WO1996010434A1 - Catheter pouvant se remplacer rapidement - Google Patents
Catheter pouvant se remplacer rapidement Download PDFInfo
- Publication number
- WO1996010434A1 WO1996010434A1 PCT/US1995/012715 US9512715W WO9610434A1 WO 1996010434 A1 WO1996010434 A1 WO 1996010434A1 US 9512715 W US9512715 W US 9512715W WO 9610434 A1 WO9610434 A1 WO 9610434A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- guidewire
- catheter
- balloon
- lumen
- distal end
- Prior art date
Links
- 239000012530 fluid Substances 0.000 claims description 4
- 238000004891 communication Methods 0.000 claims description 2
- 230000003247 decreasing effect Effects 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 abstract description 4
- KKJUPNGICOCCDW-UHFFFAOYSA-N 7-N,N-Dimethylamino-1,2,3,4,5-pentathiocyclooctane Chemical compound CN(C)C1CSSSSSC1 KKJUPNGICOCCDW-UHFFFAOYSA-N 0.000 abstract 1
- 238000000034 method Methods 0.000 description 17
- 239000004642 Polyimide Substances 0.000 description 14
- 229920001721 polyimide Polymers 0.000 description 14
- 208000031481 Pathologic Constriction Diseases 0.000 description 12
- 230000036262 stenosis Effects 0.000 description 12
- 208000037804 stenosis Diseases 0.000 description 12
- 239000000463 material Substances 0.000 description 11
- 230000009977 dual effect Effects 0.000 description 10
- 239000000560 biocompatible material Substances 0.000 description 9
- 239000003550 marker Substances 0.000 description 6
- 229920000573 polyethylene Polymers 0.000 description 6
- 239000004698 Polyethylene Substances 0.000 description 5
- 238000002399 angioplasty Methods 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- -1 polyethylene Polymers 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 4
- 239000010963 304 stainless steel Substances 0.000 description 3
- 229910000589 SAE 304 stainless steel Inorganic materials 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- 229910045601 alloy Inorganic materials 0.000 description 2
- 239000000956 alloy Substances 0.000 description 2
- 230000008081 blood perfusion Effects 0.000 description 2
- 210000004351 coronary vessel Anatomy 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 229910052741 iridium Inorganic materials 0.000 description 2
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 description 2
- 229920000126 latex Polymers 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 229920001684 low density polyethylene Polymers 0.000 description 2
- 239000004702 low-density polyethylene Substances 0.000 description 2
- 230000007257 malfunction Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 238000010926 purge Methods 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 229910002835 Pt–Ir Inorganic materials 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 229920000249 biocompatible polymer Polymers 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000000748 cardiovascular system Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 238000007887 coronary angioplasty Methods 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000002939 deleterious effect Effects 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000004816 latex Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 230000002787 reinforcement Effects 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09008—Guide wires having a balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
Definitions
- the present invention relates to over-the-wire PTCA balloon catheters, and more particularly, to a rapid exchange catheter with the guidewire lumen at the distal tip.
- Catheters comprise tube-like members inserted into the body for diagnostic or therapeutic medical reasons.
- One of the therapeutic procedures applicable to the present invention is known as percutaneous transluminal coronary angioplasty (PTCA) .
- PTCA percutaneous transluminal coronary angioplasty
- the first PTCA procedure was developed in approximately 1976-1977 by Dr. Andreas Gruntzig.
- This fixed wire system featured a core or guidewire fixed within the catheter to stiffen it so that it could be pushed into position in the vascular system.
- Blockage in a coronary artery could be reduced by positioning the balloon dilatation catheter across from the blockage and inflating the balloon causing the blockage to decrease.
- Rapid exchange catheters were developed to respond to the disadvantage of the long "exchange" wire in over-the-wire systems. These catheters have shorter guidewire lumens so that the guidewire exits from the catheter closer to the balloon than to the proximal end of the catheter. This enables the physician to anchor or hold the guidewire as he or she removes the catheter from the body, the exchange occurring over the shorter guidewire lumen.
- One of the first rapid exchange catheters in biaxial form is U.S.
- Patent No. 4,762,129 issued to Bonz ⁇ l A disadvantage of this catheter is the position of the guidewire exit port at the proximal balloon bond coupled with a short guidewire exchange lumen which can cause the balloon to become snagged during withdrawal through the tortuous path. The resultant buckling of the catheter may result in inadvertent withdrawal of the guidewire from the lesion due to seizure of the guidewire by the buckled lumen.
