Bending resistant male connector for a guide wire

The present invention is a bending resistant male connector for a guide wire, in particular a shape that allows the entire form of core wire, conductor and insulating material to optimally use the space available within the male connector. The present invention relates to a bending-resistant male connector having a core wire.

Guide wires are generally known in the art. These guide wires are used, for example, in the treatment of coronary vascular diseases. Radiographs of blood vessels performed in the treatment can detect the presence of obstruction, but the detection does not indicate a cross section of the stenotic site. It is believed that the best way to diagnose the severity of a stenotic site is to measure blood pressure upstream and downstream of the stenotic site. In this case, a guide wire is used to place the pressure measurement sensor in the area of interest. Once the guide wire is in place, the catheter can be slid along the guide wire and then balloon dilation can be performed. The electrical signal from the pressure measurement sensor at the end of the guide wire is transmitted to the male connector at the base end of the guide wire through a conductor embedded in the guide wire. In use, the male connector is connected to the female connector, the signal from the pressure measurement sensor is transmitted to the interface, which converts the signal and provides the converted signal to the operator in the desired form. To do.

The male connector arranged at the base end of the guide wire basically includes a core wire, a plurality of conductors, a plurality of conductive members, and an insulating material between them. When the male connector is connected to the female connector, the conductive member transmits an electrical signal from the conductor of the male connector to a similar conductive member inside the female connector. The core wire extending through the guide wire as before is used to prevent bending, to provide strength to the guide wire and to hold the guide wire together. In particular, when inserting the male connector into the female connector, there is a substantial risk that the male connector will bend excessively or damage the thin conductors in the male connector. For this reason, the core wire in the male connector is usually made of a material with a high elastic modulus such as stainless steel. Examples of such a male connector are disclosed in Patent Document 1 and Patent Document 2.

<patcit num="1"><text>U.S. Pat. No. 5,178,159</text></patcit><patcit num="2"><text>U.S. Pat. No. 5,938,624</text></patcit>

<p> From the above description, the core wire should be as large as possible so that a large amount of high-strength material is provided in the male connector while leaving enough space for the conductor and insulator to fit in the guide wire. It is clear that it must be large. In Patent Document 1 and Patent Document 2, it is considered that the core wire has a tubular shape and the conductor is arranged outside the core wire. In the case of this core wire shape, the overall form consisting of the core wire and the conductor forms a large part of the space inside the male conductor without optimally utilizing the core wire and the thin conductor itself, which is actually available. It will occupy, in other words, there will be excess insulating material in the male conductor. In this case, it should be noted that the space available within the guide wire is limited by the diameter of the catheter sliding over the guide wire. Since the catheter also slides over a male connector that extends from the proximal end of the guide wire, the overall dimensions of the male connector are also limited by the diameter of this catheter. The nominal diameter of conventional small catheters is as small as 0.355 mm, which provides an upper limit on the diameter of the male connector used with such catheters.</p><p> As described above, the core wire conventionally extends through the guide wire from the sensor at the end of the guide wire to the male connector at the base end of the guide wire along the entire path, and extends to the base end of the guide wire. The core wire provides hardness to the male connector. For such long cores, the most economical and practical shape of the core is cylindrical, and the overall form of the core and conductor occupies less than the optimum degree of available space, resulting in Despite the disadvantage of having the risk of bending or scratching when the male connector is inserted into the female connector, it has traditionally been possible to keep the core wire inside the male connector in a cylindrical shape. Was the idea.</p><p> As a result, there is a need for a male connector having a core that is shaped to optimally use the available space within the male connector in its overall form, consisting of a core, a conductor, and an insulating material. In order to maintain the cylindrical shape of the core wire extending from the male connector to the sensor, the male connector preferably constitutes a separate unit that can be attached to the base end of an existing guide wire. Of course, the above requirement means that the core wire in the male connector is different from the core wire in the other part of the guide wire.</p><p> A main object of the present invention is to provide a male connector having a core wire having a shape capable of providing a larger amount of material having a higher elastic modulus in the male connector while leaving sufficient space for the conductor. is there.</p><p> A second object of the present invention is to provide a male connector that is durable, has bending resistance, does not bend, and is easily inserted into a female connector.</p><p> A third object of the present invention is to provide a male connector having a core wire shaped so that the conductor is protected from damage even when the male connector is bent.</p><p> A fourth object of the present invention is to provide a male connector that retains hardness and allows a long insulation distance between conductive members.</p><p> A fifth object of the present invention is to provide a male connector that can be attached separately to an existing guide wire.</p><p> A sixth object of the present invention is to provide a male connector that can be filled with an insulating material while minimizing voids, and thus is highly waterproof and can maintain a certain quality.</p><p> The above object is achieved by the male connector according to claim 1. Preferred embodiments of the male connector according to the present invention are described in the independent claims.</p>

