Source: https://patents.google.com/patent/CA2709387C/en
Timestamp: 2020-01-23 18:24:25
Document Index: 134568924

Matched Legal Cases: ['art.\n8', 'art 622', 'art 622', 'art 722', 'art 722', 'art.\n3']

CA2709387C - Catheter assembly - Google Patents
CA2709387C
CA2709387C CA2709387A CA2709387A CA2709387C CA 2709387 C CA2709387 C CA 2709387C CA 2709387 A CA2709387 A CA 2709387A CA 2709387 A CA2709387 A CA 2709387A CA 2709387 C CA2709387 C CA 2709387C
CA2709387A
CA2709387A1 (en
2003-04-29 Priority to CA2458840A priority patent/CA2458840C/en
2003-11-13 Publication of CA2709387A1 publication Critical patent/CA2709387A1/en
2011-09-29 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=20287749&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2709387(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
2014-02-18 Publication of CA2709387C publication Critical patent/CA2709387C/en
238000009736 wetting Methods 0 abstract claims description 187
238000000926 separation method Methods 0 abstract description 39
230000004308 accommodation Effects 0 claims description 16
230000001954 sterilising Effects 0 abstract description 16
2837 l -92E
This is a divisional of Canadian Patent Application Serial No. 2,458,840 filed Apr. 29, 2003.
Field of the invention The present invention relates to a catheter assembly comprising a catheter and a receptacle for accommodation of at least part of the catheter. The invention further relates to a method for producing such a Catheter assembly.
= -Background of the invention Catheters find their use in many different medical applications, such as urinary catheters for bladder drainage. Catheters are normally pre-packed in a receptacle by the manufacturer, in order to maintain the catheter in a clean and = preferably sterile condition. However, a problem with such catheter assemblies are = that they are bulky, making them difficult and expensive to store, transport and handle. Further, a lot of packaging and wrapping material is required, making the assemblies expensive and harmful to the environment _ Urinary catheters in general need to have a lubricant applied to the outer =
surfaces thereof to facilitate insertion into the urethra. Especially, for lubrication = purposes hydrophilic urinary catheters may have a hydrophilic outer surface coating which should be wetted by a fluid such as water or saline for a certain time period prior to insertion thereof into the urethra of a patient. In order to facilitate the.use and to improve cleanliness of the catheter, the assemblies have in recent years developed to comprise a rupturable wetting fluid pouch or container as well. This is known. However, unfortunately the inclusion of such a wetting fluid container makes the above-described problem with bulkiness, etc, even more severe.
Further, there has recently been a trend towards so-called "ready-to-use"
catheters, where the catheter is arranged in the receptacle together with a wetting -fluid_ so that the catheter is maintained in a wetted, activated condition.
Such a catheter assembly is known. However, in such a catheter, a relatively large amount of wetting fluid is required to fill the receptacle to a certain degree and to ensure that an adequate wetting of the catheter is maintained.
accordingly, even this type of catheter assembly suffers from the bulkiness discussed above, and is further relatively heavy. Further, a problem with this type of catheter assemblies are that the catheter becomes wet and slippery, which makes it uncomfortable and difficult to handle.
There is further a problem with known catheter assemblies that the catheter = must normally be removed from the receptacle or package before it could be connected to other devices, such as drainage tubes, urine bags, etc. Hereby, the handling of the catheter becomes more difficult, since more work has to be done by the person responsible for the catheterization, and especially during the stressed situation when the catheter is exposed to the environment, instead of in advance, or even as a step during the production process. Further, the time period when the catheter is exposed, and accordingly vulnerable to contamination and the like, is prolonged, which increases the risk for the patient.
Summary of the invention According to one aspect of the invention, it relates to a catheter assembly comprising a catheter including a catheter tube and a connector arranged in one end of the catheter tube; and a catheter receptacle for accommodation of at least the catheter tube. Further, the receptacle is provided with an opening, said opening being connected to and closed by the connector of the catheter.
With the catheter assembly according to the first aspect of the invention, a very advantageous catheter assembly is provided. Generally, the invention relates to a catheter assembly, comprising a catheter receiving receptacle and a catheter having a connector at one end thereof, wherein the receptacle is sealed by said connector.
Since the receptacle is closed by the connector of the catheter, only part of the catheter is enclosed in the receptacle. Hereby, the assembly could be made leaner and less bulky since a receptacle of smaller volume could be used, and at the same time less material is required making the assembly easier and less costly to manufacture.
