NL2004938C2 - Reinforced cathether and method for making such a catheter. - Google Patents

Reinforced cathether and method for making such a catheter. Download PDF

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Publication number
NL2004938C2
NL2004938C2 NL2004938A NL2004938A NL2004938C2 NL 2004938 C2 NL2004938 C2 NL 2004938C2 NL 2004938 A NL2004938 A NL 2004938A NL 2004938 A NL2004938 A NL 2004938A NL 2004938 C2 NL2004938 C2 NL 2004938C2
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NL
Netherlands
Prior art keywords
catheter
wires
reinforced
cleaning
shape
Prior art date
Application number
NL2004938A
Other languages
Dutch (nl)
Inventor
Gjalt Bosma
Rudolf Teunis Mulder
Wilhelmus Petrus Martinus Maria Erp
Original Assignee
Pendracare Internat B V
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Publication date
Application filed by Pendracare Internat B V filed Critical Pendracare Internat B V
Priority to NL2004938A priority Critical patent/NL2004938C2/en
Application granted granted Critical
Publication of NL2004938C2 publication Critical patent/NL2004938C2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Description

REINFORCED CATHETER AND METHOD FOR MAKING SUCH A CATHETER
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.
Known catheters are provided with a reinforcement layer 10 often including a metal wire mesh to reinforce the catheter. The reinforcement layer with the wire mesh mainly determines the required level of torque and force that needs to be applied to achieve the desired maneuverability and kink resistance of the catheters. Known catheters have optimized 15 the reinforcement layer. For example, a variation of wired mesh designs has been proposed.
The object of the present invention is to improve the reinforcement of catheters.
This object is achieved with the reinforced catheter 20 according to the invention, the catheter comprising at least one inner layer, at least one reinforcement layer comprising braiding wires and at least one outer layer, wherein the reinforcement layer further comprising fixation means to fixate the wires to the inner and/or the outer layers.
25 Moving a catheter, like rotating and sliding the catheter in a vascular system, puts demands on the catheter in relation to the torque and pushing forces that are applied to achieve the desired manoeuvrability and kink resistance. The reinforcement layer is one of the biggest 30 factors influencing these aspects. Therefore, the reinforcement layer comprises braiding wires for making a mesh of wires. Preferably, the braiding wires fulfil the following specifications: 2 - UTS>2 O O O N/mm2 - yield point>1500 N/mm2 - strain at break>2% - Young's modulus 190,000-220,000 N/mm2.
5 Examples of materials that can be used for this mesh of braiding wires include: - SS301, SS302, SS304 or SS316 in special conditions like dbl spring, ultra spring or Hyten condition; - Nanoflex; 10 - 17-7PH steel; - MP 35N steel; - X10CrNil8-l steel; - 11R51 steel.
The thickness of the wires in the reinforcement layer is 15 0.03-0.05 mm and have a width of 0.05-2 mm, for example.
Typical angles for the wires are for guiding catheters 30-80 degrees and for diagnostic catheters 20-70 degrees, for example. Other dimensions and/or angles are also possible.
To further improve the above characteristics of the 20 catheter it is surprisingly found that the interaction of the reinforcement layer with specially the top layer, but also the inner layer, is relatively important and contributes to the overall characteristics of the catheter. Therefore, the catheter according to the invention provides 25 fixation means to fixate the reinforcement layer, more specifically the braiding wires of this reinforcement layer, to the inner and/or outer layer of the catheter. Surprisingly, it has been found that especially the fixation of the braiding wires to the top layer or outer layer of the 30 catheter is very relevant and significantly contributes to the overall characteristics of the catheter. By improving the fixation the adherence of the braiding to the inner and/or outer layer is improved. In addition, the adherence 3 of the braiding layer itself is preferably improved by improving the fixation.
The catheter according to the invention is specifically advantageous for so-called guiding and diagnostic catheters 5 as it improves positioning of the catheter and minimises the risk of damaging the vascular system, for example.
In a preferred embodiment according to the present invention the fixating means comprise cleaning means to achieve clean surfaces of the wires when making the 10 catheter.
To achieve sufficiently clean surfaces the cleaning may use soap solutions acid solutions and/or alkali solutions. Preferably, the cleaning is extended to the plastics material of the catheter. Optionally, the cleaning can be 15 performed at an increased temperature and/or in the presence of ultrasonic vibrations. Preferably, the applied preheating temperature is in the range of 100-500 °C. It has been fount that the use of this temperature and/or these vibrations improves the cleaning and thereby the fixation of the 20 reinforcement layer to especially the top layer.
