Preparation device for angioplasty and method for manufacturing the preparation device

Abstract

The present invention provides a preparatory device for percutaneous transluminal angioplasty, comprising a carrier and an angioplasty catheter held within it. [Solution] A preparation device for percutaneous transluminal angioplasty is disclosed. This device comprises a sterile or slated-to-sterilize angioplasty catheter (2), which is held on one side by one or more turns (6, 8, 10) on a flat carrier (4), having a hub (12) at a predetermined proximal end and at least one balloon (14) at a predetermined distal end. The carrier (4) has a recess (16) into which the angioplasty catheter (2) is received. Furthermore, a method for manufacturing the preparation device is disclosed.

Description

Technical Field

[0001] The present disclosure relates to a provision arrangement for percutaneous angioplasty comprising a carrier and an angioplasty catheter held therein, the catheter being sterilized or already sterilized, having a hub at one end and at least one balloon at the other end. The present disclosure also relates to a method for manufacturing a provision arrangement for percutaneous angioplasty.

[0002] The angioplasty catheter is enclosed in a sterile package and provided after being sterilized in that state. The sterile package enables sterilization on the one hand and guarantees the sterility of the catheter until its provision and use if properly stored. Generally, in the case of an angioplasty catheter after sterilization, the risk of recontamination until use should be eliminated.

[0003] In a method well-known in the prior art (e.g., the applicant's SeQuent® NEO product), the angioplasty catheter is held in a helically wound plastic tube, a so-called "dispenser", and provided in a sterile bag.

[0004] In the manufacturing process, this angioplasty catheter is packaged by passing the tip provided with the catheter balloon through a dispenser extending linearly slightly longer than the catheter body and inserting it until the connection or hub of the catheter contacts the insertion opening of the dispenser. The inserted angioplasty catheter is received in the dispenser and protected from damage and bending. Thereafter, the dispenser is arranged in 2 to 4 spiral windings, wound, and the wound one is fixed with a clip. The dispenser wound in this way is placed in a bag called a "peel bag", and the bag is particularly sealed or welded and closed. The above manufacturing process can be automated but requires a relatively high cost.

[0005] In the alternative manufacturing process, the dispensers are first arranged in a spiral shape, wrapped and secured, and then the angioplasty catheter is inserted into the wrapped dispenser.

[0006] All important information regarding the angioplasty catheter included in the peel bag is printed on the bag itself. This includes, for example, the catheter type, part number, lot number, manufacturing date, and expiration date. Other relevant data printed on the bag includes the guidewire diameter, the nominal diameter and length of the balloon, and the nominal pressure of the balloon (maximum allowable pressure, including the rated burst pressure). In addition, a table showing the pressure-diameter characteristics of the balloon, a so-called "compliance chart," is provided, highlighting the nominal pressure and maximum allowable pressure.

[0007] During percutaneous transluminal angioplasty, an assistant opens the peel bag and provides the angioplasty catheter to the surgeon. The surgeon retrieves the dispenser, which is held spirally by a clip, from inside the sterile peel pouch and pulls out the angioplasty catheter, which is approximately 1.5 to 2 meters long, from the dispenser. Finally, the surgeon withdraws the tip of the angioplasty catheter from the dispenser and inserts it into the patient through an arterial access sheath.

[0008] A drawback of the dispenser system is the large amount of plastic required for packaging and supplying angioplasty catheters. The packaging, namely the peel bags and dispensers, accounts for approximately 95% of the plastic in the product. Reuse is not possible.

[0009] Another drawback is that the angioplasty catheter must always be fully withdrawn to perform procedures such as irrigation and insertion into the guidewire before the surgeon can reach the catheter tip. This means that the angioplasty catheter is already exposed along its entire length, even if the initial task is simply to thread the catheter tip onto the guidewire and insert it into the sheath at the patient's access point. Therefore, the surgeon or assistant must ensure that the remaining 1 meter of the withdrawn angioplasty catheter is securely held and protected from damage and contamination. Furthermore, a syringe for removing air from the catheter (i.e., creating a vacuum or near-vacuum inside the catheter) may be connected to the hub. This further complicates the safe handling of the catheter. In addition to the actual main task of performing the angioplasty, this becomes an additional effort and a source of error.

[0010] Furthermore, numerous conduits are used or can be used in angioplasty. These include, for example, guide catheters for administering contrast agents, multiple balloon catheters for gradual dilation of stenoses or addressing multiple stenoses at bifurcations, and angioplasty catheters for stent placement. If each of these catheters is supplied by dispenser, a considerable amount of plastic must be handled in the operating room. In particular, the nominal values ​​and compliance charts printed on the peel bags, or the peel bags themselves, must be stored in a safe place so that surgeons can always reliably and clearly access the information. Moreover, this information should also be printed on the dispensers. Otherwise, it will be at least difficult to identify the angioplasty catheters and verify their specifications after the dispenser containing the catheters has been removed from the peel bag.

[0011] In contrast, the challenges of this disclosure are to avoid, or at least mitigate, the shortcomings of the prior art. In particular, one challenge is to create an angioplasty preparation device that allows users to remove angioplasty catheters in a more diverse range of ways. Another challenge is to create a method for manufacturing such a preparation device that reduces the effort required for automation, reduces resource use, and allows the use of more sustainable materials.

[0012] The first problem is solved by a preparation apparatus having the features of claim 1, and the second problem is solved by a method having the features of claim 14. Advantageous further developments are the subject of the dependent claims. [Overview of the project]

[0013] The basic idea of ​​this disclosure is to provide a sterile or sterilized angioplasty catheter in a recess of a flat carrier. For space-saving during dispensing, the angioplasty catheter is coiled within the recess, i.e., received after being wound one or more times. The recess is formed on one side of the flat carrier, i.e., is openly accessible from one side. This allows the surgeon or user to place the carrier and remove individual or multiple portions of the catheter, such as the hub, coiled portion, and tip, individually or together, from the aforementioned one side. This ensures that during the preparation and execution of angioplasty, the surgeon can reliably access all relevant parts of the angioplasty catheter, particularly the critical ends of the hub and catheter tip, without having to completely remove / withdraw the angioplasty catheter from the carrier, as is the case with conventional dispenser techniques.

