JPH05502813A - Expansion balloon catheter and its manufacturing method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] DILATION BALLOON CATHETER AND METHOD FOR MANUFACTURING THE SAME FIELD OF THE INVENTION The present invention relates to the field of angioplasty. It is something. In particular, the present invention relates to dilatation balloon catheters.

2. Description of conventional technology Angioplasty has recently become an efficient and effective method to treat various vascular diseases. , has been widely adopted. In particular, angioplasty is used to treat stenosis in other parts of the vascular system. It is also widely used to open stenoses in coronary arteries.

The most widespread (the form of angioplasty used is dilatation with a dilatation balloon at its distal end) It uses a catheter. Using fluoroscopy, doctors can see that the balloon is The catheter is guided through the arterial system until positioned at the stenosis site. next, Inflate the balloon by supplying pressurized fluid to the balloon through the inflation lumen. let The inflation of this balloon stretches the artery and pushes the diseased area into the artery wall. , allowing acceptable blood flow through the artery to be recanalized.

Two commonly used types of dilation catheters are "over-the-wire" and "non-over-the-wire" catheters. over· The wire catheter provides a separate guidewire lumen and guidewire - to open a passage through the stenosis. Next, attach the dilatation catheter to the valve. advance over the guide wire until the tube is positioned at the stenosis site. Non-O The bar-the-wire catheter itself functions as a guidewire, Therefore, a separate guidewire lumen is not required. Therefore, non-oats- ・The Wire Catheter eliminates the need for a guide wire lumen, resulting in its main system being It becomes possible to further reduce the outer diameter of the shaft.

It is difficult for a catheter to not only reach, but also cross a very narrow stenosis. Continuous reduction of dilation catheter profile and shaft dimensions to allow Efforts are being made. In addition, in order to be a good dilation catheter, especially curved Must be sufficiently flexible to pass through narrow bends within the coronary arteries . Another condition for a good dilation catheter is its "bush characteristic" . This involves transmitting a longitudinal force along the catheter from its proximal end to its distal end. to help the doctor push the catheter through the blood system and across the stenosis. It includes tolerating.

Summary of the invention The present invention provides a shaft with a small outer diameter, flexibility, and sufficient torque response and A non-over-the-wire product that has bush characteristics and is relatively easy to manufacture. This invention relates to a dilation catheter.

One embodiment of a catheter of the invention includes a hollow tube formed by a tubular wall defining a lumen. It comprises a unitary flexible elongated tube having a proximal end and a distal end. end of reading tube has a tapered portion whose diameter is equal to or greater than the first diameter of the tube. It becomes narrower from the first diameter to the second diameter smaller than the first diameter. The lumen has a tapered part. It terminates at the distal end, and a substantially solid terminal core is formed near the distal end of the tapered portion. be done. An inflatable balloon section circumscribes the tube and is adjacent to the tapered section. a proximal end that is adhered to the tube and a distal end that is adjacent to the solid portion and is attached to the tube. ing. The interior of the balloon portion has at least one hole extending through the tubular wall. It communicates with the lumen through.

It is desired that the tip of the flexible coil spring extends distally from the tube and balloon portion. Delicious. The end of the tube is tapered with a safety wire that extends inside the coil spring. and is attached to the end cap of the coil spring. In a preferred embodiment The reading tube is made of stainless steel hypodermic tube, and the non-narrowed part near the proximal end is moistened. Covered with slippery material.

In another embodiment, the reading tube is formed from semi-rigid plastic tubing. at the end The reading tube extends from the first diameter to a smaller second diameter formed around the metal core wire. It has a tapered portion that tapers to the distal end of the diameter. the end The portion has a generally solid cross section. Metal core wire is tapered extending outwardly from the distal portion to define a safety wire, the safety wire extending outwardly from the distal end portion; extends within the coil spring and is attached to the end cap of the coil spring.

