RU2775437C2 - Guiding catheter with large lumen - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to medical equipment, namely to guiding catheters serving for provision of a lumen for the movement of therapeutic devices through it, at least from a point of inlet into the vascular bed to the mouth of the coronary artery. In accordance with the first embodiment, the guiding catheter contains an elongated tubular case with an outer diameter, an inner diameter of at least 0.0715 inches (1.8161 mm), a proximal end, a distal end, and a total length between them; and a single reinforcing tubular structure embedded in polymer between the outer diameter and the inner diameter of the elongated tubular case from the proximal end of the elongated tubular case to the distal end of the elongated tubular case. The single reinforcing tubular structure is made exclusively of the first set of elongated wire elements and the second set of elongated wire elements bound together in a braid configuration. The elongated tubular case has a non-braided tip at the distal end, the first area adjacent to the non-braided tip, and the second area adjacent to the first area, wherein the first area is made of material with a lower hardness than that of the second area. Each of the first set of elongated wire elements is arranged in a spiral twisted counterclockwise around the central longitudinal axis of the elongated tubular case, and it has the first constant cross-sectional shape, wherein the first cross-sectional shape has a maximum thickness and a maximum width, wherein the maximum width is three times greater than the maximum thickness, and no more than four and a half times greater than the maximum thickness. Each of the second set of elongated wire elements is arranged in a spiral twisted clockwise around the central longitudinal axis of the elongated tubular case, and it has the second constant cross-sectional shape, wherein the second cross-sectional shape has a maximum thickness and a maximum width, wherein the maximum width is two times greater than the maximum thickness, and no more than three times greater than the maximum thickness. In accordance with the second embodiment of the guiding catheter, a value of peaks per inch (hereinafter – ppi) of the braid is constant and is a value between 65 and 75 ppi. In accordance with the third embodiment, the guiding catheter contains an elongated tubular case with an outer diameter of no more than 0.0835 inches (2.1209 mm) and a braided reinforcing layer. The braided reinforcing layer consists of 16 wire elements bound into a 2-over, 2-under structure, where 8 of 16 wire elements have a rectangular cross-section having a thickness of 0.002 inches and a width of 0.005 inches, and the other 8 of 16 wire elements have a rectangular cross-section having a thickness of 0.001 inches and a width of 0.004 inches.

EFFECT: inventions provide improved maximum supporting force, improved runout characteristics, improved bending resistance characteristics, while maintaining relatively the same strength, when applying a torsional force.

20 cl, 9 dwg, 5 tbl

Description

RELATED APPLICATIONS

This application claims priority of US Provisional Application No. 61/825089, filed May 19, 2013, and US Provisional Application No. 61/825481, filed May 20, 2013, the full disclosures of which are incorporated by reference.

BACKGROUND OF THE INVENTION

[02]. 1. Technical field

[03]. The invention relates to guiding catheters.

[04]. 2. Related Devices and Methods

[05]. The guiding catheter serves to provide a lumen for advancing therapeutic devices through it, at least from the point of entry into the vascular bed to the orifice of the coronary artery. It is desirable that the proximal region (closest to the physician along the longitudinal axis of the guiding catheter) be more rigid than the distal region (farthest from the physician along the longitudinal axis of the guiding catheter) in order to provide sufficient "pushability" and flexibility to advance the guiding catheter , as a rule, following the guidewire through the vascular bed to the desired site. Additional desirable properties of guiding catheters are sufficiently "auxiliary", which describe the ability of the guiding catheter to provide an equal and opposite force to the therapeutic device in it, and therefore a steady movement of the guiding catheter away from the orifice when the therapeutic device contacts the guiding catheter under force, trying, for example, advance through an occlusion or narrowing of a coronary artery. Another feature is the ability to transmit torque from the proximal end where the clinician clamps the sleeve and applies torque to the distal end, which the clinician is attempting to twist. The higher the torque transfer, the better. However, the transmission of torque without much twisting and "beating", which results in that when the clinician twists the proximal handle of the guiding catheter and the distal tip does not obey, but the rotational energy is collected until it is finally released and the distal end "beats" due to the angle of twist, which should be avoided. The smaller the angle due to which the guiding catheter “beats”, the better. Another feature is the ability to avoid kinking, as kinks close the lumen and can make it difficult to advance or withdraw the guide catheter or therapeutic device. Typically, the kinking properties are described by the minimum radius of that portion of the guiding catheter that can be considered non-kinking. The smaller the radius, the more kink resistant the guide catheter is, which means a greater chance of a successful procedure.

