Catheter storage and transport device
The dispensing device with retaining elements addresses the handling and environmental issues of PTCA catheters by enabling easy access and reducing material usage, improving handling and sustainability.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- B BRAUN MELSUNGEN AG
- Filing Date
- 2024-04-26
- Publication Date
- 2026-05-21
AI Technical Summary
Existing catheter dispensers for percutaneous transluminal coronary angioplasty (PTCA) are cumbersome to handle and environmentally unsustainable due to their plastic composition, which constitutes a significant portion of the product's plastic requirements.
A dispensing device with a support and retaining elements, featuring at least three retaining tabs positioned along a retaining circle, allows for secure coiling and easy access to both ends of the catheter, reducing material usage and environmental impact.
The device facilitates easy handling and reduces material usage, minimizing spatial requirements and costs while ensuring secure storage and transport of PTCA catheters.
Smart Images

Figure 2026516320000001_ABST
Abstract
Description
Technical Field
[0005] ,
[0001] The present invention relates to a providing device for the storage and transportation of catheters, particularly balloon catheters for percutaneous transluminal coronary angioplasty.
Background Art
[0002] Balloon catheters for percutaneous transluminal coronary angioplasty, also called PTCA catheters, are useful for treating high-grade coronary artery stenosis. To treat them, the balloon catheter is inserted into the coronary artery via a guide wire and inflated.
[0003] Currently commercially available PTCA catheters are transported and stored in so-called dispensers. These are long plastic hoses that are longer than the catheter itself. The plastic hose is wound in a circular shape with the catheter housed therein and fixed by clips so as not to unwind. The catheters to be inserted can be reliably transported and stored in this type of package. <000001十四> Problems with the described dispensers are, firstly, their handling, particularly the cumbersome removal of the catheter, and secondly, their impact on the environment. Just the plastic hoses used as packages constitute the largest proportion, i.e., about 95%, of the plastic requirements of the entire product.
[0005] It should be noted that there may be an error in the "十四" in "ID=18", which is likely a misrepresentation. It is presented as it is in the original text for the purpose of translation.In particular, a holding device for medical devices is disclosed in Japanese Patent Publication No. 2016-064089. Japanese Patent Publication No. 2012-176101 relates to a package for medical devices, particularly catheters. International Publication No. 2019 / 171672 describes a storage device for objects having a long range. German Patent Application Publication No. 4333073 discloses a package for hose-shaped articles. U.S. Patent No. 4,332,322 discloses a foldable package for holding a spool of plastic tubing, the package having a clip and a corresponding molded piece. U.S. Patent No. 5,131,537 relates to a package for medical catheters. U.S. Patent Application Publication No. 2005 / 0194276 describes a package for an elongated medical device, as well as a method for manufacturing and using the same. [Prior art documents] [Patent Documents]
[0006] [Patent Document 1] Japanese Patent Publication No. 2016-064089 [Patent Document 2] Japanese Patent Publication No. 2012-176101 [Patent Document 3] International Publication No. 2019 / 171672 [Patent Document 4] German Patent Application Publication No. 4333073 [Patent Document 5] U.S. Patent No. 4,332,322 [Patent Document 6] U.S. Patent No. 5,131,537 [Patent Document 7] U.S. Patent Application Publication No. 2005 / 0194276 [Overview of the project] [Problems that the invention aims to solve]
[0007] Therefore, the object of the present invention is to improve the type of serving device described first. [Means for solving the problem]
[0008] This objective is achieved, according to the present invention, in a dispensing device of the first type described, the dispensing device comprises a support and a retaining device disposed or formed on the support for holding a catheter wound annularly in a storage position, wherein the retaining device comprises at least three retaining elements that engage with the catheter in the storage position, and the at least three retaining elements are disposed or formed on the support spatially separated from each other, the at least three retaining elements are positioned along a retaining circle defining the midpoint of the retaining circle, at least one of the at least three retaining elements, in particular all of them, is configured in the form of a retaining tab, the free-retaining tab end of the retaining tab is oriented toward the center of the support on the support, and the retaining device comprises at least two retention elements for preventing movement of the catheter in the storage position toward the midpoint of the retaining circle.
[0009] The further developed supplying device, as proposed, particularly allows for the simple retention of a coiled catheter on a support. At least three retaining elements serve this purpose. In particular, only three retaining elements may be provided. The retaining elements help support the coiled catheter at, for example, three points or three short contact points. Such a configuration, in particular, allows for the simple handling of the catheter. Thus, in particular, both ends of the catheter can be held freely accessible on the supplying device or its support. This significantly improves the handling of the supplying device compared to the known packaging devices described earlier. In particular, depending on the specific arrangement of the retaining elements, it is possible to remove the catheter as a whole, i.e., in its coiled state, from the supplying device. This is not possible in the case of a catheter stored in a plastic hose. In the case of such hose storage, the catheter must first be completely pulled out of the hose in order to allow free access to both ends at the same time. The further developed supplying device, as proposed, also has a remarkably good environmental balance. In particular, the support can be constructed to be very flat, on the one hand, saving on the materials required to manufacture the support compared to plastic hoses, and on the other hand, allowing the catheter to adhere as flat as possible to the support, so that the serving device on which the catheter is held can be constructed to be flatter than the known hose packages described. In this way, the spatial requirements of the product can be greatly reduced. Thus, the costs of manufacturing, transporting, and storing can be greatly reduced. Positioning at least three retaining elements along a retaining circle that defines the midpoint of the retaining circle allows for a simple method of holding a catheter wound in the shape of a circular ring on the support. In particular, by arranging at least three retaining elements in correspondence, the midpoint of the retaining circle can be positioned in the region of the center of the support. It is advantageous that at least one, in particular all, of the at least three retaining elements are in the form of retaining tabs, and that the free retaining tab ends of the retaining tabs are oriented toward the center of the support. In particular, the center of the support may be the midpoint of the retaining circle.The retaining tab can be formed on the support in a simple manner, particularly by adhesion, or alternatively by being integrally formed from the support itself. This will be described in more detail below. Furthermore, the retaining device is provided to include at least two retention elements to prevent the catheter from moving in the storage position toward the midpoint of the retaining circle. In particular, the retention elements, as a complement to the retaining elements, can further improve the storage of the catheter on the supplying device. The proposed supplying device is particularly advantageous for PTCA catheters. The catheter may include a wire that forms a kind of restorative device in the form of an elastic element to stabilize the catheter in an elongated form. This is particularly advantageous when inserting the catheter into the patient's blood vessel. However, if the catheter is not properly secured, the wire may also cause the catheter to slip out of its coiled position to its elongated base position. In particular, the proposed mounting device improves upon this because, by engaging with the catheter in its storage position, at least three retaining elements, at least one of which prevents movement of the catheter in its storage position toward the midpoint of the retaining circle, and at least one which prevents movement away from the midpoint of the retaining circle, thereby enabling the catheter to be positioned securely and in a defined manner and held in its wound storage position on the support. Such mounting is not necessary for so-called OTW catheters, which are flexible. Since OTW catheters do not contain a stabilizing wire, such catheters cannot simply slip out into their elongated base position, as is the case with PTCA catheters.
