CA1170137A

CA1170137A - Infusion catheter

Info

Publication number: CA1170137A
Application number: CA000396816A
Authority: CA
Inventors: William Ganz; Ronald J. Solar; Clement Lieber
Original assignee: American Hospital Supply Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 1981-03-06
Filing date: 1982-02-23
Publication date: 1984-07-03
Also published as: US4430083A; EP0063859A3; JPS57173065A; EP0063859A2

Abstract

INFUSION CATHETER
ABSTRACT OF THE DISCLOSURE

A catheter comprising an elongated flexible tube having an elongated passage extending axially through the tube between proximal and distal openings and a helically wound wire engaging the peripheral wall of the tube and providing a portion of the peripheral wall with an uneven contour. The tube includes a radiopaque marker at the distal end of the catheter. The radiopaque marker is molded from a biocompatible metal powder and a thermo-plastic binder. The catheter is adapted for use with an angiography catheter, and it is configured to provide automatic orientation of the distal end portion of the catheter as such distal end portion emerges from the dis-tal opening of the angiography catheter.

Description

1 BACKG~OUND OF_THE INVENTION

3 Acute myocardial infarction commonly occurs 4 when a thrombus or clot occludes an artery of the heart.
~ When this occurs, a thrombolytic agent, such as strepto-6 kinase is used to obtain lysis of the clot.
7 It is known to use thrombolytic agents systemi-8 call~ by administering them lntravenously. However, 9 such use of streptokinase involves a considerable risk of bleeding in patients.
11 Alternatively, the streptokinase or other throm-12 bolytic agent can be infused locally into the general re-13 gion of the thrombus. This can be accomplished, for ex-14 ample, by utilizing an angiography catheter in a procedure which first involves injecting dye to locate the clot, 16 terminating the dye injection and then utilizing that same 1~ catheter to infuse the thrombolytic agent in the yeneral I8 region of the thrombus. Unfortunately, the angiography 19 catheter has too large a diameter to enable its distal opening to be positioned in close proximity to distal 21 clots. Accordingly, the action of the thrombolytic agent 22 is not as localized as desired, and the agent may be shunt-23 ed away from the clot by collateral vessels. Also, to de-24 termine if the clot is dissolved, infusion must be stopped

2$ and the dye flow started. This increases the time to ob-26 tain removal of the clot and, therefore, increases the 27 likelihood of necrosis of the myocardium.

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1 SUMMARY OF T~E INVENTION

3 This invention solves -these problems by util-

4 izing a catheter which allows percutaneous administration o~ a thrombolytic agent directly to a clot in a coronary ~ artery. Once acute myocardial infarction has been diag-7 nosed and the location of the clot has been identified 8 using an angiography catheter and conventional techniques, 9 the catheter of this invention can be immediately advanced directly through the angiography catheter into the coron-11 ary arterial vasculature into close proximit~ to the clot.
12 The thrombolytic agent can then be introduced through the 13 catheter of this invention directly into the clot to mini- , 14 mi~e the likelihood of permanent damage to the heart muscle. This reduces the ~uantity of the thrombolytic 16 agent infused and the risk of hemorrhaging is correspond-17 ingly reduced. Less time may be needed for this procedure, 18 and the extent of necrosis of the myocardium may also be lg reduced.
The catheter may include an elongated, flexible 21 tube having a peripheral wall, proximal and di.stal open-22 ings and an elongated passage extending generally axially 23 through the tube between the openings. Th0 flexible tube 24 is supported by a helically wound wire which engages the peripheral wall of the tube. This wire has an axial cross~
26 sectional dimension extending axially of the passage which 27 is greater than the axial cross-sectional dimension of the 28 wire which extends radially of the passage. This provides 29 a catheter which has substantial column strength, relative-ly small outside cross-sectional dimensions and a relative-31 ly large cross-sectional area lumen.

