WO2004054653A1

WO2004054653A1 - Magnetic insertion catheter

Info

Publication number: WO2004054653A1
Application number: PCT/DK2003/000886
Authority: WO
Inventors: Henrik Lindenskov Nielsen
Original assignee: Coloplast A/S
Priority date: 2002-12-16
Filing date: 2003-12-16
Publication date: 2004-07-01
Also published as: AU2003287904A1

Abstract

The invention relates to a urinary catheter with a system for non-touch insertion of the catheter into a natural or artificial urinary canal of a male or female individual. The system comprises one or more magnets which are sued to insert the catheter The magnetic force is used to transfer force from an outer handle to an inner handle such that the user of the catheter does not touch the catheter. Accordingly the catheter is not exposed to bacteria etc. present on the fingers of the user.

Description

Magnetic insertion catheter

BACKGROUND OF THE INVENTION

1. Field of the Invention The present invention relates to a urinary catheter with a system for non-touch insertion of the catheter into a natural or artificial urinary canal of a male or female individual.

2. Description of the Related Art For urinary catheterisation it is important to minimize the risk of contamination of the catheter before introduction in the urinary tract in order to prevent urinary tract infections that can be very harmful and urgently needs medical treatment. It is also important to have an easy introduction method for the catheter to ease the daily life for the users. This is even more important as a large part of the users have reduced function of their hands as well as other body parts.

An easy and contaminating risk reducing insertion of the catheter is provided by the present invention of a device for urinary catheterization with a magnetic transmitted insertion system.

SUMMARY OF THE INVENTION

The present invention relates to a device for urinary catheterisation, featuring a magnetic insertion system for avoiding exposure of the catheter to hands/fingers or the environment prior to insertion in a urinary canal, hence reducing the risk of contamination of the catheter and consequently reducing the risk of urinary tract infections for the catheter user.

Brief Description of the Drawings

The invention is disclosed more in detail with reference to the drawings in which Fig. 1 shows an embodiment of a catheterisation device of the invention prior to use. Fig. 2 shows the same embodiment of a catheterisation device of the invention, with the catheter element displaced relative to the tube as it would be during use. Fig. 3 shows an example of an outer handle (11) with embedded permanent magnets (12). Fig. 4 shows a principle sketch of an example of an outer handle with an electro magnet, comprising magnetically soft iron (13), with windings (14) of a wire (15) connected to a battery (16). The outer handle shown in this figure is equipped with guiding means (17) to keep an elongated tube in the gab between the poles of the magnet. Fig. 5 shows a principle sketch of an example of an outer handle comprising a coil (18) connected to a battery.

Figs. 6-8 show cross sections of embodiments of the invention with inner handle(s) (21) disconnected from the catheter element (22) in the tube (23). In Fig. 6 the inner handle (21 ) is an element, such as a sphere adapted to push on the distal end of the catheter element (22). In Fig. 7 the inner handle (21 ) has the shape of a ring and is adapted to push on a flange (24), which is an integrated part of the catheter element (22). In Fig. 8 two inner handles (21), such as half parts of a ring, are confined between two flanges (24) of the catheter element (22). Figs. 9-18 show cross sections of examples of inner handles connected to the catheter element.

In the example shown in Figs. 9 and 10 the inner handles comprise elements (31 ) of magnetically sensitive material attached to the catheter element (32). In the example shown in Figs. 11 and 12 the inner handle is a ring (33) of magnetically sensitive material surrounding a section of the catheter element (32).

In the example shown in Figs. 13 and 14 the inner handle is a ring (35) of magnetically sensitive material placed on the inner side of the catheter element (32). In Fig. 15 the inner handle is a ring (36) of magnetically sensitive material embedded in a section of the catheter element (32). In Fig. 16 the inner handle (37) is a ring replacing a section of the catheter element (32).

In Fig. 17 the inner handle (38) consists of multiple particles embedded in a section of the catheter element (32). In Fig. 18 the inner handle (38) consists of multiple particles embedded in the catheter element material (32).

Fig. 19 illustrates the first path (dashed-dotted line) in an example where the catheter is essentially straight in the tube (40).

Fig. 20 illustrates the first path (dashed-dotted line) in an example where the catheter (41 ) is bend.

