ES2694758T3 - Catheter device - Google Patents

Abstract

Kit for preparing a catheter for draining a body cavity, the kit comprising at least two sections of catheter (35) defining a passage inside them, the sections being adapted for their disposition in a first mutual configuration, in which the steps are joined in one step and the sections together form a catheter of a length greater than the length of each individual section, and a second mutual configuration in which the kit is shorter than when the sections are arranged in the first mutual configuration , characterized in that at least one structural transition between the at least two catheter sections is presented in the form of a folding zone (36) between two adjacent sections of the catheter.

Description

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DESCRIPTION

Catheter device

Field of the invention

The present invention relates to an elongated tubular catheter element for draining bodily fluids, for example, from the bladder.

BACKGROUND OF THE INVENTION

Catheters for bladder drainage are increasingly used for intermittent catheterization, as well as for continuous or permanent catheterization. Normally, catheters are used by patients suffering from urinary incontinence or by disabled people such as paraplegics or quadriplegics, who can not control a voluntary voiding and for whom catheterization may be the way to urinate.

Therefore, catheterization is becoming an everyday procedure that significantly improves the quality of life of a large number of patients.

Normally, the catheters are designed for a single use and, therefore, the costs for manufacturing, packaging and sterilizing a catheter pose a great problem. Current catheters are made in a single piece of a continuous catheter tube. Normally, the thickness of the catheter tube is constant over its entire length.

The length of the catheter allows the insertion of a certain piece into the urethra until the urine begins to flow. At that point, a certain excess length of the catheter must be available. The extra length helps the user to firmly hold the catheter and to pass the urine to an elimination zone and safely remove the catheter without any risk of the catheter disappearing into the urethra.

Current catheters are designed to minimize the risk of mucous membrane injuries and to generate substantially no pain sensation during introduction. Accordingly, known catheters are usually provided with a smooth, slippery surface optimized for safe and comfortable insertion into the urethra. Therefore, it can often be difficult, especially for a disabled user, to manage the catheter by handling the excess slippery length.

It is important that the tubular element does not fold or twist, thereby blocking the passage of urine draining through the catheter. Thus, current catheters are normally manufactured in the form of a tube with stable and relatively hard form, although they can be bent, made, for example, of PVC, PU or PE. Since the hardness of the tubes is selected to be relatively high to avoid kinking, it is possible for the catheters to become deformed if they are bent with too small a radius of curvature.

Accordingly, current catheters not only have a considerable length, but are also normally packaged in an elongated state. Therefore, current catheters can be difficult to handle and carry with them, especially for people for whom catheterization is an everyday procedure, in which the catheterization takes place several times a day and in which the catheters used should be discarded. the garbage, which is subsequently collected. GB2278285 discloses a catheter of the prior art.

Description of the invention

It is an object of the present invention to overcome the above-described disadvantages of known catheters by providing a kit for preparing a catheter for draining a human bladder, as described in more detail in claim 1, the kit comprising at least two catheter sections that define a passage within them, the sections adapted to be placed in such mutual configuration that the steps be joined in one step and the sections together constitute a catheter with a length greater than the length of each individual section, and having such stiffness that the entire catheter can be manipulated by manipulating at least one of the individual sections. It is another object of the invention to provide an improved method for manufacturing a urinary catheter.

Accordingly, a catheter is provided that can be bent, folded, flexed, separated or otherwise adapted for at least one configuration in which the catheter can be inserted into the urethra or into an artificial urinary channel and for a configuration in which the length of the catheter is reduced. By way of example, the length can be reduced to a length in the range of one half, one third, one quarter or even one fifth of the required normal length, including the excess length required for handling the catheter.

The catheter section may be provided in the form of oblong tubular hollow sections, in which the passage is defined within the sections or the sections may comprise a solid oblong core with one or more blades extending radially from the core and along the all its length. Thus, the vanes define a plurality of drainage passages for draining urine between the core and the bodily drainage passage, i.e., the urethra. The advantage of using a defined passage between a solid core and a wall of the urethra is that the flow of fluid

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body cleanses the urethra and thereby reduces the risk of infection compared to a traditional catheter, in which body fluid drains into the catheter isolated from the body canal.

A stiffness of substantially the entire length of the catheter allows manipulation of the catheter as a uniform catheter tube. Therefore, the introduction of the proximal end of the catheter can be performed without touching the part of the catheter to be introduced into the urethra. Preferably, the catheter is provided with a bending moment defined as the resultant between the E-module and a moment of inertia of at least 1 MPamm4 Since the proximal (inserted) end of the catheter, for men, must pass the prostate in a curved passage, the proximal end portion of the catheter, for example, the first 10-50 mm, such as the range of 20-40mm, such as the range of 25-35mm, such as the first 30mm of the catheter, can be provided with an even lower bending moment defined as the resultant between the module E and a moment of inertia less than, for example, 0.6 MPaMM4 or even less than 0.3 MPamm4. Other parts of the catheter, for example, a distal end portion in which urine drains into the toilet, a bag or similar elimination site, can also be provided with a reduced bending moment.

