ES2574587T3 - Catheter shaft with quick exchange balloon - Google Patents

Abstract

A balloon catheter having a proximal end and a distal end, for the medical treatment of a patient, comprising: a balloon (16) defining an interior; a hub (12) defining a proximal inflation port (20); a flexible shaft (14) having a proximal and distal end; extending the axis (14) between the balloon (16) and the cube (12); the hub (12) being fixed to the proximal end of the shaft (14) and the balloon (16) being fixed to the shaft (14) at, or near, its distal end; the axis (14) defining an inflation lumen (32) extending from the proximal inflation port (20) to the interior of the balloon (16), the axis (14) defining a distal guide wire port (30) in or near the distal end of the catheter and a proximal guide wire port (18); the shaft (14) defining a guide wire lumen (28) extending between the proximal and distal guide wire ports; including at least a part of the shaft (14) an internal tubular body (26), which defines the guide wire lumen (28), and an external tubular body (24), each having a proximal and distal end; wrapping the outer body (24) at least a part of the inner body (26); wherein the outer body (24) has a hypotube (48, 54, 58) with a proximal and distal end, which extends from the proximal end of the shaft (14) to a point at, or near, a proximal branch of the globe (40); a part of the hypotube (48, 54, 58) having a cutting pattern (56, 60) that provides a transition of flexibility from a proximal part to a distal part of the external body (24); characterized in that the proximal guide wire port (18) is placed between the hub (12) and the balloon (16); and because a fluid-tight outer layer wraps at least part of the cut pattern of the hypotube (48, 54, 58).

Description

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DESCRIPTION

Catheter shaft with rapid exchange balloon Background and summary of the invention Technical background:

The present invention relates to medical devices, and more specifically to balloon delivery systems or fast exchange stent with improved shaft designs.

Analysis:

Catheter systems are used in various therapeutic applications, including many vascular treatments. Various types of catheters are available, such as balloon catheters for procedures such as angioplasty. Angioplasty can be used to treat vascular diseases, in which the blood vessels are partially or totally blocked or narrowed by an injury or stenosis.

In many cases of vascular disease, a local area of a blood vessel may narrow. This narrowing is called an injury or stenosis, and can take the form of hard plaque, cholesterol, fat and viscous thrombus. Such stenosis can cause heart attack or stroke, which are significant health problems that affect millions of people every year. Normally disease patterns involve the development of stenosis, causing a blockage or partial blockage in place.

For example, various procedures are well known to address stenosis and open body vessels that have a constriction due to the accumulation of plaques or thrombi, etc. With such procedures, an expansive force can be applied to the lumen of the stenosis. This pressure towards the outside of a constriction or narrowing in the desired place in a body duct, is intended to reopen or dilate, partially or completely, that passage or body lumen, increasing its internal diameter or transverse area. In the case of a blood vessel, this procedure is called angioplasty. The objective of this procedure is to increase the internal diameter or the transverse area of the vessel or lumen duct through which the blood flows, to promote greater blood flow through the recently expanded vessel.

Often, it is considered desirable to leave a device at the site of the expanded lumen site of the stenosis, to provide support to the vessel wall at that location. Said device can provide a type of framework structure on which, for example, the development of the endothelium can occur to help repair the diseased, injured or damaged area. This framework device is called a stent or endoprotesis and can have several designs, often having an elastic, flexible and cylindrical spring shape. In some cases, the stent, which is a flexible cylinder or shell made of metal or polymers, can be permanently implanted in the vessel. The stent tends to keep the lumen open for longer, to strengthen the vessel wall and improve blood flow.

The implant of stents has begun to be a medical procedure of intervention accepted in many situations in which the vessels require prolonged support. At the time of the operation, to move the stent inwards and through a blood vessel, until the stent or the like is placed in a desired place, a catheter is used. Once the stent is in the desired place, it is deployed to provide internal support of the vessel or to perform another treatment.

Some stents are deployed using a balloon catheter for angioplasty, either during the angioplasty procedure or after the balloon has opened the stenosis. These are called stents expandable with balloon or deployed with balloon. Expandable balloon stents are expanded by force through a balloon or similar device through plastic deformation of the stent from a smaller to a larger diameter.

