US20210023339A1 - Catheter With Embedded Core Wires - Google Patents

Abstract

A kink-resistance catheter has at least a first pair of core wires residing in the catheter body on opposed side of a catheter lumen. The core wires have relatively stiff proximal ends but taper toward their distal ends. The tapered construction provides the core wires with a degree of distal flexibility that helps the catheter advance along a vasculature to a site of interest without kinking. Moreover, the core wires greatly improve the torsional rigidity of the catheter so that rotation of the catheter's proximal end translates into a substantially equivalent rotation at the distal end. If desired, shaping ribbons are provided in the catheter body adjacent to the distal ends of the core wires. The shaping ribbons can be pre-bent before a surgical procedure to help the physician advance the catheter along the vasculature. Finally, the core wires provide the ability to push the catheter through the vasculature without the need for the catheter to go over a guidewire already in-situ in the vasculature.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application claims priority to U.S. Provisional Application Ser. No. 62/878,939, filed on Jul. 26, 2019.
BACKGROUND OF THE INVENTION1. Field of the Invention
• The present invention relates to the art of delivering medical therapy to a remote site in a body. Catheters are typically used for that purpose. More particularly, the present catheters are provided with at least one core wire and, more particularly, a first pair of core wires disposed on opposite sides of a primary lumen. In alternate embodiments, the catheter has a second pair of core wires on opposite sides of the primary lumen, the second pair being spaced 90° from the first pair of core wires.
2. Prior Art
• Catheters are often used to deliver medical therapy to a remote site in a body, be it in a vasculature system or otherwise. For example, catheters are often used to deliver a medical therapy to a coronary artery in the cardiovascular system of a human or animal body, the renal vessels, the neuro-vasculature system, the fallopian tubes, and other such vessels and sites. These types of procedures often require that the catheter bend in many abrupt directions as it travels through the vasculature to the site of interest. Because of their cylindrical structure, however, should a bend radius in the vasculature be severe enough, forming a kink in the catheter is a realistic concern. Should a catheter kink inside the vasculature of a human or animal body, it can be rendered inoperative for use in the intended medical procedure and removing the kinked catheter could cause damage to the vasculature. Not only is that unacceptable, but a new catheter must be inserted into the vasculature to complete the medical procedure. This increases the time that the patient is under sedation without certainty that the second catheter will perform any better than the first.
SUMMARY OF THE INVENTION
• Accordingly, there is a needed for an improved catheter that is suitable for delivering a medical therapy to a remote site in a human or animal body. Even if the catheter is required to bend in many abrupt directions as it travels through the vasculature to the site of interest, the catheter needs to be less prone to kinking than conventional catheters.
• Kink-resistance is provided by incorporating at least one core wire, and more particularly, a first pair of core wires into the catheter body on opposed sides of the catheter lumen. The core wires, which taper from their proximal end to their distal end, extend from adjacent to a proximal end of the catheter to adjacent to the distal end thereof. That way, the tapered core wires provide a desired degree of rigidity to the proximal end of the catheter while the distal end is relatively flexible but less likely to kink or deform, even when travelling through a vasculature with a relatively tortuous path.
• Further, having the core wires end proximal the distal end of the catheter means that the catheter is less likely to puncture or rupture the vessel. Additionally, the core wires greatly improve the torsional rigidity of the catheter so that rotation of the catheter's proximal end about its longitudinal axis translates into a substantially equivalent rotation at the distal end of the catheter. Ideally, the catheter maintains a1:1 rotational integrity about its longitudinal axis from the catheter proximal end to the distal end thereof. Finally, incorporating at least one core wire into the catheter body provides the ability to push the catheter through the vasculature without the need for the catheter to go over a guidewire already in-situ in the vasculature.
• These and other objects of the present invention will become increasingly more apparent to those skilled in the art by reference to the following detailed description and to the appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a broken, perspective view of acatheter10 according to the present invention comprising spaced apartcore wires20 and22 on opposite sides of aprimary lumen16.
• FIG. 1A is a broken, perspective view of acatheter11 that is similar tocatheter10 shown inFIG. 1, but withmultiple lumens16,16A and16B.
• FIG. 2 is a cross-sectional view of thecatheter10 shown inFIG. 1.
• FIG. 3 is a cross-sectional view of another embodiment of acatheter60 according to the present invention where thecore wires20 and22 have respectiveatraumatic tips62 and64.
• FIG. 4 is a broken, cross-sectional view of acatheter100 comprising spaced apartcore wires120 and122 on opposite sides of aprimary lumen106 where the core wires are provided with correspondingdistal shaping ribbon160 and162.
• FIG. 5 is a cross-sectional view of thecatheter100 shown inFIG. 4.
• FIG. 6 is a cross-sectional view taken along line6-6 ofFIG. 4.
• FIG. 7 is a cross-sectional view taken along line7-7 ofFIG. 4.
• FIG. 8 is a broken, cross-sectional view of acatheter200 comprising a first pair of spaced apartcore wires20 and22 on opposite sides of aprimary lumen206 and a second pair ofcores120 and122 on opposite sides of the primary lumen, the second pair of core wires spaced 90° from the first pair and being provided with correspondingdistal shaping ribbon160 and162.
• FIG. 9 is a cross-sectional view taken along line9-9 ofFIG. 8.
• FIG. 10 is a broken, cross-sectional view of acatheter300 comprising a first pair of spaced apartcore wires120A and122A on opposite sides of aprimary lumen306 where the core wires are provided with correspondingdistal shaping ribbons160 and162 and a second pair ofcores120B and122B on opposite sides of the primary lumen, the second pair spaced 90° from the first pair and being provided with correspondingdistal shaping ribbons160 and162.
• FIG. 11 is a cross-sectional view taken along line11-11 ofFIG. 10.
• FIG. 12 is a cross-sectional view similar to that ofFIG. 11, but with the second pair of core wires and theircorresponding shaping ribbons160 and162 having been rotated 90°.
• FIG. 13 is a broken, perspective view of acatheter400 comprising a first pair of spaced apartcore wires120C and122C coated withpolymeric materials420 and being disposed on opposite sides of aprimary lumen406 where the core wires are provided with correspondingdistal shaping ribbon160 and162, and a second pair ofcores120D and122D coated withpolymeric materials422 and disposed on opposite sides of the primary lumen, the second pair spaced 90° from the first pair and being provided with correspondingdistal shaping ribbons160 and162.