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1 It is believed that an uneven contour on the out-2 er peripheral surface of the tube facilitates sliding move-3 ment of the tube in some environments. For example, in the 4 presence of liquids or other flowable masses, an uneven ~ contour on the peripheral surface may trap such liquids 6 to provide lubricated movement of the catheter. Accord-q ingly, this invention provides the outer peripheral sur-8 face of the tube with an uneven contour over at least a 9 portion of the length of the tube. Although this can be accomplished in different ways, the helically wound wire ll can be formed, in the winding process, into a tubular con-12 figuration which has an irregular outer peripheral surface 13 which deforms the outer peripheral surface of the tube.
14 Preferably, the wire is helically wound into a series of tight, contiguous coils to provide the outer peripheral 16 surface of the wire with an anticlastic curvature. The 17 tube can advantageously include heat shrink tubing shrunk 18 into tight engagement with the helically wound wire.
l9 The wire-tube combination remains flexible. How-ever, it is desirable to provide the tube with a distal 21 end portion which is somewhat softer and more flexible to 22 avoid any damage to the coronary artery. This can be 23 accomplished, for example, bv allowing the distal end 24 portion of the tube to extend beyond the end of the heli-cally wound wire so that the distal end poxtion is un-26 supported by the wire. Accoxdingly, the distal end por-27 tion of the tube is smooth and flexible. When in use 28 within an angiography catheter, the proximal end of the 29 distal end portion remains within the angiography cathe-ter.

()137 It is important to identify the location of the 2 distal opening of the catheter, and for this purpose, a 3 radiopaque marker is provided. Although other locations 4 are possible, it is preferred to locate the radiopaque marker at ~he distal opening so that the distal opening 6 can be accurately located when the catheter is in use.
7 Because the catheter is of very small cross-8 sectional area and because the distal end must be accu-9 rately located, a very small radiopaque marker having substantial radiopacity must be used. In addition, the 11 radiopaque marker must be strongly secured to the cathe-12 ter so that it will not become dislodged when in use. To 13 accomplish these objectives, the present invention util-14 izes a radiopaque marker which includes a biocompatible metal powder having a specific gravity greater than 11 1~ and a binder. For example, the biocompatible metal may 17 include tantalum or gold, with tantalum being preferred.
18 Of course, the biocompatible metal may include suitable 19 metal alloys. A biocompatible metal having a specific gravity grQater than 11 provides the necessary radiopa-21 city for the small radiopaque marker.
22 The tube may include plastic tubing, such as 23 heat shrinkable plastic tubing. To strongly secure the 24 radiopaque marker to the tubing, the binder is prefer-ably constructed of a material which can be fused to the 26 material of the tubing. For example, elastomeric or 27 thermoplastic materials can be used.
28 The distal end portion of the catheter can be 29 configured to seek out a par~icular coronary artery.
For example, it has been found that a straight catheter ~() l3'7 1 can be utilized to reach a clot in the right coronary ar-2 tery, whereas passage-seeking bend sections should be us-3 ed to facilitate insertion of the catheter into the left 4 anterior descending coronary artery and the circumflex branch of the left coronary artery.
For catheters of this invention which have a 7 passage-seeking bend section, it is important that this 8 bend section emerge from the distal opening of the angio-9 graphy catheter at the correct angular orientation. With this invention, orientation is automatically provided as 11 the catheter is passed through the angiography cathe-ter 12 by providing the inner catheter with at least one orien-13 tation bend section in its distal end portion. This or-14 ientation bend section cooperates with a bend section of lS the angiography catheter to angularly orient the passage-16 seeking bend section. The angiography catheter may con-17 tain two bend sections, and in this case, the inner cathe-18 ter can advantageously include two corresponding orienta-l9 tion bend sèctions cooperating with the two bend sections, respectively, of the angiography catheter. In a preferred 21 configuration, the orientation bend sections of the inner 22 catheter will roughly correspond in configuration and spac-23 ing to the bend sections of the angiography catheter so 2~ that the orlentation bend sections are within the bend sections of the angiography catheter when the passage-26 seeking bend section is just outside the distal opening 27 of the angiography catheter.
28 As described above, the outer catheter is the 29 orienting member, and the inner catheter is the orient-ed member. However, the orienting features of this ~ L'7( j~.3'~