The balloon catheter or stent supply system of the present invention has a rapid exchange configuration, and an improved catheter shaft with a hypotube (hypodermic tube) having a portion of cutting pattern that extends from the hub to a point on the globe or next to it.

As an example, the present invention will be described in relation to vascular, coronary, peripheral and neurological treatments using a balloon catheter system or fast exchange stent delivery. However, it should be understood that the present invention refers to any rapid exchange catheter system that has the features of the present invention and not that is limited to a particular type of catheter, with or without a stent, or to the location or type of treatment.

Some catheters have a relatively long and flexible tubular shaft that defines one or more ducts or lumens and can supply and deploy the stent near one end of the shaft. This end of the catheter, in which the balloon is located, is usually called the "distal" end, while the other end is called the "proximal" end. The proximal end of the shaft can lead to a hub coupling to connect the shaft and the lumen (or

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lumens) to various teams.

A usual treatment procedure for the use of said catheter is to advance the catheter into a patient's body, directing the distal end of the catheter percutaneously through an incision and along a body duct, such as a blood vessel, until the balloon is located within the desired place. The expression "desired place" refers to the location, in the patient's body, normally selected by a healthcare professional to receive the treatment. After the balloon is inflated and / or a stent is deployed, in a desired place, it will tend to expand to press outward on the body conductor.

Catheter systems are often designed with the smallest possible external diameter or profile, particularly at the distal end. This small profile may be preferred for access into small vessels, either after angioplasty or during a procedure called "direct stent implantation" in which angioplasty is not performed.

Many catheter systems are used with a flexible barbed wire. The barbed wire is frequently metallic, and is inserted slidingly along the desired body duct. The catheter system is then advanced on the barbed wire by "backloading" or insertion of the proximal end of the barbed wire into a distal barbed wire port leading to a barbed wire lumen defined by the system Catheter Said barbed wire lumen can extend over the entire length of the catheter or only part of the catheter.

Catheter systems with a full-length barbed wire lumen are described as "over the wire" catheters, since barbed wires are found within the lumen of a catheter along the entire catheter. Catheter-on-wire systems provide some advantages, including improved traceability, prevention of barbed wire prolapse, the ability to drain the lumen of barbed wire while the catheter is inside the patient, and the ability to extract and exchange Easily grab the wire while maintaining the catheter in a desired position within the patient.

EP-1,611,914A1 analyzes a catheter system on the wire. The system includes a proximal hub that defines an inflation port and a wire wire port. A flexible shaft defines an inflation lumen and a barbed wire lumen. A balloon is near a distal end of the catheter. A distal wire wire port is provided. At least a part of the flexible shaft has an internal tubular body and a surrounding external tubular body. A proximal part of the inner body is reinforced with a hypotube, the hypotube provides a transition of graduated flexibility with a distal spiral cutting segment.

In some circumstances it may be desirable to provide a "rapid exchange" catheter system, which offers the ability to easily remove and exchange the catheter while maintaining the barbed wire in a desired position within the patient. In the field of balloon catheter, in US patents numbers 5,380,283 and 5,334,147, filed by Johnson on January 10, 1995 and August 2, 1994, both entitled "Rapid-Exchange Type Dilatation Catheter" , fast exchange balloon catheters are revealed. Also, U.S. Patent No. 5,531,690, filed by Solar on July 2, 1996, entitled "Rapid-Exchange Catheter" describes a catheter with a rapid exchange balloon, as well as U.S. Patent Re. 36104 of Solar titled “Dilation Catheter With Eccentric Balloon”.

In other words, rapid exchange balloon dilatation catheters can advance into a patient's vascular system along a previously placed barbed wire, for balloon angioplasty or a similar procedure. The barbed wire occupies a catheter lumen that extends only through a distal part of the catheter. With respect to the rest of the proximal catheter part, the barbed wire leaves the lumen of the inner catheter through a proximal barbed wire port, and extends parallel along the outside of the catheter's proximal part. Of course, the entire catheter and barbed wire assembly is generally contained within the lumen of a catheter catheter, which envelops and grinds the balloon catheter system or stent supply in the desired location.

