GUIDANCE WIRE MECHANISM WITH A ROTARY ELECTRICAL CONNECTING PIECE.

This invention relates to a torqueable guide wire assembly with electrical function and connectors for use therewith and more particularly, such a guide wire assembly with male and female connectors.

In general, an embodiment of the invention provides a guide wire assembly with an electrical function and a system and apparatus for utilizing the same.

An embodiment of the invention provides a guide wire assembly of the above character which includes male and female connectors.

An embodiment of the invention provides a guide wire assembly of the above character in which two or more conductors can be provided.

An embodiment of the invention provides a guide wire assembly of the above character which is compatible with the existing guide wire exchange systems.

An embodiment of the invention provides male and female connectors of the above character which are compatible in size with existing guide wires.

An embodiment of the invention provides a guide wire assembly of the above character which can be torqued without interfering with the electrical functions.

An embodiment of the invention provides a guide wire assembly of the above character which utilizes a connector which can be utilized as a torquing device.

An embodiment of the invention provides a guide wire assembly of the above character which utilizes a rotary connector that permits rotation of the guide wire and in which a separate torquing device is utilized on the guide wire.

An embodiment of the invention provides a guide wire assembly and system and apparatus utilizing the same of the above character which permits intravascular ultrasonic imaging.

Additional features of the invention will appear from the following description in which the preferred embodiments are set forth in detail in conjunction with the accompanying drawings.

Figures 1 through 6 and the description associated therewith are disclosed in European Patent Application No. 89310919.9 published on May 9, 1990 and have been deleted from this application since the subject matter thereof is not being claimed.

Figure 7 is a cross-sectional view of a micro-miniature coaxial male connector for use on a guide wire assembly having an electrical function utilizing a continuous core wire.

Figure 8 is a schematic illustration of a system and apparatus utilizing a torqueable guide wire assembly of the present invention with a rotary connector and a separate torquing device for the guide wire.

Figure 9 is an enlarged cross sectional view of the rotary connector shown in Figure 8.

Figure 10 is another schematic illustration of a system and apparatus utilizing a torquable guide wire assembly of the present invention in which a torquable connector is utilized.

Figure 11 is a cross sectional view of the torquable connector shown in Figure 10.

Figure 12 is an enlarged side elevational view partially in cross section of the distal extremity of a guide wire assembly of the present invention which is provided with intravascular ultrasound imaging capabilities.

Figure 13 is a side elevational view in cross section of the proximal extremity of the guide wire assembly shown in Figure 12 on a reduced scale.

In general, the guide wire assembly of the present invention is comprised of a guide wire in the form of a tubular member having a proximal extremity. First and second conductors extend along the length of the tubular member. Connector means is connected to the proximal extremity of the tubular member and includes slip ring means for maintaining electrical contact with the first and second conductors during rotation of the guide wire. The guide wire can be torqued by utilizing the connector means as a torquing device or by providing a rotary connector and a separate torquing device attached to the guide wire.

A guide wire assembly 91 incorporating the present invention is shown in Figure 7 which is comprised of a guide wire 92 having a male connector 93 connected to the proximal extremity 94 of the guide wire. The guide wire 92 is comprised of stainless steel tubing 96 often called hypo tubing having an outside diameter of .018 inches or less and having a suitable wall thickness as, for example, .002 inches. The hypo tubing can have any suitable length, as for example, approximately 175 centimeters. A core wire 97 is disposed in the tubing 96 and extends substantially the entire length thereof of the tubing 96 to provide increased torquing capabilities for the guide wire which can be of a suitable diameter, as for example, .010 inches. It typically can be formed of a suitable material such as stainless steel.In connection with the present invention, it need not be conductive, because separate conductive means in the form of first and second conductors 98 and 99 are provided which extend the length of the guide wire 92 and are connected to the transducer or other electrical device at the distal extremity (not shown) of the guide wire assembly 91. As shown in Figure 7, the conductors 98 and 99 are disposed in the concentric space provided between the core wire 91 and the inside wall of the tubing 96.

