in particular in the peripheral direction. According to one embodiment, the other wall may also have a gap extending in the axial direction, the walls being arranged with respect to each other such that each wall covers the gap of the other wall.

[0031] According to one embodiment of the invention, if the bladder is arranged together with the support in the area between the pressure plates, the bladder or at least one wall of the bladder can be fixed or secured to the support, for example in a non-positive and / or positive manner.

[0032] An embodiment of the method also provides that the bladder has a projection at one (eg lower) end, in particular in the form of an open ring-shaped projection.

[0033] For the case where the bracket is inserted into the aforementioned region between the pressure plates in a vertical downward insertion direction, the projection is provided at the lower end of the wall.

[0034] An embodiment of the method also provides that the projection extends in the peripheral direction along an edge, in particular a lower edge of at least one wall (or of the other wall), in particular only interrupted by a recess of the at least one wall.

[0035] One embodiment of the method also provides that, as the balloon catheter is retracted from the aforementioned area between the pressure plates, the protrusion forms a support for at least one or all of the pressure plates, so that the bag is not retracted from the aforementioned area between the pressure plates together with the balloon catheter, but remains in the aforementioned area because the protrusion reaches, for example, behind the bottom of the pressure plate.

[0036] The empty bladder can then be removed from the area between the pressure plates when the pressure plates are reopened (particularly under the downward force of gravity).

[0037] One embodiment of the method also provides that the first part of the protection device is formed by a support for the bracket, the support having a pin which is inserted into the interior of the bracket before the bracket is arranged in the aforementioned region between the pressure plates. That is, the bracket is inserted (in particular together with the support) into the aforementioned region between the pressure plates such that the support is in contact with the stop, i.e. such that the bracket is supported by the support against the stop (in particular by the base of the support).

[0038] An embodiment of the method also provides that the support has a base, a pin protrudes from the base, and when the pin is inserted into the interior of the bracket, in particular when the bracket is inserted into the aforementioned area together with the support so that the base contacts the stop member, in particular when the bracket is supported against the stop member by the base, the base protrudes beyond the outer surface of the wall structure of the bracket in the radial direction.

[0039] An embodiment of the method also provides that an end section of the pin connected to the base is conically shaped to clamp the bracket.

[0040] One embodiment of the method also provides that the support has a head portion that is detachably connectable to the pin and / or to the base, which is connected to the pin and / or to the base before the stent is arranged in the aforementioned area. The head portion preferably protrudes beyond the outer surface of the wall structure of the stent in the radial direction. In addition, the head portion can be designed so that it forms a protective sheath around the outer surface of the stent. One embodiment also provides that the head portion is removed from the pin after the stent is inserted into the aforementioned area.

[0041] An alternative embodiment of the method also provides that the pin protrudes far enough outside the interior of the support that the support cannot come into contact with a flat surface if the base and one end of the pin are on the surface. That is, here only the longitudinal extension of the base and the pin of the support prevents the support from coming into contact with a transport system (with, in particular, one or more slides) or with another adjacent wall, so that this can be done without an additional head portion of the support.

[0042] One embodiment of the method also provides that the pin has a spring element at the end section opposite the base. This allows the bracket to be fixed to the pin by the spring element without the head part having to be connected to the pin. The advantage of having a spring element is that brackets of different sizes can be processed without having to specifically adapt the pin to one bracket.

[0043] An embodiment of the method also provides that the pin has a first end section and an opposite second end section, and the support also has a first and a second spring element, the first spring element being arranged on the first end section and the second spring element being arranged on the second end section of the pin. In such an embodiment, one of the spring elements can be compressed in a radial direction to push the bracket onto the pin, which advantageously makes it possible to do so, for example, without a detachable head portion of the support.

[0044] One embodiment of the method also provides that the pin for clamping the bracket is in the form of a torsion spring or has a torsion spring, and if the pin is inserted into the bracket, the pin is fixed to the bracket by the torsion spring.

[0045] An embodiment of the method also provides that the second part of the protective device has one or more flexible membranes, each of which can consist of PTFE or comprise PTFE, for example.

[0046] One embodiment of the method also provides that one or more membranes are guided through the aforementioned area between the pressure plates so that the one or more membranes form a membrane channel surrounding the outer surface of the wall structure in the peripheral direction of the wall structure, in particular when the pressure plate moves in the direction of the outer surface of the wall structure towards the support. Such an embodiment is advantageous when the support is arranged by gravity so that the longitudinal axis of the support runs vertically. In combination with such an embodiment, the membrane channel not only provides protection, but also provides guidance or guiding behavior in the sense of a channel.

[0047] One embodiment of the method provides that the film sheet is unwound from a feed roller and guided by a plurality of guide rollers to produce film sections opposite to each other, and the film sheet is rolled onto a take-up roller. The take-up roller can be driven to unwind the film sheet. Alternatively, it is conceivable that the film sheet is unwound by a pressure plate.

[0048] In the case of using a plurality of separate membrane sheets, the respective membrane sheets are unwound from a feed roll and rolled onto a take-up roll. The respective take-up roll can be driven to unwrap the respective membrane sheets. Alternatively, it is conceivable that the respective membrane sheets are unwound by a pressure plate.

