NL2004939C2 - Lubricious catheter, and method and use therefor. - Google Patents

Description

LUBRICIUOUS CATHETER, AND METHOD AND USE THEREFOR

The present invention relates to a catheter that can be inserted into a vascular system of animals and/or humans.

5 Such catheters include guiding and/or diagnostic catheters for guiding and diagnostic purposes, respectively. The catheter can be applied in the fields of cardiology, radiology, oncology and neurology, for example.

Catheters, like guiding and diagnostic catheters, are 10 generally known. These catheters move in a vascular system by rotating and/or sliding the catheter in such system.

Also, devices are advanced through the tubing of the catheter, more specifically, advanced through a lumen.

Moving the catheter and advancing a device therein reguires 15 the use of force. These forces also act, at least partly, on the contact areas of the vascular system. This introduces the risk of irritating these contact areas.

The object of the present invention is to improve the manoeuvrability of the catheter and/or a device therein.

20 This object is achieved with the lubricious catheter according to the present invention, the catheter comprising a tubing with at least one inner layer, at least one reinforcement layer and at least one outer layer, wherein the outer layer comprising lubricious means for reducing the 25 resistance against rotating and/or sliding the catheter in a vascular system and/or the inner layer comprising lubricious means for reducing the resistance against advancing a device through the tubing.

By providing lubricious means on the outer layer of the 30 catheter, the resistance against moving the catheter in a vascular system is reduced. These movements include rotating and sliding of the catheter. By reducing this resistance, the forces reguired for these movements are further 2 minimized, thereby reducing the risk of damaging the vascular system during the movement and/or reducing the level of damage to the vascular system caused by these movements .

5 By providing lubricious means on the inner layer the resistance against advancing a device through the tubing, and more specifically through a lumen, is further reduced.

As an additional effect by reducing this resistance the force required for advancing the device is also reduced.

10 This minimizes the forces acting on the contact area of the inner layer of the catheter and thereby also reduces the forces acting on the vascular system. This minimizes the effect of the catheter on the vascular system as described above .

15 The catheter according to the invention is specifically advantageous for so-called guiding and diagnostic catheters as it improves positioning of the catheter and minimises the risk of damaging the vascular system, for example.

In a presently preferred embodiment according to the 20 present invention, both the inner layer and outer layer are provided with lubricious means.

A further advantage of providing lubricious means to the inner and/or outer layer is that the accuracy of positioning the catheter and/or the device in the catheter 25 is improved. This is achieved by reducing the resistances required for moving the catheter and/or advancing the device therein. This reduction enables a more smooth control achieving an accurate positioning thereof.

Preferably, the lubricious means are provided at the 30 distal end of the catheter. In a presently preferred embodiment according to the invention the length of the distal range is the range of about 40 cm from the outer distal end of the catheter.

3

In a preferred embodiment according to the present invention, the lubricous means comprise a coating.

By proving a coating an effective means for improving the lubricity of the inner and outer layer is achieved.

5 Preferably, the coating comprises a high friction coating on a part of a surface of the catheter that in use comes into contact with an aorta or a vascular system. This contact area is a secondary curve of a so-called JL4-shaped catheter, for example. This prevents slipping of the 10 catheter relative to the vascular system and increases the back-up support.

Preferably, the coating comprises a high lubricious coating on at least a part of a surface of the catheter that in use comes into contact with tortuous parts of a vascular 15 system. Alternatively, or in combination therewith, a low friction coating can be used on the tortuous parts of a vascular system.

The use of high lubricious and/or high respectively low friction coating prevents or minimizes damage to parts of 20 the vascular system. These parts include the aorta and tortuous anatomy areas, like the iliac and aortic arch.

In a presently preferred embodiment according to the present invention different parts of the catheter are provided with different lubricious means including high 25 friction coating.

Preferably, the lubricious coating is a coating that becomes low lubricious or none lubricious at certain contact pressures. In addition thereto, or as alternative there for, the lubricious coating comprises hydrophilic and/or 30 hydrophobic coatings.

In a preferred embodiment according to the present invention the coating comprises a non-spasm coating.

4

By providing a non-spasm coating, the effect of the catheter on the vascular system and thereby on the entire mammal, including humans, is further minimised. Tests have shown that the introduction of a non spasm coating is 5 especially relevant for catheters used via the radial approach.

Preferably, the non-spasm coating comprises nitro compound releasing coatings. It has been shown that releasing of nitro compounds, like nitro-glycerine, has an 10 anti-spasm effect. In case of nitro-glycerine release the range of release is in the range of 25 yg per 30 minutes and 250 yg per 30 minutes with, preferably, a maximum dosage per catheter of about 400 yg.

In a preferred embodiment according to the present 15 invention the coating comprises an anti-trombogenetic coating.

