JP2672714B2 - Untwisted spiral wound catheter - Google Patents

Description

FIELD OF THE INVENTION The present invention relates to surgical devices. The present invention relates in particular to catheters suitable for treating tissue target sites within the body that are accessible through the vasculature. At the core of the present invention is the use of a reinforcing ribbon, typically made of metal, which is wound into the catheter body to create a catheter with controllable stiffness.

BACKGROUND OF THE INVENTION Catheters are being used more and more widely to access distant regions within the human body, and so approach delivery of diagnostic or therapeutic agents to distant regions. In particular, catheters that use the circulatory system as a route to these treatment sites are particularly useful. For example, it is common practice to treat cardiovascular disease by angioplasty (PCTA) using a catheter with a balloon at the distal tip. Similarly, it is common practice to use these catheters to deliver a radiopaque agent to the site of interest prior to PCTA manipulation to observe the problem site prior to treatment.

The target site to be accessed by the catheter is often in the soft tissue, such as the liver or brain. The difficulty in reaching such sites is evident from the eyes of a bystander. The catheter is introduced through the aorta as found in the groin or neck and must pass through a more narrow area of the arterial system until the catheter reaches the selected site. Such paths often meander, forming a large number of loop-like paths. These catheters must be fairly rigid at their proximal end to allow the catheter to be propelled and manipulated as it travels through the body, and the catheter tip has a looped portion and a gradual extension as described above. Must have sufficient flexibility at the distal end to allow passage through the narrowing vessel, and
At the same time, the design and use of these catheters is rather difficult in that they must not cause significant trauma to the blood vessel or the surrounding tissue. For more details on these issues and details of an early yet effective method for designing catheters for such passages, see Engelson, US Pat. No. 4,739,76.
May be found in Issue 8. These catheters are designed for use with guidewires. A guidewire is simply a wire, typically of a very elaborate design, that performs the "reconnaissance" for the catheter. As the catheter passes through the vasculature, the catheter is attached to a guidewire and slides along the guidewire. In other words, the guide wire is used by the attending physician to select an appropriate path through the vasculature, and once the appropriate path is established, the catheter slides behind the guide wire along the guide wire. To do.

Although there are other methods of advancing the catheter through the human vasculature to selected sites, guidewire-assisted catheters are believed to be extremely rapid and somewhat more accurate than other procedures. ing. One such other procedure is the use of flow-directed catheters. These devices often have a small balloon located on the distal end of the catheter, which can be deflated or inflated as the route for the catheter needs to be selected.

The present invention is an invention that can be used and is applicable to various forms of catheters. The present invention utilizes the concept of combining polymer tubing with one or more spirally wound ribbons to control the stiffness of the resulting catheter body. The catheter may be used in combination with a guide wire, but the catheter body may have a balloon attached, or particularly flexible tip, as found in, for example, Zenzen et al. U.S. Patent Application No. 08 / 023,805. It can also be used as a flow directional catheter in combination with. The entire contents of the above patents are incorporated herein by reference.

Using a ribbon to wind the catheter body
It is not a new idea. However, none have used this idea to produce a catheter having the physical performance of the catheter of the present invention.

Examples of previously disclosed catheters include Crippe
US Patent No. 2,437,542 to Ndorf. Crippend
orf describes a "catheter-type device" typically used as a ureteral catheter or urethral catheter. The physical design of the catheter is such that the distal section has more flexibility and the proximal section has less flexibility. The device is made of intertwined threads made of silk, cotton or certain synthetic fibers. This device is manufactured by impregnating a textile-based tube with a reinforcing medium that makes the tube rigid while still providing flexibility. The tubing thus plasticized may then be dipped into certain other media to form a flexible varnish of materials such as tung oil base or phenolic resins and suitable plasticizers. It has not been shown that this device has the flexibility required herein. In addition, the device appears to be of the type used in specific areas of the body other than the peripheral region or the soft tissue of the body.

Similarly, Edwards U.S. Pat. No. 3,416,531 shows a catheter having a braiding-edge wall. The device further comprises a layer of another polymer such as TEFLON. The strands found in wall braids appear to be threads with a classical circular cross section. There is no suggestion of constructing a device using ribbon material. Further, the device has been shown to be fairly rigid in that it is designed to allow the device to bend with a fairly large handle at the proximal end. There is no suggestion of simply winding a ribbon around a polymeric substrate to form a catheter, or in particular making a flexible catheter as required herein.

U.S. Pat. No. 4,484,586 describes a method of making hollow conductive medical tubing. Conductive wires are placed within the walls of hollow tubing, especially for pacemaker wiring, and especially for implantation within the human body. The tubing preferably consists of an annealed copper wire coated with a biocompatible polymer such as polyurethane or silicone. The copper wire is coated and then used in a device that winds the wire into a tube. Next, the rolled substrate is coated with another polymer to produce a tubing having a helical conductive wire in its wall.