The catheter of the present invention has a lumen formed from an elongated tube having a proximal portion and a distal portion. forming a tapered portion at the distal end of the tube such that the cross-sectional diameter of the tube tapers toward the distal end; terminating in a lumen, made of metal or plastic; Forms a generally solid terminal core of plastic formed around the core wire attaching an inflatable balloon to the distal end of the tube; Secure the end to the tube near the proximal end of the hole, and secure the distal end of the balloon section to the solid distal core. It is relatively easily manufactured by a method comprising the steps of:

The cross-sectional diameter of the distal core wire is further reduced to define the distal safety wire portion of the tube. It is desirable to do so. If the tube is a semi-rigid plastic tube, metal core wire - reduces its cross-sectional diameter and forms the safety wire section of the metal core wire.

The coil spring is fixed to the terminal core wire, and the spring is centered around the terminal safety wire. Extends distally from the rune. Next, attach the end of the terminal safety wire section to the coil. Attach to the end cap at the top.

Brief description of the drawing Fig. 1 is an overall view of the angioplasty balloon catheter according to the present invention, and Fig. 2 is a general view of the angioplasty balloon catheter according to the present invention. a detailed cross-sectional view of the distal portion of the first preferred embodiment of the forming catheter; FIG. 3 is a detailed cross-sectional view of the distal portion of a second preferred embodiment of an angioplasty catheter; It is.

Detailed description of the preferred embodiment FIG. 1 shows an overall view of an angioplasty balloon catheter 10 according to the present invention. , the catheter includes a catheter tube 12, an inflation manifold 14, and an inflatable valve. It has 16 runes. The distal portion 18 of the catheter 10 includes a flexible spring tip. It has an end 20. Catheter tube 12 is lubricated such as silicone or Teflon. The preferred material is stainless steel or semi-rigid plastic coated on its outer surface with a resistant material. It is a long flexible monolithic tube. This lubricious coating allows the catheter to withstand body movements. It allows for easy movement through the veins. An expansion manifold 14 is located at the proximal end of tube 12. is attached to provide pressurized fluid to inflate balloon portion 16. The swelling The expandable balloon 16 is made of a polymeric material such as a polyolefin copolymer. This is desirable.

In a preferred embodiment, angioplasty balloon catheter 10 has a diameter of 0° at its proximal end. It ranges from 51 to 1.02 mm (0.020 to 0.040 inch), and The outer diameter of A length of catheter tube 12 with a coiled tip 20 at the distal end of the tether 10. Preferably, the diameter is about 135 cm (53.15 inches).

FIG. 2 shows a balloon of a first embodiment of the angioplasty balloon catheter 10 of the present invention. A detailed cross-sectional view of the tube or end portion is shown. In this example, the catheter tube 12 is a stainless steel hypodermic tube with a hollow proximal portion 22 of a first diameter; and the proximal portion is tapered at an elongated tapered portion 24; a distal portion 1 terminating in an inflation lumen 26 and having a second diameter smaller than the first diameter; form 8. The tapered portion 24 of the tube 12 is connected to the tube (in the middle) as shown in FIG. tapering from the hollow proximal end portion 22) to the elongated distal end portion 18 having a generally hollow cross section. is added. In a preferred embodiment, this taper is uniform as the tube diameter decreases. However, stepwise or gradual reduction is also possible. Inflation lumen 26 is a tube. 12 within a hollow proximal portion 22 thereof. The lumen 26 extends from the elongate tape of the tube 12. The tube of tapered portion 24 extends into tapered portion 24 and is shown in FIG. Through one or more holes extending through the tube, such as hole 30 through wall 31, It is in fluid communication with the interior 28 of rune 16 .

Balloon 16 includes a proximal portion 32, an inflation portion 33, and a distal portion 34. Ru. The proximal portion 32 of the balloon 16 is tapered at a proximal adhesive connection 36. 24. The distal portion 34 of the balloon 16 has a distal adhesive isthmus. It is connected to the solid end portion 18 at 38 . The end of the balloon is made of epoxy Preferably, they are attached to their respective tube sections by suitable adhesive. at least One radiopaque marker band 40 is attached to the generally solid end of the tube within balloon 16. Circumscribes minute 18. The proximal portion 32 of the balloon portion 16 is made of highly flexible polyester. Formed from a separate flexible plastic tube such as tyrene, the proximal end of which is connected to the proximal end of the tube 22 (near the hole 30), and its end is attached to the proximal end of the balloon portion 33. Let them wear it.

