Exchangeable catheter

[Technical field]

【0001】

Background of the Invention 1. Field of Invention The present invention generally relates to medical instruments and methods. More specifically, the present invention relates to a balloon catheter having a replaceable balloon structure.

[Background technology]

【0002】

2. Explanation of background technology Percutaneous transluminal angioplasty has become the first-line treatment for the treatment of stenotic sites in patients' blood vessels, especially coronary arteries and veins. In recent years, such angioplasty has been increasingly used in combination with stenting and / or radiation therapy to prevent restenosis and hyperplasia after surgery. When performing multiple continuous treatments in this way, it is usually necessary to "replace" the catheter used for each procedure. That is, the first angioplasty is performed using an angioplasty balloon catheter. After completion of the angioplasty, a second catheter carrying a stent or other vascular prosthesis needs to be introduced to the treatment site. Introduction of the second catheter requires first removal of the angioplasty balloon catheter and then placement of the second catheter at the treatment site. Alternatively, the second catheter may be replaced with a third catheter to selectively provide radiation or other treatment to prevent hyperplasia.

【0003】

When performing multiple such continuous treatments, many physicians prefer to have a "guide wire" in place at the treatment site. The guide wire is a small diameter, highly flexible wire that can be advanced through the blood vessel to the target site, after which an angioplasty balloon catheter and other intervention catheters are introduced and It functions as a guidance path for positioning.

【0004】

Initially, angioplasty balloon catheters were designed to be introduced into blood vessels in a "wire-on" manner. That is, it was designed to have an access, commonly referred to as a guidewire lumen, over the entire length from the distal end to the proximal end of the catheter. The catheter could be loaded into the proximal end of a guidewire already indwelling in the patient and advanced over the guidewire until the distal end of the catheter reached the target site. Although this method is functional, it requires control of the guidewire during the introduction of the intervention catheter, which means that the guidewire outside the patient's body must be longer than the catheter to be introduced. Was. If the length is any short, the operator will not be able to hold the guidewire during catheter introduction. Although necessary for catheter introduction, the long length of the guidewire (optionally in the form of a removable extension) made it difficult to handle in treatment processes other than catheter manipulation.

【0005】

To overcome the drawbacks associated with long guide wires, "quick exchange" or "monorail" angioplasty catheters have been developed. Over the years, many dedicated designs have been developed. Rapid exchange catheters generally have a short guidewire lumen extending from the distal end of the catheter to an outlet port located closer to the distal end than the proximal end of the catheter. By shortening the length of the guide wire lumen, the length of the guide wire outside the patient's body can also be shortened.

【0006】

Rapid exchange catheters have become widespread and have been found to be particularly useful as stented catheters. Indwelling stented catheters are usually used after the first angioplasty. In such cases, the angioplasty catheter is removed and replaced with an indwelling stent catheter. The use of an angioplasty catheter with a rapid replacement design facilitates removal of the angioplasty catheter with a short guide wire. Similarly, the use of an indwelling stented catheter with a rapid replacement design facilitates the introduction of the catheter over a guidewire that remains indwelling in the patient's body.

【0007】

Although rapid exchange catheters are widely accepted, they also have a number of limitations. In particular, the short guidewire lumen impairs the "easiness of pushing" of the catheter.

【0008】

A second problem with the use of rapid replacement catheters is the inability to replace or reintroduce guidewires into short guidewire lumens.

【0009】

For these reasons, it would be desirable to provide improved instruments, methods, and kits that allow catheters and catheter parts to be replaced on short guide wires. In particular, a catheter component that is more "easy to push" when introduced into a blood vessel and allows catheter removal on a short guidewire and / or on a catheter body placed on the guidewire. It would be desirable to provide improved angioplasty balloon catheters and other catheters that can be replaced. At least some of these objects are achieved by the invention described in the claims described later herein.

[Disclosure of Invention]

【0010】

Outline of the Invention The present invention is directed to an in-vivo device and a method of using the device, and more specifically, an intraluminal device such as a catheter including a balloon catheter. The instruments of the present invention can be used for diagnostic and / or therapeutic applications. The present invention is suitable for treating different conditions at different locations in the patient's body, such as the patient's blood vessels. Specifically, the instruments of the present invention can be used in virtually any therapeutic modality based on techniques such as, but not limited to, balloon dilation (particularly angioplasty), stent placement, etc. within blood vessels of the patient's heart, periphery, and brain regions. Can be used.

【0011】

As used herein, the term "intracorporeal body" means a lumen in the body or tissues and organs in the body. The lumen in the body can be any blood vessel in the patient's vasculature, including veins, arteries, aortas, and especially coronary and peripheral arteries, or previously placed grafts, shunts, fistulas, and the like. You may. The present invention may also be used in other body cavities, such as the bile duct, where neoplastic excess cell proliferation can occur, which is believed to be understood. Examples of tissues and organs in the body include various organs, nerves, glands, ducts and the like.