References showing the use of helically wound ribbons of flexible material in catheters include Samson, US Pat. No. 4,51,51.
It is No. 6,972. The device is a guide catheter and can be manufactured from one or more wound ribbons. A preferred ribbon is the aramid material known as Kevlar 49. This device is also a device that must be fairly rigid. This device
It is designed to be used in a "set" and is designed to remain in a specific form as another catheter passes through it. The device must be flexible enough to cause no substantial trauma, but it is certainly not a device used as a guidewire. This device does not meet the flexibility criteria required for the inventive catheters described herein.

Rydell et al., U.S. Pat. No. 4,806,182, shows a device with a braid of stainless steel embedded in the wall of the device and with an inner layer of polyfluorocarbon.
The method described in this U.S. patent is also a method of laminating polyfluorocarbons to an inner polyurethane liner to prevent delamination.

Lenck U.S. Pat. No. 4,832,681 shows a method and apparatus for artificial fertilization. The device itself is a long piece of tubing that can be made somewhat stiffer by the addition of helical reinforcements, including stainless steel wire, depending on the particular material of construction.

Another catheter showing the use of braided wires is
No. 5,037,404 to Gold et al. Gold
Et al., The idea of varying the pitch angle between the wound strips to produce a device with different flexibility in different parts of the device. Different pitch angles result in different flexibility. No mention is made of the use of ribbons, and no particular mention of the particular use in which the Gold et al. Device may be placed.

US Pat. No. 5,069,674 shows a small diameter epidural catheter that is flexible and kink resistant when bent. The wall consists of a helical coil, typically made of stainless steel or the like, a tubular sheath, typically made of a polymer, and a safety wire that is helically formed around the coil and is often in the form of a ribbon. It has a composite structure with.

U.S. Pat. No. 5,176,660 shows the manufacture of a catheter with stiffening streaks on the sheath wall. The metallic strips are wound in a spiral cross pattern over the tubular sheath to produce a substantially stiffer sheath. Reinforcing filaments are used to increase the longitudinal stiffness of the catheter for good "pushability". This fixture is very strong, about 250,000
It is wound with a tension of lb / (inch) ² (about 17570 kg / cm ² ) or higher. The flat strip itself has a width between 0.006 inches (0.15 mm) and 0.020 inches (0.51 mm) and a thickness between 0.0015 inches (0.038 mm) and 0.004 inches (0.10 mm). There is no suggestion of using these ideas for instruments having flexibility and other configurations described below.

De Toledo, US Pat. No. 5,178,158, shows a device that is a divertable wire used as either a guide wire or a catheter. This coil is
It appears to be a ribbon forming an internal passage through the coil / catheter device. No coating was applied to the interior.

US Pat. No. 5,217,482 shows a balloon catheter having a stainless steel hypotube catheter shaft and a distal balloon. The particular section of the device shown in this patent uses a stainless steel spiral ribbon secured to the outer sleeve by a suitable adhesive and has a section of very high stiffness to a section of relatively low stiffness. Transition to section (tr
ansition section).

None of these devices are catheters with the critical bend diameters required herein, and
These devices do not have the compressive strength or flexibility of the present invention.

SUMMARY OF THE INVENTION The present invention is a catheter section, desirably composed of an inner tubular liner, one or more helically wound reinforcing ribbons, and an outer cover. The inner tubular liner, when used, is typically a tubing polymer section that can be a thermo-flexible material and which upon heating is miscible with the material found in the outer cover. The inner layer can be a thermosetting material that can be adhered to the outer material or adhesively bonded to the outer material.
In either case, the two or more polymeric layers hold the helically wound reinforcing ribbon in place within the catheter assembly.

The reinforcing ribbon can be wound on the inner tubular liner in many different ways. The reinforcing ribbon, in its most basic form, can be a ribbon consisting of a single strip wound in a single direction. The reinforcing ribbons can be many ribbons of different size and composition wrapped in each direction around a tubular liner. The ribbon is typically made of metal, but may be made of other materials.

The various catheter sections may form one integral catheter assembly. By judicious selection of materials, catheters can have good critical diameters while reducing overall diameter. Catheters can be designed to integrate smooth materials into the basic design of a particular catheter product without increasing thickness and stiffness. The catheter may be constructed entirely of a material that is stable to the radiation sterilization process.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of an exemplary catheter having three sections.

FIG. 2 is an enlarged cross-sectional view of the inner portion of one characteristic section of this catheter.

FIG. 3 is an enlarged cross-sectional view of the inner portion of one section of this catheter.

4, 5, and 6 are partial cross-sectional views showing various configurations of the inner section section of a multi-section catheter made in accordance with the present invention.

FIG. 7 is a cross-sectional view of an exemplary catheter section made in accordance with the present invention.

FIG. 8 is a partial cross-sectional view of a catheter section made in accordance with the present invention.

9A and 9B detail a method for testing the "critical bend diameter" of the present invention.

10 and 11 are partial cross-sectional views showing a highly preferred embodiment of a multi-section catheter made in accordance with the present invention.