When during the making of the catheter the wire surfaces are clean, the adherence of the top layer to the braiding wires is improved. The intensified cleaning can be achieved by degreasing the wires during the making of the 25 catheter. This removes the oily substances and improves the adherence of the other layers to the braiding wires.
Alternatively, or in addition thereto, during the making of the catheter, the catheter and more specifically the wire mesh is preheated when providing the top layer on 30 the braiding wires. This preheating improves the adherence of the material on the wires.
Cleaning and/or preheating the wires during the making of the catheter prevents additional treatments or additional 4 processing steps, like raising or buffing of the wires. Such steps may reduce the tensile strength. An example of such additional processing includes sanding.
In a preferred embodiment according to the present 5 invention the fixating means comprise raising or buffing means to achieve a relatively rough surface of the wires.
By providing raising or buffing means is possible to provide a relatively rough surface. The material of the top layer strongly adheres to the wires as the contact area is 10 improved by the raising or buffing. The roughening of the wire surfaces can be achieved by sand blasting, etching or by mechanically roughening, for example.
Alternative to, or in combination with, raising or buffing the wires comprise openings to improve the adherence 15 of the wires to the other material of the catheter, especially the top layer material. This improves the overall characteristics of the catheter according to the invention.
In a preferred embodiment according to the present invention the fixating means comprise a primary coating.
20 By providing a primary coating on the surface of the wires, the material of especially the top layer adheres more efficiently and more effectively to the wires. This improves the overall characteristics of the catheter according to the present invention.
25 In a preferred embodiment according to the present invention a number of junctions of the braided wires are welded, preferably using spot-welding. This improves the characteristics of the overall catheter.
In a further preferred embodiment according to the 30 present invention the fixating means comprise a shape and/ or extension of one or more of the wires in a direction substantially perpendicular to the axial direction of the catheter and/or in a circumferential plane of the catheter.
5
By shaping the wire in a direction substantially perpendicular it has been found that the adherence of the top layer with the wires of the reinforcement layer improves. This improves the overall reinforcement of the 5 catheter.
Preferably, the shape of the wires comprises a wave shape. Such wave shape includes a sinusoid. Alternatively, or in addition thereto, a knurl shape with types of protrusions on the wires can be provided. These shapes 10 improve the adherence of the top layers to the wires. It has been fount that reinforcement, especially in axial direction, is improved. This is especially relevant when sliding the catheter into a vascular system. As an alternative, or in combination, a wave and/or knurl shape 15 can be provided in a circumferential direction, directly at or somewhat below the surface of the catheter, therefore, in a plane substantially perpendicular to the axial direction of the catheter. This further improves the reinforcement of the catheter according to the invention.
20 In a further improved embodiment according to the present invention the fixating means comprise a shape and/or extension of some or all wires in a substantially radial direction of the catheter.
By providing a shape and/or an extension the adherence 25 of the material of the top layer to the wires is significantly improved. Preferably, the shape is a wave shape like a sinusoid. Extensions include the provision of local dents or protrusions, roughened sides of the wires and/or irregular shapes of the sides of the wires.
30 Preferably, these different shapes and/or extensions are combined to further improve the adherence to the top layers of the wires. This especially reinforces the catheter in a 6 radial direction. It has been found that this is especially relevant when rotating a catheter into a vascular system.
Preferably, the shapes and/or extensions of the wires for the axial and radial directions of the catheter are 5 combined to improve the characteristics of the catheter according to the present invention for all movements of the catheter .
The present invention also relates to a method for making a reinforced catheter as described above.
10 Such method provides the same effects and advantages as those stated with reference to the catheter. Besides providing specific shapes and/or extensions of the wires of the reinforcement layer and/or providing a primary coating on the surface of these wires, it is also possible to use 15 additional steps when making the catheter. According to the present invention these steps may comprise cleaning the surface of the wire, preheating the wires when making the catheter and raising or buffing to roughen the surface of the wire. These measures can be performed individually or in 20 combination with each other. This results in a method to provide a catheter according to the present invention in an efficient and effective way.