Detailed Description of the Present Invention

The present invention relates to a device for urinary catheterisation comprising at least one catheter element and at least one tube enveloping at least a part of said catheter, which is adapted to be displaced at least in a first direction along a first path wherein the device comprises at least one inner handle, adapted to be displaced inside at least a part of said tube at least in a second direction along a second path, and at least one outer handle, adapted to be displaced in the vicinity of the tube essentially along said second path in said second direction, said handles being magnetic counterparts, allowing mechanical forces applied to the outer handle to be magnetically transmitted to the inner handle, said inner handle being adapted to transmit mechanical force to move said catheter element in said first direction essentially along said first path.

Advantages of the present invention may be that the user need not to touch the catheter and thus does not transfer bacteria from the hands to the catheter. Furthermore as the catheter need not to be torn completely out of the tube, said tube may be used as an extension of the catheter, making it possible to control the direction of the fluid running out of the catheter. As an example the user may direct urine into a toilet. In one embodiment at least a part of the tube is adapted to serve as extension of the catheter element outside the body during catheterisation.

The invention relates to any form of urinary catheterisation including urethral and supra pubic catheterisation. Furthermore the catheters used in connection with the present invention may be indwelling catheters and/or intermitted catheters. The catheter element comprised in said device for urinary catheterisation is an elongated member with a proximal end adapted for insertion in a natural or artificial urinary duct of an individual and a distal end. The catheter element could be of any type, such as disclosed in PCT/DK02/00449 which in its entirety hereby is incorporated by reference. In addition to tubular catheters for which the drainage canal is bounded by the catheter material, an embodiment of the present invention comprises a catheter element of wing catheter type, for which a part of the drainage canals is bounded by the urinary duct.

In one embodiment the catheter element is used without providing a friction reducing means on the surface of the catheter while in others a friction reducing means is applied to the surface prior to use of the catheter. The catheter element may be adapted for lubrication prior to use, e.g. by a lubricating gel or by means of a hydrophilic coating adapted to be swelled by a swelling medium e.g. a swelling liquid such as water, sterile water or a saline solution. The catheter may be swelled prior to arrival at the end-user e.g. by being provided in a swelling liquid during production. Alternatively the catheter may be provided in a non- swelled state and the end-user can provide a swelling medium prior to insertion of the catheter.

The tube is an element of the device, which has a cavity adapted to hold at least a part of the catheter element. At least a part of the tube encircles at least a part of the catheter. In one embodiment the entire tube encircles the entire catheter while in another the tube only encircles a part of the catheter. The tube could be made from one or more foils of a sheet material joined along edges, e.g. by welding or gluing the foils together or it could be made from an extruded element, of essentially tubular shape, a welded tube or any other known type of tube like construction. In one embodiment the tube or a part of it is moulded. The foils may be of the same material or it may be of different materials having different properties. At least a part of the inner surface of the tube may be adapted to provide low friction between the part moving in relation to each other e.g. tube and the catheter or the tube and the inner handle. The tube may comprise an elongated part e.g. for accommodation of the catheter and/or a reservoir having a large volume e.g. adapted for collecting urine. In some embodiments the catheter is provided in the reservoir prior to use.

When the device is to be used the user may use the outer handle(s) to move the catheter. This is done by moving the outer handle along the outer surface of the tube (towards the proximal end of the tube) with one hand while with the other hand steering the proximal end of the tube such that the proximal end of the catheter is inserted into the human body. In embodiments where the gab between the tube and the catheter is narrow the tube will serve as guiding surfaces making it possible to steer the proximal end while applying the mechanical force at the distal end.

A plurality of inner handles may be provided along the catheter making it possible for the end-user to push the catheter at different positions along the tube and also making it possible to change the position of the outer handle during insertion of the catheter. The latter may be needed when a part of the catheter comprising a first inner handle is already inserted into the human body, thus making it impossible to use said handle for the insertion. Accordingly the user may press the sides of the tube together and thereby lock the catheter at the current position and move the outer handle without pulling the catheter out again. When the outer handle again is placed close to a second inner handler the user may remove the pressure from applied to the sides and continue the insertion of the catheter. If an electro magnetic outer handle is used the handle may be deactivated during movement of said outer handle to a position wherein another inner handle may be used.