[0049] One embodiment of the method provides that the stopper is in the form of a plunger inserted into the aforementioned area between the pressure plates to limit the movement of the bracket in the insertion direction, and when the pressure plate moves in the direction toward the outer surface of the wall structure of the bracket, the stopper is deformed in the radial direction by the pressure plate.

[0050] An embodiment of the method also provides that the membrane(s) are arranged such that they protrude beyond the pressure plate in the insertion direction.

[0051] An embodiment of the method also provides that the holder is arranged in the aforementioned region such that an end section of the holder projects beyond the pressure plate and / or beyond the at least one membrane in the insertion direction (eg downwards, in the case where the insertion direction points vertically downwards).

[0052] An embodiment of the method also provides that the first part of the protective device has a membrane or is formed by a membrane.

[0053] One embodiment of the method provides that the film for covering the stopper is unwound from a feed roll and rolled onto a take-up roll. The take-up roll can be driven to unwrap the film. Alternatively, it is conceivable that the film is unwound from the feed roll by movement of the stopper.

[0054] One embodiment of the method also provides for repositioning the stent relative to the balloon after the stent is crimped onto the balloon, and after repositioning, it is further crimped onto the balloon to secure the repositioned stent on the balloon in a final manner (ie, a final manner ready for implantation).

[0055] In other words, the first crimp is preferably a pre-crimp of the stent so that the stent sits tightly on the balloon, yet is still movable about the balloon. The pre-crimped stent is then repositioned to precisely align the stent about the balloon. The stent is then crimped on the balloon of the balloon catheter in a final manner.

[0056] Finally, it should be noted with respect to the present invention that, in principle, each of the protection devices described herein can be used alone. For example:

[0057] i) Use only the bladder bag;

[0058] ii) using only a support (e.g. if cross contamination can be excluded due to sufficiently small pressure plate forces), in which case the support only serves as a protective device, e.g. for transport to the pre-crimping head or the pressure plate;

[0059] iii) Only use membrane channels if cross-contamination of the stoppers can be excluded due to the low forces. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] The following discussion is intended to explain the embodiments, features and advantages of the present invention based on the accompanying drawings. The accompanying drawings are as follows:

[0061] Figure 1 A perspective view of a bracket arranged in a protective device in the form of a bladder;

[0062] Figure 2 Having a bracket arranged therein Figure 1 A cross-sectional view of the bladder bag shown in ;

[0063] Figure 3 –8 Use basis Figure 1 and Figure 2 The protective device is used to crimp or pre-crimp the stent onto the balloon of the balloon catheter;

[0064] Fig. 9 A schematic cross-sectional view of another embodiment of a bladder;

[0065] Fig.10 A schematic cross-sectional view of another embodiment of a bladder;

[0066] Fig.11 A schematic cross-sectional view of another embodiment of a bladder;

[0067] Fig.12 A schematic side view of another embodiment of a protective device in the form of a support member of a bracket;

[0068] Fig.13 according to Fig.12 The flaring (conical shape) of the removable head portion of the bearing and the pin of the support;

[0069] Fig.14 –19 Basis of use Fig.12 and Fig.13 Embodiments of a method for deploying or crimping a stent on a balloon of a balloon catheter using a protective device;

[0070] Fig. 20 -twenty one Fig.12 and Fig.13 A variant of the head portion of the support;

[0071] Fig. 22 –23 Basis of use Fig. 20 or an embodiment of a method of supporting a support arrangement or crimping a stent of 21;

[0072] Fig.24 –25 Another embodiment of the support member;

[0073] Fig.26 Another embodiment of the support member;

[0074] Fig. 27 Another embodiment of the support member;

[0075] Fig.28 Another embodiment of the support member;

[0076] 29 (A)-(F) Another embodiment of a method of deploying or crimping a stent using a membrane channel to protect the stent;

[0077] 30 (A)-(F) Another embodiment of a method of deploying or crimping a stent using a membrane channel to protect the stent;

[0078] Fig.31–32 Another embodiment of a method for deploying or crimping a stent using a membrane channel to protect the stent;

[0079] Fig.33 Details of an embodiment of the method, wherein the stopper is covered by a membrane, the membrane being wound up by a driven take-up roller;

[0080] Fig.34 An alternative detail of an embodiment of the method, wherein the stopper is covered by a membrane, the membrane being deployed by the stopper; and

[0081] Fig.35 A variation of the method of -40 in which a section of the stent protrudes beyond the area surrounded by the pressure plate. DETAILED DESCRIPTION

