EP0801582A1 - Katheterschaft mit länglichem querschnitt - Google Patents

Katheterschaft mit länglichem querschnitt

Info

Publication number
EP0801582A1
EP0801582A1 EP95944226A EP95944226A EP0801582A1 EP 0801582 A1 EP0801582 A1 EP 0801582A1 EP 95944226 A EP95944226 A EP 95944226A EP 95944226 A EP95944226 A EP 95944226A EP 0801582 A1 EP0801582 A1 EP 0801582A1
Authority
EP
European Patent Office
Prior art keywords
catheter
proximal
dilatation
tubular member
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP95944226A
Other languages
English (en)
French (fr)
Inventor
Motasim M. Sirhan
Jovito L. Fernando, Sr.
Troy L. Thornton
Patrick K. Campbell
Eric Williams
Lawrence D. Wasicek
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Advanced Cardiovascular Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Cardiovascular Systems Inc filed Critical Advanced Cardiovascular Systems Inc
Publication of EP0801582A1 publication Critical patent/EP0801582A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0034Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0037Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0039Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0063Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183Rapid exchange or monorail catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1097Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/0029Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports

Definitions

  • This invention generally relates to intravascular catheters, such as balloon dilatation catheters used in percutaneous transluminal coronary angioplasty (PTCA).
  • PTCA percutaneous transluminal coronary angioplasty
  • PTCA is a widely used procedure for the treatment of coronary heart disease wherein a balloon dilatation catheter is advanced into the patient's coronary artery and the balloon on the distal portion of the catheter is inflated within the stenotic region of the patient's artery to open up the arterial passageway and thereby increase the blood flow therethrough.
  • a guiding catheter having a preshaped distal tip is first percutaneously introduced into the cardiovascular system of a patient by the Seldinger technique through the brachial or femoral arteries and is advanced therein until the preshaped distal tip of the guiding catheter is disposed within the aorta adjacent the ostium of the desired coronary artery.
  • the guiding catheter is twisted or torqued from its proximal end, which extends out of the patient, to guide the distal tip of the guiding catheter into the desired ostium.
  • a balloon dilatation catheter may then be advanced through the inner lumen of the guiding catheter into the patient's coronary artery until the balloon on the dilatation catheter is disposed within the stenotic region of the patient's artery.
  • the balloon is inflated and deflated one or more times to open up the arterial passageway and increase the flow of blood.
  • over-the-wire type balloon dilatation catheter One type of catheter frequently used in PTCA procedures is an over-the-wire type balloon dilatation catheter.
  • Over-the-wire type dilatation catheters include the SIMPSON ULTRA LOW PROFILE (TM), the HARTZLER ACX (R), the HARTZLER ACX II (TM), the PINKERTON .018 (TM) and the ACS TEN (TM) balloon dilatation catheters sold by the assignee of the present invention, Advanced Cardiovascular Systems, Inc. (ACS).
  • over-the-wire dilatation catheter is the rapid exchange type catheter, which was introduced by ACS under the trademark ACS RX ® Coronary Dilatation Catheter. It is described and claimed in U.S. Patent No. 5,040,548 (Yock), U.S. Patent No. 5,061 ,273 (Yock), U.S. Patent No. 4,748,982 (Horzewski et al. ) and U.S. Patent No. 5,1 54,725 (Leopold) which are incorporated herein by reference.
  • This dilatation catheter has a short guidewire receiving sleeve or inner lumen extending through a distal portion of the catheter.
  • the sleeve or inner lumen extends proximally from a first guidewire port in the distal end of the catheter to a second guidewire port in the catheter spaced proximally from the inflatable member of the catheter.
  • a slit may be provided in the wall of the catheter body which extends distally from the second guidewire port, preferably to a location proximal to the proximal end of the inflatable balloon.