Since a greater part of the barbed wire is outside the catheter shaft, it can be held in place manually as the catheter is removed. Since the lumen of the barbed wire of the distal catheter is smaller than the length of the barbed wire that remains outside the patient, the catheter can be removed at the same time that the barbed wire is also held, until the barbed wire can grab at a distal point of the catheter. The completion of a catheter exchange simply requires reversing the extraction process. This rapid exchange technique allows a single physician to change balloon catheters, without requiring a barbed wire extension to double the length of the barbed wire.

It is desirable to provide a balloon catheter that has an optimal combination of various performance characteristics, which can be selected from: flexibility, lubricity, impulsability, traceability, traceability, low profile, tensile strength, inflation / deflation times, inflation pressures , and others. Flexibility can be related to the torsional stiffness of a medical device (catheter and / or balloon stent, for example) in a particular region or over its entire length, or it can be related to the hardness of the component material. Lubricity can refer to friction reduction using low friction materials or coatings. The

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impulsability can be related to the columnar resistance of a device or system along a selected path. Traceability can refer to the ability of a device to successfully follow a desired trajectory, for example, without prolapse. The traceability can be clarified by understanding that doctors prefer to reach the desired location with the balloon catheter while finding little or no friction or resistance. The profile can refer to a maximum lateral dimension of the balloon catheter, at any point along its entire length.

In accordance with the present invention, a balloon catheter is provided as defined in the attached claim 1.

The balloon catheter of the present invention provides several advantages, which may include: impulsability, optimized flexibility over the entire length of the catheter, torsional strength, tensile strength, low profile, etc. Some embodiments of the present invention may also provide additional benefits, including smooth transitions in flexibility, lumen of lube wire, etc.

Structurally, the catheters can have a flexible shaft that extends between a proximal end and a distal end, and define one or more tubular ducts or "lumens" that extend through part or all of the catheter shaft. Such lumens often have one or more openings, called "ports."

When a lumen is adapted to receive a sliding barbed wire, it is called a "barbed wire lumen," and will generally have a proximal and distal "barbed wire port." The distal wire wire port is often at or near the distal end of the catheter shaft.

A cube is often attached to the proximal end of the catheter. The cube can perform various functions, including providing a handle to manipulate the catheter, and / or defining one or more proximal ports that communicate with one or more lumens defined by the axis of the catheter. When the catheter has a lumen of barbed wire, a proximal barbed wire port can be located at some point along the side wall of the catheter shaft, or a cube can define the port of proximal barbed wire.

A barbed wire has a structure similar to a flexible wire that extends from a proximal end to a distal end. Normally the barbed wire will have a size selected to fit inside and slide into a lumen of corresponding barbed wire of a catheter.

The terms "tube" and "tubular" are used in their broadest sense, to include any structure arranged at a radial distance around a longitudinal axis. Accordingly, the terms "tube" and "tubular" include any structure that (i) is cylindrical or not, such as, for example, an elliptical or polygonal cross section, or any other regular or irregular cross section; (ii) have a different or changing cross section along its entire length; (iii) be arranged around a straight, curved, bent or discontinuous longitudinal axis; (iv) has an unperforated surface or cross section, or a regular or other perforated, irregular or discontinuous surface; (v) is uniformly or irregularly separated, including being separated by several radial distances from the longitudinal axis; or (vi) have any desired combination of length or transverse size.

Any additional material suitable for making catheters and cubes such as those described, including polymers and other materials suitable for use with medical devices, may also be used.

Of course it is possible to manufacture various types and designs of catheters in accordance with the present invention, by various techniques and of various materials, to obtain the desired characteristics. It should be noted that the present invention also relates to procedures for developing and using medical devices, during or in preparation for the medical treatment of a patient.

These and various other objects, advantages and features of the invention will be obvious from the following description and claims, when considered together with the accompanying drawings. The invention will be explained in more detail below with reference to the accompanying drawings of various examples of embodiments of the present invention.