Further advantages, features and details of the invention are elucidated on basis of preferred embodiments 25 thereof, wherein references is made to the accompanying drawings, wherein: - figure 1 shows a catheter according to the present invention; - figure 2 shows a wave shape of a wire in the 30 reinforcement layer of the catheter of figure 1; - figure 3 illustrates a knurl shape of the reinforcement layer; 7 - figure 4 illustrates a local wire with local dents; and - figure 5 illustrates a wire with an irregular shape.
A guiding catheter 2 (figure 1) comprises a proximal 5 end 4 and a distal end 6. Proximal end 4 and distal end 6 are connected by tubing 8. One or more of the wires 10 of the reinforcement layer of catheter 2 (figure 2) can be provided in a wave shape, like a sinusoid 12. An alternative wire 14 (figure 3) is provided with a knurl shape 16. A 10 further alternative wire 18 is provided with local dents 20 (figure 4). A further alternative wire 22 is provided with an irregular shape 24 (figure 5). Of course, one or more of these alternative wires 10, 14, 18, 22 can be combined into one single wire. Also, it would be possible to combine to a 15 more of the alternative wires 10, 14, 18, 22 into a single mesh of wires for the reinforcement layer.
The making of a catheter according to the present invention comprises several steps that are known to a skilled person. According to the present invention some 20 additional steps can be performed for efficiently and effectively making the catheter. These steps include the cleaning with a cleaning solution comprising soap, acid and/or alkali. Optionally, this cleaning is performed in combination with an increased temperature and/or the use of 25 ultrasonic vibrations. In a presently preferred embodiment these different measures are combined in one step.
Furthermore, the shape and/or extension of some or all of the wires are used for further reinforcing the catheter. Therefore, one or more of the alternative wires 10, 14, 18, 30 22 are provided when making the catheter according to the present invention. In a further preferred embodiment according to the present invention the cleaning step is combined with the providing of a specific shape and/or 8 extension of the wires. It has been found that a combination of these measures further improves the overall characteristics of the catheter according to the present invention.
5 The present invention is by no means limited to the preferred embodiments thereof. The rights sought are defined by the following claims, within the scope of which many modifications can be envisaged.
9
Clauses 1. Reinforced catheter comprising at least one inner layer, 5 at least one reinforcement layer comprising braiding wires and at least one outer layer, wherein the reinforcement layer further comprising fixation means to fixate the wires to the inner and/or the outer layers.
10 2. Reinforced catheter according to clause 1, wherein the catheter is a guiding and/or diagnostic catheter.
3. Reinforced catheter according to clause 1 or 2, wherein the fixating means comprising cleaning means for 15 cleaning surfaces of the wires when making the catheter.
4. Reinforced catheter according to clause 1, 2 or 3, wherein the fixating means comprising preheating means for preheating the wires when making the catheter.
20 5. Reinforced catheter according to any of clauses 1-4, wherein the fixating means comprising raising or buffing means to achieve a relatively rough surface of the wires .
25 6. Reinforced catheter according to any of clauses 1-5, wherein the braiding wires comprising openings.
7. Reinforced catheter according to any of clauses 1-6, 30 wherein the fixating means comprising a primary coating.
8. Reinforced catheter according to any of clauses 1-7, wherein the fixating means comprising a number of welded junctions of the braiding wires.
10 9. Reinforced catheter according to any of the clauses 1-8, wherein the fixating means comprising a shape and/or extension of one or more of the wires in a direction substantially perpendicular to the axial direction of 5 the catheter and/or in a circumferential plane of the catheter.
10. Reinforced catheter according to clause 9, wherein the shape comprises a knurl and/or wave shape.
10 11. Reinforced catheter according to any of the clauses 1-10, wherein the fixating means comprising a shape and/or an extension of some or all of the wires in a substantially radial direction of the catheter.
15 12. Reinforced catheter according to clause 11, wherein the radial shape and/or extension comprise a wave shape, one or more local dents and/or protrusions, roughened sides of the wires and/or irregular shapes of a side of the 20 wire.
13. A method for making a reinforced catheter according to any of the clauses 1-12.
25 14. The method according to clause 13, wherein a cleaning step of the wires comprising cleaning with a cleaning solution comprising soap, acid and/or alkali.
15. The method according to clause 13 or 14, wherein a 30 cleaning step of the wires comprising using an increased temperature and/or ultrasonic vibrations.