This also makes the product more environment friendly, since less material is required. Still, all parts of the catheter intended to be inserted into the patient, i.e. all insertable parts of the catheter, could nonetheless be kept in a sterile and medically safe condition, making this catheter assembly at least as reliable as previously known catheter assemblies where the whole catheter is arranged inside the receptacle.
Consequently, the invention relates to a catheter assembly comprising a catheter, part of which forms an insertable length to be inserted through a body opening; and a catheter receptacle for accommodation of at least part of the catheter.
Further, the receptacle is connected to the catheter, thereby enclosing the insertable length of the catheter, but leaving at least part of the catheter outside the receptacle.
Some preferred embodiments of the above-discussed aspect of the invention will now be discussed briefly. Preferably, the receptacle is sealingly connected to the catheter, and/or the compartment formed by the receptacle and the catheter is sealed.
Hereby, at least an insertable part of the catheter could be maintained in a clean, and preferably sterile, condition during storage. Alternatively or additionally, the compartment formed by the receptacle and the catheter could form a microbial barrier against the environment.
In one line of embodiments, the catheter assembly comprises a container containing the wetting fluid, said container being arranged to keep the wetting fluid separated from at least the insertable part of the catheter during storage and the container being openable for activation of the catheter. In such an embodiment, the wetting fluid may be kept separated from the insertable part of the catheter, i.e. the part of the catheter to be inserted through a body opening of the patient, until the time when the catheter is intended to be used. Then, the wetting fluid container may be opened, e.g. by application of a pressure, a pulling force or the like to the container, whereby the wetting fluid is allowed to discharge into the compartment housing the catheter. The container may be a compai tnient integrated with the receptacle, or a separate container. In case a separate container is used, said container may be arranged completely inside the receptacle, partly inside the receptacle or outside the receptacle but preferably with some sort of fluid communication with the receptacle.
Ic In case the container is a compartment formed by the receptacle and the catheter, said compartment is preferably gas sealed, wherein the longevity of the product is increased. For the same reason, the receptacle is preferably gas impermeable.
The receptacle could be connected to the catheter by means of a welding joint, said joint preferably being arranged between the catheter and the receptacle.
This is a simple and cost effective way of providing a tight and sufficiently strong connection.
Alternatively, the receptacle could be connected to the catheter by means of a shrink fit, which is also a simple and cost effective way of providing a tight and sufficiently strong connection. The receptacle is preferably connected to the connector of the catheter.
70 A typical sterilizing agent which could be used for sterilizing the catheter assembly of the invention is ethylene oxide. Moreover, the fluid in the fluid container would normally already be sterile when packed. For these reasons, the wetting fluid container is preferably made of a material which is impermeable or substantially impermeable to ethylene oxide as well as the fluid contained therein. Non-limiting examples of materials satisfying this condition when the fluid is water or saline are aluminium foil laminate, poly(vinylidene chloride) or a laminate comprising metallised film such as metallised poly(ethylene terepthalate), or a silicon oxide coated film, or a laminate comprising aluminum oxide. Other sterilization processes could of course be used instead, for example by irradiation. Steam treatment may also be used for sterilization.
According to another aspect of the invention, it relates to a method for producing a catheter assembly, comprising: providing a receptacle having an opening;
providing a catheter including a catheter tube and a connector arranged on one end thereof; arranging the catheter tube in the receptacle; and connecting the receptacle to the connector, thereby closing said opening.
With a production method according to this aspect of the invention, similar advantages are achieved as discussed above in relation to the first and second aspect =
In accordance with this aspect of the invention, an additional cover is provided in order to achieve a stronger and preferably gas impermeable wetting fluid compartment. Due to the use of this additional cover, the requirements on the material of the receptacle could be lowered, and the material need e.g. not be gas-impermeable. Hereby, the additional cover could provide the impermeability of the compartment wall necessary to alleviate evaporation and maintain the wetting fluid in the compaitnient during storage. At the same time, only a limited amount of cover material is needed, making the product cost effective to produce.
The additional cover may also be used as a protection for the wetting fluid against a sterilizing agent used for the sterilization of the catheter and the rest of the catheter assembly. A typical sterilizing agent which could be used for sterilizing the wetting apparatus of the invention is ethylene oxide. Moreover, the fluid in the fluid container would normally already be sterile when packed, and need not be further sterilized. Additionally, the sterilizing agent may leave unwanted residual products in the wetting fluid if exposed to the same. For these reasons, it is preferred that the additional cover of the wetting fluid container is made of a material which is impermeable or substantially impermeable to ethylene oxide as well as the fluid contained therein. Non-limiting examples of materials satisfying this condition when the fluid is water or saline are aluminium foil laminate, poly(vinylidene chloride) or a laminate comprising metallised film such as metallised poly(ethylene terepthalate), or a silicon oxide coated film, or a laminate comprising aluminum oxide. Other sterilization processes could of course be used instead, for example by irradiation in The additional cover may be attached to the compartment by means of an adhesive, welding or any other suitable connection means.
