JPH05503231A - Microbicide release catheter - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Microbicide release catheter 1 The present invention relates to a catheter that is used by being inserted into a body cavity. Provided with means for killing microorganisms growing in the area of the surface or in areas adjacent to its external surface. Concerning catheters obtained. The present invention also provides a method for manufacturing the catheter, and a method for manufacturing the catheter. Regarding products manufactured using the manufacturing method.

Oishiritan 1x Most catheters are designed to direct fluids or some type of tube-like device inserted into a part of the body to move gas can be explained. The catheter travels through the body to reach its destination. When passing through a specific area, it comes into contact with various tissues within the body. For example, the human bladder Catheters used to drain fluids (e.g. “Foley” catheters) It must pass through the urethra to reach the bladder. The nasogastric catheter does not reach the stomach. To reach it, it must pass through the nasal passages and esophagus. Some like this Is the catheter inserted through an existing passageway to reach its destination? , the external catheter is inserted through a surgically created channel.

Virtually all catheterization procedures involve attaching the catheter to each body cavity, passageway, and contact with the catheter when inserted into or withdrawn from body parts. irritating the tissues involved, as well as serious infections such as urinary tract infections, bladder infections, etc. There is a high potential for microbial growth on the external surface of the catheter. child These infections can be treated by catheterization with an indwelling catheter, such as a “Foley” catheter. This can lead to sepsis of the bladder, which is often fatal for incontinent patients. Often.

Additionally, during the period during which the catheter resides in the respective passage it occupies, The potential for irritation of tissues in contact with its outer surface is high. This means that The tethers are produced with the stimulation they cause when they rub against adjacent tissue within their respective passageways. This is a very difficult problem for patients who have to survive.

Normal rubbing and irritation are commonly caused by patient movement. Occurs due to the unavoidable slight movement of the driver. The various parts of the catheter are Connect to equipment outside the body that may or may not move in response to body movement It is well known that this is often the case. catheter when the patient moves It must also move in response to movement of the body part with which it engages.

A catheter is connected to such patient movement. A device outside the body Contrary to the inability to move or the movement of different body parts This is done by moving the catheter to one or both of the Maintaining mutual spatial contact with the outer surface of the catheter on one or both body parts Conflicts with holding. In summary, as you move, the catheter will generally move slightly. , twisted, pulled and/or pushed so that the catheter Rubbing and stimulating tissue in adjacent passageways or body parts.

The above results in a great deal of discomfort for the patient who has to have a catheter installed. You will notice that a feeling arises. Often the most unpleasant thing about being hospitalized is Patients must have a catheter in place for a considerable period of time during their hospitalization.

The catheter is highly irritating to adjacent tissue, so the patient should fear of further irritating already irritated and painful tissue in the affected area. As a result, they become relatively tense and rigid. As a result, the tissues become very painful. Virtually incapacitate a patient when even movement causes significant pain and discomfort. make someone It is also thought that irritated tissues are more susceptible to infection, resulting in Irritation of the respective tissue adjacent to the catheter may cause patient discomfort and risk of infection. It has also been noted that it increases the risks.

The use of nasogastric catheters is a clear example of the latter problem mentioned above. patient for several days When a catheter is installed, the nasal passages and throat invariably become sore. Organization begins Once the catheter rubs against the catheter and the patient becomes irritated and sensitive, the patient may not be able to touch his or her head or body. Even slight rubbing of the tube within these passageways with each movement can cause severe discomfort. wake up Additionally, the above passageway may remain painful for a considerable period of time after the catheter is removed. This is a major cause of discomfort during hospitalization or treatment.

Therefore, these and other problems associated with prior art catheters are addressed. It will be appreciated that a catheter is required. The present invention overcomes the conventional technology. The catheter provides advantages over prior art catheter manufacturing methods and It provides other advantages over the technology and solves other problems associated with the prior art. Ru.

l buttocks 21L It is therefore an object of the present invention to provide an elongated catheter having an inner surface and an outer surface. It is to be. Its inner surface forms a lumen through which the catheter passes. Main departure Ming's catheter further includes a sealing slit between the inner and outer surfaces that encircles a portion of the lumen. It has a hollow cavity. This sleeve cavity has an inner wall and an outer wall, the outer wall being generally is an elastic sleeve that can stretch independently of its inner wall, and its cavity contains a predetermined amount of Contains a suitable carrier material containing a suitable disinfectant, the inner and outer walls of which are are connected at the distal and proximal ends of the cavity. This elastic sleeve has a If the cavity is in an aqueous environment, the disinfectant can be diffused through the cavity; When not in an aqueous environment, the contents within the sleeve cavity must be exposed to moderate mechanical forces. If there is no or significant pressure difference across the elastic sleeve, the sleeve Disinfectant into the cavity is substantially restricted. In a preferred embodiment, the diffusion is The means for disinfecting has a plurality of micropores, and the micropores are arranged such that the concentration of the disinfectant in the aqueous environment is , if the concentration of the disinfectant is lower than the concentration of the disinfectant in the carrier material, the disinfectant is slipped through the elastic sleeve. from the tube cavity into a suitable aqueous environment.

The germicidal or microbicide-releasing catheter of the present invention provides no germicidal performance. It is clear that this provides significant advantages over prior art devices that do not provide the same benefits. difference Additionally, the present invention contains a disinfectant within a cavity separated by a wall from the surrounding environment. A carrier material is placed in the wall, the walls of which contain a material for transferring said carrier material to the surrounding environment. It offers advantages over large opening catheters. child Their large openings allow for unrestricted release of the disinfectant, thus reducing exposure to the surrounding environment. It will be appreciated that the disinfectant cannot be properly released. Furthermore, this Such devices are difficult to store and difficult to handle and handle in suitable environments such as the urinary tract. /or difficult to insert. The present invention provides for a ring of sterilizing agent surrounding the catheter. transfer to the aqueous environment is very well controlled, i.e. transfer is generally related to diffusion into the aqueous environment. The present invention is highly desired in the art of catheters because it is regulated by the natural forces associated with it. This technology provides new technology.

The portion of the catheter that forms the lumen by the elastic sleeve of the catheter of the present invention can be moved independently of the outer surface of the catheter in the vicinity of the sleeve cavity. can be used even when the catheter is forced to move in response to movement of the body part. The catheter's elastic sleeve does not necessarily move with the movement of other parts of the catheter. You will find that there is no need to move. For example, the end of a catheter If the end moves in response to movement of some part of the body, the elastic sleeve on the outer wall long and twisting to make relative contact with nearby or adjacent body tissues as well. The unidirectional wall and lumen can remain in close contact with the outer surface of the elastic sleeve. and destroy the relative contact or adhesion that exists between the body and adjacent body tissues. Each adjacent body tissue can be moved in and out without any need for movement. Therefore , the elastic sleeve stretches when the catheter is pulled, pushed or twisted. so that even if other parts of the catheter move, the outer surface of the elastic sleeve remains There is no need for relative displacement of adjacent tissue to the plane. The reason is that the elastic slip The tube can extend and remain in the same position relative to adjacent tissue. This is because the possibility of rubbing or irritating adjacent tissue is reduced.

The present invention provides several improvements over the prior art. These improvements Some of the improvements related to the comfort provided by the sleeved catheter of the present invention include: On the other hand, there are also automated methods for manufacturing catheters, which can be used to manufacture catheters. The catheter of the present invention, taking into account the preferred materials used, the manufacturing method and the materials used. There are improvements to handle things like prices. Many of the benefits of automated manufacturing are in co-pending applications. The same advantages listed in U.S. Patent Application No. 462,832 of It is hereby incorporated by reference into this application. The above application discloses a lubricating sleeve; sleeve has significant advantages over prior art devices, as will be apparent from the discussion below. considered to offer advantages.

Forgee-style indwelling catheters provide an artificial conduit from the bladder to an external collection device. provide Prior art Foley catheters are generally circular double lumen tubes. (round bilumen tube), this tube is connected to the bladder or Acts as a “drain” to an external collection device. The urinary tract itself is generally female in length Although it is shorter than an inch in men and several inches long in men, it is actually a fairly flat ribbon. It is considered a passageway of shapes. Foley catheter inserted into the bladder through the urethra When a catheter is used, it is generally forced into the urethra and a catheter is attached to the patient. The ribbon-shaped passage is forced open and remains open as long as the

To avoid the problem of urine leaking outside the catheter in the urethra, Use a catheter of sufficient diameter to “fill” the passageway. This is the practice of Therefore, a catheter with a sufficiently large outer diameter should be selected to remove the urethra. It is common practice to hold the ``wide open'' position. To do this , choose a catheter with an outer diameter as large as the passageway when fully opened. There is a need. Unfortunately, the tissues of the urethra are made up of soft and sensitive tissue, and these Tissue becomes painful and irritated when a catheter is pushed into a person's body and rubs against the tissue. will be done more often. Apart from the sheer discomfort associated, irritated and painful tissue It has been found that the outer surfaces of the skin are more easily colonized by bacteria than healthy tissue. this Bacterial infections occur more frequently with catheters in the urethra and bladder. It turns out. Long-term catheterization (urinary catheterization) is recommended, especially for elderly people who are incontinent. The above is a serious problem, as it is normal for Sleeve of the present invention Catheters with internal An elastic sleeve that can move independently of the main part of the catheter surrounding the lumen and body tissue adjacent to the catheter, particularly Foley with the sleeve of the present invention. It can significantly reduce the physical stress on the urethral tissue that comes into contact with the catheter. can. The rigidity of prior art catheters that do not bend relative to adjacent body tissue Instead of a hard and unacceptable outer surface, the catheter of the present invention has a an outer surface that bends against the adjacent body tissue that the catheter is in contact with when It is equipped with The outer surface of the catheter of the present invention is provided with an elastic sleeve; The sleeve, in a preferred embodiment, contains a significant amount of cushioning or lubricating material. These materials surround the elastic sleeve or surrounding adjacent body tissue when the catheter is This color provides a soft, “cushy” collar around the reduce mechanical stress on their adjacent body tissues.

The catheter of the present invention reduces stress on adjacent body tissue in the following manner: Ru. The conduit portion of the catheter is located outside the elastic sleeve portion of the sleeved catheter. It can move and twist independently of the surface. Normal patient behavior is Apply external and internal pressure to the catheter that biases movement in one direction or the other. wake up The thin elastic sleeve is cushioned by a material preferably lubricating gel etc. Because it is separated from the main lumen of the catheter, the single or Easy to move, independent of the catheter's low-flexibility main conduit section that surrounds multiple lumens. It can be moved, expanded, compressed, etc. This sleeve works in two ways. It is important to know that. Pleasure occurs when the movement of the body causes pressure or movement. A suitable sleeve can be adjusted in shape and position with negligible resistance and can be Accommodates said movement without resistance to movement of the main conduit portion of the tether. reverse In other words, the main conduit section of the catheter, especially the thin elastic sleeve on the outer surface, Independently, external movements such as twisting, stretching, bending, etc. can be performed. did Therefore, mechanical stress at the tissue/catheter interface is greatly reduced.

In addition, the volume of the sleeve cavity between the elastic sleeve and the main conduit portion of the catheter is In a preferred embodiment, the thickness of the lubricant or gel is maximized to increase the , the elastic sleeve conforms to the actual form of the passageway it extends when inserted into the body be able to. This is due to the generally non-conforming ring that most catheters have. It is preferable to a cylindrical tube. For example, a conventional foley catheter inserted into the urethra Teru puts unnatural and unstable pressure on the tissue of the urethra wall when it is held open. . On the other hand, the cushioning sleeve of the preferred embodiment of the present invention is flexible and conformable. Provides an outer surface. This surface conforms to the surface of adjacent body tissue with which it comes in contact. this In this way, the preferred catheter of the present invention allows the catheter in which it is contained to be removed. Adapts to the natural shape of the attached walkway. Moreover, the invention is useful for health protection professionals However, it is possible to provide the patient with a catheter that is more accurately sized for the passageway into which it is inserted. It should be noted that a preferred catheter is provided. For example, most women Compatible with Foley indwelling catheters with outer diameters of 16.18 and 20 French. do. - Elastic sleeve of the preferred sleeved Foley catheter of Rigi's invention The conformability of allows the volume within the sleeve cavity to move, and the sleeve cavity Provides cushioning to the elastic sleeve and allows the area of the urethra that the elastic sleeve extends into It will be moved. Preferred embodiments of the invention therefore have different requirements. To provide an outer surface that can have a variety of outer diameters to accommodate the urethra. Sara Preferred embodiments of the present invention provide a non-accommodating prior art technique for urethral wall fluctuations. Appears to be more accommodating than other devices. In addition, preferred embodiments of the present invention When the catheter is properly installed, the tubing portion of the catheter will fit inside the elastic sleeve. Disrupt the interface between the outer surface and the adjacent body tissue of the passageway through which the catheter enters You can slide it back and forth without any trouble.