Brief description of the drawings

Figure 1 is a perspective view of a balloon catheter with a rapid exchange configuration in accordance with the present invention;

Figure 2 is a partial side elevation view of a catheter shaft component having an undulating helical cutting pattern;

Figures 3-8 are partial side elevation views of catheter shaft components with an undulating helical cutting pattern, showing various positions and shapes for a barbed wire port;

Figure 9 is a partial side elevation view of a catheter shaft component with a spiral cutting pattern;

Figures 10-13 are partial side elevation views of catheter shaft components with a spiral cutting pattern, showing various positions for a barbed wire port;

Figures 14 and 15 are partial cross-sectional views of catheter shaft components, in the region of a

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proximal wire wire port;

Figure 16 is a cross-sectional view of catheter shaft components, in another possible embodiment;

Figures 17-18 are partial views of catheter shaft components, in particular internal tubular bodies;

Figures 19-20 are partial side elevation views of a balloon and stent catheter, showing alternately a folded, deflated state, and an inflated deployed state; Y

Figures 21-22 are graphic representations of possible arrangements of the helical angles of a cutting pattern, over the entire length of a hypotube catheter component.

Detailed description of preferred embodiments

The following description of the preferred embodiments of the present invention is only illustrative in nature and, as such, does not limit the present invention, its application or uses in any way.

In relation to the drawings, a balloon and stent catheter delivery system is depicted, generally showing an embodiment of the present invention with the number 10. Of course, the balloon and stent catheter supply system illustrated illustrates only some of the many different designs within the scope of the present invention.

Figure 1 shows an embodiment of the present invention, and includes a proximal hub 12, a flexible catheter shaft 14 and a balloon 16. An intermediate portion of the shaft defines a proximal barbed wire port 18. The proximal hub 12 preferably provides an operating handle for the physician, and an inflation port 20. A tubular elongation relief 22 makes a transition bridge between the proximal hub 12 and the flexible shaft 14.

At least one distal part of the catheter shaft 14 has a coaxial arrangement, which includes a tubular outer body24 that envelops at least a portion of a tubular inner body 26. The internal body 26 defines a lumen of barbed wire 28 having a lumen diameter, which extends from a distal barbed wire port 30 defined at the distal tip of the inner body 26 to the proximal barbed wire port 18. The barbed wire lumen 28 can accept a barb wire 72 by sliding it. An inflation lumen 32 is defined by the annular space between the external body24 and the internal body 26, which extends from the proximal inflation port 20 to the interior of the balloon.

The balloon catheter shown in the drawings has what is called a rapid exchange configuration, in which the lumen of barbed wire extends from a port of distal wire to a proximal port located in some intermediate position between the globe and the proximal cube.

The present invention provides a new improved shaft design that has an optimized set of performance features, including tensile strength, columnar strength, a curvature with relatively smooth flexibility over the entire length of the catheter and flexibility at the distal tip, a profile minimum deflated external, a maximum internal diameter of the lumen of wire and a tangential resistance of the internal tubular body and maximum flexibility in the distal tip.

Accordingly, the illustrated balloon catheter preferably has a hypotube 48 extending from the proximal end of the catheter shaft to a point at or near the proximal branch of the balloon. The hypotube 48 has a cutting pattern that extends from a proximal position of the proximal wire wire port, to a position at or near the proximal branch of the balloon (which is also at or near the distal end of the hypotube 48). This hypotube 48 and the cutting pattern help to pass through closed lesions and enhance the flexibility of the entire distal part of the catheter 10.

The catheter has an axis with proximal and distal ends, which extends between a balloon near the distal end and a cube at the proximal end. The axis defines an inflation lumen that extends from a proximal inflation port defined by the hub to the inside of the globe, and a lumen of barbed wire that extends from a proximal grenade wire port in an intermediate position of the shaft to a distal wire wire port at the distal end of the catheter. Therefore, the catheter has a "fast exchange" setting.

