ES2327588B1 - EXTRA-LONG VASCULAR INTRODUCTION CATHETER. - Google Patents

Abstract

Vascular introducer catheter extra large.

The present invention consists of a catheter extra-long vascular structure introducer thin tubular, being the size of the introducer and its length according to the type of catheter and desired approach, which is conceived to intravascular treatment of infrarenal arterial disease, by radial approach, allowing its introduction through balloon catheters (monorail or coaxial type), stents (self-expanding or by balloon), or medication (fibrinolytic, platelet antiaggregants Gp IIb-IIIa, heparin), and characterized by its thin tubular structure resistant to torsion and strangulation and provided with distal flexibility to  avoid difficulties in performing the technique, and to include a flexible tube or sheath that has a medium segment of greater flexibility between two segments of greater hardness in order to resist strangulation in areas of high angulation.

Description

Vascular introducer catheter extra large.

The present invention as expressed in the set forth in this specification, refers to a catheter extra-long vascular structure introducer thin tubular, the diameter of the introducer being from 1.32 to 2.31 mm (4 to 7 French) and its length between 150 and 300 cm. according to the type of catheter and desired approach.

The invention falls within the technical sector of The medical instrumentation manufacturing industry.

The use of catheters is common introductors These are used to facilitate the introduction of other catheters, guides and medication in the vascular system of patients with arterial lesions, thus reducing possible trauma to the access point when serving as support for others catheters They are also used to achieve visualization. selective distal arterial bed by contrast injection through

So far there are serious difficulties for the therapeutic approach of arterial lesions in said locations, from radial and brachial, being only possible a diagnostic attitude, due to the lack, currently, of introducer catheters with sufficient length to reach lesions, with the necessary therapeutic tools in the intervention of said peripheral lesions in arteries of infrarenal location.

There are currently several modalities of introductory catheters available in the market for diagnosis and intravascular treatment of arterial disease, the maximum length of said catheters being approximately 90 cm., So the approach is practically impossible Therapeutic renal arteries and arterial sector infrarenal peripheral from the radial track.

The "vascular introducer catheter extra-long "presented with this invention, can be used in various diagnostic interventions and intravascular treatment of peripheral arterial disease of renal and infrarenal location from a preferential approach radial, using the brachial route in cases where it is not possible the radial pathway, including lesions in renal, iliac arteries, femoral, popliteal and infrapopliteal sector, such as tibial and peroneal arteries. In addition, it could be used for remote treatment of other lesions from the femoral approach (cerebral arteries, hemodialysis fistula treatment, or other apps).

Thus, the "vascular introducer catheter extra-long "proposed in this document, It is conceived for the intravascular treatment of arterial disease infrarenal, by radial approach, allowing the introduction through balloon catheters (monorail or coaxial type), stents (self-expanding or by balloon), medication (fibrinolytic, Gp platelet antiaggregants IIb-IIIa, heparin), etc.

The radial approach in the treatment of coronary heart disease using percutaneous techniques (angioplasty balloon, coronary stent, etc.) reduces complications Vascular associated with punctures that are performed in the management of these lesions on a regular basis (via femoral artery retrograde, antegrade femoral artery, brachial artery and artery axillary), such as bruising, pseudoaneurysms, abscesses, rupture vascular, arteriovenous fistulas, and others. It also allows perform prolonged procedures such as local fibrinolysis, with significant reduction of vascular complications associated with puncture.

In addition to avoiding vascular complications, it presents other types of added advantages such as the possibility of early ambulation of the patient and decreased stay hospital with reduction of the total costs of the intervention.

By way of description of the "catheter introducer  extra-long vascular "this is characterized by its thin tubular structure resistant to torsion and strangulation and for being provided with distal flexibility to avoid difficulties in performing the technique, being the diameter of the introducer from 1.32 to 2.31 mm. (4 to 7 French) and its variable length depending on the type of catheter and the desired approach, this being equal to or greater than 150 cm., for renal treatment and iliac, 200 cm. for the treatment of femoral arteries, and of 250 cm for the infrapopliteo sector treatment, being able to reach 300 cm in extreme cases.