The elongated solid end portion 18 of the tube 12 further tapers distally and is fitted with a safety twist. It is desirable to form a layer 42. The safety wire 42 is attached to the coil spring 44. It is attached by brazing 43 at the end to form the coil spring tip 20. flexibility Coiled spring tip 20 safely guides catheter 10 through the curved passageway of the coronary artery. It works within. The coil spring 44 is brazed adjacent the distal adhesive connection 38. is attached to the solid portion 18 at a solder connection 46 . Coil spring tip 2 0 is bendable, the safety wire 42 bends in place and holds it bent. This facilitates steering the catheter 10 through the patient's arterial system. It can be done. In use, a torque is applied to the proximal end of tube 12, and the torque is applied to the proximal end of tube 12. The spring tip 20 is be reached.

FIG. 3 shows a second preferred embodiment of the angioplasty balloon catheter of the present invention. It is. In this embodiment, the catheter 12a includes an elongated tapered portion 2 the first diameter tapering distally to a second smaller diameter at 4a; It has an empty base end portion 22a. Elongated end portion 18a is a reduced diameter section of tube 12a. Define a part of the minute. In this embodiment, catheter tube 12a is a semi-rigid plastic tube. The distal end portion 18a of the semi-rigid plastic tube has a central metal core core. It is formed around the ear 50. The plastic tube and metal core wire 50 are It has a distal end portion 18a which is generally solid in transverse cross section. The balloon 16a , is identical to the balloon 16 described above with respect to the embodiment of FIG.

An inflation lumen 26a is defined within hollow proximal portion 22a of tube 12a. The lumen 2 6a extends into an elongated tapered portion 24a of tube 12a, with tube 12a distal. It terminates at a point that fits around the metal core wire 50 of the portion 18a. Lumen 2 6a is the hole 3 of the pipe 1i31a of the tapered portion 24a, as shown in FIG. with the interior of the balloon through one or more holes extending through the tube, such as 0a. In fluid communication.

The metal core wire 50 extends distally and exits from the distal end portion 18a for safety. In order to form the entire wire 42a, a reduced diameter is desirable. safety wire 42a is attached to the end of the coil spring 44a by brazing 43a, and the coil A spring tip 20a is formed. In this case too, a flexible (and therefore bendable) coil The spring tip 20a safely guides the catheter of the present invention through the curved passageway of the coronary artery. It serves as a guide.

The angioplasty balloon catheter of the present invention is relatively easy to manufacture. the catheter The method for manufacturing the bottle includes the following steps. From an elongated tube having a proximal portion and a distal portion Forms a lumen. The reading tube shall be either metal or semi-rigid plastic tube. I can do it. Form a tapered portion at the distal end of the reading tube. The tapered part , the cross-sectional dimension of the reading tube is reduced in the distal direction. The tapered portion has a first diameter uniformly taper from to a smaller second diameter. If the reading tube is made of metal , the reduced cross-sectional size end portion of the reading tube has an elongated, generally solid end point as shown in FIG. form a. In this way, it is reduced distally to a solid core or wire. The fitted metal tube forms a unitary metal inflation lumen and balloon core. reading tube If the reading tube is made of plastic, the cross-sectional dimensions of the reading tube should be The tube may be tapered to a solid distal core, or in a preferred embodiment. At this point, the plastic tube is placed around the metal core wire as shown in Figure 3. Taper evenly to the formed end. In this way, metal core wire - inflated by a semi-rigid plastic tube that is contracted distally to fit around the A lumen and balloon core are formed.

In either configuration, at least one hole is provided through the tapered portion to allow for expansion. Attach a possible balloon section to the distal section of the tube. The proximal end of the balloon part is a reading tube. The proximal end of the balloon portion is secured to the tube, while the distal end of the balloon portion is secured to the solid core.