The catheter shaft, sometimes referred to as a chassis, includes a hypotube 48, which extends from the proximal hub 12 to a position close to the proximal seal of the globe 16. The hypotube can be made of stainless steel or of a "superelastic" or "metal" with shape memory ”such as nitinol or any other suitably strong material. Hypotube 48 has a cutting pattern over a part of its distal length. This cutting pattern can be formed by laser cutting, or it can be formed by any other suitable technique. The introduction of this flexibility / stiffness profile will eliminate any need for a different reinforcing wire / tape, or a bevel on the distal part of the hypotube.

The cutting pattern can be a complex spiral configuration of variable pitch, as shown in Figures 2-8, which can be both stretch resistant and compression resistant, allowing better load transfer over the entire shaft length and allowing the system to transmit a torque. The proximal wire wire port can be placed in various locations on the hypotube 54 with respect to the cutting pattern 56, as shown in Figures 3-8. As shown in Figures 7 and 8, the wire port of

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Proximal grana can have various shapes, including any configuration properly, but in any case long enough to accommodate the outer diameter of the inner body. As shown in Figures 17 and 18, the proximal end of the inner body can be flared or segmented.

Of course, the hypotube 58 may have a regular spiral cutting pattern 60, as shown in Figures 9-13 (instead of a complex one) with the proximal wire wire port being in various locations, as shown in the Figures 10-13.

A heat shrink polymer or other fluid-tight layer or coating is placed over at least the length of the profiled hypotube in the region of the cutting pattern, excluding the rapid exchange port, and serves as a fluid-tight seal for lumen inflation. This material also serves as a bonding substrate for the proximal balloon seal and can be a fastening layer for an optional hydrophilic coating.

The barbed wire lumen may have an internal body that includes a lumen with a low friction internal surface (for example, HDPE, PTFE, FEP or PD-Slick) and a polymeric external surface that will allow the balloon seal to be fixed. As shown in Figure 16, the internal body may have a reinforcement configuration, which may include a metal serpentm or cord.

The inner body can be in the entire region of the seal of the branch of the distal globe. The outer layer and the reinforcement (or only the outer layer) distal of the balloon can be removed before the addition of additional tip material. An additional polymeric material may be placed on the internal body exactly distal to the distal seal. Another alternative is to fuse polymeric material at the distal end of the inner body. The tip can be tapered to decrease the profile or it can remain square, and can be 0-1 cm long.

The rapid exchange port for the design can exit through the wall of the hypotube, however it can also be distal to the profiled hypotube. The port can be cut in the hypotube at an angle (for example 15-90 °) with respect to the longitudinal axis of the axis and can be located in the circumferential cut pattern, between the rings of the pattern, or in the uncut part, or in the proximal appearance of the cutting pattern.

To facilitate the entry of the barbed wire, the hypotube can be serrated, as shown in Figure 16. The proximal end of the inner body can exit the port and can be attached to the outer body jacket. To aid in the union, an extension of polymeric polymer tube not reinforced to the proximal end can be added. The end can be a square cut or an angular cut, then flared and cut into segments along the circumference. As process assistants, or as a permanent material, thermo-shrinkable or other polymeric materials can be used in the device.

The union of the tip and the seals of the globe can be carried out by means of heating of matrices, union by RF (radiofrequency) or union by laser. If this last process is chosen as the preferred process, the procedure employed can use a dichroic multiple wavelength source for specific wavelength materials. The idea is that a wavelength will heat the metal hypotube or mandrel below both polymers (from the tip to the inner body, from the balloon to the shaft or from the balloon to the inner body) and induce heat to indirectly melt the polymers. The second wavelength will interact with the heat shrink to propel all materials and direct the flow,

The extension of the hypotube component more distally will eliminate the need for a different reinforcing wire along the entire length of the shaft and will allow the load to be better transferred from the proximal hub to the tip of the supply system. The elimination or minimization of sharp transitions from the solid hypotube to the polymeric distal section will help minimize or prevent torsion of the shaft while also allowing for better load transfer.

The hypotube adds design resistance, keeping its shape under pressure and flexion. This will improve inflation / deflation by resisting ovalization of the external body in narrow or sinuous vessels.