<p> One preferred embodiment of the male connector according to the invention comprises a core wire, a plurality of conductive members, a plurality of conductors, and an insulating material. Each of the conductors is connected to their respective conductive member. An annular conductive member having the same outer diameter as the guide wire is separated from each other in the longitudinal direction. Although the core is not cylindrical, part of its exterior surface is flat, which provides the core with a D-shaped cross section.</p><p> When the male connector is assembled, the conductor is located outside the straight legs of the D-shaped cross section. Therefore, when the male connector is attached to the base end of the guide wire and the D-shaped core wire is inserted into the guide wire for a short distance, the conductor at the end of the male connector is the inner surface of the cylindrical guide wire and the D-shaped core wire. It is placed in an elongated cavity formed between and. The portion of the conductor on the proximal end side in the annular conductive member is arranged in a corresponding state in the cavity formed between the conductive member and the D-shaped core wire.</p>

FIG. 1 illustrates the male connector 1 according to the present invention. The male connector 1 is located at the base end of the guide wire 2. The male connector 1 basically includes a core wire 3, a plurality of conductive members 4, and a plurality of conductors 5.

The conductive members 4 having the same outer diameter as the guide wire 2 and having an annular shape are separated from each other in the longitudinal direction. When assembling the male connector 1, each of the conductors 5 is electrically connected to the respective conductive member 4, and an insulating material 6 is provided between the core wire 3 and the conductive member 4. The insulating material 6 fixes the conductor 5 in the conductive member 4 and insulates the conductive member 4 from the core wire 3.

In FIG. 2, the male connector 1 of FIG. 1 is provided with an additional continuous outer insulating material 7, and the outer surface of the insulating material extends to the same extent as the outer surface of the conductive member 4. The insulating material 7 insulates the conductor 5 and the conductive member 4 from each other and also provides additional hardness for the male connector.

In FIGS. 1 and 2, a small gap is provided between the male connector 1 and the core wire 3, the core wire extending through the rest of the guide wire 2, i.e. male. It can be seen that the core wire 3 of the connector 1 is not an integral part of the core wire at the end and much longer portion of the guide wire 2 (not shown in FIG. 1 or FIG. 2). Therefore, this slight gap allows the male connector 1 to be considered as a separate part of the overall guidewire assembly, which is different from the prior art design. The special effect obtained by this feature will be described below.

From FIGS. 1 and 2, the base end of the conductor 5 is connected to the base end of the corresponding conductive member 4, that is, the adjacent base end portion of the conductor 5 is inside the conductive member 4 and the conductive member 4. It is recognized that it is supported by the insulating material 6 of. The conductive member 4 is relatively hard, and when the male connector 1 is bent, the connection between the conductive member 4 and the conductor 5 is more than when the conductor 5 is attached to the end of the conductive member 4. A small bending stress is applied.

The entire guidewire assembly is illustrated in FIG. 3, where the male connector 1 is attached to the base end of the guidewire 2. The guide wire 2 is inserted into the balloon catheter 8. There is a sensor 9 at the end of the guide wire 2. The male connector 1 is inserted into the female connector 10. The female connector 10 can be electrically connected to the monitoring device 11. In practice, the end of the guide wire 2 is inserted into the body, for example, into the opening of the femoral artery. Once the surgeon has placed it in the appropriate position, guide the catheter 8 of the desired type to the guide wire 2. During use, the signal from the sensor 9 is transmitted to the conductive member of the male connector 1 by the conductor wrapped in the guide wire 2. Next, these signals are transmitted from the conductive member of the male connector 1 to a similar conductive member in the female connector 10. These signals are then provided to the surgeon by the monitoring device 11.

FIG. 4 shows a cross-sectional view of a male connector designed by the prior art. In this case, the three conductors are symmetrically arranged around a cylindrical core wire that is eccentrically arranged within the male connector. A conductive member surrounds the core wire and the three conductors, and the insulating material fills the rest of the interior space of the male connector. The major disadvantage of this prior art design is that if the male connector illustrated in FIG. 4 bends during insertion into, for example, the female connector, all parts of the male connector will experience bending stress. To receive. In this case, the thin and sensitive conductors embedded in the relatively flexible insulating material can be squeezed between the harder core wire and the conductive member, which is one or more of these conductors. There is a risk of damaging or breaking the conductor.

