FR2904562A1 - Ultra long vascular introducer catheter for diagnosing and providing intravascular treatment of arterial disease, has structure resisting torsion and strangling and providing distal flexibility, where catheter has diameter of specific value - Google Patents

Abstract

The catheter (1) has a thin tubular structure that resists the torsion and strangling and provides distal flexibility. A flexible tube or case (6) is distal with respect to a proximal end (4) of the catheter, and includes a more flexible median part (18) between two parts of higher hardness to resist the strangling in zones of large angulation. The catheter has a length 150 to 300 centimeters, and has a diameter of 4 to 7 French. The catheter provides intravascular treatment for the arterial diseases by a radial path.

Description

 CATHETER INTRODUCER VASCULAR ULTRA LONG

The present invention, as indicated by the title of the description, relates to a patent on an ultra-long vascular introducer catheter, with a fine tubular structure. The dimensions of the introducer are between 4 and 7 French in diameter and between 150 and 300 centimeters in length, depending on the type of catheter and the desired approach.

The invention can be classified in the technical field of the medical device manufacturing industries.

The use of catheter introducers is common. They are used to facilitate the introduction of other catheters, guides and drugs into the vascular system of patients with arterial lesions, thereby reducing the risk of trauma at the point of introduction, with the introducer catheter operating to maintain other catheters. Similarly, they are used to allow selective visualization of the wall of the distal artery with the injection of tracer agents.

Until now, there have been serious difficulties in the therapeutic approach of arterial lesions from the radial and brachial pathways, only a diagnosis being possible, due to the absence of introductory catheters of sufficient length to reach the lesion and allow the intervention of the necessary therapeutic tools on peripheral lesions in infrared arteries.

Currently, many catheter introducers are available on the market for intravascular diagnosis and treatment of arterial diseases, with a maximum length of the order of 90 centimeters. Thus, the radial therapeutic approach is virtually impossible in peripheral renal and infrarenal arteries.

The invention, said ultra-long vascular introducer catheter, can be used in numerous interventions concerning diseases of the peripheral renal and infrarenal arteries, by a radial route or by using the brachial approach when it is impossible to access the radial, including the renal, iliac, femoral, popliteal and fibular arteries. In addition, it can also be used for the treatment of other distant lesions by the femoral route (cerebral arteries, treatment of fistulas in hemodialysis and other applications).

Thus, the ultra long vascular introducer catheter proposed herein has been designed for the intravascular treatment of intrarenal arterial diseases by the radial route, to allow the introduction of balloon catheters (monorail or coaxial type), stents (self-expanding or ballooning). ), medicines

(fibrinolytic agents, Gp 11b-111a platelet inhibitors, heparin), etc.

The radial pathway in the treatment of coronary heart disease using percutaneous techniques (angioplasty balloon, coronary stent, etc.) can reduce the complications associated with vascular punctures performed during the usual treatment of these lesions retrograde femoral artery, anterograde femoral artery, artery brachial and axillary arteries), such as hematomas, pseudoaneurysms, abscesses, vascular ruptures, arteriovenous fistulas, and others. In addition, it allows longer interventions, such as local fibrinolysis, with a significant decrease in vascular complications associated with puncture.

In addition to avoiding vascular complications, there are other additional benefits, such as the possibility of faster recovery of patients, and shorter hospital stays with lower operating costs.

In descriptive terms, the ultra long vascular introducer catheter has a thin tubular member resistant to twisting and constriction.

It has distal flexibility to prevent difficulties during interventions. The introducer has a diameter of 4 to 7 French and its length varies depending on the type of catheters and the desired approach, is equal to or greater than 150 centimeters for renal or iliac treatments. The introducer measures 200 cm for the treatment of the femoral arteries and 250 cm for the treatment of the lower popliteal area, reaching up to 300 cm in extreme cases.

Thus, this innovative catheter includes a holster or flexible tube that has a more flexible medial portion between the torsion-resistant portions in areas of high angulation as in the path of the subclavian arteries to the entrance of the thoracic aorta, since the radial, retaining the thrust and resisting torsion and strangulation at this point.