  • Some over-the-wire and rapid exchange type dilatation catheters have perfusion capabilities where one or more perfusion ports are provided in the catheter shaft proximal to the dilatation balloon which are in fluid communication with a guidewire receiving inner lumen extending to the distal end of the catheter. Additionally, one or more perfusion ports are preferably provided in the catheter shaft, distal to the balloon which are also in fluid communication with the guidewire receiving inner lumen.
  • intravascuiar catheters particularly angioplast ⁇ catheters
  • a balloon dilatation catheter with an increased flexibility and an increased pushability allow the catheter to be advanced much further into a patient's vasculature and to cross much tighter lesions.
  • the present invention satisfies these and other needs.
  • the present invention is directed to an elongated intravascuiar catheter with improved flexibility and pushability, particularly in the distal portion thereof.
  • the catheter shaft of the invention has, at least in the distal portion thereof, an oblong transverse cross-section wherein the transverse dimension in a first direction is larger than the transverse dimension in a second direction perpendicular to the first direction.
  • the larger transverse dimension is about 1.1 to about 3 times, preferably about 1.2 to about 2.5 times, greater than the smaller perpendicular transverse dimension.
  • the differential between the first and second transverse dimensions is at least about 0.003 inch (0.076 mm) and for dilatation catheters for peripheral use this differential should be at least about 0.005 inch (0.127 mm).
  • the shape of the oblong transverse cross-section proximal to the balloon is preferably oviform or elliptical in nature.
  • the length of the oblong portion of the catheter shaft is at least about 4 cm., preferably at least about 7 cm.
  • the entire length of the catheter shaft may have the desired oblong transverse cross- section or only the portion of the catheter which extends out of the guiding catheter, e.g. about 10 to about 40 cm.
  • Advantages have also been recognized with the proximal portion of the catheter shaft having an oblong transverse cross-section in accordance with this invention.
  • the intravascuiar catheter of the invention generally includes, at least in the distal portion thereof, an inner tubular member having an inner lumen extending therein and an outer tubular member disposed about the inner tubular member with at least about 30% and not more than about 90%, preferably not more than about 80%, of the inner periphery of the outer tubular member taking the shape of and being secured to exterior of the inner tubular member along a length of the catheter shaft of at least about 4 cm, preferably at least about 7 cm.
  • An inner inflation lumen extends along the secured length between the portion of the outer tubular member which does not take the shape of and which is not secured to the underlying inner tubular member. The bond between the secured inner and outer tubular member need not be continuous.
  • the inner and outer tubular members may be secured together by heat or laser bonding, adhesive bonding, heat shrinking the outer tube onto the inner tube or other suitable means.
  • the profile of the catheter body in at least one transverse dimension in that area is reduced substantially to thereby provide improved flexibility.
  • the secured portions of the inner tubular member and the outer tubular member support one another thereby providing improved pushability.
  • Substantial reductions in only one transverse dimension can provide substantial improvements in flexibility.
  • Minimum cross-sectional dimensions of the small diameter section of the outer tubular member for coronary dilatation catheters are on the order of about 0.01 to about 0.06 inch (0.51 - 1.5 mm). For peripheral arteries this dimension may be larger.
  • the improvements of the invention are applicable to a wide range of elongated intravascuiar catheters which are at least 90 cm in length and which are percutaneously introduced and advanced deep within the patient's vascular system, such as in the coronary anatomy. It is particularly suitable in essentially all types of dilatation catheters with inflatable or expandable dilatation members on their distal extremities, such as those described in the patents incorporated herein by reference.
  • Fig. 1 is an elevational view, partially in section, of a balloon dilatation catheter embodying features of the invention.
  • Fig. 2 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 2-2.
  • Fig. 3 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 3-3.
  • Fig. 4 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 4-4.
  • Fig. 5 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 5-5.
  • Fig. 6 is an elevational view, partially in section, of another dilatation catheter embodying features of the invention.
  • Fig. 7 is a transverse cross-sectional view of the catheter shown in Fig. 6 taken along the lines 7-7.
  • Fig. 8 is a transverse cross-sectional view of the catheter shown in Fig. 6 taken along the lines 8-8.