By providing an anti-trombogenetic coating the tendency to produce a trombose or cloth is minimized. Preferably, the anti-trombogenetic coating comprises a heparine releasing 20 coating. It has been shown that releasing of heparine has a significant anti-trombogenetic effect thereby improving the catheter according tot the present invention.

In a further preferred embodiment according to the present invention, the catheter further comprises a surface 25 structure so that, together with the lubricious means, in use a fluid layer is provided between the contact area of the vascular system and/or the device and the catheter.

By creating a surface structure so that a fluid layer is created between the contact area and the catheter a type 30 of aquaplaning effect is achieved when the catheter is moved relative to this contact area. Such structure can be applied on the outer layer of the catheter, thereby improving the movement of the catheter relative to the vascular system.

5

Also, such surface structure can be created for the inner layer thereby improving the advancing of the device through the catheter. In addition, such surface structure can be provided both on the outer and inner layer. Examples of such 5 surface structure are the provision of local dents, preferably in a regular structure, and a saw tooth shaped surface. Such surface structures are capable of containing an amount of fluid. Other shapes of the surface structure are also possible. Preferably, the surface area is 10 relatively smooth, for example by applying a grinding, chemical, and/or heat process to the surface. Such smooth surface improves the aquaplaning effect described above.

Preferably, the distal end of the catheter provided with lubricious means comprises rings of dents of relatively 15 hard and relatively soft material to manipulate the characteristics of the catheter. Preferably, the soft rings or dents compress somewhat towards the centre line of the catheter when bending the catheter. This minimizes irritation on the contact areas of the vascular system when 20 moving the catheter.

In a further preferred embodiment one or more parts of the catheter are provided with lubricious means that after being pushed or squeezed empty change their behaviour into anti-slip behaviour.

25 In a further preferred embodiment according to the present invention the lubricious means comprise lubricious particles .

By providing lubricious particles an efficient improvement of the lubricity of the catheter is achieved.

30 Preferably, the lubricious particles comprise Teflon and/or HDPE particles. Preferably, these particles are added to the plastic matrix of the layers of the catheter according to the present invention.

6

The present invention also relates to a method for making a catheter as described above.

Such a method provided the same effects and advantages as those related to the catheter.

5 According to the invention providing of one or more of the coatings applied to the distal end of the catheter involves the step of dipping, spraying and/or injection of the coating. Spraying includes electro spraying.

In a preferred embodiment according to the present 10 invention the providing of the coatings involves a curing step. The curing operation involves the use of radiation (UV or blue light for example) and/or heat and/or chemicals depending on the specific type of curing operation including the materials used for the catheter and the coatings.

15 The present invention further also relates to the use of a catheter as described above. Such use provides the same effects and advantages as those related to the catheter and the method of making such a catheter. Preferably, in use a fluid layer is formed between a contact area of the catheter 20 and a contact area of a vascular system and/or between the contact area of the catheter and the device that is advanced through the catheter. This enables smooth moving the catheter in a vascular system and/or a device through the catheter .

25 Further advantages, features and details of the invention are elucidated to the preferred embodiments thereof wherein references made to the accompanying drawings, wherein: - Figure 1, a catheter according to the present 30 invention; - Figure 2, illustrates a surface structure of the catheter of figure 1 ; and 7 - Figure 3 illustrates an alternative surface structure .

A guiding catheter 2 (figure 1) comprises a proximal end 4 and a distal end 6. Proximal end 4 and distal end 6 5 are connected by tubing 8 with tubing 8 comprising an inner layer, and a reinforcing layer including reinforcement wires of Nanoflex™ material, for example. The thickness of the wires in the reinforcement layer is 0.03-0.05 mm and have a width of 0.05-20 mm, for example. Typical angles for the 10 wires are for guiding catheters 30-80 degrees and for diagnostic catheters 20-70 degrees.

In the illustrated embodiment of catheter 2 the coating design for improving the inner lumen lubricity comprises reactive extruded material of the Plexar® polyethylene type 15 in combination with a high friction plastic material, like nylon or polyurethane with a ratio of 1:1. Also, alternatively ratios of 1:20 and 20:1 would also be possible. The outer surface of catheter 2 is provided with an anti-spasm coating and an anti-trombogenetic coating at 20 the distal end 6 of catheter 2. At the so-called secondary curve 10 of catheter 2 a high friction coating is applied to prevent slipping of the catheter by increasing the back-up support. The characteristics of the top coating of catheter 2 as illustrated are a high E-modulus in the range of 1200-25 2000 MPa, high strain at yield of 5-25%, a high UTS of 50-80 MPa and a high strain at break of 100-500%.

Catheter 2 is provided with a surface structure 12 (figure 2). Layer 14 of catheter 2 comes into contact with a contact area 16 of the vascular system or the device. Layer 30 14 is provided with the local dents 18 that are capable of holding an amount of fluid. In use when moving the catheter layer 14 relatively to layer 16 an aqua-plaining type effect is achieved. Other surface structures would also be 8 possible. An alternative surface structure 20 uses a type of saw-tooth shape 22 on a layer 24 of the catheter 2 that comes into contact with a contact area 26 of the vascular system or the device.

