JP2006502806A - Catheter wetting system and method - Google Patents

Abstract

The present invention includes systems and methods for wetting a catheter. The wetting system may include a catheter container, a fluid packet and a catheter. The fluid packet and catheter container are designed and configured to require opening the packet and moving the container to wet the catheter. The method includes opening the packet to wet the catheter and moving the container.

Description

  The present invention includes a catheter wetting system and method. The wetting system may include a catheter container, a fluid packet (parcel) and a catheter. The fluid packet and catheter container are designed and configured to require opening the packet and moving the container to wet the catheter. The method includes opening the packet and moving the container to wet the catheter.

  Wetting of a wettable catheter, such as a hydrophilic urinary catheter, results in lubrication that is advantageous for insertion into the urethra. Lubrication increases the comfort of the catheterization subject and facilitates catheter insertion. Inserting a dry or incompletely wetted catheter can be painful.

  Wetting catheters, particularly hydrophilic urinary catheters, can be wetted by a variety of methods. For example, the catheter can be removed from its packaging and wetted. Such wetting methods expose the risk of contaminating the catheter. Alternatively, some catheters are packaged with a fluid container, which is sufficient to wet the insertable length of the catheter by opening the fluid container. Such packaging becomes complicated and requires a large amount of fluid that must be disposed of.

  There remains a need for additional systems and methods for wetting wettable catheters.

  The present invention includes systems and methods for wetting a catheter. The wetting system may include a catheter container, a fluid packet and a catheter. The fluid packet and catheter container are designed and configured to require opening the packet and moving the container to wet the catheter. The method includes opening the packet to wet the catheter and moving the container.

  In one embodiment, the wetting system includes a catheter container designed and configured to enclose a fluid packet and a catheter. The fluid packet is designed and configured to open and release fluid without opening the catheter container. The fluid packet is designed and configured to be squeezed, pressed or struck to release fluid. The fluid packet and catheter container are designed and constructed such that the mere release of fluid from the fluid packet only wets the catheter incompletely. The mere release of fluid from the packet does not wet the catheter to a sufficient extent to allow the catheter to be inserted. The system is designed and configured such that container movement or manipulation wets the catheter to the extent that it can be inserted.

(Definition)
As used herein, the phrase “hydrophilic catheter” refers to a catheter whose handle and tip have a hydrophilic surface that provides advantageous lubrication during insertion and use of the hydrophilic catheter when wet.

  As used herein, the phrase “hydrophilic urinary catheter” refers to a hydrophilic catheter that is sized and fabricated to occupy the mammalian urethra and drain the mammalian bladder.

  As used herein, the phrase “insertable length” of a hydrophilic urinary catheter refers to the length of the catheter handle that is coated with a hydrophilic material and inserted into the urethra of the subject. For human female subjects, the insertable length is about 80-140 mm. In the case of a human male subject, the insertable length is about 200 to 350 mm.

  As used herein, the phrases “only incompletely wet”, “incompletely wet” and similar phrases include wetting less than the catheter insertable length or inserted length, and / or Or refers to not wetting the catheter's insertable length or inserted length to a sufficient extent to allow it to be inserted into the human urethra without unacceptable discomfort. For example, the entire insertable length of the catheter may be wet but not wet enough to allow it to be inserted. Wetting to a sufficient extent requires contact with sufficient wetting fluid to wet the catheter for a time sufficient to wet the catheter. For example, a wettable catheter can include a coating that requires wetting for insertion of the catheter. An individual unit volume of a coating may require contact with sufficient wetting fluid to wet its entire coating volume. Individual unit volumes of the coating may require contact with the wetting fluid for a time sufficient for the wetting fluid to wet its entire coating volume. For example, contact with visible liquid water for about 10, about 20, 30 seconds or more can wet the coating of the hydrophilic urinary catheter.

(Catheter wetting system and method)
The present invention relates to systems and methods for wetting a catheter. The system can include a catheter, a catheter container, and a fluid packet. The system can be used in the method of the present invention.