[0082] The present invention relates to a method for arranging or pre-crimping a stent 1 on a balloon 20 of a balloon catheter 2, wherein the preferably drug-coated stent 1 has a wall structure that surrounds in a peripheral direction U (e.g., formed by a plurality of struts that are integrally connected to each other), the wall structure extends along a longitudinal axis z and surrounds an interior 11 of the stent 1, the interior 11 extending along the longitudinal axis z (and then carrying blood flow), and the wall structure 10 has an inner surface 10b facing the interior 11 and an outer surface 10a facing away from the inner surface 10b (see, for example, Figure 1 and Figure 2 ).also, Figures 3 to 8The method shown in or 14 to 19 or 22 to 23 or 29 to 40 uses protective devices 4, 5 to avoid contamination of the stent 1. The method involves inserting the stent 1 into a region B between a plurality of movable pressure plates 6 of a crimping tool (also referred to as a crimping head) in an insertion direction E, a retractable stopper 7 limiting the movement of the stent 1 in the insertion direction E, and a first portion 4 of the protective device preventing contact between the face 1a of the stent 1 and the stopper 7, and further, the insertion is performed such that when the pressure plates 6 are pressed against the outer surface 10a of the stent 1 with the second portion 5 of the protective devices 4, 5 therebetween, the second portion 5 of the protective device is located between the outer surface 10a of the wall structure 10 of the stent 1 and the pressure plates 6. In order to crimp or pre-crimp the stent 1 on the balloon 20, the pressure plates 6 are moved in a direction toward the outer surface 10a of the wall structure 10 of the stent 1 (e.g., in a horizontal direction V) so that the stent 1 is held by the pressure plates 6 with the second portion 5 of the protective device therebetween. In order that the balloon catheter 2 can now be inserted into the interior 11 of the stent 1, the stopper 7 is then retracted (e.g., in the insertion direction E). When the stopper 7 has been retracted, the balloon catheter 2 is inserted into the interior 11 of the stent 1 so that the wall structure 10 of the stent 1 surrounds the balloon 20 of the balloon catheter 2. The pressure plate 6 is moved in the direction of the outer surface 10a of the wall structure 10 of the stent 1 so that the pressure plate 6 presses against the stent 1 with the second part 5 of the protective device between them, and so that the pressure plate 6 curls the stent 1 on the balloon 20 (the inner surface of the wall structure is against the outer surface of the balloon 20). This curling is in particular a pre-curling. That is, the stent 1 can still be repositioned relative to the balloon 20 thereafter, and the stent 1 is only subjected to final fixation on the balloon 20 by (further) curling the stent 1 again afterwards. After crimping or pre-crimping, the pressure panels 6 are reopened, ie, removed from the outer surface 10a of the wall structure 10 of the stent 2, and the balloon catheter 2 is withdrawn from the region B between the pressure panels 6 (eg, in a direction opposite to the insertion direction E).

[0083] The method involves arranging the support 1 in the aforementioned region B, preferably by gravity, so that the longitudinal axis z of the support 1 runs vertically and supporting the support 1 on a stop 7 arranged vertically below the support 1 by means of the first portion 4 of the protection device.

[0084] Figures 1 to 8 An embodiment provides that, in a preliminary step, the stent 1 is surrounded by a bladder 40, which is preferably deformable in the radial direction R, which bladder 40 forms the first and second parts of the aforementioned protection device. The bladder 40 is particularly robust enough to absorb the forces associated with transportation and handling. The stent 1 is preferably retained in the bladder 40 in a passive or active manner.

[0085] like Figures 3 to 8As shown in FIG. 1 , the bag 40 together with the stent 1 held therein is inserted into the region B between the opened pressure plates 6 in the vertically downward insertion direction E, so that the bag 40 can be pressed against the stopper 7 (see FIG. 1 ) positioned below the region B. Figure 3 ) supports the stent 1. The bladder 40 prevents the face 1a of the stent 1 from coming into direct contact with the stopper 7 and prevents the outer surface 10a of the wall structure 10 of the stent 1 from coming into direct contact with the pressure plate 6, so that the stent 1 is protected from contamination caused by contact with the pressure plate 6 or with the stopper 7. The pressure plates 6 are then moved so that they hold the stent 1 with the bladder 40 between them so that the stopper 7 can be retracted, for example, in the insertion direction E (see Figure 4 The balloon catheter 2 with its balloon 20 is now inserted into the interior 11 of the stent 1 in the insertion direction E (see Figure 5 ), and the stent 1 is pre-curled on the balloon 20 through the pressure plate 6, and the pressure plate 6 acts on the outer surface 10a of the wall structure 10 of the stent 1 through the bladder 40 (see Figure 6 Thereafter, the balloon catheter 2 and the stent 1 crimped thereon are withdrawn from the region B in a direction opposite to the insertion direction E (see Figure 7 ), and the bladder 40 can be removed downward through the corresponding opening of the pressure plate 6 (see Figure 8 ).

[0086] When the balloon 40 is present, the radial deformability of the balloon 40 allows the stent 1 to be pre-crimped on the catheter 2. It is advantageous if the main component of the deformation of the balloon 40 is reversible according to one embodiment (but not necessarily). This allows the stent 1 to be released from the balloon 40 after pre-crimping (the stent 1 is mainly subjected to plastic deformation due to the pre-crimping).

[0087] Enlarging the outer diameter at one lower end of the wall 41 of the bag 40 extending in the peripheral direction U of the bag 40 gives a bulge 45 of the bag 40 , ie, a bulge, which preferably extends in the peripheral direction U and protrudes toward the outside in the radial direction R.