In what follows, in order to facilitate a better understanding of the description, it is accompanied by figures which form an integral part thereof, on which is shown in an illustrative and nonlimiting manner the following:

FIG. 1: a general view of the ultra-long vascular introducer catheter according to the present invention, represented with a dilator of blood vessels,

FIG. 2: view of the main part of the ultra-long vascular introducer catheter with the characteristics of the distal part,

- Figure 3: perspective view of the ultra long vascular introducer catheter with the characteristics of the middle part.

The following features have been numbered:

1. Main body of introducer

2. Dilator of blood vessels 3. Distal end of the introducer

4. Proximal end of the introducer

5. Carcass

6. Case or flexible tube

7. Proximal end of the tube 8. Distal end of the tube

9. Radiopaque marker 10. Catheter passage

11. Inside wall of the tube

12. Helical tube guide

13. Outside case of the tube 14. Internal surface of the inner wall

15. External surface of the inner wall

16. Even spacing between spiral filaments

17. Proximal portion of the outer wall

18. Medial part of the outer wall 19. Distal part of the outer wall

20. Polyvinyl tube

21. Three-way valve

22. Atraumatic, conical, blunt tip.

Figure 1 shows, as an example of a preferred use of the ultra-long vascular introducer catheter, the main body of the introducer (1), shown with a dilator of blood vessels (2).

The introducer (1) has a distal end (3) which is inserted into the patient, and a proximal end (4) which remains outside the patient.

Thus, the main body of the catheter (1) is composed of a carcass (5) at the proximal end (4), containing the hemostatic valve - other types of valve that can be used as a valve Tuchy-Borst (valve rotating, in Y). These valves slow down the blood flowing outward when introducing catheters and guides.

The carcass (5) is connected to a polyvinyl tube (20) itself connected to a three-way valve (21) for infusing liquids, with various purposes, such as purging the catheter, introducing a tracer, medications or saline solutions or anything that is deemed necessary by the specialist.

The main body of the catheter (1) comprises the holster or flexible tube (6), distal to the proximal portion (4) of the catheter (1). The tube (6) has a proximal end (7) and a distal end (8) which has a radiopaque marker (9) which may be gold, platinum or other radiopaque material.

Thus, the catheter (1) has a passage (10) extending through the catheter parallel to its longitudinal axis. A dilator (2) penetrates the carcass (5) through the valve, through the passage (10) and exits at the distal end of the tube (6), with a length of 5 to 10 cm beyond the distal end (3) of the catheter. The dilator (2) has a conical shape (22) with a gentle atraumatic tip to facilitate penetration of the catheter (1) into the patient's blood vessel. The dilator (2) is removed once inserted at the distal end (3) into the vessel.

On the other hand, the tube (6) is composed of an inner wall (11), a helical guide (12) surrounding the inner wall and an outer tube (13).

In terms of size, the ultra long vascular introducer catheter described here is a tapered tubular structure, the diameter of the introducer extending between 4 and 7 French and its length varying depending on the type of catheter and the desired approach. The length is variable, equal to or greater than 150 cm for the renal or iliac treatments, 200 cm for the femoral artery, 250 cm for the lower popliteal treatments and 300 cm for the extreme cases, also depending on the size and patient weight and difficulties of the aorta. Thus, different lengths of catheters are available with dimensions greater than 150 cm

(150, 200, 250 and 300 cm).

For example, a 6 French diameter introducer has a standard internal diameter of 2.20 mm (0.087 ") and an outer diameter of 2.6 to 2.77 mm (0.101" to 0.111 ").

The length of the inner wall and the outer tube are similar, and in direct relation to the length of the catheter. On the other hand, the helical filament is smaller.

The material used for the manufacture of the tube or case (6) must be resistant to twisting or strangulation while remaining flexible Thus, flexible materials such as polyurethane, low durometer nylon, low density polyethylene, flexible pebax, or any other elastomeric material are used.