  • Fig. 9 is a transverse cross-sectional view of the catheter shown in Fig. 6 taken along the lines 9-9.
  • Fig. 10 is a transverse cross-sectional view of the catheter shown in Fig. 6 taken along the lines 10-10.
  • Fig. 1 1 is an elevational view, partially in section, of another dilatation catheter embodying features of the invention.
  • Fig. 12 is a transverse cross-sectional view of the catheter shown in Fig. 1 1 taken along the lines 12-12.
  • Fig. 13 is a transverse cross-sectional view of the catheter shown in Fig. 1 1 taken along the lines 13-13.
  • Fig. 14 is a transverse cross-sectional view of the catheter shown in Fig. 1 1 taken along the lines 14-14.
  • Fig. 15 is a transverse cross-sectional view of the catheter shown in Fig. 1 1 taken along the lines 1 5-15.
  • Fig. 16 is an elevational view, partially in section, of an alternative embodiment of the invention wherein a supporting tube is provided between the unsecured portion of the outer tubular member and the inner tubular member.
  • Fig. 17 is a cross-sectional view of the catheter shown in Fig. 1 6 taken along the lines 1 7-17.
  • Fig. 18 is a cross-sectional view of a catheter shaft of another embodiment of invention wherein there are two unsecured lengths of the outer tubular which define lumens with the underlying inner tubular member.
  • Fig. 19 is an elevational view, partially in section, of another embodiment of the invention in which the catheter shaft proximal to the balloon has the desired transverse cross-sectional dimensions and a hypotube formed of pseudoelastic NiTi alloy supports the inflation lumen to prevent kinking.
  • Fig. 20 is a transverse cross-sectional view of the embodiment shown in Fig. 19 taken along the lines 20-20.
  • Fig. 21 is a partial elevational view, particularly in section, of a rapid exchange version of the catheter shaft shown in Figs. 19-20.
  • Fig. 22 is a elevational view, partially in section, of an alternative embodiment of an over-the-wire dilatation catheter.
  • Fig. 23 is a transverse cross-sectional view of the embodiment shown in Fig. 22 taken along the lines 23-23.
  • Fig. 24 is a transverse cross-sectional view of the embodiment shown in Fig. 22 taken along the lines of 24-24.
  • Figs. 1 -5 schematically illustrate an over-the-wire dilatation catheter 10 embodying features of the invention.
  • the catheter 10 includes an elongated catheter shaft 11 which has an inner tubular member 12, an outer tubular member 13 disposed about the inner tubular member and an adapter 14 secured to the proximal ends of the inner and outer tubular members.
  • a relatively inelastic, inflatable balloon 15 which is integral with the outer tubular member 13 and a distal skirt 17 which is secured to the distal end of the inner tubular member 12.
  • the balloon 15 may be formed from different material and be secured to the outer tubular member 13.
  • the distal portion of the outer tubular member 13 in part takes the shape of and is secured to the exterior of the inner tubular member 12 along the length 18.
  • the unsecured portion 20 of the outer tubular member 13 along the length 18 forms with the inner tubular member 12 an inflation lumen 21 which is in fluid communication with the interior of the balloon 15.
  • the inner lumen 22 of the inner tubular member 12 extends parallel to the inflation lumen 21 along the length 18.
  • the transverse dimension of the catheter shaft 1 1 along the length 18 in the vertical direction is substantially larger than the transverse dimension of the catheter shaft in the horizontal direction along said length.
  • the proximal portion of the catheter shaft 1 1 is conventional where the outer tubular member 3 is disposed about but is unsecured to the inner tubular member 12 and defines with the inner tubular member an annular inflation lumen 23 which is in fluid communication with the inflation lumen 21 in the distal portion of the catheter shaft.
  • the use of the dilatation catheter shown in Figs. 1 -5 generally may follow conventional PTCA practices with over-the-wire type dilatation catheters.