• FIG. 14 is a cross-sectional view of thecatheter400 shown inFIG. 13.
• FIG. 15 is a cross-sectional view taken along line15-15 ofFIG. 13.
• FIG. 16 is a cross-sectional view taken along line16-16 ofFIG. 13.
• FIG. 17 is a cross-sectional view of acatheter500 that is similar to thecatheter400 shown inFIG. 14 except that instead of being coated with a polymeric material, thecore wires120 and122 and theircorresponding shaping ribbons160 and162 are disposed insidecorresponding coil springs524 and526.
• FIG. 18 is a cross-sectional view of acatheter600 that is similar to thecatheter400 shown inFIG. 14 except that only a proximal portion of the core wires is coated with apolymeric material620 and622 while the distal portion of thecore wires120 and122 and theircorresponding shaping ribbons160 and162 is disposed inside acorresponding coil spring624 and626.
• FIG. 19 is a cross-sectional view of another embodiment of acatheter700 according to the present invention that is similar to thecatheter600 shown inFIG. 18 except that theshaping ribbons160 and162 are provided with respectiveatraumatic tips160E and162E.
• FIG. 20 is a cross-sectional view of acatheter800 that is similar to thecatheter600 shown inFIG. 18 except thatcore wire120 is of a lesser cross-sectional diameter than core wore122.
• FIG. 21 is a cross-sectional view of acatheter900 that is similar to thecatheter800 shown inFIG. 20 but with theshaping ribbons160 and162 provided with respectiveatraumatic tips160E and162E.
• FIG. 22 is a cross-sectional view of acatheter1000 that is similar to thecatheter900 shown inFIG. 21 except thatcore wire122 is longer thancore wire120.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Turning now to the drawings, anexemplary catheter10 according to the present invention is illustrated inFIGS. 1 and 2. Thecatheter10 has a cylindrically-shaped catheter body12 having anouter wall14 extending along a longitudinal axis A-A from a catheterproximal end10A to a catheterdistal end10B. Thecatheter10 has aprimary lumen16 that is in open communication with aproximal opening16A at the catheterproximal end10A and a distal opening16B at the catheterdistal end10B. Preferably thecatheter lumen16 has a cylindrical shape throughout its length extending to the proximal anddistal openings16A,16B, but that is not required.
• In an alternate embodiment, the catheter lumen has an oval shape extending to the proximal anddistal openings16A,16B, or thelumen16 can have a cylindrically-shaped proximal lumen portion extending distally from theproximal opening16A in open communication with an oval-shaped distal lumen portion extending the remainder of the lumen length to the distal opening16B.
• Thecatheter body12 is formed of a biocompatible and biostable primarypolymeric material17 that has a cross-sectional thickness extending outwardly from thelumen16 to theouter wall14. Suitable biocompatible and biostable primary polymeric materials include thermoplastics such as Nylon, PEBAX®, PET, thermosets such as silicone, polytetrafluoroethylene (PTFE), polyimide and composites such as liquid crystal polymers. If desired, these materials can be glass-filled or filled with a radiopaque material. Examples of radiopaque fillers are barium sulphate, bismuth subcarbonate, and tungsten.
• As shown inFIGS. 1 and 2, in an exemplary embodiment of the present invention, afirst core wire20 and asecond core wire22 are encased or otherwise embedded in the primarypolymeric material17. Thefirst core wire20 is, for example, of stainless steel or nitinol (an extremely flexible nickel-titanium alloy) and extends longitudinally along an axis that is parallel to the axis A-A of thecatheter10. Thefirst core wire20 has a first core wire proximal end20A extending to a first core wiredistal end20B. Similarly, thesecond core wire22 is, for example, of stainless steel or nitinol and extends along a longitudinal axis that is parallel to the axis A-A of thecatheter10 and the longitudinal axis of thefirst core wire20. Thesecond core wire22 has a second core wireproximal end22A extending to a second core wire distal end22B.
• While twocore wires20 and22 are shown extending through thecatheter body12, it is within the scope of the present invention that only one of the core wires, either20 or22, is sufficient to provide thecatheter10 with the desired distal flexibility and torsional rigidity.
• As shown in the cross-sectional view ofFIG. 2, thefirst core wire20 has a first cylindrically-shapedportion24 of a first circular transverse cross-section of a first constant diameter that ranges from about 1 mm to about 0.3 mm. Atcross-sectional location26, the firstcylindrical portion24 meets a first taperedportion28 that tapers downwardly and distally along the longitudinal axis of thecore wire20 towardscross-sectional location30 where a second cylindrically-shapedportion32 begins. The second cylindrically-shapedportion32 is of a second circular transverse cross-section of a second constant diameter that is less than the first constant diameter and ranges from about 0.8 mm to about 0.2 mm. Atcross-sectional location34, the secondcylindrical portion32 meets a second taperedportion36 that tapers downwardly and distally along the longitudinal axis towardscross-sectional location38 where a third cylindrically-shapedportion40 begins. The third cylindrically-shapedportion40 is of a third circular transverse cross-section of a third constant diameter that is less than the second constant diameter and ranges from about 0.6 mm to about 0.03 mm.
• The cross-section ofFIG. 2 further shows that thesecond core wire22 has a fourth cylindrically-shapedportion42 of a fourth circular transverse cross-section of a fourth constant diameter that ranges from about 1 mm to about 0.3 mm. Atcross-sectional location44, the fourthcylindrical portion42 meets a thirdtapered portion46 that tapers downwardly and distally along the longitudinal axis of thecore wire22 towardscross-sectional location48 where a fifth cylindrically-shapedportion50 begins. The fifth cylindrically-shapedportion50 is of a fifth circular transverse cross-section of a fifth constant diameter that is less than the fourth constant diameter and ranges from about 0.8 mm to about 0.2 mm. Atcross-sectional location52, the fifthcylindrical portion50 meets a fourth taperedportion54 that tapers downwardly and distally along the longitudinal axis towardscross-sectional location56 where a sixth cylindrically-shapedportion58 begins. The sixth cylindrically-shapedportion58 is of a sixth circular transverse cross-section of a sixth constant diameter that is less than the fifth constant diameter and ranges from about 0.6 mm to about 0.03 mm.
• Preferably the proximal end20A of the firstcylindrical portion24, which is the proximal end of thefirst core wire20, is distal the catheterproximal end10A while thedistal end20B of the thirdcylindrical portion40, which is the distal end of thefirst core wire20, is proximal the catheterdistal end10B. In a similar manner, it is preferred that theproximal end22A of the fourthcylindrical portion42, which is the proximal end of thesecond core wire22, is distal the catheterproximal end10A while the distal end22B of the sixthcylindrical portion58, which is the distal end of thesecond core wire22, is proximal the catheterdistal end10B.