According to a corresponding aspect, the invention further relates to a method for producing a catheter assembly, comprising: providing a receptacle;
providing a hydrophilic catheter; arranging at least part of the catheter tube in a cavity of the receptacle; arranging a wetting fluid in a compartment forming an integrated part of the receptacle, but being separated from said cavity; and attaching an According to this method, similar advantages as discussed above are achieved.
In accordance with this embodiment of the invention, a rupture of the fluid compartment could be effectively controlled, in order for it to occur in a predetermined position. Hereby, it could be avoided that the compartment, upon application of pressure or the like, is ruptured in a random position, which could lead to leakage of the fluid, insufficient wetting of the hydrophilic surface, etc.
Instead, the rupture will always occur in the most effective position, leading to an effective wetting of the catheter surface.
Preferably, the closure is formed by a rupturable joint between the compartments, and most preferably the joint is a welded joint with a welding width variation, or a welding strength variation, thus providing the at least one point of weakness.
Alternatively, the joint could be arranged in a non-linear arrangement, thus providing the at least one point of weakness. In this case, the joint could be arranged with at least one knee directed towards the wetting fluid compartment. The knee could e.g. have an angled peak portion directed towards the wetting fluid compartment, with an obtuse or acute angle.
However, the knee may alternatively have a curbed peak portion directed towards the wetting fluid compartment. Hereby, effective rupture control may be achieved, and at the same time a very cost effective and easily producible joint is provided.
According to one aspect of the present invention, there is provided a urinary catheter assembly comprising: a hydrophilic urinary catheter, part of which forms an insertable length to be inserted through a body opening, and with a flared rearward part; a catheter receptacle for accommodation of at least part of the catheter; and a wetting fluid wherein the receptacle is connected to the flared rearward part of the catheter, thereby enclosing the insertable length of the catheter, but leaving at least part of the flared rearward part outside the receptacle, and in that a closure is also connected to the flared rearward part, at a distance from said receptacle, said closure sealingly closing the rearward end of the flared rearward part.
8a According to another aspect of the present invention, there is provided a method for producing a urinary catheter assembly, comprising: providing a receptacle having an opening; providing a hydrophilic urinary catheter including a catheter tube and a connector arranged on one end thereof; arranging the catheter tube in the receptacle;
providing a wetting fluid in said assembly; connecting the receptacle to the connector, thereby closing said opening; and closing an open rearward end of said connector by means of connecting a closure to the flared rearward part, at a distance from said receptacle, said closure sealingly closing the rearward end of the connector.
Further scope of the applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only.
Fig. 1 illustrates a first embodiment of a catheter assembly according to the invention, where fig. la is .a partly broken view and fig. lb is an unbroken view;
Fig. 5 illustrates a fifth embodiment of a catheter assembly according to the invention, where fig. 5a is a side view of the whole catheter assembly, fig.
5b is an expanded view of the connector part of the catheter assembly shown in fig. 5a, and fig. 5c is a view of the connector part of fig. 5b illustrating the activation process;
Description of preferred embodiments In the following detailed description preferred embodiments of the invention will be described. However, it is to be understood that features of the different embodiments are exchangeable between the embodiments and may be combined in different ways, unless anything else is specifically indicated.
General description of the catheter assembly and embodiments with externally accessible connector Referring first to fig. 1, a first embodiment of a catheter assembly 1 according to the invention comprises a wetting receptacle or bag 2, preferably of a transparent flexible plastics material. The receptacle 2 has a downwardly extending elongate pocket 21 at the forward end and an opening end 22.
The catheter assembly 1 further comprises a catheter, and preferably a hydrophilic urinary catheter 3, having a preferably flared rearward portion 31, an elongate shaft or tube 32 projecting forwardly from the rearward portion 31 and an open-ended lumen (not shown) which extends from the rear end of the rearward portion 31 to a drainage aperture 33 in the rounded tip 34. The rearward portion 31 could function as a connector of the catheter 3, being connectable to other devices, such as a urine collection bag, a drainage tube or the like. At least a part of the elongate tube 32 forms an insertable length to be inserted through a body opening of the user, such as the urethra in case of a urinary catheter. By insertable length is 5 normally, in the context of a hydrophilic catheter, meant the length of the elongate tube 32 which is coated with a hydrophilic material, for example PVP, and which could be inserted into the urethra of the patient. Typically, this will be 80-140 mm for a female patient and 200-350 mm for a male patient.