The core wire 97 extends beyond the proximal extremity 96a of the tubing 96 and has a crimped proximal extremity 97a of the type hereinbefore described. An insulating sleeve 101 formed of a suitable insulating material such as a polyimide hereinbefore described. First and second spaced apart conductive cylindrical members in the form of cylindrical bands 102 and 103 are mounted on the insulating sleeve 101. The insulating conductors 97 and 98 extend between the members 102 and 103 and the conductive core 97 and are secured respectively to the members 102 and 103 by suitable means, such as a solder connections at the proximal extremities thereof as indicated at 104 and 106 in Figure 7. A suitable adhesive such as that hereinbefore described can be applied at 107 in conical form at the distal extremity of the member 103 to seal the proximal extremity of the male connector 93.

From the foregoing it can be seen that the guide wire assembly 91 differs principally from that shown in Figure 1 in that the core wire 97 is not utilized as a conductor and that the required electrical conductors are provided by separate conductors provided within the guide wire assembly. As hereinbefore explained, this makes it possible to achieve improving torquing capabilities for the guide wire by having the core wire extend substantially the entire length of the guide wire.

In connection with the male and female connectors hereinbefore provided, it has been found that it is desirable to provide torquing capabilities for the guide wire in certain applications, such as in angioplasty. In angioplasty the physician should be able to rotate the guide wire to enable him to facilitate guiding the guide wire through the tortuous coronary arteries. To make this possible it is necessary to provide a connector which has the capability of providing electrical interconnections while at the same time permitting rotation of the guide wire.

A system and apparatus having such capabilities is shown in Figure 8 in which a PTCA (percutaneous transluminal coronary angioplasty) catheter 111 is shown commonly used in angioplasty procedures. Such a catheter is provided with an inflatable balloon 112 on its distal extremity and a conventional three-arm fitting 113 on its proximal extremity. A guide wire assembly 116 of the type utilized in embodiments of the present invention extends through the central arm of the fitting 113 and through the catheter 111 as shown in Figure 8. A torquing device 121 of a conventional type is mounted on the proximal extremity of the guide wire assembly 116.A rotary connector 122 is removably secured to the proximal extremity of the guide wire assembly 116 proximal of the torquing device and serves to provide electrical connections between the conductors (not shown) in the guide wire assembly 116 and a flexible cable 123 having multiple conductors (not shown) therein connected to a suitable conventional electronic device 124 which operates on the information supplied to and obtained from the conductors in the cable 123 and connected to the conductors in the guide wire assembly. This electronic device 124 can be utilized to perform various functions as, for example, measuring blood velocity, blood flow, blood pressure (static or phasic), ultrasonic imaging and the like.

A detailed cross-sectional view of the rotary connector 122 is shown in Figure 9. As shown therein, it consists of an elongate cylindrical outer housing 126 formed of a suitable insulating material such as a polymer plastic. A spindle 127 is rotatably mounted in the housing 126 in a suitable manner. For example, it can be carried by first and second micro-miniature ball bearing assemblies 129 and 131 mounted in a cylindrical recess 132 in the housing 126. A single ball bearing assembly can be utilized for this purpose. However, it has been found that to provide the desired stability for the spindle, it is desirable to utilize two such microminiature ball bearing assemblies. If desired, precision bushings may be used as alternative bearing means.As shown in Figure 9, the spindle 127 is mounted in the inner races of the ball bearing assemblies 129 and 131 and the outer races are seated in the recess 132. The spindle 127 is provided with a cylindrical bore 134 which opens forwardly through the spindle 127. The bore 134 adjoins a conical recess 136 which adjoins a smaller bore 137 that extends outwardly of the spindle 127. The small bore or hole 137 has a suitable size, as for example, .022 to .024 inches. The spindle 127 is provided with threads 138 at its outer extremity which surrounds the bore 134. A knurled cylindrical portion 139 is formed integral with the spindle 127 and is adapted to be grasped by the fingers of the hand for rotating the spindle 127 as hereinafter described.

Restraining means 140 is provided for restraining movement of the male connector 93 of the guide wire assembly 116 relative to the female connector 141 carried by the rotary connector 122. The restraining means 140 includes a removable collet 142 formed of suitable material such as brass which is positioned in the bore 134 and is provided with a central bore 143 extending longitudinally thereof. The collet 142 is provided with an enlarged head portion 142a which is provided with chamfers 144 and 145. The chamfer 144 is adapted to seat against a chamfer or seat 146 provided on the spindle 127 and adjoining the bore 134. The collet 141 is provided with circumferentially spaced slots 147 which are spaced apart a suitable angle, as for example, 90 DEG to provide spaced apart fingers 148. The slots 147 can have a width ranging from .012 to .016 inches.The chamfer 145 of the collet 142 is adapted to be engaged by a nose cap 151 formed of a suitable material such as plastic which is threaded onto the threads 138 on the spindle 127. The nose cap 151 is provided with a centrally disposed opening 152 which is in alignment with the bore 142 provided in the collet 141. The nose cap 151 is provided with longitudinally extending circumferentially spaced apart ribs 153 which are adapted to facilitate rotation of the nose cap 151 by the hand. Alternatively, if desired, knurling can be provided.