[0010] It is advantageous if the dispensing device is configured to disengage the coiled catheter and at least three retaining elements from engagement without disengaging the catheter into an elongated shape. Thus, as already described, it is possible to remove the catheter as a whole, i.e., in its coiled position, from the dispensing device. At this time, both ends of the catheter are freely accessible.
[0011] Advantageously, at least two of the three retaining elements are positioned point-symmetrically with respect to the midpoint of the retaining circle. If a third retaining element is positioned between two retaining elements along the retaining circle, this creates a free region extending approximately 180° between the retaining elements positioned opposite each other with respect to the midpoint of the retaining circle. This allows the catheter to be held securely on the dispensing device, but also allows the catheter to be removed from the dispensing device while still coiled. To do this, only a slight deformation of the coiled catheter is required.
[0012] It is preferable that at least three retaining elements define a retaining region corresponding to the inscribed angle of the retaining circle of at least 180°. In this way, the wound catheter can be securely held on the dispensing device.
[0013] The holding circle inscribed angle is preferably in the range of 180° to 240°. In particular, a range of approximately 185° to approximately 200° is also acceptable. For secure mounting, it is advantageous when the holding circle inscribed angle is greater than 180°.
[0014] In a more preferred embodiment, the support may have an outer support rim surrounding a storage area, and the catheter in storage position may be positioned within the storage area. This configuration, in particular, allows the catheter to be held in a protected manner on the dispensing device. Even if the user were to collide the dispensing device, which has a support rim and on which the catheter is stored, with an object, the catheter would still be adequately protected from damage.
[0015] It is advantageous when the retaining tab is formed on a support and is formed by a retaining notch having two free ends, when the retaining tab defines a retaining tab baseline connecting the two free ends of the retaining notch, and when the free retaining tab length of the retaining tab is defined by the distance of the free retaining tab ends from the retaining tab baseline. To form a retaining tab, it is only necessary to form a notch in the support such that the retaining notch has two free ends spaced apart from each other. The retaining tab can then pivot along the retaining tab baseline from the support surface, in particular the support plane, defined by the support. It is also conceivable to bend or fold the retaining tab along the retaining tab baseline. A catheter can be securely held on a support using such a retaining tab. A bent retaining tab forms a wedge-shaped recess that can even hold a catheter in a selective clamp, for example.
[0016] To simplify handling, it is advantageous for the retention notch to be convexly curved in the direction toward the center of the support. Therefore, a retention tab with a rounded retention tab end can be formed, which keeps the risk of damage to the catheter low.
[0017] The retaining cut line preferably has at least some sections in a curved configuration, particularly in the form of arc sections. Such retaining cut lines can be formed in a simple manner by punching cuts.
[0018] To form a triangular or quadrilateral retaining tab, it is preferable that the retaining cut lines include at least two, and especially three, retaining line portions. These can, for example, be inclined relative to one another.
[0019] This is particularly advantageous when at least two retaining line sections are configured such that at least several sections extend linearly or substantially linearly. Thus, triangular or quadrilateral retaining tabs can be created in a simple manner.
[0020] Preferably, the holding tab base lines of at least two holding tabs extend parallel or substantially parallel to each other. Such an arrangement is achieved, for example, when the two holding tabs are positioned point-symmetrically with respect to the center point of the holding circle. Thus, the holding tabs engage on opposite sides of the wound catheter in order to hold the catheter on the delivery device.
[0021] It is advantageous when the holding tab base lines of at least two holding tabs extend transversely, in particular perpendicularly, to each other. By arranging the two holding tabs in this way, it is possible to ensure, in particular, that the wound catheter cannot move in the direction of these two holding tabs and remove the catheter from the delivery device. In particular, this enables reliable fixation of the catheter on the delivery device.
[0022] For constructing the support in the smallest size, it is convenient if the distance of the holding tab base line of at least one holding tab from the support rim is smaller than its free holding tab length. Thus, the use of material for forming the delivery device can be minimized.
[0023] It is advantageous when at least one, in particular all, of the at least two retaining elements are configured in the form of retaining tabs and the free retaining tab ends of the retaining tabs are oriented radially away from the support center. In this way, a wedge-shaped receptacle that points radially away from the support center can be formed by the retaining tabs, in particular for accommodating a part of the wound catheter. The retaining tabs prevent, in particular, the movement of the wound catheter in the direction towards the support center or the center point of the holding circle.
[0024] It is convenient when at least one, in particular all, of the at least two maintaining elements are configured in the form of maintaining tabs and the free maintaining tab ends of the maintaining tabs are oriented radially away from the support center. In this way, a wedge-shaped receptacle that points radially away from the support center can be formed by the maintaining tabs, in particular for accommodating a part of the wound catheter. The maintaining tabs prevent, in particular, the movement of the wound catheter in the direction towards the support center or the center point of the holding circle.
[0025] It is advantageous when the retention tab is formed on a support and is formed by a retention notch having two free ends, when the retention tab defines a retention tab baseline connecting the two free ends of the retention notch, and when the free retention tab length of the retention tab is defined by the distance of the free retention tab ends from the retention tab baseline. In particular, as described above, the retention tab can be formed integrally with the support in this way. To achieve this, it is only necessary to form a retention tab notch, i.e., a corresponding notch, on the support. The retention tab can then be moved to a desired position by deforming the retention tab relative to the support, in particular to form a wedge-shaped receptacle for a wound catheter.
[0026] Conveniently, the retention cuts are concavely curved in at least some sections, pointing toward the center of the support, and are particularly composed of arc sections. In this way, it is possible to create a wedge-shaped receptacle that is radially open by the retention tab in a simple manner.
[0027] It is advantageous if at least one of the two retention elements, and especially all of them, are positioned along the retention circle between the two retention elements that have the largest angular distance from each other. In this way, the retention elements do not significantly hinder the removal of the wound catheter from the supplying device.
[0028] Preferably, the retention element is positioned near the two described retention elements such that the wound catheter is optimally secured both toward and toward the midpoint of the retention circle in the region where the retention tab is positioned adjacent to the retention tab.
[0029] In a more preferred embodiment, the dispensing device may be provided to include an adapter retaining device for a connecting adapter positioned or formed on the first end of the catheter. This configuration, in particular, allows the catheter to be left on the dispensing device to prepare for the intervention. Removing the catheter is not absolutely necessary. The catheter can be easily flushed by connecting a connecting adapter that is still held on the dispensing device, i.e., on the adapter retaining device. In particular, the catheter may thus remain wound on the dispensing device.
[0030] If the adapter holding device comprises at least two adapter holding elements, the connecting adapter can be reliably held on the providing device.
[0031] This is advantageous when the two cooperating adapter retaining elements are configured in the form of adapter retaining tabs, and when the free adapter tab ends of the two adapter retaining elements are oriented toward each other. This makes it possible to hold the connecting adapter by the adapter retaining tabs, in particular, when the longitudinal axis of the connecting adapter is oriented transversely with respect to the adapter tab ends that point toward each other.
[0032] The adapter tab ends pointing toward each other are conveniently spaced apart on the support, forming an adapter retaining web. In this way, the connecting adapter can be stably held on the supplying device, and in particular supported by the adapter retaining web.