[0014] The percutaneous transluminal angioplasty preparation device according to this disclosure comprises a flat carrier and a sterile or already sterile angioplasty catheter. The angioplasty catheter is wrapped around one or more times on one side of the flat carrier and held in place. According to this disclosure, the angioplasty catheter has a proximal end having a hub or connector and a distal end, particularly the catheter tip, having at least one catheter balloon. According to this disclosure, the flat carrier is provided with a recess for receiving the angioplasty catheter, so that the surgeon can safely place the carrier and remove the angioplasty catheters individually or together at different locations without having to completely remove or withdraw the angioplasty catheter from the carrier. Thus, a percutaneous transluminal angioplasty preparation device is realized, allowing the user to remove the angioplasty catheter in a variety of ways.

[0015] In a preferred further development, the carrier of the preparation device is integrally molded.

[0016] In the context of the disclosure, the term “single structure” means, in particular, that the carrier is not composed of or assembled from parts or pieces that are not connected to one another by shape, force, or material fitting. In other words, a single structure of a carrier means, in particular, that the carrier is manufactured and designed as a single, integral body from a single material.

[0017] In a preferred further development, the recess of the carrier is designed or formed to hold the angioplasty catheter solely by its design or shape. That is, no additional parts or components, such as additional cover plates or cover elements, are provided to restrict or cover the recess in order to hold the angioplasty catheter in the recess.

[0018] In a further development, the carrier for receiving, holding, and / or securing the catheter is provided with at least three support points. The support points can be provided as the edges or protrusions of recesses, as holders, as tabs, as pockets, or as clips.

[0019] Preferably, the recess or support point is curved inward relative to the angioplasty catheter, i.e., toward the angioplasty catheter, or has a projection directed toward the center, in at least part of it, thereby preventing the angioplasty catheter from slipping out of the recess or support point.

[0020] In a further developmental form, the angioplasty catheter is received and held in a carrier so that it can be removed by grasping and pulling out the hub, and / or removed as a whole, and / or the hub and / or balloon can be removed individually.

[0021] Each of the removal method options allows the surgeon to manipulate the angioplasty catheter, particularly the hub or proximal end portion and / or the balloon or distal end portion, in a controlled manner.

[0022] When removing the entire catheter, the user or surgeon can remove the angioplasty catheter while it is still coiled, connect a suction syringe (for example), thread the distal end / tip / balloon through a guidewire, and then rewind the catheter to leave it in an extended state. During the handling of this coiled angioplasty catheter, the user has better control over the entire catheter than if the catheter were first extended and then the syringe was connected and the distal end / tip / balloon through a guidewire.

[0023] According to a preferred embodiment, one or more winding portions of the angioplasty catheter exhibit flexural elasticity.

[0024] Preferably, the catheter should not be left in a coiled state. This is because uncontrollable elongation may occur due to its bending elasticity, and the sterilized state may be impaired.

[0025] According to a preferred further development form, the recess is provided with an edge or at least an edge region, and in this region, one or more winding portions are supported radially outwardly in a bending-elastic manner. Thereby, the angioplasty catheter receives tension within the recess due to its own tension or bending stress and is held on the carrier without the need for additional support points or holding devices (holders, brackets, clips, etc.).

[0026] According to an advantageous further development form, the recess has at least one independent recess region or receiving portion, and one of the end regions, namely the hub or the catheter tip, is received. This separate recess region or receiving portion not only enables each end region to be held more securely on the carrier but also allows for more precise gripping of each end region by the surgeon.

[0027] According to a further development form, the recess has a first receiving portion that extends substantially tangentially in which the hub is received, with respect to the edge region, particularly one or more windings.

[0028] Preferably, the first receiving portion is formed offset with respect to the outer contour and / or outer surface of the hub. Thereby, the hub is received within the receiving portion at a predetermined or defined position, securely fixed, and will not accidentally fall out.

[0029] As a further development form, the recess has a second receiving portion that extends tangentially from one winding or from one of a plurality of windings, and the distal end portion is received within this receiving portion.

[0030] According to a further advantageous development of the invention, the first receiving part and / or the second receiving part of the carrier are designed to be bendable, whereby it becomes possible to bend or fold the corresponding receiving part away from the hub or the distal end of the catheter respectively, so that the hub and / or the distal end / balloon are exposed and can be easily gripped.

[0031] In order to form defined fold lines or bending lines, continuous or intermittent weakening or embossing can be provided on the carrier. Linear weakening, fold lines, bending lines, or embossing are preferred.

[0032] If the carrier is not part of the sterilization barrier, continuous or sectional perforations can be provided in the carrier to form weakened parts, fold lines, or bending lines.

[0033] According to a further development, since the thickness of the carrier is reduced by weakening or embossing, the moment of inertia at the weakened or embossed part is reduced, and bending or folding can be more easily performed at this location.

[0034] In a further development, the carrier is provided with an outer peripheral edge, especially to achieve the basic rigidity against buckling of the carrier.

[0035] In a further development of the outer peripheral edge and the fold line or bending line on the carrier, it is preferred that this edge is interrupted or formed in a concave shape in the fold line or bending line region. Thereby, the basic reinforcing effect of this edge is specifically interrupted in the fold line or bending line region, making bending and folding easier.

[0036] Alternatively, instead of a fold line or bending line, a separation line may be provided, along which the corresponding part of the carrier can be separated (e.g., torn). However, the torn part needs to be discarded separately, resulting in additional work, so this embodiment is not preferred.

[0037] In a further developed form, at least one weakened portion, embossed portion, bend line, fold line, or perforation divides the carrier into a first segment having a first receiving portion and / or a second segment having a second receiving portion, and a third segment having a winding portion.