It is recognized that catheters with different sleeve cavity volumes are required for different applications. It's probably worth it. The lubricating material in the sleeve cavity of certain preferred embodiments is sufficient This material has a thickness that allows the elastic outer sleeve to be attached to the outer wall of the catheter's conduit section. It is very advantageous to be significantly separated from That is, in this case, the outer slit Is the tube flexible and malleable when inserted into or into a body passageway? , the outer surface of the elastic sleeve conforms to the difference in morphology between the orifice and the rest of the passageway. Accordingly, "cushioning" between adjacent body tissue and the preferred catheter may be desirable. ”Provides a flexible interface. It also ensures that the outer sleeve does not touch adjacent body tissue. Even if the catheter is pulled or twisted to the extent that it moves Tissue damage is typically significantly less than with prior art catheters. You will find that there are few.

This is because the surfaces of prior art catheters are generally rougher and harder. , the elastic sleeve has a cushion of cushioning material or lubricating gel within the sleeve cavity. This is because it is very flexible and malleable in response to the action of pressure, providing cushioning properties.

Furthermore, the method of the present invention is superior to prior art methods which typically use a large amount of manual labor. Other aspects of this invention provide significant benefits over the Teter manufacturing process. You'll understand. These and various other advantages and novel features which characterize the invention The features are particularly pointed out in the claims hereinafter forming a part of this application. deer In order to better understand the present invention, we will discuss the results obtained using the catheter of the present invention. Advantages and other objects may be found in other parts of this application which illustrate and describe preferred embodiments of the invention. The explanation will be given with reference to the drawings constituting the parts and the accompanying descriptions.

Simple de-B of drawings The same reference numbers in the drawings indicate corresponding parts across the figures.

FIG. 1 is a schematic partial longitudinal sectional view of an extruded tube.

FIG. 2 is a schematic front view of an intermediate tube made from the extruded tube shown in FIG. be.

Figure 3 shows an arrangement for applying an overcoat layer of a polymeric binding composition to a tube. Also racks used to hold multiple intermediate tubes during a timed series of steps. or a schematic diagram of a portion of a pallet, in which a single intermediate tube or a single support A portion of the outer surface of the intermediate tube attached to the rod and subjected to the first dipping step. is coated with a lubricating substance.

FIG. 4 is a front schematic view of an intermediate tube similar to that shown in FIGS. 2 and 3, but with a second The intermediate tube was subjected to a soaking process to remove some of the lubricating material on the outer surface of the intermediate tube. .

FIG. 5 is a schematic longitudinal cross-sectional view of an intermediate tube similar to that shown in FIG. subjected to one or more dipping steps to form an overcoat layer on its outer surface be done.

FIG. 6 is a schematic cross-sectional view of an elongated catheter of the present invention.

FIG. 7 is a schematic partial longitudinal cross-sectional view of an extruded double lumen tube.

FIG. 8 is a cross-sectional view of the extruded double lumen tube taken from line 8-8 in FIG.

Figure 9 is a schematic longitudinal cross-sectional view of the tube shown in Figure 7 after an opening has been provided on the outer surface; be.

FIG. 10 is a cross-sectional view of the tube taken along line 10-10 in FIG.

FIG. 11 shows the second lumen shown in FIG. 9 after filling a portion of the first lumen with a polymeric binding composition. FIG. 2 is a schematic vertical cross-sectional view of a double lumen tube.

FIG. 12 is a cross-sectional view of the tube taken from line 12-12 in FIG.

Figure 13 shows the dual lumen tube shown in Figure 11 after the tip has been attached to the distal end of the tube. FIG.

FIG. 14 shows how to apply an overcoat layer of a polymeric bonding composition to a tube. Also designed is a rack used to hold multiple tubes during a series of steps. In other words, it is a schematic diagram of a part of the pallet.

15 is a schematic longitudinal cross-sectional view of an intermediate tube similar to that shown in FIG. The tube is subjected to intermediate manufacturing steps in the first series of dipping steps.

FIG. 16 is a schematic longitudinal section of an intermediate tube similar to that shown in FIG. The tube is subjected to a second dipping step to coat the outer surface with anti-bond lubricant. has been partially removed.

FIG. 17 is a cross-sectional view of the intermediate tube of FIG. 16 taken along line 17-17.

FIG. 18 is a schematic longitudinal cross-sectional view of an intermediate tube similar to that shown in FIG. The tube is the tube that has been subjected to the subsequent single or multiple dipping steps.

Figure 19 shows the tube shown in Figure 18 after being subjected to another single or multiple dipping steps. FIG. 3 is a schematic longitudinal sectional view of an intermediate tube similar to .

FIG. 20 is a cross-sectional view of the balloon catheter shown in FIG. 19 taken along line 20-20. It is.

FIG. 21 shows that the intermediate layer shown in FIG. FIG. 1 is a schematic longitudinal cross-sectional view of a portion of a balloon catheter made of a tube.

FIG. 22 is a perspective view of a portion of a balloon catheter similar to that shown in FIG. 21; However, this balloon catheter is cut through the sleeve cavity and the remainder of the sleeve The part is twisted and extruded double used to make this balloon catheter. The independence of the outer surface of the lumen tube 23 is achieved using a balloon similar to that shown in FIG. 1 is a schematic longitudinal cross-sectional view of a catheter with a distal end piece and a balloon of the catheter; FIG. Figure 3 shows a longitudinal cross-sectional view of a portion of the catheter with the tube portion inflated.

FIG. 24 shows straight line 2 of FIG. 23 of another embodiment of the balloon catheter shown in FIG. 4-24 is a cross-sectional view taken along a straight line similar to FIG.

FIG. 25 is a schematic longitudinal cross-sectional view of a balloon catheter similar to that shown in FIG. , which shows other embodiments of balloon catheters made according to the present invention, and includes a plurality of A first lumen access opening is provided.

FIG. 26 is a schematic longitudinal section of yet another embodiment of the invention similar to that shown in FIG. It is a diagram.

Figure 27 shows the stamping block being stamped by a punching device within the channel-like recess of the stamping block. Figure 22 is a partial side cross-sectional view of the catheter shown in Figure 21 being tamped;

Figure 28 shows a plurality of micropores being made through the elastic sleeve of the catheter. multiple and 28 is an enlarged cross-sectional view taken along line 28-28 of FIG. 27 showing a curved elongate member; FIG.

FIG. 29 is a schematic longitudinal section of another embodiment of the invention similar to that shown in FIG. , showing a third lumen communicating with the sleeve cavity, the sleeve having a plurality of micropores (not shown). without).

FIG. 30 is a cross-sectional view of the catheter shown in FIG. 29 taken along line 30-30.

Figure 31 is a schematic longitudinal view showing a portion of the catheter shown in Figure 26 when inserted into the urethra; FIG.

FIG. 32 is a schematic diagram of an apparatus used to automate the manufacture of catheters of the present invention. It is.

33A, 33B and 33C are diagrams illustrating certain steps in the method of the invention. It is a low chart.

The best way to get rid of B The drawings, particularly FIGS. 1 to 6, will be described. The invention has an inner surface 7 and an outer surface 9 An elongated catheter 5 (see FIG. 6) is provided. Inner surface 7 forms lumen 8 to be accomplished. The elongate catheter 5 is topped with an overcoat layer 42 of elastic polymeric material. This polymer is preferably made of a tube 2 (see Figure 1) that is ultimately coated. - The material is not prevented from adhering to it by other materials or means on the outer surface 14. The overcoat of the elongate catheter 5 of the present invention is coupled to the outer surface 14 of the mule tube 2. - The coating layer 42 includes a sleeve surrounding the sleeve cavity 45 containing the lubricating material 38. 44 is included. The lubricating material or substance 38 is in contact with the outer surface 14 to provide lubrication. While making contact, insert the sleeve 44 into the outer surface of the sleeve 44 on the outer side of the tube 2. It can be effectively slid along the surface 14. Apply lubricant to sufficient thickness When pressed, the flexible sleeve 44 is separated from the tube 2 so that the outer sleeve The tube 44 is adapted under slight pressure to the form of the passage into which it is inserted or To provide a flexible, cushionable, and conformable outer surface that can be conformed to fit together. catheter Depending on the application and/or type of sleeve, the amount of lubricant 38 and sleeve cavity 4 5 minimizes the increase in the outer diameter of the catheter of the outer sleeve 44 to a very limited extent. It can be kept in place. Flexible and cushioned that can otherwise adapt to its form A flexible sleeve is preferred. In these embodiments, within the sleeve cavity 45 There is a relatively thick coating of lubricating substance 38 on the outer surface of sleeve 44. gives it a balloon-like feel and appearance. The elongated catheter 5 is made of latex or silicone. Preferably, and most preferably made of a flexible elastomeric material such as cone rubber. The new material is silicone rubber. The lubricating material or substance 38 is a lubricating contact. When this happens, the polymer surfaces can effectively slide against each other. Compatible lubricating materials are preferred. As the lubricating substance 38, petroleum such as hydrophobic oil or water-soluble soaps, detergents, gels, etc. are preferred; also lubricates the surface of the polymer and when coated with it, other polymeric substances gel. (For example, KY Jelly, Hydrogel, etc. are all registered trademarks), water Coating materials formulated to contain polyvinyl alcohols, etc. Filling with petroleum jelly or petrolatum, water-soluble soaps, detergents, and the above lubricating substances agents (e.g. glycerin, methylcellulose, PVP, carboxycellulose sodium) xanthan gum, etc.) The first step is to prepare the outer surface 14 forming the first lumen 8. and support of the molded let 24 designed to produce the inner and outer tubes 3 (see Figure 2). It is attached to the rod 26. A plurality of intermediate tubes 3 are attached to a plurality of support rods. After the intermediate tube 3 is attached to its support rod 26, the preferred method It is then subjected to a series of dipping steps.

After the intermediate tube 3 has been manufactured from the first tube 2, its outer surface is similar to the tip 2. 0 to the position of the outer surface 14 designated by dashed line A shown in FIG. Coat with quality. Next, the outer surface of the tube below the dashed line B shown in Figures 3 and 4. The lubricating material coating surface 14 is stripped from outer surface 14 and tip 20. Next to the intermediate tube 3 and the bonding composition of the elastic polymer forming the overcoat layer 42. Coat with things. This overcoat layer 42 covers the tip portion 20 and the area below the broken line B. It is connected to a portion of the outer surface 14a and a portion of the outer surface 14b above the broken line A. Ru. The area of the outer surface 14c between each of the broken lines A and B is filled with a lubricating material 38. However, in this area, the overcoat layer 42 remains coated. A sleeve surrounding a lubricating substance 38 coating the portion of the outer surface 14a between lines A and B. 44. This outer surface 14a cooperates with the sleeve 44 to A sleeve cavity 45 is formed in which the lubricating substance 38 of the sleeve 44 is contained. overcoat After the layer 42 is formed on the intermediate tube 3, a pair of fluid conduit openings 56 are preferably formed. is formed, most preferably stamped, and has a fluid flow near the distal end 16 of the lumen 8. It can flow in or out of the body.

The overcoat layer 42 and the tube wall 11 are shown as separate elements in FIG. However, most preferred embodiments of the invention made of silicone rubber do not. If present or made of the same polymeric material, the wall 11 and the overcoat layer 42 , are joined at the places where they touch each other, and as a result, the two can finally be identified. It is virtually impossible to stomach. In a preferred embodiment, these elements are connected to form an integral membrane or wall. You will see that it will be done.