[0033] This is advantageous when the adapter holding device defines the adapter holding longitudinal axis, and the adapter holding web extends parallel or substantially parallel to the adapter longitudinal axis. Thus, the connecting adapter can be held on the supplying device, in particular by the adapter holding web.
[0034] If the adapter holding device is configured symmetrically with respect to the longitudinal axis of the adapter holding, the providing device can be formed in a simple manner.
[0035] The retention tab baseline of the retention tab is advantageously oriented parallel or substantially parallel to the longitudinal axis of the adapter retention. Thus, the free end of the catheter, i.e., the first end with the connecting adapter, can be guided from the retention tab to the adapter retention device in a particularly twist-free manner when wound on the supplying device.
[0036] It is advantageous when the adapter notch is formed starting from the support rim and adjacent to the adapter retaining device on the support in an extension of the adapter retaining longitudinal axis. Such an adapter notch allows for positioning of the connecting adapter so that its connecting element, which may be configured, for example, in the form of a Luer lock connector, can protrude from the supplying device. This makes it possible to connect the catheter to a flushing device, for example, for flushing the catheter, without having to remove the catheter, and especially the connecting adapter, from the supplying device.
[0037] In a more preferred embodiment, the providing device may be provided with a balloon retaining device for an inflatable balloon positioned or formed in the region of the second end of the catheter. Such a balloon retaining device, in particular, enables secure positioning and attachment of the catheter in the region of the inflatable balloon.
[0038] This is advantageous when the balloon holding device defines a longitudinal axis for balloon holding, and when the balloon holding device is configured asymmetrically with respect to that longitudinal axis. This ensures that the second end region of the balloon or catheter is securely held on the device.
[0039] The balloon holding device preferably comprises at least two balloon holding elements. For example, it may comprise two balloon holding elements that can be configured as tabs.
[0040] It is advantageous when the two cooperating balloon-retaining elements are configured in the form of balloon-retaining tabs, and when the free ends of the balloon-retaining tabs point in the same direction at the non-deformable starting position of the supplying device. This configuration allows, for example, one of the two balloon-retaining tabs to be reshaped or folded, thereby allowing that balloon-retaining tab to support the other balloon-retaining tab and hold it away from the support. Thus, the catheter can be positioned on the supplying device so as to be optimally protected in the area of the balloon.
[0041] It is advantageous when each balloon-retaining tab is formed on a support and is formed by a balloon-retaining notch having two free ends, when the balloon-retaining tab defines a balloon-retaining tab baseline connecting the two free ends of the balloon-retaining notch, and when the free balloon-retaining tab length is defined by the distance of the free balloon-retaining tab ends from the balloon-retaining tab baseline. As already described for retaining tabs, in this way, balloon-retaining tabs for retaining a catheter in the region of an inflatable balloon can be formed in a simple manner.
[0042] To keep the risk of catheter damage as low as possible, it is advantageous when the balloon retention notch is in a curved configuration, especially in the form of an arc section.
[0043] It is advantageous when the balloon-retaining tab baselines of the two cooperating balloon-retaining tabs extend parallel or substantially parallel to each other and to the longitudinal axis of balloon retention. This allows the catheter portion with the balloon to be held linearly by the cooperating balloon-retaining tabs.
[0044] This is advantageous when the balloon-retaining cut lines of two cooperating balloon-retaining tabs are of different lengths and / or have different radii of curvature. Therefore, balloon-retaining tabs can be easily configured to have different sizes.
[0045] The lengths of the balloon-retaining tabs of two cooperating balloon-retaining tabs are advantageously equal or substantially equal. This can be achieved, in particular, even if the lengths of the balloon-retaining cut lines are different or have different radii of curvature. Thus, balloon-retaining tabs of different sizes and different surface areas can be formed in a simple manner.
[0046] This configuration is advantageous when the retention tab baseline of the retention tab is oriented parallel or substantially parallel to the longitudinal axis of balloon retention. This configuration, in particular, allows the free second end of the catheter to be extended tangentially away from the retention circle in a twist-free manner and retained by the balloon retention device.
[0047] In a more preferred embodiment, a tip recess may be provided which is positioned or formed on a support so that the second end of the catheter in storage position is positioned within the area of the tip recess. Such a tip recess facilitates the user to grasp the free end, i.e., the second end of the catheter, in order to continuously unwind the catheter from the dispensing device.
[0048] This arrangement is advantageous when the tip recess is positioned adjacent to a balloon holding device that points in the direction of the balloon holding axis. This arrangement has the particular advantage that the second end does not need to be supported, as it is reliably held adjacent to the balloon on the supplying device in the balloon region.
[0049] The tip recess is advantageous when it is formed in the form of a perforation in the support. Such a perforation can be formed in a simple manner, for example, by punching. In particular, the perforation may be formed in the shape of a circle.
[0050] For optimal handling of the dispensing device, it is advantageous if the tip recess is sized to allow the second end of the catheter held on the dispensing device to be grasped with two fingers. For example, this allows the free end to be easily grasped and handled with the thumb and index finger of one hand.
[0051] In a more preferred embodiment, it may be provided that a removal recess is located or formed on the support, and that in the storage position, at least two, in particular three, portions of the catheter, wound and held on the support, are positioned within the area of the removal recess. This configuration allows the user to securely grasp the catheter, i.e., two or more of its portions, at once, and as a result minimizes the risk of the catheter fully unfolding, i.e., moving into an elongated position, when removed from the support. This makes it easier for the user to remove the catheter as a whole from the dispensing device in its wound state.
[0052] The removable recess is conveniently formed in the form of a perforation in the support. Such a perforation can be formed in a simple manner by punching. The perforation allows free access to the coiled catheter.
[0053] The removal recess is preferably configured in the form of a circular ring section. The removal recess may be configured in particular according to the form of a coiled catheter. This, in particular, improves the handling of the dispensing device and the catheter.
[0054] It is advantageous when the centerline of the circular ring section has a curvature that substantially corresponds to the curvature of the wound catheter held on the dispensing device in the storage position. Thus, the catheter can be easily grasped by the user along the entire length of the circumferential detachment recess relative to the midpoint of the holding circle and removed from the dispensing device.
[0055] Preferably, the circular ring section extends over an angular range of about 30° to about 60°, and particularly over an angular range of about 40° to about 50°.
[0056] It is advantageous if the removal recess has a radial width relative to the midpoint of the holding circle, allowing the catheter held on the dispensing device to be grasped with two fingers. Thus, the user can remove the catheter from the dispensing device in a particularly reliable manner without damaging the catheter.
[0057] The removal recess is preferably positioned on a retaining circle between two retaining elements having the maximum angular distance from each other. In the described position, the catheter can be grasped by the user and removed from the support, i.e., particularly in a coiled form, with the least amount of force and without greater resistance from retaining tabs or the like.
[0058] In a more preferred embodiment, the supplying device may be provided with a wire retaining device for holding the free end of a wire, the wire protruding from the wire channel of the catheter, pointing toward the first end of the catheter, and exiting the opening of the wire channel. This configuration particularly allows for targeted holding of a wire, typically used for transport purposes, on the supplying device. Thus, the wire can be specifically grasped by the user. Preferably, the wire retaining device is positioned or formed on a support so as not to be positioned on the retaining circle or on the adapter retaining longitudinal axis. Thus, the free end of the wire can be held in an easily accessible manner, separate from the wound catheter and separate from its first end. The wire retaining device is conveniently positioned or formed in the region between the retaining circle and the adapter retaining device.