DESCRIPTION OF THE INVENTION The present invention is a kink resistant catheter section or catheter. This is a compound device with at least one section having a spiral wound ribbon reinforcement coaxially incorporated into that section or sections. The catheter should have at least a distal portion of the catheter no greater than 3.5 mm, preferably 2.5 mm
Is configured to have a critical bend diameter of not more than 1, most preferably of not more than 1.5 mm. In addition, the catheter section is preferably Tinius-Olsen Stiffness Tes.
Deflection of at least 6,500 ° / inch-pound (equivalent to about 5.64 ° cm-g), such as when measured by ter (20-30 ° of warp, 0.005 lb (2.27g),
0.25 inch (6.35 mm) span), preferably 7,
Has a lateral stiffness of 500 ° deflection / inch-pound (corresponding to about 6.51 ° cm-g), most preferably 9,500 ° deflection / inch-pound (corresponding to about 8.24 ° cm-g) . In addition, the radial compressive strength of this section is
It was found to be extremely high compared to other distal sections found in comparable catheter distal sections.

A typical multi-section catheter (100) that may incorporate the concepts of the present invention is shown in FIG. Such catheters are described in more detail in US Pat. No. 4,739,768 to Engelson (incorporated herein by reference in its entirety) and are suitable for neurovascular and peripheral vascular applications. . Such a catheter is, of course, also suitable for easier tasks as may be encountered in access and treatment of the heart. One difficulty that has arisen as the requirements for the length of these catheters has increased is that the diameter of the distal section is necessarily becoming smaller and smaller. This is due to the longer catheters having to reach the smaller vessel area. Such smaller diameters require that the sections of the wall be simultaneously thinned. The walls of the thinner section can twist or ripple when pushed positively along the guidewire or when pushing the vaso-occlusive device through the lumen of the catheter. The exemplary shape shown in FIG. 1 has a distal section (102) of significant flexibility, typically a less flexible middle section (104), and in turn the most flexible. A low and long proximal section (106). The distal section (102) allows deep penetration without trauma through the abnormal, tortuous convolution of the neurovascular system.
It has flexibility and flexibility. Various known and necessary accessories for catheter assemblies, such as one or more radiopaques that allow the location of the distal region to be seen in fluoroscopy. The sex band (108) and the luer assembly (110) for access of the guide wire (112) and liquid are simultaneously shown in FIG. Typical dimensions of this catheter are as follows: Length: 60-200cm Proximal section (106): 60-150cm Intermediate section (104): 20-50 Distal section (102): 2.5-30cm Of course, These dimensions are not critical to the invention and are selected depending on the malady to be treated and its body part. However, as described below, a spirally wound ribbon can be used to make the wall of the catheter somewhat thinner. This does not lead to a reduction in performance, for example crush strength or flexibility, or actually a performance improvement.

FIG. 2 shows an enlarged cross-sectional view of the catheter body or section (200) showing the most basic aspect of one variation of the present invention. As shown, the catheter body or catheter section is connected to the inner tubular member (20
2) It has a spirally wound ribbon (204). The inner tubular member (202) can be made of any of a wide variety of polymers with varying stiffness or flexibility, depending on the section of the catheter. For example, section (20
0) as the proximal section, the inner tubing (2
02) is polyimide, polyamide such as nylon, high density polyethylene (HDPE), polypropylene, polyvinyl chloride, various fluoropolymers (eg: PTFE, FEP, vinylidene fluoride, mixtures, alloys, copolymers, block copolymers, etc.), It can be polysulfone and the like. Blends, alloys, mixtures, copolymers, block copolymers of these materials are also suitable, if desired.

If a more flexible section is desired, the inner tubular member (202) can be polyurethane, low density polyethylene (LDPE), polyvinyl chloride, THV, etc., and other polymers of suitable flexibility or modulus. Can be.

It has also been found that the design of this catheter allows the use of thin walled tubing at the distal portion of the catheter, which is essentially the smoothest polymer inherently, such as PTFE and FEP and mixtures thereof. Such polymers have the advantage of being smooth. If others are used, the thickness will be somewhat larger. Of course, the greater the thickness of these polymeric tubings, the more rigid they are. The wall thickness of the inner tubular liner (202) can be as thin as 0.5 mils (0.0127mm) and as thick as 10 mils (0.254mm) depending on the catheter application, the selected portion of the catheter, the choice of polymer, and the catheter morphology. ) Can be. Representative examples of polymers for the inner tubular liner are as follows: Such dimensions are clearly only a range, and each variation of the catheter must be carefully designed for the particular purpose for which it is to be placed.

Preferred combinations of polymers for catheter construction are also described below. Each polymer described herein includes barium sulphate, bismuth trioxide,
It should also be noted here that it may be used with radiopaque materials such as bismuth carbonate, powdered tungsten, powdered tantalum and the like.