  Catheters suitable for the system and method include catheters that benefit from wetting prior to use, for example, prior to insertion into a subject. Such a catheter is referred to herein as a wettable catheter. Wetting catheters include hydrophilic catheters such as hydrophilic urinary catheters.

  In the present system and method, the catheter container and fluid packet are configured such that opening the fluid packet in the catheter container only wets the catheter incompletely. For example, the catheter container can be configured so that fluid does not move easily along the length of the catheter unless the catheter container is moved. For example, the catheter can be placed inside the catheter container so that fluid does not move easily along the length of the catheter unless the catheter container is moved. For example, a fluid packet may contain an amount of fluid that does not move easily along the length of the catheter unless the catheter container is moved. For example, the fluid packet may be arranged so that the fluid does not move easily along the length of the catheter unless the catheter container is moved.

  For example, the catheter container may be configured such that it must be moved to contact the catheter with sufficient wetting fluid for a sufficient time to completely wet the catheter. For example, the catheter may be placed inside the catheter container such that the container must be moved to contact the catheter with sufficient wetting fluid for a sufficient time to fully wet the catheter. For example, the fluid packet may contain an amount of fluid such that the container must be moved to contact the catheter with sufficient wetting fluid for a time sufficient to completely wet the catheter. For example, the fluid packet may be placed inside the catheter container such that the container must be moved to contact the catheter with sufficient wetting fluid for a sufficient time to fully wet the catheter.

  For example, the catheter container can be configured such that it must be moved to bring the insertable length of the catheter into contact with the wetting fluid. For example, the catheter can be placed inside the catheter container such that the container must be moved to bring the insertable length of the catheter into contact with the wetting fluid. For example, the catheter can be placed inside the catheter container such that the container must be moved to bring the insertable length of the catheter into contact with the wetting fluid. For example, the fluid packet may contain an amount of fluid such that the container must be moved to contact the insertable length of the catheter with the wetting fluid. For example, the fluid packet can be placed inside the catheter container such that the container must be moved to bring the insertable length of the catheter into contact with the wetting fluid.

  The catheter container can have a suitable configuration for enclosing the catheter and fluid packet and can be fabricated from a qualified material. The catheter container has a suitable configuration and / or structure for moving the container to move fluid within the container over the length of the catheter. A catheter container moves a container in space (eg, rotates, tilts or shakes the container), moves a portion of the container (eg, bends the container), or manipulates the container (eg, wetting fluid) Can be designed and configured to be exercised in any of a variety of ways, including pushing the material that makes up the container or the contents of the container. For example, the catheter container can be sufficiently small and lightweight so that it can be tilted or twisted to move water over the length of the catheter. For example, the catheter container can be made of a flexible material that can be manipulated to move fluid over the length of the catheter.

  In one embodiment, the catheter container has a configuration such as an elongated shape, a pouch, an envelope, and a pocket. In one embodiment, the catheter container may be made from a material that allows the catheter to be viewed on an opaque or translucent background. For example, the catheter container can be made from a sheet of transparent material and a sheet of opaque or translucent material. The sheets can be joined together at the periphery of the cavity containing the catheter and fluid packet. For example, the catheter container may be in the form of a pouch formed of a translucent material and a transparent material, wherein the first side of the pouch is made of a translucent material and the second side of the pouch is made of a transparent material. Become. Such pouches can be sealed around the edges.

  In one embodiment, the catheter is floating inside the catheter container. In one embodiment, the catheter is removably disposed within the catheter container. Similarly, in one embodiment, the fluid packet is floating within the catheter container. In one embodiment, the fluid packet is fixedly disposed within the catheter container. In one embodiment, the fluid packet is removably disposed within the catheter container. In one embodiment, the fluid packet is a compartment formed from the material of the catheter container.