[0038] In a further developmental form, the recess has an outer contour that at least partially surrounds the angioplasty catheter to be received therein. To ensure that the angioplasty catheter can be easily inserted and removed, it is preferable that the outer contour of the recess is offset relative to the angioplasty catheter.

[0039] It is preferable that the outer contour of the recess forms its boundary along the entire length of the angioplasty catheter, so that the entire angioplasty catheter is held / fixed within the recess.

[0040] In a further developmental form that facilitates manufacturing, the carrier forms a shell at its edge or marginal region, in order to facilitate and highly automate the insertion of the angioplasty catheter into the recess of the carrier, particularly during the manufacturing of the preparation device.

[0041] In a preferred further development, the edge or marginal region where one or more windings are flexibly elastically supported radially on the outside extends at most one turn, so that a shell is formed by the carrier. This causes the windings to be supported radially on the outside of the edge or marginal region as a bundle or cluster. The advantage of this is that the angioplasty catheter and its windings can be grasped most easily "as a whole," or conversely, they can be inserted into the recess "as a whole" during the manufacture of the preparation device.

[0042] In another embodiment, an edge or edge region, in which one or more windings are flexibly and radially supported outward, is wound multiple times, particularly in a helical manner. This ensures that each winding is supported individually; that is, one winding is supported for each turn of the edge or edge region. Alternatively, it can be said that the angioplasty catheter is radially supported outward for each winding.

[0043] In one design, the spirally wound edge region is formed by the radially outer side surface of the spirally wound circumferential groove.

[0044] In a preferred further development, the marginal region in which one or more windings are flexibly and radially supported outward is designed to be at least partially steep and / or undercut in shape, thereby guiding the angioplasty catheter in the marginal region and preventing the windings from popping out of the recess when the angioplasty catheter is grasped at the hub and withdrawn from the recess.

[0045] This configuration, in addition to or as an alternative to the aforementioned "overall" angioplasty catheter grasping, allows surgeons to guide the withdrawal of the angioplasty catheter from the carrier in a manner familiar to them, such as the conventional technique using a spirally wound tubular dispenser.

[0046] Undercuts can be formed along the entire circumference, particularly by complete circumferential projections.

[0047] Alternatively, or additionally, undercuts may be formed circumferentially in sections, particularly by multiple protrusions.

[0048] The two forms of undercuts, fully circular or partially circular, both prevent the angioplasty catheter from accidentally popping out when it is fully seated in the recess.

[0049] Furthermore, the undercuts in each compartment have the advantage that when the catheter's hub or tip is removed from the recess, the rest of the catheter simply slides or pops out of the recess until it contacts the next undercut compartment, particularly the tip edge of the next projection that forms this undercut. At this edge, the catheter is self-retaining due to outward bending elasticity. To proceed further removal, it is necessary to deform it inward again against the outward bending elasticity to overcome this projection. Due to the bending elasticity, this cannot be done automatically, thereby preventing the angioplasty catheter from popping out automatically. Instead, manual intervention by the user or surgeon is required to guide the angioplasty catheter around the projection and continue removal in a controlled manner until the next projection. Manual intervention is again required here, and so on.

[0050] In a preferred embodiment, at least three projections are provided on the radial outer edge of the recess in which the winding portion of the angioplasty catheter is supported, for each winding portion of the angioplasty catheter. These projections are distributed across the circumferential angle of each winding portion, and this circumferential angle is set to be greater than 180°, thereby realizing the aforementioned self-locking mechanism and preventing uncontrolled jumping or slipping of the angioplasty catheter.

[0051] In a preferred further development, the projections are arranged to be substantially evenly distributed around the inscribed angle, and in particular, at regular angular intervals.

[0052] In a preferred further development, the projection extends radially inward, particularly toward the center or central region of the carrier.

[0053] In a preferred further development, particularly when the winding portion is supported radially in a bundle or tufted manner at the outer edge or marginal region, the projection extends at least partially toward the base or bottom of the recess. This ensures that the angioplasty catheter is held more securely within the recess.

[0054] In a preferred further development, particularly when the winding portion is supported radially in a bundle or clump shape at the outer edge or edge region, the projection extends radially inward by at least the bundle or clump diameter, preferably by at least 125% to 150% of the bundle or clump diameter. This ensures that the bundle or clump is securely held within the recess.

[0055] In a preferred further development, particularly when the edge or marginal region of the recess is wound multiple times, especially when each winding portion is individually radially supported outside the edge or marginal region, the projection extends radially inward by at least one-quarter (25%) of the diameter of the angioplasty catheter. Preferably, they extend radially inward by about 50%, and up to about 100% to 150%, of the diameter of the angioplasty catheter. This radial inward extension of the projection relative to the diameter of the angioplasty catheter achieves optimal withdrawal of the angioplasty catheter from the recess and optimal retention of the angioplasty catheter within the recess.

[0056] In a preferred further development, the projection is curved in a hook shape toward the bottom or base of the recess, particularly U-shaped or V-shaped. This ensures that the angioplasty catheter is held particularly securely within the recess.

[0057] A combination of a complete circumferential undercut and a partial circumferential undercut (projection) is possible; for example, a complete circumferential undercut can be configured such that the projection repeatedly extends radially inward.

[0058] In a preferred further development, a gripping recess is provided on the carrier to improve the gripping of the angioplasty catheter in the recess, particularly in the peripheral region of the recess, especially in the region of the hub and / or winding and / or catheter balloon, and is provided to at least partially cover the received angioplasty catheter, particularly the hub, winding, or catheter balloon.

[0059] Alternatively, at least one through-hole is provided in the carrier, which at least partially overlaps with the hub, winding, or catheter balloon. A through-hole means a hole provided in the carrier.

[0060] Alternatively, this recess can be said to be interrupted by a gripping recess or a through hole. In the case of a gripping recess, interruption means that the gripping recess is formed deeper than the recess.