The spirally wound ribbon (204) shown in FIG. 2 may also be made of a variety of different materials. Metal ribbons are preferred because of their strength-to-weight ratio, but fibrous
s) Materials (both synthetic and natural) can also be used. Preferred in terms of cost, strength, and availability are stainless steel (308, 304, 318, etc.) and tungsten alloys. Materials that may be similarly used, but have various disadvantages in strength, density, and ductility, include noble metals such as gold, platinum, palladium, rhodium, and alloys of these metals. Alloys of many of these precious metals, such as tungsten, are less ductile than pure precious metals.

The class of alloys known as superelastic alloys is also a desirable choice. However, it is not easy to process these alloys into small ribbons. A suitable superelastic alloy is
Includes a material class known as nitinol. These are the US Navy Ordnance
Laboratory) is an alloy found in. These materials are described in Buehler et al., U.S. Pat.No. 3,174,851, Rozner et al., U.S. Pat.No. 3,351,463, and Harrison et al. U.S. Pat.
For a long time, in 3,753,700. These alloys are not readily available commercially in the small ribbons required by the invention described herein, but are a very good choice for very high performance catheters.

Metal ribbons (204) suitable for use in the present invention desirably have a thickness of 0.75 mil (0.019 mm) and 1.5 mil (0.038 m).
m) and the width is between 2.5 mil (0.064 mm) and 8.0 mil (0.203 mm). For superelastic alloys, especially Nitinol, the thickness and width may be somewhat smaller,
For example 0.5 mil (0.0127 mm) and 1.0 mil (0.0254 mm) respectively
mm). 1 mil x 3 mils ((0.0254mm) x is currently preferred in terms of strength, cost, and ease of use.
(0.0762mm)) 2mil x 6mil ((0.0508mm) x (0.
152mm)), and 2 mils x 8 mils ((0.0508mm) x
(0.203mm)) stainless steel ribbon.

Suitable non-metallic ribbons are polyaramids (eg KE
VLAR), carbon fiber, and low performance polymers such as Dacron and nylon. Available natural fibers include silk and cotton. The preferred method of using a non-metallic ribbon in the present invention is to combine it with a metallic ribbon to "tune" the stiffness of the resulting composite, or to provide an opposite "handed" ribbon in the composite. As a result, the metal ribbon is unwound, which reduces the tendency for protrusions or constructs to form within the catheter lumen.

Returning to FIG. 2, the stiffening ribbon (204) may simply be wrapped over the inner tubular liner (202). Depending on the choice of material for the inner tubular liner (202), a reinforcing ribbon (2
04) can be glued together. The adhesive is primarily used to adhere an outer cover (described below) to the inner tubular liner (202). For the components of the catheter, it is desirable to choose a thermoplastic material that will be compatible with each other upon application of appropriate heat, such as polymers that inherently adhere to each other, such as certain polyethylenes and polyimides, or PEBAX and polyurethanes. preferable. When the catheter section is constructed using only the material found in each tubular section, or using a third material to improve the miscibility of the material found in each liner and cover, this construction is It is called "binder-free". When an adhesive is used to improve the adhesiveness between the outer layer and the inner layer, it is not "binder-free".

Thermoplastic materials that are inherently adhesive to each other or miscible with each other are suitable in the middle and distal regions of the catheter. This allows the adhesive to be omitted, as the various reinforcing ribbons are held in place by the joining of the inner tubular liner (202) and the outer cover (not shown in this figure).

The wound internal sector, shown in FIG. 2, has a single spiral wound reinforcing ribbon (204) wound in one direction or "hand". FIG. 3 shows a second stiffening ribbon (206) wrapped around both the first stiffening ribbon (204) and the inner tubular liner (202) in a second direction or “handedness”.

For economical production, it is desirable to "gang-wind" the reinforcing ribbon onto the inner tubular liner. That is, for example, a catheter in which the primary or first reinforcing ribbon (204) is wound at 12 turns per inch, the catheter tubing is turned 12 times and wrapped around the tubing with a single ribbon. Can be manufactured by
Alternatively, it may be manufactured by making 6 turns of the catheter tubing and wrapping it with a pair of reinforcing ribbons spaced apart from each other to produce a device that looks like 12 turns of the ribbon. Similarly, the inner tube can be wound four times by winding three ribbons together. The same applies hereinafter. As described below, the required wound ribbons need not be the same size. Each reinforcing ribbon of each section of the catheter assembly may be of different width and thickness.

Another aspect of the present invention is shown in FIG. Catheter (210)
Has three different sections: a proximal section (212), a middle section (214), and a distal section (216). This catheter (210) is similar in overall function to the catheter shown in FIG. In particular, the proximal section (212) of the catheter is the most rigid in that it has the tightest number of reinforcing ribbons (218) wrapped around the tubular substrate. The distal portion (216) is wound to be the least rigid in that the number of reinforcing ribbons (218) is the least dense. Mid section (214)
Is an intermediate density between two adjacent sections,
It is wrapped with a reinforcing ribbon. As mentioned above,
Although most of the examples provided herein describe catheters with three sections, the invention is not so limited. There may be fewer or more sections of the catheter of the present invention depending on the ultimate use in which the catheter will be deployed.