  The fluid packet can have a suitable configuration for containing fluid in the catheter container and can be fabricated from a qualified material. The fluid packet only wets the catheter incompletely without movement of the catheter container, but may be configured to contain enough fluid to fully wet the catheter with movement of the catheter container. The fluid packet may be configured to release fluid upon application of force to the packet without opening the catheter container. For example, the fluid packet may comprise a fluid filled cavity defined by two pieces of material joined at a seam. By squeezing or striking such a fluid packet, the material or seam can be broken and the fluid released. The material or seam can be substantially uniform around the edges.

  The fluid packet can be in any of a variety of forms such as a pouch, ampoule, tube, and the like. The fluid packet can be made of any of a variety of materials such as aluminum foil, polyvinylidene chloride, metallized film, and the like. The metallized film can be or include metallized polyethylene terephthalate. Preferably, the fluid packet is made of a hydrophobic material, such as a hydrophobic plastic such as polyethylene or a material comprising polyethylene. The fluid packet may include a first piece of packet material and a second piece of packet material. In this configuration, the first piece and the second piece of packet material can be sealed together around the edge. The seal can be substantially uniform around the edge.

  The fluid packet can contain any of a variety of fluids that are eligible to wet the catheter. In one embodiment, the fluid is an aqueous wetting composition. The aqueous wetting composition can be any of a variety of aqueous wetting compositions that are suitable for wetting a catheter, such as a hydrophilic catheter. The aqueous wet composition is or includes a sterile composition such as sterile water (eg, tap water, pure water or distilled water), sterile saline solution, and the like. In one embodiment, the aqueous wetting composition is or is made of distilled water.

  In one embodiment, the fluid packet is of a volume that provides insufficient fluid to fully wet the catheter if the catheter container is not moved or manipulated. For example, the fluid packet may have a volume of about 10-15 ml in a much larger container. Advantageously, such a low volume fluid packet results in less water, less waste water, and / or packaging and transport during use of the catheter and / or disposal of used containers. There may be less mass and volume.

  The system can include any of a variety of components useful in catheters. For example, the additional components can be useful for insertion, use, removal or disposal of the catheter. The system may include a urine collection bag. The system may include instructions regarding the use of the system or any part of the system. Such instructions may describe, for example, that the catheter container must be moved to move the wetting fluid over the insertable coating length of the catheter. Such instructions can be printed on the catheter container or on instructions included with the system. A product may include one or more of these additional components in addition to the system.

(Method)
The present invention relates to a method of wetting a catheter. The method prepares a catheter and a fluid packet in a catheter container, breaks the fluid packet to release fluid into the container, thereby only wets the catheter incompletely, and moves the container to wet the catheter Can include. The method can include providing a system of the present invention. In one embodiment, the provisioning includes providing a catheter container comprising a catheter and fluid packet sealed therein.

  The method may include breaching the fluid packet to release the fluid by any of a variety of mechanisms or conditions suitable for releasing fluid from the fluid packet into a container, such as a catheter container. Breaking can be accomplished by a medical profession or by a person using a catheter. In one embodiment, breaking can also be accomplished by a person with reduced strength, coordination, or hand dexterity. Breaking may include, for example, hitting, piercing or squeezing a fluid packet. Preferably, breaking includes, for example, striking, piercing or squeezing a fluid packet without opening the catheter container. For example, breaking can include squeezing or striking a fluid packet through the material of the catheter container.

  Moving the container to wet the catheter can be accomplished by typical methods in which a person moves or manipulates a small container, such as a catheter container. For example, moving the container includes tilting or rotating one end of the catheter container relative to its opposite end, manipulating the catheter container to move water, or moving and manipulating the container. obtain. For example, manipulating the container can include applying finger pressure to the material forming the catheter container to push fluid within the catheter container. Preferably, moving the catheter container provides for movement of fluid over the insertable coating length of the hydrophilic catheter. Moving the catheter container may be performed for a time period sufficient to repeatedly contact each portion of the insertable length of the catheter. As such, the insertable length may be contacted for a time sufficient to completely wet the catheter. Preferably, breaking the fluid packet and moving the container is performed without opening the catheter container.