  • a guidewire 24 is backloaded into the inner lumen 22 of the inner tubular member 12 and both the guidewire and the catheter 10 are advanced together through a guiding catheter (not shown) which has been previously disposed within the patient's arterial system, with the distal end of the guiding catheter seated within the ostium of the desired coronary artery.
  • the guidewire 24 is advanced out the distal end of the guiding catheter into the patient's coronary anatomy until it crosses the lesion to be dilated, and then the dilatation catheter 10 is advanced over the guidewire which is being held in position, until the balloon 1 5 on the dilatation catheter is properly disposed within the stenotic region, so that the lesion can be dilated upon one or more inflations of the balloon. After the dilatation, the balloon 1 5 is deflated and the catheter 10 and the guidewire 24 may be withdrawn from the patient.
  • the guidewire 24 can be replaced with an exchange wire before removing the dilatation catheter so that the first catheter can be removed and another advanced into the desired location or an extension wire can be attached to the proximal end of the guidewire in place which extends out of the patient to perform essentially the same function. See the discussion of exchange wires and extension wires in U.S. Patent 4,827,941 (Taylor et al. ) which has been incorporated herein by reference.
  • Figs. 6-10 schematically illustrate another dilatation catheter
  • the distal section of the catheter shaft 31 includes an outer tubular member 32 which is disposed about an inner tubular member 33 and which in part takes the shape of and is secured to the exterior of the inner tubular member along a length 34 of the distal shaft.
  • An unsecured portion 35 of the outer tubular member 32 forms an inflation lumen 36 which is in fluid communication with the relatively inelastic balloon 37.
  • the outer tubular member 32 and the balloon 37 are formed in a unitary construction.
  • the distal skirt 38 of the balloon 37 is secured to the distal end of the inner tubular member 33.
  • Guidewire receiving inner lumen 40 extends proximally within the inner tubular member 33 from a distal guidewire port 41 in the distal end of the inner tubular member to a proximal guidewire port 42.
  • a guidewire 43 is slidably disposed within the inner lumen 40 and extends out both the distal port 41 and the proximal port 42.
  • a slit 44 is provided in the secured sections of the inner and outer tubular members 33 and 32 respectively and it extends distally from the proximal guidewire port 42 to a location 45 proximal to the balloon 37 to facilitate separation of the guidewire 43 and the catheter shaft 31 when replacing catheter 30 with another catheter as described in U.S. Patent 4,748,982 (Horzewski et al.) which is incorporated herein by reference.
  • the proximal guidewire port 42 is located at least about 5 cm but not more than about 45 cm from the distal end of the catheter.
  • the proximal portion of the catheter shaft 31 has a high strength inner tubular member 46, e.g. hypotubing, with a tightly fitting outer plastic jacket or coating 47.
  • An adapter 48 is secured to the proximal end of the catheter shaft 31 to direct inflation fluid through the inner lumen 50 in the high strength tubular member 46 and the inflation lumen 36 between the inner tubular member 33 and the unsecured portion of the outer tubular member 32 to the interior of balloon 37.
  • the distal extremity 51 of the high strength tubular member 46 is tapered to facilitate extension into the proximal end of the inflation lumen 36 where it is secured by suitable means such as an adhesive or by heat shrinking the proximal end of the outer tubular member about the tapered extremity
  • the high strength tubular member may be formed of stainless steel or a NiTi alloy, particularly a NiTi alloy with pseudoelastic properties, such as described in co-pending applications Serial No 07/629,381 , filed December 18, 1990; Serial No. 07/994,679, filed December 22, 1992 and Serial No. 08/212,431 , filed March 1 1 , 1994, assigned to the present assignee, Advanced Cardiovascular Systems, Inc. which are incorporated herein by reference.
  • a dual lumen type construction such as described in Horzewski ef al. above may also be used in the portion of the catheter shaft 31 proximal to the proximal guidewire port 42. There are at least two modes of inserting the dilatation catheter 30 of this embodiment into the patient's coronary anatomy.
