Source: https://patents.google.com/patent/EP0521595A2/en
Timestamp: 2018-10-19 20:44:56
Document Index: 443383599

Matched Legal Cases: ['arts 92', 'art 93', 'arts 218', 'arts 238', 'art 238', 'arts 311', 'arts 328']

EP0521595A2 - Torquable catheter and method - Google Patents
EP0521595A2
EP0521595A2 EP19920301259 EP92301259A EP0521595A2 EP 0521595 A2 EP0521595 A2 EP 0521595A2 EP 19920301259 EP19920301259 EP 19920301259 EP 92301259 A EP92301259 A EP 92301259A EP 0521595 A2 EP0521595 A2 EP 0521595A2
EP0521595B1 (en )
EP0521595A3 (en )
The disclosure relates to a catheter (21) having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft (22) having proximal and distal extremities (23, 24). The shaft (22) is comprised of a torque tube (31) extending substantially the entire length of the shaft (22). The torque tube (31) has a cylindrical wall with at least one flexible portion (31a, 31b, 31c) therein with the flexible portion being characterised in that at least one slot (41) is provided in the cylindrical wall subtending an angle of less than 360o. A flexible sleeve (46) encloses the torque tube (31) and serves to cover the flexible portion while transmitting the torque tube (31) to bend in the vicinity of the slot (41) a predetermined amount which is less than that which would create a permanent strain in the torque tube (31).
In the past, steerable catheters have heretofore been provided to facilitate manoeuvering in blood vessels. However, in the past with such devices it has been difficult to achieve a substantially one to one rate of movement for the proximal and distal extremities of the catheter. There is therefore a need for a new and improved catheter which can achieve such a one-to-one ratio and a method for making the same.
FIGURE 3 is a cross sectional view of the catheter shaft and distal extremity of the catheter shown in Figure 1.
FIGURE 9 is a plan view of another embodiment of a torquable catheter incorporating the present invention.
FIGURE 17 is a plan view of still another embodiment of a torquable catheter incorporating the present invention.
FIGURE 23 is a plan view of still another embodiment of a torquable catheter incorporating the present invention.
FIGURE 35 is a side elevational view of another embodiment of a torquable catheter incorporating the present invention with portions of the same being shown in cross-section.
The catheter shaft 22 consists of a flexible elongate torque tube 31 which extends from the steering handle 26 to near the distal extremity 24 of the catheter shaft. The torque tube 31 is formed of a suitable material such as 13 gauge thin wall stainless steel. Such stainless steel tube 31 has an outer diameter of 2.4X10⁻³m (.095") and inside diameter of 2.0X10⁻³m (0.077") to provide a wall thickness of 0.2X10⁻³m (.009"). It should be appreciated that it is within the scope of this invention to utilize torque tubes of various diameters and wall thicknesses depending upon the torque capability required for the torque tube 31. For example, utilizing the same diameter, a different wall thickness ranging from 0.2X10⁻³m (.007") to 0.3X10⁻³m (.012") can be provided. The torque tube can have a suitable length as determined by the length of the catheter 21.
Each of the flexible portions 31a, 31b and 31c is comprised of at least one slot and preferably a plurality of slots 41 which extend through the cylindrical wall 36 and are spaced longitudinally of the torque tube 31. The slots 41 are radially offset with respect to each other. Each of the slots subtends less than one circumference of the tube wall 36 or in other words less than 360°. Preferably the slots subtend an angle ranging from 270° to 300°. Thus, as shown in Figure 5, there is provided a slot 41 which is cut into the cylindrical wall until the inside surface 38 on the other side of the of the wall 36 is reached so that there remains material in the wall which extends over 1.6X10⁻³m(.064") or approximately 60°. The slots are radially offset with respect to each other by a suitable angle as for example 120°. However, these radial offsets can range from 30° to 120°. The slots 41 shown in the drawings extend transversely or normal to the longitudinal axis of the torque tube 31.