The specific procedures used to make the elongated catheter 5 of the present invention include the following: Similar steps are included in slaps used for similar purposes.

In a preferred embodiment of the elongated catheter 5, a plurality of microscopic pores (too small to be shown) to allow the catheter 5 to be inserted into the sleeve cavity 4. The concentration of the specific bacterial agent or agents contained in the carrier material 38 in 5. From the elastic sleeve 45, when inserted into a suitable aqueous environment lacking a microbicide. Alternatively, a carrier material 38 containing a disinfectant can be diffused.

However, some combinations of carrier agent, bactericidal agent, and sleeve materials are simply Depending on the structure of the sleeve material and the properties of the carrier agent and/or disinfectant, elastic sleeves may Diffusion can be achieved through In the embodiments described above, the disinfectant is The agent can be diffused directly through the sleeve, or the sleeve can be used in other ways. No micropores are required to pass through the provided barrier.

Single or multiple microbicides or disinfectants contained in carrier material 38 microorganisms or bacteria in the area of the outer surface 9 of the catheter 5 or in the area adjacent thereto. Any drug that is effective in killing will suffice. These drugs include, but are not limited to, This includes biological substances, sulfa drugs, and other microbicides and bactericidal agents. these Drugs such as nitrofurantoin, sulfamethoxazole, trimethoprim , mixtures thereof such as Bactrim® and other equivalents. be caught. The bacterial agent is introduced into the sleeve cavity by an elastic sleeve 44 having a plurality of micropores. When enclosed within a sinus, the outer surface 9 of the resilient sleeve 44 is placed in an aqueous environment. Once released, it can diffuse from the cavity 45. However, the outer surface of the elastic sleeve 44 If the surface 9 is not placed in a suitable aqueous environment, the contents of the sleeve cavity 44 When not subjected to the action of a moderate mechanical force or a moderate pressure difference, the elastic sleeve When not present through 44, the micropores (not shown) allow the disinfectant to pass through the sleeve. Small enough to substantially stop in cavity 45.

The pressure difference across the elastic sleeve 44 used in the present invention is It is the pressure difference between the inner and outer surfaces. Furthermore, when used in this application, fine The holes are orifices with sufficiently small circumferential diameters that the carrier material does not evaporate. or be subjected to forces resulting from pressure differences across the elastic sleeve 44. If the carrier material is effectively placed within the sleeve cavity 45 of the catheter embodiment of the present invention, Hold.

Embodiments of the present invention may include a single unit contained within the sleeve cavity 45 of certain embodiments. May contain one or more disinfectants and lubricants 38 or carrier agents 38. And even if the elastic sleeve 45 of these embodiments has the above-mentioned micropores, However, these micropores are barely visible to the naked eye, if at all perceptible. You will understand the words. The above and below explanations will help us understand the fine details we considered earlier. More on holes (see discussion of Figures 27 and 28 below). sleeve is in a suitable aqueous environment as described above to diffuse the disinfectant from the cavity 45. unless possible, and the contents of the sleeve cavity are subjected to moderate mechanical forces. unless otherwise, or when no moderate pressure difference exists across the elastic sleeve. , a resilient material having a plurality of micropores (not shown) that retain the disinfectant in the sleeve cavity 45. Sleeve 44 allows the material holding the disinfectant to be exposed to normal forces such as gravity. The substance contained within the catheter cavity, which simply passes through the wall when acted upon. Significant advantages are obtained over walls having large openings as passageways. Like that Under circumstances, store catheters with walls above that have large openings as above. It will prove to be very difficult to package. of the above catheter Other drawbacks are apparent when inserted into passageways such as the urethra. In such cases, urine The force of the canal wall exerts pressure on the catheter wall, causing the carrier material that holds the bacterial agent to Disinfectants tend to be released immediately from the catheter cavity through the large orifice. for immediate distribution into the urethra and thus for future migration through the wall. This reduces the amount of carrier material that holds the disinfectant left behind. Normal body functions are impaired. At some future time after the amount of fungicide has been reduced and/or removed from the vicinity of the In this case, the area of the outer surface of the catheter and the area adjacent to the outer surface has no bactericidal activity. (It will be appreciated that there will be a plurality of A preferred embodiment of the invention includes micropores (not shown) that are placed within the catheter. a wall with an opening large enough for the carrier material holding the disinfectant to simply pass through. It will be appreciated that the present invention provides advantages over catheters having

7 and 8 will be explained. The first process of making the balloon catheter that was the subject of this invention is preferably provided with a double lumen 2° made of extruded silicone rubber. , but a double lumen tube 2° can be made by known methods in which this is obtained. You will see what you can do. Furthermore, the tube 2' can be inserted into a human body cavity. The material can be made of a flexible, elastic polymeric material, preferably a biocompatible polymeric material. Ru. Dual lumen tubing 2° has a small capillary lumen 6′ and a large fluid conduit tube. It has a cavity of 8°.

9 and 10 will be explained. Cut the double lumen tube 2' to the desired size. Ru. Connect the capillary lumen access opening 12° to the outer surface of the double lumen tube 2°. Make it 14゛. This capillary lumen access opening 12' is connected to the capillary lumen 6. It communicates with ゛.

11 to 13 will be explained. Next, from the double lumen tube 2' shown in Figure 9, 3. Prepare an intermediate tube 3.

In the first step of this process, a measured amount of the polymer-bound composition, preferably a Apply silicone rubber or other suitable polymer bonding material to the far end of the double lumen tube 2'. Inject into the capillary lumen 6° from the distal end 16°. As a result, the capillary lumen G ゛゛ is the polymer fill material to a point directly below the capillary lumen access opening 12゛. Filled with 18゛. Tip 20゛, preferably the ex-husband's silicone rubber tip Next, it is fixed to the distal end 16° of the tube 2°, and the intermediate tube 3° shown in Fig. 13 is manufactured. Complete construction. In a preferred method, the distal end 16' of tube 2' A forming device (not shown) designed to form a tip 20° at the distal end of the insert.

14-21 and 32 will be described. A preferred method of the invention includes FIG. A plurality of intermediate tubes 3'', such as the intermediate tube 3' shown in Fig. 24'. Rack or pallet 24゛ can hold multiple Support rods 26" are provided, each of which is provided with a retaining clip 28". It is.

Into the larger of the two lumens of the intermediate tube 3°, called fluid line 8°. The individual support rods 26' are engaged so that the proximal point 30' of the tube 3' is in the retention clip. 28' or preferably as shown in FIGS. 15 and 16. The distal end 20' of each tube 3' is aligned with the distal tip 26' of each support rod 26'. Slide tube 3' upwardly along support rod 26' until it snaps into place. This fixes the tube 3° to the support rod 26'. Illustrated However, the intermediate tube 3' can be attached to the support rod without the aid of the retaining clip 28'. It is thought that it can be fixed at 26°. The reason is that it is used to make the intermediate tube 3°. The preferred extruded double lumen tubing 2' generally has a unidirectional orientation when suspended. This is because it is slightly bent in the other direction. As a result, the intermediate tube 3' The slight bend in the middle tube supports the 3° intermediate tube without the aid of the 28° clip. It can be attached to the holding rod 26'. Commonly used to make intermediate tube 3゛ Due to the nature of the polymeric material used, the tube 3' tends to stick to other surfaces. However, as most tubes, including tube 2 above, demonstrate, this material Resist the movement of a surface along a surface.

When the intermediate tube 3° is attached to the support rod 20', the pallet 24' Can be transported to various locations, the intermediate tube 3' on the pallet 24° Immersion in a series of baths (see Figure 26) prepared to carry out the series of process steps. can be done. In a preferred method of the invention, the intermediate tube 3° is made entirely of silicone. It is made of spring rubber and mounted on a spring steel support rod 26'.

As shown in Figure 13, the tip 20' of the intermediate tube 3° and the filling material 18° are double pipes. Manufactured from the same material (silicone rubber) as cavity 2'. Therefore, the tip 20' and the filler material 18° preferably form an integral part of the intermediate tube 3°. This is shown in Figures 15-21.

After attaching the intermediate tube 3' to the pallet 24°, the elastic of the balloon catheter 4' is An automatic controller that makes the sexual sleeve 44° and the balloon part 32° (see Figure 21). The first two steps in the coating or dipping method are to connect the intermediate tube 3' A lubricant or lubricant substance 38, preferably a removable anti-coupling lubricant coating with a chemical agent. This coating is preferably applied to the pallet 24. Each attached tube 3' is coated with a removable anti-bonding agent, preferably once cooled. A bath 33a of a substance which may form a semi-solid film on the surface and then dry is provided. This is done by simultaneous immersion into the first immersion tank 33 contained therein. This way Examples of such substances include petroleum jelly or petrolatum, which becomes semi-solid when cooled to room temperature. Other oil-based substances that form bodies, liquid soaps that dry to form semi-solids water-based soap or detergent solutions, polyvinyl alcohol aqueous solutions, emulsions or suspensions, lubricating gels, aqueous or oil-based film-forming solids. There are emulsions etc. In one embodiment described herein, hot petrolatum is used; Other embodiments use liquid soap; Natty, sold by Proctor & Gamble, and 1quid. Ivory 5 oap is preferred. In other embodiments of the invention, a lubricating gel is used. KY JellY, Hydrogel (all registered trademarks), etc. Water-soluble formulations are preferred. These anti-bonding agents or lubricants are It will be appreciated that it can also be used as a carrier material for microbial or fungicidal agents.

If a disinfectant that is sensitive to fluctuations such as temperature changes is mixed into the carrier material, the efficacy of the disinfectant must be may be necessary in environments where appropriate modifications to the procedures may be made to avoid Something happens.

Intermediate tube 3° from said first bath 33a of removable anti-bonding lubricant 38°. Upon removal, the drug or substance 38° is attached to the outer surface 14° of the intermediate tube 3'. and occupy capillary lumen access opening 12° and capillary lumen 6'. Melt. In one embodiment, the agent is petrolatum, at about 140-160°F. Preferably it is heated to about 150°F. At these temperatures, petrolatum Draw fluid into capillary lumen 6 to the level of petrolatum in tank 33 With the aid of "capillary action," the capillary lumen access opening 12' It flows into the capillary lumen 6°. In other embodiments, petrolatum is applied to the outer surface. Heat to a lower temperature to obtain a heavy and somewhat thick coat of lubricant over 14°. This is often done. Pull the middle tube 3° out of the hot Vaseline and each tube The petrolatum on the tube cools and solidifies, leaving a semi-solid coating 3 on the outer surface 14'. 8°, capillary lumen 6° and capillary lumen access opening 12° create a semi-solid filling (not shown) within the capillary that cooperates to access the capillary lumen. Close the opening 12'.

In another embodiment, the anti-binding agent in the first tank 33 is at room temperature (approximately 62-74 degrees Fahrenheit). liquid soap. When the tube 3 is pulled out from the first immersion tank 33, the hot water Phosphorus forms a semi-solid as well when cooled. In yet other embodiments, the combination The inhibitor is a carrier material containing a fungicide, preferably nitrofurantoin. So The carrier may be petrolatum, which is preferably heated to about 60° C. for this purpose. Often, and more preferably, the Hydr. Water-soluble lubricants such as formulations such as Ogel®.

In a preferred method of the invention, the intermediate tube 3' contains a first bath containing petrolatum. This petrolatum coats the smaller lumen when it is immersed in gas 33a. 6° so that the outer surface 14 of the tube can be coated while limiting the degree of inflow. maintained at a valid temperature. Vaseline flows into the first lumen access opening 12° However, it is preferable that the water does not flow into the smaller lumen 6' to a significant depth.

The temperature of the petrolatum in the first tank 33 is preferably maintained at about 40-80°C; The temperature is more preferably about 50 to 70°C, and even more preferably about 55 to 65°C. The most preferred temperature for this purpose is about 60°C. As shown in Figure 15, The intermediate tube 3° is bonded to the surface 14° to the position of dashed line A shown in Figure 15. It is coated with anti-lubricant 38', but this coating extends 3° from the intermediate tube. This is done by immersing into the first immersion tank 33 up to the position indicated by the broken line A above.