1 invention are equally applicable when the inner catheter 2 or other inner member is the oxienting member and the 3 outer catheter or other outer member is the oriented 4 member. Thus, either the inner or outer member may or-ient the other and either, or both of these mem-8 bers may be catheters.
Although the configuration of the distal end 8 portion of the catheter will vary depending upon the 9 configuration of the outer catheter which is to be us-ed, in one preferred construction, the orientation bend 11 sections lie in the same plane, and the passage-seeking 12 bend section lies in a plane transverse to the plane of 13 the orientation bend sections. In one embodiment, the 14 first orientation bend section has an included angle which is substantially greater than the included angle 1~ of the second orientation bend section.
1~ Although the catheter is described as being for 18 use with an angiography catheter in treating acute myo-19 cardial infarction, the catheter can be used for other purposes and in conjunction with other catheters.
~1 The invention, together with further ~eatures 22 and advantages thereof, may best be under~tood by refer-23 ence to the following description taken in connection X4 with the accompanying illustrative drawing.

28 Fig. 1 is a perspective view of a catheter con-29 structed in accordance with the teachings of this inven-tion.

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1 Fig. 2 is an enlarged, fragmentary ~ectional view 2 taken generally along line 2-2 of Fig. 1.
3 Fig. 3 is an enlarged, fragmentary sectional view 4 taken on an axial plane through the tubing of the catheter S and showing portions of the helically wound spring in ele-6 vation.
Fig. 4 is an enlarged, fragmentary sectional ~iew 8 showiny an end portion of the catheter.
9 Fig. 5 is an enlarged, fragmentary sectional view of a region of the distal end portion of the catheter.
ll Fig. 6 is a fragmentary plan view illustrating a 12 catheter having an end portion of a different configuration.
13 Fig. 7 is a fragmentary side elevational view tak-14 en generally along line 7-7 of Fig. 6.
Fig~ 8 is a fragmentary sectional view similar 16 to Fig. 7 showing another configuration for the catheter.
1~ Fig. 9 is an enlarged fragmentary sectional view 18 illustrating one of the bend sections of the catheter of l9 Fig. 6.
Fig. 9A is an enlarged sectional view taken gen-21 erally along line 9A-9A of Fig. 9.
22 Fig. lO is a diagrammatic illustration of an an-23 giography catheter and the catheter of this invention be-24 ing utilized to infuse a thrombolytic agent into the heart.
26 Fig. 11 shows the catheter of Figs. 1-5 being 27 utilized in association with an angiography catheter to 28 infuse a thrombolytic agent directly onto a clot in the 2~ right coronary artery.

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1 Fi~. 12 is a view simila~ to Fig. 11 showing 2 the catheter of Figs. 6 and 7 being utilized to infuse 3 a thrombolytic agent into a clot in the left anterior 4 descending coronary artery.
~ Fig. 13 is a view similar to Fig. 11 showiny 6 the catheter of Fig. 8 being utilized to infuse a throm-7 bolytic agent directly onto a clot in the circumElex 8 branch of the left coronary artery.

BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS

lZ Fig. 1 shows a catheter 11 which generally in-13 cludes a hub or connector 13 adapted for connection to 14 an infusion pump 15 (Fig. 10) or other fluid handling device and a tube 17 coupled to the connector. The tube 16 17 includes a relatively short length of strain relief 17 tubing 19, flexible tubing 21 which extends for substan-18 tially the full length of the tube 17, and a radiopaque 19 marker 23 (Fig. 4). The catheter 11 also includes a hel~
ically wound wire 25 within the tubing 21.
21 The connector 13 is constructed of a rigid plas-22 tic material and has an axial bore 27 (Fig. 2), a counter-23 bore 29 and a threaded section 31 to facilitate its at-24 tachment to the infusion pump 15 (Fig. 10). The strain Z5 relief tubing 19 is constructed of heat shrink plastic 26 and is seated in the counterbore 29. The tubing may be 27 attached to the connector 13 by adhesive or by direct fu-28 sion of the plastic materials of the tubing 19 and the 29 connector 13. The strain relief tubing is stiffer than the tubing 21 and projects a short distance axially of 1.~'7~3'~