[06]. Braided guiding catheters have been commercialized for many years for cardiovascular and endovascular stent delivery procedures to provide thin-walled tubular devices that allow either smaller outer diameters for the same inner diameter size or larger inner diameter for the same outer diameter size. diameter. After years of competing and optimizing armored catheters, the largest internal lumen diameter of the 6 French guiding catheter is marketed as 0.071 inches in products sold by Terumo, as is Medtronic's LAUNCHER™ guiding catheter. Most others on the market today have a 0.070 inch ID for a 6 French guiding catheter.

[07]. SUMMARY OF THE INVENTION

[08]. A medical device comprising an elongated tubular body with an outer diameter of not more than 0.0835 inches (2.1209 mm), an inner diameter of at least 0.0715 inches (1.8161 mm), a proximal end, a distal end, and a total length between them ; and a single reinforcing tubular structure embedded in the polymer between the outer diameter and the inner diameter of the elongated tubular body from the proximal end of the elongated tubular body to the distal end of the elongated tubular body, wherein the single reinforcing tubular structure is made exclusively from the first plurality of elongated wire bands and the second plurality of elongated wire elements woven together in a braid configuration; wherein each of the first plurality of elongated wire elements is arranged in a counterclockwise spiral around the central longitudinal axis of the elongated tubular body and has a first constant perpendicular cross-sectional shape, which first cross-sectional shape has a maximum thickness and a maximum width, with a maximum width of at least least three times the maximum thickness and not more than four and a half times the maximum thickness; and each of the second plurality of elongated wire elements is arranged in a clockwise spiral around the central longitudinal axis of the elongated tubular body and has a second constant perpendicular cross-sectional shape, which second cross-sectional shape has a maximum thickness and a maximum width, with a maximum width of at least least twice the maximum thickness and not more than three times the maximum thickness.

[09]. A medical device comprising an elongated tubular body with an outer diameter of not more than 0.0835 inches (2.1209 mm), an inner diameter of at least 0.0720 inches (1.8288 mm), a proximal end, a distal end, and a total length between them ; and a single reinforcing tubular structure embedded in the polymer between the outer diameter and the inner diameter of the elongated tubular body from the proximal end of the elongated tubular body to the distal end of the elongated tubular body, wherein the single reinforcing tubular structure is made exclusively from the first plurality of elongated wire bands and the second plurality of elongated wire elements woven together in a braid configuration; wherein each of the first plurality of elongated wire elements is arranged in a counterclockwise spiral around the central longitudinal axis of the elongated tubular body and has a first constant perpendicular cross-sectional shape, which first cross-sectional shape has a maximum thickness and a maximum width, with a maximum width of at least least three times the maximum thickness and not more than four and a half times the maximum thickness; and each of the second plurality of elongated wire elements is arranged in a clockwise spiral around the central longitudinal axis of the elongated tubular body and has a second constant perpendicular cross-sectional shape, which second cross-sectional shape has a maximum thickness and a maximum width, with a maximum width of at least least twice the maximum thickness and not more than three times the maximum thickness.

[ten]. A medical device, comprising: an elongated tubular body having a first overall length, a proximal end, a distal and central longitudinal axis and a clearance through it, and consisting of: the innermost polymeric tubular layer having a second overall length, a proximal end, and a distal end; an outermost polymeric tubular layer having a third overall length, a proximal end and a distal end; and a braided reinforcing layer entirely embedded in one or more inner and outer polymeric tubular layers, and having a fourth overall length, a proximal end, and a distal end; wherein the braided reinforcing layer consists of 16 wire elements woven into a 2-over, 2-under pattern/pattern, where 8 of the 16 wire elements have a perpendicular rectangular cross-section having a thickness of 0.002 inches and a width of 0.005 inches, and the other 8 of 16 The wire elements have a rectangular cross-section having a thickness of 0.001 inches and a width of 0.004 inches.

[eleven]. These and other features, benefits and advantages of the present invention will become apparent with reference to the following detailed description, the appended claims and the accompanying figures, in which like reference numerals refer to structures that are either the same structures or perform the same functions as others. structures, in several forms.