The cross-sectional flow area or the hydraulic radius defined as the ratio of the cross-sectional flow area to the wet perimeter can be selected independently as a function of length, for example, depending on the size of the urethra, whose size depends on the person who uses the catheter. Each of the sections may have the same cross-sectional or radial radio flow area or each section may have cross-sectional flow areas or individual hydraulic radii. However, at least a part of a section must have a cross-sectional shape and size adapted to the size of the urethra or of an artificial urinary channel. Similarly, a section should preferably have a length selected as a function of the length of the urethra or urinary canal. Therefore, it can be achieved that only one section is introduced and, therefore, it is not necessary to introduce any transition between sections. However, especially for men in whom the urethra is particularly long, a catheter having an inserted length divided into two or more sections can be provided. In this specific case, it will be suitable to provide a transition between the sections that, at least on the outer surface of the catheter, substantially does not present any recess or sharp edge.

Preferably, at least one of the catheter sections is provided with a length in the range of 50-90 mm, such as in the range of 55-85 mm, such as in the range of 60-80 mm, such as with a length of the size of 70 mm, length which is considered an insertable length suitable for most women. For men, the catheter sections can preferably be provided with a length in the range of 180-250 mm, such as in the range of 190-240 mm, such as in the range of 200-230 mm, such as with a size of 220 mm. For men, it may also be preferred to provide at least a portion of the inserted end of the catheter in a material or in such dimensions that the tube becomes very flexible, without twisting. This will facilitate the passage of the catheter beyond the prostate.

Preferably, the outer cross-sectional shape of at least one of the sections should be substantially circular with a cross-sectional area in the range of 0.5 mm2 to 30 mm2.

Even more preferably, at least one of the sections is provided with a hydraulic radius ("cross-sectional area" / "circumferential length") with a size of 0.2-1.5 mm.Alternatively, at least one of the Sections must have a cross-sectional shape that suits the shape of the urethra or of an artificial urinary channel, still with a cross-sectional area in the range of 0.5 mm2 to 30 mm2 or with a hydraulic radius with a size 0.2-1.5 mm However, the other section does not necessarily have the same cross-sectional shape or the same hydraulic radius, the wall thickness of the catheter should preferably be in the range of 0 , 5 and 1.5 mm.

The catheter or at least part of the catheter can be manufactured from a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture thereof, ie, the group can comprise materials such as PVC, PU, PE, latex and / or Kraton®.

According to a preferred embodiment, the present invention relates to a urinary catheter divided into completely separate catheter sections. Each catheter section has at least one end provided with means for connecting the section with another section corresponding to an adjacent part of the catheter. By way of example, the catheter can be divided into two tubular connectable pieces connected by connection means.

Preferably, the connecting means are provided with a stiffness that allows manipulation of at least one of the catheter sections by manipulation of one of the other catheter sections. At least the connection between each of the pieces must provide sufficient rigidity to allow introducing a proximal section in the urethra by manipulating one of the other sections. Therefore, the connection is preferably provided so that at least the part of the catheter extending the connection zone has a bending moment defined as the resultant between the module E and a moment of inertia of at least 0.6 MPa.m.m., such as at least 1 MPamm4. In order for the individual sections not to separate during use, the connection must preferably be adapted to support an axial force of at least 0.5 Newton or at least to support an axial force greater than the axial force required to remove the catheter from the urethra or of an artificial urinary channel.

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The pieces can be connected, for example, telescopically or through a joint that allows one of the two sections to rotate with respect to another of the two sections. It should be appreciated that the sections are firmly coupled so that they do not separate during the use of the catheter, while urine is drained through the catheter. However, since urine is always drained in one direction, the connection does not necessarily have to be fluid-tight. By way of example, a telescopic connection can be established by introducing the section adapted for introduction into the urethra within a distal section. The flow direction of the urine will at least substantially prevent the connection from leaking even though the connection as such is not completely liquid tight. However, a completely sealed connection can provide an even safer catheter with a lower risk of contaminating hands, etc.

In an embodiment in which the two catheter sections are disposed telescopically, a first of the catheter sections may be provided for insertion into the human urethra, while a second of the catheter sections is normally provided to form an extension of the catheter outside the human urethra during the use of the catheter. During use, that is, in the first mutual configuration of the two catheter sections, the second catheter section preferably extends simultaneously to the first catheter section away from a distal end of the first catheter section. In the second mutual configuration, which is usually the configuration in which the telescopic kit is stored and transported, at least a part of the first catheter section may be surrounded by the second catheter section. In the second mutual configuration a tubular protective element can be provided between an outer surface of the first catheter section and an inner wall of the second catheter section. The dimensions of the tubular protective element and the catheter sections can be such that, in the second mutual configuration, a substantially annular and longitudinally extending cavity is formed between an outer surface of the first catheter section and an inner wall. of the second catheter section. The first catheter section may have a hydrophilic surface and a liquid swelling medium may be provided in the annular cavity to inflate the hydrophilic surface of the first catheter section, whereby the first catheter section which is encapsulated in the sealed annular cavity hermetically it can be preserved in its swollen and moist state for a period of 1-5 years, such as 3-5 years or more. A hermetic seal of the annular cavity is desirable for all types of catheter surfaces, including hydrophilic and hydrophobic catheter surfaces, in order to prevent contamination from entering the cavity. Therefore, in the second mutual configuration, the telescopic joint can serve to define a liquid tight seal and contamination between the second catheter section and an ambient atmosphere.