[0061] In this way, the ends constituting the hub, one or more coils, or balloon can be easily gripped / undergrip / held in the gripping recess or through hole, and can be lifted, removed, or pulled out from the recess.

[0062] Preferably, in order to improve the removal of the angioplasty catheter "as a whole" from the previous procedure, two, three, or four gripping recesses or through-holes are arranged along one or more winding sections, preferably at equally spaced angular intervals.

[0063] According to a preferred further development, the carrier is designed and configured to be permeable to sterile media and impermeable to bacteria. Naturally, this further development is not effective in the aforementioned embodiment having a through-hole for improving the grip of the angioplasty catheter.

[0064] Preferably, the carrier is permeable to water vapor and / or ethylene oxide gas. In designs with gripping recesses, this is preferably achieved by the porosity of the material used. In designs with the aforementioned through holes to improve gripping, such porosity is not required.

[0065] In a preferred further development, the carrier is deep-drawn from a film, preferably a biofilm, or molded from a fibrous material, preferably a biofibrous material. By using the aforementioned biomaterials, the carrier can be completely free of plastic, potentially reducing the amount of plastic waste generated. This improves sustainability.

[0066] For example, it is possible to use a polylactic acid-based thermoformable film (PLA film).

[0067] In a further developmental form, the carrier is provided with at least one opening, which reduces the amount of material that can be fed into the carrier and its weight.

[0068] Preferably, the opening is located in the center of the carrier and is arranged radially inward or concentrically with respect to one or more winding sections.

[0069] In a further development, this recess is covered by a sealing film connected to a carrier, thereby holding the angioplasty catheter within the recess by the sealing film. In other words, it prevents unintended dropping or ejection.

[0070] In a preferred further development, the recess is aseptically sealed with a sealing film. In this case, the carrier forms a sterile barrier with the sealing film. A prerequisite for this further development is that the carrier does not have the aforementioned through-holes to improve gripping.

[0071] According to another embodiment, a packaging bag or "peel bag" is provided in which the carrier is placed in an unsealed state, and the packaging bag is sealed in a sterile state. In this case, the carrier is solely responsible for holding and subsequently storing / supplying the angioplasty catheter, and the sterile barrier is formed by the packaging bag or peel bag.

[0072] Further developments using this seal bag to form a sterile barrier are particularly necessary when the carrier has at least one of the aforementioned through-holes, in order to improve the grip of the angioplasty catheter.

[0073] In a preferred further development, at least one parameter of the angioplasty catheter is inscribed on the seal film. Examples include the catheter type, part number, lot number, manufacturing date, expiration date, guidewire diameter, balloon nominal diameter and length, nominal pressure, maximum allowable pressure, and / or balloon pressure-diameter characteristics.

[0074] When the seal film is opened, the seal film is retained on the carrier, and to ensure that the aforementioned information, particularly regarding at least one parameter, is not lost, the opening portion of the seal film is detachably connected to the carrier, while the connection portion of the seal film is more firmly connected to the carrier than the opening portion, and is particularly retained on the carrier. When this preparation device is open, the angioplasty catheter is freely available within the recess of the carrier, while the characteristic variables are reliably retained on the carrier without being lost. This ensures that the specification information of the angioplasty catheter is always available.

[0075] In a preferred further development, the connection and opening are bonded to the carrier.

[0076] In further developmental forms, the connection and opening are bonded to the carrier by adhesive layers of different designs, achieving a stronger bond between the connection and the carrier.

[0077] In further developmental forms, different process parameters are applied to the carrier during bonding of the connection and opening, achieving a stronger bond between the connection and the carrier. Specifically, the bonding process parameters are as follows: preliminary surface treatment of the connection, opening and / or carrier; type and application method of the adhesive; temperature and pressure during application and / or curing; curing time and / or setting time.

[0078] According to another preferred further development, the connection and opening are sealed or welded to the carrier.

[0079] In further developmental forms, different process parameters are applied to the carrier during sealing or welding of the connection and opening to achieve a stronger connection with the carrier. Specifically, these process parameters during sealing or welding include heating time, temperature, and / or contact pressure for the connection, opening, and / or carrier.

[0080] After partially removing the sealing film, the angioplasty catheter can be prepared for angioplasty without removing the catheter. After partially removing the sealing film, the carrier can also be reused for temporary storage of the angioplasty catheter.

[0081] A method for manufacturing a preparatory device for percutaneous transluminal angioplasty, in particular a method of manufacturing a preparatory device designed according to at least one aspect of the above description, includes the following steps: - A step of primary molding or remolding a flat carrier having a recess; and - The step of inserting an angioplasty catheter having a hub at a predetermined proximal end and at least one catheter balloon at a predetermined distal end into the recess, wherein the angioplasty catheter is received and held in the recess with one or more wraps around it.

[0082] Flat carriers with recesses can be manufactured at low cost by primary molding or remolding. Primary molding or remolding further allows for a virtually unlimited variety of recess shapes. This enables the cost-effective manufacturing of recesses, allowing for the simplest possible insertion and secure retention of angioplasty catheters into the recesses. This results in a manufacturing method for preparation devices that minimizes or eliminates the labor required for automation.

[0083] In a further development of this method, molding is performed by deep drawing of a film, preferably a biofilm, and primary molding is performed by fiber casting of a fibrous material, preferably a biofiber material. This improves sustainability. It is also possible to injection mold non-fibrous materials.

[0084] In one variation of this method, the following process steps are provided: - A step of covering the recessed parts of the carrier with a sealing film; and - For example, a process of connecting a sealing film to a carrier by sealing (heat sealing), bonding, fusion welding (including ultrasonic welding, laser welding, butt welding with heating elements), or press welding. This ensures that the angioplasty catheter is packaged in a sterile state within a limited receiving space provided by the carrier and sealing film. Thus, the carrier, together with the sealing film, forms a sterile barrier.