[12]. BRIEF DESCRIPTION OF THE FIGURES:

[13]. The figures are given by way of example only and are not intended to limit the present invention.

[fourteen]. FIG. 1 shows guiding catheters according to the invention.

[fifteen]. FIG. 2 is a partial cross-sectional view along a plane containing the central longitudinal axis of the distal portion of a guiding catheter according to the invention, including the distal end without the braid.

[16]. FIG. 3 is a copy of a photograph of a perpendicular cross section of a guiding catheter in accordance with the invention.

[17]. FIG. 4 shows the braid configuration 2-over, 2-under.

[eighteen]. FIG. 5 shows the braid configuration 1-over, 1-under.

[19]. FIG. 6 is a perpendicular cross section of a first prior art guiding catheter at the same magnification as in FIG. 3.

[twenty]. FIG. 7 is a copy of a perpendicular cross-sectional photograph of a second prior art guiding catheter at the same magnification as in FIG. 3.

[21]. FIG. 7 is a copy of a perpendicular cross-sectional photograph of a third prior art guiding catheter at the same magnification as in FIG. 3.

[22]. FIG. 7 is a copy of a perpendicular cross-sectional photograph of a prior art fourth guiding catheter at the same magnification as in FIG. 3.

[23]. DETAILED DESCRIPTION

[24]. Guide catheters shown in FIG. 1 have useful use as a guiding catheter for guiding a therapeutic device, such as a dilated PTCA catheter (balloon catheter), a stent delivery system, or a drug-coated or similar balloon catheter to a target site such as a narrowed section of a coronary artery. Each guiding catheter 10 has a proximal sleeve 12, an unloader sleeve 14, coaxial with the main body of the catheter 16, which is visible in FIG. 1 extending to the left of the relief sleeve 14, although the overall length of the main body of the catheter 16 is not shown, the respective distal portions 18 of each guiding catheter take on a predetermined shape when not under external forces. These distal portions are "straightened" as they are introduced into and expanded within the vascular system along the guidewire, and regain their predetermined shape when the placed guidewire is withdrawn proximally from at least the distal portion. Once the distal site returns to a predetermined shape, advancing the guidewire distally through it does not straighten the guide catheter, but instead, the guidewire is aligned with the curvature of the guide catheter lumen.

[25]. Let us turn to FIG. 2, a guiding catheter 10 according to the invention may include an unbraided tip 20 that exhibits relatively high flexibility and is mounted on the distal side or distal end of the main body 16 of the catheter. The catheter main body 16 is an elongated tubular body 22, the distal portion of which is shown in partial longitudinal section in FIG. 2. The elongated tubular body 22 has an outer surface 24 consisting of a first region 26, a second region 28 proximally adjacent to the first region 26, a third region 30 proximally adjacent to the second region 28, a fourth region (not shown), adjoining in the proximal direction to the third region 30, and the fifth region (not shown) adjoining in the proximal direction to the fourth region. The third region 30 is made from a material having a lower hardness and is more flexible than the fourth region, the second region 28 is made from a material having a lower hardness and is more flexible than the third region 30, and the first region 26 is made from a material having a lower hardness and is more flexible than the second region 28. Thus, the elongated tubular body 10 can gradually increase flexibility along the distal direction along the longitudinal axis 32. In certain embodiments, the material of the region 26 is the same material as the regions 28, even if originally assembled as a separate item.

[26]. With the exception of the unbraided end 20, the elongated tubular body 22 has three layers, an outer layer 34, a braided layer 36, and an inner layer 38. The outer layer 34 includes a range of materials selected for the various areas described above, and in each area, the material constituting the outer layer may be a polyamide based material such as nylon or PEBAX, a mixture thereof, or a polyurethane such as Pellathane. The material constituting the inner layer 38 is a slippery polymer such as polytetrafluoroethylene ("PTFE") or high density polyethylene (HDPE).

[27]. The unbraided end 20 may be made entirely of a single material, or it may be of a combined design, as shown in FIG. 2. In FIG. 2, the unbraided distal tip is formed from the distal extension of the polymer, forming the outer layer of the elongated tubular body region 26, except for its proximal and inner surface, which is formed from the distal extension of the slippery polymer, forming the inner layer 38.