As mentioned above, a separate proximal or waist portion of the balloon (the tape of the tube as a whole) (extending above the pared section) may also be provided. This allows this proximal The constriction part (i.e., part 32 in Figure 2) is made of a different material than the balloon part. This increases flexibility, thereby improving trackability.

The tapered portion of the tube may be used to impart rolling or compressive loads to the tube. It can be formed by any suitable means. During this forming process, the tube is similarly It can be heated and axially stretched. In this way, the tube diameter decreases distally. Because it is the most flexible part of the catheter, it is naturally the most flexible part of the catheter. the end of the tube that must be made acceptable for advancement through the coronary artery The flexibility of the part is increased. In addition, we adopted polishing technology in combination with the manufacturing method described above. , to achieve a reduced diameter and to reduce the weakness at these ends of the tube, as shown in FIG. The wall thickness of the tapered portion 24 and the distal portion 18) can be reduced.

Substantially solid terminal core reduces its cross-sectional diameter to an extremely thin wire or ribbon core The bending of the tube 12 is further formed so that the tube 12 is made of metal. A possible terminal safety wire section 42 is formed (see FIG. 2). Tube 12 is semi-rigid In the case of a plastic tube, the metal core wire 50 is further formed and its cross section is The diameter is reduced to an extremely thin wire or core, thereby making the metal core wire 50 terminal safety wire sections 42a are formed (see FIG. 3). Next, the coil Secure the wire to the solid end of the tube and insert the balloon around the end safety wire. It extends distally. The end of the terminal safety wire part is fixed to the coil spring. This allows the distal tip to be placed on a catheter that is flexible and has no sharp edges. Define the edge. This prevents you from accidentally puncturing the artery wall when advancing the catheter. The risk of injury is minimal.

In use, the physician first positions the guidewire within the diameter of a typical blood vessel. Take the forming procedure. Next, the angioplasty balloon catheter of the present invention is attached to the guide wire. and advanced distally into the stenotic coronary artery. Next, the doctor examines the dilation Push the catheter further until the possible balloon is positioned at the stenosis site. . Injected into the coronary artery through a guide catheter and detectable by fluoroscopy By using a certain dye, it is possible to detect the stenosis site. Also, cat Radiopaque markers on the surface of the membrane are detectable by fluoroscopy, which allows The physician can then precisely position and inflate the balloon at the stenosis site.

The flexible and steerable distal coil spring tip of the catheter assists in safely and effectively advancing the tube through the curved passageway of the coronary arteries. expansion Using an inflation device (not shown) connected to manifold 14, the physician inflates tube 12. Inflation media (typically salt and linograph Inflate the balloon with a 50/50 solution of 100% fluorine 76. Inflated portion of balloon 16 33 inflates and stretches the artery wall, pushing the affected area into the artery wall and opening the artery. Re-canalize acceptable blood flow through. Next, the expansion manifold 14 supplies The balloon 16 is deflated by the negative and positive signals. Arteries are similarly treated with dyes and vascular fluoroscopy. Visually observe the catheter and remove the catheter if the stenosis has dilated.

If the stenosis is not sufficiently dilated, the dilation procedure can be repeated.

In conclusion, the present invention is an improved angioplasty dilation catheter. Proximal expansion By designing the tube, the distal balloon core, and the catheter tip as a single unit, This allows sufficient torque to be transmitted from the proximal end to the distal end, and is relatively easy to manufacture. come. A design in which a semi-rigid plastic tube is formed around a terminal metal core wire may also be used. , allows for sufficient transmission of torque from proximal to distal end and is relatively easy to manufacture. .

If the catheter tube is made of metal, the unitary tube itself tapers distally. to form a guide or safety wire, the catheter of the present invention can be No guide wire or safety wire is required. Catheter tube is semi-rigid plus If made of metal, the guide/safety wire is provided by a metal core wire; Form a plastic tube over the wire. These conditions reduce the outer diameter of the catheter. necessitates cutting, resulting in the inherent Reduces problems associated with friction and reduces the amount of dye in guide catheters and coronary arteries. Minimize disturbance to flow.