- Rapid exchange catheter designs such as those in Yock, U.S. Patent Nos. 5,040,548 and 5,061,273, responded to the Bonzel catheter disadvantages by lengthening the guidewire exchange lumen.
- the guidewire lumen passes through the balloon and is generally coaxial with respect to the inflation lumen, but exits (or enters) in the side port at least 10 centimeters from the distal tip of the catheter.
- the Yock disclosure suggests a lumen of 10 or more centimeters; in catheters on the market, the lumen varies from about 9 to 35 centimeters in length.
- the lengthened guidewire lumen induces friction between the catheter and guidewire during catheter manipulation and withdrawal. Such friction can contribute to extraneous guidewire movement.
- German patent application P 39 34 695.1 to Ruppr ⁇ cht discloses a longitudinal slot 2 which extends up the central axis of the catheter reaching from any location on the catheter to the end of the catheter.
- the longitudinal slot allows the rapid exchange of the guidewire by guiding it up the central guide channel 3 throughout the entire length of the catheter.
- balloon catheters such as that described by Bj ⁇ rn Nord ⁇ nstrom in Acta radiol , 57: 411-416, November 1962.
- a flexible steel wire is introduced through the tip of the catheter and taken out through the side hole distal to the balloon (page 112 Fig. I type I and page 413 Fig. 2 type 2) .
- the Nordenstr ⁇ m catheter materials consist of teflon or opaque polythene material plus latex rubber balloons. (See page 412). Thus air bubbles are not visible during the purging process to alert the operator to malfunction.
- latex balloons do not have a known diameter at specific pressures and may expand beyond the size of the vessel.
- An angiocardiographic balloon catheter is also described by Bj ⁇ rn Nordens r6m in RADIOLOGY, 85: 256 - 259, July-December 1965.
- Page 257, Fig. A depicts a relatively long tip through which the guidewire is passed to facilitate the injection of contrast medium.
- the guide loop 10 or lumen comprising a member which may be threaded over a primary guidewire 14. This allows passage of an instrument over the guidewire 14 without the use of a through- lumen.
- the guide loop 10 is positioned at the tip or distal end of the instrument. The instrument is advanced alongside the guide wire 14 and is kept on course via the secondary guide wire 12 pushing behind the instrument.
- U. S. patent No. 5,046,497 to Millar discloses a coupling structure 20 slidably engaging the guidewire allowing a plurality of diagnostic or therapeutic catheters such as sensor-carrying catheters to be coupled to a common guidewire.
- the present invention discloses a rapid exchange medical catheter having a wire guiding means external to the shaft for slidably mounting over the guidewire, the wire guiding means being a short tubular member having a proximal end and a distal end extending proximally from the distal end of the shaft and terminating before the distal end of the therapy means.
- the advantages of applicant's invention are first, only one operator is required for the procedure, second, an inner lumen is not required to accommodate the guidewire, third, a short exchange lumen results in less friction and a faster exchange, and fourth, pinching the guidewire is minimized as the catheter is being removed through the tortuous path thereby tending to minimize pulling out the guidewire upon withdrawal of the catheter.
- FIG. 1 represents the longitudinal cross-sectional view of a dual lumen embodiment of an angioplasty catheter incorporating the present invention
- FIG. 2 represents the cross-sectional view shown in Fig. 1 along the line 2-2 of the dual lumen embodiment's region preceding the proximal end of the balloon;
- FIG. 3 represents the cross-sectional view along the line 3-3 of the dual lumen embodiment's region following the distal end of the balloon;
- FIG. 4 represents the side elevational view of a dual lumen embodiment
- FIG. 5 represents the longitudinal cross-sectional view of a single lumen embodiment
- FIG. 6 represents the cross-sectional view along the line 6-6 of the single lumen embodiment's region following the distal end of the balloon;
- FIG. 7 represents the cross-sectional view along the line 7-7 of the single lumen embodiment's region preceding the proximal end of the balloon;
- FIG. 8 represents the side elevational view of a single lumen embodiment
- FIG. 9a represents a one piece molded tip
- FIG. 9b represents a staked pin tip attachment
- FIG. 9c represents a bored and bonded tip attachment
- FIG. 9d represents a tip with recessed lumen
- FIG. 9e represents a tip with a tubular member parallel to the shaft.
- FIG. 10 represents the longitudinal cross-sectional view with the polyimide tip.
- FIG. 11 represents the cross-sectional view along the line 11-11 in Fig. 10.
- Applicants have developed a rapid exchange balloon dilatation catheter with a short tubular guidewire lumen at the distal tip.
- the purpose of a guidewire is to aid in positioning the catheter across a specific intervascular obstruction.