[28]. Returning to the structure of the elongated tubular body 22, the braided layer comprises a first plurality of elongated wires wound in a clockwise direction around the longitudinal axis 32 and a second plurality of elongated wires wound in a counterclockwise direction around the longitudinal axis 32. The elongated wireform 40 is one of the first plurality of elongated wireforms; and the elongated wireform 42 is one of the second plurality of elongated wireforms. The first set and the second set of wires that form the braided layer are embedded in the polymer between the outer surface 24 and the inner surface 44. Preferably, they are embedded in the polymer forming the outer layer 34 and the outer surface 24. Thus, the braid layer 36 overlaps in space, with at least an outer layer 34. The braided layer 36 forms a single reinforcing structure in the elongated tubular body 22. There are no other reinforcing structures, such as fibers, running generally parallel ("straight") to the longitudinal axis 32.

[29]. FIG. 3 is a copy of a photograph of an enlarged perpendicular cross-section of an elongate tubular body with a first set of elongated wires and a second set of elongated wires. In this embodiment, there are sixteen elongate wireframes in total, with eight forming the first set and eight forming the second set. For ease of description, only one of each set has been labeled in FIG. 3. Also in FIG. 3 marked inner diameter d with subscript 3, outer diameter D with subscript 3, lumen 50, outer layer 34, outer surface 24, total wall thickness t with subscript 3T, inner layer wall thickness 38, and t with subscript 3i. FIG. 3 shows a cross section where the elongated wires of the first set of elongated wires intersect the elongated wires of the second set of elongated wires. The braid structure in this embodiment is such that, at each individual location around the annular cross section of the elongated tubular body 22, when the elongated wire of the first plurality of elongated wires is "above" the elongated wire of the second plurality of elongated wires, and elsewhere the elongated the wire element of the first set of elongated wire elements is "under" the elongated wire element of the second set of elongated wire elements. It should be noted that the cross-sectional areas of the elongated wireframes are larger than their corresponding perpendicular cross-sectional area due to the angle of the braid, which can be calculated by knowing the number of elongated wireframes used in the braid, ppi, and the arrangement of the elongated wires around the ring. and braided diameter.

[thirty]. FIG. 4 shows a first plurality of elongate wireforms interlaced with a second plurality of elongate wireforms in a 2-over, 2-under braid configuration. The distance between the centers of intersection of two axially aligned sets of crossed wires is defined as "peak", and explains the expression, PPI ppi.

[31]. FIG. 5 illustrates a first set of elongated wires intertwined with a second set of elongated wires in a 1-over, 1-under braid configuration.

[32]. FIG. 6 is a copy of a photograph of an enlarged perpendicular cross section of an elongated tubular body with a first plurality of elongated wireforms and a second plurality of elongated wireforms. In this embodiment, there are forty-eight elongate wireframes in total, with thirty-two forming the first set and sixteen forming the second set. Thirty-two of the first set are grouped into subsets of four, generally circular in cross-section, small elongated wire elements in place of one "flat" (rectangular cross-section) wire band having a width equal to the sum of four diameters and a thickness equal to the diameter elongated wire elements. (Note again that the cross-sectional shapes in the photograph are not round due to the angle of the braid.) The sixteen elongated wires of the second set are grouped into subsets of two generally round cross-sectional elongated wires in place of one "flat" ( rectangular cross-section) of the wire strip, where the two elongate wire members are each shown to have a diameter twice as large as one of the thirty-two elongated wire members of the first set. For ease of description, only one of each set has been labeled in FIG. 6. Also in FIG. 6 marked inner diameter d with subscript 3, outer diameter D with subscript 3, lumen 50, outer layer 34, outer surface 24, total wall thickness t with subscript 3T, inner layer wall thickness 38, and t with subscript 3i.