• Thus, the distance from the catheterproximal end10A to the proximal ends of the first andsecond core wires20,22 ranges from about 2 mm to about 5 mm. Similarly, the distance from the catheterdistal end10B to the distal ends of the first andsecond core wires20,22 ranges from about 2 mm to about 5 mm. That way, the proximal end20A of the firstcylindrical portion24 and thedistal end20B of the thirdcylindrical portion40 of thefirst core wire20, and theproximal end22A of the fourthcylindrical portion42 and the distal end22B of the sixthcylindrical portion58 of thesecond core wire22 are encased or embedded in theprimary polymeric material17 of thecatheter10. This helps prevent the first andsecond core wires20,22 from puncturing through theprimary polymeric material17 and becoming exposed, which is undesirable.
• FIG. 1A illustrates acatheter11 that is similar tocatheter10 shown inFIG. 1, but withmultiple lumens16,19A and19B. Thelumens16,19A and19B can have the same or different diameters. For example,lumens19A and19B can have diameters that are smaller than that oflumen16.Core wires20 and22 are shown extending along the length of thecatheter10A.
• FIG. 3 shows another embodiment of acatheter60 according to the present invention.Catheter60 is similar to thecatheter10 shown inFIGS. 1 and 2 except that to help prevent the first andsecond core wires20 and22 from puncturing through thedistal end10B of theprimary polymeric material17, the respective third and sixth cylindrically-shapedportions40 and58 are provided with a respectiveatraumatic tip62 and64. The firstatraumatic tip62 has an enlargedcylindrical portion62A connected to the third cylindrically-shapedportion40 of thefirst core wire20 and extending to a curved distal surface62B. Similarly, the secondatraumatic tip64 has an enlargedcylindrical portion64A connected to the sixth cylindrically-shapedportion50 of thesecond core wire22 and extending to a curved distal surface64B. While both of the first andsecond core wires20 and22 are shown with respectiveatraumatic tips62 and64 in this embodiment, that is not necessary. Either one of thecore wires20 or22 can have an atraumatic tip while the other does not. Moreover, the distance from the curved distal surfaces62B,64B of the respectiveatraumatic tips62,64 to the catheterdistal end10B ranges from about 1 mm to about 0.2 mm.
• FIGS. 4 to 7 illustrate another embodiment of acatheter100 according to the present invention.Catheter100 is similar to thecatheter10 shown inFIGS. 1 and 2 in that it comprises a cylindrically-shapedcatheter body102 having anouter wall104 extending along a longitudinal axis B-B from a catheterproximal end100A to a catheterdistal end100B. Thecatheter100 has aprimary lumen106 that is in open communication with aproximal opening106A at the catheterproximal end100A and adistal opening106B at the catheterdistal end100B. Preferably, thecatheter lumen106 has a cylindrical shape throughout its length extending to the proximal anddistal openings106A,106B, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• Thecatheter body102 is formed of a biocompatible and biostable primarypolymeric material107 that has a cross-sectional thickness extending outwardly from thelumen106 to theouter wall104. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3.
• As shown in the exemplary embodiment ofFIGS. 4 to 7, athird core wire120 and afourth core wire122 are encased or otherwise embedded in theprimary polymeric material107. Thethird core wire120 is, for example, of stainless steel or nitinol and extends along a longitudinal axis that is parallel to the axis B-B of thecatheter100. Thethird core wire120 has a third core wireproximal end120A extending to a third core wiredistal end120B. Similarly, thefourth core wire122 is, for example, of stainless steel or nitinol and extends longitudinally along an axis that is parallel to the axis B-B of thecatheter100 and the longitudinal axis of thethird core wire120. Thefourth core wire122 has a fourth core wireproximal end122A extending to a fourth core wire distal end122B.
• As shown in the cross-sections ofFIGS. 5 and 6, thethird core wire120 has a seventh cylindrically-shapedportion124 of a seventh circular transverse cross-section of a seventh constant diameter that ranges from about 1 mm to about 3 mm. At cross-sectional location126, the seventhcylindrical portion124 meets a fifthtapered portion128 that tapers downwardly and distally along the longitudinal axis of thecore wire120 towards cross-sectional location130 where an eighth cylindrically-shapedportion132 begins. The eighth cylindrically-shapedportion132 is of an eighth circular transverse cross-section of an eighth constant diameter that is less than the seventh constant diameter and ranges from about 0.8 mm to about 0.2 mm. Atcross-sectional location134, the eighthcylindrical portion132 meets a sixthtapered portion136 that tapers downwardly and distally along the longitudinal axis towardscross-sectional location138 where a ninth ribbon-shapedportion140 begins. The ninth ribbon-shapedportion140 has a rectangular shape in cross-section (FIG. 7) with opposed majorplanar surfaces140A,140B extending to and meeting spaced apart edges140C,140D. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• The cross-section ofFIG. 5 further shows that thefourth core wire122 has a tenth cylindrically-shapedportion142 of a tenth circular transverse cross-section of a tenth constant diameter that ranges from about 1 mm to about 3 mm. Atcross-sectional location144, the tenthcylindrical portion142 meets a seventhtapered portion146 that tapers downwardly and distally along the longitudinal axis of thecore wire122 towardscross-sectional location148 where an eleventh cylindrically-shapedportion150 begins. The eleventh cylindrically-shapedportion150 is of an eleventh circular transverse cross-section of an eleventh constant diameter that is less than the tenth constant diameter and ranges from about 0.8 mm to about 0.2 mm. Atcross-sectional location152, the eleventhcylindrical portion150 meets an eighthtapered portion154 that tapers downwardly and distally along the longitudinal axis towardscross-sectional location156 where a twelfth ribbon-shapedportion158 begins. The twelfth ribbon-shapedportion158 has a rectangular shape in cross-section (FIG. 7) with opposedmajor surfaces158A,158B extending to and meeting spaced apart edges158C,158D.
• Preferably theproximal end120A of the seventhcylindrical portion124, which is the proximal end of thethird core wire120, is distal the catheterproximal end100A a distance of from about 2 mm to about 5 mm while thedistal end120B of the ninth ribbon-shapedportion140, which is the distal end of thethird core wire120, is proximal the catheter distal end1002 a distance of from about 5 mm to about 50 mm. In a similar manner, it is preferred that theproximal end122A of the tenthcylindrical portion142, which is the proximal end of thefourth core wire122, is distal the catheterproximal end100A a distance of from about 2 mm to about 5 mm while the distal end122B of the twelfth ribbon-shapedportion158, which is the distal end of thefourth core wire122, is proximal the catheterdistal end10B a distance of from about 5 mm to about 50 mm.
• FIGS. 4, 5 and 7 further illustrate that a shapingribbon160 is provided in theprimary polymeric material107 adjacent to the ninth ribbon-shapedportion140 of thethird core wire120. The shapingribbon160 is, for example, of stainless steel or nitinol and spaced from but in an overlapping relationship with a distal portion of the ninth ribbon-shaped portion140 (FIG. 7). The shapingribbon160, which terminates a relatively short distance of from about 2 mm to about 5 mm proximal thedistal end100B of thecatheter100, has a length of about 3 mm to about 30 mm and a rectangular shape in cross-section with opposed majorplanar surfaces160A,160B extending to and meeting spaced apart edges160C,160D. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm. As shown inFIG. 7, the majorplanar surfaces160A,160B are parallel to each other and parallel to the majorplanar surfaces140A and140B of the ninth ribbon-shapedportion140 of thethird core wire120.