A distal end of the second catheter section is preferably provided with a watertight seal that can be leak tight to both liquids and contamination and that can be removed, so that when a distal end of the second catheter section is inserted, for example, in a urine collection bag, a passage for urine is formed in the location from which the seal has been removed. The tubular protective element can preferably be removed when the first and second catheter sections are in the first mutual position, so that when the tubular protective element is removed, the proximal end portion of the first catheter section is exposed and ready to be inserted. in the human urethra. The distal end of the second catheter section can be provided, as an alterative, in one piece with a collection bag. By way of example, the second catheter section may be provided with a plastic weld bead for bonding a plastic collection bag to the second catheter section with adhesive.

The catheter comprises at least two sections not separated, but divided by a zone that can be bent. The area that can be bent could be, for example, a section in the form of a bellows or the area could be an area in which the thickness of the tubular material is smaller and in which, consequently, the area has a lower moment of flexion. For example, the area could be provided in a more elastic or flexible material, allowing the catheter tube to be bent without twisting or damaging the tube.

In general, the problems that occur when introducing a catheter into the urethra depend not only on the size of the inserted part of the catheter, but also on the sliding of the inserted part. The catheter section or at least a portion of the catheter section or sections adapted to be inserted into the urethra or into an artificial urinary channel can provide surface slippage for simple and safe insertion. However, it has been observed that lubricated or slippery surfaces are difficult to handle, especially for a user with less dexterity. Therefore, it is an object of the present invention to provide a catheter with an inserted part treated to provide a slippery surface and with another untreated part to provide a surface that can be easily manipulated. The division of the catheter into a treated part and an untreated part may preferably follow the aforementioned division of the catheter in order to cause the catheter to fold or separate. According to an alternative embodiment, the parts can be provided in the form of a smooth part and another part provided with a rough surface.

According to a preferred embodiment, at least one of the sections is provided with gripping means that facilitate a firm grip of the catheter. The grasping means will greatly improve the usefulness of the catheter, especially for disabled users. The gripping means may be provided as a flange or several flanges extending radially or as an area having a large diameter of outer cross section. The catheter, or at least one of the catheter sections, may also be provided with means for coupling an external handle. By way of example, one of the tubular catheter tubes may be provided with a ring-shaped projection

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to fix a handle. The ring-shaped projection can be provided as a short tubular piece of plastic with a larger radial size than the catheter, the catheter being inserted and attached to the short piece of plastic.

A section provided with a hydrophilic surface treated with a liquid swelling medium can provide excellent lubrication for introduction and also provide compatibility with the body tissue. Therefore, a further preferred embodiment of the invention consists in providing at least one of the sections with a hydrophilic surface layer.

One of the catheter sections can be used as a sterile package for the other sections, for example, by arranging the sections in a telescopic fashion within a section, closing and sealing that section at both ends, for example, by a peelable sheet and optionally metalized material made, for example, from a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers and any mixture thereof, ie, the group may comprise materials such as PVC, PU, PE, latex and / or Katron®, thereby allowing sterilization of the whole by radiation.

The liquid swelling medium for the hydrophilic surface can be provided in the package to already initiate the low friction characteristic when the catheter is being packaged. The liquid dilation medium can simply be a saline solution, a bactericidal solution which can swell the hydrophilic surface and which can maintain the surface in a sterile state or can be pure water. The inflation can also be initiated before the catheter is packaged, the catheter being then packaged in a container substantially impervious to gas for the preservation of the moistened surface. In addition, the liquid inflation medium can be provided in a capsule or container packaged together with the catheter to inflate the hydrophilic material immediately prior to introduction.

According to a second aspect, the present invention relates to a flexible urinary catheter for draining a human bladder, comprising:

- a flexible elongated tube with an internal cross-sectional shape and a size defining a first duct for draining urine, said tube having an introduction end and a discharge end, and

- a support element that is inserted into the first conduit and having an outer cross-sectional shape and a radial size substantially identical to the internal cross-sectional shape and to the size of the elongated tube to support said tube against deformation when it is bent the tube, the support element having a flexibility that allows its rolling.

The flexible elongated tube may have the shape of a regular catheter of the known type. Preferably, the tube or at least one part of the tube is made of a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture thereof, ie, the group may comprise materials such as PVC, PU, PE, latex and / or Katron®.

The support element supports the catheter to prevent the catheter from being deformed when bent, for example, in order to pack the catheter into small, easy-to-handle packages. The support element can be solid or the support element can be hollow and therefore define a second conduit. The solid support element must be adapted to be removed before draining the bladder, while a hollow support element may remain inside the tube while the bladder is emptied through the first and second conduits.

The support element can, for example, stick inside the elongated tube or the support element can even be molded into the tube during the tube manufacturing process. The support element can even be completely integrated into the elongated tube.

The support element can be made of any suitable material such as, for example, plastic, steel, aluminum, a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture thereof. By way of example, the support element may be a helical spring with a length in the range of 20-60 mm, such as in the range of 30-50 mm, such as in the range of 35-45 mm. The spring should be placed within the elongated tube in the region where it is desired to bend the catheter, for example, midway along the longitudinal axis of the elongated tube. During use, the urine is drained through the first conduit of the elongated tube and beyond the support member through the second conduit.