[33]. Fig. 7, 8 and 9 are copy photographs of an enlarged perpendicular cross-section of an elongated tubular body with a first plurality of elongated wireforms and a second plurality of elongated wireforms, where the magnification for each is the same as in FIG. 3. In each prior art catheter, there are a total of sixteen elongated wire members with eight forming the first set and eight forming the second set. For ease of description, only one of each set has been marked on the corresponding FIGURE. Also marked in the respective FIGURES are the inner diameter d with a subscript 3, the outer diameter D with a subscript 3, the lumen 50, the outer layer 34, the outer surface 24, the total wall thickness t with a subscript 3T, the wall thickness of the inner layer 38 and t with a lower index 3i. The catheter shown in FIG. 7 has a plurality of elongate rectangular cross section wireforms and a second plurality of elongated rectangular cross section wireforms. The catheters shown in FIG. 8 and 9 each has a first plurality of elongate rectangular cross-section wires and a second plurality of elongated rectangular cross-section wires. From FIG. 8 shows that the sizes of the elements of the first set are the same as the sizes of the elements of the second set. The catheter shown in FIG. 8 is a Medtronic's LAUNCHER™ guiding catheter.

[34]. SUMMARY SIZE CHART

Catheter
in FIG. External
diameter
D (inch) Interior
diameter
d (inch) 1st width
(inch) 1st thickness
(inch) 2nd width
(inch) 1st thickness
(inch) 3 0.0835 0.072 0.004 0.001 0.005 0.002 6 0.0835 0.070 *
(diameter) *
(diameter) 2*
(diameter) 2*
(diameter) 7 0.0835 0.070 0.003 0.001 0.0025 0.0025 eight 0.0835 0.071 8W 8T 8W 8T 9 0.0835 0.071 9W 9T 9W 9T

[35]. In certain embodiments, the ppi of the braid is constant over the overall length of the elongated tubular body. In certain embodiments, the ppi of the braid varies along the overall length of the elongated tubular body. It should be understood that differences in ppi due to the influence of the time interval of the manufacturing process are considered insignificant and the resulting ppi is considered constant.

[36]. In certain embodiments, the braid ppi is constant and is between 60-70 ppi. In certain embodiments, the braid ppi is constant and is between 65-75 ppi. In certain embodiments, the braid ppi is constant and is between 60-90 ppi.

[37]. In certain embodiments, the ppi of the sheath varies along the catheter in an increasing manner along the longitudinal axis 32, with specific values falling between 60 and 90 ppi.

[38]. In certain embodiments, a 6 French guiding catheter with an ID of 0.072" and an OD of 0.0835" is substantially constant along the length of the guiding catheter. At the distal end, there are three layers in the guiding catheter: an outer tubular polymer layer of four (or five) sections along the axial length, an inner tubular polymer layer, and an intermediate tubular braided layer. The braided layer is embedded in the outer tubular layer.

[39]. In certain embodiments, the inner tubular polymeric layer is made of PTFE with no radiopaque material.

[40]. In certain embodiments, the braided tubular structure comprises 16 stainless steel bands spaced at regular intervals around the circumference, 8 spirally wound around the inner layer in a clockwise direction, and 8 spirally wound around the inner layer in a counterclockwise direction, and 16 The ribbons are woven into a 2-over, 2-under pattern with 70+/-3 comprehension with 70+/-3 ppi, which is constant throughout the length of the braided layer. Each of the counterclockwise tapes has a rectangular cross section with a thickness of 0.002" and a width of 0.005", oriented with respect to the inner tubular layer such that the width is perpendicular to the radial direction and the thickness is located in the radial direction. Each of the clockwise tapes has a rectangular cross section having a thickness of 0.001" and a width of 0.004", oriented with respect to the inner tubular layer such that the width is perpendicular to the radial direction and the thickness is located in the radial direction.

[41]. In certain embodiments, the outer tubular polymeric layer comprises four separate tubular sections that are adjacent to each other and are individually made from blends of nylon 12 and polyetherblockamide. The four sections have successively decreasing hardness, but all are higher (Shore D hardness) than the 80 Shore A hardness of the distal tip.

[42]. In certain embodiments, the outer tubular polymeric layer has a fifth outer tubular polymeric layer that is distal to the four outer sections and proximal to (and adjacent to) the distal tip. The fifth section is made of the same material as the distal tip.

[43]. In certain embodiments, the implementation of the distal tip is made of urethane, sold as Pellethane 80AE, with radiopaque filler (bismuth trioxide). Pellethane 80AE has a hardness of 80 Shore A.