• FIGS. 4, 5 and 7 further illustrate that a shapingribbon162 is provided in theprimary polymeric material107 adjacent to the twelfth ribbon-shapedportion158 of thefourth core wire122. The shapingribbon162 is, for example, of stainless steel or nitinol and spaced from but in an overlapping relationship with a distal portion of the twelfth ribbon-shapedportion158. The shapingribbon162, which terminates a relatively short distance of from about 2 mm to about 5 mm proximal thedistal end100B of thecatheter100, has a rectangular shape in cross-section with opposed majorplanar surfaces162A,162B extending to and meeting spaced apart edges162C,162D. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm. As shown inFIG. 7, the majorplanar surfaces162A,162B are parallel to each other and parallel to the majorplanar surfaces158A and158B of the twelfth ribbon-shapedportion158 of thefourth core wire122.
• Thus, the distance from the catheterproximal end100A to the proximal ends of the third andfourth core wires120,122 ranges from about 2 mm to about 5 mm. Similarly, the distance from the catheterdistal end100B to the distal ends of the third andfourth core wires120,122 ranges from about 5 mm to about 50 mm. That way, theproximal end120A of the seventhcylindrical portion124 and thedistal end120B of the ninth ribbon-shapedportion140 of thethird core wire120, and theproximal end122A of the tenthcylindrical portion142 and the distal end122B of the twelfth ribbon-shapedportion158 of thefourth core wire122 are encased or embedded in theprimary polymeric material107 of thecatheter100. Further, as shown inFIG. 7, the shapingribbon160 resides between thecore wire120 and theouter wall104 of thecatheter100 while the shapingribbon162 resides between thecore wire122 and thelumen106. The distance from the catheterdistal end100B to the distal ends of the shapingribbons160 and162 ranges from about 2 mm to about 5 mm. Having a sufficient length of primary polymeric material between thedistal end100B of the catheter and the distal ends of the third andfourth core wires120 and122 and between their corresponding shaping ribbons helps prevent the third andfourth core wires120,122 and theirshaping ribbons160 and162 from puncturing through theprimary polymeric material107 and becoming exposed, which is undesirable.
• The shapingribbons160 and162 have sufficient of ductility that allows them to be bent into a desired deflection angle and to hold the angle. This is helpful when thecatheter100 is intended to be used in a medical procedure where the vasculature leading to the target site has a generally known approach angle.
• FIGS. 8 and 9 illustrate another embodiment of acatheter200 according to the present invention.Catheter200 is a hybrid ofcatheters10 and100 and comprises a cylindrically-shapedcatheter body202 having anouter wall204 extending along a longitudinal axis C-C from a catheterproximal end200A to a catheterdistal end200B. Thecatheter200 has aprimary lumen206 that is in open communication with a proximal opening (not shown) at the catheterproximal end200A and adistal opening206B at the catheterdistal end200B. Preferably thecatheter lumen206 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• Thecatheter body202 is formed of a biocompatible and biostable primarypolymeric material207 that has a cross-sectional thickness extending outwardly from thelumen206 to theouter wall204. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3.
• Thefirst core wire20 and thesecond core wire22 shown inFIGS. 1 and 2 are encased or embedded in theprimary polymeric material207. Theprimary lumen206 is intermediate the diametrically opposed first andsecond core wires20 and22. Further, the third andfourth core wires120 and122 shown inFIGS. 4 to 7 are encased or embedded in theprimary polymeric material207 and diametrically opposed to each other. The third andfourth core wires120 and122 are also provided with corresponding stainless steel ornitinol shaping ribbons160 and162. Theprimary lumen206 is intermediate the third andfourth core wires120 and122. Moreover,FIG. 8 shows that the third, first, fourth andsecond core wires120,20,122 and22 and theircorresponding shaping ribbons160 and162 reside at respective 0°, 90°, 180° and 270° locations about the circumference of theprimary lumen206.
• While not shown inFIGS. 8 and 9, the proximal ends of thecore wires20,22,120 and122 are spaced distally from theproximal end200A of the catheter. Further, the distal ends of thecore wires20,22,120 and122 are spaced proximally from thedistal end200B of the catheter. Thecore wires120 and122 are provided with corresponding stainless steel ornitinol shaping ribbons160 and162 which are also spaced proximally from thedistal end200B of the catheter. This spacing, which was previously described with respect to thecatheters10 and100, helps prevent thecore wires20,22,120 and122 and the shapingribbons160 and162 from penetrating through the primary polymeric material.
• FIGS. 10 and 11 illustrate another embodiment of acatheter300 according to the present invention.Catheter300 comprises a cylindrically-shapedcatheter body302 having anouter wall304 extending along a longitudinal axis D-D from a catheterproximal end300A to a catheterdistal end300B. Thecatheter300 has aprimary lumen306 that is in open communication with a proximal opening (not shown) at the catheterproximal end300A and adistal opening306B at the catheterdistal end300B. Preferably thecatheter lumen306 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• Thecatheter body302 is formed of a biocompatible and biostable primarypolymeric material307 that has a cross-sectional thickness extending outwardly from thelumen306 to theouter wall304. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3.
• A first diametrically opposed pair of the third andfourth core wires120A and122A shown inFIGS. 4 to 7 is encased or embedded in theprimary polymeric material307. Theprimary lumen306 is intermediate the first pair ofcore wires120A and122A. A second diametrically opposed pair of the third andfourth core wires120B and122B is encased or embedded in theprimary polymeric material307 with theprimary lumen206 residing intermediate the second pair.
