NL2004937C2 - Catheter with locally adjusted characteristics and method therefor. - Google Patents
Catheter with locally adjusted characteristics and method therefor. Download PDFInfo
- Publication number
- NL2004937C2 NL2004937C2 NL2004937A NL2004937A NL2004937C2 NL 2004937 C2 NL2004937 C2 NL 2004937C2 NL 2004937 A NL2004937 A NL 2004937A NL 2004937 A NL2004937 A NL 2004937A NL 2004937 C2 NL2004937 C2 NL 2004937C2
- Authority
- NL
- Netherlands
- Prior art keywords
- catheter
- soft
- top layer
- distal end
- locally
- Prior art date
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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
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
-
- 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
- A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
- A61M2025/0081—Soft tip
-
- 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
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
CATHETER WITH LOCALLY ADJUSTED CHARACTERISTICS AND METHOD
THEREFOR
The present invention relates to a catheter that can be 5 inserted into a vascular system of animals and/or humans. 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.
10 At present catheters are provided with a distal end with a tip that is made more flexible in order to achieve an a-traumatic distal section. This enables the positioning of the tip of the catheter in the ostium of a coronary. A problem with these existing catheters is that they are often 15 difficult to move in a vascular system. Furthermore, moving these catheters in a vascular system may damage this system.
The object of the present invention is to improve existing catheters, including guiding and/or diagnostic catheters .
20 This object is achieved with the catheter according to the present invention, the catheter comprising an elongate tube having a proximal and a distal end, and an outer and an inner diameter, wherein: the tube comprising at least one plastic inner 25 layer, at least one reinforcement layer, and at least one plastic top layer; and the distal end comprising, in the direction of the distal end towards the proximal end, a soft tip, adjacent to the soft tip an intermediate tip, and 30 separated from the soft tip by the intermediate tip a distal tip, wherein the tips are provided with different characteristics relating to the resistance against bending and/or positioning 2 and/or relaxation of the catheter in a vascular system.
Providing the distal end of a catheter with at least three tip regions, a soft tip at the outer end of the distal 5 end, adjacent thereto an intermediate tip, and adjacent thereto towards the proximal end of the catheter a distal tip. The tips are provided with different characteristics. The distal end of the catheter can be tuned to minimize resistance against bending and/or positioning and/or 10 relaxation of the catheter in a vascular system. These movements also include rotating and/or sliding of the catheter in the vascular system. By minimizing the resistance moving the catheter in a vascular system is made easier. Additionally, the damage to the vascular system due 15 to the movement of the catheter is also minimized.
Preferably, in an embodiment of the catheter according to the present invention the distal end gradually becomes softer towards the soft tip end. The relatively soft tip at the outer end of the distal end is very flexible to enable 20 alignment with the coronary take-off and to achieve an a- traumatic behaviour of the catheter according to the present invention. The intermediate tip or intermediate region is provided with sufficient stiffness. In use, this intermediate tip realizes a high backup force. This enables 25 keeping the tip in the ostium when a force is applied to the catheter during an interventional procedure. This is especially relevant for guiding catheters. The distal tip, the region of the distal end the most close to the proximal end of the catheter, is less important for tip alignment and 30 a-traumatic behaviour. Therefore, this distal tip is relatively stiff to enable applying relatively high pushing forces and torques, together with a low resistance during catheter movement.
3
Preferably, the distal tip is made of a relatively very elastic material as compared tot the intermediate and soft tips to improve the kink resistance. By providing the different regions of the distal end with different 5 characteristics the backup support and/or the alignment in the ostium is improved including the placement of the tip in a vascular system. In addition, damage to such system is minimised.
The catheter according to the invention is specifically 10 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.
Preferably, the soft tip comprises a top layer of a soft material, more preferably a soft polyamide. The use of 15 this soft material has proven to result in a very flexible tip and to minimize damage to the vascular system when moving the catheter. A soft polyamide that can be used for the catheter according to the present invention is PEBAX®. Preferably, the intermediate tip and/or the distal tip 20 comprise a rigid polymer. More preferably, the rigid polymer comprises fillers, most preferably polyamide (Vestamid®) . Alternatively, polyamide and/or PEBAX® is used.
Preferably, the top layer of the soft tip and other tips comprise the materials mentioned above. According to 25 the invention it is also possible for the top layer of the individual regions to only consist of the materials mentioned above.
