ES2461859B1 - INTRODUCTIVE DEVICE FOR INTRODUCTION OF A TUBULAR ELEMENT IN THE BODY OF A MAMMAL - Google Patents

Abstract

Introducing device for introducing a tubular element into the body of a mammal, where said tubular element is a catheter, guide wire, probe or the like to a suitable position of a tissue or a body duct such as a blood vessel or a bile duct , where the reading means are housed at least partially in the introducer body and arranged perpendicularly to the direction of travel of said tubular element through and where at least one connection between the reading means and the transmitting means to the external unit is external to the introducer body.

Description

DESCRIPTION

Introducing device for introducing a tubular element into the body of a mammal.

Field of the invention 5

The present invention relates to an introducer device for the introduction of a tubular element into the body of a mammal, wherein said tubular element is a catheter, guide wire, probe or the like. In particular, it refers to an introducer device and the assembly that contains it for the introduction of tubular elements to a suitable position of a body duct such as a blood vessel, a bile duct or even a muscular or fatty tissue.

Background of the invention

International patent application WO2004 / 050156 describes a catheter arrangement with respect to the sleeve of said catheter and a guide wire where the transmitting means are connected to the reading means by internal connections so that, in operation, the transmitting means are located inside the body of the mammal.

International patent application WO2007 / 124289 describes a device and method for releasing a stent transported by a catheter into the body 20 of a mammal indicating the distance traveled by the catheter with respect to its sliding outer sheath or sheath where the transmitting means are connected to the reading means through internal connections so that, in operation, the transmitting means are located inside the mammalian body.

 25

International patent application WO2003 / 092488 describes a method of transcutaneous catheter guidance based on a device with pulleys that, by friction and with the passage of a catheter through said pulleys, measures the distance traveled by the catheter. Said device depends on a traction system that can be prone to mechanical failures or failures during handling.

 30

Therefore, the drawbacks arising from the connections between the reading media and the external unit have not yet been resolved in the prior art, nor have reading media been proposed that, in operation, are housed outside the mammalian body. .

Description of the invention 35

With the introductory device of the invention, the aforementioned drawbacks are resolved, presenting other advantages that will be described.

The present invention is defined by the particularities of the appended claims and provides an introducing device for introducing a tubular element into the body of a mammal, said tubular element comprising markings that allow measuring the length of introduction of said tubular element into the body of the mammal, wherein said introducer device comprises:

- an introducer body 1 provided inside of a through-guide channel that allows the tubular element 2, 3 to pass through the introducer body 1; Four. Five

- reading means 4 for the detection of the markings 5 arranged on the tubular element 1;

- an external unit 6 interconnected with the reading means 4 by means of transmitting means 7 for counting the markings detected by the reading means 4;

- said transmitting means 7 connected to the reading means 4 by means of at least one connection,

and is characterized by the fact that said reading means 4 pass through the wall of the introducer body 1 at level 50 of the reading point being said external connection to the introducer body 1.

In the present invention, by the term "tubular" in the expression "the tubular element" includes both a hollow tubular element and a solid tubular element.

 55

The objective technical problem of having to provide transmission means along the longitudinal cavity between the tubular element and the introducer body is solved with the introducing device of the invention.

According to the introducer device according to the present invention, said transmission means can be wired or they can also be wireless, for example, when a radio frequency transmitter or equivalent is used.

In the introducer device of the invention said reading means 4 are at least partially housed in the introducer body 1 and arranged substantially perpendicularly to the direction of travel of said tubular element 2, 3 through the introducer body 1, said connection being external to the introducer body 1. 65

In this invention, the term "substantially perpendicular" indicates that it may be perpendicular, that is, 90 ° but also includes that there may be some deviation of up to  30 ° from the perpendicular of 90 °, that is, 90 °  30 ° .

Advantageously, with the introducer device according to the present invention, the length of the transmission means 5 does not vary with the displacement of the tubular element within the body of a mammal. In addition, the introducing device of the invention is practical, simple, reliable and economical. In particular, the introducer device according to the invention is practical in its use and economical to manufacture. In addition, thanks to the special design of the introducer device, it can be disposable since its manufacture is very low cost.