[0059] The wire holding device conveniently comprises at least one wire holding element. This wire holding element ensures that the wire is securely held on the device in a desired orientation.
[0060] It is advantageous when at least one wire retaining element is configured in the form of a wire retaining tab, and when the free wire retaining tab end of the wire retaining tab is oriented toward the center of the support. This configuration, in particular, enables secure retention of the free wire end on the supplying device. In particular, the orientation of the wire retaining tab can prevent the free end from extending beyond the support rim of the support, in particular.
[0061] When a wire retaining tab is formed on a support and formed by a wire retaining notch having two free ends, it is advantageous when the wire retaining tab defines a wire retaining tab baseline connecting the two free ends of the wire retaining notch, and when the free wire retaining tab length of the wire retaining tab is defined by the distance of the free wire retaining tab ends from the wire retaining tab baseline. As has already been described in detail above in relation to retaining tabs, such a wire retaining tab can be formed integrally with the support in a simple manner.
[0062] If the dispensing device is made from flat material, it can be manufactured in a simple and cost-effective manner. Therefore, its size, especially the volume it occupies, can be kept to a minimum.
[0063] Preferably, the flat material forming the blank of the dispensing device is a cardboard or paperboard sheet. The dispensing device can be manufactured from the sheet in a cost-effective and simple manner, for example, by die-cutting. The flat material is conveniently coated with a plastic material. Therefore, in particular, the dispensing device can be configured to be water-resistant, i.e., water-resistant even if the flat material is not water-resistant, such as in the case of cardboard or paperboard.
[0064] It is advantageous when the flat material forming the blank of the dispensing device is made of plastic. This makes it possible to form a monolithic support from the plastic material in particular. In particular, such a dispensing device can be configured to be water-resistant. Furthermore, the cut edges on a flat material made of cardboard or paperboard sheets can cause problems because such sheets always contain fibers, and their edges can protrude freely. This can cause fibers to detach from the support, which is undesirable, especially in a sterile environment. Therefore, it may be necessary to treat the cut edges of such a support made of cardboard or paperboard sheets by additional processing steps, for example by coating or laminating the cut edges and optionally further areas of the support, or by covering the partially exposed fibers in a different way or bonding them to the support. This problem does not occur in the case of a flat material made of plastic. The flat material can be made in the form of a film or a sheet, in particular.
[0065] To prevent damage to the support made of cardboard or paperboard sheets from liquids as much as possible, it is advantageous to provide a liquid-repellent coating on the support. For example, the coating may be configured to be water-repellent.
[0066] The liquid-repellent coating is preferably made of a plastic material. In particular, the coating may be formed by a plastic film on which a support is laminated.
[0067] Preferably, the plastic material used to coat or form the flat material is polypropylene (PP), high-density polyethylene (HDPE), polylactic acid (PLA, especially PLLA), polyamide (PA), polyethylene (PE), low-density polyethylene (LDPE), and / or polyethylene terephthalate (PET), or comprises these. Therefore, the providing device can be formed in a simple and cost-effective manner.
[0068] The manufacturing of the supply device can be further simplified if it is formed as a single unit, especially monolithically.
[0069] To minimize the spatial requirements for the supply device, it is advantageous when the support has a thickness in the range of approximately 0.05 mm to approximately 1 mm, particularly in the range of approximately 0.2 mm to approximately 0.4 mm.
[0070] In a more preferred embodiment, the providing device may be provided to have a front and a rear surface, and the retaining device may be configured to hold the catheter at the front surface. In particular, all elements of the retaining device and all other elements described above may be arranged or formed on the providing device such that the catheter can be securely fixed to one surface of the support, i.e., the front surface, in the storage position.
[0071] The device is preferable if it includes at least one data storage element for storing characteristic data about the catheter, particularly its length, diameter, inflation pressure, and balloon diameter. In particular, the data storage element may be an electronic data storage element. For example, the data storage element can be read wirelessly using a corresponding reading device. This, in particular, simplifies the documentation of medical procedures.
[0072] It is advantageous if at least one data storage element is located on the front or rear and is configured to be optically readable. For example, the data storage element may be in the form of a barcode or a QR code (registered trademark). Optionally, characteristic data about the catheter may also be printed in legible characters in spatially separated data areas on the front and / or rear so that the user can directly read all characteristic data of the catheter without the need to use technical aids such as a reading device.
[0073] In a more preferred embodiment, the providing device may be provided with a catheter, in particular a PTCA catheter. The catheter may include a wire that forms a kind of restorative device to stabilize the catheter in an elongated form. This is particularly advantageous when inserting the catheter into a patient's blood vessel. The proposed providing device is particularly advantageous for this type of catheter because, by at least three retaining elements that engage with the catheter in a storage position, at least one of which prevents movement of the catheter in the storage position toward the midpoint of the retaining circle, and at least one which prevents movement away from the midpoint of the retaining circle, the catheter can be positioned in a secure and defined manner and held in a wound storage position on a support. In the case of a flexible so-called OTW catheter, such attachment as proposed is not necessary. Since OTW catheters do not include a wire, the catheter cannot simply snap into an elongated basic position as in the case of a PTCA catheter.
[0074] It is advantageous when the catheter has a first end and a second end, when a connecting adapter is located or formed at the first end, and when an inflatable balloon is located or formed in the region of the second end. In particular, coronary artery stenosis can be optimally treated using such a catheter, i.e., by dilating the coronary artery with a balloon, as already described in detail above.
[0075] To protect the catheter, particularly the balloon, it is advantageous to have a removable protective cover surrounding the balloon positioned at the second end.
[0076] Because it is possible to inflate the balloon with gas in a simple manner, it is advantageous when the catheter has a fluid channel that fluidly connects the connecting adapter to the balloon.
[0077] It is even more advantageous if the catheter has a wire channel for a wire, and the wire channel extends proximal to an insertion opening located or formed on the catheter between the first and second ends, starting from the second end. Preferably, the insertion opening is located or formed closer to the second end than to the first end where the connecting adapter is located. The wire channel, in particular, allows the catheter to be guided into the coronary artery using a guidewire.
[0078] This is advantageous when the catheter has a wire positioned within a wire channel, and the wire is longer than the wire channel. For example, a wire positioned within a wire channel for transport purposes may protrude from the wire channel at one end, and as a result, the user can easily grasp and pull it out.
[0079] The wire is conveniently configured in the form of a transport wire. The wire serves only the purpose of transport, particularly to hold the catheter as dimensionally stable as possible on the dispensing device.
[0080] It is advantageous when the catheter is held on the dispensing device in storage position such that the first end and / or the second end are oriented transversely, particularly perpendicularly, to the support rim. In particular, both the first end and the second end may be held on the dispensing device pointing to the same side of the support. This, in particular, greatly improves the handling of the dispensing device.