According to a preferred embodiment, the support element is provided with a length in the range of 60-120 mm, such as in the range of 70-110 mm, such as in the range of 80-100 mm, and the support element it can even extend outside the discharge end of the elongated tube. This will allow the user to remove the support element during the process of introducing the catheter into the urethra.

According to another preferred embodiment, the support element is provided with gripping means to facilitate the removal of the support element from the discharge end during the introduction of the catheter.

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In a third aspect, a kit for preparing a catheter for the drainage of a human bladder is provided, the kit comprising at least two catheter sections defining a passage therein, extending longitudinally therein, being The sections are arranged in a manner in which they extend simultaneously to a tubular protective element surrounding a first proximal section of said catheter sections, the kit further comprising a joint for connecting the first and second catheter sections together, defining the seal a liquid tight seal at a proximal end of a substantially annular and longitudinally extending cavity provided between the proximal end portion of the first catheter section and an inner wall of the tubular protective element, the tubular protective element being connected to the seal and / or to the second catheter section in a removable manner so that when the element is removed Tubular shield, the proximal end portion of the first catheter section is exposed and prepared to be inserted into the human urethra. The passage can be defined either within the hollow tubular catheter sections or between a solid core and the wall of the urethra or similar body canal.

The foregoing with respect to the first aspect of the invention features of embodiments in which the first and second catheter sections are disposed telescopically, also applies to the kit of the third aspect of the invention. Thus, embodiments of the kit according to the third aspect of the invention can be considered modifications of telescopic embodiments of the kit according to the first aspect of the invention, the modification comprising that a longitudinal movement of the two sections of catheter to each other is not normally carried out and that normally a single mutual configuration is established. In addition, all the elements and features discussed above with respect to the first aspect of the invention can be provided in the kit according to the third aspect of the invention, insofar as such features and elements are suitable in the catheter according to the third aspect of the invention.

In particular, the catheter according to the third aspect can be provided so that the sections are adapted to move with each other between at least two positions. Being a position in which the second section surrounds the first section and the other position being that in which the second section forms an extension for the first section.

Preferably, the joint between the first section and the second section is a telescopic joint that provides a liquid tight seal between the sections when they move between the first and the second position. As an example, the first section may be provided with a piston seal adapted to slide along the inner surface of the second section when the first section leaves the second section between the first and second positions.

In order for the user to be able to insert the first section in a body line, it should be appreciated that a locking arrangement of the first and / or second catheter section will be available to lock the position of the first section with respect to the second section when the sections are in the second position, that is, when the catheter is in a configuration prepared for introduction into the body pathway.

In order to allow the user to remove the first catheter section out of the second catheter section without touching the insertable part of the catheter, the tubular protective element can preferably be provided to engage the first catheter section in a locking coupling. Thus, the tubular protective element can be used to draw the first catheter section out of the second catheter section.

When the first catheter section has been pulled out of the first catheter section, that is, when the sections are in the second position, that is, in the position in which the second catheter section forms an extension for the first section of catheter, the tubular protective element must be able to be separated from the first catheter section. When the tubular protective element has been removed, the catheter will be in a "ready to be inserted" state.

In order to use the second catheter section as a sealing package or wrapping for the first catheter section, ie, for the insertable catheter section, the distal end of the first catheter section may be preferably adapted to seal a catheter. opening at a distal end of the second catheter section when the sections are in the first position and adapted not to seal the opening when the sections are in the second position. When the sections are brought to the second position, ie, when the catheter is "ready to be inserted", the opening of the distal end of the second section can be used to drain body fluids, eg, urine, out of the catheter.

In order to allow the annular cavity to be used, for example, to contain a substance that reduces friction, for example, an aqueous or saline solution for a hydrophilic catheter, a hydrogel or a similar lubricating substance, the kit can be provided preferably of a sealing coupling between the tubular protective element and the first catheter section when the tubular protective element is coupled to the first catheter section. When the tubular protective element is separated from the first catheter section, ie, after the catheter has reached its "ready-to-go" state, the annular cavity is open to the ambient atmosphere thereby exposing the insertable tip of the catheter. First section of catheter and allowing the user to drain excess substances that reduce friction.

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According to a preferred embodiment, the first catheter section is provided with a hydrophilic surface and the substance that reduces friction in the annular cavity is a liquid dilating means, for example, water or a saline solution.

In a fourth aspect, there is disclosed a method for producing a urinary catheter comprising a proximal introduction section defining an interior elongate passage for urine and at least one opening adjacent a proximal end of the proximal introduction section to allow passage from the urine of the human bladder to the internal elongated passage, the method comprising the steps of:

- providing a mold, which defines the shape of at least the proximal introduction section,

- forming the proximal introduction section by injection molding,

- Remove the proximal introduction section of the mold.

Although longitudinally extending catheters made of plastic materials have been manufactured to date by a relatively expensive process that involves extruding the body of the catheter, forming a rounded tip thereof by heat treatment, cutting transversely extending passages for urine together To the tip of the catheter by means of a cutting tool and rounding the edges of the transversely extending passages by heat treatment, the method according to the fourth aspect of the invention has the advantage that it allows obtaining a more efficient and controllable manufacturing process of more accurate way with less material expenditure and less production stages.