【0012】

In one embodiment, the intravascular catheter of the present invention comprises a therapeutic or diagnostic structure. In one embodiment, the therapeutic or diagnostic structure is a balloon structure. Hereinafter, various features and aspects of the present invention will be further described with respect to the balloon catheter, but this does not limit the scope of the present invention.

【0013】

In one embodiment, the instruments of the invention are placed on an elongated catheter shaft having proximal and distal ends, proximal and distal portions, and the distal portion of the elongated shaft, wherein the device is sealed. An intravascular catheter that includes a diagnostic or therapeutic structure, such as an expandable component, such as a fixed inflatable component (eg, a balloon). At least one lumen, such as an inflated lumen, extends along at least a portion of the catheter shaft. In some embodiments, the inflatable lumen terminates proximally to the distal end of the catheter shaft and is in fluid contact with the inside of the balloon. The catheter shaft may be an integral structure or may be formed of a plurality of portions capable of fluid connection in the longitudinal direction.

【0014】

In one embodiment, the catheter shaft is an elongated component receiving lumen extending along at least a portion of the shaft having a proximal end and a distal end, a tubular body, a guide wire, or a guide disposed within the tubular body. It further includes an elongated component receiving lumen such that the wire or the like is slidably and detachably received or received on them. In one embodiment, the elongated component receiving lumen extends to the distal port at the distal end of the shaft. The proximal end of the elongated component receiving lumen may be located along the length of the catheter shaft, such as the proximal end of the catheter shaft; with respect to the proximal end of the catheter shaft. Distal and substantially closer to the proximal end of the shaft than the distal end of the shaft; distal to the proximal end of the catheter shaft, from the proximal and distal ends of the shaft Positions where the distances are substantially equal; such as, but not limited to, positions distal to the proximal end of the catheter shaft and proximal to the proximal end of the balloon. The multiple lumens of the catheter shaft may be formed as a single double lumen catheter body or as separate tubular parts with lumens therein.

【0015】

An elongated component receiving lumen includes an access having a proximal end and a distal end over at least a portion of its entire length. At least a portion of the interior of the elongated component receiving lumen can be fluidly connected to the exterior of the catheter shaft by access. The access may further have a lateral end extending in the longitudinal direction. The lateral edges of the access may overlap or be adjacent to each other, or may be spaced apart. In one embodiment, the lateral end is flexible enough to allow the elongated component to be inserted into and / or removed from the elongated component receiving lumen. In one embodiment, the catheter shaft along at least the lateral end allows the lateral end to return to a contracted state after the elongated component has been inserted into and / or removed from the elongated component receiving lumen. It is made of a flexible material with elasticity. If there is a gap between the lateral ends, the spacing is large enough to allow access of the elongated component (eg, tubular component or guidewire) to and from the elongated component receiving lumen, and in addition. Small enough to minimize unintentional escape of elongated parts from the elongated component lumen.

【0016】

The proximal end of the access may coincide with the proximal end of the elongated component receiving lumen or may be located distal to the proximal end of the elongated component receiving lumen. The position distal to the proximal end of the elongated component receiving lumen is distal to the proximal end of the elongated component receiving lumen and is substantially closer to the proximal end of the shaft than the distal end of the shaft. Close position; distal to the proximal end of the elongated component receiving lumen and substantially equal in distance from the proximal and distal ends of the shaft; distal to the proximal end of the elongated component receiving lumen There are positions that are on the side and proximal to the proximal end of the balloon, but are not limited to these.

【0017】

The distal end of access may be at any location between the proximal end of access and the inside of the balloon, usually in close proximity to the proximal end of the balloon.

【0018】

The access may include a single contiguous access, or may include a plurality of intermittent accesses along the overall length of the elongated component receiving lumen. In one embodiment, the access comprises a continuous access extending from the first end to the distal end of the access.

【0019】

Alternatively, a selective flexible tubular component, such as a sleeve that may form integrally with the balloon or exist as a separate component, extends proximally from the balloon along at least a portion of the distal portion of the catheter shaft. You may be. In one embodiment, the sleeve is attached to the catheter shaft.

【0020】

In one embodiment, the hypotube may extend along at least a portion of the elongated component receiving lumen to further enhance the ease of pushing the instrument of the invention.

【0021】

The dimensional characteristics of the instruments included within the scope of the present invention may vary depending on the target site in the body and the intended clinical use.

【0022】

In one embodiment, the elongated parts (eg, guide wires) may be, at least in part, placed within the elongated component receiving lumen during the procedure. By arranging the slender parts (eg, guide wires placed within the lumens of the tubular parts) inside the slender part receiving lumens, the pushing strength required for improved advancement of the slender parts in the body is obtained. This also helps reduce buckling of the shaft.