[0081] The following description of preferred embodiments of the present invention may be useful in conjunction with the drawings for further explanation. [Brief explanation of the drawing]
[0082] [Figure 1] This diagram shows a schematic overall view of the device that holds the catheter in its storage position. [Figure 2] A cross-sectional view along line 2-2 in Figure 1 is shown. [Figure 3] Figure 2 shows an enlarged view of region A. [Figure 4] An enlarged view of region B in Figure 2 is shown. [Figure 5] Figure 1 is a schematic diagram of the configuration when removing a wound catheter from the supplying device. [Figure 6] A diagram of a coiled catheter is shown. [Figure 7] A diagram of the front of the device being supplied is shown. [Figure 8] This shows a rear view of the supply device. [Figure 9] A diagram illustrating the first option for removing the catheter from the device is shown. [Figure 10] This diagram shows a schematic representation of how to handle the second end of the catheter when removing it from the supplying device. [Figure 11] A schematic diagram of the approach (second option) for removing the entire catheter from the supplying device is shown. [Figure 12] This section provides general instructions for handling the removed and coiled catheter after it has been removed from the supplying device. [Figure 13] A schematic diagram of a third option for removing the catheter from the device is shown. [Figure 14] A schematic diagram shows the third option for removing the catheter from the device. [Modes for carrying out the invention]
[0083] Figure 1 schematically depicts a first embodiment of a supply device, collectively referred to as reference numeral 10, for the storage and transport of catheter 12. Catheter 12 is configured in the form of a balloon catheter 14 for percutaneous transcatheter coronary angioplasty.
[0084] The catheter 12 has a first end 16 and a second end 18. A connecting adapter 20 having a so-called Luer lock connector 22 is positioned or formed at the first end 16. An inflatable balloon 24 is positioned or formed in the region of the second end 18. A protective cover 26 slides around the balloon 24 to protect it, starting from the second end 18.
[0085] The catheter 12 includes a fluid channel (not shown) that fluidly connects the connection adapter 20 and the balloon 24.
[0086] Furthermore, the catheter 12 has a wire channel formed for a wire 28. The wire channel, not shown, starts from the second end 18 and extends proximal to the insertion opening 30, which is located or formed on the catheter 12 between the first end 16 and the second end 18. The distance from the second end to the insertion opening 30 is less than the distance from the first end 16.
[0087] A wire 28 is positioned within the wire channel of the catheter 12. The wire is longer than the wire channel such that its proximal end 32, which points toward the connecting adapter 20, protrudes from the insertion opening 30. The wire 28 is configured as a transport wire that is removed before the medical procedure.
[0088] The supplying device 10 comprises a support 34 on which a retaining device 36 for holding a ring-shaped catheter 12 in a storage position is disposed or formed. The retaining device 36 comprises at least three retaining elements 38a, 38b, and 38c, i.e., exactly three in the embodiment depicted in the figure, which engage with the catheter 12 in the storage position.
[0089] As can be easily seen in the figure, the three retaining elements 38a, 38b, and 38c are arranged or formed spatially separated from each other on the support 34. However, they work together to hold the catheter 12 on the support 34.
[0090] The supply device 10, i.e., the support 34, is made of a flat material that forms a support blank. Cardboard and paperboard sheets are particularly suitable as flat materials.
[0091] In an alternative embodiment, the flat material for forming the support 34 is made of plastic.
[0092] The support 34 is optionally provided with a liquid-repellent coating 40 on both the front surface 42 and the rear surface 44. The coating 40 is made of a plastic material. In particular, the coating may be in the form of a plastic film.
[0093] The plastic materials from which the flat material is made or coated are polypropylene (PP), high-density polyethylene (HDPE), polylactic acid (PLA, especially PLLA), polyamide (PA), polyethylene (PE), low-density polyethylene (LDPE), and / or polyethylene terephthalate (PET), or include these.
[0094] The supply device 10 is formed as a whole, as a single unit, that is, monolithically.
[0095] The support 34 has a support thickness 46 in the range of approximately 0.05 mm to approximately 1 mm. In particular, the support thickness 46 may have a value in the range of approximately 0.2 mm to approximately 0.4 mm.
[0096] The holding device 36 is configured to hold the catheter 12 on the front surface 42 of the support 34, as described in detail below.
[0097] The three retaining elements 38a, 38b, and 38c are positioned along a retaining circle 48, which is schematically shown by a dashed line in Figure 7. The retaining circle 48 defines the midpoint 50 of the retaining circle.
[0098] Two of the three retaining elements 38a, 38b, and 38c, namely retaining elements 38a and 38c, are positioned point-symmetrically on the support 34 with respect to the midpoint 50 of the retaining circle.
[0099] The three retaining elements 38a, 38b, and 38c define a retaining region 52 extending around the midpoint 50 of the retaining circle. The retaining region 52 of the retaining circle 48 defines a retaining circle inscribed angle 54 of at least 180°. Preferably, the value of the retaining circle inscribed angle 54 is in the range of 180° to 240°. In the embodiment depicted in the figure, the retaining circle inscribed angle 54 is approximately 200°.
[0100] The support 34 has an outer support rim 56. The entire area of the front surface 42 surrounded by the support rim 56 encloses the storage area 58. The catheter 12 in storage position is placed within the storage area 58, with the exception of one example described later.
[0101] The three retaining elements 38a, 38b, and 38c are configured in the form of retaining tabs 60. The free-retaining tab ends 62 of the retaining tabs 60 are oriented toward the center 64 of the support 34. In the embodiment depicted in the figure, the midpoint 50 of the retaining circle forms the center 64 of the support.
[0102] The retaining tab 60 is formed by a retaining notch 66 formed in the support 34. The retaining notch 66 has two free ends 68. The retaining tab baseline 70 of the retaining tab 60 connects the two free ends 68.
[0103] The free-retaining tab length 72 of the retaining tab 60 is defined by the distance of the free-retaining tab end 62 from the retaining tab baseline 70. The retaining notch line 66 is curved convexly in the direction toward the center 64 of the support. The retaining notch line 66 has the form of an arc section.
[0104] The retaining tab baselines 70 of the two retaining tabs 60 that form retaining elements 38a and 38c extend parallel to each other.
[0105] The retaining tab baselines 70 of the retaining tabs 60 that form retaining elements 38a and 38b extend transversely, i.e., perpendicular to each other. The retaining tab baselines 70 of the retaining tabs 60 that form retaining elements 38b and 38c also extend transversely, i.e., perpendicular to each other.
[0106] The distance 74 from the support rim 56 of the retaining tab baseline 70 of the retaining tab 60 that forms the retaining element 38b is less than the free retaining tab length 72.
[0107] The three retaining tabs 60 that form the retaining elements 38a, 38b, and 38c are each positioned near the support rim 56. The baseline 70 of each retaining tab extends parallel or substantially parallel to the support rim 56.
[0108] The support 34 has a substantially rectangular shape. Two adjacent corners 76 and 78 are rounded with a small radius, and a further corner 80 adjacent to corner 78 is rounded with a large radius. In the region of a fourth corner 82 defined between corners 76 and 80, an adapter notch 84 is formed that shortens both the linearly extending support rim portions 86 and 88 of the support rim 56 that define the corner 82.
