DE102007036874A1 - Extra long vascular inserter catheter - Google Patents

Abstract

The invention relates to an "extra-long vascular inserter catheter" for intravascular diagnosis and / or treatment of peripheral arterial disease in renal and / or infrarenal areas, preferably in a radial or radial approach or by brachial approach. The inserter catheter according to the invention is characterized by a resistance to twisting and buckling and a variable length of between 150 and 300 cm, wherein the outer diameter is 4 to 7 French. As a result, intravascular treatment of infrarenal arterial diseases and the like is made possible, in which the introduction of balloon catheters, vascular prostheses, also called stents, drug treatments, etc. is made possible.

Description

The The present invention relates to an extra long vascular introducer catheter with a fine tubular Structure. The inserter has a size of 4 to 7 French and one Length between 150 and 300 cm on, depending the type of catheter and the desired purpose.

The Invention may be within the technical field of industrial Fabrication of medical instruments can be arranged (or classified).

The Use of inserter catheters is common. Inserter catheter will be used to insert other catheters, guides and drugs in the vascular system of patients with arterial lesions to facilitate in this way the possibility of trauma at the Access point because the inserter catheter supports other catheters. As well it is used for the selective visualization of distant arteries by means of Injecting a contrast agent.

So far There were considerable difficulties for the therapeutic treatment to arterial lesions by a radial, radial or brachial access, due to the non-existence of inserter catheters with a sufficient length only one diagnosis possible was. With the known inserter catheters, it was not possible to close the lesion reach, so that the required therapeutic tools not in peripheral lesions in infrarenal Arteries could intervene.

Present are on the market a variety of introducer catheters for intravascular Diagnosis and treatment of arterial disease with a maximum length of about 90 cm available. For this reason, the therapeutic treatment is in renal and peripheral infrarenal arteries virtually impossible.

The present invention of the "extra long vascular inserter catheter "can be used in a number of procedures at peripheral, renal and infrarenal arterial diseases where it is otherwise impossible to have peripheral, renal (kidney), to reach iliac, femoral, popliteural and fibular arteries. About that In addition, the catheter can also be used for the treatment of other, more distant lesions a femoral approach (cerebral arteries, treatment of fistulas in hemodialysis and other applications).

Accordingly was the "extra long vascular inserter catheter ", which is incorporated herein by reference is proposed, conceived for the intravascular treatment of infrarenal arterial diseases through an access in which the insertion of balloon catheters (monorail or coaxial type), vascular prostheses, Also called stents, (self-expanding or balloon), drug treatments (fibrinolytic additives, Gp IIb-IIIa platelet inhibitors, heparin), etc. is enabled.

Of the Access for the treatment of coronary disease using percutaneous techniques (angioplasty balloons, coronary vascular prostheses (stents), etc.) allows to reduce complications associated with vascular punctures if these injuries are treated regularly (retrograde femoral artery, antegrade femoral artery, brachial artery and axillary artery), such as hematomas, Pseudo-aneurysms, abscesses, vascular fractures, arteriovenous fistulas and other. About that In addition, the inserter catheter allows to carry out prolonged procedures, such as for example, local fibrinolysis, with a significant reduction of vascular complications associated with the puncture are.

Next avoidance of vascular Complications, the introducer catheter achieves other additional Benefits, such as the possibility a faster recovery of the patient and shorter hospital stays with reduced costs for the Intervention.

In descriptive words, the "extra-long vascular inserter catheter" designates a thin, tubular structure, which is resistant to twisting and buckling. He allows a distally located mobility to avoid difficulty in performing the Technology to avoid. The inserter is 4 to 7 French and its length varies dependent of the type of catheter and the intended treatment of greater or equal 150 cm for renal or iliac treatments. The inserter measures 200 cm for the Treatment of femoral arteries and 250 cm for the treatment of the deeper Popliteus sector, where it can reach 300 cm in extreme cases.

As well includes the catheter according to the invention a flexible shield or cover, which is a more flexible has middle section between slightly harder sections, to prevent buckling in these areas at larger angles as in subclavian arteries for entry into the thoracic aorta, and which is resistant to twisting and buckling at this point, with the introducer catheter maintaining propulsion during insertion.