[0088] This allows the pressure plate 6 to be used to remove the bladder 40 from the stent 1 after pre-crimping. Figure 7 and Figure 8 It can be seen that after the actual pre-crimping, the pre-crimping head 6 opens to a diameter between the outer diameter of the balloon 40 and the outer diameter of the bulge or bulge 45. If the pre-crimped catheter 2 is now withdrawn from the pre-crimping head 6 or from the region B (see Figure 7 ), the bag 40 with the protrusion 45 is stuck on the bottom 6a of the pressure plate 6.

[0089] The pouch 40 can be designed as a disposable item or as a reusable item that can be cleaned. It is therefore advantageous that the design is as simple as possible. Furthermore, according to one embodiment, the pouch 40 can also be provided with identification means (barcode or something similar), which serves, for example, for the unique traceability of the stent 1. This allows the system to specify the stent 1 in a clear manner.

[0090] Possible materials for the bladder 40 are, for example, HDPE and in particular also PA12 or PTFE. One embodiment provides that the wall 41 of the bladder 40 has a gap 42 (see Figure 1 and Figure 2 ), the width of which preferably corresponds to the reduction in the circumference of the stent 1 or wall structure 10 caused by the pre-curling.

[0091] The projection or bulge 45 can be produced, for example, by thermal deformation of the tubular blank of the pouch 40 or wall 41. The inner diameter of the tube or wall 41 is preferably smaller than the original outer diameter of the (not yet pre-crimped) stent 1. This holds the stent 1 in the pouch 40 or wall 41 with a non-active connection.

[0092] The inner diameter of the tube or wall 41 is preferably larger than the outer diameter of the processed (ie, pre-crimped) stent 1. This makes it easier to release the balloon 40 from the stent 1 after pre-crimping.

[0093] Another exemplary embodiment provides that the balloon 40 has a wall 41 with a void 42 extending in the axial direction, the wall 41 having an inner diameter that is identical to the outer diameter of the processed stent 1. This holds the stent 1 by a non-active connection and the balloon 40 no longer unclamps from the stent 1 after pre-crimping.

[0094] Another exemplary embodiment provides that the pouch 40 may have a wall 41 having overlapping edges 41a, 41b, such as Fig. 9 In addition, the pouch 40 may have two walls 41, 43, each of which has a gap 42, 44, and the gap 42, 44 of the corresponding wall 41, 43 is covered by the other wall 43, 41 (see Fig.10 ).

[0095] In principle, it is not absolutely necessary for the balloon 40 or the wall 41 to have slits or gaps 41. If the reduction in the diameter of the stent 1 caused by the pre-crimping is relatively small, the elastic deformability of the tubular balloon 40 is sufficient even without slits.

[0096] In addition, the stent 1 can also be held in the pocket 40 by the pocket regions 41d, 41c in a form-fit manner, such as Fig.11 shown.

[0097] The use of the pouch 40 as a protective device may provide an economical solution for preventing cross contamination during machine delivery and pre-crimping of the drug coated stent 1 .

[0098] Figures 12 to 28 An aspect of the inventive method or embodiment is shown as an alternative to the bladder 40 , which is replaced by a support 50 forming at least the first portion 4 of the protective device.

[0099] The support member 50 plays a role in supporting the bracket 1 and may be, for example, dumbbell-shaped to protect the bracket 1 and according to Fig.12 and Fig.13 In one embodiment shown in FIG. 1 , the support 50 has, for example, a pin 51 which is arranged in the region B between the aforementioned pressure plates 6 (see FIG. 1 ). Fig.14 ) is inserted into the interior 11 of the bracket 1 before.

[0100] The support 50 is preferably inserted together with the bracket 1 into the area B between the aforementioned pressure plates 6, so that the support 50 is in contact with the stop 7, or the bracket 1 is supported against the stop 7 by the support 50, so that direct contact between the bracket 1 and the stop 7 is avoided with respect to the stop 7 (see Fig.16 ).

[0101] The support 50 preferably has a base 52 connected to the pin 51, which base 52 protrudes in the radial direction R to protect the support 1 above the outer surface 10a of the support 1. In the same way, the support can have a head portion 53, that is, for example, the head portion 53 is detachably connected or connectable to the pin 51, and the head portion 53 also protrudes in the radial direction R beyond the outer surface 10a of the support 1 (see Fig.12 ).

[0102] The two ends 52, 53 of the dumbbell 50 or support 50 (i.e., for example, the base 52 and the head portion 53) form the support surface of the support 50 in the delivery system, or provide a gripping surface for the gripper. Therefore, the ends 52, 53 have a larger outer diameter than the stent 1 itself.

[0103] The support 50 is preferably designed so that one side (e.g., the head portion 53) can be opened manually or by machine (e.g., by screws, magnets, or by a snap-on connection). This allows the stent 1 to be assembled in a manual preparation step. Ideally, this is done immediately after the actual stent production (coating). This allows the support 50 to simultaneously also function as a transport container between production locations. Furthermore, the stent 1 can then be opened during a corresponding processing step in the system (e.g., during pre-curling (see Fig.18 )) is released from the support 50.