[0109] The retaining device 36 also comprises two retaining elements 90a and 90b. The retaining elements 90a and 90b are configured to prevent the catheter 12 from moving in the storage position toward the midpoint 50 of the retaining circle.
[0110] The retention elements 90a and 90b are configured in the form of retention tabs 92. The free retention tab ends 94 of the retention tabs 92 are oriented radially away from the center 64 of the support.
[0111] The retention tab 92 is formed by a retention notch 96 on the support 34. The retention notch 96 has two free ends 98. The free ends 98 are connected by the retention tab baseline 100. The free retention tab length 102 of the retention tab 92 is defined by the distance of the retention tab ends 94 from the retention tab baseline 100. The retention notch 96 is concavely curved in the direction toward the center 64 of the support, i.e., it is in the form of an arc section.
[0112] The two retaining elements 90a and 90b are positioned along the retaining circle 48, i.e., between the two retaining elements 38a and 38c that have the largest angular distance from each other. The angular distance between retaining elements 38a and 38b is approximately the same as the angular distance between retaining elements 38b and 38c, both of which are about 80°. In contrast, the angular distance between retaining elements 38a and 38c is about 170°.
[0113] The supplying device 10 further comprises an adapter holding device 104 for holding a connection adapter 20 positioned at the first end 16 of the catheter 12. The adapter holding device 104 comprises two adapter holding elements 106a and 106b.
[0114] The two cooperating adapter retaining elements 106a and 106b are configured in the form of adapter retaining tabs 108. The free adapter tab ends 110 of the two adapter retaining elements 106a and 106b are oriented to point toward each other.
[0115] The adapter tab ends 110 pointing toward each other are spaced apart from each other, thus forming the adapter retaining web 112 on the support 34.
[0116] The adapter retaining device 104 defines the adapter retaining longitudinal axis 114. The adapter retaining web 112 extends parallel to the adapter retaining longitudinal axis 114.
[0117] The adapter retaining device 104 is configured symmetrically with respect to the adapter retaining longitudinal axis 114. The adapter retaining tab 108 is defined by an adapter notch line 116, which includes three straight sections, so that a substantially rectangular adapter retaining tab 108 is formed. The free ends 118 of the adapter notch line 116 are connected to each other by an adapter retaining tab baseline 120. The two adapter retaining tab baselines 120 of the two adapter retaining tabs 108 extend toward the adapter notch at an angle so as to be slightly away from each other, and are therefore not parallel to the adapter retaining longitudinal axis 114. Alternatively and preferably, the two adapter retaining tab baselines 120 extend parallel to each other, in particular parallel to the support rim portion 88.
[0118] The retaining tab baseline 70 of the retaining tab 60 that forms the retaining element 38a extends parallel to the adapter retaining longitudinal axis 114.
[0119] As already explained, the adapter notch 84 is formed starting from the support rim 56 and adjacent to the adapter holding device 104. By providing the adapter notch 84, a portion of the support 34, whose boundary is defined in the direction toward the corner 82 by the extensions of the support rim portions 86 and 88, is missing.
[0120] The supply device 10 further comprises a balloon retaining device 122 for a balloon 24 positioned or formed in the region of the second end 18 of the catheter 12. The balloon retaining device 122 defines a balloon retaining longitudinal axis 124. The balloon retaining device 122 is configured asymmetrically with respect to the balloon retaining longitudinal axis 124. The balloon retaining device 122 comprises two balloon retaining elements 126a and 126b.
[0121] The two cooperating balloon retaining elements 126a and 126b are configured in the form of balloon retaining tabs 128a and 128b. The free balloon retaining tab ends 130a and 130b of the balloon retaining tabs 128a and 128b point in the same direction at the non-deformation start position of the supplying device 10, i.e., when only the cuts to form them are applied to the support. This is schematically depicted in Figure 7. The free balloon retaining tab ends 130a and 130b point in the direction of the support rim portion 88.
[0122] The balloon retaining tabs 128a and 128b are formed by balloon retaining notches 132a and 132b on the support 34. The free ends 134a and 134b of the balloon retaining notches 132a and 132b are connected to each other by balloon retaining tab baselines 136a and 136b, respectively. The free balloon retaining tab lengths 138a and 138b are defined by the distance of the respective free balloon retaining tab ends 130a and 130b from the respective balloon retaining tab baselines 136a and 136b.
[0123] The balloon retaining cut lines 132a and 132b are in the form of a curved configuration, i.e., an arc section.
[0124] The two balloon-retaining tab baselines 136a and 136b extend parallel to each other and parallel to the balloon-retaining longitudinal axis 124.
[0125] The balloon retaining notches 132a and 132b of the two cooperating balloon retaining tabs 128a and 128b are of different lengths and have different radii of curvature. Balloon retaining notch 132a is longer than balloon retaining notch 132b. In contrast, balloon retaining notch 132b is more curved than balloon retaining notch 132a. Therefore, the radius of curvature of balloon retaining notch 132b is smaller than that of balloon retaining notch 132a. Nevertheless, the lengths 138a and 138b of the two balloon retaining tabs 128a and 128b are substantially equal.
[0126] Furthermore, the retaining tab baseline 70 of the retaining tab 60 that forms the retaining element 38c is oriented parallel to the balloon retaining longitudinal axis 124. Thus, the second end of the catheter 12 can be guided tangentially to the balloon retaining device 122 so as to move away from the winding area.
[0127] The supplying device 10 further comprises a tip recess 140. The tip recess 140 is formed in the form of a perforation 142 on the support 34. The tip recess 140 is positioned adjacent to the balloon holding device 122, i.e., in the area of the corner 76, and points in the direction of the balloon holding longitudinal axis 124. The balloon holding longitudinal axis 124 points in the direction of the support rim portion 86.
[0128] As schematically shown in Figure 1, the second end 18 of the catheter 12 is positioned in the area of the tip recess 140 in the storage position.
[0129] The tip recess 140 is further sized to allow the user to grasp the second end 18 of the catheter 12, which is held on the support 34, with two fingers.
[0130] Furthermore, a removal recess 144 is located or formed on the support 34. As schematically depicted in Figure 1, in the storage position, at least two catheter portions or windings of the catheter 12, which are wound and held on the support 34, i.e., three portions in the embodiment depicted, extend within the area of the removal recess 144.
[0131] The removable recess 144 is formed in the form of a perforation 146 on the support 34. The removable recess 144 is molded in the form of an elongated hole, i.e., a circular ring section 150.
[0132] The centerline 148 of the circular ring section 150 has a curvature that is approximately corresponding to the curvature of the catheter 12 when it is wound and held on the dispensing device 10 in the storage position, as schematically depicted in Figure 1.
[0133] The circular ring section 150 extends over an angular range 152 of approximately 30° to approximately 60°. In particular, the angular range may be approximately 40° to approximately 50°. In the embodiment depicted in the figure, the angular range extends to approximately 45°.
[0134] The detachable recess 144 has a radial width 154 with respect to the midpoint 50 of the retaining circle. The width 154 is sized to allow the catheter 12, held flat on the support 34, to be grasped by two fingers, namely the thumb 156 and the index finger 158, as schematically depicted in Figure 11.