[44]. In certain embodiments, the inner tubular polymer layer is the longest of the three layers. The distal end of the braided layer is closest to the distal end of the inner cylindrical polymeric layer. The distal end of the fourth (or fifth, if any) section of the outer tubular polymeric layer is closest to the distal end of the braided layer. The distal tip extends closer to abut the distal outer polymeric section of the layer and the braided layer is embedded in the distal tip material. At the end of the distal end of the braided layer, there are only two layers, the distal tip material is the outer layer, and the PTFE patch is the inner layer. The remaining distance from the distal end of the guiding catheter consists entirely of the distal tip material and has the same OD (0.0835") and ID (0.072") of the remainder of the catheter main body or elongated tubular body.

[45]. In certain embodiments, the outer surface of the inner layer is chemically etched to assist in mechanical bonding between it and the various outer tubular layers. The distal tip and all components are assembled over a metal core and encased in heat shrink tubing and heated to bond all adjacent polymeric surfaces and embed the braided layer into the appropriate outer layer material. After bonding, the heat shrink tubing is cut lengthwise and separated from the guiding catheter, and the outer diameter of the distal tip is ground down to size.

[46]. In certain embodiments, the outer layer may be extruded onto a braided layer over the inner layer, and then ground off for areas where tubular sections of different hardness can be assembled and glued.

[47]. COMPARISONS

[48]. The following tables show comparisons between the prior art catheter shown in FIG. 8 and an embodiment in accordance with the invention.

[49]. EXAMPLE 1

[fifty]. In an embodiment according to the invention, the outer diameter is 0.0835 inches and the inner diameter is 0.0720 inches, the braid pattern is 2-over, 2-under at 70 ppi. There are sixteen flat wires, all with a rectangular cross section. Dimensions of the shape of the first perpendicular cross section

[51]. COMPARATIVE EXAMPLE 1

[52]. The catheter shown in FIG. 8 has an outer diameter of 0.0835" and an inner diameter of 0.0710" (although it actually looks more like a polygon than a circle), has a 2-over, 2-under braid pattern at approximately 63 ppi. There are sixteen flat wires, and all with a rectangular cross section and the same dimensions. It is assumed that the cross-sectional dimensions of each of the 16 wires are 0.004 inches wide and 0.0015 inches thick. It is sold by Medtronic under the trade name LAUNCHER™.

[53]. In Table 2 below, the three Medtronic LAUNCHER™ guiding catheters and the three catheters of Example 1 were tested to determine the maximum support force they would provide without moving from the target location (when intended to be used at a coronary ostium). The results show that even though the catheters of EXAMPLE 1 have a thinner wall, they provide more support for therapeutic catheters applying forces to them as the therapeutic catheters are driven over narrowed areas of the coronary artery.

[54]

TABLE 2 Group instance Time Max. supportive
force (g), t=0 COMPARATIVE. NOTE one S1 0min 178.3783 COMPARATIVE. NOTE one S2 0min 168.0737 COMPARATIVE. NOTE one S3 0min 171.4017 EXAMPLE 1 S1 0min 219.2893 EXAMPLE 1 S2 0min 187.5608 EXAMPLE 1 S3 0min 226.9528 Average EXAMPLE 1 211.2676 Medtronic
LAUNCHER™ 172.6179

[55]. In Table 3 below, three catheters from Comparative Example 1 and three catheters from Example 1 were tested to determine the torque required to turn the proximal handle of the catheter either clockwise ("CW") or counterclockwise ("CCW"). ”), when the distal tip is held motionless, until the catheter kinks. In practice, clinicians rarely turn the proximal handle of the guiding catheter more than 1.5 turns (540 degrees) without seeing distal tilt movement. The following data represents the torque required to rotate the proximal handle 360 degrees with respect to the distal tip. Higher values are better as the stronger structure resists twisting with more force.