【0023】

In one embodiment, the elongated component is a tubular component having a lumen for receiving another elongated component, such as a guide wire. The cross section of the catheter may be of any suitable shape, including circular, oval, or oval.

【0024】

The distal end of one or both of the catheter shaft and the elongated component is preferably at least 3 mm, typically at least 0.5 mm, preferably at least 0.5 mm, to facilitate manipulation as it passes through the meandering portion of the body part. It has an axial taper over a length of at least 0.1 mm. The elongated component may also have a non-injurious distal end.

【0025】

The instruments of the present invention may be used independently or as an assembly. Optionally, the assembly may be an assembly assembly further comprising at least a second therapeutic or diagnostic instrument. As an example, when available as an assembly, instruments such as balloon catheters are usually pre-mounted on elongated parts (eg, guidewires, tubulars, guidewires within the tubular body) and the assembly is sterilized as a complete unit. It will be packaged. A second therapeutic or diagnostic structure, such as a second balloon catheter, may have an elongated component receiving lumen that is receptible on the elongated component by sliding. The second balloon catheter may be included with the first balloon catheter and elongated component as part of a single assembly assembly, or as a separate package for use with the assembly or elongated component of the invention. It may be available.

【0026】

Typically, a second balloon catheter has some aspect, such as dimensions such as diameter, length, or both; shape; balloon material; balloon properties such as compliance, flexibility, elasticity; or other features. Is different from the first balloon catheter. In one embodiment, at least one of the balloon catheters, usually a second catheter, may carry a stent or other vascular prosthesis. Although not required, the first balloon catheter is usually used for the purpose of performing angioplasty or other therapeutic or diagnostic procedures, and the second balloon catheter is to carry the stent after angioplasty. Used for purposes. Other examples include drug infusion balloon catheters, radioactive material delivery balloon catheters, and porridge resection catheters. Of course, an endovascular catheter assembly containing only a single balloon catheter may be adapted for stent delivery, drug infusion balloons, radioactive material delivery balloons, and the like.

【0027】

In one embodiment, the intravascular catheter and / or assembly of the present invention may further have an embolic capture component that can be deployed on one or both of the elongated component and the balloon catheter. The deployable embolic capture component may include coils, wires, braids, meshes and the like, and may have various shapes such as funnel-shaped or parachute-shaped. Preferably, the embolic capture component is made of a material such as nickel titanium alloy (such as Nitinol alloy), spring stainless steel, and may be further coated or encapsulated with a polymeric material. A deployable embolic capture component filters and / or aspirates any embolus (which may occlude the internal lumen) before, during, and / or after treatment with an endovascular catheter. Will be possible. Embolic filters typically have tiny holes that are about 1 micron (μm) to about 200 μm, typically about 1 μm to about 100 microns, to recover the embolus. The embolic filter may be at least partially opened and closed by a balloon structure or axial or radial movement of the catheter body.

【0028】

In another aspect, the intravascular catheter and / or assembly of the present invention further comprises a second inflatable balloon configured to be distal to the first balloon catheter on an elongated component. May be good. The dimensions, properties, and forming material of the second balloon may be similar to those of the first balloon described above. The second balloon may also carry a vascular prosthesis that can be deployed by the balloon. In some cases, the first balloon is used for angioplasty or other therapeutic or diagnostic procedure, and the second balloon is used to deliver a stent (a balloon-deployable stent) after angioplasty. You may. Therefore, such an embodiment is suitable for performing continuous treatment with a single catheter structure.

【0029】

In another aspect, the intravascular catheter of the present invention may have a self-expanding vascular prosthesis on an elongated component. The self-expanding vascular prosthesis may be made of steel, nickel titanium, shape memory alloys, cobalt, composites and the like. Typically, self-deploying vascular prostheses are at least partially deployed by axial or radial movement of the first balloon catheter and / or elongated component.

【0030】

In one exemplary method embodying the features of the invention, a guide catheter is inserted into the coronary artery in a conventional manner. Instruments of the invention, such as balloon catheters, are prepared to be inserted into a guide catheter in a conventional manner. An elongated component, such as a guide wire, is then introduced into the catheter by a back loading operation. The proximal end of the guide wire is inserted reversely through the elongated component receiving lumen into the distal tip at the distal end of the catheter. Hold the distal end of the balloon catheter with one hand and advance the guide wire in the opposite direction to advance the guide wire in the opposite direction. The guide wire may be advanced toward the proximal end of the catheter either inside or outside the elongated component receiving lumen. However, preferably during the advance towards the proximal end, the guide wire is maintained within the elongated component receiving lumen. Advance the guidewire proximally until at least a portion of the distal end of the guidewire with a flexible or flexible tip protrudes from the distal end of the catheter.