The catheter receptacle 2 is adapted for accommodation of the catheter tube 32 10 in the elongate pocket 21, and the opening of the opening end 22 is connected to and closed by the connector or rearward end 31 of the catheter. Hereby, the receptacle 2 encloses at least the insertable length of the catheter 3, but leaves a part of the catheter 3 outside the receptacle.
The receptacle 2 could be connected to the catheter 3 in various ways. For example, the connection could be provided by means of a welding joint arranged between the catheter and the receptacle. However, it is also possible to connect the receptacle 2 to the catheter 3 by means of a shrink fit, an adhesive or the like. In the disclosed embodiment, the receptacle 2 is arranged on the outward side of the connector 31. However, the connector 31 may comprise a lower end protruding over apart of the elongate tube 32 of the catheter 3, and in such a case the receptacle 2 may alternatively be connected to the inward side of said protruding part.
The receptacle 2 preferably comprises opening means for facilitating opening of the receptacle in order to expose the catheter 3 for use. The opening means could comprise a tear line 23 connected to a gripping handle 24, such as a pulling tab.
Hereby, the user could pull the gripping handle 24, and thereby tearing open the side wall of the receptacle. Additionally, or alternatively, a gripping handle may be arranged in the opposite end of the tear line. However, alternative opening means are also feasible, such as tear-lines arranged in different fashions, peel-offjoints, etc. It is also possible to construct the receptacle so that it is openable by a screwing or twisting action, e.g. by screwing or twisting open the end part of the receptacle being opposite to the connector.
In a method of wetting the catheter 3 according to this embodiment, the user opens the catheter compartment, i.e. the compartment of the receptacle housing the catheter, and applies a wetting fluid onto the insertable end for wetting of the catheter, thereby activating it for catheterization. Different ways of wetting the catheter are feasible. For example, the assembly I may be opened in the connector end, by removing the cap 4, whereafter the wetting fluid may be introduced through the catheter lumen. After the activation, the receptacle 2 may be teared opened in order to expose the catheter for insertion into a patient. Alternatively, the receptacle 2 may be opened directly whereby the catheter 3 is exposed and the wetting fluid may be applied directly onto the catheter surface.
With reference to fig. 3, a third embodiment of the catheter assembly will now be discussed. In this embodiment, the catheter assembly generally corresponds to the second embodiment in that it also comprises a wetting fluid container 350 containing a wetting fluid 360. In this case, however, the wetting fluid container 360 is not formed in a separate compartment of the receptacle, but is integrated with the compartment holding the catheter. Hereby, the catheter is activated already during production, and is then maintained in a activated, ready-to-use condition.
Thus, in this embodiment, the hydrophilic surface layer is preserved in a wetted state during accommodation in the receptacle and a ready-to-use catheter assembly is provided. In order to preserve this wetted condition the compartment formed by the receptacle and the catheter is preferably gas sealed, and further, the receptacle is preferably gas impermeable.
With reference to fig. 5, a fifth embodiment of the catheter assembly will now be discussed. In this embodiment, the catheter assembly 510 comprises a wetting receptacle or bag 520, preferably of a transparent flexible plastics material.
The receptacle 520 has a downwardly extending elongate pocket 521 at the forward end and an opening end 522 (see fig. 5b).
As in the previously discussed embodiments, the catheter assembly 510 further comprises a catheter, and preferably a hydrophilic urinary catheter 530.
However, in this case a different type of connector 531 is used, with a different type of connection interface for connection to other devices, such as a urine collection bag a drainage tube or the like.
In the disclosed embodiment in fig. 5, one side wall of the wetting fluid container 550 is formed by the wall 531 forming the connection interface and three side walls 552 are formed integrated with the connector and arranged inside the receptacle. Further, one bottom wall 554 is formed integrated with the connector, whereas the top wall is formed as a separation wall formed by the receptacle.