The tube is adapted to allow essentially displacement of the catheter element in at least one direction along a first path and displacement of the inner handle in at least a second direction along a second path. In a preferred embodiment the second path is essentially coinciding with the first path. In a further preferred embodiment the second path is essentially coinciding with the first path and the second direction equals the first direction. In yet other embodiments a part of the first path substantially coincides with a part of the second part while another part of the first and the second path does not coincide. The definition of the first path is exemplified in Fig. 19 and 20.

In an additional embodiment the first and the second direction and/or path may differ from each other. An example of this is that the first direction is opposite the second direction e.g. if a first end of a wire is connected to the distal end of the catheter element while the second end of the wire is connected to an inner handle via a tackle located in the area of the proximal end of the catheter. When the inner handle is moved in the second direction then the catheter is moved in the opposite first direction. Accordingly the catheter and the inner handle are moved away from each other. In the latter example the first path is linear while the second pats is curved such as U-shaped.

The inner and outer handles are magnetic counterparts in the sense that they are adapted to act on one another by magnetic attraction or repulsion. The magnetic properties of the handles may be essentially permanent or they may be changeable by means of an electrically powered unit such as an electro magnet. The electro magnet may be provided with or without a core e.g. of iron. The electro magnet may be provided by one or more series of windings, such that the magnetic field force may be varied. The device according to the present invention may be adapted to be inserted automatically. This may be done by means of a motor pulling a wire or pushing a rod connected to an inner handle or a motor may move an outer handle in relation the tube. In a further embodiment the outer handle may be provided as a plurality of coils provided along the tube. In the latter example the coils must be switched on in a predetermined order as is known from electronic linear actuators. Accordingly the first coil that is activated is the one furthest away from the proximal end of the tube. The next that is activated is the one second furthest away from the proximal end etc.

In one embodiment the force used to transfer the mechanical force from the outer handle to the inner handle is an electrostatic force e.g. in combination with a magnetic force. The user may then rub any material against the outer handle which then by means of the electrostatic force can be used to move the inner handle. One advantage of this is that the user may use any object which may be made electrically static to move the inner handle and thus the catheter.

Both handles are adapted to be magnetically sensitive, i.e. subjected to magnetic attractive or repulsive forces when placed in a magnetic field. At least one handle is furthermore adapted to be actively magnetic, i.e. to provide a magnetic field, which is not induced by the other handle and has a strength sufficient to attract the other handle from close vicinity i.e. within a predetermined distance. The distance may vary according to the shielding effect of the tube. The distance may be between 0.01 and 100 mm, such as between 0,05 and 80 mm, such as between 0,1 and 50 mm, such as between 0,2 and 25 mm, such as between 0,5 and 10 mm such as between 1 and 5 mm. In some embodiments it may be seen that the distance is between 0,01 and 3 mm.

In some embodiment both handles are active magnets while in others only one of the handles is an active magnet while the other is of a material which can be attracted by a magnet. The inner and/or the outer handle may comprise iron or any other material which is (or can be made) sensitive to a magnetic field. The magnets of the present invention may be ringshaped, rodshaped or shaped like a horseshoe - independently of whether the magnetic field is provided with or without electricity. Other cross sectional shapes of the magnet could be polygonal shapes with three edges, or four edges or five edges or six edges etc.

In a further embodiment the inner handle is made of an active magnet making it possible for the user to use any object which can be attracted by a magnet to move the catheter. Thus if the user looses the outer handle or if it is not supplied in the package an object such as a spoon or a key can be used as an outer handle e.g. in an emergency situation.

Examples of sources of the magnetic field of an actively magnetic handle, comprises current carrying coils, electro magnets and permanent magnets. Preferably the handles are, if not in themselves corrosion safe, protected against corrosion, e.g. by a polymer coating, galvanic coating, anode coating, metal plating, passivation (nitrated, phosphated etc.) or any other known coating process.

In a preferred embodiment at least a part of at least one of the handles is a permanent magnet. Suitably one or more magnets such as bar magnets or any of the aforementioned shapes are embedded in a handle or the entire handle is made of a magnetised material. Examples of permanent magnets include neodymium, AINiCo, ferrites, samarium cobalt, etc.