The invention will be described with reference to an embodiment shown in the drawing game explained in more detail, but the invention is not limited thereto. In the drawing show:

1 a general view of an "extra long vascular inserter catheter" with the features of the invention, shown with a blood vessel dilator,

2 a main portion of the "extra-long vascular inserter catheter" with a detail of a distal segment,

3 a perspective view of the "extra long vascular inserter catheter" with details of a middle section.

As an example of a preferred application of the "Extra Long Vascular Inserter Catheter" 1 the main body 1 an introducer catheter with a blood vessel dilator 2 ,

The inserter 1 has a distal end 3 which is inserted into the patient, and a near end 4 which remains outside the patient.

As a result, the main body is 1 of the catheter from a connecting valve 5 at the near end 4 which has a hemostasis valve, other types of valves could be used, such as a Tuohy-Borst valve ("Y" rotating valve) .These valves prevent blood from escaping when inserted through the catheter and guidewires.

The connection valve 5 is with a polyvinyl tube 20 connected, which in turn with a three-way valve 21 is connected to introduce fluids for a variety of reasons, such as cleaning the catheter, introducing a contrast agent, drugs, saline solutions, or whatever is considered appropriate by the specialist.

The main body 1 The catheter has a flexible shaft or shield 6 on which of a near segment 4 of the catheter is spaced.

The shaft 6 has a near end 7 and a distal end 8th ; which is a radiopaque marker 9 which may be made of gold, platinum or other radiopaque material.

Likewise, the catheter has a passageway 10 which extends through the catheter parallel to its longitudinal axis.

A dilator 2 penetrates the connecting valve 5 through the valve and through the catheter passage 10 and comes from the distal end 8th of the shaft 6 with a length between 5 and 10 cm above the distal end 3 of the catheter.

The dilator 2 is cone-shaped (cone 22 ) with a soft a-traumatic nozzle to facilitate penetration of the catheter into the patient's blood vessel. Once the distal end 3 introduced into the vessel becomes the dilator 2 away.

On the other side is the shaft 6 from an inner situation 11 , a spiral guidewire 12 which the inner situation 11 surrounds, and an outer shaft 13 produced.

In Regarding the size of the "extra long vascular inserter catheter "as described here has a slender tubular Structure with the inserter between 4 and 7 French. French (FR) is a common one Dimension for the outside diameter tubular Items. 1 FR corresponds to 0.33 mm. The length The size of the introducer catheter will vary depending on the type of catheter and the desired Use varies. The length varies at equal or greater than 150 cm for renal or iliac treatments, 200 cm for femoral arteries, 250 cm for deeper lying Popliteus treatment and 300 cm for extreme cases, whatever the length and Size of the patient and the difficulty of reaching the aorta, what of the structure and the configuration of each aorta depends. As a result, they are different catheter lengths with a length greater than 150 cm available (150, 200, 250 and 300 cm).

For example For example, a 6 French introducer catheter has an inside diameter of 2.20 mm (0.087 ''), as is the standard corresponds, and an outer diameter from 2.6 to 2.82 mm (0.101 "-0.111").

The Length of inner layer and the outer shaft are similar and directly to the length of the Matched catheter. On the other side is the spiral wire smaller.

That for the shaft or the shield 6 used material must be resistant to twisting and buckling and still get some flexibility. Thus, flexible materials such as polyurethane, low hardness nylon, low density polyethylene, soft pebax, or any other elastomeric material are suitable.

The inner situation 11 of the shaft 6 has a flexible inner cover, such as PTFE (Polytetraflouräthylen), which the inner surface layer 14 is and has a uniform inner diameter that is between 4 and 7 French lies. The thickness of the inner layer is between 0.036 and 0.040 mm (0.0014 "to 0.0015").

Yet the dimensions are given here by way of example only, as the given Diameter exactly to the specific application of the present embodiment customized is. The inner surface area must be smooth and should not be too porous be.

The spiral wire 12 is around the outer surface of the inner layer 15 wrapped and secured by compression. In addition, the spiral is wound with uniform spacing between the individual turns. The material consists of a smooth stainless steel as flat wire or other materials or biologically compatible materials. The flat stainless steel wire is between 0.074 and 0.080 mm (0.0028 "to 0.0031") thick and about 0.25 to 0.35 mm (0.0097 "to 0.0136") wide.