Following this step, an anti-bonding lubricant 38' is applied to the outer surface 14' of the tube 3'. Peel it off to the position indicated by the broken line B in FIGS. 15 and 16. This operation is described below. Depending on the method of stripping the particular lubricant, it is preferable to use one or more dipping steps. stomach. The intermediate tube is coated between the positions of dashed lines A and B as shown in Figure 16. is preferable.

The intermediate tube 3° shown in Figure 16 is then inserted into the next dip tube containing the second anti-bonding agent. immersed in the tank. Chemicals such as Vaseline are also used in this step, but liquid Body soap is given priority. During this step, the middle tube 3° as shown in Figure 16 is for coating the part from the bottom of the tip 20' to the position of broken line C. is immersed in the tank up to the point of dashed line C on the outer surface 14' of the intermediate tube 3'. . In a preferred embodiment of the invention, any anti-bonding lubricant described above may be used. Can be done. However, as an anti-bonding lubricant, preferably at about 130-150°F. Hot Vaseline heated to about 1406F (about 60℃) or room temperature (about 62-7 4°F) liquid soap is preferred. The middle tube 3' is pulled out of the hot Vaseline. Once removed, the petrolatum cools and solidifies to form a semi-solid layer on the outer surface 14'', as shown in Figure 18. Generate body coat 39, capillary lumen 6° and capillary lumen access A semi-solid filling 34' is formed in the opening 12'' and they work together to form a capillary opening of 12°. close. As mentioned above, room temperature soap performs the same function as Vaseline. obtained The intermediate tubes shown in FIG. The intermediate tube is immersed in a dipping tank above to apply a coating of anti-bonding agent 39. 3. Peel off the outer surface 14' below the dashed line in FIGS. 18 and 19.

The intermediate tube 3' is coated in the manner described above and the capillary lumen access opening 1 After the tube 3' is closed with the anti-binding agent 40, the tube 3' is coated with a polymeric binding composition. Preferably immersed in a series of dip tanks provided for coating with silicone rubber. (See Figure 26). This coating can be done in single or multiple steps. The balloon catheter 5° elastic sleeve 44'' and the balloon part shown in FIG. An overcoat layer 42' is formed that includes both portions 58'. In a preferred way , the intermediate tube 3' is dipped into silicone rubber two or more times in succession, and then The resulting overcoat layer 42° consists of overlapping layers (not shown). These layers form an integral part of the balloon catheter 5' and are located at 14° on the outer surface 14°. a’.

14b' and 14d', i.e. the part below the dashed line, between the dashed lines B and C and the part above the broken line A, respectively. Above dashed line A Portion 14d° is the final dip designed to apply the overcoat layer 42'. This is the part 14a'' below the broken line, which was not coated before the dipping process. The coating was removed before the other steps.

In the next step, attach the 30° proximal end of the balloon catheter 5' to the 46° distal piece. A complete set of Foley catheter 4° (shown in FIG. 23) is prepared. the end of this End piece 46' closes proximal access opening 49' to fluid line lumen 8'. A cap 48' is provided and a proximal cap communicating with the capillary lumen 6'. A luer valve that engages and closes the capillary lumen access upper opening 52°. alve) 50'. End piece 46゛ with sleeved balloon Create a 4” set of Foley catheter with sleeve by attaching it to catheter 5° Allow the sleeved balloon catheter to air dry before overcoating. Preferably, the solvent in layer 42 is evaporated and then the temperature is raised to cure. O - To prevent undesirable bubbling of the solvent in the bar coat layer 42', Take care to keep the curing temperature below the point. The overcoat layer 42° is Preferably, they are made with the same polymer bond composition, even if made in multiple dipping steps. Therefore, a single overcoat layer 42'' is shown in FIGS. 21-25.

However, this single overcoat layer 42' is composed of several layers stacked one above the other. may or may not represent an integral layer formed by a series of dipping steps. You will understand that there is something. In addition, the outer surface of the Fawso catheter 4' 62° with a fluid line access opening 56°. This fluid line access opening 56 communicates with fluid conduit lumen 8''.

Figures 27 and 28 show the steps of the stamping operation. Catheter 5° shown in Figure 21 In a step subsequent to manufacturing the sleeve 44' of the alternative embodiment of FIG. After completing the complete set of Forceau catheter 4' shown in Figure 1, catheter 5' was also installed. Alternatively, place the 4° elastic sleeve 44″ section in the stamping box 86 as an elongated piece. into the channel-shaped recess 84. Catheter 5' or 4° is approximately 32° Preferably, the temperature is below F. multiple l very small pointed elongations Using a puncher or stamper 90 with a hollow member 92 (see FIG. 28), , the elastic sleeve 44' is held in the channel-like recess 84 for stamping. A plurality of micro holes 81' are created in the elastic sleeve 44°. long and narrow channel shape The recess 84 is designed to hold a 4" or 5" elastic sleeve 44°. When the stamping device 90 is formed and impacted, the stamping device 90 becomes resilient in a preferred manner. Drill a hole only at 44° in the sex sleeve. Catheter 4° or 5° polymer Since the material is not compressible, the catheter has a channel-like recess 8 as shown in FIG. It can be seen that once pressed into the bottom of 4, it cannot be displaced significantly. Dew.

Depending on the type of lubricant/carrier contained within the sleeve cavity 45', the lubricant flow may be affected. mechanical pressure of the stamper 90 during the drilling process. reduce loss of lubricant/carrier through micropores that may occur due to To prevent this, the lubricant/carrier may be cooled before the process of drilling holes in the elastic sleeve 44. or even freezing may be necessary.

With reference to FIG. 22, the independence and extensibility of the elastic sleeve 44' will be explained. elastic pickpocket The tube 44' is not only thinner than the inner wall 21° of the catheter 5', but also thicker than the inner wall 21° of the catheter 5'. It is preferable that the material is more flexible and extensible, and has less hardness than 21'. sleeve A lubricating substance 38' contained within cavity 45' coats outer surface 14' and sleeve 44'. When the sleeve 44' is brought into lubricated contact with the outer surface 14' and both are pulled independently, the outer surface 14' It can be slid along and against the surface. As shown in Figure 22, the bullet The flexible sleeve 44' is designed to prevent twisting of the inner wall 21' or the respective lumens 6'' and 8'. It can be twisted against the inner wall 21° without twisting.

In addition, the elastic sleeve 44' can be stretched without pulling on the inner wall 21' of the catheter 5'. You can also As above, the inner wall of the sleeved balloon catheter 5° 2 1' and other points along its length, the catheter 5°. Elastic sleeves, even when forced to move in response to impact forces. relative contact with adjacent body tissue (not shown) in contact with the tube 44'' or can maintain adhesion. Also, the elastic sleeve 44 contains From its initial circumferential configuration to It can change into a round oval shape. Preferably depending on the volume of the sleeve cavity 45 , the outer diameter of the sleeve portion of the catheter is increased. i.e. at least about 5%, Preferably about 10%, more preferably about 20%, even more preferably about 25% , even more preferably by about 35% and even more preferably by about 50%. Ru. The thickness of the lubricating material within the sleeve cavity 45 increases the volume of the sleeve cavity. It is believed that applications will be found for increased use for this purpose. In this case, the catheter The outer diameter of the sleeve portion 44 of the cable may be reduced by approximately 50% to 100% or 50% depending on the particular application. Increase it to ~200% or more. The important factor is the sleeve or the features it contains. can conform to the shape of a given passageway, while simultaneously filling the passageway and filling the passageway wall or catheter. restricts fluid flow along the outer surface of the catheter and at the same time moving the portion independently relative to the outer surface of the catheter sleeve 44; The sleeve is soft and malleable so that it can be used.

In a preferred method of the invention, the end piece 46' is manufactured by injection molding. pickpocket The proximal end 30' of the tubed balloon catheter 5' has an overcoat layer 42'. After curing, it is preferably inserted into an injection molding machine (not shown). However, the terminal Piece 46' can be added to intermediate tube 3' before starting the dipping process. Wear. A polymeric bonding composition, preferably silicone rubber, is injected into the mold ( (not shown), then the distal piece 46' is placed on the proximal end 30' of the balloon catheter 5'. A set of Foley catheter 4' shown in FIG. 23 is made. Forge depending on the type of composition or compositions used to make the catheter set. If deemed necessary, after further drying and curing, microporous (too small) (not shown) is made into an elastic sleeve 44' to allow disinfectant in the carrier material 38'. Allowing for diffusion into a suitable aqueous environment, the completed catheter 4° is then machined. Test to determine if the product is working properly and if there are any leaks. This test is A body duct access opening 56'' is formed in the outer surface 62'' to communicate with the fluid line lumen 8°. This can be done either before or after.

To test the integrity of the completed catheter 4°, remove the proximal catheter within the distal piece 46'. Before engaging the plug 50° to the pillary lumen access opening 52', the proximal capillary A hot water nozzle (not shown) is inserted into the Lee lumen access opening 52' and the A measured amount of a hot aqueous solution, preferably at a temperature of 160°F, preferably about 1400F. Add water or water containing a small amount of surfactant to a commercially available water pump. 6" to inflate balloon portion 58". for the specific application desired. Use higher or lower temperatures as long as the desired coachability characteristics are obtained. You will see that it is possible. Overcoat layer 42' (D balloon part 58' is coupled to the outer surface 14' of the intermediate tube 3' of the balloon cavity 54'. This is the part of the overcoat layer that is not covered. Balloon part with overcoat layer 42° 58° before the step of dipping the intermediate tube 3' into the polymer bonding composition. A portion 14c of the outer surface 14' remains coated with the anti-coagulation agent.

The balloon cavity 54' is formed in cooperation with the balloon cavity 54'. The balloon cavity 54' has a capillary Communicates with rally lumen 6' through capillary lumen access opening 12° . Pump or inject a hot aqueous solution into the capillary access lumen 6. When testing the completed catheter 4° and balloon part 58°, the balloon part 58' and balloon cavity 54 are inflated. The integrity of balloon portion 58' is significant. If water is insufficient, introducing water in this manner will result in exposure. Balloon part 5 In addition to the 8° test, the aqueous solution, when removed, will cause the balloon lumen to 54° and Remove any anti-binding agent remaining within the 6° capillary lumen. Anti-binding agent During the curing process of the overcoat layer 42°, the proximal capillary lumen The hot aqueous solution is released from the capillary lumen 6 through the access opening 52'. is generally believed to remove most of the anti-binding agent, although a residue remains.

The preliminary test described above is based on visual observation to determine whether completeness is insufficient. However, following this preliminary test, it is determined that the balloon portion 58 is leak-free. Another test may be used to obtain further assurance. This separate test Connect the 52° opening of the rally lumen access to the nozzle of a commercially available leak tester (not shown). It is done together. As one of these testers, Caps Himmelstei Model from Company N (Hoffman Nistera, IL 60195, USA) There is No. 6510 Caps Te5ter. Place the completed catheter 4' Once firmly attached to the nozzle, use a manual switch, preferably a foot pedal. An electrical switch is used to release a measured amount of air into the capillary lumen 6'. I can stay. When air is introduced into the capillary lumen 6°, the air enters the balloon cavity 54°. through the capillary lumen access opening 12' and the balloon portion 58'. inflate, thereby inflating the balloon cavity 54°. Leak tester is a balloon Designed to sense any pressure loss when expanding section 58°, it Therefore, an indication will be given if there is a measurable leak. Complete this exam and then pass all exams. The finished Foley catheter with sleeve 4″ is preferably a Tyvek (Trademark, DuPont) and boxed in a breathable material. next Sterilize the box with ETO (Ethylene Oxide) and store it until shipping. Ru.

In a preferred embodiment of the invention, the extrusion tube used to make the intermediate tube 3' is The heavy lumen tube 2' has a series of approximately parallel waves extending approximately parallel to the longitudinal axis of the tube. A tube (not shown) having a shape (see FIG. 24).