[0085] Alternatively, in addition to, or instead of, the steps of covering the recesses of the carrier with a sealing film and connecting the sealing film to the carrier, this method includes the following steps: - The process of sealing the carrier into a sealed bag; and - For example, a process of sealing a seal bag using one of the connection technologies described in the previous section. This eliminates the need to seal the recess with a separate sealing film, and the carrier and the catheter held within it are packaged in a sterile condition within the sealed bag.

[0086] These last two steps are particularly necessary when the carrier is not suitable for forming a sterile barrier. For example, this would be the case if it has at least one of the aforementioned through-holes to improve the grip of the angioplasty catheter.

[0087] Disclosures relating to the preparation apparatus under this disclosure shall apply to the methods under this disclosure, and vice versa. [Brief explanation of the drawing]

[0088] The disclosed information will be further explained below with reference to the diagrams.

[0089] [Figure 1] Figure 1 is a plan view of a first embodiment of the preparation apparatus according to the present disclosure, which includes a carrier, an angioplasty catheter to be received in the carrier, and a partially removed seal film. [Figure 2] Figure 2 is a rear view of the preparation apparatus shown in Figure 1. [Figure 3] Figure 3 is a plan view of a second embodiment of the preparation apparatus according to the present disclosure, which includes a carrier, an angioplasty catheter to be received in the carrier, and has the sealing film completely removed. [Figure 4] Figure 4 is a rear view of a third embodiment of the preparation device according to the present disclosure, which includes a carrier, an angioplasty catheter to be received in the carrier, and a sealing film. [Figure 5] Figure 5 is a cross-sectional view of the preparation apparatus shown in Figure 1. [Figure 6] Figure 6 is a cross-sectional view of a fourth embodiment of the preparation apparatus according to this disclosure. [Figure 7] Figure 7 is a cross-sectional view of a fifth embodiment of the preparation apparatus according to this disclosure. [Figure 8] Figure 8 is a flowchart illustrating a method for manufacturing a preparation apparatus according to one embodiment of the present disclosure. [Modes for carrying out the invention]

[0090] Figure 1 shows a top view of the preparation device 1 for percutaneous transluminal angioplasty according to the first embodiment, as seen by the surgeon when the preparation device 1 is opened.

[0091] The preparation device 1 mainly has a circular, flat carrier 4, on which a sterile angioplasty catheter 2 is placed and held. The angioplasty catheter 2 is held on the carrier 4 in a wound state with multiple winding sections 6, 8, and 10. The angioplasty catheter 2 has a hub 12 or connector, particularly for connecting an angioplasty syringe, at a predetermined proximal end, and a catheter balloon 14 at a predetermined distal end.

[0092] The carrier 4 has a recess 16 on its flat side 15, into which the entire angioplasty catheter 2 is received and held. The recess 16 has a first receiving portion 28 or holding portion, which extends tangentially to the radially outermost winding portion 6, and into which the hub 12 is received. The first receiving portion 28 has an offset with respect to the outer contour of the hub 12, and its dimensions are set so that the hub 12 can be easily inserted into the first receiving portion 28, preventing slippage or detachment, while still being easily grasped and removed. In the area of ​​the first receiving portion 28, the carrier 4 has a corner portion that interrupts the circular shape.

[0093] As shown in Figure 1, the recess 16 is covered with a sealing film 18. The sealing film 18 is connected to the flat surface 15 of the carrier 4 by a material fixing method, specifically by a heat seal.

[0094] The recess 16 shown in Figure 1 is designed to extend spirally in the circumferential direction. To avoid overloading Figure 1, the spiral arms of the recess 16, which are covered with the sealing film 18, are omitted from the illustration. The winding sections 6, 8, and 10 extend from the hub 12 toward the catheter balloon 14 within the spiral circumferential groove 16. The winding sections 6, 8, and 10 and the catheter balloon 14 are all covered with the sealing film 18 and are therefore shown with dashed lines in Figure 1.

[0095] In the illustration in Figure 1, the sealing film 18 is pulled back just enough from the flat surface 15 of the carrier 4 to expose the hub 12. This is intended to represent the moment when the surgeon opens the preparation device 1 to remove the angioplasty catheter 2 during preparation for or during angioplasty.

[0096] When the preparation device 1 is closed, the seal film 18 is connected to the carrier 4 along its entire length or across its entire flat surface 15. The seal film 18 then, together with the carrier 4, forms a sterile barrier for the angioplasty catheter 2 held in the recess 16. The recess 16 constitutes a sterile receiving space for the angioplasty catheter 2.

[0097] The carrier 4 and sealing film 18 of the preparation device 1 shown in Figure 1 thus form a compact sterile barrier to the angioplasty catheter 2 with minimal material use.

[0098] A data field 22 containing all relevant parameters of the angioplasty catheter 2 is displayed on the upper or outer surface of the seal film 18 facing the surgeon. The parameters listed are as follows: catheter type, part number and lot number, manufacturing date and expiration date, guidewire diameter, balloon nominal diameter and total length, nominal pressure and maximum allowable pressure, and balloon pressure-diameter characteristics (compliance chart).

[0099] At a position directly opposite the corner region of the flat surface 15, i.e., directly opposite the first receiving portion 28 or hub 12, the seal film 18 has a connecting portion 26 that is securely connected to the carrier 4, thereby ensuring that the aforementioned parameters and information regarding the angioplasty catheter 2 are not lost and remain available even if the seal film 18 is opened. As shown in Figure 1, the opening 24 of the seal film 18 is located diametrically opposite the connecting portion 26 and extends from the connecting portion 26 to the corner region of the flat surface 15.

[0100] Compared to the connection point 26, the opening 24 is more loosely connected to the carrier 4, allowing the surgeon to remove it with moderate force.

[0101] The opening 24 is sized to cover the entire angioplasty catheter 2, and when the opening 24 is pulled back, the hub 12, all the windings 6, 8, 10, and the catheter tip 14 are exposed. However, the more securely connected connector 26 makes further removal difficult, allowing the surgeon to intuitively stop the removal.