The catheter may further comprise a connection portion for connecting the proximal insertion section to an additional catheter section or to a urine collection bag. The connection part can be made of the same material as the proximal introduction section whereby, in the step of forming the proximal introduction section, the proximal introduction section and the connection part can be formed substantially simultaneously. Alternatively, the connection part can be made of a material different from the material of the proximal introduction section, whereby the connection part and the proximal introduction section are formed in different process steps, for example, in a process of Multi-component injection molding.

BRIEF DESCRIPTION OF THE DRAWINGS

Next, preferred embodiments of the invention will be described in detail with reference to the drawings, in which:

Figure 1 shows a catheter kit according to the present invention,

Figure 2 shows the catheter kit of Figure 1, mounted in a configuration for use,

Figure 3 shows an embodiment of "Swiss Army knife" of a catheter kit according to the present invention,

Figure 4 shows the catheter kit of figure 3 deployed and arranged in a usage configuration,

Figure 5 shows a folded catheter provided with a reinforcement sleeve,

Figure 6 shows the catheter kit of figure 5 deployed and in a usage configuration,

Figure 7 shows an embodiment of the kit, in which a catheter part is inserted for storage in another of the catheter parts, thus replacing a catheter package,

Figure 8 shows the embodiment of Figure 7, in which the inserted catheter part is partially removed from one end of the package,

Figure 9 shows the embodiment of Figures 7 and 8, in which the inserted catheter part is completely removed from the container and then fixed to the other end of the container, the container therefore functioning as a handle for handling the catheter,

Figure 10 shows a folded telescopic catheter kit,

Figure 11 shows the catheter kit of Figure 10 in an extended configuration,

Figure 12 shows the catheter kit of figure 10 unfolded and after removal of the combined closure and withdrawal cap,

Figure 13 shows a preferred embodiment of a combined closing and removal plug for the kit shown in Figures 11 and 12,

Figure 14 shows another additional preferred embodiment of a combined closing and removal plug for the kit shown in Figures 11 and 12,

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Figures 15-18 show an embodiment of a kit according to the invention, in which the catheter sections are arranged telescopically,

Figures 19-22 show another embodiment, in which the catheter sections are arranged telescopically,

Figure 23 shows a kit in which a distal part of the catheter is wound on the inserted part of the catheter to protect the inserted part of the catheter,

Figure 24 shows a catheter that can be bent with a support element,

Figure 25 shows a catheter part provided with holding means to facilitate the manipulation of the catheter,

Figure 26 shows a preferred cross-sectional shape of a catheter part adapted for insertion into the urethra,

Figure 27 shows a catheter made by the method described, and

Figures 28, 29 and 30 show an embodiment of a catheter section in which the passage is defined between a solid core and the wall of a body channel such as the urethra.

Detailed description of the drawings

With reference to Figure 1, a catheter kit according to the present invention comprises a first section of elongate tubular catheter 1 adapted for introduction into the urethra or into an artificial urinary channel and a second elongated tubular catheter section 2 adapted for the manipulation of the catheter. At the proximal end 3, the tubular catheter section is provided with holes 4 that allow urine to drain into the tubular element. To protect the mucous membrane, the holes may preferably be arranged on the side of the tubular element. Alternatively, a tubular element may be provided with a hole in the tip. It is important that the edge of the hole be rounded smoothly or that the material, at least of this part of the tubular element, be selected so as not to cut or damage the urethra, ie, for example, a soft elastic rubber material.

At the distal end 5, the tubular element is provided with connection means 6 for connecting the catheter section to corresponding connecting means 7 of the second tubular catheter section. Preferably, the first and second sections are made of a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture thereof, ie, the group may comprise materials such as PVC, PU, PE , Latex, Kraton®, PTFE (Teflon), FEP, Siloxane (silicone rubber) and / or fEp.

Figure 2 shows a view of the mounted catheter. The second catheter section is adapted to elongate the first catheter section so that the first and second sections together form a rigid catheter that is of sufficient length to allow catheterization. The stiffness of the first section should be sufficient to allow the introduction of the section into the urethra without deforming the section. As shown in Figure 1, the second section and the connection 6, 7 between the second section and the first section have some rigidity that allows the introduction of the first section by manipulation of the second section. As can be seen in FIGS. 1 and 2, the catheter can preferably have holding means 8 to facilitate firm attachment and manipulation of the catheter. In the embodiments of Figures 1 and 2, the kit can preferably be packaged in a sterile package.

As indicated in Figure 2, the kit may comprise a handle section and several catheter sections adapted for insertion or the kit may alternatively be packaged in two containers, one containing a multipurpose handle and another container which can be sterilized separately containing one or more sections adapted for its introduction and for a single use. The sections may be packaged, for example, in a manner similar to cartridges in a revolver or in a belt of cartridges, i.e., connected together to form a long row or tube of sections.

Figure 3 shows an embodiment of "Swiss army knife" of the catheter kit. The first catheter section 10 is folded into a sheath 11 in the second catheter section 12. The first catheter sections are rotatably hinged with respect to the second catheter section in the joint connection 13.

Figure 4 shows the embodiment of "Swiss army knife" deployed. For example, the sleeve 11 could be covered with a thin latex sheet, in order to seal the second section of the catheter. When the catheter is folded, the first catheter section will simply fold the latex sheet radially inwardly into the second catheter section. As the catheter is deployed, the elasticity and a slight pre-tension of the sheet will move the sheet out of the groove and thereby allow the free passage of urine to carry out drainage through the second section of the catheter. catheter. The latex sheet is not shown in Figures 3 and 4.