 10

It is noteworthy that, with the introducer device according to the present invention, the reading means are not in physical contact with the tubular element comprising the markings that allow measuring the length of introduction of said tubular element into the body of the mammal, therefore that wear is avoided and a certain mechanical resistance is not necessary.

 fifteen

The introducer device comprises an introducer body provided inside of a through guide channel that allows the tubular element to pass through the introducer body, wherein said element is a guide wire, a catheter, a guide wire and catheter, a probe or the like. .

The design of the introducer device according to the present invention makes it very versatile because it can be used to introduce a guide wire and a catheter into the body of a mammal but can also be used to introduce a probe or the like. The design of the device allows it to be introduced into the system of vascular, alimentary or biliary tree channels such as bile, hepatic or pancreatic ducts or it can be introduced into one of the natural orifices of the body of a mammal such as nose, anus, etc. ., or in muscle tissue, fatty or similar. 25

When the tubular element comprises two elements such as a guide wire and a catheter, or two catheters within each other, the markings can be arranged both in one of the elements and in the other of the elements, as well as in both of them weather. In the case of markings only on the internal element, the external element will be of a transparent material so that the reading means can read through it the markings of the tubular element that passes through the interior of the second tubular element .

The markings are preferably in the form of rings, a continuous spiral or the like, so that the perpendicular displacement of the tubular element that contains them with respect to the reading means allows to distinguish spaces with markings and spaces without markings. Other designs of the markings such as a grid or weft engraved or printed on the surface of the tubular element containing them or even the surface texture of said element when optical reading media are used are part of the scope of the present invention. .

In one embodiment, a light source illuminates the surface of the guide wire or catheter. The markings on it 40 can be a plot or grid printed or drawn or, simply, the rough texture of its surface. A lens and a CMOS or CCD sensor composed of a matrix of photosensitive semiconductors captures the image that, subsequently and practically in real time, is computed by a DSP processor and algorithms to obtain the exact position or distance traveled by the catheter or guide. By this embodiment, based on the operation of an optical computer mouse (US4521772), the turning radius of the catheter can be advantageously and additionally known.

The present invention contemplates any material that can be applied to the tubular element by way of markings such that the reading means can read or detect said markings. Thus, for example, the material of the markings can be reflective, opaque, magnetic or metallic, and this can be deposited, painted, screen printed, glued or printed on the surface of the tubular element or be part of it as a texture.

Reading media and markings can be of different types and materials. In a preferred embodiment said reading means comprise at least one transmitter and at least one receiver, and said markings are reflective. Advantageously, said at least one emitter is at least one optical fiber that from the external unit 55 receives a light signal and said at least one receiver is at least one optical fiber that collects and sends to the external unit, by way of Light guide, light reflected and emitted by reflective markings. Said information is transmitted by the transmitting means 7, in this case fiber optic, to the external unit where the information is translated into a unit of measurement to know, in real time, the distance traveled by the tubular element within the introducer body. The configuration of the external unit takes into account and discriminates between 60 forward and reverse of the tubular element. In the preferred embodiment of the invention, said reading means are exclusively of optical fiber so that the introducing device according to the invention is especially useful for use in nuclear magnetic resonance (NMR) because it does not contain metallic elements or electrical devices that can distort the images obtained by the NMR team. In addition, in this embodiment where the reading media and the transmitting media are exclusively fiber optic, the introducer device is completely safe and compatible with an NMR equipment where the metallic elements close to its field

magnetic would be heated due to the strong high frequency electromagnetic induction to which they would be subjected, in addition to the fact that the magnetic field could displace metal objects.

In another embodiment, said reading means may contain an LED, a phototransistor, an inductive sensor, a capacitive sensor, a "Hall effect" magnetic sensor, a CMOS or CCD sensor or other means, including optical fibers or a diversity. of several of these elements that allow the reading of the markings arranged on the tubular element. Therefore, it is part of the general knowledge of a person skilled in the art to choose the material of the markings according to the property of the sensor to be used.