【0031】

Next, with the flexible tip of the guide wire protruding, the distal end of the catheter is slid into the guide catheter previously placed in the patient. The catheter with the guide wire in the elongated component receiving lumen is grasped between the fingers of one hand and advanced in the guide catheter. Continue this procedure until most of the catheter is inside the guide catheter. During this distal advance, the inclusion of a guide wire in the catheter's elongated component receiving lumen improves the ease of pushing the catheter.

【0032】

In one embodiment, the distal end of the guidewire holds the catheter with the guidewire in the elongated component receiving lumen of the catheter in a stable manner with the fingers of one hand and attempts to open or dilate the stenosis. Advance distally until a therapeutic or diagnostic site, such as a balloon, has passed through and reaches the desired lesion. Since at least most of the guide wire and the catheter are advanced together, the ease of pushing the balloon dilatation catheter forward to the constricted area is greatly improved. In other words, if the opening of the stenosis or lesion is very small, it is possible to apply more force to the balloon to allow it to pass through.

【0033】

Alternatively, if desired, the proximal end of the guide wire may be located outside the elongated component receiving lumen of the catheter and the ToruCa may be attached to the guide wire near the proximal end of the guide wire. The guide wire is then advanced beyond the catheter until it enters the patient's artery. While holding the catheter with the guide wire housed in the elongated component receiving lumen stably with the fingers of one hand, advance the guide wire to the position distal to the distal end of the catheter. The placement of the guide wire in the desired artery can be observed by a fluoroscope using X-ray techniques well known to those skilled in the art. As is well known to those of skill in the art, to facilitate the placement of the flexible tip within the desired artery so that the distal end of the guidewire can be advanced into the stenotic site to be opened or dilated. A toruca for rotating the guide wire may be used. When the guidewire reaches the desired position, immediately hold the proximal end of the exposed guidewire stationary with two fingers of one hand and immediately place a therapeutic or diagnostic part, such as a balloon, on the desired lesion. Advance the catheter on the guide wire until it reaches the site. If the balloon resists the passage of the lesion or stenosis and the operator finds it difficult to introduce the catheter, the guide wire may be pulled back slightly. The operator may then use a fluoroscope to confirm that the tip of the guide wire is swaying in the bloodstream (indicating that the tip of the guidewire is free to move in the bloodstream). The surgeon may then grasp both the guidewire and the catheter with one hand and move them forward together so that they pass through the stenosis site together.

【0034】

After the balloon has passed through the stenosis or lesion, the balloon may be inflated in a conventional manner by introducing an X-ray opaque contrast medium through the inflatable lumen of the catheter. Once the swelling has occurred and the desired procedure has been completed by dilating the opening in the stenosis, the operator grasps the proximal end of the guidewire outside the catheter's elongated component receiving lumen with two fingers. This allows the catheter to be removed quickly (if you are using ToruCa, you may remove it before this step).

【0035】

When the catheter is withdrawn proximally from the guide catheter, more proximal ends of the guide wire are removed from the catheter's elongated component receiving lumen. If desired, the rest of the catheter may be removed from the guide catheter until the distal end of the catheter passes the proximal end of the guide wire. At this time, if desired, a second catheter (for example, a second balloon catheter, a second catheter carrying a deployable prosthesis such as a stent) is provided at the distal tip of the elongated component receiving lumen of the second catheter. It may be loaded in the reverse direction on the guide wire by introducing the proximal end of the guide wire into the guide wire. In one embodiment, the second catheter is a catheter that embodies the features of the present invention. In this case, preferably, the elongated component receiving lumen of the second catheter may be advanced distally on the guide wire while maintaining most of the overall length of the guide wire within the elongated component receiving lumen of the second catheter. Good.

【0036】

The second catheter and preferably the guide wire substantially housed within the elongated component receiving lumen of the second catheter may be advanced to the desired position as described above.

【0037】

The catheter embodying the features of the instrument of the invention may be a type of catheter other than the balloon dilation catheter and the stent deployment catheter, the features of the invention may require advancing on another elongated component, etc. May be incorporated into the design and use of catheters. This should be understood.