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Figure 5 shows an embodiment of the invention in which a catheter is simply bent, the catheter being divided into a first catheter section 14 and a second catheter section 15 by a folded portion of catheter 16. The catheter is provided with a catheter. a reinforcing sleeve 17. The connector 18 allows the connection of the catheter, for example, to a bag for collecting urine.

Figure 6 shows the deployed catheter of Figure 5. The sleeve 17 has in this case moved along the catheter to support the catheter around the folded portion 16 of the catheter.

Figure 7 shows an embodiment of the catheter kit according to the present invention, in which the first catheter section, not shown in figure 7, is sterile packaged inside the second catheter section 21, sealing the second catheter section at both ends with plugs or sealing foils 22, 23.

Preferably, the first section is coated with a hydrophobic coating, which provides a low friction surface of the first catheter section when treated with a liquid swelling medium. The coating could be of the type that allows its activation with the liquid swelling medium for a longer time, for example, for several months. In this way the liquid swelling medium could be disposed in the catheter package from the time of packaging to obtain a ready-to-use catheter. Hydrophilic coatings are known per se, see, for example, published patent applications WO 98/58988, WO 98/58989, WO 98/58990 or EP 0570370. For this purpose, sealing plugs or sheets should preferably be provided in a gas-impermeable material for the preservation of moisture and, therefore, the lubricating capacity of the catheter, for a longer time, for example, for several months. By way of example, the second catheter section and / or the sealing plugs may be made of a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture thereof, ie the group it may comprise materials such as PVC, PU, PE, latex and / or Kraton®. The plugs may be provided with a thickness that allows sufficient gas impermeability. Alternatively, they can be made of metallized sheets.

As can be seen in Figure 8, the first catheter section can be easily removed from the second catheter section by pulling on the cap 23, the cap or sheet being coupled to the distal end of the first catheter section.

Figure 9 shows the catheter mounted after the first catheter section has been fixed to the second catheter section. The sheet or plug 23 can be completely removed, as shown in Figure 9, or it can be traversed by the connecting means 24 of the second catheter section.

Figure 10 shows an embodiment of the catheter kit, in which the first and second catheter sections are telescopically connected. The first catheter section is sterile packaged within the second catheter section 26. The second catheter section is sealed by a first seal 27 and a second seal 28. Prior to use, it is removed the first sealing closure. If the first catheter section is provided with a hydrophilic surface layer, and if the catheter section is packaged with a liquid swelling medium, the liquid medium can be evacuated through the passageway opened by the first seal. As can be seen more clearly in Figure 11, the second seal is coupled to the first catheter section 30 for easy removal of the first catheter section. When the first catheter section has been completely removed, the distal portion of the first catheter section is attached to the proximal end of the second catheter section in the connection zone 31 and the second seal is easily separated from the first section. of catheter. In this way, the catheter is in a usage configuration.

Figure 13 shows a preferred embodiment of the second sealing closure 28, wherein the closure is provided with internal projections extending radially inwardly 33 adapted to engage the hole 32 shown in Figure 12.

Figure 14 shows another embodiment of the second seal 28, in which flexible grasping ridges 34 gently grip the proximal (inserted) end of the first catheter section for easy removal of the first catheter section from the second section of catheter with the removal of the second seal.

The telescopic embodiment of the catheter kit, described in Figures 10-14, should preferably be configured so that the internal diameter of the second catheter section is slightly larger than the outer diameter of the first catheter section. This is advantageous, for example, in cases where the first catheter section is coated with a hydrophilic surface coating and so as not to damage the coating with the sliding of the first catheter section outside the second catheter section. On the other hand, an important aspect is to provide a connection zone in which the first catheter section and the second catheter section are firmly coupled. In this way, the introduction and orientation of the first section are possible simply by manipulating the second section and without the sections slipping on each other in the telescopic connection. In addition, it is important to ensure that the first catheter section does not slip out of the second section, in which case the first catheter section may disappear inside the urethra. For this purpose, the distal end (opposite the inserted end) of the first catheter section may be provided with a rim that extends radially outward and which makes it impossible to slide the first catheter section out of the second catheter section. .

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Figures 15-18 show a second embodiment of a catheter kit in which the first and second sections 42, 44 are connected to each other telescopically. A tubular protective element 46 surrounds a portion of the first catheter section 42 and forms a substantially annular cavity 48 around the first catheter section. In the second mutual configuration, shown in Figure 16, in which the kit is arranged for storage and transport, the first catheter section 42 and the tubular protective element 46 are introduced as far as possible into the second catheter section. 44. A hydrophilic swelling medium, such as water, can be provided in the cavity 48, so that a hydrophilic surface coating optionally disposed on the surface of the first catheter section 48 is stored in its swollen state, i.e. wet state. A surplus of hydrophilic swelling media may be present in the cavity 48 to prevent the hydrophilic surface coating from drying out. A liquid tight seal 50 is disposed at the distal end of the first catheter section 42. A liquid tight seal member 52 closes the distal end of the second catheter section 44. In one embodiment, the closure element 52 can withdrawing so that a passage is formed between the second catheter section 44 and a urine collection bag or other device for accumulating or transporting urine, which is mounted at the distal end of the catheter section 44 when the closure element 52 it is removed. In another embodiment, the closure element 52 is an integrated part of the second catheter section 44, in which case a wall 53 of the closure element 52 can be punctured to form a passageway between the second catheter section 44 and a surgical bag. collection of urine or other device for accumulating or transporting urine, which is mounted at the distal end of the catheter section 44. In yet another embodiment, the closure element 52 can be replaced by a perforated end wall, eg, a wall made from a central plate connected to the outer wall of the second catheter section 44 at its distal end by ribs or radially extending spokes. In such an embodiment, the first catheter section 42 and the seal 50 may be formed as a single integrated part.