The sections of the catheter of FIG. 4 are shown with the same size reinforcing ribbon in each section. The various reinforcing ribbons are also the same size in each winding direction.
Roll density is one way to control the overall stiffness of the catheter section.

Another method of controlling stiffness is shown in FIG. As with the catheter shown in FIG. 4, a three-part catheter (220) is shown. However, in this example, the method of controlling the rigidity is different. In this example, the width of each reinforcing ribbon is varied to obtain a particular desired stiffness. For example, in the catheter assembly (220), the proximal portion (222) uses a relatively wide reinforcing ribbon (228) that is shown rolled in both directions. The middle part (224) uses a narrower reinforcing ribbon (230),
The distal portion (226) uses the narrowest reinforcing ribbon (232).

Again, each section is shown as having the same size ribbon wound in each direction, but it is clear that this is not a requirement of the invention.

The width of the ribbon may be selected so that different sizes of ribbon are wound in different directions, or reinforcing ribbons of different sizes are wound together in the same direction. Alternatively, of course, a combination of these two methods is also suitable.

Figure 6 shows three parts: the proximal section (24
2 shows a three-part catheter (240) having an exemplary configuration consisting of 2), an intermediate section (244), and a distal section (246). In this configuration, the proximal section (242) has a reinforcement ribbon (24) that is wide in one winding direction.
8) and a narrow reinforcing ribbon (250) are both used, and only the narrow reinforcing ribbon (252) is used in the other winding direction. The middle sector (244) uses the same ribbon combination in each winding direction: two narrow ribbons (254) and one wide ribbon (256). The distal section (246) uses a single width ribbon (258) in each winding direction. This figure "tunes" the stiffness of the catheter section for specific purposes by varying the winding spacing of the reinforcing ribbons, using ribbons of varying widths, and using ribbons of varying widths in combination. A wide variety of modifications are shown.

When the stiffening ribbon is wrapped around the inner tubular liner, the next outer cover is formed.

FIG. 7 shows an inner tubular liner (272), a reinforcing ribbon (27).
4) and a catheter (27) having an outer cover (276)
It is sectional drawing which shows 1 section of (0). The outer cover or outer layer can be formed in various ways. As mentioned above,
The preferred method is to shrink the appropriate tubing on the reinforcing ribbon,
As shown in FIG. 7, the tubing continues to shrink so that the tubing fills the gaps between the windings of the reinforcing ribbon (274). This allows the outer cover (276) to directly contact the inner tubular liner (272). Even more desirably, the outer tubing (276) is further heated to cause the outer cover (276) to mix with the inner tubular liner (272) at their interface, thereby providing one strong integral catheter section ( 270) is to be formed. Mixing the two polymer layers at this interface will further improve the bond strength.

The outer layer (276) is also formed by dipping the inner tubular layer (272) / reinforcing ribbon (274) into a bath of molten polymer or suspension or latex containing a solid dissolved polymer or an outer cover polymer. Can be done.
Of course, the cover may be formed on the catheter by spraying or otherwise applying the material. Such material classes include polyurethane, polysilicone, polyvinylpyrrolidone and the like.

The catheters and catheter sections of the present invention may be coated or otherwise treated to improve smoothness.

FIG. 8 shows another variation of the inventive catheter body with the inner polymer layer removed. This section is extremely simple in structure. That is, an outer layer (280) of polymeric material is formed on the pre-wound coil (282). These outer layers may preferably be made of heat-shrinkable tubing with a thin wall thickness. Polyethylene, polyurethane, polyvinyl chloride, polyfluoroethylene, and blends or copolymers containing these polymers (eg, THV) are particularly suitable.

The variation of FIG. 8 is a coil (282) having a pitch selected to space the adjacent windings of the coil.
When used with a wire or ribbon, it is particularly useful as a distal or middle section of a catheter that is extremely flexible, kink resistant, and extremely easy to construct.

As noted above, the most distal portion of the distal section of the catheter (and preferably the other sections as well) does not exceed 3.5 mm, preferably does not exceed 2.5 mm, and most preferably does not exceed 1.5 mm. Has no critical bending diameter. In addition, this section should
Deflection of at least 6,500 ° / inch-pound (equivalent to about 5.64 ° cm-g), such as when measured by Tinius-Olsen Stiffness Tester (20-30 ° deflection, 0.005 °
Pound (2.27 g), measured in 0.25 inch (0.635 mm) span), preferably 7,500 ° warp / inch-pound (approx.
6.51 ° cm-g), most preferably 9,500 ° warp / inch-pound (corresponding to about 8.24 ° cm-g) lateral stiffness.

In the test used by the present inventors to measure the critical bending diameter,
The test outlined in Figures 9A and 9B is used.

Generally, a catheter section (300) is placed between two flat plates (preferably made of plastic or glass or the like for viewing with the naked eye), as shown in FIG. 9A,
And often as needed, pegs (p) for holding the catheter section (300) in a loop in place.
eg) (302) is used. Then, attach both ends of the catheter until twist appears in the catheter body, or
Ratio of outer diameters measured at the apex (304) (larger diameter:
Pull until the smaller diameter) reaches a value of 1.5. Figure 9
B shows a cross section of the catheter sector at position (304) and further shows how to measure the larger and smaller diameters. These two methods provide roughly equivalent results, although the latter method is more repeatable.