• FIGS. 10 and 11 illustrate that a first pair of the stainless steel ornitinol shaping ribbons160 and162 is provided in theprimary polymeric material307 adjacent to the respective ninth ribbon-shapedportion140 of thethird core wire120A and the twelfth ribbon-shapedportion158 of thefourth core wire122A of the first pair. In the first pair, the shapingribbon160 is spaced from but in an overlapping relationship with the distal portion of the ninth ribbon-shapedportion140. The shapingribbon160 terminates a relatively short distance proximal thedistal end300B of thecatheter300 and has a rectangular shape in cross-section with opposed majorplanar surfaces160A,160B extending to and meeting spaced apart edges160C,1600 (FIG. 7). The majorplanar surfaces160A,160B are parallel to each other and parallel to the majorplanar surfaces140A and140B of the ninth ribbon-shapedportion140 of thethird core wire120A. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• Further, the shapingribbon162 is spaced from but in an overlapping relationship with the distal portion of the twelfth ribbon-shapedportion158 of thefourth core wire122A of the first pair. The shapingribbon162 terminates a relatively short distance proximal thedistal end300B of thecatheter300 and has a rectangular shape in cross-section with opposed majorplanar surfaces162A,162B extending to and meeting spaced apart edges162C,162D (FIG. 7). The majorplanar surfaces162A,162B are parallel to each other and parallel to the majorplanar surfaces158A and158B of the twelfth ribbon-shapedportion158 of thefourth core wire122A of the first pair. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• FIGS. 10 and 11 further illustrate that a second pair of the stainless steel ornitinol shaping ribbons160 and162 is provided in theprimary polymeric material307 adjacent to the respective ninth ribbon-shapedportion140 and the twelfth ribbon-shapedportion158 of the second pair of the third andfourth core wires120B and122B. In the second pair, the shapingribbon160 is spaced from but in an overlapping relationship with the distal portion of the ninth ribbon-shapedportion140. The shapingribbon160 terminates a relatively short distance proximal thedistal end300B of thecatheter300 and has a rectangular shape in cross-section with opposed majorplanar surfaces160A,160B extending to and meeting spaced apart edges160C,160D (FIG. 7). In the second pair of shaping ribbons, the majorplanar surfaces160A,160B are parallel to each other and parallel to the majorplanar surfaces140A and140B of the ninth ribbon-shapedportion140 of thethird core wire120B. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• In the second pair, the shapingribbon162 is spaced from but in an overlapping relationship with the distal portion of the twelfth ribbon-shapedportion158. The shapingribbon162 terminates a relatively short distance proximal thedistal end300B of thecatheter300 and has a rectangular shape in cross-section with opposed majorplanar surfaces162A,162B extending to and meeting spaced apart edges162C,162D (FIG. 7). The majorplanar surfaces162A,162B are parallel to each other and parallel to the majorplanar surfaces158A and158B of the twelfth ribbon-shapedportion158 of thefourth core wire122. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• A characteristic of thecatheter300 shown inFIGS. 10 and 11 is that the planar surfaces of the ribbon-shapedportions140 and158 of the first and second pairs of the third andfourth core wires120A,120B and122A,122B and theircorresponding shaping ribbons160 and162 are parallel to each other. This contrasts with the embodiment shown inFIG. 12 where the planar surfaces of the ribbon-shapedportions140 and158 of the first pair ofcore wires120A and122A and theircorresponding shaping ribbons160 and162 are aligned perpendicular to the planar surfaces of the ribbon-shapedportions140 and158 of the second pair ofcore wires120B and122B and theircorresponding shaping ribbons160 and162. If desired, however, the angle between the planar surfaces of the ribbon-shapedportions140 and158 of the first pair ofcore wires120A and122A and theircorresponding shaping ribbons160 and162 with respect to the planar surfaces of the ribbon-shapedportions140 and158 of the second pair ofcore wires120B and1226 and theircorresponding shaping ribbons160 and162 can be other than perpendicular. The relative angle can range from about 1° to about 89°.
• FIGS. 13 to 16 illustrate another embodiment of acatheter400 according to the present invention.Catheter400 comprises a cylindrically-shapedcatheter body402 having anouter wall404 extending along a longitudinal axis E-E from a catheterproximal end400A to a catheterdistal end400B. Thecatheter400 has aprimary lumen406 that is in open communication with aproximal opening406A at the catheterproximal end400A and adistal opening406B at the catheterdistal end400B. Thecatheter body402 is formed of a biocompatible and biostable primarypolymeric material407 that extends outwardly from thelumen406 to theouter wall404. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3. Preferably thecatheter lumen406 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• A first diametrically opposed pair of the third andfourth core wires120C and1220 and theircorresponding shaping ribbons160 and162, as shown inFIGS. 4 to 7, is first coated in with a secondarypolymeric material420 and this assembly is encased or embedded in theprimary polymeric material407. Suitable polymeric materials forcoating420 are PTFE and polyimide. Theprimary lumen406 is intermediate the first pair ofcore wires120C and122C. A second diametrically opposed pair of the third andfourth core wires120D and122D and theircorresponding shaping ribbons160 and162 is also coated with a secondarypolymeric material422, which is similar to thepolymeric coating420, and this assembly is encased or embedded in theprimary polymeric material407 with theprimary lumen406 residing intermediate the second pair.
• Preferably, the secondarypolymeric coatings420 and422 provide the respective coated assemblies with a uniform cross-sectional diameter extending from the proximal ends of the first pair of the third andfourth core wires120C and1220 to the distal ends of theircorresponding shaping ribbons160 and162, and from the proximal ends of the second pair of the third andfourth core wires120D and122D to the distal ends of theircorresponding shaping ribbons160 and162. However, the cross-sectional diameters of the first pair of thecoated core wires120C and122C and their shaping ribbons need not be the same as that of the second pair of thecoated core wires120D and122D and theircorresponding shaping ribbons16 and162.
• The first pair of shapingribbons160 and162 is provided adjacent to the respective ninth ribbon-shapedportion140 of thethird core wire120C and the twelfth ribbon-shapedportion158 of thefourth core wire122C. In the first pair, the shapingribbon160 is spaced from but in an overlapping relationship with the distal portion of the ninth ribbon-shapedportion140. The shapingribbon160 terminates a relatively short distance proximal thedistal end400B of thecatheter400 and has a rectangular shape in cross-section with opposed majorplanar surfaces160A,160B extending to and meeting spaced apart edges160C,160D (FIG. 7). The majorplanar surfaces160A,160B are parallel to each other and parallel to the majorplanar surfaces140A and140B of the ninth ribbon-shapedportion140 of thethird core wire120C of the first pair. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• Further, the shapingribbon162 is spaced from but in an overlapping relationship with the distal portion of the twelfth ribbon-shapedportion158 of thefourth core wire1220 of the first pair. The shapingribbon162 terminates a relatively short distance proximal thedistal end400B of thecatheter400 and has a rectangular shape in cross-section with opposed majorplanar surfaces162A,162B extending to and meeting spaced apart edges162C,162D (FIG. 7). The majorplanar surfaces162A,162B are parallel to each other and parallel to the majorplanar surfaces158A and158B of the twelfth ribbon-shapedportion158 of thefourth core wire122C. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• FIGS. 13 to 16 further illustrate that the second pair of shapingribbons160 and162 is provided adjacent to the respective ninth ribbon-shapedportion140 and the twelfth ribbon-shapedportion158 of the second pair of the third andfourth core wires120D and122D. In the second pair, the shapingribbon160 is spaced from but in an overlapping relationship with the distal portion of the ninth ribbon-shapedportion140. The shapingribbon160 terminates a relatively short distance proximal thedistal end400B of thecatheter400 and has a rectangular shape in cross-section with opposed majorplanar surfaces160A,160B extending to and meeting spaced apart edges160C,160D (FIG. 7). In the second pair of shaping ribbons, the majorplanar surfaces160A,160B are parallel to each other and parallel to the majorplanar surfaces140A and140B of the ninth ribbon-shapedportion140 of thethird core wire120B. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• Further, in the second pair, the shapingribbon162 is spaced from but in an overlapping relationship with the distal portion of the twelfth ribbon-shapedportion158. The shapingribbon162 terminates a relatively short distance proximal thedistal end400B of thecatheter400 and has a rectangular shape in cross-section with opposed majorplanar surfaces162A,162B extending to and meeting spaced apart edges162C,162D (FIG. 7). The majorplanar surfaces162A,162B are parallel to each other and parallel to the majorplanar surfaces158A and158B of the twelfth ribbon-shapedportion158 of thefourth core wire122D of the second pair. The planar surfaces have a length from about 3 mm to about 30 mm and a width from about 0.6 mm to about 0.005 mm.
• A characteristic of thecatheter400 shown inFIGS. 13 to 16 is that the planar surfaces of the first and second pairs of the third andfourth core wires120C,122C and120D,122D and theircorresponding shaping ribbons160 and162 are parallel to each other. However, in a similar manner as shown in the embodiment ofFIG. 12, the planar surfaces of the first pair ofcore wires120C and122C and theircorresponding shaping ribbons160 and162 can be aligned perpendicular to the planar surfaces of the second pair ofcore wires120D and122D and theircorresponding shaping ribbons160 and162. If desired, however, the angle between the planar surfaces of the ribbon-shapedportions140 and158 of the first pair ofcore wires120C and122C and theircorresponding shaping ribbons160 and162 with respect to the planar surfaces of the ribbon-shapedportions140 and158 of the second pair ofcore wires120D and122D and theircorresponding shaping ribbons160 and162 can be other than perpendicular. The relative angle can range from about 1° to about 89°.
• FIG. 17 is a cross-section of another embodiment of acatheter500 according to the present invention.Catheter500 comprises a cylindrically-shapedcatheter body502 having anouter wall504 extending along a longitudinal axis F-F from a catheterproximal end500A to a catheter distal end500B. Thecatheter500 has aprimary lumen506 that is in open communication with aproximal opening506A at the catheterproximal end500A and adistal opening506B at the catheter distal end500B. Thecatheter body502 is formed of a biocompatible and biostablepolymeric material507 that extends outwardly from thelumen506 to theouter wall504. Preferably thecatheter lumen506 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3.
• FIG. 17 further shows that the first andsecond core wires20 or120 and22 or122 and theircorresponding shaping ribbons160 and162 are disposed inside respective helically-wound coil springs524 and526. The coil springs524 and526 extend from the proximal ends of the third andfourth core wires120 and122 to the distal ends of theircorresponding shaping ribbons160 and162. The coil springs524 and526 are, for example, of stainless steel or nitinol and serve as respective sleeves having a generally circular transverse cross-section of substantially constant outer diameter in the range of about 0.2 mm to about 0.5 mm.
• If the first and second core wires are 20 and 22 respectively, then they have cylindrically-shapeddistal portions40 and58. On the other hand, if they are 120 and 122 respectively, then they have ribbon-shapedportion140 and158.
• FIG. 18 is a cross-section of another embodiment of acatheter600 according to the present invention.Catheter600 comprises a cylindrically-shapedcatheter body602 having anouter wall604 extending along a longitudinal axis G-G from a catheterproximal end600A to a catheterdistal end600B. Thecatheter600 has aprimary lumen606 that is in open communication with aproximal opening606A at the catheterproximal end600A and a distal opening606B at the catheterdistal end600B. Thecatheter body602 is formed of a biocompatible and biostablepolymeric material607 that extends outwardly from thelumen606 to theouter wall604. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3. Preferably thecatheter lumen606 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• FIG. 18 further shows that the first andsecond core wires20 or120 and22 or122 are coated with the secondarypolymeric material620 for a portion of their lengths in a similar manner as shown with thecatheter400 ofFIGS. 13 to 16. Suitable polymeric materials forcoating620 are PTFE and polyimide. The secondarypolymeric coating620 extends from the proximal ends of the respective seventh and tenthcylindrical portions124 and142 to a location somewhere along the length of the respective eighth and eleventhcylindrical portions132 and150. Respective helically-wound coil springs624 and626, for example of stainless steel or nitinol, then extend from the distal ends of thepolymeric coatings620 to the distal ends of therespective shaping ribbons160 and162.
• If the first and second core wires are 20 and 22 respectively, then they have cylindrically-shapeddistal portions40 and58. On the other hand, if they are 120 and 122 respectively, then they have ribbon-shapedportion140 and158.
• FIG. 19 is a cross-section of another embodiment of acatheter700 according to the present invention.Catheter700 comprises a cylindrically-shapedcatheter body702 having anouter wall704 extending along a longitudinal axis H-H from a catheterproximal end700A to a catheterdistal end700B. Thecatheter700 has aprimary lumen706 that is in open communication with aproximal opening706A at the catheterproximal end700A and a distal opening706B at the catheterdistal end700B. Thecatheter body702 is formed of a biocompatible and biostablepolymeric material707 that extends outwardly from thelumen706 to theouter wall704. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3. Preferably thecatheter lumen706 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• Thecatheter700 is similar to thecatheter600 shown inFIG. 18 with the exception that the shapingribbons160 and162 are provided with respectiveatraumatic tips160E and162E. The atraumatic tips1605 and1625 end proximal the distal end702B of thecatheter700.