  The method may also include other procedures involving catheters, particularly urinary catheters. For example, the method may include opening the catheter container, removing the wetted catheter from the opened container, and / or using the wetted catheter.

(Exemplary embodiment)
FIG. 1 schematically illustrates an embodiment of a wetting system according to the present invention. An exemplary embodiment of the system includes a catheter pouch 1, a wettable catheter 2 and a fluid pouch 3.

  The catheter pouch 1 defines a pouch interior 4 that houses a wettable catheter 2 and a fluid pouch 3. The pouch interior 4 is defined by a seam 5. In one embodiment, the catheter pouch 1 is composed of an opaque or translucent backsheet 6 and a transparent cover sheet 7. The backsheet 6 may be composed of a plastic polymer such as polyethylene such as low density polyethylene. The cover sheet 7 can be made of a plastic polymer such as polyethylene such as high-density polyethylene. The backsheet 6 and the coversheet 7 can be joined to form the seam 5 by adhesive, welding or the like. The seam 5, back sheet 6 and cover sheet 7 are preferably liquid tight. The backsheet 6 and the coversheet 7 are preferably permeable to a sterilant such as ethylene oxide.

  The wettability catheter 2 includes a flared outlet 8, a handle 9, a tip 10, and an eyelet 11. The handle 9 and the tip 10 define a lumen (not shown) that leads from the eyelet 11 to the outlet 8. Most of the tip 10 and handle 9 of the wettability catheter 2 is coated with a wettability coating (not shown).

  The fluid pouch 3 defines a fluid chamber 12 that can contain fluid for wetting the wettable catheter 2. The fluid pouch 3 may contain sterile water, sterile saline or another fluid that is suitable for wetting the wettable catheter 2. The fluid pouch 3 can be opened, for example, by applying pressure with a finger or hand or by striking with a hand or a small object. Opening the fluid pouch 3 releases almost all of the fluid it contains into the pouch interior 4 without completely wetting the handle 9 of the wettable catheter 2. In particular, the release of fluid from the fluid pouch 3 only wets the wettable coating incompletely. The fluid pouch 3 can be placed in any position within the pouch interior 4.

  In one embodiment, the fluid pouch 3 can be made from polyethylene and aluminum foil. The individual pieces that make up the fluid pouch 3 may include layer aluminum foil sandwiched between polyethylene layers. Polyethylene is attached to the aluminum foil.

  FIG. 2 schematically illustrates an embodiment of the wetting system according to FIG. 1 with the fluid pouch 3 opened and the fluid 14 released from the fluid pouch 3. Almost all of the fluid 14 has been released from the fluid pouch 3, but the fluid 14 has only incompletely wetted the handle 9 of the wettable catheter 2.

  FIG. 3 shows in FIGS. 1 and 2 that the catheter pouch 1 is rocked, manipulated or otherwise moved to diffuse the fluid 14 along a substantial portion of the handle 9 of the wettable catheter 2. Fig. 3 schematically illustrates an embodiment of a wetting system according to the present invention.

(Segmented catheter pouch)
FIG. 4 schematically illustrates an embodiment of a wetting system according to the present invention. An exemplary embodiment of the system includes a catheter pouch 1, a wettable catheter 2 and a fluid pouch 3. In this embodiment, the catheter pouch 1 is in the form of a segmented catheter pouch 15. The segmented catheter pouch 15 is made similar to the catheter pouch 1 and includes the features of the catheter pouch 1.

  As illustrated in FIG. 4, the segmented catheter pouch 15 includes one or more pouch partitions 16. In the illustrated embodiment, the pouch dividers 16 are paired and each pair is configured to narrow the catheter pouch 1 to partition the catheter pouch 1 into two or more sections 17. The segmented catheter pouch 15 may include, for example, three pairs of pouch partitions (FIG. 4). Alternatively, a single pouch partition 16 may be used to partition the catheter pouch 1 into two or more sections 17 by, for example, expanding the catheter pouch 1 across the same distance as the pair of pouch partitions 16. It can be narrowed. In general, the pouch partition 16 includes a back sheet 6 and a cover sheet 7. The backsheet 6 and the coversheet 7 can be joined to form the pouch divider 16 by, for example, adhesive, welding or the like. The pouch divider 16 can be an extension of the seam 5 or a protrusion therefrom.