5 The present invention is by no means limited to the above described preferred embodiments thereof. The rights sought are defined by the following claims within the scope of which many modifications can be envisaged. For example, the invention is not limited to single lumen catheters, 10 measures according to the invention can also be applied to catheters provided with multiple lumen.

9

Clauses 1. Lubricious catheter, comprising a tubing with at least one inner layer, at least one reinforcement layer and 5 at least one outer layer, wherein the outer layer comprising lubricious means for reducing the resistance against rotating and/or sliding the catheter in a vascular system and/or the inner layer comprising lubricious means for reducing the resistance against 10 advancing a device through the tubing.

2. Lubricious catheter according to clause 1, wherein the lubricious means comprising a coating.

15 3. Lubricious catheter according to clause 2, wherein the coating comprising a high friction coating on at least a part of a surface of the catheter that in use comes into contact with an aorta or the vascular system, and/or a high lubricious coating and/or low friction 20 coating on at least a part of a surface of the catheter that in use comes into contact with tortuous parts of the vascular system.

4. Lubricious catheter according to clause 2 or 3, wherein 25 the coating comprising a non spasm coating.

5. Lubricious catheter according to clause 5, wherein the non spasm coating comprising a nitro compound releasing coating.

30 6. Lubricious catheter according to any of clauses 3-6, wherein the coating comprising an anti-thrombogenetic coating.

10 7. Lubricious catheter according to clause 7, wherein the anti-thrombogenetic coating comprising a heparine releasing coating.

5 8. Lubricious catheter according to any of the clauses 1- 7, wherein catheter further comprising a surface structure so that, together with the lubricious means, in use a fluid layer is provided between a contact area of the vascular system and/or the device and the 10 catheter.

9. Lubricious catheter according to any of the clauses 1- 8, wherein the lubricious means comprise a relatively smooth surface.

15 10. Lubricious catheter according to any of the clauses 1- 9, wherein the lubricious means comprising lubricious particles .

20 11. Lubricious catheter according to clause 10, wherein the particles comprising Teflon and/or HDPE particles.

12. Lubricious catheter according to any of clauses 1-11, wherein the catheter is a guiding and/or diagnostic 25 catheter.

13. A method of making a catheter according to one or more of the clauses 1-12.

30 14. The method according to clause 13, wherein providing one or more coatings involves dipping, spraying and/or inj ection.

15. The method according to clause 13 or 14, wherein 35 providing one or more coatings involves a curing step.

11 16. Using a catheter according to any of clauses 1-12.

Claims (16)

A lubricating action catheter, comprising: - a tube with an inner layer, a reinforcement layer and an outer layer, wherein the outer layer comprising lubricants for reducing the resistance to rotation and / or sliding of the catheter in a vascular system, and / or the inner layer comprising lubricants for reducing the resistance to passing a device through the tube. A lubricating action catheter according to claim 1, wherein the lubricants comprise a cover layer. 3. A lubricating action catheter as claimed in claim 2, wherein the cover layer comprising a low friction cover layer and / or a cover layer with a high lubricating action on at least a part of the surface of the catheter that comes into contact with an aorta and / or tortuous parts of the vascular system. A lubricating action catheter according to claim 2 or 3, wherein the cover layer comprises an anti-spasm cover layer. The lubricating catheter according to claim 4, wherein the anti-spasm coating comprises a nitrogen compound releasing coating. 6. A lubricating action catheter as claimed in one or more of claims 2-5, wherein the cover layer comprises an anti-thrombogenetic cover layer. The lubricating catheter according to claim 6, wherein the anti-thrombogenetic coating comprises a heparin-releasing coating. 5 8. Lubricating action catheter according to one or more of claims 1-7, wherein the catheter further comprising a surface structure such that, together with the lubricants in use, a fluid layer is provided between a contact area of the vascular system and / or the device and the device. catheter. A lubricating action catheter as claimed in one or more of claims 1-8, wherein the lubricants comprise a relatively flat surface. 15 A lubricating action catheter as claimed in one or more of claims 1-9, wherein the lubricants comprise lubricating particles. The lubricating action catheter of claim 10, wherein the particles comprise Teflon and HDPE particles. 12. Lubricating action catheter according to one or more of claims 1-11, wherein the catheter is a guide and / or diagnostic catheter. A method for manufacturing a catheter according to one or more of claims 1-12. A method according to claim 13, wherein providing one or more coatings comprising dipping, spraying and / or injecting. Method according to claims 13 and 14, wherein it is provided with one or more cover layers comprising a curing step. Use of a catheter according to one or more of claims 1-12.