In the compartment formed by said walls the wetting fluid is stored. Preferably, the compartment is formed around the catheter lumen, and in that case, a tube 553 is arranged in the compartment for provision of a fluid communication between the connector interface and the elongate tube of the catheter. The wetting fluid container is openable in order to allow the wetting fluid to discharge from the wetting fluid container into the elongate pocket of the receptacle for wetting of the catheter. For example, such an openable container may be provided by making the connection between the separation wall and the rest of the container peelable. Hereby, the separation wall may be peeled opened by applying a relative force between the separation wall and the rest of the container, whereby the wetting fluid is discharged into the rest of the receptacle. The application of such a force may be provided by provision of a handle 526 or the like. In that case, a pulling force may be applied to the handle 526 in relation to the rest of the receptacle, whereby the separation wall 555 is peeled open from the container. This is illustrated schematically in fig. 5c.
To facilitate the removal of the catheter from the receptacle and the insertion into the urethra of the patient, at least one area of weakness 523a, 523b, such as a tear line, is preferably arranged on the receptacle in the area of the elongate pocket arranged to receive the fluid, in which the catheter is placed. Most preferably, two such areas of weakness 523a, 523b are provided, and separated in the lengthwise direction of the receptacle. The intermediate part of the receptacle may be used as an insertion aid for guiding and holding the wetted catheter when it is inserted into the urethra. There is therefore no need to directly handle the catheter 530 for insertion thereof into the urethra, which is an advantage as the outer surface of the catheter 530 will be slippery due to the wetting procedure and therefore difficult to grip and 5 furthermore because the possibility of contamination of the catheter 503 at this stage is avoided, whereby the cleanness and sterility of the catheter may be maintained.
In a method of wetting the catheter according to this embodiment, the user 10 applies e.g. a pulling force to the handle 526, thereby peeling open the separation wall 555 and discharging the wetting fluid into the catheter compartment.
Preferably, the wetting fluid container contains a sufficient amount of wetting fluid for the insertable length of the catheter to be sufficiently wetted.
After release of the wetting fluid into the catheter compartment the receptacle 15 may be opened and part of it may even be used as an applicator, as is discussed above.
With reference to fig. 6, a sixth embodiment of the catheter assembly will now be discussed. In this embodiment, the catheter assembly 610 comprises a wetting receptacle or bag 620, preferably of a transparent flexible plastics material.
The receptacle 620 has a downwardly extending elongate pocket 621 at the forward end and an opening part 622 with an opening.
As in the previously discussed embodiments, the catheter assembly further comprises a catheter, and preferably a hydrophilic urinary catheter 630, with a connection interface for connection to other devices, such as a urine collection bag a drainage tube or the like. The catheter receptacle 620 is adapted for accommodation of the catheter tube in the elongate pocket 621, and the opening of the opening part 622 is connected to and closed by the connector 631 or rearward end of the catheter.
Hereby, the receptacle encloses at least the insertable length of the catheter, but leaves at least part of the catheter outside the receptacle, said part comprising the connection interface.
The assembly also comprises a wetting fluid container 650 containing a wetting fluid 660. In this case, the wetting fluid container is formed in a compartment of the receptacle being separated from the compartment accommodating the catheter.
The wetting fluid container 650 is in this embodiment arranged in a part of the receptacle extending rearwardly from the catheter, i.e. behind the connector part of the catheter. Said rearward part of the receptacle is preferably in fluid communication with the forward part housing the catheter. This fluid communication may be provided by the arrangement of at least one channel 626 past the catheter connector.
Preferably, two such channels 626 are arranged, one on each side of the connector.
Thereby the receptacle frames an opening 627 in which the protruding part of the catheter is situated.
The wetting fluid compartment of the receptacle is separated from the compartment holding the catheter by means of a rupturable separation wall 651.
The separation wall 651 may be formed by a separable joint between the compartments, In order to achieve a stronger and preferably gas impermeable wetting fluid Even in this embodiment the receptacle could comprise opening means for facilitating opening of the receptacle in order to expose the catheter for use. The opening means could comprise one or several areas of weakness, such as tear lines 623a, 623b connected to one or several gripping handles 624a, such as a pulling tab.
Further, alternatively or additionally, opening means may be arranged close to the distal end of the catheter. Said opening means may comprise a peelable joint 623c connected to tabs 624b extending from the edge for enabling opening by peeling the receptacle is arranged to allow a significant degree of separation of the foil walls, thereby making it possible to expose an essential part, and preferably the whole, insertable part of the catheter during this opening process. There is therefore no need to directly handle the catheter 630 during the insertion thereof into the urethra, which is an advantage as the outer surface of the catheter 630 will be slippery due to the wetting procedure and therefore difficult to grip, and furthermore because the possibility of contamination of the catheter at this stage is avoided, whereby the cleanness and sterility of the catheter may be maintained.