[0104] The dumbbell design in particular allows the stent 1 to be held in a pre-crimping head, or if it is arranged in zone B, even if it is still guided by parts of support 50. In addition, it allows handling of the stent 1 in other processing steps, for example during coating or during visual inspection.

[0105] Furthermore, the support 50 may also be provided with identification means (eg a QR code, RFID or the like) which serve for example for the unique traceability of the support 1. This allows the system to specify the support 1 in an unambiguous manner.

[0106] The support 50 may be designed as a disposable item or as a reusable item that can be cleaned.

[0107] like Figures 15 to 19 As can be seen in detail in the figure, the brackets 1 of the batch (for example, immediately after coating and hardening) are assembled on the support 50, the pins 51 are inserted into the interior 11 of the brackets 1, so that the brackets 1 rest, for example, on the base 52 or on the conical end section 51b of the pin 51 (see Fig.12 and Fig.13 ). In addition, it is conceivable that the bracket is fixed to the pin 51 by a torsion spring 56 (see Fig.26 ).

[0108] To save space, balloon catheters 2 (some of which are relatively long) are preferably processed in vertical direction, i.e., the catheters 2 are moved vertically to the processing level at the respective processing station (e.g., crimping head or area B). Thus, the actual processing level is below the delivery level.

[0109] The stent assembly starts in particular with a pre-crimping step. This involves roughly positioning the stent 1 on the balloon 20 and crimping the stent 1 until it is tightly against the balloon 20, but still movable. When this is done, the pressure plate 6 is covered with one or more membranes 60, in particular made of PTFE, to avoid cross contamination. That is, here (multiple) membranes 60 form the second part 5 of the protective device.

[0110] In order to pre-curl the stent 1, it can be inserted with its support 50, for example by means of a slide, vertically downwards in the insertion direction E into the region B between the pressure plates 6, so that for example the head portion 53 of the support 50 comes to lie on the pressure plates 6 (see Fig.14 ). The upper head portion 53 of the support 50 is then loosened from the lower portion or from the pin 51 , for example by a machine, and the head portion 53 is removed.

[0111] The lower part of the support 50 (here, for example, the pin 51 and the base 53) now falls together with the bracket 1 onto the lower end of the zone B, where the mechanical stop 7 defines the position of the support 50 (and therefore the position of the bracket 1) (see Fig.16). The mechanical stop 7 is preferably arranged at least the thickness of the base further down than the corresponding lower end of the pressure plate 6. Now, if the pressure plate 6 is closed (see Fig.17 ), the bracket 1 is retained and the lower part of the support 50 (ie, the pin 51 and the base 52) can be removed together (see Fig.18 ).

[0112] The balloon catheter 2 is now pushed through region B into the interior 11 of the stent 1, as shown in FIG. Fig.19 As shown, the wall structure 10 of the stent 1 surrounds the balloon 20. The pressure plate 6 now crimps or pre-crimps the stent 1 onto the balloon 20 ( Fig.19 ). The parts 51 , 52 , 53 of the support 50 can in particular be collected, cleaned and then reused as a unit.

[0113] Fig.24 and Fig.25 It is shown how this can be done without a separate head portion 53, to further simplify the process. To accomplish this, the pin 51 can, for example, protrude far enough from the interior 11 of the stent 1 that if the base 52 and the end 51 b of the pin 51 are located on the surface F, the stent 1 cannot come into contact with a plane surface F or a surface of a transport system (e.g. a slide).

[0114] In addition, according to Figures 20 to 23 The head portion 53 can also be designed so that it can be detachably connected to the pin 51 and / or the base 52 and forms a protective sheath, which surrounds the outer surface 10a of the support 1 when the head portion 53 is connected to the pin 51 and / or to the base 52 in the appropriate manner. Here again, the head portion 53 is removed after the support 50 together with the support 1 has been arranged in the area B between the pressure plates 6 (see Fig.23 ).

[0115] Furthermore, the support 50 may have a spring element 54 that allows the bracket 1 to be screwed onto the pin 51, instead of a removable head portion 53 at the end section 51a of the pin 51. In the same way, the plate-shaped base 52 may be replaced by another second spring element 55, which may be provided at the opposite end section 51b of the pin instead of the aforementioned base 52. Here, the support 50 then rests on the stop 7 via the second spring element 55 or the end of the pin 51 of the support 50.

[0116] Finally, Figures 29 to Fig.40 A further embodiment of the inventive method is shown, in which the first part 4 of the protective device is preferably formed here by a membrane 62 arranged on the stop 7, so that the support 1 cannot be subjected to any direct contact with the stop 7. The second part 5 of the protective device is formed by a flexible membrane 60, which is preferably guided by guide means, in particular by guide rollers 71 (see for example, Fig.31 and Fig.32 ), or is formed by a plurality of separate flexible membranes 60, each of which can be guided individually.

[0117] Again, the actual assembly of the stent begins with a pre-crimping step. This involves roughly positioning the stent 1 on the balloon 20 by means of the pressure plates 6 of the crimping tool and crimping the stent 1 until it rests tightly against the balloon 1 but is still movable. The position of the stent 1 in the area B between the pre-crimping heads or pressure plates is preferably defined in the insertion direction E. This is done, for example, by Fig.35 The retractable mechanical stop 7 shown in FIG.