l the connector 13 to provide strain relief for the tubing 2 21.
3 The tubing 21 is long and flexible and, in the embodiment illustrated, it is constructed of heat shrink polyvinylchloride (PVC). The tubing 21 is fused directly 6 to the plastic material of the strain relief tubing 19, 7 although an adhesive could be utilized, if desired.
8 The helically wound wire 25 forms a tubular 9 structure within the passage of the tubing 21, and the tubing is shrunk into tight engagement with the helically 11 wound wire 25. The wire 25 is tightly wound with the ad-12 jacent coils being in contact with each other. The heli-13 cally wound wire 25 extends from the proximal end of the 14 tubing 21 to a location 33 (Fig. l) spaced from the dis-tal ehd of the tube. The wire may be constructed of 16 metal or a suitable plastic.
17 As shown in Fig. 3, the wire 25 has an inner sur-18 face 35 and an outer surface 37. In the unwound condition, 19 the surfaces 35 and 37 are planar and parallel. However, the wire is wound sufficiently tightly and is otherwise 21 constructed and arranged so as to induce stresses to pro-22 vide a transverse curvature known as anticlastic curvature in the 23 er surface 37 as shown in Fig. 3. In addition, the wire 24 25 has end faces 39 which are separated to form a gap, and this gap can be the result of the anticlastic curvature 26 and/or the configuration of the end faces. The anticlastic 27 curvature ancl the ~aps provide the helically wound wire 25 28 with an irregular outer periphera]. surface. ~hen the tub-29 ing 21 is shrunk into tight contact with the outer surface 37 of the wire 25, the uneven contour of the outer surface 7~ 37 1 37 provided by the anticlastic curvature deforms the tub-2 lng 21. Accordingly, the tubing 21 has an outer periph-3 eral surface 41 which is uneven and which contains a 4 multiplicity of peaks 43 separated by valleys 45.
As shown in Figs. 2 and 3, the wire 25 has an 6 axial cross-sectional dimension which is substantially 7 greater than the radial cross-sectional dimension of the 8 wire. The aspect ratio is preferably at least 2-to-1, 9 and in the embodiment illustrated, is 3-to-1. This pro-vides good column strength and an increased lumen diame-11 ter for the catheter 11.
12 The tube 17 extends beyond the location 33 (Fig.
13 3) at which the helically wound wire 25 terminates to de-14 fine a distal end portion 47 which is unsupported by the wire 25 and is, therefore, more flexible than the portion 16 of the tube ~hich is supported by the wire. The distal 17 end portion may be considered as being joined to a proxi-18 mal portion of the catheter. In addition, the distal 19 end portion 47 has a smooth outer peripheral surface as shown in Fig. 4. The tubing 21 necks down slightly at 21 the location 33 to provide the distal end portion 47 with 22 a reduced diameter. In the ~orm shown in Figs. 1-4, the 23 distal end portion 47 is normally generally cylindrical, 24 although it can be readily deformed due to its flexible 2~ nature.
26 The radiopaque marker 23 (Figs. 4 and 5) includes 27 a biocompatible metal powder having a specific gravity of 28 greater than 11 and a binder. In the embodiment illustrated, 29 the metal powder is tantalum and the binder is PVC. Al-though different ratios can be used, the tantalum and PVC