  The segmented catheter pouch 15 may include two, three, four or more segments 17. The wettable catheter 2 can be present across multiple sections 17. The fluid pouch 3 can be in a single section 17. In one embodiment, the fluid pouch 3 is in a section 17 that is also occupied by the tip 10 of the wettable catheter 2. In one embodiment, the fluid pouch 3 is in a section 17 that is not occupied by the tip 10 of the wettable catheter 2. In one embodiment, the fluid pouch 3 is in a section 17 that is also occupied by the handle 9 of the wettable catheter 2. In one embodiment, the fluid pouch 3 is in a section 17 that is also occupied by the flared outlet 8 of the wettable catheter 2.

  The section 17 of the segmented catheter pouch 15 that houses the fluid pouch 3 may be in the form of a pouch housing 18. The pouch housing 18 is generally of a larger volume than the other sections to provide space for housing the fluid pouch 3. The sachet housing 18 may be composed of, for example, a back sheet 6 and a cover sheet 7, which defines a larger volume than in the other section 17. For example, the backsheet 6 and coversheet 7 may define a rectangular volume for the pouch housing 18 (FIG. 4).

  The catheter pouch 1 or segmented catheter pouch 15 may include a catheter passage 19. The catheter passage 19 can be composed of, for example, the back sheet 6 and the cover sheet 7. The catheter passage 19 accommodates the wettable catheter 2 and is sized to hold the fluid 14 near or to the catheter 2.

  FIG. 5 schematically illustrates an embodiment of the wetting system according to FIG. 4 in which the fluid pouch 3 is opened and the fluid 14 is released from the fluid pouch 3. Almost all of the fluid 14 is released from the fluid pouch 3, but the fluid 14 only wets the handle 9 of the wettable catheter 2 incompletely. In one embodiment, the pouch divider 16 restricts the flow of fluid 14 in the segmented catheter pouch 15. The pouch divider 16 may also direct fluid toward the wettable catheter 2 in the segmented catheter pouch 15.

  FIG. 6 shows that the segmented catheter pouch 15 is rocked, manipulated or otherwise moved to diffuse the fluid 14 along a substantial portion of the handle 9 of the wettable catheter 2. Fig. 6 schematically illustrates an embodiment of a wetting system according to Figs.

  As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” refer to the contents clearly and differently. It should be noted that it includes multiple instructions unless otherwise indicated. Thus, for example, reference to a device comprising “a part” includes a device comprising one or more parts. It should also be noted that the term “or” is generally used in its sense including “and / or” unless the content clearly dictates otherwise.

  Also, as used herein and in the appended claims, the phrase “designed and configured” refers to a system that is fabricated or configured to perform a specific task or adopt a specific configuration, It should be noted that the device or other structure is described. The phrase “designed and configured” means “arranged and configured”, “fabricated and arranged”, “designed”, “fabricated”, “configured”, “manufactured and arranged”, Can be used interchangeably with phrase.

  The invention has been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention.

Fig. 3 schematically illustrates an embodiment of the present system including a catheter pouch, a fluid packet and a wettable catheter. 1 schematically illustrates the embodiment of FIG. 1 in which fluid is released from the packet but the pouch is not moved. FIG. 3 schematically illustrates the embodiment of FIG. 2 where the pouch has been moved to wet the coated surface of the wettable catheter. Fig. 4 schematically illustrates an embodiment of the present system including a catheter pouch in the form of a segmented catheter pouch, a fluid packet and a wettable catheter. Fig. 5 schematically illustrates the embodiment of Fig. 4 where fluid has been released from the packet but the pouch has not been moved. Fig. 6 schematically illustrates the embodiment of Fig. 5 where the pouch has been moved to wet the coated surface of the wettable catheter.