In another preferred embodiment at least one of the handles comprises an electrically powered unit, such as a coil of electrically conducting material or an electro magnet. An electrically powered unit has the advantage that the magnetic field can be switched off between catheterisations. In one embodiment the outer handle comprises a means for providing energy to an electromagnet e.g. a battery. The battery may be adapted to provide enough electricity to make it possible for the user for the device to insert the catheter. An advantage of this may be that the user need not have access to external energy sources - movable or not movable.

In a preferred embodiment the outer handle comprises at least one element adapted to be actively magnetic, such as a permanent magnet or an electrically powered unit. In a preferred embodiment of the invention the tube is an elongated element and the outer handle is adapted to at least partly surround a section of the tube in order to guide the movement of the handle relative to the tube essentially along the second path. Examples include a ring shaped outer handle with an inner radius allowing displacement of the tube through the outer handle (Figs. 3 and 5) or an outer handle equipped with guiding elements to at least partly embrace the tube as shown in Fig. 4.

In a preferred embodiment of the invention the outer handle is provided separately from the rest of the device, and can be reused for a number of catheterisations.

In a further preferred embodiment of the invention the inner handle comprises a material, which is actively magnetic due to a permanent magnetisation.

In one embodiment of the invention, the inner handle is disconnected from the catheter element and adapted to push the catheter element in at least one direction. In a further embodiment of the invention the inner handle is adapted to push on the distal end of the catheter element. In another embodiment of the invention the catheter element is equipped with a flange or other means adapted to fill some part of the void/gab between the catheter element and the tube, preventing the inner handle from advancing relative to the catheter element past said means and the inner handle is adapted to push on said means. In a further preferred embodiment the inner handle is ring shaped.

In another embodiment of the invention the inner handle is connected to the catheter element, e.g. by means of a string, in which case the catheter element may be pulled in a first direction, which is different to the second direction of movement of the inner and outer handle.

In a preferred embodiment of the invention, the inner handle is attached to the catheter element, e.g. rigidly attached. In other embodiment the inner handle is not permanently attached to the catheter, but may be brought out of engagement with the catheter. The inner handle may comprise an engaging surface adapted to engage a corresponding engaging surface of the catheter. The inner handle may be attached to the catheter element by means of glue, welding, a snap lock or any other means for attachment. The catheter element and the inner handle may be moulded into one piece, e.g. such that the inner handle may not be detached from the catheter element.

In one embodiment of the invention the inner handle is ring- or tube shaped, placed with its centre line essentially coinciding with the centre line of the catheter element. In another embodiment the inner handle consists of multiple particles of magnetically sensitive material dispersed in at least a part of the catheter material. Fig. 4 shows examples of various embodiments of the inner handle.

To provide more handy waste, the magnetic insertion system of a preferred embodiment of the invention is made at least partly reversible, facilitating drawing the catheter element at least partly back in the tube.

In a preferred embodiment of the invention the device has sealing means, such as welding or plugs. The seal may be adapted to be removed. The catheter element could preferably be an integrated part of the sealing means.

In one embodiment the catheter is provided in the proximal end with a seal. When said seal is pulled out of the tube, the proximal end of the catheter is accessible. i" i / !. t"_. y a i V SJ U ^{SJ J} 11

In another embodiment a seal is provided at the proximal end of the tube. The catheter may then be pushed out through the seal while a swelling medium remains in the tube. An advantage of the latter embodiment may be that the catheter may be provided in a swelling medium and the user may use the catheter without spilling swelling medium on the surroundings e.g. on his clothes.

In a preferred embodiment of the invention the tube and the sealing means together are adapted to confine a volume of liquid swelling medium. Preferably the tube is made of a material, which is essentially gas impermeable as described in PCT/DK02/00449 or the tube is enveloped in an outer package, which has gas impermeable properties.

In a further embodiment of the invention at least a part of the catheter element has a hydrophilic coating and at least a part of the device e.g. the tube contains a liquid swelling medium for swelling the hydrophilic coating.

The term "gas impermeable" should be understood in this context to mean any material that will be sufficiently tight against diffusion by evaporation of the actual liquid swelling medium for a period exceeding the recommended shelf life time of the device which could be up to five years, typically 36 months.

In a further embodiment of the invention, at least a part of the tube is adapted to serve as an integrated extension of the catheter element outside the body during catheterisation. For this purpose connection means preferably provides an essentially liquid tight connection between tube and catheter element.