The inner wall (11) of the tube (6) has a flexible inner lining, such as

PTFE (polytetrafluoroethylene) which forms the inner surface (14) and has a uniform inner diameter of between 4 and 7 French. The thickness of the inner wall varies between 0.036 and 0.040 mm (0.0014 "and 0.0015"). Nevertheless, these dimensions are given by way of example, because the diameter is adapted according to the specific use of the invention. The inner surface area is expected to be rather smooth than porous.

The spiral filament (12) is wrapped around the outer surface of the inner wall (15) and secured by compression. In addition, the turns are spaced evenly. The material used is composed of a smooth stainless steel flat wire or other metal, or a biologically compatible material. The stainless steel flat wire has a thickness of 0.074 to 0.080 mm (0.0028 "to 0.0031") and a width of 0.25 to 0.35 mm (0.0097 "to 0.0136). ").

The end of the spiral is about 5 to 10 mm from the distal edge of the inner wall and 2 mm from the proximal edge of the tube

Preferably, the turns of the spiral filaments are uniformly spaced about 0.25 to 0.35 mm (0.0097 "to 0.0136") (16).

However, non-uniform distances or variations between the turns may also occur. The function of the filament is to give a better consistency to the catheter.

The outer tube (13) may be made of a heat-formable polyamide material such as nylon, so as to press against the outer surface of the spiral filament and the turns unite with the rough outer surface of the inner wall. The thickness before removal of the wall of the nylon tube is between 0.16 mm and 0.24 mm.

The outer wall is divided into three parts, a proximal part (17) measuring between 40 and 70 cm long, and preferably 45 cm, with anurometry between 65 and 80 on the short scale D, and preferably 70. Durometry is a term used for the resistance of materials to deformation under pressure. The short scale D is a measure of the hardness of plastics. Any material with high durometry is relatively hard, while low durometer materials are more flexible.

Subsequently, the medial portion (18), distal to the proximal portion (17), has a length of between 39 and 60 cm, and preferably 45 cm, its durometry is lower than that of the previous part to obtain greater flexibility and resistance of the catheter to torsion at this point, which is the most tortuous passage through which the catheter passes down the aorta. Thus, it must adapt as it passes through the right radial artery, the curve of the right subclavian artery, the innominate artery, and the entrance of the rising aorta, and crossing the left radial artery. , because of the winding of the left subclavian artery and the entrance of the descending aorta.

Thus, the middle portion (18) will be more flexible with a hardness of between 30 and 60 on the short scale D, and preferably 55, so that the tube (13) can bend without constriction and support angles greater than 100 °.

Following the medial portion (18) is the distal portion (19) with a hardness similar to that of the proximal portion (17) already defined. The length of this portion (19) depends on the length of the catheter used as a function between the distal edge of the medial portion (18) and the distal edge (3) of the catheter

(1) ^.

For example, the approximate length of the distal portion (19) may be 60, 110, 160 and 210 cm for an ultra-long vascular introducer catheter of 150, 200, 250 and 300 cm, respectively.

Alternatively, a hydrophilic cover can be used on the distal edge of the introducer (3) over an area of 40 cm measured from the tip. This description need not be more extensive since anyone skilled in the art will understand the scope of the invention and the benefits that flow from it. The terms used to describe the invention have been in a descriptive and limited sense, so that the materials, shapes, dimensions, or tube reinforcement systems and component layouts, as well as the ends, can be modified without it does not affect the substance of the intention.

Claims (2)

1. Ultra long vascular introducer catheter for the diagnosis and intravascular treatment of renal and infrarenal arterial diseases, preferably by the radial or brachial approach when the radial path is not possible, characterized by the use of a flexible introductory catheter resistant to twisting and constriction with a variable length of between 150 and 300 cm, and an introducer size of 4 to 7 French. 2. Ultra-long vascular introducer catheter according to claim 1, characterized in that its tube has a more flexible median portion between two parts of higher hardness designed to resist strangulation in areas of large angulation as in the path of Subclavian arteries to the entrance of the thoracic aorta, from the radial, retaining the thrust and resisting torsion and strangulation at this point.