System torsion can be achieved more effectively, since the load will be transmitted through the hypotube component. This will help overcome any static friction between the system and a catheter and / or vessel walls.

The interlocking cut pattern will make the system more resistant to narrowing or twisting when the system is advanced or retracted.

A reinforced internal body will minimize or eliminate ovalization of the barbed wire lumen, which will subsequently minimize or eliminate friction interactions of the supply system / barbed wire of the stent.

Various modifications are possible, such as the placement of the rapid exchange port, anywhere along the entire length of the axis when it is practical to function as a rapid exchange system. The cutting pattern may have various shapes, and may define a constant helical angle or variable angles, as shown in Figures 21 and 22. In addition, as shown in Figures 7 and 8, the shape of the rapid exchange port may to vary. For example, it can be oval, rhomboidal, circular, asymmetric or rectangular.

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If the rapid exchange port is not located in the hypotube, the rapid exchange port may be at the end of or distal to the hypotube, which may or may not include a cut profile. The external body can be reinforced with a serpentm or cord, with flat or round wires of metallic materials, such as stainless steel or nitinol. The hypotube may be serrated in the port to facilitate the entry of the barbed wire.

The polymeric jacket of the external body can have a simple or variable durometer, depending on the desired performance characteristics that are desired to be obtained.

The cutting pattern may have a variable pitch profile with one or more gradual transitions or a stepped profile with one or more abrupt transitions, depending on the desired performance characteristics.

The specific dimensions of the cutting pattern can be modified to influence the performance characteristics of the hypotube axis.

The inner body of the lumen of the barbed wire can be made of different materials, depending on the desired performance characteristics (for example PTFE, FEP, HDPE or PD Slick). The outer layer of this component can use single or multiple durometric materials. These materials will serve as adhesion surface for the union of the distal globe.

The PPI (peaks per inch) for the cord or WPI (turns per inch) for the serpentm will be constant throughout the length of the lumen, or will vary to give specific performance characteristics at different locations throughout the length.

The balloon 16 preferably has a central cylindrical working part 34, tapered proximal and distal portions 36 and 38 and proximal and distal branches 40. The proximal branch 40 of the balloon is fixed to a distal end of the external body 24 by any suitable procedure, including heat sealing or adhesives. Similarly, the distal branch 42 of the balloon is directly or indirectly fixed to the inner body 26 near its distal end by any suitable procedure. Various tip configurations are also possible, including a soft tip component that can be inserted between the distal branch of the balloon and the inner body. The positions of the proximal and distal ends of the cylindrical working part 34 of the globe can be indicated with fluoroscopy by a pair of proximal and distal radiopaque marker bands 44 and 46 attached to the internal body 26.

In Figures 19 and 20, balloon 16 and stent 50 are shown in a deflated and inflated state respectively.

For the various components of a balloon catheter according to the present invention various different materials can be used. The mayone of the balloon catheter components should preferably be made of materials that have acceptable properties, including biocompatibility, tensile strength, longitudinal or columnar strength and folding flexibility. Some of the preferred materials may include various plastics, called polymers, including nylon, polyethylenes, polyurethanes or PET. For example, the barbed wire is preferably made of metal such as stainless steel, while the balloon 16 is preferably made of nylon. Catheter shaft components, including internal and external bodies 26 and 24, can be made of nylon, or of a coextrusion of nylon and another polymer. Various radiopaque materials are available for markers, including gold, iridium and platinum.

Of course, the present invention can be made with any suitable selection of dimensions and sizes.

Catheter manufacturing techniques are generally known in the art, including extrusion and coextrusion, coating, adhesives and molding. The scope of the present invention includes the full extent of the claims, regardless of the specific materials, numbers or other details present in this description of the preferred embodiments.

One of the many possible procedures to make a balloon catheter for angioplasty to perform a therapeutic procedure in a patient according to the principles of the present invention, includes the steps of forming an internal tubular body, an external tubular body and forming a balloon for angioplasty using known techniques, including extrusion. The internal and external bodies, and the globe completely define proximal and distal ends. Next, a radiopaque marker is attached to the inner tubular body and a mandrel is inserted into a lumen defined by the inner tubular body. The internal body and mandrel assembly are inserted into the balloon, and the external body is inserted into the proximal branch of the balloon. The proximal branch of the globe is heat sealed to the external body and then the distal branch of the globe is heat sealed to the internal body in a distal position of the wall thickness transition.