Likewise, the catheter object of the present invention includes a flexible tube or sheath that has a segment  medium of greater flexibility between two segments of greater rigidity in order to resist strangulation in large areas angulation such as the path of the subclavian arteries to their entrance to the thoracic aorta, from the radial track, retaining its thrust, and being resistant to torsion and strangulation of catheter at this level.

Then, to facilitate a better understanding of this descriptive report and being an integral part of the same, some figures are accompanied in which with character Illustrative and not limiting, the following has been represented:

Figure 1.- Shows a main elevation view of "Extra-long vascular introducer catheter" according to the present invention, represented with a vessel dilator  blood.

Figure 2.- Longitudinal section view of the "Extra-long vascular introducer catheter", to level of its distal segment of the outer layer (19).

Figure 3.- Perspective view of the "Catheter extra-long vascular introducer ", at the level of your middle segment of the outer layer (18).

The following details are numbered in them:

one.

Main body of the catheter.

2.

Blood vessel dilator

3.

Distal end of the introducer

Four.

Proximal end of the introducer

5.

Case

6.

Sheath

7.

Proximal end of the tube

8.

Distal tube end

9.

Radiopaque marker

10.

Catheter passage

eleven.

Inner sheath layer

12.

Helical sheath guide

13.

Sheath outer layer

14.

Internal surface of the inner layer

fifteen.

External surface of the inner layer

16.

Uniform spaces between filament turns spiral

17.

Proximal segment of the outer layer

18.

Middle segment of the outer layer

19.

Distal segment of the outer layer

twenty.

Polyvinyl tube

twenty-one.

Three way stopcock

22

Soft tip conical end atraumatic

By way of example of preferred embodiment of the one of the "vascular introducer catheter extra-long "in Figure 1 the body is shown main catheter (1) represented with a vessel dilator blood (2).

The main body of the catheter (1), has a distal end (3) that is inserted into the patient and one end proximal (4), which is kept out of the patient.

Thus the main body of the catheter (1) is constitutes by a housing at its proximal end (4), which has housed a housing (5) containing a hemostatic valve, may consist of other types of valves such as the Tuohy-Borst (rotary valve in the form of "Y"). With these valves blood flow is prevented when catheters and guides are introduced through it.

The housing (5) is connected to a pipe polyvinyl (20), which in turn connects to a stopcock three ways (21), in order to infuse fluids through it, with different objectives, such as purging the catheter, introducing contrast, medication, saline or whatever is deemed necessary by the subject matter specialist

The main body of the catheter (1) is composed of a sheath (6), distal to the proximal segment (4) of the catheter
(one).

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The sheath (6) has a proximal end (7) and a distal end (8), having a radiopaque marker in the latter (9) that can be done in gold, platinum or other material radiopaque

The main body of the catheter (1) includes also a passage (10) that extends through the catheter parallel to its longitudinal axis.

A dilator (2) penetrates the housing (5), by the valve, through the passage (10) and exits at the distal end (8) of the sheath (6), with a length between 5-10 cm. superior to the distal end of the catheter (3).

The dilator (2) has the conical end of atraumatic soft tip (22) to facilitate the introduction of main body of the catheter (1) in the patient's blood vessel. Once the distal end (3) of the catheter is inserted into the vessel of the patient, the dilator is removed (2).

On the other hand, the sheath (6) is composed of a inner layer (11), a helical guide (12) around the layer internal, and an external layer (13).

As for dimensions, the "Catheter extra-long vascular introducer "object of this invention comprises a thin tubular structure being the diameter of the introducer of 1.32 mm. to 2.31 mm. (4 to 7 French) and its variable length, depending on the type of catheter and the desired approach, being equal to or greater than 150 cm. for renal and iliac treatment, 200 cm for femoral artery, 250 cm. for the treatment infrapopliteo, and 300 cm. in extreme cases, also depending its length of the patient's height and the tortuousness of the aorta. Therefore, the different catheter lengths available according to this invention they are greater than 150 cm. (150, 200, 250 and 300 cm.).

As an example, a 2.0 introducer catheter mm (6 French), will have an internal diameter of about 2.20 mm., As usual and an external diameter of about 2.6-2.77 mm.

The inner layer and the outer tube will have the same length, the helical filament being one length Minor.

The material used for the realization of the sheath (6) must be resistant to torsion and strangulation retaining its flexibility, so materials will be used flexible as polyurethane, low durometry nylon, polyethylene Low density, soft pebax® or any elastomeric material.