Using such a tube, the balloon part of the completed Foley catheter 4' Sleeved Foley catheter with a ribbed inner surface of 60 mm 4' is obtained. This is because the anti-bonding coating on the middle tube 3° 40゛ (not shown) reciprocates in a 14° corrugation on the outer surface of the intermediate tube 3゛ Because it does. Therefore, when making the balloon portion 58- of the overcoat layer, The inner surface 60 has a bond coating the coated portion 140'' of the outer surface 14. Ribs 59 are provided to reciprocate the corrugations in the anti-coating material 40'.

Another embodiment of the invention, shown in FIG. 25, has multiple capillary openings of 12° from the capillary lumen 6'' to the balloon lumen 54'' and vice versa. It provides a Foley catheter 4' with a complete sleeve that can be inserted and removed in multiple ways. be. This inflates the balloon portion 58°° of the overcoat layer 42°°. When the balloon lumen 54'' is placed in the capillary lumen 6° This is very important when you want to guarantee that the system will not be disconnected.

When the preferred method of the invention is used by the applicant, the production of balloons and sleeves is almost completely automated. The entire sleeved balloon catheter 5' The sets are manufactured at the same time. The preferred pallet 24 has 40 attached to it. Each loft 26 is equipped with 0 spring steel support rods 26 (20 rows of 20 rods each). are approximately 1 inch apart from each adjacent rod. Single and double lumen tubing (Fig. (not shown) are preferably made by extrusion methods known to those skilled in the art. blood Tubes 2 and 2' are cut to length as the tubes exit the extruder (see Figure (not shown). A 12° opening is preferably provided on the outer surface 14' of the double lumen tube 2'. are made with hollow drill bits or drill tubes (not shown); It communicates with the capillary lumen 6' within 2° of the tube. Then the distal end of tube 2' 16' and the capillary lumen access opening 12'. - in the distal part 6a' of the lumen 6°, a measured amount of polymer binding composition, preferably is injected with silicone rubber, so that the distal part 6a' is filled and sealed. Ru. Next, preferably by inserting the tube 2° into a former (not shown). Thus, a pre-tipped tip 20° is formed at the distal end 16′ of the double lumen tube 2′.

Referring to Figure 26, the present invention is shown as a sleeved Foley catheter 4''''''. Another embodiment of the present invention will be described. This embodiment has a balloon cavity of 54° The space between the rib cavities 45'' is adjusted so that the space accommodates the urethral sphincter of the bladder. It is very similar to the catheter shown in Figure 23, except that it is much smaller. the The volume of the lubricating substance 38'' in the upper sleeve cavity 45'' is as shown in FIG. significantly larger than . This is due to the moisture that is coated on the intermediate tube during the manufacturing process. This is achieved by increasing the thickness of the lubricating material 38. Lubricating substance 38"" thickness By increasing the stiffness, the sleeved Foley catheter 4°°° Extremely flexible and “comfortable” that can adapt to variations in the surface that the catheter 4°°゛′ comes into contact with. A conformable outer surface 9'' can be provided on the sleeve 44°.

29 and 30, another implementation similar to the catheter 4°°'° shown in FIG. A Foley catheter with a sleeve according to an embodiment of the present invention will be described. this catheter 4-' is provided with a third lumen 97 that communicates with the sleeve cavity 45''. This is different from the catheter 4° shown in FIG. The sleeve 44"" also has multiple microscopic pores (too small to show) and the elastic sleeve 44°°° is water-based. environment and the concentration of disinfectant in the aqueous environment causes sterilization within the sleeve cavity 45''. If the concentration of the disinfectant in the carrier material 38" is lower than the concentration of the disinfectant in the carrier material 38" can be diffused from the cavity 45''. This special catheter 5“°° ° When the catheter is installed for a long period of time and placed in the sleeve cavity 45”’” This is useful when it is desired to replenish a supply of 38°゛°° carrier material. In Figure 30 A cross-sectional view of catheter 5'' is shown.

FIG. 31 shows the sleeved catheter 4'' shown in FIG. 4 is inserted. Balloon part 58 of catheter 4 is female. It is in the bladder 72 of the sex 70. The balloon part 58°"° is inflated and the catheter is removed. 4-°° is retained within the urethra 74. Lubricating substance 3 inside the sleeve cavity 45° The 8°°°' volume is large compared to other embodiments of the invention, so that the wall of the urethra 74 The outer surface of the sleeve 44” is cushioned for conformability. It helps provide. The lubricating substance 38°"°° is also applied to the catheter 4-° The inner wall 21°°'° or the pipe section 21°'° of the sleeve 44°'°° without disrupting the interface between the outer surface 9°'°' and the adjacent body tissue of the urethra 74. It can be moved back and forth within the urethra 74°'' to a limited extent. The result As a result, the catheter 4"" can be inserted to a limited extent without destroying the above-mentioned interface. Patients with a catheter 4-°, since it can be moved in all directions. Increase comfort. In this embodiment, the lubricating substance 38"" contains a disinfectant. This catheter 4°" is also shown in Figures 27 and 28. A plurality of microscopic holes (too small to be shown) made using a tool 90 are The sex sleeve is held at 44°. Catheter 4 "" has a channel-shaped recess 84 and a series of stamping steps similar to those described above (see Figures 27 and 28). (see above explanation), micropores are formed around the entire circumference of the catheter. You will understand that. Insert the catheter 4-° into the urethra 74 as shown in Figure 31. The aqueous environment normal to the urethra 74 then enters the sleeve cavity 45''. ing. Facilitates the diffusion of the disinfectant contained in the lubricant or carrier material 38"" You will know that it is progressing. Diffusion is a net flow of matter. ), and in this particular example, the disinfectant is transferred from an area of high concentration to a low concentration. This is diffusion into the concentration region. Except in special cases, the aqueous environment of the urethra is Since this is a low area, the aqueous nature of this environment causes the The disinfectant is introduced into the urine from the sleeve cavity 45°°゛° through the elastic sleeve 44''. It can be spread over the road 74. From this, it can be seen that outside the elastic sleeve 44° Bacteria growing on or adjacent to the surface will be reduced or It disappears.

Although not certain, diffusion includes the forces normally associated with immersion and diffusion as well as tube action. This is thought to be due to a number of phenomena. Diffusion rate is 44°'° with elastic sleeve Concentration gradient across ° [This concentration gradient is Eneyclapedia Br1ta nnlca (15th edition, copyright, 1985).

Note that this description is considered to be in proportion to [this description is hereby incorporated by reference].

In the most preferred embodiment of the invention, 400 intermediate tubes 3' are provided as described above. Attach vertically to the hard spring steel support rod 26° of the pallet 24' using the same method. . The pallet 24' may be similar to the following examples further disclosing preferred elements of the invention. The transport mechanism 22 (see Figure 28) moves it over a series of immersion tanks in this way. let

Example 1 (A) A cell in which the pallet 24' is stopped above the first tank 33. In this tank 33 , white USP petrolatum containing nitrofurantoin. Nito Heat petrolatum containing lofurantoin to about 60°C (about 140'F).

Raise the tank to the depth to reach the proximal end of the Vaseline or desired sleeve location Immerse the intermediate tube 3° until Next, lower the immersion tank 33 and A portion of the outer 14° surface of tube 3' was coated with nitrofurantoin-containing vaseline. It will be done. This section is located midway from the approximate point where the proximal end of the elastic sleeve 44° begins. The tip of the tube 3° extends to the distal end 20a of 20°. By increasing the thickness of the lubricating material, the outside of the tube 2 or 2° conduit portion of this invention is It is repeated if it is desired to increase the outer diameter of a particular catheter by more than the circumferential diameter.

(B) Next, the pallet 24' is moved forward to a temperature of approximately 120°C (approximately 250°F). over a second dip tank 35 containing white USP petrolatum heated to make it stop. The second immersion tank 35 is raised and the intermediate tube 3' is exposed to the heated water. (A) The intermediate chimney derived from the dipping process is soaked in serine and heated. Vaseline coating 38' on outer surface 14' of tube 3' and elastic sleeve Contact approximately where the distal end of 44' ends. Next, the second immersion tank 35 lower. By this dipping step, (A) Vaseline coating derived from the dipping step is the middle position from the bottom where the distal end of the elastic sleeve 44° is located (indicated by dashed line B). Portion 14 of outer surface 14 up to distal end 20a' of tip 20' of tube 3' It is almost removed from a. Some residual petroleum jelly will remain in this area of the outer surface 14°. may remain on the outer surface 14' of the intermediate tube 3° in the area. But almost of Vaseline is removed.

(C) The 24° bellet is then automatically advanced and the mine heated to approximately 200'F. It is stopped above the third immersion tank 37 containing Ral Spirit. Third immersion tank 37 and insert the intermediate tube 3' into the heated vaseline in the second dipping tank 35. Immerse it in mineral spirits to the same depth as it was immersed in it. Then the tank 37 and apply all but a trace amount of petroleum jelly to the outer surface located below dashed line B. 14 (this location will ultimately be the location of sleeve 44'). (D) The pallet 24' is then automatically advanced and the toluene, trichloroethane Stop above the fourth dip tank 40 containing any volatile organic solvent. 4th dip The tank 40 is raised and the water is immersed in the second and third tanks 35 and 37 in the same manner as before. The intermediate catheter 3 is immersed to the same depth. Therefore, this part of the outer surface 14' Almost all traces of petrolatum are removed. intermediate catheter tube 3' is the axis of the intermediate tube 3' at the position where the sleeve cavity 45° is created. It has a 38° band of semi-solid petrolatum located on the outer periphery of the direction.

(E) Next, on the pallet 24', the immersion tanks 41, 43 of No. 5, 6, 7 and 8 ．． 47 and 49 respectively. In these immersion tanks, step A ,B.

The steps performed in each of C and D are repeated with the following changes. Palais When the cut 24' is stopped above the fifth immersion tank 41, the intermediate tube 3' is Immerse it to the position indicated by the broken line C shown in Figures 18 and 19. Next, the pallet 24' is Pallet 24° when stopped continuously over dip tanks 43.47 and 49 The intermediate tube 3° attached to the let These steps will remove petroleum jelly or the outside of the area below the dashed line. It is cut off from a portion 14a° of the side surface 14'. Apply petroleum jelly to 14゜ of the outer surface. It not only coats the portion 14c' but also fills the 6° portion of the capillary lumen. to close the gear pillar-lumen access opening 12'. This part shows the completed file. is ultimately used to inflate the balloon portion 58' of the Ollie catheter 4'. This is the part where

(F) Next, lower the pallet 24゛, and then lower the silicone rubber/solvent with low solids content. It is advanced to the ninth immersion tank 51 containing the dispersion liquid. This dispersion is Coat the petroleum jelly remaining on portions 14e and 14c of the outer surface 14' of tube 3'. 38' and 40' and to minimize disruption of the integrity of the outer surfaces of This is the part where the sleeve cavity 45゜ and the balloon cavity 54゜ will be created in the next dipping process. Ru. Next, the ninth tank 51 is raised and the intermediate tube 3 is placed in the solution as shown in FIG. Immerse it to a position above the broken line A. This step is then preferably carried out with sufficient solvent. The same tank or higher concentration silicone rubber should be added at intervals of time to allow volatilization. overcoat layer 42 and the overcoat layer 42 using the next tank containing the Repeat until balloon portion 58 of layer 42 has the desired balloon thickness. vinegar. However, in this embodiment, tank 51 is lowered and pallet 24' is removed from the ninth dip. Silicone rubber containing a higher concentration of silicone rubber than the dispersion in tank 51 Advance the tube 3' to the 10th immersion tank 53 containing the dispersion liquid, and complete the tube 3' again. completely immersed.

Preference for overcoat layer 42'', elastic sleeve 44° and balloon portion 58° The correct thickness is 0.0175 (±0025 inches). next silicone rubber When using a dipping tank, the concentration of silicone rubber in the next tank should be the same as that of the ninth dipping tank. It is preferable that the concentration be higher than that of the silicone rubber in the tank 51. Is it even more shiny? silicone used in the final coating to provide a smoother finish. It is recommended to change the rubber. However, the concentration and solvent should be adjusted appropriately. Can be done.