[0118] It is advantageous if all parts that potentially come into contact with the stent 1 during pre-crimping of the stent 1 on the balloon 20 of the balloon catheter 2 are covered with retractable or rolled-up membrane sheets 60, 62. This ensures that the drug placed on the stent is always in contact with a fresh portion of the corresponding membrane or membrane sheet.

[0119] In order to allow the stent 1 or balloon catheter 2 to be guided in the region B between the pressure plates 6 , at least three membrane sections are preferably provided, which are opposite to each other. These membrane sections can be provided by a single guided membrane sheet 60 or by three or more separate membrane sheets 60 .

[0120] As shown in, for example, Figures 29(A) to (F), the membrane 60 (e.g., three membranes 60) are pulled through between adjacent pressure plates 6 and arranged in region B. As the pressure plate 6 moves in a direction toward the outer surface of the stent 1 and the balloon 20 arranged therein (for clarity, the stent 1 and the balloon 20 are not shown in Figure 29), the three membranes 60 move toward each other by the movement of the pressure plate 6 until they together create a membrane channel 61 surrounding the stent 1 in the peripheral direction. Now, the outer surface 10a of the stent 1 can no longer be in direct contact with the pressure plate 6.

[0121] As an alternative to three diaphragms 60, five diaphragms 60 may be used, as shown in Figures 30(A) to (F). Instead of the diaphragms 60 being guided and driven separately, a corresponding number of membrane segments 63 may be generated in the region B by, for example, guiding a single diaphragm 60 by a guide roller 71 through between corresponding adjacent pressure plates 6 to the region B between the pressure plates 6, so that as the pressure plates 6 move in the direction toward the outer surface 10a of the support 1, the aforementioned membrane channels 61 are formed, in which every two adjacent membrane segments 63 contact each other.

[0122] In this regard, Fig.31 and Fig.32An embodiment is shown in which the membrane 60 is guided by a guide roller 71 so that five membrane sections 63 are formed in the region B between the pressure plates 6 (here, for example, 10 pressure plates 6), which then form the aforementioned membrane channel 61 as the pressure plates 6 advance in the direction toward the support 1. This can involve the membrane 60 being unrolled from the feed roller 70 and onto the take-up roller 72, which can be driven by a motor to be completed. Alternatively, separate membranes 60 can of course be provided, each of which can be guided and driven separately. Each individual membrane 60 can, for example, be unrolled from a feed roller and rolled onto, for example, a driven take-up roller.

[0123] The mechanical stop 7 is preferably protected by a separate membrane 62, e.g. Figure 33 to Figure 37 as shown in .

[0124] After pre-crimping, the stent 1 may be repositioned and subjected to final crimping. Typically, repositioning is necessary because pre-crimping and radial tapering still allow slight changes in the position of the stent 1. Thus, repositioning allows, for example, more precise positioning between X-ray markings of a balloon catheter and thus makes it easier for the physician to position the stent using X-ray images in the case of stenosis.

[0125] Vertical handling of the balloon catheter 2 is advantageous, in particular space-saving.

[0126] In order to arrange the stent 1 on the balloon 20 of the balloon catheter 2 , the stent 1 is transported to the pressure plate 6 , for example, via a cassette by a slide system, a gripper or the like.

[0127] like Figures 35 to 40 As shown, the support 1 is then inserted into the region B between the pressure plates 6 in the insertion direction E, for example by using gravity, so that the support 1 falls onto the stop 7. This is for example Fig.35 Shown in. Fig.36 An alternative arrangement of the stop 7 is shown, which is explained below.

[0128] After the support 1 is arranged on the stop 7 with the membrane 62 therebetween, the pressure plate 6 is moved in the direction towards the outer surface 10a of the wall structure 10 of the support 1 until the support 1 is held by the pressure plate 6 (see Fig.38 ). The stopper 7 is now moved back (e.g., in the insertion direction E), and the balloon catheter 2 can be pushed from above through the interior 11 of the stent, so that the balloon 20 is arranged in the interior 11 of the stent 1. Moving the pressure plate 6 in the direction toward the outer surface 10a of the stent 1 now pre-crimps the stent 1 onto the balloon 20 of the balloon catheter 2 (see Fig.39 ).

[0129] Since the support 1 is arranged in the aforementioned membrane channel 61 in the region B, the pressure plate 6 cannot be in direct contact with the support 1, but is pressed against the support 1 by the membrane 60 or the membrane segment 63 of the membrane 60. As already explained above, the membrane channel 61 is formed by arranging, for example, three or five membranes 60 or three or five membrane segments 63 opposite to each other in the region B, each of at least one membrane 60 being guided through between adjacent pressure plates 6, so that a membrane channel 61 is formed if the pressure plates 6 are close to each other (see Figures 29 to 32). Depending on the embodiment of the pressure plate 6, the membrane 60 or the segment 63 can be in contact from the beginning or only after a certain reduction in the inner diameter of the region B.