Preferably, in an embodiment of the catheter according to the present invention the distal tip has a length in the 30 range of 5-20 cm, preferably 10-15 cm and most preferably has a length of about 10 cm. Experiments have shown that most preferably a length of 10 cm provides the highest manoeuvrability of the catheter during movement of the 4 catheter in a vascular system, and at the same time minimizes damage to the vascular system due to these movements. Specific dimensions of the catheter depend on the required backup support and/or the (local) anatomic shape.
5 In an advantageous preferred embodiment of the catheter according to the present invention the reinforcement layer comprises so-called braiding and the top layer extends between the braiding.
By providing top layer material between the braiding 10 the characteristics of the catheter are improved. In known catheters material between the braiding does not origin from the top layer. In the catheter according to the invention this material is provided between the braiding using a heat shrink or pressure, for example.
15 The present invention also relates to a method of making a guiding and/or diagnostic catheter as described above, comprising the steps of: providing the catheter with an elongate tube; locally at the distal end of the catheter removing 20 material from and/or preventing material to be provided on the top layer of the tube; replacing the removed material with, and/or placing, a different material.
Such a method provides the same effects and/or 25 advantages as those mentioned for the guiding and/or diagnostic catheter. Preferably, the top layer is locally removed at the distal end of the catheter. More preferably, material is also removed from between the braiding of the reinforcement layer. For the purpose of this application 30 removing material includes removal of material as well as the prevention of material being provided during the production of the catheter according to the present invention .
5
Preferably, the entire top layer is removed with the method according to the present invention. Removal of the top layer of an already produced tube can be achieved by etching, laser ablation, water jets, dissolving material, or 5 by an appropriate heat treatment, for example.
In a preferred embodiment according to the present invention replacing the removed material includes providing a heat shrink tubing, injection molding and/or dipping to locally define the catheter characteristics.
10 By removing material and providing a heat and shrink tubing the characteristics, like stiffness of the region, can be defined locally depending on the function of this specific region of the catheter. This enables providing a dedicated catheter. Alternative ways to replace the material 15 according to the present invention include the use of a dipping process, evaporation of fluid of a dissolved plastic, and injection moulding, for example. Also, other processes to replace material can be used, using pressure, for example. Preferably, the material of the top layer 20 extends between the braiding of the reinforcement layer.
This shows a relevant improvement of the characteristics of the catheter that is achieved.
In a preferred embodiment according to the present invention during locally removing material from the top 25 layer slots are provided that are filled, when replacing the removed material, with a different material.
By providing slots it is possible to design the characteristics of this region of this distal end of the catheter relating to the desired characteristics, like 30 stiffness and flexibility. The amount, dimensions and/or orientation of the slots are relevant for the characteristics of this region and should be designed depending on the purpose. Slots can be provided by etching 6 and/or by using mechanical techniques, such as water jets and/or punch rod. Preferably, the diameter or size of the slots is smaller than the size of the braiding wires in the reinforcement layer.
5 Alternatively, or in combination with the above approach, when removing material from the outer or top layer some parts of the former material are kept. Next, the final top layer material is provided. The resulting catheter according to the invention comprises alternately relatively 10 hard and relatively soft parts. Preferably, over the entire outer surface the final top layer material is provided.
In a preferred embodiment according to the present invention replacing the removed materials involves providing cross linkers which can be activated to change catheter 15 characteristics.
By activating the cross linkers the flexibility of the region provided with the cross linkers and the top coat material will change. The activation step can be provided using UV light, laser, X-ray or by using a chemical source, 20 for example.
In a further preferred embodiment according to the present invention during replacing the removed material hard and soft areas are provided.
By providing hard and soft areas in the top layer of a 25 tip region of the distal end of the catheter the characteristics of this region can be manipulated. Preferably, these hard and soft areas comprise alternately provided hard and soft rings. The dimensions and number of these rings determine, together with the material that is 30 provided, the characteristics of the catheter region. This provides sufficient freedom to design the catheter according to its needs. For example, by changing the frequency of the hard and soft rings, the flexibility in axial direction of 7 the catheter of this region of the distal end can be manipulated.
In a further preferred embodiment according to the present invention during the providing of the catheter the 5 angle of the reinforcement wire in the reinforcement layer is locally adjusted.