[56]

TABLE 3 Group instance Torque for 360 CW (oz-in) Torque for 360 CCW (oz-in) COMPARATIVE. NOTE one S1 2.55 2.65 COMPARATIVE. NOTE one S2 2.7 2.45 COMPARATIVE. NOTE one S3 2.45 2.5 EXAMPLE 1 S1 2.6 2.9 EXAMPLE 1 S2 2.65 2.85 EXAMPLE 1 S3 2.65 2.8 Average EXAMPLE 1 2.85 oz-in Medtronic
LAUNCHER™ 2.53333 oz-in

[57]. In Table 4 below, two catheters from Example 1 and two catheters from Comparative Example 1 were tested to determine the percentage of "beat" of the distal tip when tested in 37 degrees F water when first placed in water (t=0 minutes) and after 5 minutes (t=5 minutes). In this test, the catheter is in a U-shaped arch made to simulate the aortic arch, and the sleeve is rotated at a constant low speed (rpm) for a set period of time (here, enough time to make five revolutions of the proximal piston). The distal end of the guiding catheter is unrestricted (other than being in the large tubular "U"), and thus faces 180 degrees in the opposite direction to the proximal plunger. The rotation of the distal end is monitored and the two rotations are superimposed on each other (proximal entry versus distal exit). When "beating" occurs, the distal tip rotates a large amount for a small amount of input rotation. The numbers shown indicate the percentage of test time during which the distal end "beat". The lower the beats, the better.

[58]

TABLE 4 Group Rotation instance Time (minutes) beat COMPARATIVE. NOTE one CCW one 0 23 COMPARATIVE. NOTE one CCW 2 0 23 COMPARATIVE. NOTE one CCW one 5 34.6 COMPARATIVE. NOTE one CCW 2 5 34.6 EXAMPLE 1 CCW one 0 5 EXAMPLE 1 CCW 2 0 four EXAMPLE 1 CCW one 5 7.4 EXAMPLE 1 CCW 2 5 13 Average EXAMPLE 1 7.35 Medtronic
LAUNCHER™ 28.75

[59]. In Table 5 below, 6 catheters from Comparative Example 1 were compared with 3 catheters from Example 1 in determining the minimum radius of curvature before kink of the elongated tubular bodies. The results show that Example 1 has a smaller radius of curvature, and thus resists kinking surprisingly better than Comparative Example 1.

[60]

TABLE 5 A series of experiments Segment Bend Radius (mm) COMPARATIVE. NOTE one Body 4.68846 COMPARATIVE. NOTE one Body 4.6392 COMPARATIVE. NOTE one Body 4.61731 COMPARATIVE. NOTE one Body 4.68969 COMPARATIVE. NOTE one Body 4.94188 COMPARATIVE. NOTE one Body 4.86646 EXAMPLE 1 Body 4.07229 EXAMPLE 1 Body 4.01941 EXAMPLE 1 Body 3.85478 Medium Bending Radius (mm) EXAMPLE 1 3.98216 Medtronic
LAUNCHER™ 4.7405

[61]. The present invention is not limited to the details of the examples and embodiments described above. The scope of the invention is defined by the appended claims and all changes, modifications and equivalents falling within the scope of the claims, which are covered by the claims.

Claims (37)