(G) Next, the pallet 24' is advanced to create a drying area where the solvent is evaporated and a heat curing process. pass through the process. The balloon catheter 5' formed in this step is made of silicone Curing occurs at a temperature below the boiling point of any solvent used in the rubber dispersion. Tor In the case of ene, this temperature is approximately 200'F.

(H) After heat curing, the sleeved balloon catheter 5' is cooled and then Remove the support rod from 26°.

The proximal point 30' of each balloon catheter 4 obtained was placed in an injection molder (not shown). Insert to form the final piece 46 of the Foley catheter 4° with the completed sleeve. Shape.

(1) Next, the completed Foley catheter 5 has fluid line access openings on the outer surface 62'. An opening 56' is provided by punching so that the surface of the balloon portion of the overcoat layer 42' portion 58' is in communication with fluid line lumen 8' at a location below or distally. A plurality of micro holes (not shown) are stamped into the elastic sleeve 44'' and the elastic sleeve 44''. Allows trofurantoin to diffuse into the aqueous environment such as the urethra, where bacteria finishing by minimizing or eliminating the growth of this minute The holes are created using a plurality of very small pointed elongated members 92 in the stamper 90. It is made by drilling holes in the elastic sleeve 44°. Catheter 5 is first cooled to a room temperature below 32°F, then placed into an elongated channel-like recess 84; Stamping is performed using a stamping machine 90 to create micropores.

(J) The completed Foley catheter 4° is then sent through the test series described above. . During this test series, the balloon portion 58' of each completed Foley catheter 4° was inflated. Upon tensioning, the Vaseline band 40' within the balloon cavity 54' is largely removed. .

As shown in FIGS. 33A, 33B and 33C, the present invention consists of the following steps: A method of manufacturing a sleeved Foley catheter 4' is provided. sand (A) a tube having an outer surface and first and second lumens; (B) cut the tube to the desired length; (C) cut the first lumen access opening outward; fabricated on the surface to communicate with the first lumen; CD) Place the polymer binding composition in the first lumen at the end closest to the first lumen access opening. filling from the end to the first lumen access opening; (E) unrolling the end of the tube closest to the first lumen access opening; and (F) Attach the obtained tube to a mobile pallet; this is the step.

These steps are followed by the following steps: (A) a removable anti-bond lubricant; or a carrier material containing a disinfectant coats the first portion of the outer surface and Close the luminal access opening; (B) removable anti-bonding lubrication from a second portion of the outer surface adjacent to the first portion; At the same time, the outer surface is coated with a removable anti-bonding agent (C). coating a third portion of the outer surface adjacent to the second portion of the surface and closing with the first lumen opening; character: (D) a fourth portion of the outer surface located adjacent to and below the third portion of the outer surface; removing the removable anti-bond coating from; (E) Appropriately clean the outer surface and any remaining coating of removable anti-bonding agent. coated with an overcoat layer of a film-forming polymeric binding composition; ) curing the overcoat layer: step.

Following these steps, the method of the invention includes the following steps. That is, (A) Attach the distal piece to the end of the tube furthest from the first lumen access opening. hair.

(B) Through a series of stamping processes, multiple fine particles are formed on the entire outer surface of the elastic sleeve. Stamping the hole: (C) Simultaneously testing the balloon section of the resulting catheter. a removable anti-binding agent from the first portion of the outer surface and the first lumen access opening. (D) remove catheter capillary lumen and balloon portion from leakage; and further test; (E) Punching a second lumen access opening on the outer surface of the catheter to open the second tube. (F) Packing the resulting sleeved Foley catheter: call (G) Sterilize the sleeved Foley catheter: Step.

In another embodiment of the invention, a plurality of intermediate tubes 3' are arranged on a mobile pallet 24°. Once installed, the balloon catheter is manufactured as follows. That is, ( A) Stop the pallet 24' on the first tank 33. In this tank 33, Prevents bacterial growth on the outer surface of the elastic sleeve when inserted into a suitable aqueous environment A white United States Pharmacopeia petrolatum containing an amount of nitrofurantoin effective to prevent Contains phosphorus. Heat this vaseline to about 6°C. Next, raise tank 33. Place the intermediate tube 3' in Vaseline until the Vaseline reaches the desired position along the dashed line in FIG. Immerse to a depth that reaches the proximal end of the elastic sleeve location. Next, immersion tank 3 3 and coat the outer surface 14' of the intermediate tube 3' with petroleum jelly. . This section extends from the approximate point where the proximal end of elastic sleeve 44' begins to each intermediate point. It extends to the distal end 2a' of the 3° tip 20' of the tube. In other embodiments This process results in a 38° thickness of the lubricating coating and a final volume of the sleeve cavity 45'. repeated to increase the size of the outer diameter of the sleeve 44' of the catheter 5°. returned.

(B) The steps described in Sections B, C, and D of Example 1 above are then repeated as described in Example 1. Execute in the same manner as above.

(C) Next, the pallet 24' is stopped on the fifth immersion tank 41. this tank liquid soap (Proct, Cincinnati, OH 45202, USA) Liquid Ivoty 5oap from or & GambleCo, Inc. ) is included. This soap is suitable for use at room temperature (approximately 60-80°F, preferably 65-70°F). 2°F). Raise the fifth immersion tank 41 and insert the intermediate tube 3° into the liquid. Dip your body in soap J, and add the soap to the tube 3 at the position indicated by the broken line C in Figure 18. Coat until dry. Next, when the immersion tank 41 is lowered, the liquid soap becomes semi-solid. Coating 40' of each intermediate tube 3' from the position of straight line C to the distal end 20° formed on the outer surface 14' of each tube 3' extending to the distal end 20a' of the tube 3'.

(D) Pallet 24 is then automatically advanced and a trace amount of a suitable wetting agent or interface is applied. It is stopped above the sixth dipping tank 43 containing the aqueous solution containing the activator. good In a preferred embodiment, 3 gallons of water are mixed with 2 ounces of a suitable surfactant.

Surfactants generally account for less than 1% of the total volume of the solution. Next, the sixth immersion tank 43 18 and 19. Immerse it up to the point. Next, lower the sixth immersion tank 43 to below the position indicated by the broken line. A semi-solid liquid soap coating of 14° on the outer surface of the to remove.

(E) Next, the pellet 24' is automatically advanced, and the seventh immersion tank 4 containing water is Stop above 7. Next, the seventh dipping tank 47 is raised, and the dipping step (D) is performed. Similarly, immerse it in water until it becomes straight. Next, lower the seventh immersion tank 47, Finally, pour all of the liquid soap onto the outside surface 14" below the straight line. It is removed from minute 14a'.

(F) The pallet 24'' is then automatically advanced to form the balloon cavity 5 in the next dipping step. 4 is formed on the outer surface 14° of the outer surface 14c' (broken Is Part between C and D) Completely remove the remaining liquid soap coating 40' Low isomorphic content of silicone and rubber/solvent content that is effective in minimizing damage to the adhesive. It is stopped above the eighth immersion tank 49 containing the dispersion liquid. Next, the 8th tank 49 Raise it up and immerse the middle tube 9 3 degrees into the silicone rubber dispersion. .

(Providing a suitable dispersion of silicone rubber and coating certain lubricants) It will be appreciated that any solvent suitable for i can be used. Use water-based solvent Although it is considered possible to do so, it is currently not preferred. This engineering process preferably for a long enough time so that much of the solvent can evaporate). The overcoat layer 42 and the balloon portion of the overcoat layer 42 are repeatedly removed. It will be seen that a thickness addition of 58 minutes is made. However, [different solutions] Other steps may be followed.

(G) Next, lower the fourth immersion tank 39 and coat a part of the outer surface 14°. Silicone rubber and vaseline coating 38° and soap coating 40' to dry. Next, the pallet 24° is further removed from the eighth immersion tank 49. Ninth dip tank 51 containing different silicone rubber dispersions with high solids content advance until. The ninth immersion tank 51 is raised and the intermediate tube 31 is further removed. immersed in silicone rubber dispersion.

Next, lower the ninth immersion tank 51 and apply silicone rubber to coat the tube 3°. dry.

(H) Next, the pallet 24 is automatically further advanced to the 10th immersion tank 53. Ru. This tank features silicone rubber that provides a high-gloss, smooth-touch surface. Contains a silicone rubber dispersion containing. Immerse tube 3 in the same way as above. Then lower the 10th dipping tank 53 and remove the silicone coating the tube 3'. Dry the cone rubber.

(G) Next, the pallet is advanced 24 degrees and passed through a drying process and then a heat curing process. Then, the distal piece 46° is attached to each completed sleeved balloon catheter 5'. A liquid conduit access opening 56' is provided and the elastomeric sleeve is cooled below the freezing point. Multiple micro-holes (too small to show) are placed on the plate by stamping. , tested, packaged and then sterilized.

Applicants' claimed automated system is a complete sleeved Foley catheter. 4' can be produced at a rate of approximately 1,600 catheters per hour. Wear.

Finally no manual labor is involved in manufacturing the balloons and sleeves. The manufactured catheter 4' is of very high quality with no variation. Outer surface 62' is smoother than a hand-glued balloon, and the outer diameter of balloon portion 58' is perfect. The outer diameter of the other parts of the 4° Foley catheter is almost the same as that of the other parts. balloon It is undesirable for the outer diameter of the part to be large. In that case, the balloon part makes insertion and withdrawal more difficult and causes additional trauma during withdrawal. moreover, When manufacturing the silicone rubber balloon catheter 5゛, the balloon part 58゛ Eliminates manual labor associated with gluing to intermediate tube 3 Eliminates the separate process of secondary processing of the rune part, and eliminates manual errors. Applicants' new method The direct production cost of all kinds of silicone rubber balloon catheters is reduced by conventional technology. Approximately 25% less than the estimated cost for surgical silicone rubber balloon catheter. It can be reduced by ~50%.

However, the numerous features and advantages of the present invention are apparent from the foregoing description, which provides more details of the structure and function of the present invention. , the specific order of steps, or the actual compositions, solvents, temperatures used in each step, Although mentioned together with the environmental conditions, the disclosed items are for illustrative purposes only. , changes in particular as to shape, size, arrangement of parts or order of events or elements. , within the principles of the invention, the broad general meaning of the terms indicated in the claims of this application. It should be understood that this can be done in as much detail as shown in .

@ Bribe L FIG, 33 people FIG, 33rd FIG, 33C Summary book An elongated catheter (4°゛°°) having an inner surface and an outer surface, the inner surface being An elongated catheter that forms a lumen (8") that passes through the catheter. further includes a cavity (45") enclosed between the inner and outer surfaces surrounding the lumen. ing. The cavity has an inner wall and an outer wall, the outer wall generally being able to extend independently of the inner wall. It is an elastic sleeve. While the elastic sleeve is in lubricating contact with the outer surface of the inner wall, When the elastic sleeve is stretched independently of the inner wall, the elastic sleeve is stretched along the outer surface of the inner wall. a lubricating substance containing a disinfectant in an amount effective to enable sliding; is contained in the cavity, and the inner and outer walls are at the distal and proximal ends of the enclosed cavity. connected. The elastic sleeve allows the disinfectant to diffuse into a suitable aqueous environment. Equipped with multiple micropores that allow A detailed process including a series of automated dipping steps. A method for automatically manufacturing a long catheter is disclosed. As shown above, the balloon part (5 8°′°′) and “Foley” catheter with lubricated elastic sleeve. The present invention discloses a method for manufacturing the same.

Submission of translation of written amendment (Article 184-8 of the Patent Law) ゛) July 10th, 1992 1. Commissioner of the Patent Office 5 Makoto 11. International application number PCT/US91100161 , name of invention Microbicide release catheter 3. Patent applicant [Address: 1 Stuartville, Minnesota, 55976, USA Second Avenue North West 1500 Name: Lochinister Medical Corporation 4, Agent 1-20-10 Nishi-Shinbashi, Minato-ku, Tokyo 105 Nishi-Shinbashi Excel Building 2nd floor The sleeve is capable of conforming to the actual configuration of the passageway it extends when inserted into the body. can. This is due to the generally non-compliant cylindrical tube that most catheters have. It is preferable to For example, a conventional Foley catheter inserted into the urethra , which puts unnatural and unstable pressure on the tissues of the urethral wall as it holds the urethra apart. on the other hand , the cushioned sleeve of the preferred embodiment of the present invention has a soft, conformable outer surface. I will provide a. This surface conforms to the surface of adjacent body tissue with which it comes into contact. in this way Preferred catheters of the present invention have a structure in which the catheter contained therein is attached. Adapts to the natural shape of the walkway. Moreover, the present invention can be used by health protection professionals or patients. The preferred method is to provide the patient with a catheter that is more accurately sized for the passageway into which it is to be inserted. It should be noted that a new catheter is provided. For example, most women Foley indwelling catheters with outside diameters of 16.18 and 20 French are compatible.