The distance between each slot 41 in a flexible portion can be defined as the pitch and can range from 0.8X10⁻³m(.03") to 0.2X10⁻³m(.09") and preferably approximately .055". A flexible length of the torque tube 31 can be considered to be a flexible portion associated with a solid wall portion as for example portions 31f and 31c.
By way of example, a torque tube having a length of 0.97m(38") and made in accordance with the present invention had a tip portion 31g which has a length of 5.1X10⁻³m (1.5"). It had a first flex group comprised of five flex portions each having a length of 0.025m (1") for a total of 0.13m (5"), a second flex group of seven flex lengths of 0.038m (1 1/2") each for a total of 0.27m (10 1/2") and a third flex group of 10 flex lengths of 0.051m (2") each for a total of 0.51m (20") and a shaft portion 31d having a length of 0.051m (2"). A flex length can be comprised of a single flex section plus a solid length of tubing ending at the first slot in the next flex section. By providing such flex groups, it has been found that the desired flexibility can be achieved for the catheter while still retaining high torque capabilities of the torque tube. It should be appreciated that additional flexibility can be obtained in the catheter by providing additional slots in the torque tube with some sacrifice in the torque capabilities of the torque tube.
The shrink tubing 46 is very flexible and permits desired flexing of the torque tube 31 but prevents undue bending or stress in the material of the side wall in any one slot and thereby prevents the placement of a permanent strain in any portion of the tube. In other words, the tubing 46 prevents bending or flexing of the torque tube beyond the point from which it will not yieldably return to its original configuration. The tubing 46 also serves to prevent blood or any other liquid in the lumen in which the catheter is introduced from entering into the slots 41 and causing possible clotting. The shrink tubing 46 can have an appropriate wall thickness such as 50.8X10⁻⁶m (.002") with a wall thickness ranging from 25.4X10⁻⁶ to 101.6X10⁻⁶m (.001 to .004").
A sleeve or tube 48 formed of a suitable insulating material such as a plastic as for example a polyamide is disposed within the torque tube 31 (see Figure 5) which extends the length of the torque tube 31. An elongate tightly coiled coil spring 51 is disposed within the sleeve or tube 48 and also extends the length of the torque tube 41. The coil spring 51 is formed of a spring steel wire rectangular in cross section. It can have suitable inside and outside diameters, as for example an outside diameter of 0.91X10⁻³m (0.0360") and an inside diameter of 0.66X10⁻³m (0.0260") and a wall thickness of 0.13X10⁻³m (.005"). The wire for the coil spring 51 can have side dimensions of 0.13X10⁻³m (.005") for a square cross section. The use of square wire for the coil 51 also serves to prevent collapsing of the turns of the coil during flexing of the catheter.
The distal extremity of the coil spring 51 extends beyond the distal extremity of the tube 31 and extends into a flexible braided tubular member 54 formed of a suitable material such as a plastic with braided wire embedded therein. The braided member 54 which extends within the shrink tubing 46 up to the distal extremity of the torque tube 31 to the line 56 shown in Figure 3. The distal extremity of the insulating tube 48 extends to the line 57 in Figure 3. The braided tubular member 54 extends distally beyond the distal extremity of the coil spring 51 and is bonded by a suitable means such as an adhesive (not shown) to a soft plastic tubing 61.
This housing 91 has a handle portion 91a which is elongate and which is adapted to be engaged by the hand of the user. The housing is provided with a large cylindrical portion 91b which has a steering lever 96 and a locking lever 97 rotatably mounted thereon. The handles 96 and 97 are provided with enlarged finger engaging portions 96a and 97a respectively which extend slightly outward of the cylindrical portion 91b and extend inwardly diametrically of the housing as shown particularly in Figure 8. The housing 91 is also provided with an elongate portion 91 which receives the proximal extremity of the shaft 22. Means is provided within the housing 91 for connecting the levers 96 and 97 to the pull wires 76 and 77 so that the pull wires can be pulled in accordance with the positioning of the steering lever 96 and locked in place by locking lever 97.