In a further embodiment a bag for collecting drained fluids (liquid swelling medium, urine) is included in the device or the device has connecting means for attaching such a bag. The bag and the tube may be integrated into the same element or may be made in at least two pieces. In a further embodiment of the invention, the device is adapted to use magnetic force transmission to perform other operations in addition to insertion of the catheter by magnetic force transmission. Examples include manipulation of at least a part of the sealing means and bringing elements of the device into attachment.

At least one of the inner or the outer handles may comprise gripping means. Such means may be provided in one or more zones on the inner and/or the outer handle. The gripping means may be a flap or any other surface extending away from the inner and/or outer handle. The griping means may also be a rough outer surface of the inner or outer handle or rivets or a knurled surface.

The gripping means is in one embodiment adapted to ease use of the device for people with reduced hand function or dexterity such as some spinal cord injured people. The gripping means may as so be useful for a third person inserting the catheter on e.g. a patient. Such third persons could be nurses, doctors etc.

The catheter element may comprise a proximal end adapted for insertion into a duct and a distal end, the inner handle being provided in the distal end. If the catheter is flexible it may be difficult for some users to steer the catheter when pushing at the proximal end if the rest of the catheter is not guided in some way.

Thus is may be seen as an advantage of the present invention the tube is used to steer the catheter as the inner sidewalls of the tube serves as guiding surfaces.

Accordingly even with a flexible catheter it is possible to push at the distal end, which during insertion is furthest away from the user, and at the same time steer or guide the proximal end of the catheter without touching the catheter surface with the hands.

Description of the Preferred Embodiments A preferred embodiment of the invention is now explained more in detail with reference to the drawings showing preferred embodiments of the invention. Fig. 1 shows one embodiment of the invention. The device for urinary catheterisation 50 comprises a catheter element 1 , a tube 2, inner handle 3 and outer handle 5. The catheter element 1 comprises holes 60 through which urine may pass in order to enter the canal 62 of the catheter element. The inner handle 3 is shaped as a ring of magnetically sensitive material, such as iron. The inner handle 3 is attached to the distal end of the catheter element 1 and shaped such that it is possible to move the inner handle 3 and the catheter element 1 inside the tube 2. Thus the inner diameter of the tube 2 is at least equal to the outer diameter of the inner handle. The outer handle 5 is a ring shaped active magnet, such as 3 rings of neodymium magnet, each ring with inner/outer diameter of 20mm/10mm and a thickness of 1 ,6 mm. The catheter element 1 is provided in the tube 2 such that the tube encircles the catheter element 1 in the longitudinal direction. The enveloping tube 2 is a pipe section having a distal 52 end and a proximal end 54, which are sealed by plugs 4,6 and 8. The sealing of the proximal end 54 of the tube consist of two plugs, a first proximal plug 8 which is removed before use of the device and a second proximal plug 6 which is adapted to guide the catheter during insertion and prevent the distal end of the catheter element from being displaced beyond the proximal end of the tube. Furthermore the second proximal plug 6 is designed to provide a comfortable contact between the body and the device. The catheter element could have a hydrophilic coating and the tube 2 could be made of a gas impermeable material and containing a liquid swelling medium 7 for swelling the hydrophilic coating of the catheter element 1.

Initially the catheter element 1 is located inside the tube 2. The user removes the first proximal plug 8 in order to make it possible to move the catheter element 1 out of the tube 2. By means of outer handles 5 the user can now move the inner handle 3 which can push the catheter element 1 is the direction indicated by arrow 56.

When the device is in use the distal plug and the first proximal plug is removed and the outer handle is encircling the tube and is displaced towards the proximal end of the tube causing the inner handle to move the catheter element in essentially the same direction for insertion in the urethra. Fig. 2 shows the device in an inserted position, with the tube providing an extension of the catheter element.

Fig. 3 shows an outer handle 1 1 comprising permanent magnets 12. Fig. 4 shows another embodiment of the outer handle 5 which is an electro magnet. The outer handle 5 comprises a core 13 around which windings 14 are provided. The windings 14 are connected to an energy source 16. Two guiding means 17 are provided such that a guiding hole 58 is provided through which the tube 2 can be inserted. In some embodiments an electrical contact is provided such that it is possible to turn the energy source on and off. In fig. 5 the electro magnet is provided with a tube formed core 60 around which windings 18 are provided. The windings 14 are connected to the energy source 20.