- Adaptation of the elastic sleeve of the preferred sleeved Foley catheter of the strength tree invention. The nature of this allows the volume within the sleeve cavity to move, and the sleeve cavity Provides cushioning to the elastic sleeve and allows the area of the urethra that the elastic sleeve extends into It will be moved. Preferred embodiments of the invention therefore have different requirements. To provide an outer surface that can have a variety of outer diameters to accommodate the urethra. Sara Preferred embodiments of the present invention provide a non-accommodating prior art technique for urethral wall fluctuations. A more compliant polymer-bonded material is added to the distal portion of the dual lumen tube 2' than the device described above. Inject into capillary lumen 6' through end 16'. As a result, the capillary lumen 6 ° polymer fill material 1 to a point directly below the capillary lumen access opening 12 ° Filled with 8゛. The tip 20', preferably the ex-husband's silicone rubber tip, is then Manufacturing the intermediate tube 3° shown in Figure 13 by fixing it to the distal end 16° of tube 2' complete. In a preferred method, the distal end 16° of tube 2' is into a forming device (not shown) designed to form a 20° tip at the distal end of the Enter.

14-21 and 28 will be described. A preferred method of the invention includes FIG. A plurality of intermediate tubes 3', such as the intermediate tube 3' shown in Fig. 24'. The rack or pallet 24' can hold multiple Support rods 26' are provided, each of which is provided with a retaining clip 28'. It is.

The larger of the two lumens of the intermediate tube 3' is called fluid conduit 8°. the proximal point 30' of the tube 3° is engaged with the individual support rod 26° so that the proximal point 30' of the tube 3° or preferably as shown in FIGS. 15 and 16. The distal end 20' of each tube 3' is aligned with the distal end 26' of each support rod 26'. Slide tube 3' in the L direction along support rod 26' until it is a snug fit. This fixes the tube 3' to the support rod 26'. Illustrated However, the elastic sleeve 44' and valve of the intermediate tube 3" rune catheter 4" automatic coating or dipping method to create the curved section 32' (see Figure 21). The first two steps in the process involve sealing the intermediate tube 3 with a lubricant or lubricant to prevent binding. Coating with a lubricating substance 38, preferably a removable anti-bonding agent. child The coating preferably coats each tube 3' attached to the pallet 24. Removable anti-binding agent, preferably forming a semi-solid film on the surface when cooled a first immersion tank 33 containing a bath 33a of material which may then be dried; This is done by simultaneously soaking the Examples of such substances include petroleum i.e. Vaseline, other oil bases that form a semi-solid when cooled to room temperature substances, liquid soaps, water-based soaps or detergents that form semi-solids when dried. solutions, polyvinyl alcohol aqueous solutions, emulsions or suspensions, lubricating gels, These include aqueous or oil-based film-forming solid emulsions. Described in this application In one embodiment, hot petrolatum is used; in another embodiment, liquid soap is used. Proctor & Co., Cincinnati, Ohio, USA Liquid Iv is commercially available from Gamble.

ry 5oap is preferred. In other embodiments of the invention, a lubricating gel is used; KY Jelly, Hydrogel (all registered trademarks), etc. Water-soluble formulations are preferred. These anti-binding agents or lubricants are It is understood that the invention can also be used as a carrier material for disinfectants or fungicides. 1. An elongated catheter consisting of an inner surface and an outer surface.

the inner surface defines a first lumen passing through the catheter; Further, a cavity enclosed between the inner surface and the outer surface surrounding a portion of the first lumen. wherein the enclosed cavity has an inner wall and an outer wall, and the outer wall is generally free from the inner wall. an elastic sleeve that can be stretched in relation to the cavity, and a carrier material containing a disinfectant in the cavity; Contains.

Inner and outer walls connect at the distal and proximal ends of the enclosed cavity and are connected to the catheter. The tell further has a second lumen, an inflatable balloon and a balloon cavity, the second lumen having a The balloon cavity is in communication with the inflatable valve such that fluid flows from the second lumen into the balloon cavity. the elastic sleeve is inflatable when in an aqueous environment. enabling diffusion of the disinfectant from the enclosed cavity; the diameter of the elongate catheter, the sleeve cavity having a volume of at least about 5%; An elongated catheter that is sufficient to increase the.

2. The means for enabling diffusion has a plurality of micropores in the elastic sleeve. The elongated catheter of claim 1.

3. A bladder in which the catheter communicates with the urethra of the individual requiring catheter attachment. A "Foley" catheter with retention means for retaining said catheter portion within the bladder. 3. The elongate device of claim 2, wherein the indwelling means includes an inflatable balloon portion. catheter.

4. The elongated catheter of claim 2, wherein the disinfectant is an antibiotic.

5. Antibiotics include nitrofurantoin, sulfamethoxazole, trimethopri 5. The elongate catheter of claim 4, wherein the elongate catheter is selected from the group consisting of: .

6. The carrier material may be Vaseline, polyvinyl alcohol lubricating gel, or water-soluble soap. 5. The elongate catheter of claim 4, wherein the elongate catheter is selected from the group consisting of: and a water-soluble filler.

7. An elongated catheter consisting of a tube having an inner surface and an outer surface, The inner surface defines a first lumen, and the catheter further defines an outer surface of the tube. An overcoat that includes both an elastic sleeve portion and an inflatable balloon portion surrounding the face. layer, the overcoat layer at the distal and proximal ends of the elastic sleeve portion. and is secured to the outer surface so that the sleeve portion and the sleeve portion of the outer surface A sleeve cavity is formed between the sleeve region and the sleeve cavity contains a disinfectant. The overcoat layer covers the remote part of the inflatable balloon. fixed to the outer surface at the distal and proximal ends, so that the inflatable balloon portion and the outer A balloon cavity is formed between the inflation balloon portion of the side surface and the balloon region, and the An elongated catheter in which the balloon cavity is in fluid communication with the second lumen.

8. While the elastic sleeve portion is in lubricating contact with the sleeve area on the outer surface, the former When the elastic sleeve portion is stretched independently of the latter, the carrier material Enables sliding along and against the sleeve area of the side surface It is a lubricating substance, and when the surfaces of each polymer are in lubricating contact with each other, , the lubricating substance allows each polymer surface to slide approximately equally against each other. 8. The elongated catheter of claim 7, wherein the elongated catheter is effective for

9. Lubricating substances include petrolatum, polyvinyl alcohol-containing water-soluble gel, and water-soluble 9. The elongated catheter of claim 8 selected from the group consisting of soap.

10. Fungicides include nitrofurantoin, sulfamethoxazole, trimethopri 10. The elongated catheter of claim 9, wherein the elongate catheter is selected from the group consisting of: .

11. A long and thin catheter to be inserted into the human body, manufactured by the method consisting of the following steps: - the following steps: namely (a) providing a tube having an inner surface and an outer surface, the inner surface being a first lumen; form; (b) generally prevents bonding to the first portion of the outer surface and to the first portion of the outer surface; an amount of lubricant effective to form a coating of lubricant on the first outer surface; coating the part and the lubricating substance is useful in reducing bacterial growth in an aqueous environment. (c) a second portion of the outer surface and a coating of a lubricating substance; an elastic polymer bonding composition, such that an elastic polymer overcoat layer is produced. an overcoat of the lubricant coating on the first portion of the outer surface; a first segment of the top layer cooperates with a first portion of the outer surface to form a sleeve cavity; A coating of lubricant is placed inside the sleeve cavity. and generally movable independently of the first portion of the elastic sleeve or outer surface; While the elastic sleeve is in lubricating contact with the first portion of the outer surface, the former is independent of the latter. When stretched, the lubricant causes the elastic sleeve to slide along the first portion of the outer surface. and (d) the elastic outer sleeve is a plurality of micropores that allow the disinfectant to diffuse out of the cavity when Made into an elastic outer sleeve; An elongated catheter manufactured by a process consisting of a process.

12. Further, following step (b) and before step (c), a lubricating substance is applied to the outer surface of the outer surface. It is manufactured using a method that includes a step of peeling it off from three parts.

coating a third portion of the outer surface with the lubricating material in the step of coating the first portion; the second and third portions of the outer surface being opposite each other on opposite sides of the first portion; Toward.

and the overcoat layer made in step (C) is on the opposing surface of the sleeve cavity. and secured to the outer surface at second and third portions of the outer surface.

12. The elongated catheter of claim 11.

13. The following steps: i.e. (a) providing a tube having an outer surface and a plurality of lumens including first and second lumens; and the tube provides first lumen access to the outer surface communicating with the first lumen. having an opening; (b) an amount of lubricating substance generally effective to prevent it from bonding to the outer surface; coating a first portion of the outer surface of the catheter, when the catheter is located in an aqueous environment; An effective amount of disinfectant to prevent germicidal growth in the area of the outer surface of the lubricant is added to the lubricant. quality contains; (c) then stripping the lubricating material from the second portion of the outer surface; (d) then simultaneously coat the third portion of the outer surface and the first lumen with an anti-binding agent; closing the access opening, the first lumen access opening passing through the third portion of the outer surface; communicating with the first lumen; (e) then stripping the anti-bonding agent from the fourth portion of the outer surface; (f) The tube is then coated with a polymeric bonding composition and an elastic overcoat layer. is made and secured with its second and fourth portions to the outer surface of the tube and has a The first and third portions are not bonded and the overcoat layer is on the outer surface of the first portion. secured at a fifth portion of the outer surface adjacent to the second portion and opposite the second portion to the first portion; and (g) the compound is then placed so that the disinfectant can diffuse out of the cavity within the aqueous environment. creating a number of micropores in the elastic overcoat layer of a first portion of the outer surface; An improved sterile "Foley" catheter manufactured by a process consisting of a process.

14. The following steps: i.e. (a) providing a tube having an outer surface and an inner surface, the inner surface being a first lumen; form; (b) Useful for creating coatings that are generally effective in preventing bonding to external surfaces. coating a first portion of the outer surface with an amount of an effective lubricant, said lubricant containing a disinfectant; (c) then coat the outer surface so that an elastic polymer overcoat layer is formed; coating the second portion and the coating of lubricant with an elastomeric polymer bonding composition; a first segment of an overcoat layer of a coating of lubricant material on a first portion of the outer surface; an elastic member that cooperates with an outer surface of the elastic sleeve to form a sleeve cavity; a sleeve with a coating of lubricant contained within the sleeve cavity; and Beauty (d) a disinfectant in which the environment surrounding the elastic sleeve has a lower concentration than the disinfectant in the lubricating substance; If the aqueous environment has a concentration of A long and thin sterilization catheter consists of creating multiple micropores in an elastic sleeve; manufacturing method.

15. Further, following step (b) and before step (c), a lubricating substance is added to the third layer of the outer surface. Including the process of peeling it off from the part.

coating a third portion of the outer surface with the lubricating material in the step of coating the first portion; wherein the elastomeric polymer overcoat layer made in step (c) is second and third portions of the outer surface located adjacent to opposite sides of the first portion on the side surface; 15. The method of claim 14, wherein:

16. Further, following the step of stripping the lubricating substance from the third portion of the outer surface. prior to (c), coating the fourth portion of the outer surface with an anti-bonding agent.

the tube has a first lumen access opening in the fourth portion and the second lumen; and The elastomeric polymer overcoat layer made in step (c) covers the outer surface of the fourth the portion includes an elastic balloon, said balloon cooperating with a fourth portion of the outer surface; a balloon cavity communicating with the first lumen through a first lumen access opening; 16. The method according to claim 15.