Means is provided for securing the proximal extremities of the pulling wires or elements 76 and 77 of the housing and consists of a holding block 131. The holding block 131 is rectangular in shape and is provided with a pin 132 which is seated within a recess 133. The pull wires 76 and 77 after they leave the eccentric 103 extend forwardly into a lumen 136 of a tension adjustment screw 137 which is provided therewith a slotted adjustment head 138. The adjustment screw 137 is threaded into a nut 139 and is disposed in a slot 141 provided in an H-shaped structure 142 formed integral with the parts 92 and 93. The H-shaped structure 142 includes upstanding leg portions 142 which define a space 143 therebetween and permit adjustment longitudinally of the H-shaped structure 142. From Figure 2, it can be seen that the coil spring 151 abuts the head 138 of the tension adjustment screw 137. A removable cover 144 is provided in the part 93 to permit access to the head 138 of the adjustment screw 137 to permit adjustment of the tension on the pull wires 76 and 77.
Operation and use of the catheter having high torque capacity shown in Figures 1-8 and method for utilizing the same may now briefly be described as follows. Let it be assumed that it is desired to carry out mapping in a chamber of the heart as for example the right ventricle and thereafter if necessary to carry out an ablation procedure. The catheter can be advanced into the chamber of the heart in a conventional manner as for example, through a femoral artery. The catheter can be advanced into a femoral artery by use of a guiding catheter. The physician while holding the steering handle 26 in one hand introduces the distal extremity of the catheter 21 into the vessel of the patient having a lumen therein. The catheter has sufficient rigidity so that it can be pushed or advanced into the lumen while observing the advancement under a fluoroscope. In view of the fact that the catheter is relatively flexible and small in size, as for example 3.2X10⁻³m (1/8") or less, it can be readily advanced through the arterial vessel of the patient into a chamber of the heart.
Another embodiment of a torquable catheter incorporating the present invention is shown in Figures 9 through 16. As shown therein, the torquable catheter 201 consists of a flexible elongate tube or shaft 202 which has proximal and distal extremities 203 and 204. The steering handle 206 is substantially identical to the steering handle 26 hereinbefore described, and is secured to the proximal extremity 203 of the tube or shaft 202. At least one electrode and preferably first and second electrodes are provided in which the first electrode is in the form of a ring electrode 207 and the second electrode is in the form of a tip electrode 208.
The torque tube 211 can have the same dimensions as hereinbefore previously described, as for example it can be in the form of 13-gauge, thin-wall hypodermic tubing having an outside diameter of 2.4X10⁻³m (0.095"), a wall thickness of 0.23X10⁻³m (.009") and an inside diameter of 2.0X10⁻³m (0.077") to form a bore 213. As also pointed out previously, torque tubes of various diameters and wall thicknesses can be provided depending upon the particular application as hereinbefore previously pointed out. The torque tube 211 has a suitable length as determined by the length of the torquable catheter 201.
In connection with the present invention, it has been found desirable to provide the torque tube 211 in two sections, one section 211a having a length ranging from 2 to 3 feet which provides 4-way or universal joint action, and a second section 211b having a suitable length as for example 2-3 inches which provides 2-way bending. Although the torque tube 211 is flexible and can be bent, additional flexibility is provided in both of the sections 211a and 211b as hereinafter described. In section 211a, opposed semicircular slots 216 are formed in spaced apart positions spaced axially of the section 211a. The slots 216 extend through the wall of the torque tube 211 a sufficient distance so that there remain circumferentially spaced apart hinges 217 which serve to join adjacent parts 218 forming the section 211. As shown, the hinges 217 are spaced 180° apart and can have a suitable thickness as for example 0.15X10⁻³m (.006"). The slots 216 can have a suitable width as for example 0.30X10⁻³m (.012"). Every other pair of opposed slots 216 are offset 90° with respect to the adjacent slots as shown in Figure 9 and by the cross sectional views as shown in Figures 11 and 12. The slots 216 can be formed in a suitable manner as for example by a spark erosion technique identified as EDM machining.