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1 may represent 75 percent and 25 percent, respectively, 2 by weight of the marker 23.
3 Although different methods of construction can 4 be emploYed, the marker 23 is preferably molded into a tubular section having an axial passage extending through it. The tubular section is placed within the outer end 7 portion of the tubing 21 and they are fused together with 8 heat and pressure to cause the plastic of -the binder and 9 the plastic of the tubing to become an integral ~ass, with the powdered tantalum dispersed therein. This re-ll sults in the radiopaque marker 23 being soft and resil-12 iently flexible. Preferably, this assembly process also 13 provides a tapered outer surface 49 on the tubing 21 as 14 shown in Figs. 4 and 5.
The tube 17 has an elongated axial passage or 16 lumen 51 extending between a proximal opening 53 and a 17 distal opening 55. ;As shown in Figs. 4 and 5, the ra-18 diopaque marker forms the very distal tip o the tube 17 l9 and also defines the distal opening 55, and although this is preferred, other constructions can be utilized.
21 The tube 17 and the wire 25 are constructed in 22 small diameters. Bv way of example and not by way of li-23 mitation, the region of the tubing 21 supported by the 2~ heIically wound wire 25 may have an outside diameter of .033 inch and the inside diameter of the helically wound 26 wire 25 may be .014 inch. The wire 25 may have an axial 27 dimension of about .015 inch and a radial transverse di-28 mension of about .005 inch. With this construction, the 29 wall thickness of the tubing 21 may be about .0045 inch.
The distal end portion may have a length of about 7.8 1 inches, and the radiopaque marker may have a lenyth of 2 approximately .200 inch~
~ Although the ca~heter 11 may be used for dif-4 ferent purposes, it is particularly adapted for treat-ing acute myocardial infarction. To accomplish this, 6 an angiography catheter 57 (Figs. 10 and 11) of conven-7 tional construction is utilizecl. Although various dif-8 ferent kinds of angiography catheters may be used, the 9 catheter 57 is a right coronary catheter of the Judkins type and it includes a body member 59 which can be coup-11 led to a pressure monitor 61 through a port 62, a proxi-12 mal opening 63, a distal opening 65, a ].umen extending 13 between the openings, and a bend section 67 adjacent the 14 distal opening.
In use, the angiograph~ catheter 57 is percu-16 taneously inserted through an artery, such as the femoral 17 artery, using conventional techniques to bring the distal 18 end portion of the catheter through the aorta 68, with lg the distal opening 65 being at, or closely adjacent, the ostium 69. Using conventional angiography techniques, a 21 clot or occlusion 71 can be located in the right coronary 22 artery 73. The clot or occlusion may totally or only par-23 tially block the artery 73.
24 To accomplish this, the distal end portion o~ the 2~ catheter 11 is introduced through the proximal opening 63 26 of the angiography catheter 57 and into the lumen of the 27 angiography catheter. Initial insertion of the catheter 28 11 is facilitated by a lead-in sleeve 75 slidably mounted 29 on the tube :L7. The catheter 11 is passed through the lu-men of the ~ngiography catheter 57 out the distal opening ~1 1 65 through the os-tium 69 and lnto the rlyht coronary artery 2 73- The distal end ~ortion 47 is long enough so that the 3 location 33 remains within the angiography catheter. The 4 location of the radiopaque marker 23 and, hence, -the dis-tal opening~55 can be closely monitored fluoroscopically.
6 When the distal opening 65 is in close proximitv to the 7 clot 71 in the right coronary artery, a thrombolytic agent 8 can be introduced through the catheter 11 utilizing the 9 infusion pump 15. The thrombolytic agent may be, for ex-ample, streptokinase, urokinase or Thrombolysin. The 11 pressure within the heart can be monitored through the 12 angiography catheter 57 by the pressure monitor 61 while 13 the infusion is taking place. At the direction of the 14 physician, pressure monitoring can be terminated and a dye introduced through the port 62 to determine whether 16 or not the artery 73 has been cleared of the clot 71.
17 Infusion of the agent can continue until the clot is re-18 moved.
19 Figs. 6 and 7 show a catheter lla which is iden-tical to the catheter 11 in all respects not shown or des-21 cribed herein. Portions of the catheter lla correspond-22 ing to portions of the catheter 11 are designated by cor-23 responding reference numerals followed by the letter "a."
24 The only difference between the catheters 11 and 2~ lla is in the configuration of the distal end portions.
26 Specifically, the distal end portion 47 is straight, where-27 as the distal end portion 47a has two resilient orienta-28 tion bend sections 101 and 103 and a passage-seeking bend 29 section 105 which is also resilient. The passage-seeking bend section 105 is configured to seek out the left ~ ~70 ~