【0038】

Detailed Description of the Invention In FIGS. 1-4, the features of the invention are embodied, a catheter shaft with a flexible tubular shaft 17, a proximal end 19, a distal tip 23, a distal end 22, a proximal. The features of the intravascular catheter assembly 10 generally include an intravascular catheter 13 including a catheter shaft 16 having a portion 25, a distal portion 28, and a lumen 31 extending along at least a portion of the catheter shaft. At least one lumen that terminates proximally to the distal end 22 of the catheter shaft 16, such as the inflating lumen 34, extends along at least a portion of the catheter shaft. In the embodiment shown in the figure, the catheter shaft further comprises a second lumen 37 for receiving an elongated component 40 such as a guide wire 42, a tubular body 43 having a lumen 44, or a tubular body 43 having a guide wire 42 therein. Including. The proximal end of the catheter shaft may have only the inflating lumen 34 as shown in the exemplary embodiments of FIGS. 2P1-4, or the inflating lumen and the elongated component receiving lumen 37 as shown in FIG. 2P5. And may have. The catheter shaft elongated component receiving lumen 37, at least along a portion thereof, may be formed by a tubular body 46 disposed within the catheter shaft lumen 31 as shown in FIG. 3 and the corresponding cross-sectional view. Good. Alternatively, the expansion lumen 34 and the elongated component receiving lumen 37 may be formed by a flexible tubular shaft 17 having an integral double lumen structure, for example by extrusion molding, as shown in FIG. It should be understood that the flexible tubular shaft and / or its lumens may be formed by a single longitudinally extending structure or by multiple longitudinally extending fluid-connected lumens. Is. Inflatable with inflatable inner 58 in between the proximal end 52 and the distal end 55 and in fluid contact with the inflatable lumen 34A Noh balloon 49 is placed in the distal portion 28 of the catheter shaft. The distal tip 23 may be tapered to facilitate follow-up in the intravascular pathway. The distal tip 23 may be formed integrally with other parts of the catheter shaft 17, or may be formed separately and attached by adhesive, thermal fusion, or other means. In some cases, the distal tip 23 may be made of a particularly soft material to enhance non-injury of catheterization.

【0039】

As shown in FIG. 1, a part of the intravascular catheter 13 of the present invention is arranged in the guide catheter 61. As shown in the figure, the catheter assembly 10 includes a luer fitting 63 attached to the proximal end 66 of the catheter shaft 16 and is a syringe or other type for introducing an X-ray contrast agent into the catheter shaft 16. Fitted to connect appliances. For the sake of clarity, it is understood that not all assembly components that can be used with the devices of the invention for expansion, stent delivery systems, or other applications are shown. Should be.

【0040】

As shown in FIG. 3, in one embodiment, the flexible tubular part 69, such as the sleeve 72, extends distally from the proximal end 52 of the balloon to form a liquidtight seal with the flexible tubular shaft 17. Then, the inflating lumen 75 of the balloon creates a fluid contact between the inflating lumen 34 and the inside 58 of the balloon. Alternatively, the flexible tubular part 69 may be integrally formed with the balloon 49 as shown in FIG. 3S2, or may simply be an extension of the proximal shaft of the balloon. The flexible tubular shaft 17 may extend with the flexible tubular component 69 to form a butt joint. Alternatively, as shown in FIG. 3S3, the flexible tubular part 69 may form an overlap joint with the flexible tubular shaft 17.

【0041】

The flexible tubular shaft 17 is longitudinal for sliding and guiding the elongated component 40 along at least a portion of the catheter shaft 16 (more specifically, within at least a portion of the elongated component receiving lumen 37). It has access 78, such as directional access 81, along at least a portion of its tubular shaft.

【0042】

Access 78 is located close to the proximal end of the flexible tubular part 69, or proximal to the flexible tubular part 69, respectively, as shown in FIGS. 3 and 6, respectively. It may extend distally to a position proximal to the inside of the balloon or its proximal end, such as.

【0043】

Access 78 may extend proximally to any position along the length of the catheter shaft 17, such as the proximal end of the flexible tubular shaft 17; Positions that are substantially proximal to the distal end of the catheter shaft relative to the distance from the proximal end; positions that are substantially equidistant from the proximal and distal ends of the catheter shaft; equidistant Positions that are distal to the position and proximal to the inside of the balloon; or any other position between the proximal end of the catheter shaft and the inside of the balloon, but are not limited to these. Absent.

【0044】

3P1-2 and P1-2 show some of the catheters that embody the features of the invention with access 78. These drawings show any portion of the catheter having access in the longitudinal direction.

【0045】

As shown in FIGS. 7 and 8, and the cross-sectional view, the access 78 may be continuous or consists of a plurality of intermittent access portions 84 longitudinally separated by non-access portions 87. You may. In one embodiment, the access 78 comprises a continuous access portion 87 over the entire length of its proximal portion and guides an elongated component including a guide wire 42, a tubular body 43, or a tubular body that houses the guide wire 42. It functions as an access area for. In one embodiment, the access 78 comprises a single continuous access portion 87 over its entire length.

【0046】

Access 78 may further include lateral edges such as lateral edges 90 and 93 extending longitudinally. The lateral ends may overlap or be adjacent to each other, or may be spaced apart. 9T1-9T3 and 9A1-9A5 are exemplary embodiments characterized by access and lateral edges. In one embodiment, the lateral ends 90 and 93 are flexible enough to allow the elongated component 40 to be inserted into and / or removed from the elongated component receiving lumen 37. In one embodiment, along at least the lateral end of the catheter shaft so that the lateral end can return to a contracted state after the elongated component is inserted into and / or removed from the elongated component receiving lumen. The portion is formed of an elastic flexible material. If there is a gap between the lateral ends, the spacing is large enough to allow access to and from the slender part receiving lumen of the slender part (eg, tubular part or guidewire), and even more slender parts. Small enough to minimize unintentional escape from the elongated component receiving lumen. The spacing between the lateral ends may be substantially the same size as each other, or may be axially different, for example increasing or decreasing towards the distal side.