The torque tube section 211b is formed in a manner similar to that utilized for section 211a, the principal differences being that alternate opposed sets of slots are not offset by 90° because it is only desired to achieve 2-way bending by the relatively short tip section 211b. Thus, there are provided pairs of opposed slots 236 having a suitable width as for example 0.30X10⁻³m (.012") spaced apart a suitable distance as for example 2.8X10⁻³m (.110"). The slots 236 are cut to a sufficient depth so that there remain a pair of hinges 237 spaced 180° apart which form connections between adjacent parts 238 of the section 211b. It can be seen that the hinges 237 lie in a single plane so as to permit bending in only two directions, forward and back with respect to the hinges 237. The hinges again have a suitable width as for example 0.15X10⁻³m (.006"). The most proximal part 238 of the section 211b is provided with an annular recess 237 to provide a cylindrical portion 238 in which there are provided a pair of teats 239 spaced 180° apart having the same shape as the teats 223. These teats 239 engage the bores 232 in the section 211a.
A protective cover 261 formed of shrink tubing similar to the shrink tubing 46 hereinbefore described is provided. This shrink tubing is formed of polyolefin and encapsulates the outer surface of the torque tube 211 and extends from the ring electrode 207 at the distal extremity to the proximal extremity adjacent the steering handle 206. As pointed out previously, the protective cover 261 serves to prevent blood and other body fluids from entering into the slotted torque tube 211 while still permitting the desired bending of the torque tube. It also provides a smooth outer surface with low friction to facilitate movement of the torquable catheter tool in a vessel. As pointed out previously, the protective cover 261 can have a suitable wall thickness ranging from 25.4X10⁻⁶m to 101.6X10⁻⁶m (.001" to .004") and preferably 50.8X10⁻⁶m (.002").
Still another embodiment of a torquable catheter 301 incorporating the present invention is shown in Figures 17 through 22. The torquable catheter 301 consists of the flexible elongate tube or shaft 302 having proximal and distal extremities 303 and 304. The proximal extremity is connected to a steering handle 306 of the type hereinbefore described. The catheter shaft 302 consists of a flexible elongate torque tube 307 which is formed of a plastic. A plastic suitable for this purpose is polypropylene which, in addition to being very strong, provides a desired hinge action which may be flexed repeatedly, as for example millions of times, without breaking.
The torque tube 307 is formed in two sections 307a and 307b, in which section 307a permits 4-way bending whereas section 307b permits 2-way bending as described in connection with a previous embodiment of the torquable catheter. The section 307a has a length of 2-3 feet and section 307b has a length of 2-4 inches. Section 307a is provided with pairs of opposed semicircular slots 308 which extend through the wall of the plastic torque tube 307 a sufficient distance so that there remains a pair of hinges 309 which are spaced 180° apart having a suitable width as for example 0.15X10⁻³m (.006") and with the slots having a width of suitable dimension as for example 0.30X10⁻³m (.012"). The pairs of opposed slots 308 are spaced apart by a suitable distance as for example 2.5X10⁻³m (.100"), with every other pair of slots being offset by 90° so that the hinges 309 lie in two planes which are angularly offset with respect to each by 90° to provide the 4-way bending similar to that obtained by universal joint hereinbefore described. The hinges 309 provided bending between adjacent parts 311 to permit flexing of the hinges between the parts in an amount determined by the width of the slots 308.
In order to provide a return memory at the distal extremity of the torque tube 211, TINEL superelastic wire by Raychem Corporation, 300 Constitution Drive, Menlo Park, California 94025, is utilized having a diameter ranging from 0.20X10⁻³m to 0.30X10⁻³m (.008" to .012") and preferably a diameter of 0.25X10⁻³m (.010"), which extends longitudinally of the section 211b through the hinges 237 as shown particularly in Figure 15. This superelastic wire, because it provides extreme flexibility, is kink resistant and provides shape recovery to the distal extremity of the torquable catheter when the distal extremity is permitted to return to its original condition.