The external unit may contain a numerical display with the indication, for example, of the millimeters that the tubular element moves through the inside of the introducer body and, therefore, inside the body of the mammal. Said external unit has a data output so that, for example, by means of a computer and with suitable software, the location of the distal end of the tubular element inserted in the tube can be known accurately and based on the distance traveled by the tubular element. muscle tissue or the carcass system of the mammalian body. fifteen

Advantageously, the introducer body has a cylindrical, substantially cylindrical, conical or substantially conical shape with the end proximal to the body of the narrowest and most prolonged mammal in order to facilitate its insertion into the muscular or fatty tissue, or into the system of vascular, alimentary canals , biliary tree or hole of the mammal. Once the proximal end is inserted into the mammalian body for operation, a part 20 of the introducer body is subtracted out of the mammalian body. It is in this remaining and external part where the reading media are located.

In one embodiment, the introducer body is substantially T-shaped so as to provide a lateral port external to the body of the mammal through which a head or plunger 8 is introduced containing the reading means 4 25 at its end proximal to the tubular element. Said reading means 4 are housed inside the head or plunger 8, partially in the introducer body 1, and arranged substantially perpendicularly to the direction of travel of the tubular element. The head or piston 8 can be approached or moved away with a perpendicular movement with respect to the tubular element so that the excess space of the through guide channel of the introducer body can be adjusted according to the diameter of the tubular element that passes through the interior of the introducer body 30. Said side port comprises fixing means 9 of the head or piston 8 to secure it once its position in the introducer body has been regulated. With the introducer device according to this embodiment, tubular elements of different diameters can be used due to the adjustable movement of the head or plunger that allows to approach or move away from the tubular element and to the fixing means that allow the head or piston 8 to be fixed in the desired position. 35

In another embodiment, the introducer body has substantially annular shape. Advantageously, when the introducer body is substantially annular in shape, the introducer device for introducing a tubular element into the body of a mammal will have application in the holes that are naturally found in said body or even in holes made therein. , as it can be in the skull. 40

The present invention also relates to the introducer device comprising the tubular element, said tubular element comprising markings.

Brief description of figures 45

To better understand how much has been exposed, some drawings are attached in which, schematically and only by way of non-limiting example, a practical case of realization is represented.

Figure 1 is a perspective view of a background of the invention. Figure 1 shows a catheter 2, 50 with a catheter sleeve 1, wherein said catheter 2 comprises in its inner wall sensors 5 connected with transmitter wires 8 to an external evaluation unit 6. Said sensors 5 collect the reading of the markings of the guide wire that passes through the inside of the catheter as it progresses. Figure 1 shows that the transmitter wires 8 are connected to the external evaluation unit 6 by means of internal connections to the catheter body. The evaluation unit 6 estimates the values of the sensors 5 and based on these values and other fixed parameters 55 determines the position and / or the displacement of two basic elements between them.

Figure 2 is a perspective view of an embodiment of the introducer device according to the present invention, where the introducer device is T-shaped with the end proximal to the body of the conical shaped mammal to facilitate its insertion into the mammalian canal system . Figure 2 shows the introducer body 60 provided therein with a through guide channel allowing the passage of the catheter 2 and guide wire 3 through the introducer body 1, the reading means 4 for the detection of the markings 5 arranged on the tubular element 2,3, the external unit 6 interconnected with the reading means 4 by means of transmitting means 7 for counting the markings detected by the reading means 4, where said reading means are at least partially housed in the introducer body 1 by means of a head or plunger 8, shown in enlarged perspective view of said figure 2, and fixed to the introducer body 1 with fixing means 9, screw

prisoner. Said reading means 4 are arranged perpendicularly to the direction of travel of said catheter 2 and said guide wire 3 through the introducer body 1. In Figure 2 it can be seen that said connections between the reading means 4 and the transmitting means 7 with The external unit 6 are external to the introducer body 1.