By providing a reinforcement layer that is locally provided with a different angle, the flexibility of this reinforcement layer is also locally adjusted. The 10 reinforcement layer comprises SS304 material, for example. The thickness of the wires in the reinforcement layer is 0.01-0.20 mm and have a width of 0.05-20 mm, for example. Other dimensions are also possible depending on diameter and wall thickness, for example. Typical angles for the wires 15 are for guiding catheters 30-80 degrees and for diagnostic catheters 20-70 degrees. Also other angles are possible depending on the specific use, diameter and wall thickness, for example. During a treatment of the catheter in accordance with the invention the braiding wires are kept in 20 place. For example, when performing a heat treatment spools can be used with an opposite field to prevent heating of the wires so that they maintain their desired position.
In a further preferred embodiment according to the present invention during the providing of the catheter 25 locally the top layer is omitted.
By preventing the top layer to be provided on a part of the catheter the actual removal of material is not required. This results in an efficient making of the catheter according to the present invention. This can be achieved by 30 using intermittent extrusion with one material stream, or by shielding sections on top of the reinforcement layer to prevent the forming of a top layer thereon, for example.
8
In a further preferred embodiment according to the present invention during the providing of the catheter the top layer is prevented to strongly adhere to the other layers of the catheter.
5 By preventing a strong adherence of a top layer to the reinforcement layer in one or more specific locations of the distal end, the material at these locations can be removed relatively easy. For example, the prevention of a strong adherence can be achieved by applying oil, grease or an 10 alternatively bad adherent solution on top of a reinforcement layer before the top layer is provided. Removing the material ad these locations is relatively easy and after cleaning the removed material can be replaced by a different material with the desired characteristics.
15 Further advantages, features and details of the invention are elucidated on basis of preferred embodiments thereof, wherein reference is made to the accompanying drawings : figure 1, a catheter according to the present 20 invention; figure 2, a detail of the distal end of the catheter of figure 1; figure 3, a cross section of the catheter of figure 1.
25 A guiding catheter 2 (figure 1) comprises a proximal end 4 and a distal end 6. Proximal end 4 and distal end 6 are connected by tubing 8.
Distal end 6 (figure 2) starts from basic polymer material 10 with a distal tip 12 of a relatively high 30 elastic stiff material. The next part of distal end 6 is the intermediate tip 14 of a relatively stiff material. In the illustrated embodiment the stiff material of intermediate tip 14 is similar to the body material of the body part 10.
9
The outer end of distal end 6 is soft tip 16 that comprises a soft material without reinforcement, at least not in the illustrated embodiment. For the illustrated embodiment of catheter 2 radial stiffness of body part 10 and distal tip 5 12 is about 50 N/mm and bending stiffness between 6.0 and 10 N/mm, for the intermediate tip 14 radial stiffness is about 27 N/mm and bending stiffness is about 0.5-4 N/mm, and for the soft tip 16 radial stiffness is about 0.5 N/mm and bending stiffness is about 0.05-0.25 N/mm.
10 In an embodiment of catheter 2 (figure 3) the reinforcement layer comprises braiding 18. Towards the outside 20 of catheter 2 is provided top layer 22. Towards the inside 24 of catheter 2 is provided inside inner layer 26. Material of top layer 22 extends between braiding 18 15 over a part of the length of catheter 2. Optionally, in case when removing material to enable providing top layer 22 some parts of the former material 28 are kept in place. This provides relatively hard and relatively soft parts of the catheter 2. The outside 20 of catheter 2 is smooth as top 20 layer 22 extends over the entire surface area of catheter 2.
The process for making catheter 2 comprises a number of steps that are known to the skilled person. In addition to these steps locally material of the top layer is removed and/or providing material at these locations is prevented.
25 Specific material realizing the desired characteristics of specifically the distal end 6 of catheter 2 replaces the original material.
In use catheter 2 provides an optimal back-up support, especially for the guiding catheter 2, and a shape that can 30 be straightened relatively easy for easy loading of the catheter over the guide wire into the vascular system, optimal alignment of the tip to the local take-off angle of 10 the coronary artery and an improved a-traumatic distal end 6 of catheter 2.
The present invention is by no means limited to the above described preferred embodiments thereof. The rights 5 sought are defines by the following claims within the scope of which many modifications can be envisaged. The means and method steps described above can be applied to the distal end, on one or more of the parts or sections thereof.
11
Clauses 1. Catheter comprising an elongate tube having a proximal and a distal end, and an outer and an inner diameter, 5 wherein: the tube comprising at least one plastic inner layer, at least one reinforcement layer, and at least one plastic top layer; and the distal end comprising, in the direction of the 10 distal end towards the proximal end, a soft tip, adjacent to the soft tip an intermediate tip, and separated from the soft tip by the intermediate tip a distal tip, wherein the tips are provided with different characteristics relating to the resistance 15 against bending and/or positioning and/or relaxation of the catheter in a vascular system.