17, further following the step of coating a fourth portion of the outer surface with said anti-binding agent; before step (C), stripping the anti-bonding agent from the fifth portion of the outer surface; said step of coating the first portion comprises coating a fifth portion; and said step of stripping the lubricating material from the portions strips the lubricating material from the fourth and fifth portions; said overcoat layers facing each other on opposite sides of the balloon cavity. and secured to the outer surface at the third and fifth portions of the outer surface.

17. The method according to claim 16.

18. Said step of coating the fourth portion of the outer surface with an anti-bonding agent simultaneously coats the outer surface with an anti-bonding agent. The fourth portion of the outer surface in an amount of anti-bonding agent effective to prevent bonding to the fourth portion of the surface. 4 portions and close the first lumen access opening, and a polymer binding composition. 17. The method of claim 16, comprising closing the first lumen access opening with.

19. The carrier material is sufficiently deformable such that an elastic sleeve extends along its outer surface. Sufficiently deformable to enable and maintain contact with the inner wall of the elastic sleeve or sleeve cavity 2. The elongated catheter of claim 1, wherein the elongated catheter is

20. When the opposite sides of the inner wall are in contact with the elastic sleeve, the elongated catheter 20. A cross section of the elastic sleeve relative to the longitudinal axis of the elastic sleeve is substantially elliptical. elongated catheter.

21. Inserted into a mammalian body passageway consisting of a tube having an inner surface and an outer surface. A long and thin catheter for a tube having an inner surface and an outer surface, the inner surface forming a first lumen; , the catheter further comprises a cushioned sleeve, the cushioned sleeve The tube has an elastic sleeve portion surrounding the outer surface of the tube and a sleeve cavity. The sleeve portion connects to the outer surface at the distal and proximal ends of the sleeve cavity and The tube cavity is located between the sleeve portion and the sleeve area of the sleeve portion on the outer surface of the tube. a cushioned sleeve further displaced within said sleeve cavity; the carrier material contains a bactericidal agent and the cushioning sleeve The sleeve cavity includes a cushioned sleeve extending radially from the central axis of the catheter. Contains a sufficient amount of displaceable carrier material to permit outward deformation of at least about 5%. A long, thin catheter.

22 When the catheter is inserted into the body passageway of the mammal, the sleeve cavity contains Sufficient to allow the cushioned sleeve to conform to the configuration of the passageway. 22. The elongate catheter of claim 21, further comprising a sufficient amount of displaceable carrier material.

23 The catheter further includes a second lumen, an inflatable balloon, and a balloon cavity. the second lumen is in communication with the balloon cavity, and fluid is communicated from the second lumen to the balloon cavity. 22. The elongate catheter of claim 21, wherein the elongate catheter is capable of flowing in and inflating the inflatable balloon. -tel.

24. When the cushioned sleeve is in an aqueous environment, the disinfectant is applied to the sleeve. 22. The method according to claim 21, further comprising means for enabling diffusion from the cavity. A long thin catheter.

25. The means for enabling diffusion has a plurality of micropores in the elastic sleeve portion. 25. The elongate catheter of claim 24.

26. The elongated catheter of claim 25, wherein the disinfectant is an antibiotic.

27. Antibiotics such as nitrofurantoin, sulfamethoxazole, trimetop 27. The elongate catheter of claim 26 selected from the group consisting of rims and mixtures thereof. Tell.

28 The carrier material is petrolatum, polyvinyl alcohol lubricating gel, water-soluble soap and a water-soluble filler. Le.

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Claims (18)

[Claims] 1. An elongated catheter comprising an inner surface and an outer surface, the inner surface defines a lumen passing through the catheter, the catheter further comprising: having a cavity enclosed between said inner and outer surfaces surrounding a portion of said lumen; The cavity has an inner wall and an outer wall, and the outer wall is generally elastic and expandable independently of the inner wall. The cavity contains a carrier material containing a disinfectant, and the inner wall and an outer wall are intricately connected at the distal and proximal ends of the cavity, and the elastic sleeve is , allowing said disinfectant to diffuse out of said cavity when in an aqueous environment; , the contents of the sleeve cavity are subjected to moderate mechanical forces when not in an aqueous environment. If there is no pressure difference between the elastic sleeves, the above sterilization A thin strip comprising means for permitting diffusion that substantially confines the agent to the sleeve cavity. long catheter. 2. The means for enabling said diffusion comprises a plurality of micropores within said elastic sleeve. The elongated catheter of claim 1. 3. The catheter is placed in the bladder in communication with the urethra of the individual requiring catheterization. A "Foley" catheter with retention means for retaining the portion of the catheter within the bladder. 3. The elongate device of claim 2, wherein the indwelling means includes an inflatable balloon portion. catheter. 4. 3. The elongate catheter of claim 2, wherein the disinfectant is an antibiotic. 5. Antibiotics such as nitrofurantoin, sulfomethoxanthol, trimetop 5. The elongate catheter of claim 4 selected from the group consisting of rims and mixtures thereof. Le. 6. The carrier material may be petrolatum, polyvinyl alcohol lubricating gel, water-soluble soap or 5. The elongate catheter of claim 4, wherein the elongate catheter is selected from the group consisting of: and a water-soluble filler. 7. An elongated catheter consisting of a tube having an inner surface and an outer surface, the catheter comprising: The inner surface defines a first lumen, and the catheter further defines an outer surface of the tube. an overcoat layer including an elastic sleeve portion surrounding the surface; A layer is formed between the sleeve portion and the sleeve region of the sleeve portion on the outer surface. fixed to the outer surface at the distal and proximal ends of the sleeve cavity; An elongated catheter containing a carrier material containing a disinfectant. 8. While the elastic sleeve portion is in lubricating contact with the sleeve area on the outer surface, the former When the elastic sleeve portion is stretched independently of the latter, the carrier material Enables sliding along and against the sleeve area of the side surface It is a lubricating substance, and when the surfaces of each polymer are in lubricating contact with each other, , the lubricating substance allows each polymer surface to slide approximately equally against each other. 8. The elongated catheter of claim 7, wherein the elongated catheter is effective for 9. Lubricating substances include petrolatum, polyvinyl alcohol-containing water-soluble gels, and water-soluble 9. The elongated catheter of claim 8 selected from the group consisting of soap. 10. Fungicides include nitrofurantoin, sulfamethoxazole, and trimethopri. 10. The elongated catheter of claim 9, wherein the elongate catheter is selected from the group consisting of: . 11. A long and thin catheter to be inserted into the human body manufactured by the following process: - the following steps: i.e. (a) providing a tube having an inner surface and an outer surface, the inner surface being a first lumen; form; (b) generally prevents bonding to the first portion of the outer surface and to the first portion of the outer surface; an amount of lubricant effective to form a coating of lubricant on the first outer surface; coating the part and the lubricating substance is useful in reducing bacterial growth in an aqueous environment. (c) a second portion of the outer surface and a coating of a lubricating substance; an elastic polymer bonding composition, such that an elastic polymer overcoat layer is produced. an overcoat of the lubricant coating on the first portion of the outer surface; a first segment of the top layer cooperates with a first portion of the outer surface to form a sleeve cavity; A coating of lubricant is placed inside the sleeve cavity. the resilient sleeve is movable generally independently of the first portion of the outer surface; While the elastic sleeve is in lubricating contact with the first portion of the outer surface, the former is independent of the latter. When stretched, the lubricant causes the elastic sleeve to slide along the first portion of the outer surface. and (d) the elastic outer sleeve is a plurality of micropores that allow the disinfectant to diffuse out of the cavity when Made into an elastic outer sleeve; An elongated catheter manufactured by a process consisting of a process. 12. Furthermore, following step (b) and before step (c), a lubricating substance is added to the outer surface of the outer surface. Manufactured by a method that includes a process of peeling off from three parts, coating a third portion of the outer surface with the lubricating material in the step of coating the first portion; and the second and third portions of the outer surface are opposite each other on opposite sides of the first portion. and said overcoat layer made in step (c) is in the opposite direction of the sleeve cavity. on the facing surface and secured to the outer surface at the second and third portions of the outer surface; 14. The elongate catheter of claim 13. 13. The following steps: i.e. (a) providing a tube having an outer surface and a plurality of lumens including first and second lumens; and the tube has a first lumen access on the outer surface that communicates with the first lumen. having an opening; (b) an amount of lubricating substance generally effective to prevent it from bonding to the outer surface; coating a first portion of the outer surface of the catheter, when the catheter is located in an aqueous environment; An effective amount of disinfectant to prevent germicidal growth in the area of the outer surface of the lubricant is added to the lubricant. quality contains; (c) then stripping the lubricating material from the second portion of the outer surface; (d) then simultaneously coat the third portion of the outer surface and the first lumen with an anti-binding agent; closing the access opening, the first lumen access opening passing through the third portion of the outer surface; communicating with the first lumen; (e) then stripping the anti-bonding agent from the fourth portion of the outer surface; (f) The tube is then coated with a polymeric bonding composition and an elastic overcoat layer. is made and secured with its second and fourth portions to the outer surface of the tube and has a The first and third portions are not bonded and the overcoat layer is on the outer surface of the first portion. secured at a fifth portion of the outer surface adjacent to the second portion and opposite the second portion to the first portion; and (g) the compound is then placed so that the disinfectant can diffuse out of the cavity within the aqueous environment. creating a number of micropores in the elastic overcoat layer of a first portion of the outer surface; An improved sterile "Foley" catheter manufactured by a process consisting of steps. 14. The following process: i.e. (a) providing a tube having an outer surface and an inner surface, the inner surface being a first lumen; form; (b) Useful for creating coatings that are generally effective in preventing bonding to external surfaces. coating a first portion of the outer surface with an amount of an effective lubricant, said lubricant containing a disinfectant; (c) then coat the outer surface so that an elastic polymer overcoat layer is formed; coating the second portion and the coating of lubricant with an elastomeric polymer bonding composition; a first segment of an overcoat layer of a coating of lubricant material on a first portion of the outer surface; an elastic member that cooperates with an outer surface of the elastic sleeve to form a sleeve cavity; a sleeve with a coating of lubricant contained within the sleeve cavity; and Beauty (d) a disinfectant in which the environment surrounding the elastic sleeve has a lower concentration than the disinfectant in the lubricating substance; If the aqueous environment has a concentration of A long and thin sterilization catheter consists of creating multiple micropores in an elastic sleeve; manufacturing method. 15. Further, following step (b) and before step (c), a lubricating substance is added to the third layer of the outer surface. coating the first part includes removing a third part from the outer surface. coating the portion with said lubricating substance, the elastomeric polyester made in step (c) a mer overcoat layer positioned on the outer surface adjacent an opposite side of the first portion; 15. The method of claim 14, wherein the second and third portions of the outer surface are fixed at both the second and third portions. 16. Furthermore, following the step of stripping the lubricating substance from the third portion of the outer surface, a step of (c), including coating a fourth portion of the outer surface with an anti-bonding agent; a first lumen access opening in the fourth portion and a second lumen; (c) the elastic polymer overcoat layer made of the fourth portion of the outer surface; an elastic balloon, the balloon cooperating with a fourth portion of the outer surface of the first tube; forming a balloon cavity in communication with the first lumen through the lumen access opening; 16. The method according to claim 15. 17. Further, following the step of coating a fourth portion of the outer surface with said anti-binding agent, before step (c), stripping the anti-bonding agent from the fifth portion of the outer surface; said step of coating the first portion comprises coating a fifth portion; and said step of stripping the lubricating material from the portions strips the lubricating material from the fourth and fifth portions; the overcoat layers facing each other on opposite sides of the balloon cavity; fixed to the outer surface at the third and fifth portions of the outer surface; 17. The method according to claim 16. 18. Said step of coating a fourth portion of the outer surface with an anti-bonding agent simultaneously coats the fourth portion of the outer surface. The fourth portion of the outer surface in an amount of anti-bonding agent effective to prevent bonding to the fourth portion of the surface. 4 portions and close the first lumen access opening, and a polymer binding composition. closing the first lumen access opening with a 17. The method according to claim 16.