At least one, and preferably both, of the end parts of the catheter assembly are preferably provided with gipping means, such as openings 670, for facilitating handling of the catheter assembly.
With reference to fig. 7, a seventh embodiment of the catheter assembly will now be discussed. In this embodiment, the catheter assembly 710 comprises a wetting receptacle or bag 720, preferably of a transparent flexible plastics material.
The receptacle 720 has a downwardly extending elongate pocket 721 at the forward end and an opening part 722 with an opening.
As in the previously discussed embodiments, the wetting apparatus further comprises a catheter, and preferably a hydrophilic urinary catheter 730, with a connection interface for connection to other devices, such as a urine collection bag a drainage tube or the like. The catheter receptacle is adapted for accommodation of the catheter tube in the elongate pocket 721, and the opening of the opening part 722 is connected to and closed by the connector or rearward end of the catheter.
Even in this embodiment the receptacle could comprise opening means for facilitating opening of the receptacle in order to expose the catheter for use. The opening means could comprise one or several areas of weakness, such as tear lines 723a, 723b connected to one or several gripping handles 724a, such as a pulling tab.
Said opening means could be used to facilitate the removal of the catheter from the receptacle and the insertion into the urethra of the patient Further, alternatively or additionally, opening means may be arranged close to the distal end of the catheter. Said opening means may comprise a peelable joint 723c connected to tabs 724b extending from the edge for enabling opening by peeling the tabs apart, thereby separating the foil walls of the receptacle. Preferably, the receptacle is arranged to allow a significant degree of separation of the foil walls, thereby making it possible to expose an essential part, and preferably the whole insertable part of the catheter during this opening process. There is therefore no need to directly handle the catheter 730 for insertion thereof into the urethra, which is an advantage as the outer surface of the catheter will be slippery due to the wetting procedure and therefore difficult to grip and furthermore because the possibility of contamination of the catheter at this stage is avoided, whereby the cleanness and sterility of the catheter may be maintained.
At the other end of the receptacle, preferably arranged relatively close to proximal end of the catheter, further opening means may be arranged, comprising e.g.
a peelable joint 723d connected to tabs 724c extending from the edge for enabling opening by peeling the tabs apart, thereby separating the foil walls of the receptacle.
Said opening means may be used for the provision of a wetting fluid introduction opening for introduction of a wetting fluid into a wetting fluid receiving compartment of the receptacle when the catheter is to be wetted and activated before use.
The opening means for providing the wetting fluid introduction opening is preferably arranged in a part of the receptacle extending rearwardly from the catheter, i.e. behind the connector part of the catheter. Said rearward part of the receptacle is preferably in fluid communication with the forward part housing the catheter.
This fluid communication may be provided by the arrangement of at least one channel past the catheter connector. Preferably, two such channels 726 are arranged, one on each side of the connector. Thereby the receptacle frames an opening 727 in which the protruding part of the catheter is situated. With this constructional arrangement, the wetting fluid introduction opening could be made relatively large, which facilitates the introduction of the wetting fluid.
95 In the assemblies discussed above, the receptacle may actually be regarded as a receptacle where part of the receptacle is formed by a part of the catheter.
However, this is not applicable for the examples described with reference to fig 8-10, discussed in the following.
Catheter assemblies havinza wetting fluid container with additional cover As is already discussed above with reference to fig 6, the arrangement of an additional cover 660 around the wetting fluid compartment of the receptacle is advantageous.
The additional cover may also be used as a protection for the wetting fluid 5 against a sterilizing agent used for the sterilization of the catheter and the rest of the catheter assembly. A typical sterilizing agent which could be used for sterilizing the wetting apparatus of the invention is ethylene oxide. Moreover, the fluid in the fluid container would normally already be sterile when packed, and need not be further sterilized. Additionally, the sterilizing agent may leave unwanted residual products in 10 the wetting fluid if exposed to the same. For these reasons, it is preferred that the additional cover of the wetting fluid container is made of a material which is impermeable or substantially impermeable to ethylene oxide as well as the fluid contained therein. Non-limiting examples of materials satisfying this condition when the fluid is water or saline are aluminium foil laminate, poly(vinylidene chloride) or a 15 laminate comprising metallised film such as metallised poly(ethylene terepthalate), or a silicon oxide coated film, or a laminate comprising aluminum oxide.