It should be understood that, for the present invention, an unlimited number of configurations can be carried out. The above analysis describes only exemplary embodiments illustrating the principles of the present invention, the scope of which is detailed in the following claims.

Claims (18)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 1. A balloon catheter having a proximal end and a distal end, for the medical treatment of a patient, comprising: a balloon (16) that defines an interior; a hub (12) defining a proximal inflation port (20); a flexible shaft (14) having a proximal and distal end; extending the axis (14) between the balloon (16) and the cube (12); the hub (12) being fixed to the proximal end of the shaft (14) and the balloon (16) being fixed to the shaft (14) at, or near, its distal end; the axis (14) defining an inflation lumen (32) extending from the proximal inflation port (20) to the interior of the balloon (16), the axis (14) defining a distal wire wire port (30) in or near the distal end of the catheter and a proximal wire wire port (18); the shaft (14) defining a barbed wire lumen (28) that extends between the proximal and distal barbed wire ports; including at least a part of the shaft (14) an internal tubular body (26), which defines the lumen of barbed wire (28), and an external tubular body (24), each having a proximal and distal end; wrapping the outer body (24) at least a part of the inner body (26); wherein the outer body (24) has a hypotube (48, 54, 58) with a proximal and distal end, which extends from the proximal end of the shaft (14) to a point at, or near, a proximal branch of the globe (40); a part of the hypotube (48, 54, 58) having a cutting pattern (56, 60) that provides a transition of flexibility from a proximal part to a distal part of the external body (24); characterized in that the proximal wire wire port (18) is placed between the hub (12) and the balloon (16); Y because a fluid-tight outer layer wraps at least part of the cut pattern of the hypotube (48, 54, 58). 2. The balloon catheter of claim 1, wherein the cutting pattern (60) has a spiral helical shape. 3. The balloon catheter of claim 2, wherein an angle of passage of the cutting pattern (60) is constant throughout the region of the cutting pattern. 4. The balloon catheter of claim 2, wherein an angle of passage of the cut changes in a linear manner. 5. The balloon catheter of claim 2, wherein an angle of passage of the cut changes in a manner along a curve that has more than one slope. 6. The balloon catheter of claim 2, wherein an angle of passage of the cut changes exponentially. 7. The balloon catheter of claim 1, further comprising a stent (50) folded around the balloon (16) in a deflated state. 8. The balloon catheter of claim 1, wherein the fluid-tight outer layer is a heat shrink polymeric material. 9. The balloon catheter of claim 1, wherein the cutting pattern (56) follows an undulating serpentine path. 10. The balloon catheter of claim 1, wherein the cutting pattern (56) follows an undulating path in an overlapping serpentine having inflection points. 11. The balloon catheter of claim 1, wherein the cutting pattern has an interlocking form. 12. The balloon catheter of any one of the preceding claims, wherein the wire wire port is proximal (18) is placed in the cutting pattern part of the hypotube (48, 54, 58), between a proximal and distal end of the cutting pattern part, and the fluid-tight outer layer wraps at least the part of the cut pattern of the hypotube (48, 54, 58), except for an opening for the proximal wire wire port (18). 13. The balloon catheter of claim 12, wherein the proximal wire wire port (18) is positioned between adjacent cutting portions of the cutting pattern (56, 60). 14. The balloon catheter of claim 12, wherein the proximal wire wire port (18) intersects with the cutting pattern (56, 60). 15. The balloon catheter of claim 1, further comprising a soft tip component, fixed to the inner body (26) and to the distal balloon branch (42). 16. The balloon catheter of claim 1, wherein the hypotube (48, 54, 58) is made of stainless steel. 17. The balloon catheter of claim 1, wherein the hypotube (48, 54, 58) is made of nitinol. 18. The balloon catheter of claim 1, further comprising a hydrophilic coating.