[0135] The detachable recess 144 is further positioned on the retaining circle 48, i.e., between the two retaining elements 38a and 38c having the maximum angular distance from each other, as already discussed in detail above. The circular ring section 150 may include a portion of the retaining circle 48.
[0136] The supply device 10 further comprises a wire retaining device 160 for holding the end 32 of the wire 28 protruding from the wire channel. In the embodiment depicted in the figure, the wire retaining device 160 is positioned in the region between the retaining element 38a and the adapter retaining device 104.
[0137] The wire holding device 160 comprises a wire holding element 162. The wire holding element 162 is configured in the form of a wire holding tab 164. The free wire holding tab end 166 of the wire holding tab 164 is oriented toward the center 64 of the support.
[0138] A wire-retaining notch 168 is formed on the support 34 to form a wire-retaining tab 164. The wire-retaining tab 164 defines a wire-retaining tab baseline 170. This baseline connects the free ends 172 of the wire-retaining notch 168 to each other. The wire-retaining tab length 174 of the wire-retaining tab 164 is defined by the distance of the wire-retaining tab end 166 from the wire-retaining tab baseline 170.
[0139] The dispensing device 10 further comprises a data storage element 176 for storing characteristic data relating to the catheter 12 held on the dispensing device 10. The characteristic data relating to the catheter includes, in particular, its length, catheter sheath diameter, inflation pressure, and balloon diameter, the balloon diameter being dependent on the inflation pressure.
[0140] The data storage element 176 is configured in the form of a printed data area 178, i.e., on the front surface 42 of the support 34. The data storage element 176 is optically readable. The characteristic data is printed in Latin characters so that it can be read directly by the user.
[0141] The retaining elements 38a, 38b, and 38c extend over a circular angle 180 of approximately 10°. The circular angle is defined by the opening angle from the midpoint 50 of the retaining circle to the free end 68 of the retaining cut line 66. In this way, each of the retaining elements 38a, 38b, and 38c can hold the wound catheter 12 over a circular angle 180 of approximately 10°.
[0142] An instruction manual 182 for the use and handling of the supply device 10 and the handling of the catheter 12 is printed on the rear surface 44. The instruction manual may be a depiction of Figures 9 to 14, which are briefly described below. The instruction manual 182 also forms a data area and thus defines the data storage element.
[0143] The specific design of the supply device 10 allows for three different removal options for the catheter 12 from the support 34. Figure 9 shows a first modification. In this configuration, the user grasps the support 34 with their right hand within the area of the adapter holding device 104, and thus firmly holds the connecting adapter 20. The user can then remove the catheter 12 from the support 34 by grasping the second end 18 of the catheter 12 with their other hand and winding it up. In particular, the user can leave the catheter 12 on the support 34 so that only the portion of the catheter 12 containing the wire channel is removed from the support 34. Figure 10 shows the connecting adapter 20 still being held on the adapter holding device 104 but already coupled to the flushing device. Furthermore, the protective cover 26 can be easily removed from the second end 18 when the second end 18 is released from the support 34.
[0144] According to the second modification, the supplying device 10 also allows the coiled catheter 12 and the three retaining elements 38a, 38b, and 38c to be disengaged without elongating the catheter 12. To achieve this, the user only needs to grasp the catheter 12 with two fingers in the area of the release recess 144, the thumb 156 and index finger 158 shown as an example in Figure 11. If the user holds the support 34 in the area of the corner 78 with their other hand, the user can remove the coiled catheter 12 as a whole. To prevent the catheter 12 from unfolding, the user should now wrap the first end 16 with the connecting adapter 20 around the coiled catheter 12 twice, as schematically depicted in Figure 12.
[0145] A third option for removing the catheter 12 from the dispensing device 10 is schematically illustrated in Figures 13 and 14. In this method, the user grasps the second end 18 by reaching the tip recess 140 with one hand. The user firmly holds the connecting adapter 20 together with the support 34 with the other hand. As the user pulls the second end 18 to the left in the direction of the arrow, the catheter 12 unfolds, and the user can hold the catheter 12 in a linear, elongated position between both hands.
[0146] In the embodiment shown in the drawings, the catheter 12 in storage position is held on the dispensing device 10 such that the first end 16 and the second end 18 are oriented transversely, i.e., perpendicularly, to the support rim 56, i.e., to the support rim portion 86.
[0147] Each of the three retaining elements 38a, 38b, and 38c may optionally include a plurality of fold lines 184 extending parallel to each other and parallel to the retaining tab baseline 70. This allows the retaining tabs 60 to be bent or curved along the fold lines so that they extend in an arc shape and engage in an arc shape with the wound catheter 12.
[0148] The two balloon-retaining tabs 128a and 128b are used to retain the catheter 12 in the area of the balloon 24 as follows: The balloon-retaining tab 128b is inverted toward the balloon-retaining tab 128a around the balloon-retaining tab baseline 136b, but it is not bent or folded toward the support 34 along the balloon-retaining tab baseline 136b. The balloon-retaining tab 128b is slid with its free balloon-retaining tab end 130b below the balloon-retaining tab 128a. Due to the somewhat elastic nature of the material from which the support 34 is made, the balloon-retaining tab 128a is pressed somewhat away from the front surface 42 so that the balloon-retaining tabs 128a and 128b wrap together in an arc over the balloon 24, as schematically depicted in Figure 4.
[0149] The provided device allows the catheter 12 to be stored flat on the front surface 42 of the support 34. In particular, it is possible to store the catheter 12 as flat as possible overall.
[0150] Furthermore, the provided device allows for three variations in removal, as described above.
[0151] Once the second end is removed from the support 34, the protective cover 26 and wire 28 can be removed. The catheter 12 can be screwed onto an actual guidewire used in a medical procedure and then inserted into a guide catheter.