Accordingly, in a production method of this catheter assembly, the receptacle 20 is manufactured, and the catheter is arranged in the receptacle, as is discussed in more detail below. Further, the wetting fluid is introduced into the wetting fluid compartment, and the additional cover is arranged outside said compartment.
Then, the assembly could be sterilized, whereby the additional cover serves as a protection for the wetting fluid against the sterilizing agent.
The assembly also comprises a wetting fluid container 850 containing a wetting fluid (not illustrated). The wetting fluid container is formed in a compartment _________________________________________________________________ of the receptacle being separated from the compai talent accommodating the catheter.
The wetting fluid container 850 is in this embodiment arranged in a part of the receptacle extending rearwardly from the catheter, i.e. behind the connector part of the catheter. Said rearward part of the receptacle is preferably in fluid communication with the forward part housing the catheter. This fluid communication may be provided by the compaitment of the recektacle housing the catheter being rearwardly open towards the separation to the wetting fluid container.
The wetting fluid compartment of the receptacle is separated from the compartment holding the catheter by means of a rupturable separation wall 851.
The separation wall 851 is in this case formed by a separable joint between the compartments, such as is discussed in more detail in the following. Hereby, the wetting fluid may be discharged into the other compartment of the receptacle by compressing the wetting fluid container, or by applying a pulling force between the end parts of the assembly.
Catheter assemblies having a wetting fluid container with improved rupture control A catheter assembly is e.g. disclosed in fig 6 as comprising a hydrophilic catheter, a catheter receptacle forming a cavity for accommodation of at least part of the catheter and a compartment accommodating said wetting fluid, wherein said compartment forms an integrated part of the receptacle, but being separated from said cavity. In this type of catheter assembly, it is advantageous if the separation between the wetting fluid compartment and the cavity accommodating the catheter provides a rupturable sealed closure, in which it is provided at least one point of weakness, in order for an induced rupture to occur in a predetermined position, thereby enabling fluid communication between the compartment and the cavity housing the catheter.
In the assembly of fig 6, a wetting fluid container 650 is formed in a compartment of the receptacle being separated from the compartment accommodating the catheter. The wetting fluid container 650 is in this embodiment arranged M
a part of the receptacle extending rearwardly from the catheter, i.e. behind the connector part of the catheter. Said rearward part of the receptacle is preferably in fluid communication with the forward part housing the catheter. The wetting fluid compartment of the receptacle is separated from the compartment holding the catheter by means of a rupturable separation wall 651. The separation wall 651 may be formed by a separable joint between the compat tments, such as weld of less strength than the other welds forming the compartment. Consequently, a whole segment of the total weld joint is weakened, viz. the part of the joint facing the catheter compartment.
When a rupture is induced, e.g. by manual compression of the wetting fluid compartment or by applying a pulling force between the end parts of the assembly, the rupture will inevitably occur in this predetermined position, thus ensuring the intended functionality of the catheter assembly product.
In order to achieve an even better control of the rupture process, the area of weakness could be even narrower. It is preferred that the weakness is maximized in a limited number of discrete points, such as in one, two or three maxima.
However, the points of weakness may also be evenly distributed over a limited area. In that case, it is preferred if the area of weakness is distributed over less than 10% of the joint length, and more preferably over less than 5 %, and most preferably over less than 1%.
In fig 10d, a separation joint is illustrated comprising a double knee directed towards the wetting fluid compartment. The joint has two angled peak portion 5 directed towards the wetting fluid compartment, with acute angles. The peak portions defines the area of maximal stress build-up, and accordingly the area of maximal weakness, and consequently the rupture will inevitably commence in one, or both, of these points, leading to a controllable and predictable rupture process.
In fig 10e, a separation joint is illustrated comprising two welds, wherein a 10 discontinuity is arranged in one of the welds. In this embodiment, an interruption is arranged in the innermost weld, and essentially in the center of the joint.
Hereby, the strength of the joint is at a minimum at the discontinuity area, and consequently the rupture will inevitably commence in this area, leading to a controllable and predictable rupture process.
15 In fig 10f, a separation joint is illustrated comprising a weld comprising different qualities or weld strengths. In this embodiment, a part of the weld is of a poorer quality and less strength that the rest of the weld, and this part is positioned essentially in the center of the joint. Hereby, the strength of the joint is at a minimum at the area of the weaker weld, and consequently the rupture will inevitably 20 commence in this area, leading to a controllable and predictable rupture process.