Throughout this specification, we refer to the "region" section of the catheter. Where the context allows, the term "region" means within 15% of the specified points. For example, “distal region of the distal section” can mean the most distal 15% of the length of the distal section.

Figures 10 and 11 show two highly desirable catheter designs in partial cross-section. In particular, FIG. 10 shows a catheter with two sections of differing stiffness. The proximal section (320) has an inner tubular liner (322) made of polyimide, a spirally wound reinforcing ribbon (324) made of 1 mil x 3 mil stainless steel, and a shrink-wrap FEP-vinylidene fluoride (THV). -200) consists of an outer cover. The distal section (328) has the same outer cover (326) but an inner tubular liner (330) made of FEP-vinylidene fluoride (THV-200). In these two sections, reinforcing ribbons (324)
It can be observed that the spacing between the turns of the is very different. The proximal section has 12 turns per inch, while the distal section has only 4 turns per inch.

Figure 11 shows the proximal section (342), the intermediate section (3
44) and a catheter (340) having three sectors of different flexibility with a distal section (346). The proximal section has an inner liner (34
8); 1x3 millimeter spirally wound ribbon of stainless steel (350), with 12 turns per inch spacing in each direction on the inner liner; and FEP
-Composed of an outer layer of vinylidene fluoride (THV-500).

The middle section (344) includes an extension of the proximal inner liner (348) found in the proximal section (342) and an outer distal section (354). External distal cover (35
4) can also be made by FEP (but somewhat more flexible configuration than the proximal inner liner (348)), but preferably THV
It consists of FEP-vinylidene fluoride such as -200. FEP and FEP-vinylidene copolymers are miscible on heating. The turn spacing for this section is 9 turns per inch.

Finally, the distal section (346) is composed of an extension of the outer distal section (354) and the inner distal tubing (356). In this case, the inner distal section consists of the same material as the outer distal section (356). The winding spacing for this section is 6 turns per inch.

The present invention has been disclosed and specific embodiments of the invention have been described. The use of these particular examples is not intended to limit the invention in any way. Further, to the extent there are modifications of the invention that are within the spirit of the disclosure and are still equivalent to the invention found in the claims, this patent may include these modifications as well. Intended.

Claims (55)