FIG. 5-1 illustrates one preferred embodiment of the male connector according to the invention. In this case, the core wire 3 having a uniform D-shaped cross section constitutes the central portion of the male connector. In this case, the three conductors 5 are arranged outside the flat portion of the D-shaped core wire 3, and the cylindrical conductive member 4 surrounds the conductor 5 and the D-shaped core wire 3. The rest of the internal space of the cylindrical conductive member 4 is filled with insulating material 6, and a minimum amount of insulating material 6 is provided between the conductive member 4 and the curved portion of the D-shaped core wire 3. ing.

The D-shape of the core 3 provides a cavity between the inner surface of the cylindrical conductive member 4 and the flat portion of the D-core 3. This cavity, in which the conductor 5 is placed, remains virtually intact, even when the male connector is bent. This means that there is no risk of the conductor 5 being squeezed between the core wire 3 and the conductive member 4 even when bending stress is applied to the male connector. For example, it will clearly prevent damage to the conductor 5 during insertion into the female connector. From FIG. 5-1 the requirement for such a protective cavity is that the end of the linear leg of the D-shaped cross section be located near the conductive member 4, that is, the inner surface of the conductive member 4 and the D-shaped core line. It is clear that there is a minimum amount of insulating material 6 between these parts of 3. The term "cavity" should not be taken literally herein. As is clear from FIG. 5, the cavity is filled with a continuous insulating material 6.

The enlarged portion X of the core line 3 in Fig. 5-1 is illustrated in Fig. 5-2. FIG. 5-2 shows that the core wire 3 is provided with a separate insulating material layer 12. Therefore, the core wire 3 can be regarded as an insulating core wire 3, and the amount of the insulating material 6 provided between the curved portion of the D-shaped core wire 3 and the conductive member 4 is practically reduced to zero. Can be made to. An example of such insulating material 12 is ceramic particles held in a polymer matrix. As an alternative, the insulating material 12 can consist of a metal oxidized to a ceramic state. For example, core wire 3 is formed from titanium and its surface is oxidized to titanium dioxide, or core wire 3 is Al.₂O₃It may be formed of a metal having an aluminum coating that has been oxidized to. It is also possible to manufacture the core wire 3 with an insulating material, and in this case, it is not necessary to provide any insulating material between the curved portion of the D-shaped core wire 3 and the conductive member 4. By properly selecting the material for the core wire 3 and / or the insulating material 12, the conductor 5 can be connected to the conductive member 4 by the crimping technique.

FIG. 5-3 illustrates the enlarged portion Y of the conductor 5 in FIG. 5-1. FIG. 5-3 shows that each of the conductors 5 is provided with a separate insulating material layer 13. Therefore, the conductor 5 can be regarded as an insulated conductor 5, which means that the conductors 5 can be arranged in close proximity to each other, that is, no insulating material 6 is provided between them.

As mentioned above, the conventional design of the male connector for the guide wire is to allow the core wire to extend into the male connector, that is, the core wire of the male connector is an integral part of the core wire in the guide wire. It is a part. As an example, since the guide wire will be quite long and thin, such as 300 cm in length and 0.355 mm in diameter, it would be practical and economical to have a cylindrical core wire inside the guide wire. The core wire in such a conventional 0.355 mm guide wire is typically only 0.15 mm in diameter. Simply flattening a portion of the exterior surface of the core so that the thin cylindrical core extends into the male connector and can form a D-shaped cross section has the special advantage described above. I can't get any points. This is easily recognized from FIG. 4, in which the core lines of the conventional design are illustrated. By simply stripping off a portion of the exterior surface of such a small diameter core wire, of course, when the male connector bends, it does not form a cavity in which the conductor is located, without the risk of damage. Can not. Extending a portion of the core that extends into the male connector and extends from this portion into the desired cross section, such as a D-shaped cross section, is conceivable and falls within the scope of the present invention, but is better. The solution is to provide a male connector that can be attached separately to the existing guide wire.

FIG. 6 illustrates a cross-sectional view of a first alternative embodiment of the male connector according to the invention. In this embodiment, the core wire 3 is provided with a gutter-shaped recess in which the conductor 5 is received. The cavity formed by this gutter-shaped recess clearly protects the conductor 5 from being squeezed between the conductive member 4 and the core wire 3 if the male connector is bent.

In FIG. 6, the conductors 5 are all arranged in a common cavity formed by a single recess on the exterior surface of the core wire 3. However, each of the connectors 5 may be located in a separate cavity. The form of this model is illustrated in FIG. 7, in which case three recesses are provided on the exterior surface of the core wire 3. Each of these three recesses accepts a single conductor 5.