  • the first method is for the most part the same as in the prior embodiment, namely, the guidewire 43 is preloaded into the short guidewire receiving inner lumen 40 of the inner tubular member 33 and both are advanced through a guiding catheter (not shown) previously disposed within the patient's arterial system with the distal end of the guiding catheter seated within the ostium of a coronary artery.
  • the second mode frequently called the "bare wire” technique, involves first advancing a guidewire 43 through and out the guiding catheter until the distal extremity of the guidewire is positioned within the patient's coronary artery across the lesion to be dilated. The proximal end of the guidewire 43, which is outside the patient, is backloaded, i.e.
  • the catheter 30 is advanced over the guidewire through the patient's vascular system until the dilatation balloon 37 on the catheter is positioned across the stenotic region.
  • the stenosis is dilated upon the inflation of the balloon 37, and, after the dilatation of the lesion, the balloon is deflated and the catheter is removed from the patient's artery.
  • the catheter 30 is slidably withdrawn over the guidewire 43, leaving the guidewire in place so that other catheters can be advanced over the in-place guidewire in a similar manner without the need for exchange wires or guidewire extensions, thereby significantly reducing the overall time for the procedure.
  • Figs. 11 through 15 illustrate yet another dilatation catheter 60 embodying features of the invention which provides for the perfusion of blood distal to the catheter during the dilatation of a stenotic lesion.
  • the catheter 60 includes the catheter shaft 61 , an inner tubular member 62 which has an inner lumen 63, an outer tubular member 64 disposed about the inner tubular member, an adapter 65 secured to the proximal ends of the inner and outer members, and a relatively inelastic balloon 66 which is secured by its distal end to the distal end of the inner tubular member 62.
  • a portion of the outer tubular member 64 has a distal section 67 a length 68 of which is secured to the exterior of the inner tubular member 62 as previously described in the first two embodiments of the invention.
  • the above-described portion of this embodiment has essentially the same structure as the embodiments shown in Figs. 1-10.
  • the dilatation catheter shown in Figs. 11 -15 differs from the other embodiments in that it has a plurality of perfusion ports 69 proximal to the balloon 66 which pass through the secured walls of the inner and outer tubular members 62 and 64 respectively and which are in fluid communication with the inner lumen 63 of the inner tubular member 62.
  • one or more perfusion ports 70 are provided distal to the balloon 66 through the wall of the inner tubular member 62 and are in fluid communication with the inner lumen 63 extending therein.
  • oxygenated blood is forced to pass through the proximal perfusion ports 69, through the inner lumen 62 and then out the distal perfusion ports 70 to provide oxygenated blood distal to the catheter 60 and thereby avoid the generation of ischemic conditions in downstream tissue.
  • the transverse dimensions of the inner tubular member 62 within the secured section are preferably larger than in the embodiments previously discussed to allow for an increased flow of blood.
  • Figs. 1 1 -1 5 The use of the embodiment shown in Figs. 1 1 -1 5 is essentially the same as the embodiment shown in Figs. 1 -5.
  • the only essential difference is that the balloon 66 can be inflated for significantly longer periods than the first described embodiments, e.g. typically about 20-30 minutes but possibly up to 5 hours or more, because oxygenated blood is continuously flowing to the tissue distal to the inflated balloon.
  • the dilatation catheter 30 shown in Figs. 6-10 may be modified by providing a plurality of perfusion ports in the catheter shaft as shown in Figs. 1 1-1 5 distal to the proximal guidewire port 42.
  • the guidewire port 42 is preferably spaced sufficiently far proximally from the portion of the secured distal section having the perfusion ports so that the guidewire 43 can be pulled proximally and remain within the inner lumen 40 of the inner tubular member 33 while the balloon is inflated during a long term dilatation but not interfere with the flow of blood through the perfusion ports.
  • the guidewire 43 can then be advanced distally through the inner lumen 40 and out the distal end thereof in order to maintain access to the lesion in case further treatment or diagnosis is necessary or desirable.