The two-way bendable section 307b is provided with opposed semi-circular slots 326 which extend substantially through the wall of the tubular section 307b so that there remains a pair of hinges 327 spaced 180° apart. The slots 326 have a suitable width as for example 0.30 X 10⁻³m (.012") and are spaced apart a suitable distance as for example 2.5X10⁻³m (.100") to provide hinges 327 between parts 328 which lie on a plane so as to permit flexing in two directions. The proximal extremity of the section 307b is connected to the distal extremity of the section 307a by a cylindrical spring backup module 331 which is provided with a cylindrical extension 332 having teats 333 provided 180° apart thereon which engage the bores 317 in the distal extremity of the section 307a. As can be seen, the distal extremity of the spring 324 abuts against the cylindrical extension 332. The other end of the spring backup module 331 is provided with a cylindrical recess 334 having diametrically extending bores 336 extending into the recess. The proximal extremity of the section 307b is provided with a cylindrical extension 337 having teats 338 mounted thereon spaced 180° apart which are received by the bores 336 to secure the section 307b to the section 307a.
In a similar manner, the distal extremity of the section 307b is provided with a cylindrical recess 341 having diametrically extending bores 342 opening therein. The recess 341 is adapted to have mounted therein a cylindrical steering wire retainer 346 which is provided with a cylindrical extension 347 having a pair of teats 348 mounted 180° apart thereon which are adapted to seat in the bores 342. The pull wires 321 and 322, which also can be called steering wires, extend through the section 307a between the interior of the section 307a and the exterior of the coil spring 324 through the spring backup module 331 and then through the section 307b disposed in elongate recesses 349 provided therein on opposite sides of a central open bore 351 which extends through the section 307b. The pull wires 321 and 322 can be formed of a suitable material such as KEVLAR. The distal extremities of the pull wires 321 and 322 extend into the steering wire retainer 346 and are secured therein by a retaining ring 352 which is secured to the retainer by suitable means such as an adhesive. The retaining ring 352 is provided with a central bore 353 which is in axial alignment with the bore 351 of the section 307b.
In order to provide shape recovery to the distal extremity of the torquable catheter 301, a pair of superelastic wires formed of a suitable material such as TINEL of a suitable size such as .010" in diameter are provided in the section 307b of the torque tube 307. As shown particularly in Figure 21, these wires 371 and 372 are insert-molded into the hinges 327 of the section 307b and extend longitudinally through the length thereof. These superelastic insert-molded wires 371 and 372 urge the distal extremity 304 to its normally straight condition after it has been formed into a bend by the steering handle 306 and then released.
The wye adapter 368 is also provided with a side arm 381 which is provided with a central bore 382 that is in communication with a bore 383 which is in communication with the bore 361 extending through the coil spring 324. The side arm 381 is also provided with an O-ring 386 and a thumbscrew 387 which is threaded therein, and is adapted to clamp the O-ring 386 about any device (not shown) which extends through a bore 388 provided in the thumbscrew 387 through the O-ring 386 and into the bores 382 and 383. Such a device can extend into the bore 361 of the coil spring 324 and through the bores 351 and 353 provided in the distal extremity of the catheter and out through the open end. Thus, by way of example in connection with the present invention, it is possible to readily provide a open central lumen access having a diameter of 1.3X10⁻³m (.052") through the 2-way flex section 307b and a 0.97X10⁻³m (.038") diameter central lumen access through the 4-way flex section 307a. It can be readily be seen that this central lumen is a size that can accept many different types of medical devices for conducting operations in the human body.
Still another embodiment of a torquable catheter 401 incorporating the present invention is shown in Figures 23 through 34. As shown therein, it consists of a shaft 402 which is provided with proximal and distal extremities 403 and 404. The shaft 402 consists of a flexible elongate torque tube 406. The torque tube 406 consists of a 4-way bend section 407 which is comprised of a plurality of axially aligned joined-together modules 408 and the 2-way bend section 409 which is comprised of axially aligned joined-together modules 411 and 412.