As mentioned above, a main object of the present invention is to provide a large amount of material with a high elastic modulus in the male connector and to have a core wire, thus a core wire shaped to make the male connector as stiff as possible. To provide a male connector. For this purpose, it is also conceivable to replace the recesses described above with one or several longitudinal holes in which the conductors are located. An example of such a form is illustrated in FIG. 8, in which case the core wire 3 is provided with a cavity in the form of a central hole in which the conductor 5 is received.

From the illustrated embodiment of the present invention, the conductive member 4 can be considered to be supported by the core wire 3 from a manufacturing point of view, that is, at least two places on the exterior surface of the core wire 3. This is because there is only one method for positioning the core wire 3 in the radial direction in the conductive member 4. Therefore, the core wire 3 can be described as automatic centering or automatic centering core wire 3, and therefore, no additional positioning step is required when manufacturing the male connector 1 of the present invention. From FIG. 4, this advantage is different from the prior art design, where the core wire must be carefully placed in the center of the conductive member or at some other location within the conductive member. it is obvious.

FIG. 9 illustrates a male connector 1 with another form of conductor 5. In the illustrated form, each of the conductors 5 is pulled out in a 180 ° loop before being connected to the respective conductive member 4. As a result of the test, it was found that this loop extending toward the proximal end of the male connector 1 further improves the durability of the conductor 5 before returning to the end of the conductive member 4 (where the conductor 5 is connected). .. In particular, when the conductor arrangement according to FIG. 9 is combined with one of the cross sections of the core wire described above, a male connector that is surprisingly less susceptible to bending is provided.

The cross section of the conductor arrangement in Figure 9 clearly shows the cross section of the additional conductor, because one of the loops of the conductor holds two conductors that extend forward and the other extends backward. is there. An example of such a cross section is illustrated in FIG. 10, where the D-shaped core line according to FIG. 5 is combined with the conductor arrangement according to FIG. In this case, the three conductors 5 give rise to the cross sections of the four conductors within the conductive member 4.

In summary, according to the male connector of the present invention, which has a design in which the entire form consisting of the core wire and the conductor provides a nearly circular cross section, the inside of the male connector is compared with the design of the prior art. More materials with high modulus of elasticity can be provided. This feature makes the male connector according to the invention durable and bend resistant, while this risks bending the male connector, thereby damaging the conductor and other parts of the male connector. Facilitates insertion of the male connector into the female connector with minimal sex.

In addition, the presence of a large amount of material with a high modulus makes the male connector stiffer, which means that the long insulation distance is maintained between the annular conductive members separated in the longitudinal direction. Allows the existence of. This is advantageous because a long insulation distance means that the risk of current leakage between the conductive members is minimized.

In addition, the presence of a large amount of material with a high modulus reduces the amount of insulating material in the male connector, which allows the insulating material to be filled with the minimum porosity, while this is The design will be waterproof and of constant quality.

Although the present invention has been described for a particular embodiment and illustrated in the accompanying drawings, those skilled in the art will appreciate numerous modifications within the scope of the invention described herein and in the claims. It will be clear that examples and modifications can be embodied.

<figref num="1">It is a figure of the male connector by this invention attached to the guide wire.</figref><figref num="2">It is a figure of the male connector of FIG. 1 provided with the surplus insulating material.</figref><figref num="3">It is a figure of a guide wire including a male connector used in a catheter and a female connector connected to a monitoring device.</figref><figref num="4">It is sectional drawing of the male connector by a prior art.</figref><figref num="5-1">It is sectional drawing of the 1st Embodiment of the male connector by this invention.</figref><figref num="5-2">It is the figure of the enlarged part X of FIG. 5-1.</figref><figref num="5-3">It is the figure of the enlarged part Y of FIG. 5-1.</figref><figref num="6">It is sectional drawing of the 2nd Embodiment of the male connector by this invention.</figref><figref num="7">It is sectional drawing of the 3rd Embodiment of the male connector by this invention.</figref><figref num="8">It is sectional drawing of the 4th Embodiment of the male connector by this invention.</figref><figref num="9">FIG. 5 is a diagram of a male connector with one alternative conductor form.</figref><figref num="10">It is sectional drawing of the male connector by FIG.</figref>

Code description

1 Male connector 2 guide wire 3 core wire 4 Conductive member 5 conductor 6 Insulation material 7 Outer insulation material 8 balloon catheter 9 sensor 10 female connector 11 Monitor device 12,13 Insulation material layer