  • the above described catheters may be made by conventional techniques well known to those skilled in the art. Many suitable techniques are described in the references referred to herein.
  • the small diameter distal sections may be formed by heat shrinking the portion of the outer tubular members which form the distal sections onto the underlying inner tubular members with a mandrel disposed in the space between the inner and outer tubular members so that upon the heat shrinking of the outer tubular member an inflation lumen is formed through the distal sections which is in fluid communication with the lumen in the proximal portion of the catheter bod ⁇ and the interior of the balloon. This bonds the small dimensioned distal section to the inner tubular member.
  • a mandrel ma ⁇ also be inserted into the inner lumen of the inner tubular member to support the latter during the heat shrinking of the outer tubular member thereon to maintain its circularit ⁇ .
  • Alternate methods ma ⁇ be emplo ⁇ ed to make the small dimensioned distal section.
  • the small dimensioned distal section 17 ma ⁇ be preformed and then be adhesivel ⁇ bonded to the exterior of the inner tubular member.
  • Multiple lumens similar to the inflation lumen ma ⁇ be formed in the small dimensioned section, such as the top and bottom thereof, b ⁇ emplo ⁇ ing multiple mandrels when heat shrinking the outer tubular member onto the exterior of the inner tubular member.
  • a slit 45 extending from the proximal guidewire port 42 through the secured portion of the catheter shaft 31 to facilitate the separation of the catheter and the guidewire
  • the opening of the slit allows the guidewire to extend through the expanded or opened slit 44, but upon deflation of the balloon the slit closes onto the guidewire 43 which precludes independent movement of the guidewire and catheter.
  • Fig. 18 is an alternative distal shaft construction wherein an additional inner lumen 80 which can be used as an additional inflation lumen to vent air or to deliver other fluids.
  • the additional lumen 80 should extend to the proximal end of the catheter shaft so that fluid can be introduced into or withdrawn from the additional lumen through an adapter mounted on the proximal end.
  • the lumen 80 should terminate within the interior of the inflatable dilatation member.
  • the lumen 80 should extend to the distal end of the catheter to deliver fluids distal to the catheter.
  • Figs. 19-20 illustrate an alternative embodiment of an over- the-wire dilatation catheter 90 which has a flexible distal shaft section 91 , a stiffer proximal shaft section 92, an inflation lumen 93 and a guidewire receiving lumen 94.
  • a dilation balloon 95 is mounted on the distal shaft section 91 having an interior which is in fluid communication with inflation lumen 93 through inflation port 96.
  • the inflation lumen 93 extends from the adaptor 97 to the inflation port 96 through the proximal and distal shaft sections 92 and 91 .
  • An inflation lumen 93 and a guidewire receiving inner lumen 94 are stacked in the long direction of the transverse cross-sectional profile as shown in Fig. 20.
  • the proximal shaft section 91 of the dilatation catheter 90 has a flexible h ⁇ potube 98 which defines the inflation lumen 93 as shown in Fig. 20 to prevent the kinking of the inflation lumen when the catheter is advanced through tortuous passagewa ⁇ s.
  • the h ⁇ potube 98 is preferabl ⁇ formed of an alloy, such as pseudoelastic NiTi alloy, having an austenite phase which is stable at bod ⁇ temperature and exhibiting a stressed induced austenite -to- martinsite phase transformation.
  • the h ⁇ potube 98 extends at least the length of the proximal section of the catheter to a location proximal to the dilation balloon 95.
  • Both proximal and distal shaft sections 92 and 91 have eliptical transverse cross-sections with the inflation lumen 93 and the guidewire receiving lumen 94 being stacked in the long direction of the transverse cross-sectional profile.
  • the embodiment shown in Figs. 19-20 depict an over-the-wire version of the catheter 90 with a guidewire 99 extending through the guidewire lumen 94 throughout its entire length.