The module 408 is in the form of a cylinder and has a suitable dimension such as an outside diameter of .095" and a cylindrical bore 414 extending longitudinally thereof and having a diameter of a suitable dimension as for example 1.5X10⁻³m (.060") to provide a cylindrical wall 416 having a thickness of 0.44X10⁻³m (.0175"). The module 408 can have a suitable length as for example 4.8X10⁻³m (.188"). A pair of longitudinally extending tangs or legs 417 are provided which are formed integral with the wall 416 and are disposed parallel to the longitudinal axis of the bore 414. The legs 417 can have a suitable length as for example 1.1X10⁻³m (.042") and have a width of 0.46X10⁻³m (.018") and a thickness of 0.25X10⁻³m (.010"). The legs 417 are provided with portions which have a reduced cross section in a direction perpendicular to the longitudinal axis of the bore 414 and serve to form "living hinges" to permit repeated flexing without breaking of the legs with respect to the wall 416 as hereinafter described. Ears 419 are formed integral with the outer extremities of the legs 417 and are generally rectangular in cross section and can have a suitable thickness as for example 0.46X10⁻³m (.018") and a length of 0.46X10⁻³m (.018") inches. The hinges 418 are formed by providing radii of a suitable size as for example 0.15X10⁻³m (.006") in a hinge having a length of 0.30X10⁻³m (.012"). A pair of recesses 421 are provided in the outer surface of the wall 416 on the end opposite the legs 417 spaced 180° apart which are offset 90° with respect to the legs 417 of another module 408. The recesses 421 are sized so that they can receive the legs 417 of another module 408 and have a width of approximately .018" and a length of 0.76X10⁻³m (.030"). The recesses 421 extend into rectangular recesses or holes 422 which extend through the wall 416. These holes or recesses 422 are dimensioned to receive the ears 419 and thus are provided with sides having a dimension of 0.46X10⁻³m (.018").
It can be seen that the holes or recesses 422 are positioned in such a manner so that when the modules 408 are assembled as shown in Figure 23 with the legs 417 extending into the recesses 421 and with the ears 419 seated within the holes or recesses 422, there is provided a spacing between the axially aligned, joined modules 408 of a suitable dimension as for example 0.30X10⁻³m (.012") corresponding to the length of the hinges 418 so as to permit bending of the modules 408 with respect to each other in a 4-way motion which is similar to the universal joint action hereinbefore described. As can be seen, bending of one module with respect to the other in a pair of modules 408 can occur in two directions at right angles to the hinges 418 whereas another pair of modules can be bent in two different directions offset by 180° with respect to the directions in which the modules in the first-named pair can be bent.
The modules 411 forming a part of the 2-way bend section 409 are also of cylindrical form and can have an outside dimension as for example 2.4X10⁻³m (.095") and a length of 2.9X10⁻³m (.114") with a cylindrical bore 426 having a suitable diameter as for example 1.5X10⁻³m (.060") to provide a wall 427 having a thickness of 0.44X10⁻³m (.0175"). Pairs of recesses 428 and 429 spaced 180° apart are provided on opposite ends of the cylindrical wall 427 and extend through the outer surface thereof and are in axial alignment with each other and extend longitudinally of the bore 426. The recesses 428 and 429 open respectively into rectangular recesses or holes 431 and 432 provided in the wall 427. These recesses 428 and 429 and the holes or recesses 431 and 432 are dimensioned in a manner similar to the recesses 421 and the holes or recesses 422 in the module 408.
The module 412 is also cylindrical in shape and is provided with an outside diameter of 2.4X10⁻³m (.095") with a cylindrical bore 436 extending longitudinally therethrough and having a diameter of 1.5X10⁻³m (.060") and a wall 437 having a thickness of 0.44X10⁻³m (.0175"). Pairs of legs 438 and 439 are formed integral with the wall on opposite ends of the wall 437 and extend outwardly therefrom. The legs in each pair spaced 180° apart are in axial alignment with the legs of the other pair. The legs can have suitable dimensions as for example a length of .060" and a width of 0.46X10⁻³m (.018"). Hinges 441 and 442 are formed by providing portions of reduced cross sectional area and width of the legs by providing hinges having a length of 0.30X10⁻³m (.012") and by forming radiuses of 0.15X10⁻³m (.006"). Rectangular ears 443 and 444 are provided on the outward extremities of the legs 438 and 439 and have suitable dimensions as for example 0.46X10⁻³m by 0.46X10⁻³m (.018" by .018"). The ears 443 and 444 and the legs 438 and 439 are dimensioned so that they can fit within the recesses 428 and 429 and 431 and 432 provided in the module 411.