1 anterior descending coronary artery 107 (Fig. 12). The 2 orientation bend sections 101 and 103 automatically orient 3 the passage-seeking bend section 105 when the catheter 4 lla is used within an angiograE)hy catheter, such as an an-giography catheter 57a (Fig. 12) which is designed for ex-6 plorin~ the left coronary arteries.
7 The catheter 57a is a let coronary catheter of 8 the Judkins type and has bend sections 67a and 109 adja-9 cent the distal opening 65a of the catheter 57a. ~lthough the specific features of the catheter lla are tailored to 11 make that catheter compatible with a Judkins type left 12 coronary catheter, other configur~tions for the catheter 13 of this invention can be used to adapt the catheter for 14 use with other outer catheters.
The bend sections 101 and 103 are preferably 16 spaced a distance approximately equal to the spacing be-17 tween the bend sections 10~ and 67a, and the bend sec-18 tions 101 and 103 are similar to the bend sections I09 19 and 67a, respectively, in that corresponding bend sec-O tions bend or curve in the same direction. ~he included 21 angles formed by the bend sections 101 and 109 are less 22 than the included angles for~ed by the bend sections 103 23 and 67a, respectively.
24 With re~erence to Figs. 6 and 7, it can be seen that the bend section 105 lies in a plane which extends 26 transverse to the plane of the bend section 103. In the ~7 embodiment of Figs. 6 and 7, the bend sections 101 and 103 28 are in the same plane, although other arrangements can be 29 used. In the specific form shown in Figs. 6 and 7, the bend section 101 joins legs 111 and 113, and the bend J(~37 section 103 joins the legs 113 and a leg 115. Each of the 2 bend sections 101, 103 and 105 is a portion of a circle 3 with the radius of the bend section 103 being the largest 4 and the radius of the bend section 105 being the smallest.
The bend section 105 is joined to the leg 115D The radio-6 paque marker 23a is at the distal end of the bend section 7 105.
8 The catheter 57a is used in the same manner as 9 the catheter 57, except that the former has its distal open-:1.0 ing 65a at the ostium 69a. The catheter lla is used in 11 the same manner as the catheter 11, except that the pas-12 sage-seeking bend section 105 enters the left anterior de-13 scending coronary artery 107 to administer the thromboly-14 tic agent to a clot 71a in that artery. In addition, the advancing o~ the catheter lla through the catheter 57a 16 brings about the necessary cooperation between the bend 17 sections 109 and 67a with the orientation bend sections 18 101 and 103, respectively, to properly angularly orient 1~ the passage-seeking bend section 105 so that it will en-ter the artery 107. It is believed that orientation of 21 the bend section 105 takes place as a result of orienta-22 tion bend sections 101 and 103 resiliently seeking their 23 natural or unstressed condition, and this they are allow-24 ed to do when they are within the associated bend sec-tions 109 and 67a, respectively, of the catheter 57a.
26 This rotates the bend section 105 into the correct posi-27 tion so that the bend section 105 is angularly oriented 28 as it emerges from the distal opening 65. The bend sec-29 tion 105 can then be advanced the short distance between the ostium 67a and the beginning of the artery 107 so 31 that it will enter the artery 107.

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Fig. 8 shows a catheter llb which is identical to 2 the catheter lla, except -that the bend section 105b is 3 displaced 180 degrees from the bend section 105. The 4 catheter llb can be used with the angiography catheter 57a as shown in ~ig. 13 in the same manner as described above 6 with reference to Fig. 12. In terms of the operation, the 7 only difference i.s that the bend section 105b emerges from 8 the distal opening 65a approximately 180 degrees displaced 9 from the bend section 105. Accordingly, the passage-seek-ing bend section lO5b tends to travel toward and enter the 11 circumflex branch 201 of the left coronary artery so that 12 it can be used to administer a thrombolytic agent to a 13 clot 71b in the circumflex branch. In use, the catheter 14 57a would be advanced beyond the position shown in Fig.
13 to brin~ the distal end of the cathe-ter closer to the 1~ clot 7lb.
17 The bend sections of the catheters of Figs. 6-8 18 are flexible and resilient, and a preferred form of con-19 struction is shown in Figs. 9 and 9a. Fig. 9 shows a por-tion of the bend section 101 which is integrally formed by 21 a region of the tubing 2la and has the lumen 5la therein.
22 The bend section 101 has an inner concave region 121 and 23 an outer convex region 123, with the peripheral wall of the 24 tubing 21a being thicker at the inner concave region than the outer convex region. By causing the material of 28 the tubing 21a to take a "permanent set", the thickened 27 inner concave region 121 tends to resist outward bending 28 of the tubing 21a. For example, if the tubing 21a is 29 constructed of PVC, the tubing can be bent into the con-3~) figuration shown in Figs. 6 and 7 and additional PVC in a ~.~'7~