[0130] The mechanical stop 7 below the pressure plate 6 can be protected in a relatively simple manner by a diaphragm 62. Fig.35 As shown, the stopper 7 can be arranged flush with the bottom 6a of the pressure plate 6. However, it is constructively difficult to ensure a correspondingly precise covering of the pressure plate 6 with the at least one membrane 60 or membrane segment 63. Therefore, it is advantageous if the stopper 7 is arranged so that it is not flush with the bottom 6a of the pressure plate 6, as shown in FIG. Fig.36 This makes it possible to make the corresponding diaphragm 60 or the corresponding diaphragm segment 63 protrude beyond the bottom 6a of the corresponding pressure plate 6, as shown in FIG. Fig.36 As shown. The section of the support 1 also protrudes downwards outside the area B. That is, the support 1 does not need to be completely surrounded by the side membrane 60 or the membrane section 63. Therefore, the required membrane positioning accuracy is lower and it is therefore more robust.

[0131] Pre-curling can cause Fig.40 The diameter difference in the pre-crimped stent 1 shown, i.e., the adjacent sections 10c, 10d of the stent 1 have different diameters. This difference can be equalized, for example, by pre-crimping again. To this end, the balloon catheter 2 can be pulled up a little in region B so that the stent 1 is completely surrounded by the membrane 60 or the membrane section 63. However, the diameter difference does not necessarily become equal during pre-crimping, because the stent 1 can also be processed with a diameter difference in subsequent processing steps (repositioning and crimping).

[0132] Instead of vertically inserting the stent 1 or the balloon catheter 2 into the region B between the pressure plates 6, horizontal handling of the stent 1 or the balloon catheter 2 is also conceivable. Instead of a stopper 7 positioned outside the pressure plates 6, a stopper 7 in the form of a plunger is conceivable, which enters into the region B between the pressure plates 6 and in this way defines the position of the stent 1 (see above).

[0133] Furthermore, the advancement of at least one diaphragm 60 in region B or the advancement of diaphragm 62 on stop 7 can also be produced by a movement of pressure plate 6 or mechanical stop 7, rather than by a motorized drive. For this purpose, a spring-ratchet system (e.g. Fig.34) for the stopper 7. Here, when the stopper 7 moves to the bottom 6a of the pressure plate 6, the membrane 62 is unwound from the feed roller 73 and secured by the ratchet 75. In addition, the membrane 61 can be rolled onto a take-up roller 74, which is acted upon by a spring 76 and which can also be locked in place by a ratchet 77.

[0134] In contrast, Fig.33 An embodiment is shown in which the film 61 on the stopper 7 is unwound from a feed roller 73 and wound onto a driven take-up roller 74 .

[0135] As before, in the case of a pouch-based or support-based protector, a membrane-based protector also allows effective prevention of cross-contamination during machine pre-crimping of a drug-coated stent. The membrane channels 61 produced in the method (preferably formed by at least three separate membrane sheets 60 or by at least three membrane segments 63 of a membrane sheet 60) also facilitate final crimping, in particular because there is no relative movement between the membrane and the stent 1.

Claims

1. A method for arranging a stent (1) on a balloon (20) of a balloon catheter (2), the method comprising the following steps: a) providing a support (1) having a wall structure (10), the wall structure (10) surrounding in a peripheral direction (U) and extending along a longitudinal axis (z) and surrounding an interior (11) of the support (1) extending along the longitudinal axis (z), the wall structure (10) having an inner surface (10b) facing the interior (11) and an outer surface (10a) facing away from the inner surface (10b); b) providing protective means (4, 5) to avoid contamination of the support (1); c) inserting the support (1) into the area (B) between the plurality of movable pressure plates (6) in an insertion direction (E), so that the stopper (7) limits the movement of the support (1) in the insertion direction (E); d) moving the pressure plate (6) in a direction toward the outer surface (10a) of the bracket (1) so that the bracket (1) is held by the pressure plate (6), and then retracting the stopper (7); e) inserting the balloon catheter (2) into the interior (11) of the stent (1) so that the wall structure (10) of the stent (1) surrounds the balloon (20) of the balloon catheter (2); f) moving the pressure plate (6) in a direction toward the outer surface (10a) of the wall structure (10) of the stent (1) so that the pressure plate (6) crimps the stent (1) onto the balloon (20); and g) opening the pressure plates (6) and retracting the balloon catheter (2) away from the area (B) between the pressure plates (6), wherein the stent (1) is crimped onto the balloon (20); in, According to step c), the support (1) is inserted into the region (B) so that - at least a first portion (4) of the protection device prevents contact between the face (1a) of the support (1) and the stop (7); and / or - when the pressure plate (6) is pressed against the outer surface (10a) of the stent (1), at least the second part (5) of the protective device is located between the outer surface (10a) of the wall structure (10) of the stent (1) and the pressure plate (6), the stent (1) is held by the pressure plate (6) in step d), wherein the second part (5) of the protective device is between the stent (1) and the pressure plate (6), and the pressure plate (6) crimps the stent (1) onto the balloon (20) in step f), wherein the second part (5) of the protective device is between the stent (1) and the pressure plate (6), The protective device (4, 5) is formed by a bag (40) having at least one elastically deformable wall (41), the support (1) is arranged in the bag (40) before being arranged in the aforementioned area (B), so that the at least one wall (41) surrounds the outer surface (10a) of the wall structure (10) of the support (1), and the bag (40) has a protrusion (45) at its lower end, wherein, as the balloon catheter (2) is retracted from the aforementioned area (B) between the pressure plates (6), the protrusion (45) forms a support for at least one of the pressure plates (6).