As shown in Figure 16, an outer wall of the second catheter section 44 forms a handle, the tubular protective member 46 being disposed so that it extends out of the handle at its proximal end. The tubular protective element 46 can form a rim at its proximal end, in order to facilitate the removal by a user of the first catheter section 42 and the tubular protective element 46 of the handle / second catheter section 44. After its In this embodiment, the tubular protective element 46 and, therefore, the first catheter section 42 surrounded therein, extend simultaneously with the handle or second catheter section 44, as shown in FIG. The distal end of the tubular protective element 46 releasably attaches the tubular protective element 46 to the seal 50, as shown in Figures 15, 17 and 18. The seal 50 may be designed to be attached to the proximal end portion of the seal. second catheter section 44 by a snap-fit action once the seal 50 and the tubular protective element 46 have reached the fully extracted position shown in Figure 17. In In the example shown in Figure 15, the seal 50 has a groove 51 which, in the extracted position shown in Figures 17 and 18, engages a flange 45 at the proximal end of the second catheter section 44. Immediately prior to Using the catheter, the tubular protective element 46 is removed, so that the first catheter section 42 is exposed, as shown in Figure 18.

Figures 19-22 show another embodiment of a catheter kit in which the catheter sections are disposed telescopically. As shown in the exploded view of Figure 22, the kit comprises the following parts: a first catheter section 62, a second catheter section 64 with one or more interior flange portions 65, a guide element 66 with protrusions 67, a gasket 69 with a ring portion 70 and grooves 71 for the guide element 66, as well as a distal closure element 72 and a proximal closure element 73. The kit is stored and transported in the configuration shown in the figure 19, in which the second catheter section surrounds the first catheter section 62 and the guide element 66. Before using the catheter, the distal closure element 72 is removed and the guide member 66 is removed, as shown in FIG. shown in figure 20. The guide element 66 is extracted as much as possible, that is, until the projections 67, thanks to their elasticity, are coupled to respective grooves (not shown) provided in the grooves 71 of the joint 69 , see figure 22. The board 69 it is fixed to prevent its sliding out of the second catheter section 64 by the inner flange portions 65 of the second catheter section 64. The proximal closure member 73 is also removed. Next, the guide element 66 is moved back into the second catheter section 64. As the guide element engages the seal that is firmly connected to the distal end of the first catheter section, the seal 69 and the first catheter section 62 is moved out of the distal end of the second catheter section 64 when the guide member 66 is moved into the second catheter section 62. When the ring portion 70 of the seal 69 engages to an inner ledge or projection disposed at the proximal end of the second catheter section 64, the kit is ready to use and the first catheter section 62 can be inserted into a person's urethra. A urine collection bag or other means for accumulating or transporting urine may be mounted at the proximal end of the second catheter section 64.

Figure 23 shows an embodiment of the catheter kit in which it is possible to turn over a second catheter section surrounding a first proximal catheter section, so that the second catheter section protects the first catheter section before its use. By incorporating sheets or closure plugs at both ends, the first catheter section can even be maintained under sterile conditions within the second section. Before use, the second catheter section is turned over by rolling or bundling, so that the catheter is disposed in use configuration.

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With reference to Figure 24, a catheter that can be bent is described. The catheter is provided, for example, as a flexible plastic hose 35, for example, made at least partially from a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture thereof , ie, the group may comprise materials such as PVC, PU, PE, latex, Kraton®, PTFE (Teflon), FEP, Siloxane (silicone rubber) and / or FEP. The catheter is provided with an area 36 that allows the catheter to bend. For example, the zone may be formed as a bellows-shaped part of the catheter. If the catheter is relatively long and if a fairly large part of the catheter should be introduced into the urethra, as is normally the case with male users, it may be advantageous to use a catheter having a bendable area that is so soft on the catheter. outside that can enter the urethra. For this purpose, the invention relates to a catheter having a support element inserted in at least the area that can be bent. The support element may be a part of an elongated helical spring provided with a conduit for draining the urine. The spring will easily form a support for the catheter, so that the catheter does not fold. The spring should have an outer diameter as close as possible to the inner diameter of the catheter hose. By way of example, the support element may be provided with a small piece of a spring, adhered to the interior of the catheter in the area adapted to be bent. In another example, the support element may be provided as a longer spring 37 extending outwardly through the opening of the catheter at the distal end (opposite the inserted end) of the catheter. In this way, the support element can be removed before the introduction of the catheter into the urethra or even simultaneously with the introduction of the catheter into the urethra. For this purpose, the support element can be provided with a handle 38.