[0152] A further advantage of the described providing device 10 is that the catheter 12 remains on the support 34 and the data area 178 remains connected to the catheter 12 by the connection adapter 20 until the final removal of the catheter 12, particularly until the removal of the connection adapter 20 from the adapter holding device 104, so that the user always has all information about the catheter 12 being used that is directly available to the user. [Explanation of Symbols]
[0153] 10 Providing device 12 Catheters 14 Balloon catheter 16 First end 18. Second end 20 Connection Adapters 22 Luer lock connectors 24 Balloons 26 Protective Covers 28 wires 30 Insertion opening 32 End 34 Support 36 Retaining devices 38a, 38b, 38c retention elements 40 Coating 42 Front 44 Rear 46 Support thickness 48 yen 50 Midpoint of the holding circle 52 Holding area 54. Circumferential angle of the circle 56 Support Rim 58 Storage area 60 retaining tabs 62 Retaining tab end 64 Support center 66 Retaining cut line 68 End 70 Retention tab baseline 72 Retaining tab length 74 distance 76 corners 78 corners 80 corners 82 corners 84 Adapter notch 86 Support rim portion 88 Support rim portion 90a, 90b maintenance elements 92 Maintenance tab 94 Maintenance tab end 96 Maintenance cut line 98 End 100 Maintenance Tab Baseline 102 Maintenance tab length 104 Adapter Retaining Device 106a, 106b Adapter retaining elements 108 Adapter Retention Tab 110 Adapter tab end 112 Adapter Retaining Web 114 Adapter holding longitudinal axis 116 Adapter cut line 118 End 120 Adapter Retention Tab Baseline 122 Balloon holding device 124 Balloon holding longitudinal axis 126a, 126b Balloon holding elements 128a, 128b Balloon retention tab 130a, 130b Balloon retaining tab ends 132a, 132b Balloon holding cut lines 134a, 134b end 136a, 136b Balloon retention tab baseline 138a, 138b Balloon retention tab length 140 Tip recess 142 Perforation 144 Removable recess 146 Perforation 148 Center line 150 circular ring sections 152 Angle Range 154 width 156 Thumb 158 Index finger 160 Wire Holding Devices 162 Wire holding element 164 Wire Retaining Tabs 166 Wire holding tab end 168 Wire holding cut wire 170 Wire Retention Tab Baseline 172 End 174 wire holding tab length 176 Data Storage Elements 178 Data Areas 180 inscribed angle 182 Instructions for Use 184 Fold lines
Claims
1. A device (10) for storing and transporting catheters (12), particularly balloon catheters (14), for percutaneous transcatheter coronary angioplasty, The providing device (10) is The device includes a support (34) and a retaining device (36) disposed or formed on the support (34) to hold a catheter (12) wound in an annular shape in a storage position, wherein the retaining device (36) includes at least three retaining elements (38a, 38b, 38b) that engage with the catheter (12) in the storage position, and The at least three retaining elements (38) are arranged or formed on the support (34) so as to be spatially separated from each other. The at least three retaining elements (38) are positioned along a retaining circle (48) that defines the midpoint (50) of the retaining circle. At least one, and in particular all, of the three retaining elements (38a, 38b, 38c) is configured in the form of a retaining tab (60). The free-holding tab end (62) of the retaining tab (60) is oriented toward the center (64) of the support (34), and The providing device (10) is characterized in that the holding device (36) includes at least two retention elements (90a, 90b) for preventing the catheter (12) from moving in the storage position toward the midpoint (50) of the holding circle.
2. The dispensing device according to claim 1, characterized in that the dispensing device (10) is configured to disengage the coiled catheter (12) and the at least three retaining elements (38a, 38b, 38c) from engagement without making the catheter (12) into an elongated shape.
3. The supply device according to claim 1 or 2, characterized in that two of the at least three holding elements (38a, 38b, 38c) are positioned point-symmetrically with respect to the midpoint (50) of the holding circle.
4. The at least three retaining elements (38a, 38b, 38c) define a retaining region (52) corresponding to the inscribed angle (54) of the retaining circle (48) of at least 180°, In particular, the supplying apparatus according to claim 3, wherein the holding circle circumference angle (54) is in the range of 180° to 240°, and especially in the range of about 185° to about 200°.
5. The retaining tab (60) is formed on the support (34) and is formed by a retaining notch line (66) having two free ends. The retaining tab (60) defines a retaining tab baseline (70) that connects the two free ends (68) of the retaining cut line (66), and The supply apparatus according to any one of claims 1 to 4, characterized in that the free-holding tab length (72) of the retaining tab (60) is defined by the distance of the free-holding tab end (62) from the retaining tab baseline (70).
6. At least one, and in particular all, of the two retention elements (90a, 90b) is configured in the form of a retention tab (92), and The supply apparatus according to any one of claims 1 to 5, characterized in that the free-retaining tab end (94) of the retaining tab (92) is oriented to point in the radial direction away from the center of the support (64).
7. The providing device (10) includes an adapter holding device (104) for a connecting adapter (20) that is positioned or formed on the first end (16) of the catheter (12), In particular, the adapter holding device (104) includes at least two adapter holding elements (106a, 106b), Furthermore, the supply device according to any one of claims 1 to 6, characterized in that the two cooperating adapter holding elements (106a, 106b) are configured in the form of adapter holding tabs (108), and the free adapter tab ends (110) of the two adapter holding elements (106a, 106b) are oriented to point toward each other.
8. The providing device (10) includes a balloon holding device (122) for an inflatable balloon (24) positioned or formed in the region of the second end (18) of the catheter (12), In particular, the balloon holding device (122) includes at least two balloon holding elements (126a, 126b), Furthermore, the serving device according to any one of claims 1 to 7, characterized in that, in particular, the two cooperating balloon holding elements (126a, 126b) are configured in the form of balloon holding tabs (128a, 128b), and the free balloon holding tab ends (130a, 130b) of the balloon holding tabs (128a, 128b) point in the same direction at the non-deformation start position of the serving device (10).
9. The tip recess (140) is positioned or formed on the support (34), and the second end (18) of the catheter (12) in the storage position is positioned in the region of the tip recess (140). In particular, the tip recess (140) a) It is positioned adjacent to the balloon holding device (122) with respect to the longitudinal axis (124) of the balloon holding, and / or, b) The support (34) is configured in the form of a perforation (142), and / or, c) The dispensing device according to any one of claims 1 to 8, characterized in that the second end (18) of the catheter (12) held on the dispensing device (10) is sized to allow grasping with two fingers.
10. The removal recess (144) is located or formed on the support (34), and in the storage position, at least two, particularly three, catheter portions of the catheter (12) wound and held on the support (34) are positioned in the area of the removal recess (144). In particular, the removal recess (144) a) The support (34) is configured in the form of perforations (146), and / or, b) The supply device according to any one of claims 1 to 9, characterized in that it is configured in the form of a circular ring section (150).
11. The providing device (10) includes a wire holding device (160) for holding the free end (32) of the wire, wherein the wire protrudes out of the opening of the wire channel of the catheter (12) in a direction toward the first end (16) of the catheter, In particular, the wire holding device (160) includes at least one wire holding element (162), Furthermore, the providing apparatus according to any one of claims 1 to 10, characterized in that, in particular, at least one wire holding element (162) is configured in the form of a wire holding tab (164), and the free wire holding tab end (166) of the wire holding tab (164) is oriented toward the center of the support (64).
12. The aforementioned serving device (10) is made of a flat material, In particular, the flat material is a) Cardboard or paperboard sheets coated with plastic material, or b) Made of plastic material, Furthermore, the providing apparatus according to any one of claims 1 to 11, characterized in that the plastic material is polypropylene (PP), high-density polyethylene (HDPE), polylactic acid (PLA, especially PLLA), polyamide (PA), polyethylene (PE), low-density polyethylene (LDPE), and / or polyethylene terephthalate (PET), or comprises these.
13. The dispensing device according to any one of claims 1 to 12, characterized in that the dispensing device (10) is formed integrally, particularly monolithically.
14. The providing device (10) includes at least one data storage element (176) for storing characteristic data relating to the catheter (12), particularly length, diameter, inflation pressure, and balloon diameter. In particular, the supply device according to any one of claims 1 to 13, characterized in that at least one data storage element (176) is located on the front (42) or rear (44) and is configured to be optically readable.
15. The aforementioned supplying device (10) includes a catheter (12), particularly a PTCA catheter, In particular, the apparatus according to any one of claims 1 to 14, characterized in that the catheter (12) has a first end (16) and a second end (18), a connecting adapter (20) is arranged or formed on the first end (16), and an inflatable balloon (24) is arranged or formed in the region of the second end (18).