Claims (25)

A catheter wetting system,
A catheter container;
A fluid packet;
A hydrophilic catheter,
The fluid packet and the hydrophilic catheter are sealed within the catheter container;
The catheter wetting system, wherein the fluid packet and the catheter container are designed and configured such that opening the packet only wets the coating length of the hydrophilic catheter incompletely.   The catheter wetting system of claim 1, wherein the catheter container is designed and configured to be moved to move a wetting fluid over an insertable coating length of the hydrophilic catheter.   The catheter wetting system of claim 1, wherein the catheter container is constructed of a flexible material that is manipulated to diffuse wetting fluid over the coating length of the hydrophilic catheter.   The catheter container comprises a translucent material and a pouch formed of a transparent material, the first side of the pouch includes a transparent material, the second side of the pouch includes a translucent material, and the pouch The catheter wetting system of claim 1, wherein the is sealed around the edges.   The fluid packet is composed of a first packet material piece and a second packet material piece, and the first packet material piece and the second packet material piece are sealed to each other around an edge. The catheter wetting system of claim 1, wherein the catheter wetting system is substantially uniform around the edges.   The catheter wetting system of claim 1, wherein the fluid packet is comprised of a hydrophobic material.   The catheter wetting system of claim 6, wherein the hydrophobic material comprises polyethylene and aluminum foil.   The catheter wetting system of claim 1, wherein the fluid packet is comprised of an aqueous wetting composition.   9. The catheter wetting system of claim 8, wherein the aqueous wetting composition comprises sterile water or a sterile saline solution.   9. The catheter wetting system of claim 8, wherein the sterile water or sterile salt solution comprises sterile distilled water.   The catheter wetting system of claim 1, wherein the hydrophilic catheter comprises a hydrophilic coating over its insertable length.   The catheter wetting system of claim 1 further comprising a urine collection bag.   The catheter wetting system of claim 1, further comprising an indication that the catheter container must be moved to move the wetting fluid across the insertable coating length of the hydrophilic catheter.   The catheter wetting of claim 1, further comprising instructions printed on the catheter container, stating that the catheter container must be moved to move the wetting fluid over the insertable coating length of the hydrophilic catheter. system. A hydrophilic catheter wetting method comprising:
Providing a catheter with a hydrophilic catheter and a fluid packet;
Breaking the fluid packet to release fluid into the container and incompletely wet the coating length of the hydrophilic catheter;
Moving the container to move a wetting fluid across the insertable coating length of the hydrophilic catheter;
A wet process comprising:   The method of claim 15, wherein the preparing step includes providing a catheter container with the hydrophilic catheter and the fluid packet sealed therein.   16. The method of claim 15, wherein the breaking step comprises striking, piercing or squeezing the fluid packet.   The method of claim 17, wherein the breaking step comprises squeezing or striking the fluid packet without opening the catheter container.   The method of claim 17, wherein the breaking step comprises squeezing or striking the fluid packet through the catheter container material.   16. The moving step includes both tilting one end of the catheter container relative to its opposite end, manipulating the catheter container to move water, or tilting and manipulating the container. the method of.   The method of claim 15, wherein manipulating the catheter container includes applying finger pressure to a material forming the catheter container to push fluid within the catheter container. Opening the catheter container;
Removing the wetted hydrophilic catheter from the opened catheter container;
And using the wetted and removed hydrophilic catheter.   16. The method of claim 15, wherein the breaking and moving steps are performed without opening the catheter container. A catheter container;
A fluid packet;
A hydrophilic catheter;
An indication that the catheter container must be moved in order to move a wetting fluid over the insertable coating length of the hydrophilic catheter,
The fluid packet and the hydrophilic catheter are enclosed by a seal inside the catheter container;
The product wherein the fluid packet and the catheter container are designed and configured such that opening the packet only wets the coating length of the hydrophilic catheter incompletely.   25. The product of claim 24, comprising instructions printed or attached to the catheter container.

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