【0047】

In one embodiment characterized in FIG. 10 and the corresponding cross-sectional view, the catheter shaft 16 spans at least a portion of its overall length and, more specifically, at least one of its lumens (usually an elongated component receiving lumen). It may further have a stiffening component including a hypotube 84, which covers at least a part of 37). The hypotube 84 may extend towards the proximal end of the flexible tubular part 69 and is proximal to the inside of the balloon, such as at or near the flexible tubular part 69. It may extend distally towards the position. The hypotube 84 may extend proximally to any position along the length of the catheter shaft 17, such as the proximal end of the flexible tubular shaft 17; the catheter shaft. Positions that are substantially proximal to the distal end of the catheter shaft relative to the distance from the proximal end of the catheter shaft; positions that are substantially equidistant from the proximal and distal ends of the catheter shaft; etc. There are, but are not limited to, positions distal to the distance position and proximal to the inside of the balloon; or any other position in between.

【0048】

The hypotube 84 may be placed in the flexible tubular shaft 17 by inserting it into the elongated component receiving lumen 37. Optionally, the hypotube 84 may be attached to the surface of the lumen 37 over at least a portion of its overall length. In one embodiment characterized by FIGS. 10M1-10M4, a hypotube 84 having longitudinal access over at least a portion of its overall length is inserted into the lumen 31 of a flexible tubular shaft 17 followed by flexibility. An elongated component receiving lumen 37 may be formed between the lateral ends of the access by deforming (eg, crimping) the sex tubular shaft 17 to fit the outer surface of the hypotube 84. The hypotube 84 may be further attached to the flexible tubular shaft 17 by appropriate means, such as adhesive 99, over at least a portion thereof.

【0049】

Hypotubes may be made of any suitable material, such as metals and / or metal alloys, polymers, or combinations thereof (stainless steel, nickel titanium alloys (eg Nitinol alloys), etc.). Or a combination of them, etc.). The hypotube may be further coated or encapsulated with a polymeric material. Other examples include hypotubes made of composites and / or polymers with different longitudinal compositional distributions.

【0050】

The dimensions of the catheter of the present invention are selected to fit a particular target site within the body part to be treated, especially within a blood vessel. Usually, when used for the treatment of coronary arteries and veins, the longitudinal dimension of the catheter shaft 16 is about 10 cm to about 200 cm, usually about 50 cm to about 200 cm, typically about 125 cm. ~ About 150 cm.

【0051】

The length of the balloon or other inflatable structure is generally shorter than the length of the sleeve, usually much shorter than the length of the sleeve, typically about 4 to about 60 mm, usually about 10 to about. It is 50 mm, typically about 20 to about 40 mm, and the effective length of the balloon is about 5 to about 40 mm.

【0052】

The length of the inflatable lumen 34 is usually about the same as the length of the catheter shaft, excluding the length of the catheter shaft distal to the end point of the inflatable lumen inside the balloon, usually about 10 cm ~ It is about 150 cm.

【0053】

The length of the elongated component receiving lumen 37 may generally be from about 1 cm to about 200 cm, usually from about 1 cm to about 150 cm, and typically from about 10 cm to about 150 cm.

【0054】

The size of the elongated component receiving lumen 37 is suitable for accommodating elongated components such as the guide wire 42 and the tubular component 43. The inner diameter of the elongated component receiving lumen 37 is typically about 0.0145 inches (0.368 mm) to 0.03 inches (0.762 mm), preferably about 0.016 inches (0.406 mm) to about 0.02 inches (0.512 mm).

【0055】

The diameter of the guide wire is typically about 0.006 inch (0.15 mm) or about 0.008 inch (0.20 mm) to about 0.035 inch (0.89 mm). The diameter of the guidewire lumen is typically 0.2 mm to 2 mm, usually 0.4 mm to 0.6 mm. In embodiments where the tubular body 43 is used, the outer and inner diameters of the tubular component can be placed within the elongated component receiving lumen 37 and set to accept the guide wire 42.

【0056】

The longitudinal dimension of the access 81 may be substantially equal to the length of the flexible tubular shaft, excluding the length from the distal end of the flexible tubular shaft 17 to the distal end of the access. .. In one embodiment, the longitudinal dimensions of the access 81 are such that the distance from the proximal end of the flexible tubular shaft 17 to the proximal and distal ends of the flexible tubular shaft is substantially equal. It becomes even shorter on the proximal side by the distance to. In this case, the equidistant position defines the proximal end of the access. Alternatively, the longitudinal dimension of Access 81 extends from the proximal end of the flexible tubular shaft 17 to a position closer to the distal end of the flexible tubular shaft than the proximal end of the flexible tubular shaft. It becomes even shorter on the proximal side by the distance of.