2. Catheter according to clause 1, wherein the distal end gradually becomes softer towards the soft tip.
20 3. Catheter according to clause 1 or 2, wherein the soft tip comprises a top layer of a soft material, preferably a soft polyamide.
25 4. Catheter according to clause 1, 2 or 3, wherein the intermediate tip and/or distal tip comprising a rigid polymer .
5. Catheter according to clause 4, wherein the rigid polymer 30 comprises fillers.
12 6. Catheter according to any of the clauses 1-5, wherein the distal end is relatively elastic as compared to the intermediate and soft tips.
5 7. Catheter according to any of clauses 1-6, wherein the distal tip has a length in the range of 5-20 cm, preferably 10-15 cm, and most preferably has a length of about 10 cm.
10 8. Catheter according to any of clauses 1-7, wherein the reinforcement layer comprising braiding and wherein the top layer extends between the braiding.
9. Reinforced catheter according to clause 1, wherein the 15 catheter is a guiding and/or diagnostic catheter.
10. Method of making a catheter according to any of the clauses 1-9, comprising the steps of: providing the catheter with an elongate tube; 20 - at the distal end of the catheter locally removing material from and/or preventing material to be provided on the top layer of the tube; and replacing the removed material with and/or placing a different material.
25 11. Method according to claim 10, wherein replacing the removed material includes providing a heat shrink tubing, injection molding and/or dipping to locally define the catheter characteristics.
30 12. Method according to clause 10 or 11, wherein during locally removing material from the top layer slots are 13 provided that are filled when replacing the removed material.
13. Method according to clause 10, 11 or 12, wherein 5 replacing the removed material or placing material involves providing cross linkers which can be activated to change catheter characteristics.
14. Method according to clause 13, further comprising the 10 step of activating the cross linkers.
15. Method according to any of the clauses 10-14, wherein during replacing the removed material or placing material hard and soft areas are provided.
15 16. Method according to clause 15, wherein the hard and soft areas comprise alternately provided hard and soft rings.
17. Method according to any of the clauses 10-16, wherein 20 during the providing of the catheter the angle of a reinforcement wire in the reinforcement layer is locally adjusted.
18. Method according to any of clauses 10-17, wherein during 25 the providing of the catheter locally the top layer is omitted.
19. Method according to any of the clauses 10-18, wherein during the providing of the catheter locally a different 30 material is provided.
14 20. Method according to any of the clauses 10-19, wherein during the providing of the catheter the top layer is prevented to strongly adhere to the other layers.
Claims (20)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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NL2004937A NL2004937C2 (en) | 2010-06-22 | 2010-06-22 | Catheter with locally adjusted characteristics and method therefor. |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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NL2004937A NL2004937C2 (en) | 2010-06-22 | 2010-06-22 | Catheter with locally adjusted characteristics and method therefor. |
NL2004937 | 2010-06-22 |
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NL2004937C2 true NL2004937C2 (en) | 2011-12-27 |
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NL2004937A NL2004937C2 (en) | 2010-06-22 | 2010-06-22 | Catheter with locally adjusted characteristics and method therefor. |
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995029726A1 (en) * | 1994-05-02 | 1995-11-09 | Medtronic, Inc. | Improved method of catheter segment attachment |
WO1995029725A1 (en) * | 1994-05-02 | 1995-11-09 | Medtronic, Inc. | Improved method of soft tip attachment for thin walled catheters |
US5811043A (en) * | 1995-01-04 | 1998-09-22 | Medtronic, Inc. | Method of soft tip forming |
EP1004327A1 (en) * | 1998-11-09 | 2000-05-31 | Medtronic Inc. | Soft tip guiding catheter and method of fabrication |
-
2010
- 2010-06-22 NL NL2004937A patent/NL2004937C2/en active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995029726A1 (en) * | 1994-05-02 | 1995-11-09 | Medtronic, Inc. | Improved method of catheter segment attachment |
WO1995029725A1 (en) * | 1994-05-02 | 1995-11-09 | Medtronic, Inc. | Improved method of soft tip attachment for thin walled catheters |
US5811043A (en) * | 1995-01-04 | 1998-09-22 | Medtronic, Inc. | Method of soft tip forming |
EP1004327A1 (en) * | 1998-11-09 | 2000-05-31 | Medtronic Inc. | Soft tip guiding catheter and method of fabrication |
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