Although the invention has been described in terms of preferred embodiments, those skilled in the art will understand that the spirit and scope of the invention can be understood by those skilled in the art. It will be understood that changes may be made in form and detail without departing from the invention.

abstract The angioplasty catheter has a tapered hollow proximal portion (22, 22a); a unitary flexible elongate forming a solid end core (18, 18a) of solid cross section; It is equipped with a deep tube (12, 12a). The core (18, 18a) is further tapered. is attached to form a safety wire (42, 42a) at the distal end of the catheter.

An inflatable balloon (16, 16a) circumscribes the elongated tube (12, 12a) and The inside of the rune (16, 16a) passes through the tube wall (31, 31a) to the inside of the balloon ( 28, 28a) through at least one hole (30, 30a) extending to the tube ( 12, 12a) defined by the hollow proximal portion (22, 22a) of the lumen (26 , 26a). A coil spring (44, 44a) is connected to a solid end core (1). 8, 18a) and the balloon (16, 18a) around the safety wire (42, 42a). 16a), the safety wire (42, 42a) extends distally from the coil spring ( 44, 44a) is fixed to the end cap (43, 43a).

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Claims (28)

[Claims] 1. As an angioplasty catheter, a unitary body having a hollow proximal end defined by a tubular wall defining an inland area and a distal end; a flexible elongated tube, a narrowing formed at the distal end of the tube from a first diameter to a second diameter smaller than the first diameter; a tapered portion formed at the distal end of the tube and having a diameter such that the second diameter a distal portion having a generally solid cross section, circumscribing said tube and having said tapered portion; a proximal end glued to the tubing adjacent to the distal end and a distal end glued to the tubing adjacent to the generally solid distal portion; an inflatable balloon portion having an end, the interior of the balloon portion being a tube. communicating with the lumen through at least one hole extending through the shaped wall. angioplasty catheter. 2. An angioplasty catheter according to claim 1, wherein the angioplasty catheter comprises a substantially solid end of the tube. An angioplasty catheter further comprising a flexible tip extending from the end portion. Le. 3. The angioplasty catheter according to claim 2, wherein the flexible tip is a bar. attached to said generally solid distal portion adjacent an end of a rune portion; Angioplasty catheter. 4. An angioplasty catheter according to claim 2, wherein the flexible tip is An angioplasty catheter characterized in that it is soldered to a substantially solid end portion of a tube. Le. 5. The angioplasty catheter according to claim 2, wherein the flexible tip is An angioplasty catheter characterized by having a spring tip. 6. The angioplasty catheter of claim 5, wherein the unitary tube comprises: The end is tapered and attached to the end cap at the tip of the coil spring. An angioplasty catheter characterized by forming a safety wire. 7. The angioplasty catheter according to claim 1, wherein the tapered portion A blood vessel characterized in that the length is uniformly tapered from the first diameter to the second diameter. Formation catheter. 8. The angioplasty catheter according to claim 1, wherein the tube is made of stainless steel. An angioplasty catheter characterized in that it is formed from a steel hypodermic tube. 9. The angioplasty catheter according to claim 8, wherein the stainless steel skin An angioplasty catheter characterized in that the lower injection tube is coated with a lubricious material. 10. An angioplasty catheter according to claim 1, wherein the tube is semi-rigid. An angioplasty catheter characterized in that it is formed from a plastic tube. 11. An angioplasty catheter according to claim 10, wherein the semi-rigid plug An angioplasty catheter characterized in that a stick tube is coated with a lubricious material. 12. The angioplasty catheter according to claim 10, wherein the tapered The tapered portion is uniformly tapered to a distal portion, and said distal portion is a metal core wire. An angioplasty catheter characterized in that the catheter is formed around the ear. 13. An angioplasty catheter according to claim 12, comprising a metal core wire. is further tapered distally to form a safety wire. Angioplasty catheter. 14. An angioplasty catheter according to claim 1, wherein the tube is a plurality of holes passing through the perforated portion to communicate the lumen with the inside of the balloon portion; An angioplasty catheter characterized by: 15. An angioplasty catheter according to claim 1, wherein the expandable bulb is An angioplasty catheter characterized in that the rune portion is formed from a polymeric material. 16. The angioplasty catheter according to claim 1, comprising a radiopaque polymer. A blood vessel characterized in that the carrier band circumscribes a portion of the tube within the balloon portion. Formation catheter. 