 5

Figure 3 is a perspective view of another embodiment of the device according to the present invention, where the introducer device is substantially cylindrical in shape with the end proximal to the body of the conical shaped mammal to facilitate its insertion into the canal system of the body of the mammal . Figure 3 shows the introducer body 1 provided inside of a through guide channel that allows the passage of the catheter 2 and guide wire 3 through the introducer body, the reading means 4 for the detection of the arranged markings 10 10 on the catheter 2 and the guide wire 3, the external unit 6 which is interconnected with the reading means 4 by the transmitting means 7 for counting the markings 5 detected by the reading means 4, where said reading means are housed in the introducer body 1 as represented in the enlarged perspective view of said figure 3. Said reading means 4 are arranged perpendicularly to the direction of travel of said catheter 2 and guide wire 3 through the introducer body 1. In Figure 3 shows that said connections between the reading means 4 and the transmitting means 7 with the external unit 6 are external to the introducer body 1.

Figure 4 is a perspective view of another embodiment of the device according to the present invention equal to that described in Figure 3, but in this case with a single internal element, catheter or guide. The introducer device has a substantially cylindrical shape with the end proximal to the body of the mammal in a cylindrical shape but with a smaller diameter to facilitate the introduction into the body or into a vein. Figure 4 shows the introducer body 1 provided therein with a through guide channel that allows the passage of the catheter 2 through the introducer body, the reading means 4 for the detection of the markings 5 arranged on the catheter 2, the external unit 6 which is interconnected with the reading means 4 by the transmitting means 7 for counting the 25 markings 5 detected by the reading means 4, where said reading means pass through the wall of the introducer body 1 at the point level reading being said external connection to the introducer body 1.

Although not shown in the figures, the introducer body may additionally and advantageously incorporate another port for insufflating liquids or gases. 30

Description of preferred embodiments

A non-limiting, preferred embodiment of the invention is described below where the introducer device is T-shaped as shown in Figure 2. 35

In this embodiment, the reading means 4 operate in reflection mode and contain a minimum of two optical fibers as light guides with receiving function and an optical fiber with emitting function. In this double reception configuration, the direction or direction of advancement of the catheter 2 and guide wire 3 through the inside of the introducer body 1 can be determined and taken into account. The optical fibers as receiving light guides are arranged in such a way that they receive the light reflected by the catheter 2 and guide wire 3 markings which, in turn, are illuminated by an optical fiber with emitting function and arranged on the same side as the optical fibers with receiving function as seen in the view enlarged figure 2.

The catheter 2 or guide wire 3 has all or part of its length and surface distributed in the form of reflective rings 45 that can, for example, be drawn by suitable screen printing techniques. These markings alternate with others of a dark or slightly reflective hue.

In this embodiment where the introducer device is T-shaped, a head or plunger 8 is shown that incorporates and groups the optical fibers, thus obtaining some practical advantages. This head or piston 50 is properly accommodated in the port of the introducer body 1. The optical fiber with emitting function arranged in the head or piston 8 receives the light from the external unit 6 and directs it towards the catheter 2 and guide wire 3 remaining an area of its illuminated surface. In this way, the reflective markings 5 of the catheter 2 and guide wire 3 reflect the light that is captured by other optical fibers that act as receptors and that are located in the same head or plunger 8. The light variations that occur when moving the catheter 2 and guide wire 3, 55 impact on said receivers and are instantly transmitted by these same optical fibers by means of transmitting wires 7, also of optical fiber, to the external unit 6. In another similar embodiment more fibers could be used to, for For example, evenly illuminate a larger area of the catheter.

The head or piston 8 is prepared to house inside several optical fibers that function as 60 light guides. The head or plunger 8 has internally and longitudinally holes that pass through it and house one or more fiber optic filaments. The head or plunger 8 is sealed at both ends to immobilize and protect said optical fibers. The sealing of the front part of the head or plunger 8, which is close to the catheter 2, can be done with a transparent resin compound or with a suitable method that allows the passage of light. In the enlarged view of Figure 2, a possible distribution of the optical fibers 65 is shown inside the head or piston 8. It is also observed in this same figure that, from the opposite end or back of the head or plunger,

the optical fibers split through the transmitting means 7, also of optical fiber, which connect the head or plunger 8 with the external unit 6. Although it is not represented, optionally and if it is necessary to direct the light to, for example, have higher resolution in reading, this same front protective resin can be molded in the form of converging and / or divergent lenses as is usually done in the encapsulates of photodiodes, phototransistors and LED diodes for commercial application. 5