  • Fig. 21 illustrates a modification of the catheter 90 shown in
  • Figs. 19-20 which is provided with a proximal guidewire port 100 in communication with the guidewire receiving lumen 94.
  • 97 ma ⁇ be provided with a slit 102 such as described in U.S. Patent 4,748,982 (Horzewski) and U.S. Patent 5,135,535 (Kramer) which are incorporated herein b ⁇ reference.
  • the dilatation catheter 1 10 has a catheter shaft 1 1 1 with a distal section 112 having an oblong transverse cross-sectional shape and a proximal section 113 having an inner tubular member 1 14 and an outer tubular member 115.
  • the distal end of the outer tubular member 115 is secured about the exterior of the proximal end of the distal section 112 and the distal end of the inner tubular member 1 14 is secured to a c ⁇ lindrical extension 1 16 of the distal shaft section 112.
  • the distal shaft section 112 preferabl ⁇ tapers to smaller dimensions at location 117 to increase the flexibility of the distal most portion of the catheter shaft.
  • a guidewire receiving inner lumen 118 extends within the inner tubular member 1 14 from the central arm 119 of the adapter 120 on the proximal end of the catheter shaft 1 1 1 through the distal section 112 to a guidewire port 121 in the distal end of the shaft.
  • An inflation lumen 122 extends from the second arm 123 of adapter 120 through the annular space between the inner and outer tubular members 1 14 and 115, through the distal shaft section 112 into the interior of the inflatable member 124.
  • the various components of the catheters and guidewires of the invention can be formed from a wide variet ⁇ of conventional materials.
  • the catheter shaft including the inner and outer tubular members ma ⁇ be made from pol ⁇ meric materials such as pol ⁇ eth ⁇ lene, pol ⁇ amide, pol ⁇ vin ⁇ l chloride, poi ⁇ ester (e.g. H ⁇ trel ® which is available from DuPont), pol ⁇ etheretherketone (e.g. Grade 381 G from Victrex U.S.A.) and other suitable pol ⁇ meric materials.
  • the h ⁇ potubing ma ⁇ be formed of stainless steel or NiTi superelastic alloy material, such as described previousl ⁇ .
  • the balloon ma ⁇ be made from pol ⁇ eth ⁇ lene, pol ⁇ eth ⁇ lene terephthalate and other relativel ⁇ inelastic pol ⁇ mers and other materials.
  • the dimensions of the catheters generall ⁇ follow the dimensions of conventional intravascuiar catheters.
  • the length is t ⁇ picall ⁇ about 135 cm and the maximum outer diameter of the outer tubular member is about 0.02 to about 0.06 inch (0.51 -1 .52 mm).
  • the transverse shape of the proximal section of the catheter shaft ma ⁇ be circular, oviform or elliptical.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
EP95944226A 1995-01-04 1995-12-21 Katheterschaft mit länglichem querschnitt Withdrawn EP0801582A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US36879495A 1995-01-04 1995-01-04
US368794 1995-01-04
PCT/US1995/016851 WO1996020752A1 (en) 1995-01-04 1995-12-21 Catheter shaft with an oblong transverse cross section

Publications (1)

Publication Number Publication Date
EP0801582A1 true EP0801582A1 (de) 1997-10-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP95944226A Withdrawn EP0801582A1 (de) 1995-01-04 1995-12-21 Katheterschaft mit länglichem querschnitt

Country Status (4)

Country Link
EP (1) EP0801582A1 (de)
JP (1) JP4255135B2 (de)
CA (1) CA2209633C (de)
WO (1) WO1996020752A1 (de)

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WO2014122760A1 (ja) 2013-02-07 2014-08-14 テルモ・クリニカルサプライ株式会社 バルーンカテーテル
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Also Published As

Publication number Publication date
CA2209633A1 (en) 1996-07-11
WO1996020752A1 (en) 1996-07-11
CA2209633C (en) 2008-04-22
JP4255135B2 (ja) 2009-04-15
JPH10511873A (ja) 1998-11-17

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