25 Conclusion and summary The invention has now been discussed in relation to different embodiments.
However, it should be appreciated by someone skilled in the art that several further alternatives are possible. For example, the features of the different embodiments discussed above could naturally be combined in many other ways. Specifically, the features and details discussed in relation to the different main aspects of the invention are usable also in relation to the other aspects, even though this may not be specifically discussed in the exemplification. Further, the different main aspects of the invention are useable either separately or in various combinations.
Further, different ways of connecting the receptacle with the catheter are possible, such as by welding, different types of adhesives, shrink fits, etc.
Further, it is possible to connect the receptacle to the connector or to a part of the catheter tube, as long as the insertable part of the catheter is arranged within the receptacle. In the later case, the catheter need not even have a connector. The catheter may also be arranged to have more than one part at least partly protruding out from the receptacle, such as several connectors.
Further, the catheter need not be a hydrophilic catheter, but other types of catheters may be used as well. In that case, other types of lubricants may be used instead of the wetting fluid discussed in relation to the above-disclosed embodiments.
In case the catheter assembly comprises a wetting fluid container, it is possible to arrange this container in many different ways. For example, the container may be a separate container. Such a container may be arranged completely inside the receptacle, partly inside the receptacle, or completely outside the receptacle.
Alternatively, the wetting fluid container may be an integrated compartment of the receptacle. This compartment may be separated from the compartment housing the insertable part of the catheter, or be integrated with such a compartment. In the latter case, the catheter could be maintained in a wetted, activated state. Further, the wetting fluid container may be arranged close to the distal part of the catheter, close to the proximal part of the catheter, or in any other suitable location in the assembly. In case the wetting fluid is arranged separate from the insertable part of the catheter, the separation wall or joint could e.g. be a breakable or peelable membrane wall, but alternative embodiments are naturally feasible, such as various types of detachable or openable caps or closings. The wetting fluid container could be arranged to be discharged upon application of a twist, a compression, a pull or the like on the fluid container. Preferably the wetting fluid could be discharged without breaking or rupturing the receptacle, even though this may not be necessary, depending on the intended use, etc.
a hydrophilic urinary catheter, part of which forms an insertable length to be inserted through a body opening, and with a flared rearward part;
a catheter receptacle for accommodation of at least part of the catheter; and a wetting fluid wherein the receptacle is connected to the flared rearward part of the catheter, thereby enclosing the insertable length of the catheter, but leaving at least part of the flared rearward part outside the receptacle, and in that a closure is also connected to the flared rearward part, at a distance from said receptacle, said closure sealingly closing the rearward end of the flared rearward part.
3. The catheter assembly of claim 1, wherein the wetting fluid is arranged in a compartment of the receptacle.
4. The catheter assembly of claim 3, wherein the wetting fluid compartment is formed by a compartment of the receptacle housing the catheter, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly.
5. The catheter assembly of any one of claims 1 to 4, wherein the wetting fluid compartment is arranged to keep the wetting fluid separated from at least the insertable length of the catheter during storage, the compartment container being openable for activation of the catheter.
6. The catheter assembly of any one of claims 1 to 5, wherein the receptacle is gas impermeable.
7. The catheter assembly of claim 1, wherein the wetting fluid container forms a compartment being separated from the receptacle.
8. The catheter assembly of claim 1, wherein the receptacle is openable by means of a tear-line, extending along the axial direction of the catheter.
9. The catheter assembly of claim 1, wherein the receptacle is removably attached to the flared rearward part of the catheter.
10. A method for producing a urinary catheter assembly, comprising:
providing a hydrophilic urinary catheter including a catheter tube and a connector arranged on one end thereof;
connecting the receptacle to the connector, thereby closing said opening; and closing an open rearward end of said connector by means of connecting a closure to the flared rearward part, at a distance from said receptacle, said closure sealingly closing the rearward end of the connector.
11. The method of claim 10, wherein the receptacle is connected to the connector thereby sealingly closing the receptacle.
CA2709387A 2002-04-30 2003-04-29 Catheter assembly Active CA2709387C (en)
CA2709387A1 CA2709387A1 (en) 2003-11-13
CA2709387C true CA2709387C (en) 2014-02-18
CA2709391A Expired - Fee Related CA2709391C (en) 2002-04-30 2003-04-29 Catheter assembly
CA2709387A Active CA2709387C (en) 2002-04-30 2003-04-29 Catheter assembly
CA2458840A Expired - Fee Related CA2458840C (en) 2002-04-30 2003-04-29 Catheter assembly
EP1131128B1 (en) 2004-12-15 Catheter having improved bonding region