(57) [Claims] 1. A catheter section comprising an elongate tubular member having a proximal end, a distal end, and a passageway defining a lumen extending therebetween, the elongate tubular member comprising a first cover. An inner tubular liner made of a first liner material in coaxial relationship with an outer tubular cover having a material, and having one circumference, spirally and coaxially wound on the outside of the inner tubular liner, the outer tubular cover At least one first ribbon stiffener, the catheter section in the region of the distal end having a critical bend diameter not exceeding 3.5 mm and 6500 ° / inch-pound (5.64 ° cm-g). ) A catheter section with greater lateral flexibility. 2. The catheter section of claim 1, wherein the section has a lateral flexibility of greater than 8500 ° / inch -pond (7.37 ° cm-g) . 3. The catheter section of claim 1, wherein the liner material and cover material are miscible in a molten form. 4. The catheter section of claim 3, wherein the liner material is mixed with the cover material within a coaxial region of the first ribbon reinforcement. 5. The catheter section of claim 1, wherein no binder is used between the inner tubular liner and the outer tubular cover. 6. The catheter section of claim 1, wherein the liner material and the cover material are radiation sterilizable without substantially reducing their physical attributes. 7. The first ribbon stiffener is spirally and coaxially wrapped around the inner tubular liner, the catheter section having a circumference opposite the first ribbon stiffener, Further comprising a second ribbon reinforcement wound helically and coaxially on the first ribbon reinforcement.
The catheter section according to claim 1. 8. The method of claim 1, further comprising at least one additional ribbon stiffener helically and coaxially wrapped around the inner tubular liner and having the same circumference as the first ribbon stiffener. Catheter section as described. 9. The method of claim 7, further comprising at least one additional ribbon stiffener helically and coaxially wrapped around the inner tubular liner and having the same circumference as the first ribbon stiffener. Catheter section as described. 10. Further comprising at least one further ribbon stiffener spirally and coaxially wrapped around said first ribbon stiffener and having the same circumference as said second ribbon stiffener. Item 7. A catheter section according to item 7. 11. Further comprising at least one further ribbon stiffener that is spirally and coaxially wrapped around the first ribbon stiffener and has the same circumference as the second ribbon stiffener. The catheter section of paragraph 10. 12. The catheter section of claim 1, wherein the elongate tubular member has at least one region of variable stiffness between the proximal end and the distal end. 13. The catheter section of claim 11, wherein the elongate tubular member has at least one region of variable stiffness between the proximal end and the distal end. 14. The catheter section of claim 1, wherein the first ribbon stiffener has a varying pitch between the proximal end and the distal end. 15. The catheter section of claim 9, wherein the first ribbon reinforcement has a varying pitch between the proximal end and the distal end. 16. The catheter section of claim 7, wherein the second ribbon stiffener has a varying pitch between the proximal end and the distal end. 17. The catheter section of claim 8, wherein the second ribbon stiffener has a varying pitch between the proximal end and the distal end. 18. The cover material comprises polyimide, polyamide, polyethylene, polypropylene, polyvinyl chloride, fluoropolymers including PTFE and FEP, vinylidene fluoride, and mixtures, alloys, copolymers and block copolymers thereof, polysulfones, and the like. The catheter section of claim 1, which is selected. 19. The liner material and cover material are
A catheter section according to claim 1 selected from polyurethane, low density polyethylene (LDPE), polyvinyl chloride, fluoropolymers including PTFE and FEP, vinylidene fluoride, and mixtures, alloys, copolymers and block copolymers thereof. . 20. The first ribbon reinforcement is 0.75 mil
The catheter of claim 1, having a thickness between (0.019 mm) and 2.5 mils (0.064 mm) and a width between 2.5 mils (0.064 mm) and 8.0 mils (0.203 mm). section. 21. The second ribbon reinforcement is 0.75 mil.
The catheter of claim 7, having a thickness between (0.019 mm) and 2.5 mils (0.064 mm) and a width between 2.5 mils (0.064 mm) and 8.0 mils (0.203 mm). section. 22. The catheter section of claim 1, wherein at least one of the liner material and the cover material is radiopaque. 23. A catheter section comprising an elongated tubular member having a proximal end, a distal end, and a passageway defining a lumen extending therebetween, the elongated tubular member comprising: a. A rigid rigid proximal segment, and b.) A relatively flexible distal segment, the distal segment being coaxial with an outer distal tubular cover having a distal cover material. An inner distal tubular liner having a material and at least one first ribbon reinforcement having a first wrap and helically and coaxially wrapped around the inner distal tubular liner and covered by the outer distal tubular cover And a critical bend diameter not exceeding 3.5 mm and 6500 ° /
A catheter having lateral flexibility greater than inch-pound (5.64 ° cm-g) . 24. The catheter of claim 23, wherein the distal section has a lateral flexibility greater than 8500 ° / inch-pound (7.37 ° cm-g) . 25. The catheter of claim 23, wherein the liner material and cover material are miscible in molten form. 26. The proximal segment comprises an inner proximal tubular liner having a proximal liner material in coaxial relationship with an outer proximal tubular cover having a proximal cover material, the first ribbon stiffener comprising: 24. The catheter of claim 23, helically and coaxially wrapped around the inner proximal tubular liner and covered by the outer proximal tubular cover. 27. Further comprising at least one intermediate segment defining a passage between the relatively rigid proximal segment and the relatively flexible distal segment, the at least one intermediate segment comprising: An extension of the inner proximal tubular liner in coaxial relationship with an extension of the outer distal tubular cover, wherein the first ribbon reinforcement is helical and coaxial about the inner proximal tubular liner. 27. The catheter of claim 26, rolled up and covered by the outer distal tubular cover. 28. The catheter of claim 26, wherein the distal liner material is mixed with the distal cover material within a coaxial region of the first ribbon reinforcement. 29. No binder is used between the distal inner tubular liner and the distal outer tubular cover.