As can be seen in Figure 23, the modules 411 and 412 are joined together by snapping the legs 438 and 439 into the recesses 428 and 429 so that the ears 443 and 444 snap into the recesses 431 and 432 to provide the 2-way bend section 409 so that the hinges 441 and 442 are axially aligned and to provide a suitable spacing between the modules as for example 3.0X10⁻³m (.12") to permit 2-way bending of this section of the shaft.
A still further embodiment of a torquable catheter 501 incorporating the present invention is shown in Figures 35 through 50. The torquable catheter 501 consists of a flexible elongate shaft 502 which has a proximal extremity 503 and a distal extremity 504. A handle 506 is secured to the proximal extremity 503.
The main torque tube portion or section 511a can have a suitable length as for example 38 inches and can be formed of a suitable material such as 13 gauge thin-wall stainless steel as hereinbefore described. It is formed in the matter hereinbefore described in connection with the previous embodiments and as shown particularly in Figure 36 is provided with a plurality of longitudinally spaced apart slots 512 which extend through the cylindrical wall of the torque tube section 511a and which are radially offset with respect to each other as hereinbefore described.
One or more ring electrodes can be provided on the tubular member 523 and as shown three of such ring electrodes 536, 537 and 538 have been provided which are spaced apart longitudinally of the tubular member 522. Wires 539, as for example three, formed of a suitable material such as stainless steel extend the length of the torque tube 11. Conductors 541, 542, 543 and 544 are provided for making electrical contact to the RF electrode 532 and to the ring electrodes 536, 537 and 538. Thus the conductor 541 as well as the three wires 539 extend into a bore 546 provided in the RF electrode 532 and are soldered therein by solder 547. The conductors 542, 543 and 544 extend through holes 548 provided in the tubular member 522 and are bonded to the ring electrodes 536, 537 and 538 in a suitable manner such as by spot welding. The conductors 541, 542, 543 and 544 in order to provide greater strength so that they can serve as safety wires in the same manner as wires 539 for preventing the tip piece 521 from being accidentally separated from the torque tube 511 are also formed of stainless steel to provide strength and are copper plated to provide the desired conductivity. The conductors 541, 542, 543 and 544 extend distally toward the distal extremity of the flexible elongate shaft 502 and extend through a bore 549 provided in the fitting 526. The conductors 541, 542, 543 and 544 are insulated from each other and from the wires 539 by suitable insulation (not shown) provided on the conductors. The wires 539 and conductors 541-544 are enclosed in a tubular member 551 formed of a suitable insulating material such as a suitable plastic, as for example polyamide. This tubular member 551 serves as a jacket for the wires 539 and conductors 541-544 and extends into a bore 549 of the fitting 526 (see Figure 36). By way of example, the tubular member or jacket 551 can have a suitable outside diameter as for example 0.76X10⁻³m (.030") and an inside diameter of 0.64 X10⁻³m (.025") so that there is adequate space for receiving the three wires 539 and the four conductors 541-544.
A catheter comprising an elongated flexible body having an axis, a proximal end, and a distal end, the body including a tubular wall having at least one slotted-wall segment that includes at least one slot extending through the wall that subtends an angle of less than 380o to impart additional flexibility and a flexible sleeve encasing the slotted-wall segment to permit the slotted wall segment to bend about the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the axis by transmitting the rotational torque to and through the slotted-wall segment, and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body.