17. The angioplasty catheter according to claim 1, wherein the balloon portion Angioplasty tube characterized in that the proximal and distal ends of the tube are adhered to the tube by epoxy. Teter. 18. As an angioplasty catheter, a unitary body having a hollow proximal end defined by a tubular wall defining a lumen and a distal end; a flexible elongated tube, a second end formed at the distal end of the tube and smaller in diameter than the first proximal end; A tapered portion with a diameter that narrows to a diameter of a solid portion formed at the distal end of the body and extending distally from the tapered portion a solid portion having a long and solid cross section; a solid portion circumscribing the tube and having the tapered portion; a proximal end glued to said tube adjacent to said solid portion; and a proximal end glued to said tube adjacent said solid portion. an inflatable balloon portion having a closed end; with a tapered tube extending through the tube wall between said inland and the interior of the balloon portion. communicating with the inland through at least one hole disposed along the section; Furthermore, a wire portion formed at the distal end portion of the tube continuous with the proximal end portion thereof, , a wire portion decreasing in diameter from said solid portion and extending toward its distal end; Attached to the distal end of the tube and extending toward the distal end around the wire section a flexible coil spring having said wire portion adjacent each end thereof; an angioplasty catheter comprising: a coil spring affixed to the coil spring; 19. A method for manufacturing an angioplasty balloon catheter, comprising: forming a proximal end portion and a distal end portion; forming a lumen from an elongated tube having a tapered portion at a distal end portion of the tube; forming a section such that the cross-sectional diameter of the tube decreases distally; forming a reduced cross-sectional diameter distal portion of the tube into a substantially solid distal core; providing at least one hole in the tapered portion of the recording tube; A balloon is attached to the distal end of the tube, and the proximal end of the balloon is placed near the proximal end of the hole. and securing the distal end of the balloon to the substantially solid distal core. A method characterized by: 20. The manufacturing method according to claim 19, wherein a solid terminal core wire is further comprising the step of further reducing the cross-sectional diameter to define a distal safety wire portion of the tube. A method characterized by: 21. In the manufacturing method according to claim 20, the coil spring is formed into a solid end core. The end of the balloon is attached to the end safety wire, and the end of the balloon is A method further comprising the step of elongating in an end direction. 22. The manufacturing method according to claim 21, wherein the end of the terminal safety wire portion is further comprising the step of securing the end to the end cap on the coil spring. Method. 23. The manufacturing method according to claim 19, wherein the cross-sectional diameter of the tube is adjusted in the distal direction. The method further comprises the step of uniformly reducing the size of the material. 24. A method for manufacturing an angioplasty balloon catheter, comprising: forming a proximal end portion and a distal end portion; forming a lumen from an elongated tube having a tapered portion at a distal end portion of the tube; forming a section such that the cross-sectional diameter of the tube decreases distally; forming a reduced cross-sectional diameter end portion of the tube around a metal core wire; , providing at least one hole in the tapered portion of the tube; Place the balloon over the distal end of the tube, with the proximal end of the balloon near the proximal end of the hole. and affixing the distal end of the balloon to the distal end portion. A method characterized by: 25. A method of manufacturing according to claim 24, wherein a solid terminal core wire is further comprising the step of further reducing the cross-sectional diameter to define a distal safety wire portion of the tube. A method characterized by: 26. In the manufacturing method according to claim 25, the coil spring is formed into a solid end core. The end of the balloon is attached to the end safety wire, and the end of the balloon is A method further comprising the step of causing elongation in an end direction. 27. The manufacturing method according to claim 26, wherein the end of the terminal safety wire portion is further comprising the step of securing the end to the end cap on the coil spring. Method. 28. The manufacturing method according to claim 24, wherein the cross-sectional diameter of the tube is adjusted in the distal direction. The method further comprises the step of uniformly reducing the size of the material.