The inner layer of the sheath (11) will consist of a  flexible internal coating like PTFE (polytetrafluoroethylene), which will be the inner surface of the layer internal (14) and will have a uniform internal diameter in range between 1.32 mm. to 2.31 mm. The wall thickness of the inner layer will be between 0.036-0.040 mm However, these dimensions are expressed by way of example, since the mentioned diameter will adapt to the specific application that It is intended with the present invention. The aforementioned internal surface It must be done in a way that is smooth and non-porous.

The spiral filament (12) is found rolled on the outer surface of the inner layer (15), fixed to it by compression. In addition said spiral presents various turns that include uniform spaces between the turns of the spiral The material that will be composed will be a flat guide of stainless steel, or other metals or materials biologically compatible. The stainless steel flat guide will be around 0.074-0.080 mm. thick and around 0.25-0.35 mm. Wide.

The end of the spiral will end approximately between 5-10 mm. of the distal edge of the inner layer and 2 mm. from the proximal edge of the sheath.

Preferably between the filament turns spiral will have uniform spaces of approximately 0.25-0.35 mm. (16). Although non-uniform distances, or variations in the spiral turns can also be used. The objective of this filament is to give greater consistency to the catheter.

The outer layer of the sheath (13) can be perform in a heat moldable polymeric material such as nylon, so that it sits on the outer face of the spiral filament and the spaces between the spiral turns. The thickness before melting of the wall of the nylon tube will be approximately between 0.16-0.24 mm.

The outer layer will be divided into three segments, a proximal segment (17) of length between 40-70 cm., But preferably 45 cm. and a durometry in the range between 65-80 of the Shore D scale, although preferably 70. Durometry is a term used to refer to the resistance of materials to deformation, under a load. The Shore D scale is a measure of the hardness of plastic materials. A material with high durometry is relatively inflexible (hard), while a low durometry is
flexible.

Subsequently and distal to the proximal segment (17) a middle segment (18) of length comprised is positioned between 30-60 cm., but preferably 45 cm. Y which will have a durometry less than the previous segment, with the objective of achieving greater flexibility and resistance to strangulation of the catheter at this level, which is the most important step tortuous, through which the catheter sails, to the descending aorta. This should be adapted when navigating the right radial artery; by the curvature of the right subclavian artery, the artery Unnamed and the entry into ascending aorta, and when navigating the left radial artery due to the tortuosity of the artery left subclavian, and the entrance at the level of the aorta falling.

Therefore, the middle segment (18) must be more flexible through a range of durometry between 30 and 65 of the Shore D scale, although preferably 55, to get that the sheath (13) can bend without being strangled, supporting angulations greater than 100º.

Successive to this middle segment (18), it position the distal segment (19), which has a similar stiffness to the proximal segment (17). The length of this distal segment (19) will depend on the length of the catheter used.

For example, the approximate length of the segment  distal (19), could be 60 cm. for an introducer catheter extra-long vascular of 150 cm., of 110 cm. for one 200 cm., 160 cm. for one of 250 cm. and 210 cm. for a 300 cm catheter.

Alternatively you can carry out some hydrophilic coating on the distal edge of the introducer (3) in a section of 40 cm. measured from its end.

It is not considered necessary to extend this  description so that any subject matter expert understands the scope of the invention and the advantages derived therefrom. The terms used to describe the invention have been used descriptively and not in terms of limitation, thus, the materials, shape, size or systems to reinforce the sheath and arrangement of the elements as well as their terminations they will be susceptible of variation as long as it does not imply an alteration in the essentiality of the invention.

Claims (2)

1. Extra-long vascular introducer catheter for diagnosis and intravascular treatment of peripheral arterial disease of renal and infrarenal location from a preferably radial approach, using the brachial route in cases where the radial route is not possible, characterized by being carried out from of an introducer catheter whose main characteristic is flexibility, of variable length but between 150 and 300 cm., and diameter of the introducer of 1.32 mm. at 2.31 mm (4 to 7 French). 2. Vascular introducer catheter extra-long according to claim 1 because it incorporates a sheath, composed of an inner layer, a helical guide around the inner layer, an outer layer, and that presents a middle segment of greater flexibility between two segments of greater rigidity.