The catheter according to 28. 30. The catheter of claim 23, wherein the proximal and distal liner materials and the proximal and distal cover materials are radiation sterilizable without substantially reducing their physical attributes. . 31. A second ribbon reinforcement, wherein the catheter has a circumference opposite to the first ribbon reinforcement and is spirally and coaxially wrapped about the first ribbon reinforcement. 24. The catheter of claim 23, further comprising: 32. The distal segment, the intermediate segment,
24. The catheter of claim 23, wherein at least one of the proximal segments has a constant stiffness. 33. The distal segment, the intermediate segment,
28. The catheter of claim 27, wherein at least one of the proximal segments has a constant stiffness. 34. The distal segment, the intermediate segment,
28. The catheter of claim 27, wherein at least one of the proximal segments has a variable stiffness. 35. The distal segment, the intermediate segment,
32. The catheter of claim 31, wherein at least one of the proximal segments has variable stiffness. 36. The cover material comprises polyimide, polyamide, polyethylene, polypropylene, polyvinyl chloride, fluoropolymers including PTFE and FEP, vinylidene fluoride, and mixtures, alloys, copolymers and block copolymers thereof, polysulfones, and the like. 24. The catheter section of claim 23, selected. 37. The liner material and the cover material are
24. The catheter section of claim 23 selected from polyurethane, low density polyethylene (LDPE), polyvinyl chloride, fluoropolymers including PTFE and FEP, vinylidene fluoride and mixtures, alloys, copolymers and block copolymers thereof. . 38. The first ribbon reinforcement is 0.75 mil.
The catheter of claim 23 having a thickness between (0.019 mm) and 2.5 mils (0.064 mm) and a width between 2.5 mils (0.064 mm) and 8.0 mils (0.203 mm). . 39. The second ribbon reinforcement is 0.75 mil
The catheter of claim 31, having a thickness between (0.019 mm) and 2.5 mils (0.064 mm) and a width between 2.5 mils (0.064 mm) and 8.0 mils (0.203 mm). . 40. The catheter of claim 23, wherein at least one of the liner material and the cover material is radiopaque. 41. A catheter comprising an elongated tubular member having a proximal end, a distal end, and a passageway defining a lumen extending between the ends, the elongated tubular member comprising: a. A rigid proximal segment having an inner proximal tubular liner having a proximal liner material in coaxial relationship with an outer proximal tubular cover having a proximal cover material, the inner proximal tubular liner having one wrap, A proximal segment, spirally and coaxially wrapped around a liner, and having a first ribbon stiffener covered by the outer proximal tubular cover; and b.) A relatively flexible distal segment. An inner distal tubular liner having a distal liner material in coaxial relationship with an outer distal tubular cover having a distal cover material;
With the first ribbon stiffener spirally and coaxially wrapped around the inner distal tubular liner and covered by the outer distal tubular cover, the catheter being 3.5 mm in the region of the distal end. Critical bending diameter not exceeding and 6500 °
Having a lateral flexibility greater than 1 / inch-pound (5.64 ° cm-g), and wherein the second ribbon reinforcement is spirally and coaxially wrapped around the first ribbon reinforcement. ing,
A distal segment, and c.) At least one intermediate segment defining a passage between the relatively rigid proximal segment and the relatively flexible distal segment, the outer distal tubular An extension of the inner proximal tubular liner in coaxial relationship with an extension of the cover and the first ribbon spirally and coaxially wound between the inner proximal tubular liner and the outer distal tubular cover. A stiffener and an intermediate segment in which the second ribbon stiffener is spirally and coaxially wrapped about the first ribbon stiffener. 42. The first ribbon reinforcement is 0.75 mil
(0.019 mm) and 2.5 thickness and 2.5 mil between mils (0.064 mm)
42. The catheter of claim 41, comprising a metal ribbon having a width between (0.064 mm) and 8.0 mils (0.203 mm) . 43. The first ribbon reinforcement is about 1.0 mil.
43. The catheter of claim 42, comprising a ribbon having a thickness (0.025 mm) and a width of about 3.0 mils (0.076 mm) . 44. The second ribbon reinforcement is 0.75 mil
(0.019 mm) and 2.5 thickness and 2.5 mil between mils (0.064 mm)
43. The catheter of claim 42, comprising a metal ribbon having a width between (0.064 mm) and 8.0 mils (0.203 mm) . 45. The first ribbon reinforcement is about 1.0 mil.
45. The catheter of claim 44, comprising a ribbon having a thickness (0.025 mm) and a width of about 3.0 mils (0.076 mm) . 46. A catheter section comprising an elongated tubular member having a proximal end, a distal end, and a passageway defining a lumen extending between the ends, the elongated tubular member including an outer tubular liner. The outer tubular liner comprises
Coaxial with at least one first ribbon stiffener having a wrap and spirally and coaxially wrapped and covered by the outer tubular liner, and the catheter section in the region of the distal end. , Critical bending diameter not exceeding 3.5 mm and 6500 ° / inch-pound (5.64 ° cm)
-g) A catheter section with greater lateral flexibility. 47. The section has a lateral flexibility greater than 8500 ° / inch-point (7.37 ° cm-g) .
The catheter section according to claim 46. 48. The cover material is radiation sterilizable without substantially degrading its physical properties.
The catheter section according to 46. 49. The catheter section comprises the first section.
47. The method of claim 46, further comprising a second ribbon reinforcement having an opposite circumference of the ribbon reinforcement of claim 1 and spirally and coaxially wrapped around the first ribbon reinforcement. Catheter section. 50. The catheter section of claim 46, further comprising at least one additional ribbon reinforcement having the same circumference as the first ribbon reinforcement. 51. The catheter section of claim 46, wherein the elongate tubular member has at least one region having variable stiffness between the proximal end and the distal end. 52. The first ribbon stiffener has a varying pitch between the proximal end and the distal end.
The catheter section according to 46. 53. The second ribbon stiffener has a varying pitch between the proximal end and the distal end.
The catheter section according to 49. 54. The cover material comprises polyimide, polyamide, polyethylene, polypropylene, polyvinyl chloride, fluoropolymers including PTFE and FEP, vinylidene fluoride, and mixtures, alloys, copolymers and block copolymers thereof, polysulfones, and the like. 47. The catheter section of claim 46, selected. 55. The first ribbon reinforcement is 0.75 mil.
(0.019 mm) and 2.5 thickness and 2.5 mil between mils (0.064 mm)
47. The catheter section of claim 46, including a ribbon having a width between (0.064 mm) and 8.0 mils (0.203 mm) .