The nose cap 151 is adapted to receive the proximal extremity of the guide wire assembly 116 shown in Figure 7 so that it can be inserted through the collet 141 of the spindle 127 and into the outer housing 126 where it is adapted to engage cooperative slip ring means 156. The cooperative slip ring means 156 is in the form of yieldable finger members 157 and 158 formed of a suitable material, such as beryllium copper or stainless steel.

The finger members 157 and 158 are mounted within the outer housing 126 in a suitable manner. For example, they can be mounted on a member 161 formed of an insulating material which can be formed integral with the outer housing 126 or formed as a separate member mounted within the outer housing 126. The member 161 is provided with a centrally disposed bore 166 of a suitable size, as for example, from .020 to .024 inches which is provided with a chamfer 167 at its outer extremity which is adapted to receive the male connector 93. As can be seen from Figure 9, the bore 166 does not extend all the way through the member 161 but has a length so that when the proximal extremity 97a of the core wire 97 engages the end of the bore 166, the cylindrical members 102 and 103 are in registration with openings or slots 168 and 169 through which the yieldable finger members 157 and 158 extend.As can be seen, the slots or openings 168 and 169 are offset in longitudinal and circumferential directions. The spring-like finger members 157 and 158 are provided with U-shaped portions 157a and 158a respectively which extend through the slots 168 and 169 and are adapted to engage the conductive cylindrical members or bands 102 and 103. In order to ensure excellent electrical contact, the finger members 157 and 158, including the U-shaped portions may be gold plated. The finger members 157 and 158 can be secured to the insulating member 161 by suitable means such as screws 171.

If more than two conductors are desired in the guide wire assembly, it can be readily seen that such additional conductors can be readily accommodated by providing additional conductive bands or cylindrical members on the proximal extremity of the guide wire and by providing additional spring-like finger members within the housing 126 which are offset from the other spring-like finger members in longitudinal and circumferential directions.

The cable 123 hereinbefore described extends through a hole 176 provided in the outer housing 126 and has a knot 177 tied therein to permit the cable from being withdrawn from the housing 126. Conductors 178 and 179 forming a part of the cable 123 are connected by suitable means such as the screws 171 to the spring-like fingers 157 and 158 as shown in Figure 9.

Operation and use of the rotary connector 122 in connection with a guide wire assembly 116 of the present invention in connection with the apparatus and system shown in Figure 8 may now be briefly described as follows. The PTCA catheter 111 shown in Figure 8 and the guide wire 116 can be inserted into a patient in a conventional manner. The guide wire assembly 116 can be connected to the electronic device 124 through the use of a rotary connector 122. The torquer 121 is first placed on the guide wire assembly 116 in a conventional manner and thereafter the guide wire is connected to the rotary connector 122.This is accomplished by grasping the proximal extremity of the guide wire assembly and opening the nose cap 151 by rotating it counterclockwise on the threaded spindle 127 and then inserting the male connector 93 of the guide wire assembly 116 into the opening 152 in the nose cap and into the bore 142 of the collet and then into the recess 136 and through the bore 137 and thence through the chamfer 167 and into the bore 166 until the proximal extremity 97a of the core wire 97 has seated against the end of the bore 166. The nose cap 151 is then rotated clockwise to clamp the collet 142 onto the guide wire assembly 116 and to hold it firmly in place and to maintain the longitudinal orientation of the guide wire.In tightening or loosening the nose cap 151, the outer housing 126 can be grasped by one hand with two fingers of that hand while grasping the knurled collar 139 provided on the spindle 127 and with the other hand grasping the nose cap 151 to tighten or loosen the same.