[0102] The stronger connection of the aforementioned connection part 26 is designed to be strong enough to allow the connection part 26 to be detached manually or automatically for subsequent waste sorting.

[0103] After partially removing the sealing film 18 up to the connection portion 26, the angioplasty catheter 2 can be prepared for angioplasty without removing it from the carrier 4, or more precisely, from its recess 16. Furthermore, after partially removing the sealing film 18, the carrier 4 can be reused for temporary storage of the angioplasty catheter 2.

[0104] The carrier 4 has a circular through-hole or through-opening 20 located in the center, i.e., approximately concentric with the winding sections 6, 8, and 10, in order to keep the material consumption of the preparation device 1 low.

[0105] Figure 2 shows a rear or bottom view of the preparation device 1 according to Figure 1. The flatness of the carrier 4 can be clearly recognized from the fact that the recess 16 on the flat surface 15 of the carrier 4 bulges toward the observer. As described above, the angioplasty catheter 2 (shown by a dashed line) extends from the first receiving portion 28 of the recess 16 to the distal end equipped with the balloon catheter 14, with its radially outer winding portion 6, radially middle winding portion 8, and radially inner winding portion 10.

[0106] According to the first embodiment shown in Figures 1 and 2, the recess 16 extends from the first receiving portion 28 as a spiral groove.

[0107] To prevent bending, the carrier 4 is provided with a posterior peripheral edge 52 (see also Figure 5). The edge 52 is formed at the posterior end so as not to obstruct the closure or sealing of the anterior recess 16 and the seal foil 18, or the removal of the angioplasty catheter 2 from the recess 16.

[0108] Figure 3 shows a plan view of a second embodiment of the preparation device 101 according to the present disclosure, which includes a carrier 104 and an angioplasty catheter 2 held in the carrier 104, with the sealing film completely removed.

[0109] To avoid redundant explanations, only the differences from the first embodiment shown in Figures 1 and 2 will be discussed below. Furthermore, common components in each embodiment will be denoted by the same reference numerals.

[0110] As shown in Figure 3, the carrier 104, more precisely on its flat surface 15, has multiple gripping recesses 30, 32, each opening into a recess 116. Since the gripping recess 30 opens to the first receiving portion 28 from the side, the hub 12 can be grasped from the side with one finger and removed from the first receiving portion 28. The other four gripping recesses 32 are arranged at equal angles along the winding portions 6, 8, and 10, and are formed deeper in the flat surface 15 than the spiral recess 116, thus blocking the recess 116. Therefore, the winding portions 6, 8, and 10 are positioned to straddle each of the gripping recesses 32. This arrangement allows the winding portions 6, 8, and 10 to be grasped simultaneously from the radially inward and outward directions, enabling the angioplasty catheter 2 to be removed from the carrier 104 "as a whole" or "as a unit".

[0111] In another embodiment of the preparation apparatus according to this disclosure (not shown), access to the angioplasty catheter is achieved not by a grasping recess, but by a through-hole (essentially a hole in the carrier) provided in the carrier. Importantly, a carrier thus perforated can no longer perform its sterile barrier function. In this case, the carrier is limited to a mere holding function. In this embodiment, additional packaging is required to form a sterile barrier. For example, the carrier holding the angioplasty catheter may be placed in a sealable bag ("peel bag") that is impermeable to bacteria.

[0112] Figure 4 shows a rear view of a third embodiment of the preparation device 201 according to this disclosure, and includes a carrier 204, an angioplasty catheter 2 received in the carrier 204, and a sealing film 18.

[0113] In the region of the carrier 204 located approximately diametrically opposite to the first receiving portion 28, the recess 216 on the carrier 204 forms an elongated projection / extension, thereby separating the catheter balloon 14 from the remaining winding portions 6, 8, and 10, and allowing it to be individually grasped when the seal film 18 is removed. This allows the surgeon to grasp the catheter tip / catheter balloon 14 independently and insert it into the sheath at the patient's arterial access site during the preparation or execution of angioplasty, without having to remove the remaining components of the angioplasty catheter 2 (i.e., the winding portions 6, 8, and 10 and the hub 12). This facilitates the surgeon's operation because the majority and longest portion of the angioplasty catheter 2 remains neatly and securely housed within the carrier 204 even during catheter tip insertion.

[0114] To allow the surgeon to more easily grasp the hub 12 and the catheter tip / catheter balloon 14, the carrier 204 is provided with two linear weak points 37, 38 formed by embossing, which function as bending or folding lines. This significantly reduces the moment of inertia of the carrier 204 in that region, thereby reducing its resistance to bending / folding.

[0115] These embossed sections 37 and 38 divide the carrier 204 into three segments 40, 42, and 44, which are bendable / foldable relative to each other. This allows the first receiving section 28 and the second receiving section 34 to be folded away from the third segment in the center of the carrier 204, thereby exposing the hub 12 and / or catheter balloon 14 as desired and allowing them to be grasped without any obstruction.

[0116] In the embodiment shown in Figure 4, the embossed portions 37 and 38 are straight. Alternatively, they may be curved overall or partially, for example, to conform to the curved path of the recess 216 in the regions of the adjacent winding portions 8 and 6.

[0117] The carrier 204 in the embodiment shown in Figure 4 also has a rim 252 surrounding its outer circumference. Unlike the rim 52 in the embodiments shown in Figures 1 and 2, the rim 252 shown in Figure 4 is interrupted in the regions of the embossed portions 37 and 38. The edge portion 252 has gaps 46 and 48 in each of these regions, thereby interrupting its reinforcing effect in particular in those regions. This makes it particularly possible and easy to bend or fold each segment 40 and 42 away from the central third segment 44, while the edge portion 252 continues to exert its reinforcing effect except for the gaps 46 and 48.