• FIG. 20 is a cross-section of another embodiment of acatheter800 that is similar to thecatheter600 shown in FIG.18.Catheter800 comprises a cylindrically-shapedcatheter body802 having anouter wall804 extending along a longitudinal axis I-I from a catheterproximal end800A to a catheterdistal end800B. Thecatheter800 has aprimary lumen806 that is in open communication with aproximal opening806A at the catheterproximal end800A and adistal opening806B at the catheterdistal end800B. Thecatheter body802 is formed of a biocompatible and biostablepolymeric material807 that extends outwardly from thelumen806 to theouter wall804. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3. Preferably thecatheter lumen806 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• In this embodiment the diameters of the proximalcylindrical portion124, the firsttapered portion128, the intermediatecylindrical portion132, the secondtapered portion136 and the distal ribbon-shapedportion140 of thethird core wire120 are less than the corresponding diameters of the proximalcylindrical portion142, the firsttapered portion146, the intermediatecylindrical portion150, the secondtapered portion154 and the distal ribbon-shapedportion158 of thefourth core wire122. Thethird core wire120 is provided with a secondarypolymeric coating820 of PTFE or polyimide that ends somewhere along the length of the intermediatecylindrical portion132. A helically-wound stainless steel ornitinol coil spring824 serving as a sleeve houses the remainder of thethird core wire120 beginning at the distal end of thepolymeric coating820 and extends to the distal end of the shapingribbon160. Thefourth core wire122 is similarly coated with a secondarypolymeric material822 of PTFE or polyimide that ends somewhere along the length of the intermediatecylindrical portion150. A helically-wound stainless steel ornitinol coil spring826 houses the remainder of thefourth core wire122 beginning at the distal end of the secondarypolymeric coating822 and extends to the distal end of the shapingribbon162.
• FIG. 21 is a cross-section of another embodiment of acatheter900 that is similar to thecatheter800 shown inFIG. 20.Catheter900 comprises a cylindrically-shapedcatheter body902 having anouter wall904 extending along a longitudinal axis J-J from a catheterproximal end900A to a catheter distal end9003. Thecatheter900 has aprimary lumen906 that is in open communication with a proximal opening906A at the catheterproximal end900A and adistal opening906B at the catheter distal end9003. Thecatheter body902 is formed of a biocompatible and biostablepolymeric material907 that extends outwardly from thelumen906 to theouter wall904. Suitable biocompatible and biostable primary polymeric materials are similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3. Preferably thecatheter lumen906 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• In this embodiment the diameters of the proximalcylindrical portion124, the firsttapered portion128, the intermediatecylindrical portion132, the secondtapered portion136 and the distal ribbon-shapedportion140 of thethird core wire120 are less than the corresponding diameters of the proximalcylindrical portion142, the firsttapered portion146, the intermediatecylindrical portion150, the secondtapered portion154 and the distal ribbon-shapedportion158 of thefourth core wire122. Thethird core wire120 is provided with a secondarypolymeric coating920 of PTFE or polyimide that ends somewhere along the length of the intermediatecylindrical portion132. A helically-wound stainless steel ornitinol coil spring924 serving as a sleeve houses the remainder of thethird core wire120 beginning at the distal end of thepolymeric coating920 and extends to the distal end of the shapingribbon160.
• Thefourth core wire122 is similarly coated with a secondarypolymeric material922 of PTFE or polyimide that ends somewhere along the length of the intermediatecylindrical portion150. A helically wound stainless steel ornitinol coil spring926 serving as a sleeve houses the remainder of thefourth core wire122 beginning at the distal end of the secondarypolymeric coating922 and extends to the distal end of the shapingribbon162.
• In that respect,catheter900 is similar to thecatheter700 shown inFIG. 19 with the exception that the shapingribbons160 and162 are provided with respectiveatraumatic tips160E and162E. Theatraumatic tips160E and162E end proximal the distal end702B of thecatheter700.
• FIG. 22 is a cross-sectional view of acatheter1000 that is similar to thecatheter900 shown inFIG. 21 except thatcore wire122 is longer thancore wire120. In that respect,catheter1000 comprises a cylindrically-shapedcatheter body1002 having anouter wall1004 extending from a catheterproximal end1000A to a catheterdistal end1000B. Thecatheter1000 has aprimary lumen1006 that is in open communication with aproximal opening1006A at the catheterproximal end1000A and adistal opening1006B at the catheterdistal end1000B. Thecatheter body1002, which is formed of a biocompatible and biostablepolymeric material1007 similar to those described above forpolymeric material17 shown inFIGS. 1, 1A, 2 and 3, extends outwardly from thelumen1006 to theouter wall1004. Preferably thecatheter lumen1006 has a cylindrical shape throughout its length extending to the proximal and distal openings, but, as described above with respect to thecatheter10 shown inFIGS. 1 and 2, that is not required.
• FIG. 22 further shows that the first andsecond core wires120 and122 are coated with respective secondarypolymeric materials1020 and1022 of PTFE or polyimide for a portion of their lengths in a similar manner as shown with thecatheter400 ofFIGS. 13 to 16. The secondarypolymeric coatings1020 and1022 extend from the proximal ends of the respective seventh and tenthcylindrical portions124 and142 to a location somewhere along the length of the respective eighth and eleventhcylindrical portions132 and150. Respective helically-wound stainless steel ornitinol coil springs1024 and1026 then extend from the distal ends of thepolymeric coatings1020 and1022 to the distal ends of therespective shaping ribbons160 and162. The stainless steel ornitinol shaping ribbons160 and162 are provided with respectiveatraumatic tips160E and162E, which end proximal the distal end1002B of thecatheter1000.
• Further, the ribbon-shapedportion158 ofcore wire122 is axially longer than the corresponding ribbon-shapedportion140 ofcore wire120. Additionally, the shapingribbon160 corresponding to thecore wire120 is shorter than the shapingribbon162 corresponding tocore wire122. Thecatheter1000 is shown in a pre-bent orientation bending towards the ribbon-shapedportion140 of the lesser length. Providing the ribbon-shapedportion158 ofcore wire122 and itscorresponding shaping ribbon162 with the greater length helps maintain this bend. Since thecore wire122 and itsshaping ribbon162 reside on the outside of the bend, they must have a greater length than thecore wire120 andcorresponding shaping ribbon160 residing on the inside of the bend. That is becausecore wire122 and shapingribbon162 have a greater radius of curvature than theinner core wire120 and corresponding shaping ribbon.
• Thus, various embodiments of catheters with at least one pair of core wires disposed on opposite sides of a central lumen are described. In the broadest sense, however, a catheter according to the present invention is provided with at least one core wire extending along but spaced from a central catheter lumen. The core wire or wires have reduced diameter distal portions, which can be cylindrical or of a ribbon shape. This provided the distal end of the catheter with a desired degree of flexibility. Further, the embedded core wires greatly improve the torsional rigidity of the catheter so that rotation of the catheter's proximal end translates into a substantially equivalent rotation at the distal end of the catheter. Finally, the present catheter being provided with at least one core wire have the ability to be pushed through the vasculature without the need for the catheter to go over a guidewire already in-situ in the vasculature.
• It is appreciated that various modifications to the inventive concepts described herein may be apparent to those skilled in the art without departing from the spirit and scope of the present invention as defined by the hereinafter appended claims.