【0057】

The length of the portion of the catheter shaft, extending from the distal end of the catheter shaft to the most distal position of access of the elongated component receiving lumen 37, can be from about 3 cm to about 50 cm, usually about 4 cm. It is ~ about 40 cm, typically about 5 cm ~ about 25 cm.

【0058】

Typically, the spacing between the lateral ends of the access is set to be suitable for guiding the elongated component 40 to and from the elongated component receiving lumen 37, which may be from about 0.01 inch to about 0.1 inch. , Usually about 0.001 inch to about 0.014 inch.

【0059】

Catheter and tubular body may be formed of polymer material, composite material, braid material, metal material, or a combination thereof. Typically, the tubular body is formed by extrusion of a polymeric resin. Suitable resin materials include polyamide (nylon), polyimide, polyvinyl chloride, PEBAX, PTFE and the like. Optionally, the catheter body may be selectively reinforced with braids, coils, filaments, or other materials to improve pushability and / or reduce wall thickness.

【0060】

In an exemplary method embodying the features of the present invention, the guide catheter 61 is inserted into the coronary artery in a conventional manner. The instrument of the invention, such as a balloon catheter, is prepared to be inserted into the guide catheter 61 in a conventional manner. Next, the elongated component 40 such as the guide wire 42 is introduced into the catheter 13 by a reverse loading operation. The proximal end of the guide wire 42 is inserted reversely through the elongated component receiving lumen 37 into the distal tip at the distal end of the catheter. Hold the distal end of the balloon catheter with one hand and advance the guide wire in the opposite direction. The guide wire may be advanced toward the proximal end of the catheter either inside or outside the elongated component receiving lumen, but preferably during this advance towards the proximal end, the guide wire is an elongated component. Maintained within the receiving lumen. Advance the guidewire proximally until at least a portion of the distal end of the guidewire with a flexible or flexible tip protrudes from the distal end of the catheter.

【0061】

Next, with the flexible tip of the guide wire protruding, the distal end of the catheter 13 is slid into the guide catheter 61 previously placed in the patient. The catheter 13 with the guide wire in the elongated component receiving lumen is grasped between the fingers of one hand, and the inside of the guide catheter is advanced. Continue this procedure until most of the catheter is inside the guide catheter. During this distal advance, the inclusion of a guide wire in the catheter's elongated component receiving lumen improves the ease of pushing the catheter.

【0062】

In one embodiment, the distal end of the guidewire holds the catheter with the guidewire in the elongated component receiving lumen of the catheter in a stable manner with the fingers of one hand and attempts to open or dilate the stenosis. Advance distally until a therapeutic or diagnostic site, such as a balloon 49, passes through and reaches the desired lesion. Since the guidewire and catheter are advanced together, at least in large part, the ease of pushing through the balloon dilatation catheter through the stenosis site is greatly improved. In other words, if the opening of the stenosis or lesion is very small, it is possible to apply more force to the balloon to allow it to pass through.

【0063】

Alternatively, if desired, the proximal end of the guide wire may be located outside the elongated component receiving lumen of the catheter and the ToruCa may be attached near the proximal end of the guide wire. The guide wire is then advanced beyond the catheter until it enters the patient's artery. While the catheter with the guide wire housed in the elongated component receiving lumen is stably held by the fingers of one hand, the guide wire is advanced to the end of the distal end of the catheter. The entry of the guide wire into the desired artery can be observed by a fluoroscope using an X-ray technique well known to those skilled in the art. As is well known to those of skill in the art, to facilitate the placement of the flexible tip within the desired artery so that the distal end of the guidewire can be advanced to the site of stenosis that is to be opened or dilated. A toruca for rotating the guide wire may be used. When the guidewire reaches the desired position, immediately hold the proximal end of the exposed guidewire stationary with two fingers of one hand and immediately place a therapeutic or diagnostic part, such as a balloon, on the desired lesion. Advance the catheter on the guide wire until it reaches the site. If the balloon resists the passage of the lesion or stenosis and the operator finds it difficult to introduce the catheter, the guide wire may be pulled back slightly. The operator may then use a fluoroscope to confirm that the tip of the guide wire is swaying in the bloodstream (indicating that the tip of the guidewire is free to move in the bloodstream). The surgeon may then grasp both the guidewire and the catheter with one hand and move them forward together so that they pass through the stenosis site together.