[0118] Figure 5 shows a cross-section AA of the preparation device 1 according to Figure 1. Therefore, in Figure 5, the spiral circumferential recess 16 is cross-sectioned on the right side in the regions of the three winding sections 6, 8, and 10, and on the left side in Figure 5, it is cross-sectioned only in the regions of the radially outer winding section 6 and the radially central winding section 8. The recess 16 is designed as a groove with a rounded groove bottom.

[0119] Because the edges on both sides of the groove, i.e., the radial outer edge or edge region 36 and the radial inner edge or edge region 38 of the recess 16, are formed steeply relative to the flat surface 15, the groove / recess 16 tapers slightly again toward the flat surface 15. This creates a complete circumferential undercut in the recess 16, particularly from the radial outer edge or edge region 36, thereby fundamentally fixing the winding portions 6, 8, and 10 against protrusion or slippage from the groove / recess 16.

[0120] In addition to a complete circumferential undercut, a partially circumferential undercut is provided, which is formed by individual protrusions 50 arranged at equal intervals along the radial outer edge or edge 36. In the illustrated embodiment, there are four protrusions 50 for each winding section 6, 8 and three protrusions 50 for each winding section 10, but due to the cross-sectional view in Figure 5, only two are visible for each winding section 6, 8 and one for each winding section 10. The protrusions 50 are distributed substantially evenly across the circumferential angle of each winding section 6, 8, and 10.

[0121] For example, as shown in Figure 1, when the user removes the balloon 14 of the angioplasty catheter 2 from the recess 16, the complete circumferential undercut of the aforementioned edge 36 is already invalidated by this removal action alone, and the catheter 2 begins to slide along this undercut due to outward bending elasticity. However, the angioplasty catheter 2 will not slide out of the recess 16 until it contacts the tip of one of the projections 50. Here again, the bending elastic force acts radially outward, causing the angioplasty catheter 2 to self-lock on the corresponding projection 50. If the user deforms the angioplasty catheter 2 radially inward (in the sense of elastic deformation) at this point, it can overcome the corresponding projection 50 and continue to be removed in a controlled manner up to the next projection 50. "Deformation" here means moving the portion of the catheter protruding from the carrier toward the center of the carrier, which causes the catheter to partially elastically deform.

[0122] Another advantage of the fully circumferential undercuts and projections 50 is that when the angioplasty catheter 2 is withdrawn from the carrier 4 at the hub 12 (see Figure 1), it can be withdrawn almost tangentially to the radially outer winding portion 6. This ensures that it remains guided within the groove / recess 16 until the end of the withdrawal, preventing it from unintentionally popping out of the groove / recess 16.

[0123] Figure 6 shows a portion of a fourth embodiment of the preparation device 301 according to the present disclosure. Unlike the embodiments described above in Figures 1, 2, and 5, the recess 316 is designed as a groove with a highly asymmetrical cross-sectional shape. The radial outer edge 36 of the recess 316 is designed to be steep and have the aforementioned complete circumferential undercut, and to include the projection 50, similar to that shown in Figure 5. In contrast, the radial inner edge 38 of the recess 316, i.e., the radial inner surface of the groove 316, is designed to be flat. This allows for easy manual or automatic insertion of the angioplasty catheter 2 into the recess 316 during the manufacturing of the preparation device 301 shown in Figure 6.

[0124] Due to the elasticity of the windings 6, 8, and 10, the angioplasty catheter 2 is subjected to tension radially outward, pressing against the edge 36 and being supported radially there, similar to the embodiments described above. This support, combined with the aforementioned full-circumferential undercut and projection 50 on the radial outer edge 36, prevents the angioplasty catheter 2 from flying out when it is withdrawn from the recess 316, as in the embodiment shown in Figure 6. The effects and advantages of the projection 50 in the preparation device 301 are the same as those of the preparation device 1 shown in Figures 1, 2, and 5.

[0125] Figure 7 shows a cross-sectional view of a fifth embodiment of the preparation device 401 according to the present disclosure. In contrast to all the embodiments described above, the recess 416 is not designed to extend spirally around the circumference, but extends at most once around the circumference. Except for the corner region described above, this recess 416 is designed to extend in an annular shape, so that all the winding portions 6, 8, and 10 are supported together as a "group" or "bundle" at the radial outer edge 436. Therefore the recess 416 is very wide in the radial direction, which further simplifies the insertion of the angioplasty catheter 2, whether manual or automatic, during the manufacture of the preparation device 401. In this embodiment as well, the radial outer edge 436 is formed with the aforementioned complete circumferential undercut and projection 450, so that the angioplasty catheter 2 can be removed without popping out.

[0126] In contrast to the projections 50 shown in Figures 5 and 6, the projection 252 shown in Figure 7 is formed in a hook, claw, or rake shape, extending significantly longer radially inward from the recess 416 and having a larger undercut. This is because, unlike the individually spirally guided winding sections 6, 8, and 10 as shown in Figures 1 to 6, the group-arranged winding sections 6, 8, and 10 are not individually guided. For example, when pulling or lifting the hub 12 out of the recess 416, the winding sections 6, 8, and 10 may slightly interfere with each other. In this case, the large protruding projection / rake 252 prevents, for example, one winding section from unintentionally lifting the other winding section and pulling it out of the recess 416.

[0127] Figure 8 shows a flowchart of the method according to the disclosure for manufacturing a preparation apparatus according to the disclosure, in particular a preparation apparatus designed according to at least one aspect of the preceding description.

[0128] The first step is S0 initialization or manufacturing initiation. A detailed explanation with reference to Figures 1, 2, and 5 is provided for the purpose of supplementing the explanation with drawings showing a first embodiment of the manufactured supply arrangement 1.

[0129] Following the initialization in step S0, in step S1, the flat carrier 4 having the recess 16 is subjected to primary molding and / or remolding. Primary molding and / or remolding can be carried out by deep drawing of a film (preferably a biofilm) or by fiber casting of a fibrous material (preferably a biofiber material). Such biofilms or biomaterials enhance sustainability. Non-fibrous materials can be injection molded.