Claims (15)

1. Versterkt katheter omvattende ten minste één binnenlaag, ten minste één versterkingslaag en ten minste één 5 buitenlaag, waarbij de versterkingslaag omvattende gevlochten draden, en waarin de versterkingslaag verder omvattende fixatiemiddelen voor het fixeren van de draden aan de binnenlaag en/of buitenlaag.1. A reinforced catheter comprising at least one inner layer, at least one reinforcement layer and at least one outer layer, wherein the reinforcement layer comprises braided wires, and wherein the reinforcement layer further comprises fixing means for fixing the wires to the inner layer and / or outer layer. 2. Versterkt katheter volgens conclusie 1, waarin het katheter een geleidings- en/of diagnostisch katheter is.The reinforced catheter of claim 1, wherein the catheter is a guide and / or diagnostic catheter. 3. Versterkt katheter volgens conclusie 1 of 2, waarin de fixatiemiddelen omvattende reinigingsmiddelen voor het 15 reinigen van de oppervlakken van de draden bij het maken van de katheter.3. A reinforced catheter as claimed in claim 1 or 2, wherein the fixation means comprise cleaning means for cleaning the surfaces of the wires when making the catheter. 4. Versterkt katheter volgens conclusie 1, 2 of 3, waarin de fixatiemiddelen omvattende voorverwarmingsmiddelen 20 voor het voorverwarmen van de draden bij het maken van de katheter.The reinforced catheter according to claim 1, 2 or 3, wherein the fixation means comprises preheating means 20 for preheating the wires when making the catheter. 5. Versterkt katheter, volgens één of meer van de conclusies 1-4, waarin de fixatiemiddelen omvattende 25 opruwings- of verruwingsmiddelen voor het realiseren van een relatief ruw oppervlak van de draden.5. Reinforced catheter, according to one or more of the claims 1-4, wherein the fixation means comprise roughening or roughening means for realizing a relatively rough surface of the wires. 6. Versterkt katheter volgens één of meer van de conclusies 1-5, waarin de draden omvattende openingen. 30The reinforced catheter of any one of claims 1-5, wherein the wires comprise openings. 30 7. Versterkt katheter volgens één of meer van de conclusies 1-6, waarin de fixatiemiddelen omvattende een primaire deklaag.A reinforced catheter as claimed in one or more of claims 1-6, wherein the fixation means comprises a primary cover layer. 8. Versterkt katheter volgens één of meer van de conclusies 1-7, waarin de fixatiemiddelen omvattende een aantal gelaste kruisingen van de gevlochten draden.The reinforced catheter of any one of claims 1-7, wherein the fixation means comprises a plurality of welded crossings of the braided wires. 9. Versterkt katheter, volgens één of meer van de conclusies 1-8, waarin de fixatiemiddelen omvattende een vorm en/of extensie van één of meer van de draden in een richting in hoofdzaak loodrecht op de axiale richting van de katheter en/of in een omtreksvlak van de 10 katheter.The reinforced catheter as claimed in one or more of claims 1-8, wherein the fixation means comprising a shape and / or extension of one or more of the wires in a direction substantially perpendicular to the axial direction of the catheter and / or in a peripheral surface of the catheter. 10. Versterkt katheter volgens conclusie 9, waarin de vorm omvattende een geribde en/of gegolfde vorm.The reinforced catheter of claim 9, wherein the shape comprises a ribbed and / or corrugated shape. 11. Versterkt katheter, volgens één of meer van de conclusies 1-10, waarin de fixatiemiddelen omvattende een vorm en/of extensie van enkele of alle draden in een in hoofdzaak radiale richting van de katheter.The reinforced catheter as claimed in one or more of claims 1-10, wherein the fixation means comprises a shape and / or extension of some or all of the wires in a substantially radial direction of the catheter. 12. Versterkt katheter volgens conclusie 11, waarin de radiale vorm en/of extensie omvattende een gegolfde vorm, één of meer locale deuken en/of uitsteeksels, verruwde zijden van de draden en/of onregelmatige vormen van de zijden van de draden. 25The reinforced catheter of claim 11, wherein the radial shape and / or extension comprising a corrugated shape, one or more local dents and / or protrusions, roughened sides of the wires and / or irregular shapes of the sides of the wires. 25 13. Werkwijze voor het vervaardigen van een versterkt katheter volgens één of meer van de conclusies 1-12.A method for manufacturing a reinforced catheter according to one or more of claims 1-12. 14. Werkwijze volgens conclusie 13, waarin het reinigen van 30 de draden omvattende het reinigen met een reinigingsoplossing omvattende zeep, zuur en/of alkali.14. Method as claimed in claim 13, wherein cleaning the threads comprising cleaning with a cleaning solution comprising soap, acid and / or alkali. 15. Werkwijze volgens conclusie 13 of 14, waarin het reinigen omvattende het gebruik maken van een verhoogde temperatuur en/of het gebruik maken van ultrasone vibraties.A method according to claim 13 or 14, wherein the cleaning comprising using an elevated temperature and / or using ultrasonic vibrations.
NL2004938A 2010-06-22 2010-06-22 Reinforced cathether and method for making such a catheter. NL2004938C2 (en)