1 solvent applied to the inner concave region. The solvent 2 is then driven off leaving the inner concave region 121 3 thicker than the outer convex region to thereby give the 4 tubing a permanent set at the bend section 101. The other bend sections can be similarly constructed.
6 ~lthough the invention has been described and 7 illustrated with reference to a preferred embodi~ent which 8 is particularly adapted for infusing a thromholitic agent 9 into the heart, it would be apparent that the apparatus and method can be equally advantageous for the infusion of other 11 types of fluids into different areas of the vascular system.
12 For exam~le, the catheter of this invention can be used to 13 infuse a thrombolitic agent into the lower limbs and thereby a facilitate lower limb salvage. The catheter may also be of advantage in chemotherapy wherein various agents must 16 necessarily be infused into specific areas of the vascular 17 system.
18 It should also be understood that the infusion 19 catheter can be used alone or in conjunction with interior or exterior guide means. In the latter case, the catheter 21 can be moved either exteriorly of a guide wire or interiorly 22 of a guide catheter to achieve its desired location.
23 These and other features and advantages, as well as 2~ modifications and substitutions, will he apparent to those having ordinary skill in this art, so that the scope of the 26 invention should be ascertained only with reference to the 27 following claims.

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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A catheter comprising:
an elongated flexible tube having a distal end, a peripheral wall, proximal and distal openings and an elongated passage extending generally axially through the tube between said openings;
a helically wound wire engaging the peripheral wall of the tube, said helically wound wire including a plurality of turns and providing increased column strength, said tube with said helically wound wire therein being flexible;
said wire having an axial cross-sectional di-mension which extends axially of said passage and a ra-dial cross-sectional dimension which extends radially of said passage, said axial cross-sectional dimension being greater than said radial cross-sectional dimension; and said helically wound wire having an outer periph-eral surface and being wound and configured so as to pro-vide said outer peripheral surface with an anticlastic curvature, said tube being in tight engagement with the outer peripheral surface of said helically wound wire and being deformed thereby so as to provide the outer peripheral surface of the tube with an uneven contour over at least a portion of the length of the tube.

2. A catheter as defined in claim 1 wherein said tube includes heat shrink tubing shrunk into tight engagement with said helically wound wire.

3. A catheter as defined in claim 1 wherein said tube has a distal end portion which extends beyond the end of the helically wound wire whereby said distal end portion is unsupported by said helically wound wire and is more flexible than the portion of said tube which is supported by said helically wound wire and said tube includes radiopaque marker means at the distal end of said tube.

4. A catheter as defined in claim 1 including radiopaque marker means adjacent said distal end, said marker means including a biocompatible metal powder and a binder.

5. A catheter as defined in claim 3 or 4 wherein said distal end portion has at least one bend section therein spaced from said radiopaque marker means.

6. A catheter as defined in claim 4 wherein said biocompatible metal powder has a specific gravity greater than 11.

7. A catheter as defined in claim 6 wherein said biocompatible metal powder is selected from the group consisting of tantalum and gold.

8. A catheter as defined in claim 6 wherein said biocompatible metal powder includes tantalum and tantalum is present in an amount equal to at least about 75 percent by weight of the radiopaque marker means.

9. A catheter as defined in claim 4 wherein said tube includes flexible tubing extending for substan-tially the full length of said tube and terminating in an outer end said binder and said tubing being construct-ed of thermoplastic or elastomeric materials which can be fused together with heat and pressure, said radiopaque marker means includes a tubular section mounted on the outer end of said tubing to define said distal end, said tubular section being flexible and resilient.

10. A catheter as defined in claim 9 wherein said tube has a distal end portion which extends beyond the end of said helically wound wire whereby the distal end portion is more flexible than the portion of said tube which is supported by said helically wound wire, said distal end portion having at least one bend section spaced from said tubular section.

11. A catheter as defined in claim 10 wherein said distal end portion has a second bend section, said bend sections being in different planes.

12. A catheter as defined in claim 3 wherein said radiopaque marker means includes a flexible tubular section.

13. A catheter as defined in claim 1 wherein the catheter has a distal end and includes a resilient radiopaque marker at the distal end of the catheter.

14. A catheter as defined in claim 1 wherein said tube has a distal end portion and at least one bend section in said distal end portion, said tube at said bend section has an inner concave region and an outer convex region, said tube having a peripheral wall which is thicker at said inner concave region than said outer convex region.