With the guide wire assembly 116 so positioned, the slip ring means 156 provided in the rotary connector 122 will be engaged by having the cylindrical members 102 and 103 in engagement with the spring-like finger members 157 and 158 so that the electronic device 124 can be made operational. While the electronic device is operational and while the rotary connector 122 is connected to the guide wire assembly and the physician grasps the torque device or torquer 121 and manipulates the guide wire in a conventional manner to rotate the same to advance the tip of the guide wire and the guide wire into coronary arterial vessels. The spindle 127 readily rotates with the guide wire because of its mounting in the spindle bearings 129 and 131.This makes it possible for the attending physician to maintain good tactile feel of the guide wire while controlling and manipulating it and still maintaining electrical contact through the cable 123 connected to the rotary connector 122.

In applications of the present invention where it is not necessary to have complete freedom and rotation of the guide wire 116, a torquer connector 186 can be utilized in the apparatus and system shown in Figure 10. The use of a separate torquer is eliminated. The torquer connector 186 is shown in Figure 11 and is very similar to the rotary connector 122 shown in Figure 9 with the exception that a stationary member 191 has been provided in place of the rotatable spindle 127. The stationary member 191 is provided with a centrally disposed bore 192 which has a chamfer 193 at one end and which opens into a conical passage 194 at the other end. The conical passage 194 opens into a small bore 196 which has a suitable diameter, as for example, .020 to .024 inches which is in alignment with the bore 166 in the member 161.The stationary member 191 is provided with a boss 197 which is seated in the cylindrical recess 132 in the outer housing 126. The stationary member 191 is also provided with an enlarged knurled portion or member 198. It is also provided with threads 199 which are adapted to be engaged by the nose cap 151 that is adapted to engage the collet 141 provided in the bore 192.

Operation of the torque connector 186 in connection with the system and apparatus shown in Figure 10 may now be briefly described as follows. The catheter 111 and the guide wire assembly 116 can be inserted in the manner hereinbefore described. An electrical connection can be made to the electrical device 124 by the use of the torquer connector 186 which is connected by taking the proximal extremity of the male connector 93 shown in Figure 7 into the nose cap 151 and advancing it until it reaches the home position in which the portion 97a of the core wire 97 reaches the terminal extremity of the bore 166 so that the slip ring means 156 formed by the cylindrical members 102 and 103 are in engagement with the spring-like finger members 157 and 158.The nose cap 151 is then tightened by the fingers of one hand while the fingers of the other hand are utilized for holding the knurled member 198 to cause the collet to clamp onto the guide wire 116 in the torquer connector 186. The collet 141 remains stationary with the housing 126 and will not rotate. Since this is the case, the torquer connector 186 can be utilized as a torquer or torquing device. The torquer connector 186 can then be utilized by the attending physician to torque the guide wire. Because any rotation of the guide wire 116 will be applied to the cable 123 extending from the other end of the torquer connector 186, there will be less freedom of movement of the guide wire assembly.For this reason, it is believed that the attending physician would not have as good a tactile feel of what is occurring with the guide wire assembly 116 than with a rotary connector 122 where there is substantially complete freedom of movement because of the use of the bearing mounted spindle 127 and the use of a separate torquer 121. The tactile feel provided, however, should be adequate for many applications.

It should be appreciated that the apparatus and system shown in Figures 8 and 10 can be utilized with exchange wires when that becomes necessary. It is merely necessary to remove the proximal extremity of the guide wire 116 from the rotary connector 122 or from the torquer connector 186 and insert the same into the exchange wire. After the exchange operation has been completed, the rotary connector 122 or the torquer connector 186 can be reconnected to the proximal extremity of the guide wire 116.

It also should be appreciated that the guide wire assembly and the connector assemblies used therewith can be utilized in other applications in which it is desired to transmit and receive electrical signals through the guide wire. An embodiment making possible intravascular ultrasound imaging is shown in Figure 12 in which a guide wire assembly 201 is provided. The guide wire assembly 201 has an elongate tubular member 202 formed of a suitable material such as stainless steel having an outside diameter of .018 inches or less. As hereinbefore described, if desired, a core wire 203 can be provided within the tubular member 202 which extends substantially the entire length of the tubular member to provide additional and torsional rigidity for the tubular member 202.A housing 206 of a suitable material such as stainless steel can be provided separate and apart from the tubular member 201 or alternatively, if desired, it can be formed integral therewith. As shown in Figure 12, the housing 206 is separate from the distal extremity of the tubular member 201 and is connected thereto by suitable means such as a helical coil spring 208 which is mounted on the distal extremity of the tubular member 202 and to the proximal extremity of the housing 206. The connection to the housing 206 can be by way of a screw-type joint as shown in which the spring 208 is threaded into a helical groove 209 formed on the proximal end of the housing 206. A coil spring tip 210 is secured to the distal extremity of the housing 206 and is provided with a rounded tip 211.The coil spring tip 210 is threaded onto the distal extremity of the housing 206 by threading the same into another helical groove 209. The housing 206 is provided with a cut out 212 in one side wall of the same between the proximal and distal extremities.