Figs. 6-18 disclose different embodiments of the inner handles. In fig. 6 the inner handle 21 is provided as a ball shaped element. The inner handle 21 may be attached to the catheter element 22. In some embodiments the inner handle 21 is provided without being attached to the catheter element 22. The outer diameter of the inner handle 21 is less than or equal to the inner diameter of the tube 23. The inner element is adapted to push on the distal end 52 of the catheter element. In fig. 7 the catheter element 22 comprises retaining means 24 which are adapted to retain the inner handle 21 on the distal side of the catheter. Accordingly the inner handle 21 need not to be attached to the catheter element 22 as the inner handle cannot pass the distal end 52 of the tube 23. In fig. 8 the catheter element is provided with two sets of retaining means 24 - one on each side of the inner handle 21. Accordingly the inner handle 21 may be retained at the distal end 52 of the catheter element 22 without being attached to the catheter element 22.

In fig. 9 the inner handle 31 is provided as two elements attached to the outer surface of the catheter element 32. A cross-section of the embodiment in fig. 9 is shown in fig. 10 wherein it can be seed that the two elements are provided opposite each other. However in other embodiments more elements may be provide or they may be provided in other positions than opposite each other.

In figs. 11 and 12 the inner element 33 is provided an a ring shaped element extending along an outer surface of the catheter element 32. In other embodiments the ring shaped element extends along an inner surface of the catheter 32 as shown in figs. 13 and 14 wherein the inner element 35 in provided inside the catheter element. The inner diameter of the inner element may be substantially equal to the inner diameter of the catheter element 32.

In figs. 15 and 16 the inner elements are provided inside the catheter element 32. Thus the inner and outer diameter of the catheter element in the area provided with the inner element is substantially equal to the inner and outer diameter of areas of the catheter which does not comprise the inner element. The inner elements of figs. 15 and 16 may be provided as ring shaped elements or as a plurality of pieces provided in the catheter element.

In figs. 17 and 18 the catheter element 32 comprises a magnetic material which has been moulded into the catheter. In fig. 17 the magnetic elements are only provided in the distal end 52 while in fig. 18 the magnetic elements are provide in the entire catheter element 32.

In figs. 19 and 20 a first path is indicated by the dotted line 62. The catheter elements are adapted to follow the first path when moved inside the tube 40. In some embodiments the first path is defined as the centre line of the tube 40.

Claims

1. A device for urinary catheterisation comprising

at least one catheter element and at least one tube enveloping at least a part of said catheter, which is adapted to be displaced at least in a first direction along a first path

wherein the device comprises

at least one inner handle, adapted to be displaced inside at least a part of said tube at least in a second direction along a second path, and at least one outer handle, adapted to be displaced in the vicinity of the tube essentially along said second path in said second direction,

said handles being magnetic counterparts, allowing mechanical forces applied to the outer handle to be magnetically transmitted to the inner handle, said inner handle being adapted to transmit mechanical force to move said catheter element in said first direction essentially along said first path.

2. A device according to claim 1 , wherein said second path is essentially coinciding with said first path.

3. A device according to claim 2, wherein said second direction equals said first direction.

4. A device according to any of the preceding claims, wherein said inner handle is attached to said catheter element.

5. A device according to any of the preceding claims, wherein said inner handle is embedded in the catheter element.

6. A device according to any of the preceding claims, wherein said inner handle comprises multiple particles of magnetically sensitive material dispersed in at least a part of the catheter material.

7. A device according to any of the preceding claims, wherein at least a part of at least one of said handles is a permanent magnet.

8. A device according to any of the preceding claims, wherein at least one of said handles comprises an electrically powered unit.

9. A device according to any of the preceding claims, wherein said inner and/or outer handle is adapted to be actively magnetic.

10. A device according to any of the preceding claims, wherein said device comprises sealing means, and said tube and said sealing means together are adapted to confine a volume of liquid swelling medium.

11. A device according to any of the preceding claims, wherein at least a part of said catheter element has a hydrophilic coating, and at least a part of said tube is of gas impermeable material and containing a liquid swelling medium for swelling said hydrophilic coating.

12. A device according to any of the preceding claims, wherein the catheter element comprises a proximal end adapted for insertion into a duct and a distal end, the inner handle being provided in the distal end.