Claims (24)

What is claimed is:

1. A catheter, comprising:

a) a catheter body comprising an outer wall extending longitudinally from a catheter proximal end to a catheter distal end;

b) a first catheter lumen extending through the catheter body to the catheter proximal and distal ends; and

c) at least a first core wire residing in the catheter body, wherein the first core wire has a first core wire proximal end disposed adjacent to but spaced from the catheter proximal end and a first core wire distal end disposed adjacent to but spaced from the catheter distal end.

2. The catheter ofclaim 1, wherein the first core wire has at least one first tapered portion intermediate a first proximal cylindrical portion and a first distal cylindrical portion.

3. The catheter ofclaim 1, wherein the first core wire has at least one first tapered portion intermediate a first proximal cylindrical portion and a first distal ribbon-shaped portion.

4. The catheter ofclaim 3, wherein a first shaping ribbon resides in the catheter body adjacent to the first distal ribbon-shaped portion, the first shaping ribbon being disposed adjacent to but proximal the catheter distal end.

5. The catheter ofclaim 4, wherein the first shaping ribbon has an atraumatic tip.

6. The catheter ofclaim 1, wherein a second core wire resides in the catheter body, the second core wire comprising a second core wire proximal end disposed adjacent to but spaced from the catheter proximal end and a second core wire distal end disposed adjacent to but spaced from the catheter distal end.

7. The catheter ofclaim 3, wherein a second core wire resides in the catheter body, the second core wire comprising at least one second tapered portion intermediate a second proximal cylindrical portion and a second distal ribbon-shaped portion, and wherein a second shaping ribbon resides in the catheter body adjacent to the second distal ribbon-shaped portion.

8. The catheter ofclaim 7, wherein the first distal ribbon-shaped portion has a greater length than the second distal ribbon-shaped portion.

9. The catheter ofclaim 7, wherein the first shaping ribbon has a greater axial length than the second shaping ribbon.

10. The catheter ofclaim 7, wherein the first and second distal ribbon-shaped portions of the first and second core wires and their corresponding first and second shaping ribbons are aligned parallel to each other.

11. The catheter ofclaim 7, wherein the first distal ribbon-shaped portion of the first core wire and its corresponding first shaping ribbon are aligned perpendicular to the second distal ribbon-shaped portion of the second core wire and its corresponding second shaping ribbon.

12. The catheter ofclaim 4, wherein the first core wire and its corresponding shaping ribbon are housed inside a first helically-wound coil spring extending from a proximal end of the first core wire to a distal end of the first shaping ribbon.

13. The catheter ofclaim 4, wherein the first core wire and its corresponding first shaping ribbon are provided with a polymeric coating so that the first core wire and the first shaping ribbon have a uniform coated diameter extending from a proximal end of the first core wire at least part-way toward a distal end of the first shaping ribbon.

14. The catheter ofclaim 13, wherein the first core wire and its corresponding first shaping ribbon are provided with the polymeric coating extending from the first core wire proximal end part-way along a length of the first core wire, and wherein a helically-wound coil spring extends from a distal end of the polymeric coating to a distal end of the first shaping ribbon.

15. The catheter ofclaim 13, wherein the polymeric coating is selected PTFE and polyimide.

16. The catheter ofclaim 6, wherein the first core wire comprises at least a first tapered portion intermediate a first proximal cylindrical portion and a first distal ribbon-shaped portion and the second core wire comprises at least a second tapered portion intermediate a second proximal cylindrical portion and a second distal ribbon-shaped portion, and wherein the first proximal cylindrical portion has a greater cross-sectional diameter than the second proximal cylindrical portion, and the first distal ribbon-shaped portion has a greater cross-sectional diameter than the second ribbon-shaped portion.

17. The catheter ofclaim 6, wherein the catheter lumen is intermediate the first and second core wires.

18. The catheter ofclaim 6, wherein the first and second core wires are diametrically opposed to each other.

19. The catheter ofclaim 1, wherein a second catheter lumen extends through the catheter body to the catheter proximal and distal ends.

20. The catheter ofclaim 1, wherein the catheter body is of a primary polymeric material selected from the group of Nylon, PEBAX®, PET, silicone, polytetrafluoroethylene (PTFE), polyimide and liquid crystal polymers.

21. A catheter, comprising:

a) a catheter body comprising an outer wall extending longitudinally from a catheter proximal end to a catheter distal end;

b) a first catheter lumen extending through the catheter body to the catheter proximal and distal ends;

c) a first pair of core wires residing in the catheter body, the first pair comprising a first core wire and a second core wire on opposite sides of the catheter lumen; and

d) a second pair of core wires residing in the catheter body, the second pair comprising a third core wire and a fourth core wire on opposite sides of the catheter lumen,

e) wherein the first, second, third and fourth core wires are spaced at 90° intervals about a circumference of the catheter lumen.

22. The catheter ofclaim 21, wherein:

a) the first core wire comprises at least a first tapered portion intermediate a first proximal cylindrical portion and a first distal ribbon-shaped portion, a first shaping ribbon residing in the catheter body adjacent to the first distal ribbon-shaped portion;

b) the second core wire comprises at least a second tapered portion intermediate a second proximal cylindrical portion and a second distal ribbon-shaped portion, a second shaping ribbon residing in the catheter body adjacent to the second distal ribbon-shaped portion;

c) the third core wire comprises at least a third tapered portion intermediate a third proximal cylindrical portion and a third distal ribbon-shaped portion, a third shaping ribbon residing in the catheter body adjacent to the third distal ribbon-shaped portion; and

d) the fourth core wire comprises at least a fourth tapered portion intermediate a fourth proximal cylindrical portion and a fourth distal ribbon-shaped portion, a fourth shaping ribbon residing in the catheter body adjacent to the fourth distal ribbon-shaped portion.

23. The catheter ofclaim 22, wherein the first, second, third and fourth distal ribbon-shaped portions of the first, second, third and fourth core wires and their corresponding first, second, third and fourth shaping ribbons are aligned parallel to each other.

24. The catheter ofclaim 22, wherein the first pair of core wires comprising the first and second distal ribbon-shaped portions of the first and second core wires and their corresponding first and second shaping ribbons are aligned parallel to each other, and wherein the second pair of core wires comprising the third and fourth distal ribbon-shaped portions of the third and fourth core wires and their corresponding third and fourth shaping ribbons are aligned parallel to each other, and wherein the first pair of core wires are aligned perpendicular to the second pair of core wires.

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