【0064】

After the balloon has passed through the stenosis or lesion, the balloon may be inflated in a conventional manner by introducing an X-ray opaque contrast medium into the inflatable lumen 34 of the catheter. Once the swelling has occurred and the desired procedure has been completed by dilating the opening in the stenosis, the operator uses two fingers to squeeze the proximal end of the guidewire out of the catheter's elongated component receiving lumen 37. The catheter can be removed quickly by grasping (if using ToruCa, the ToruCa may be removed before this stage).

【0065】

When the catheter is withdrawn proximally from the guide catheter, more proximal ends of the guide wire are removed from the catheter's elongated component receiving lumen. If desired, the rest of the catheter may be removed from the guide catheter until the distal end of the catheter passes the proximal end of the guide wire. At this time, if desired, a second catheter (for example, a second balloon catheter, a second catheter carrying a deployable prosthesis such as a stent) is placed distal to the elongated component receiving lumen of the second catheter. It may be loaded in the reverse direction on the guide wire by introducing the proximal end of the guide wire at the tip. In one embodiment, the second catheter is a catheter that embodies the features of the present invention. In this case, preferably, the elongated component receiving lumen of the second catheter may be advanced distally on the guide wire while maintaining most of the overall length of the guide wire within the elongated component receiving lumen of the second catheter. Good.

【0066】

The second catheter and preferably the guide wire substantially housed within the elongated component receiving lumen of the second catheter may be advanced to the desired position as described above.

【0067】

Catheter embodying the features of the instruments of the invention may be of any type other than balloon dilatation catheters and stent deployment catheters, these features of other catheters that may need to be advanced on another elongated component. It should be understood that it may be incorporated into design and use.

【0068】

Although specific aspects and methods have been disclosed herein, various modifications and modifications can be made to these aspects and methods without departing from the spirit and scope of the invention, which is described above. It seems to be obvious to those skilled in the art. Therefore, the above description and drawings should not be considered as limiting the scope of the invention as defined by the appended claims.

[Simple explanation of drawings]

【0069】

FIG. 1 is a partially cut elevation view of a balloon catheter assembly embodying the features of the present invention.

2P1-5 are cross-sectional views showing some of the other aspects of the catheter that embody the features of the invention, having proximal portions.

FIG. 3 is a partially cut-out elevation view of a balloon catheter embodying the features of the present invention. 3A1 to 3A4 are cross-sectional views of various aspects of the balloon catheter of FIG. 3 as viewed from line AA. 3S1 to 3S3 are cross-sectional views of various aspects of the balloon catheter of FIG. 3 as viewed from line SS. FIG. 3B is a cross-sectional view of one aspect of the balloon catheter of FIG. 3 as viewed from line BB. 3P1 and 3P2 are partially cut-out perspective views showing various aspects of the catheter of FIG.

4D1-4D3 are partially cut-out elevations showing another aspect of the distal portion near the proximal end of a balloon catheter that embodies the features of the present invention.

FIG. 5 is a partially cut elevation view showing another aspect of the catheter of FIG. 5A1 and 5A2 are cross-sectional views of various aspects of the balloon catheter of FIG. 5 as viewed from line AA. 5S1 to 5S3 are cross-sectional views of various aspects of the balloon catheter of FIG. 5 as viewed from line SS. FIG. 5B is a cross-sectional view of one aspect of the balloon catheter of FIG. 5 as viewed from line BB. 5P1 and 5P2 are partially cut-out perspective views showing various aspects of the catheter of FIG.

FIG. 6 is a partially cut elevation view showing another aspect of the catheter of FIG. 6A, 6Z, 6S, and 6B are cross-sectional views of the aspects of the balloon catheter of FIG. 6 as viewed from lines AA, ZZ, SS, and BB, respectively.

FIG. 7 is a partially cut elevation view showing another aspect of the catheter of FIG. 7A, 7N1 and 7N2 are cross-sectional views of the various aspects of the balloon catheter of FIG. 7 as viewed from lines AA and NN, respectively. FIG. 7P is a partially cut-out perspective view of the catheter of FIG.

FIG. 8 is a partially cut elevation view showing another aspect of the catheter of FIG. 8A, 8N, and 8S are cross-sectional views of the various aspects of the balloon catheter of FIG. 8 as viewed from lines AA, NN, and SS, respectively.

9A1-9A5 are cross-sectional views showing another aspect of the catheter of FIG. 3 having various access lateral ends. 9T1-9T3 are partially cut-out top views showing another aspect of the catheter of FIG.

FIG. 10 is a partially cut-out elevation view showing another aspect of the catheter of FIG. 3 with a hypotube placed therein. 10H, 10N1-10N3, 10A1-10A2, and 10S1-10S2 are cross-sectional views of the balloon catheter aspects of FIG. 10 as viewed from lines HH, NN, AA, and SS, respectively. 10M1 to 10M4 are cross-sectional views showing how to make the catheter of FIG. 10 containing a hypotube.