Figure 25 shows a handle 40 to facilitate manipulation of the catheter. The handle can be very useful especially for disabled users of the catheter, for example, for people who have less dexterity.

Figure 26 shows a preferred cross-sectional shape of the part that can be introduced from the catheter. Because the introduced part has an oval cross-sectional shape, the bending moment around the x-axis (indicated in Figure 26) will be different from the bending moment about the y-axis. The relatively reduced bending moment around the y-axis will improve the ability of the catheter to bend in one direction and, thus, facilitate the introduction of the catheter as it passes through the prostate. The relatively high bending moment around the x-axis will improve the overall stiffness of the catheter, thereby facilitating the manipulation of the inserted part of the catheter from the non-introduced part of the catheter.

Figure 27 shows a catheter produced by the method according to the present invention, the catheter having a proximal catheter section 60, at least part of which is adapted for introduction into the human urethra. The catheter section 60 forms one or more transverse passages 62 through which the urine can flow once a proximal end of the catheter section 60 is inserted into the bladder. The section 60 is also provided with a rounded proximal tip 64 which ensures that the section can be introduced without damaging the urethra membrane. The catheter section 60 is formed in a single piece by injection molding. The connector portion 66 is formed integrally with the catheter section 60 during the same molding operation. The connector part 66 may be adapted for connecting the section to a handle section or to a urine bag.

Figure 28 shows a perspective view of an embodiment of the catheter or a catheter section comprising a solid core 281 with one or more vanes 282 extending radially from the core and along its entire length. Thus, the vanes define several drainage steps 283 for draining the urine between the core and a bodily drainage passage, for example, the urethra. The advantage of using a defined passage between a solid core and a wall of the urethra is that the flow of body fluid cleanses the urethra and, therefore, reduces the risk of infection.

Fig. 29 shows a side view of the catheter section shown in Fig. 28. Fig. 30 shows a top view of the catheter shown in Figs. 28 and 29. Fig. 30 shows the solid portion 281 connected to several paddles 282. Figs. pallets are again connected to a connector 302 through several spokes 301. Several openings 303 are formed between the solid catheter portion 281 and the connector 302. Except for the fact that the passage is defined between a solid core and the wall of the body channel and not inside a hollow tubular body, the catheter section of Figures 28-30 corresponds to the catheter section 42 of Figure 15. The openings 303 correspond to the perforations of the catheter section of Figure 15. The openings are arranged to allow drainage of a friction reducing substance out of the cavity 48 defined between the first and second catheter sections, as can be seen in Figure 15. The spokes 301 may be preferably formed according to aspects of fluid dynamics to allow drainage of the fluid as it passes through the spokes without causing turbulence and without spreading the fluid. Radii with a diamond cross-sectional shape disposed with the longer leg parallel to the direction of flow will withstand substantially uninterrupted flow as they pass through the spokes.

Claims (15)

5 10 fifteen twenty 25 30 35 40 Kit for preparing a catheter for draining a body cavity, the kit comprising at least two sections of catheter (35) defining a passage inside them, the sections being adapted for their disposition in a first mutual configuration, that the steps are joined in one step and the sections together form a catheter of a length greater than the length of each individual section, and a second mutual configuration in which the kit is shorter than when the sections are arranged in the first mutual configuration, characterized in that at least one structural transition between the at least two catheter sections is presented in the form of a folding zone (36) between two adjacent sections of the catheter. Kit according to claim 1, wherein the catheter is provided having a stiffness such that the catheter can be manipulated by manipulation of at least one of the catheter sections. Kit according to any one of the preceding claims, in which the area that can be bent is defined by a part of the tubular element that has a different bending moment than other parts of the tubular element. Kit according to any one of the preceding claims, in which the area that can be bent is defined by a bellows-shaped part of the tubular element. Kit according to any one of the preceding claims, wherein the area that can be bent is defined by an area in which the thickness of a wall of the tubular material of some, or both, of the at least two sections of catheter It is less. The kit of claim 5, wherein the bent area has a lower bending moment than either, or both, of the at least two catheter sections. Kit according to any one of the preceding claims, further comprising a displaceable reinforcing sleeve for supporting the foldable area of the catheter in the first configuration. 8. Kit according to claim 7, wherein the sleeve is arranged surrounding the tubular element. 9. Kit according to claim 7 or 8, wherein the sleeve is disposed within the tubular element. 10. Kit according to any of the preceding claims, wherein a support element is inserted in the area that can be bent. Kit according to claim 10, in which the support element is an elongated helical spring provided with a duct for draining the urine. The kit of claim 10, wherein the support member is provided as a spring, extending from the foldable area and through a catheter opening at a distal end of the catheter. Kit according to any one of the preceding claims, in which at least one structural transition allows the inside of a section to be turned over so as to allow the one section to wrap around the other section or sections. Kit according to any one of the preceding claims, wherein the catheter is provided as a soft and flexible plastic hose. Kit according to any one of the preceding claims, wherein the catheter can at least be made from one or more of the following materials: a thermoplastic elastomeric material, other thermoplastic materials, curable elastomeric materials, resins or polyamide elastomers or any mixture of these, ie, the group may comprise materials such as PVC, PU, PE, latex and / or Kraton®, PTFE (Teflon), FEP, Siloxane (silicone rubber) and / or FEP.