[0130] Next, step S2 is performed in which the angioplasty catheter 2 is inserted into the recess 16 manually or preferably automatically. At this time, the angioplasty catheter 2 is received by the recess 16 and held by the multiple winding portions 6, 8, and 10. This holding is due, on the one hand, to the shape of the recess 16 having a radial outer edge portion 36 with an undercut and a first receiving portion 28 as described above, and on the other hand, to the elasticity of the winding portions 6, 8, and 10. As a result, the angioplasty catheter 2 is subjected to tension relative to the radial outer edge portion 36 in a bending elastic manner.

[0131] In order to package the angioplasty catheter 2 in a sterile state and form a sterile barrier, a modified version of this method includes step S3 of covering the recess 16 with a sealing film 18, and step S4 of connecting the sealing film 18 to the carrier 4, particularly by means of adhesion or ultrasonic welding, thereby aseptically packaging the angioplasty catheter 2 within a receiving space surrounded by the carrier 4 and the sealing film 18.

[0132] Alternatively, in addition to steps S3 and S4, the carrier and the catheter held therein can be sterilely packaged in a sealable bag by performing step S5, which involves packaging the carrier in a sealable bag, and step S6, which involves sealing the sealable bag.

[0133] This is followed by step SE, which completes the manufacturing process. [Explanation of symbols]

[0134] 1 Preparation equipment 2. Angioplasty catheter 4;104;204;304;404 Career 6, 8, 10 Winding section 12 hubs 14 Catheter balloon 15 flat surface 16;116;216;316;416 recess 18 Seal film 20 through-holes 22 data fields 24 openings 26 Connection part 28 First Receptor 30, 32 Gripping recess 34 Second Receptor 36 Radial outer edge 37 First Embossing 38 Second Embossing 40. Segment 1 42. Segment 2 44 Third Segment 46 The first gap 48 The second gap 50;450 Undercut / Protrusion 52;252 connection S0 Manufacturing start process S1 Carrier primary molding process S2 Angioplasty catheter insertion procedure S3 Process of covering the carrier with sealing film S4 connection process S5 Process of packaging carriers into sealed bags S6 Seal bag sealing process SE End-of-Production Process

Claims

1. A preparation device for percutaneous transluminal angioplasty, Includes sterile or sterilizable angioplasty catheters, An angioplasty catheter is held by being wrapped around one or more times on one side of a flat carrier, has a hub at a predetermined proximal end, and has at least one balloon at a predetermined distal end. The carrier has a recess into which an angioplasty catheter is received. Preparation equipment.

2. The recess has an edge region in which one or more winding portions are supported radially outward in a bending elastic manner by their own bending elasticity. The preparation apparatus according to claim 1.

3. The recess has a first receiving or retaining portion which receives the hub and extends substantially tangentially with respect to the edge region, The preparation apparatus according to claim 2.

4. The recess has a second receiving or holding portion that receives a predetermined distal end or at least a balloon and extends substantially tangentially to the winding or to one of the windings, The preparation apparatus according to claim 2 or 3.

5. The first receiving portion and / or the second receiving portion are designed to be bent so that the first receiving portion can be bent or folded away from the proximal end or hub, and / or the second receiving portion can be bent or folded away from the distal end or balloon, so that the proximal end or hub and / or the distal end or balloon are exposed and can be easily grasped. The preparation apparatus according to claim 3.

6. The marginal region wraps around at most once, and the wound portion is supported by the marginal region as a bundle or cluster. The preparation apparatus according to claim 2.

7. The marginal region wraps around multiple times, and the angioplasty catheter is supported by the marginal region at each winding section. The preparation apparatus according to claim 2.

8. The marginal region is designed to be at least partially steep and / or undercut in shape, so that the angioplasty catheter is guided in the marginal region and the coiled portion does not protrude from the recess when grasping the angioplasty catheter at the hub and withdrawing the angioplasty catheter from the recess. The preparation apparatus according to claim 2.

9. The carrier is provided with at least one gripping recess or at least one through-hole that at least partially overlaps with the angioplasty catheter. The preparation apparatus according to claim 1.

10. The carrier is provided and designed to be permeable to sterile media, and the carrier is provided and designed to be impermeable to bacteria. The preparation apparatus according to claim 1.

11. The carrier is made from a deep-drawn film or molded from a fibrous material. The preparation apparatus according to claim 1.

12. A recess is covered by a sealing film connected to a carrier, and the recess is aseptically sealed by the sealing film, or a packaging bag is provided in which a carrier is placed, and the packaging bag is aseptically sealed. The preparation apparatus according to claim 1.

13. At least one characteristic value or parameter of the angioplasty catheter is inscribed on the seal film, and / or the seal film has an opening that is detachably connected to the carrier, and / or the seal film has a connection that is more firmly connected to the carrier than the opening and is designed to remain on the carrier if the opening comes off. The preparation apparatus according to claim 12.

14. A method for manufacturing a preparatory device for percutaneous transluminal angioplasty, The steps include: primary molding or remolding a flat carrier having a recess, A step of inserting an angioplasty catheter having a hub at a predetermined proximal end and at least one catheter balloon at a predetermined distal end into the recess, wherein the angioplasty catheter is housed and held in the recess with one or more wraps around it; including, method.

15. Primary forming and / or reforming is performed by deep drawing of the film or by casting of the fiber material. The method according to claim 14.

16. The steps include covering the recessed part of the carrier with a sealing film, The angioplasty catheter is packaged in a sterile condition within a limited receiving space defined by the carrier and the sealing film, by connecting the sealing film to the carrier, The steps include sealing the carrier in a sealed bag, The process includes the step of sealing a seal bag so that the carrier and the angioplasty catheter held therein are sterilely packaged within the seal bag, The method according to claim 14 or 15.

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