2. The method according to claim 1, wherein: The stent (1) is repositioned relative to the balloon (20) after being crimped onto the balloon (20), and after the repositioning, the stent (1) is crimped onto the balloon (20) again to fix the repositioned stent (1) onto the balloon (20).

3. A method for arranging a stent (1) on a balloon (20) of a balloon catheter (2), the method comprising the following steps: a) providing a support (1) having a wall structure (10), the wall structure (10) surrounding in a peripheral direction (U) and extending along a longitudinal axis (z) and surrounding an interior (11) of the support (1) extending along the longitudinal axis (z), the wall structure (10) having an inner surface (10b) facing the interior (11) and an outer surface (10a) facing away from the inner surface (10b); b) providing protective means (4, 5) to avoid contamination of the support (1); c) inserting the support (1) into the area (B) between the plurality of movable pressure plates (6) in an insertion direction (E), so that the stopper (7) limits the movement of the support (1) in the insertion direction (E); d) moving the pressure plate (6) in a direction toward the outer surface (10a) of the bracket (1) so that the bracket (1) is held by the pressure plate (6), and then retracting the stopper (7); e) inserting the balloon catheter (2) into the interior (11) of the stent (1) so that the wall structure (10) of the stent (1) surrounds the balloon (20) of the balloon catheter (2); f) moving the pressure plate (6) in a direction toward the outer surface (10a) of the wall structure (10) of the stent (1) so that the pressure plate (6) crimps the stent (1) onto the balloon (20); and g) opening the pressure plates (6) and retracting the balloon catheter (2) away from the area (B) between the pressure plates (6), wherein the stent (1) is crimped onto the balloon (20); in, According to step c), the support (1) is inserted into the region (B) so that - at least a first portion (4) of the protection device prevents contact between the face (1a) of the support (1) and the stop (7); and / or - when the pressure plate (6) is pressed against the outer surface (10a) of the stent (1), at least the second part (5) of the protective device is located between the outer surface (10a) of the wall structure (10) of the stent (1) and the pressure plate (6), the stent (1) is held by the pressure plate (6) in step d), wherein the second part (5) of the protective device is between the stent (1) and the pressure plate (6), and the pressure plate (6) crimps the stent (1) onto the balloon (20) in step f), wherein the second part (5) of the protective device is between the stent (1) and the pressure plate (6), The first part (4) of the protective device is formed by a support (50) of the support (1), the support (50) having a pin (51) which is inserted into the interior (11) of the support (1) before the support (1) is inserted into the aforementioned area (B) between the pressure plates (6), and the second part (5) of the protective device has a flexible membrane (60) or a plurality of separate flexible membranes (60), wherein one or more flexible membranes (60) are guided through the aforementioned area (B) between the pressure plates (6) so that when the pressure plates (6) move in a direction toward the outer surface (10a) of the wall structure (10) of the support (1), the one or more flexible membranes (60) form a membrane channel (61), which surrounds the outer surface (10a) of the wall structure (10) of the support (1) in the peripheral direction (U).

4. The method according to claim 3, wherein: The one or more flexible membranes (60) are arranged such that they protrude beyond the pressure plate (6) in the insertion direction (E).

5. The method according to claim 3, wherein: The support (1) is arranged in the aforementioned region (B) such that an end section (1b) of the support (1) protrudes beyond the pressure plate (6) and / or beyond the one or more flexible membranes (60) in the insertion direction (E).

6. The method according to claim 3, wherein: The first part (4) of the protective device has a membrane (62).

7. The method according to claim 3, wherein: The stent (1) is repositioned relative to the balloon (20) after being crimped onto the balloon (20), and after the repositioning, the stent (1) is crimped onto the balloon (20) again to fix the repositioned stent (1) onto the balloon (20).

8. The method according to claim 3, wherein: The support (50) has a base (52) from which the pin (51) protrudes, and the base (52) protrudes beyond the outer surface (10a) of the wall structure (10) of the bracket (1).

9. The method according to claim 8, wherein: The bracket (1) is inserted into the aforementioned region (B) together with the support member (50) so that the base (52) is in contact with the stopper (7).

10. The method according to claim 8, wherein: The support (50) has a head portion (53), which is detachably connected to the pin (51) and / or the base (52). The head portion (53) is connected to the pin (51) and / or the base (52) before the bracket (1) is arranged in the aforementioned area (B), and the head portion (53) is removed from the pin (51) after the bracket (1) is inserted into the aforementioned area (B).

11. The method according to claim 8, wherein: The pin (51) has a spring element at an end section opposite the base (52).

12. The method according to claim 3, wherein: The pin (51) has a first end section (51a) and an opposite second end section (51b), and the support (50) also has a first spring element and a second spring element, the first spring element being arranged on the first end section (51a) and the second spring element being arranged on the second end section (51b) of the pin (51).

Images