The Ends of the spiral are about 5 to 10 mm from the distal edge of the spiral inner layer and 2 mm from the near edge of the shaft spaced.

Preferably, there are uniform spacings between the turns of the helical wire 16 from 0.25 to 0.35 mm (0.0097 "to 0.0136"). However, nonuniform distances or variations of the turns can also be used. The task of the wire is to give the catheter a greater consistency.

The outer shaft 13 For example, it may be formed of a thermoformable polyamide material, such as nylon, disposed on the outside of the helical wire and in contact with the outer surface of the inner layer at the inter-turns. The thickness is between about 0.16 to 0.24 mm (0.0062 "to 0.0093") prior to assembly with the nylon shaft.

The outer layer is divided into three segments; a near segment 17 with a length between 40 and 70 cm, preferably 45 cm, and a hardness in the range of 65 to 80 on the Shore D scale, preferably 70. Hardness is a term used to refer to the resistance of the material against Refer to deformations under tension. The Shore D scale is a measurement method for the hardness of plastics. Any material with high hardness is relatively hard, while materials with lower hardness are more flexible.

Subsequently and distal to the near segment 17 is a middle section 18 with a length between 30 and 60 cm, preferably 45 cm. The hardness of this range is lower than that of the above-described range to provide greater flexibility and greater resistance to kinking of the catheter in this region, which has the most turns and through which the catheter must be passed to the descending aorta. Consequently, it must be adapted as it is moved through the right radial artery; by the curvature or right subclavian artery, unknown artery or access to the ascending aorta, and when passing through the left radial artery due to the turns of the left subclavian artery and access to the descending aorta.

For this, the middle section 18 be more flexible and have a hardness of 30 to 65 Shore on the D scale, preferably 55, so that the outer shaft or the shield 13 remains flexible without being pinched off and can withstand angles of more than 100 °.

Then to the middle section 18 there is a distal segment 19 with a hardness similar to the hardness of the already mentioned near segment 17 is. The length of this segment 19 depends on the length of the catheter used, with a distance from the distal edge of the middle segment 18 to the distal edge 3 of the catheter 1 is provided.

For example, the approximate length of the distal section 19 60, 110, 160 or 210 cm for the "extra long vascular inserter catheter" of 150, 200, 250 or 300 cm.

Alternatively, a hydriophilic cover may be attached to the distal edge of the introducer 3 in a 40 cm section measured from the nozzle 5 be used.

These Description does not need more detail be in the field of protection of a person skilled in the art to make clear the present invention and its advantages. The in this description The terms used in the invention are described in a descriptive manner Meaning and not in a limiting Senses, with the result that materials, shaping, Size and systems to amplify the shielding and the arrangement of the elements, as well as the Ends accessible to all variations as long as this the essence of the invention does not change.

1

Main body of the inserter

2

Blutgefäßdilator

3

distal End of the inserter

4

close End of the inserter

5

connecting valve

6

flexible Shaft or shield

7

close End of the shaft

8th

distal End of the shaft

9

radiopaque marker

10

Catheter passage

11

inner Location of the shield

12

spiral guidewire of the shield

13

outer shaft of the shield

14

inner surface the inner situation

15

outer surface of the inner location

16

uniform distance between the spiral turns

17

close Segment of the outer layer

18

average Segment of the outer layer

19

distal Segment of the outer layer

20

Polyvenylrohr

21

Three-way valve

22

conical, atraumatic jet

Claims (2)

"Extra long vascular Inserter catheter "for intravascular Diagnosis and / or treatment of peripheral arterial disease in renal and / or infrarenal areas, preferably one radial or radial Approach or by means of a brute access, marked through a resilience against twisting and buckling and a variable length of between 150 and 300 cm, the outside diameter being 4 to 7 French is. "Extra long vascular inserter catheter" according to claim 1, characterized by a shield having a more flexible central section ( 18 ), which between two harder segments ( 17 . 19 ) to prevent constrictions in areas of larger angles, such as in subclavian arteries to reach torax arteries, while maintaining propulsion while resisting twisting and constrictions of the catheter at that point.