The head or piston 8 can be moved, manually, a few millimeters to the catheter 2 or the guide wire 3 to, eventually, adapt to their diameter in cases where it is necessary to use catheters or guides of different diameters. Although not shown in Figure 2, the head or plunger 8 may have small grooves arranged along its length that coincide with projections arranged in their corresponding housing in the introducer body 1 that prevent the head or plunger 8 Rotate on its axis and lose its reading ability by misaligning the catheter 2 or guide wire 3 markings when it is in operation. The fixing means, a small captive screw 9, immobilize the head or plunger 8 in the introducer body 1. In applications where only a single diameter of catheter, guide wire or probe with markings is used, the head or plunger 8 can dispense of slits and fixing means 9 and can be solidly connected to the introducer body 1.

The external unit 6 houses a light source conveniently directed towards one or several optical fibers as a transmitting means 7 responsible for directing this available light to the head or plunger 8, so that the catheter or guide wire markings remain illuminated In the same external unit 6, two optical sensors 20 (for example, photodiodes), receive the light reflected by the markings of the catheter 2 and guide wire 3 thanks to the optical fibers with receiver function located and coming from the head or plunger 8. These optical sensors located in the external unit 6 will accuse the variations of light in the form of current variations.

These current variations are transformed and adapted to be evaluated by means of a processor 25 contained in this external unit 6. The measurement is based on a linear or incremental decoder, also called "quadrant", which evaluates the 90 ° outdated signals received by the two sensors to handle, finally and for example, an ascending / descending counter. This external unit 6 can include a display that will show the count and discount of the markings captured on the catheter 2 and guide wire 3 when they move; for this, the markings 5 must be repeated regularly at intervals, for example, of one millimeter, along the catheter 2 and guide wire 3. Thanks to these two signals offset by 90 °, a change of direction in the catheter 2 can be determined or guide wire 3. Then, a numerical display can be obtained that increases or decreases its figures in 1mm steps and in real time when the catheter 2 and guide wire 3 are moved and that can effectively and accurately show the distance traveled during forward and reverse. The external unit 6 can also contain a counter zero button for partial measurements. This external unit 35 can have an output as an electrical or similar connector that supplies the signals and / or data where required. The functions of the external unit 6 are not part of the scope of the present invention, although they can be carried out by means of a small microprocessor programmed for this purpose.

Next, a second, non-limiting embodiment of the invention is described, wherein the introducer device 40 is substantially cylindrical in shape with the end proximal to the body of the conical shaped mammal as shown in Figure 3.

In Figure 3, the numerical references refer to the same components described in the previous embodiment represented by Figure 2. In this embodiment, the reading means 4 are housed directly in the introducer body 45, without using any head or plunger 8. In this embodiment, the transmitting means 7 are also optical fibers that connect the reading means 4 with the external unit 6. The operation of this embodiment is the same as that described in the previous embodiment.

Next, a third, non-limiting embodiment of the invention is described, wherein the introducing device 50 is substantially cylindrical in shape with the end proximal to the mammalian body in a cylindrical shape but of smaller diameter to facilitate introduction into the body or into a vein as depicted in figure 4.

In Figure 4, the numerical references refer to the same components described in the previous embodiments represented by Figure 2 or 3. In this embodiment, only one catheter 2 is inserted into the introducer body 1. Optionally, said catheter 2 can be only the guide wire 3. The reading means 4 are housed directly in the introducer body 1, without using any head or plunger 8. In this embodiment, the transmitting means 7 are also optical fibers that connect the reading means 4 with the external unit 6. The operation of this embodiment is the same as described in the previous embodiments.

 60

The embodiments shown above can be manufactured almost entirely with plastic or non-metallic materials to be electromagnetically compatible and usable with NMR equipment in which the presence of metals is not adequate or in environments particularly sensitive to electromagnetic radiation. Only the external unit 6, which can be conveniently installed away, contains metallic materials.