1. Guide catheter, containing: an elongated tubular body with an outside diameter, an inside diameter of at least 0.0715 inches (1.8161 mm), a proximal end, a distal end, and a total length therebetween; a single reinforcing tubular structure embedded in the polymer between the outer diameter and the inner diameter of the elongated tubular body from the proximal end of the elongated tubular body to the distal end of the elongated tubular body, and the single reinforcing tubular structure is made exclusively from the first set of elongated wire elements and the second set of elongated wire elements, woven together in a braid configuration; and the elongated tubular body has an unbraided tip at the distal end, a first region adjacent to the unbraided ferrule, and a second region adjacent to the first region, the first region being made of a material having a lower hardness than the second region; each of the first plurality of elongated wire elements is arranged in a counterclockwise spiral around the central longitudinal axis of the elongated tubular body and has a first constant cross-sectional shape, the first cross-sectional shape having a maximum thickness and a maximum width, with a maximum width three times than the maximum thickness, and not more than four and a half times more than the maximum thickness; and each of the second plurality of elongated wire elements is arranged in a clockwise spiral around the central longitudinal axis of the elongated tubular body and has a second constant cross-sectional shape, the second cross-sectional shape having a maximum thickness and a maximum width, with a maximum width twice than the maximum thickness and not more than three times the maximum thickness. 2. The catheter according to claim. 1, in which the elongated tubular body has a third region adjacent to the second region, the second region is made of a material having a lower hardness than the third region. 3. The catheter according to claim. 2, in which the elongated tubular body has a fourth region adjacent to the third region, the third region is made of a material having a lower hardness than the fourth region. 4. The catheter according to claim. 1, in which the polymer forming the inner diameter of the elongated tubular body contains a slippery polymer. 5. The catheter of claim. 1, in which the polymer forming the outer diameter of the elongated tubular body contains polyamide. 6. The catheter according to claim. 1, in which the hardness of the polymer forming the outer diameter of the elongated tubular device has different values. 7. The catheter according to claim 1, in which the braid has a 2-over, 2-under configuration. 8. The catheter according to claim 1, wherein the maximum width of the first cross-sectional shape is three times greater and not more than four times greater than the maximum thickness of the first cross-sectional shape. 9. The catheter according to claim 1, wherein the maximum width of the second cross-sectional shape is two and a half times the maximum thickness of the second cross-sectional shape. 10. The catheter according to claim 1, wherein the first cross-sectional shape is selected from the group consisting of a rectangle, an oval, and an ellipse. 11. The catheter of claim 10, wherein the second cross-sectional shape is selected from the group consisting of a rectangle, an oval, and an ellipse. 12. Guide catheter, containing: an elongated tubular body with an outside diameter, an inside diameter of at least 0.0715 inches (1.8161 mm), a proximal end, a distal end, and a total length therebetween; a single reinforcing tubular structure embedded in the polymer between the outer diameter and the inner diameter of the elongated tubular body from the proximal end of the elongated tubular body to the distal end of the elongated tubular body, and the single reinforcing tubular structure is made exclusively from the first set of elongated wire elements and the second set of elongated wire elements, woven together in a braid configuration; and the elongated tubular body has an unbraided tip at the distal end, a first region adjacent to the unbraided ferrule, and a second region adjacent to the first region, the first region being made of a material having a lower hardness than the second region; each of the first plurality of elongated wire elements is arranged in a counterclockwise spiral around the central longitudinal axis of the elongated tubular body and has a first constant cross-sectional shape, the first cross-sectional shape having a maximum thickness and a maximum width, with a maximum width three times than the maximum thickness, and not more than four and a half times the maximum thickness; each of the second plurality of elongated wire elements is arranged in a clockwise spiral around the central longitudinal axis of the elongated tubular body and has a second constant cross-sectional shape, the second cross-sectional shape having a maximum thickness and a maximum width, with a maximum width twice than the maximum thickness, and not more than three times the maximum thickness; and wherein the peaks per inch (ppi) of the braid is constant between 65 and 75 ppi. 13. The catheter according to claim. 12, in which the elongated tubular body has a third region adjacent to the second region, the second region is made of a material having a lower hardness than the third region. 14. The catheter according to claim. 13, in which the elongated tubular body has a fourth region adjacent to the third region, the third region is made of a material having a lower hardness than the fourth region. 15. The catheter according to claim 12, wherein the polymer forming the inner diameter of the elongated tubular body contains a slippery polymer. 16. The catheter according to claim 12, wherein the polymer forming the outer diameter of the elongated tubular body contains polyamide. 17. Guide catheter, containing: an elongated tubular body with an outer diameter of not more than 0.0835 inches (2.1209 mm), an inner diameter of not less than 0.0715 inches (1.8161 mm), a proximal end, a distal end, and an overall length therebetween; a braided reinforcing layer embedded in the polymer between the outer diameter and the inner diameter of the elongated tubular body from the proximal end of the elongated tubular body to the distal end of the elongated tubular body; wherein the braided reinforcement layer consists of 16 wire elements woven into a 2-over, 2-under pattern, where 8 of the 16 wire elements have a rectangular cross-section having a thickness of 0.002 inches and a width of 0.005 inches, and the other 8 of the 16 wire elements have a rectangular cross-section having a thickness of 0.001 inches and a width of 0.004 inches; and wherein the elongated tubular body has an unbraided tip at the distal end, a first region adjacent to the unbraided ferrule, and a second region adjacent to the first region, the first region being made of a material having a lower hardness than the second region. 18. The catheter according to claim. 17, in which the elongated tubular body has a third region adjacent to the second region, the second region is made of a material having a lower hardness than the third region. 19. The catheter according to claim 18, in which the elongated tubular body has a fourth region adjacent to the third region, the third region is made of a material having a lower hardness than the fourth region. 20. The catheter according to claim 17, wherein the polymer forming the inner diameter of the elongated tubular body contains a slippery polymer.

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