Means is provided for directing ultrasonicenergy through the cut out 212 and consists of a transducer 213 which is mounted on the proximal side of the cut out 212 and is mounted in the housing 206 by a suitable means such as by attaching the transducer to one end of a stainless steel cylindrical insert 214 by a suitable adhesive. The core wire 203 has its distal extremity bonded to the insert 214 by a suitable adhesive. The conductors 98 and 99 shown in Figure 7 are connected to the front and back sides of the transducer 213.The ultrasonic energy supplied by the transducer 213 propagates in a direction which is perpendicular to the transducer 213 and strikes an angled mirrored surface 216 which is positioned at a suitable angle, as for example, an angle of 45 DEG to direct the ultrasonic energy out through the cut out 212 in a direction which is generally perpendicular to the longitudinal axis of the housing. The mirrored surface can be provided on a stainless steel insert 217 mounted in the housing 206. The insert 217 can be a short piece of stainless steel wire which has the ground and polished surface 216 thereon. The insert 217 is tapered as shown and has its distal extremity bonded to the rounded tip 211. The mirror surface 216 and the transducer 213 can be positioned apart a suitable distance, as for example, 1 millimeter and can be positioned on the same longitudinal axis.It should be appreciated that with respect to the mirror surface 216, it is possible to grind or lap the surface 216 to provide a surface which can be utilized for focusing the beam, as for example, a concave surface. In order to provide improved resolution, a matching layer 218 is provided on the transducer 213.

In the present invention, it is preferable to have the imaging device be approximately 3 to 5 centimeters proximal from the distal extremity of the tip of the catheter. This makes it possible to place a floppy guide wire tip as shown distal to the housing 206.

In order to achieve imaging through 360 DEG of the vessel in which the guide wire assembly 201 is inserted, the guide wire assembly 201 can be rotated at an appropriate speed by placing a gear 221 on the collar 139 of the spindle 127 (see Figure 13) and then driving the same by another gear 222. The gear 222 can be driven by a motor 223 of a conventional type controlled through wiring 224 connected to the electronic device 124 to control the speed of rotation of the guide wire assembly 201. In order to synchronize the rotation of the mirror surface 216 with the rotation of the motor 223 a shaft encoder 226 is provided for measuring shaft rotation which also connected by the wiring 224 to the electronic device 124. The rotary connector 122, the gears 221 and 222, the motor 223 and the encoder 226 are mounted in a housing 228.

Since the guide wire assembly 201 can be readily rotated, because of the rotatable spindle 127 utilized, it is possible to achieve imaging with the guide wire assembly 201 so that it can be used therapeutically and diagnostically. For example, the guide wire assembly 201 can be utilized in an angioplasty procedure to position the catheter 111, while at the same time providing imaging of the vessel in which the procedure is taking place. Thus it is possible to examine the plaque and visualize the same prior to performing an angioplasty. After the angioplasty has been performed the guide wire assembly 201 can be used to ascertain what has occurred with respect to the plaque in that vessel. With such a device it is possible to obtain cross-sectional imaging of the plaque deposit.In addition, it is possible to ascertain whether any damage had been introduced into the arterial wall by the angioplasty procedure and whether there is any danger of any plaque separating from the arterial wall.

It is apparent from the foregoing that there has been provided in the present invention a torquable guide wire assembly which has electrical functions and in which male and female connectors are provided. The torquable guide wire device can be utilized in a system and apparatus for performing various functions. It is possible with the torquable guide wire assembly of the present invention to provide a guide wire which has substantially and the same tactile feel as a guide wire which has no electrical connections thereto. This makes it possible for a skilled physician to operate in the same manner he has operated previously in angioplasty procedures without having to accommodate differences which would occur when the guide wire is connected electrically to an electronic device.The torquable guide wire assembly is capable of being utilized in different types of systems requiring electrical functions, as for example, in connection with intravascular ultrasound imaging by the guide wire assembly itself.