A catheter according to Claim 1 wherein the slotted wall segment is slotted to impart a first degree of flexibility about the axis, wherein the tubular wall includes a second segment that is spaced from the first mentioned segment and that has at least one slot that subtends at an angle of less than 360o to impart a second degree of flexibility different than the first degree of flexibility and wherein the flexible sleeve also encloses the second slotted segment and permits the second slotted segment to bend without breaking.
A catheter according to Claim 1 or Claim 2 wherein the first means is a handle adapted to be grasped by the human hand and wherein the second means includes first and second pull strings secured between the handle and the distal end of the body and extending through the body and means carried by the handle for pulling on said pull strings for causing the bending of the distal end of the body.
A catheter as in Claim 3 wherein said tubular wall is provided with a tip section and a tractable section proximal of the tip section together with means for connecting one of said pull strings to said tip section and the other of said pull strings to said tractable section whereby the tip section can be bent by pulling on one of said pull strings and the tractable section can be bent by pulling on the other of said pull strings.
A catheter according to Claim 4 wherein said one pull string is secured to said tip section at the distal extremity of the tip section and wherein said other pull string is secured to the tractable section at the distal extremity of the tractable section together with anchoring means for anchoring the tip section at the proximal extremity of the tip section and anchoring means for anchoring the tractable section at the proximal extremity of the tractable section.
A catheter as in any preceding claim wherein the tubular wall is provided with a tip section having a plurality of longitudinally spaced apart slots substantially in radial alignment with each other and serving to provide a rib extending longitudinally of the tip section and generally lying in a plane.
A catheter as in Claim 6 wherein said slots in said tip section subtend various angles to provide a backbone at least a portion of which is tapered to provide variable flexibilities in the tip section.
A catheter according to Claim 3 wherein the distal extremity of said tubular wall has a coil spring therein which is substantially imcompressible in a direction parallel to the axis of the tubular wall, a bendable element having first and second ends supported by the substantially incompressible coil spring portion of the flexible tubular element, and wherein the second means includes first and second flexible pull elements extending through the body and being connected to said bendable element in spaced apart positions on the bendable element, a flexible sheath disposed over said bendable element and said first and second flexible pull elements whereby when said pull elements are pulled, the bendable element will bend in relatively smooth curves.
In a method for mapping a chamber in the heart by use of a catheter having proximal and distal extremities and by having at least one electrode carried by the distal extremity, rotating the proximal extremity of the catheter after the distal extremity of the catheter has been positioned in the chamber of the heart by a small incremental distance by bringing the electrode into contact with the wall of the heart and making a potential measurement, thereafter rotating the proximal extremity of the catheter an additional incremental amount, bringing the electrode of the catheter into contact with the wall of the heart and making an additional potential measurement.
A method as in Claim 9 for positioning a catheter in a vessel with the catheter having proximal and distal extremities, and having first and second pull lines with distal extremities secured to the distal extremity of the catheter and means for applying a tension to the pull lines, the catheter having a tip section and a tractable section proximal of the tip section, the method further comprising the steps of forming a slight bend in the tractable section of the catheter outside of the vessel, introducing the catheter into the vessel and using one of the pull lines to place an additional bend in the tractable section, and utilizing the other pull line to place a bend in the tip section.
EP19920301259 1991-02-15 1992-02-17 Torquable catheter Expired - Lifetime EP0521595B1 (en)
US725660 2000-11-29
EP19970107769 EP0790066B1 (en) 1991-02-15 1992-02-17 Steerable catheter
EP19970107769 Division EP0790066B1 (en) 1991-02-15 1992-02-17 Steerable catheter
EP0521595A2 true true EP0521595A2 (en) 1993-01-07
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EP0790066A2 (en) 1997-08-20 application
EP0521595A3 (en) 1993-03-03 application
EP0790066B1 (en) 2000-04-12 grant
DE69229147D1 (en) 1999-06-17 grant
US5322064A (en) 1994-06-21 grant
JPH07255855A (en) 1995-10-09 application
CA2061215A1 (en) 1992-08-16 application
EP0790066A3 (en) 1998-01-21 application