Priority Applications (1)

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NL2004938A NL2004938C2 (en) 2010-06-22 2010-06-22 Reinforced cathether and method for making such a catheter.

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Application Number Priority Date Filing Date Title
NL2004938 2010-06-22
NL2004938A NL2004938C2 (en) 2010-06-22 2010-06-22 Reinforced cathether and method for making such a catheter.

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NL2004938C2 true NL2004938C2 (en) 2011-12-27

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5746696A (en) * 1995-05-16 1998-05-05 Fuji Photo Optical Co., Ltd. Flexible sheathing tube construction
US6942654B1 (en) * 2000-01-19 2005-09-13 Scimed Life Systems, Inc. Intravascular catheter with axial member
EP1955724A1 (en) * 2007-02-06 2008-08-13 Terumo Kabushiki Kaisha Medical catheter
EP2174685A1 (en) * 2008-10-11 2010-04-14 Asahi Intecc Co., Ltd. Catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5746696A (en) * 1995-05-16 1998-05-05 Fuji Photo Optical Co., Ltd. Flexible sheathing tube construction
US6942654B1 (en) * 2000-01-19 2005-09-13 Scimed Life Systems, Inc. Intravascular catheter with axial member
EP1955724A1 (en) * 2007-02-06 2008-08-13 Terumo Kabushiki Kaisha Medical catheter
EP2174685A1 (en) * 2008-10-11 2010-04-14 Asahi Intecc Co., Ltd. Catheter

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