 65

In one embodiment, the catheter has one or more visible markings by, for example, an equipment of

X-rays. The catheter with millimeter markings and a small radiopaque metal marker at its distal end is introduced until the beginning of an injury to an artery or vein, such as a stenosis or narrowing. The location of said tip can be done by radioscopy. Once the radiopaque marker reaches the lesion, the distance traveled by it in millimeters can be known. This magnitude serves so that, in case of having to reach that same point again (the beginning of the lesion) for the second or consecutive times 5 with the same or with another type of catheter or guide wire also with markings, it is possible to approximate new to him with fewer x-ray exposures, with the consequent advantage for the patient and medical staff. In addition, and by activating the zeroing device of the external unit when the visible marker of the catheter tip or the guide wire is at the beginning of the injury, its length will be known in real time if the marker is advanced to the end of said injury. 10

Although reference has been made to particular embodiments of the invention, it is apparent to one skilled in the art that the described introducer device is susceptible to numerous variations and modifications, and that all the mentioned details can be replaced by other technically equivalent ones, without departing from the scope of protection defined by the appended claims. fifteen

Claims (16)

1. Introducing device for introducing a tubular element (2,3) into the body of a mammal, said tubular element (2,3) comprising markings (5) that allow measuring the introduction length of said tubular element (2, 3) in the body of the mammal, wherein said introducing device comprises: - an introducer body (1) provided inside of a through-guide channel that allows the tubular element (2,3) to pass through the introducer body; - reading means (4) for the detection of the markings (5) arranged on the tubular element (2,3); - an external unit (6) interconnected with the reading means (4) by means of transmitting means (7) for counting the markings detected by the reading means (4); 10 - said transmitting means connected to the reading means by at least one connection, characterized in that said reading means (4) cross the wall of the introducer body at the level of the reading point said connection being external to the introducer body. 2. An introducer device according to claim 1, wherein said tubular element (2,3) comprises at least one guide wire (3), a catheter (2), a probe or the like. fifteen 3. An introducing device according to claim 1, wherein said markings (5) are in the form of rings, a continuous spiral, a printed or drawn grid or similar or a rough texture on the surface of the tubular element. 4. An introducer device according to claim 1, wherein said markings (5) are arranged on the guide wire (3) and catheter (2) at the same time, or on the guide wire (3) or on a probe. twenty 5. An introducer device according to claim 1, wherein said markings (5) are reflective, opaque, magnetic or metallic, deposited, painted, glued or printed on the surface of the tubular element (2,3). An introducer device according to claim 1, wherein said tubular element (2,3) is made of a transparent material, preferably when the markings (5) are arranged on and only on the guide wire. 25 7. An introducer device according to claim 1, wherein said introducer body (1) has a cylindrical, substantially cylindrical or conical shape. 8. An introducer device according to claim 1, wherein said introducer body (1) is substantially T-shaped. 9. An introducer device according to claim 1, wherein said introducer body (1) is substantially annular in shape. 10. An introducer device according to claim 1, wherein said reading means (4) comprise a combination of at least one transmitter and at least one receiver. 11. An introducer device according to claim 1, wherein said reading means (4) are optical fiber. 12. An introducer device according to claim 1, wherein said reading means (4) are a LED emitting diode, a phototransistor, an inductive sensor, a capacitive sensor, a "Hall effect" magnetic sensor, a CMOS or CCD sensor or other similar means, including optical fibers or a variety of several of these elements or any other means for detecting the markings arranged on the tubular element. 13. An introducer device according to claim 1, wherein said transmission means (7) are wired or wireless. 40 14. An introducer device according to claim 1, wherein said reading means (4) are at least partially housed in the introducer body (1) and arranged substantially perpendicular to the direction of travel of said tubular element (2,3) through the introducer body (1). 15. Device according to any of the preceding claims, wherein said introducer body (1) comprises fixing means (9) for immobilizing said reading means (4). Four. Five 16. An introducer device according to any one of the preceding claims, wherein said introducer body (1) is provided inside of a through-guide channel that allows the tubular element (2,3) to pass through the introducer body (1) having substantially T-shaped and accommodates in said T and in position substantially perpendicular to the tubular element (1) a head or plunger (8) containing the reading means (4). fifty