- This invention is intended for use as a dilatation catheter having a balloon means at the distal end to be placed across a stenosis. Under fluoroscopic guidance, the guidewire can be placed first in proximity to a stenosis and then across the stenosis. The rapid exchange balloon dilatation catheter can then be inserted into the stenosis following the path established by the guidewire. Further manipulations of the catheter are made to position the device across the obstruction.
- the balloon is inflated in such a manner that the diameter of the obstructed area is increased.
- multiple catheters are frequently required during a procedure. Once a stenosis has been crossed and dilated with the dilating balloon, the dilatation catheter can be withdrawn, leaving the guidewire in position across the stenosis.
- a different device can then be inserted over the guidewire, as for example, an intervascular ultrasound device, an angioscopy device, a fiber optic viewing catheter, an arterial stent delivery catheter, or another dilatation catheter to further enlarge the cross sectional diameter of the obstruction by means of repeated dilatation with a balloon of greater diameter. Additionally, it may be desirable for the physician to be able to place the guidewire across another obstruction and to dilate this with a balloon dilatation catheter having a balloon of a different diameter.
- the average number of catheters used per patient procedure is 1.6.
- the guidewire is instead back-loaded through a distal tip tubular member.
- a typical rapid exchange guidewire is of approximately 180 cm in length.
- Conventional over-the-wire methods of loading the distal end of the catheter over the proximal end of the guidewire require a lumen running throughout the catheter shaft.
- the conventional over-the-wire guidewire and catheter requires a guidewire length of approximately 300 cm thereby requiring two operators for the procedure.
- the inner lumen in applicant's catheter shaft is not used by the guidewire and is therefore free for other uses such as blood perfusion.
- the inner guidewire lumen can also be eliminated entirely thereby reducing shaft profile.
- a short exchange lumen causes less friction during the procedure resulting in a faster exchange. Additionally, friction between the catheter and the guidewire must be kept to a minimum to reduce extraneous movement of the guidewire and keep it stationary.
- the present invention addresses this matter by shortening the length of the contact surface between the catheter and the guidewire as well as by forming the exchange portion of the catheter out of a material with a very low coefficient of friction.
- the present invention addresses the problem of pinching the guidewire as the catheter is being removed through the tortuous path thereby pulling out the guidewire and resulting in the loss of guidewire positioning over the stenosis.
- a factor which contributes to guidewire pinching includes the position of the guidewire exit port.
- the position of the guidewire exit port at the proximal balloon bond can cause the balloon to become snagged during withdrawal of the catheter into the ancillary guide catheter.
- the resultant buckling of the catheter may result in inadvertent withdrawal of the guidewire from the lesion due to seizure of the guidewire by the buckled lumen. This may have deleterious effects upon the patient undergoing angioplasty.
- the present invention tends to minimize the likelihood of guidewire seizure during catheter withdrawal by positioning the exchange component distal to the inflatable balloon and by using a short exchange lumen which keeps the guidewire relatively straight.
- a guidewire lumen of .75 cm can be used.
- Another factor which tends to minimize the likelihood of guidewire seizure in the present invention includes the low coefficient of friction in materials such as polyimide.
- the distal tip guidewire lumen is a short tubular member consisting of any biocompatible material such as polyethylene, polycarbonate, polyimide, combinations thereof or biocompatible metals such as #304 stainless steel.
- the guidewire lumen is open on both ends and extends rearwardly (proximally) from the distal extremity of the catheter and terminates before the distal end of the balloon attachment.
- This tubular member allows rapid exchange of angioplasty catheters by sliding the original catheter over the guidewire and out the vessel while maintaining the position of the guidewire across the stenosis so that a new catheter can be advanced to the stenosis if required.
- the simple design results in lower manufacturing costs than conventional over-the-wire catheters as fewer components, fewer manufacturing steps and less tubing is required.
- This invention can be implemented as either a single lumen catheter or a dual lumen catheter.
- the advantage of the single lumen configuration over a dual lumen configuration is that of its lower profile. A low profile enhances the ability of a catheter to cross a stenosis.
- the advantage of the dual lumen embodiment is that the inner lumen can be used for fluid delivery such as blood perfusion or the infusion of an oxygenated liquid, anticoagulants or other drugs.
- the single lumen invention can be better understood by referring to the drawings in FIGs. 5 through FIG. 8.
- the balloon catheter 5 single lumen system consists of the following.
- a central core wire 10 is made of any biocompatible material, preferably of #304 stainless steel.
- the core wire 10 provides stiffness which improves pushability and torquability.
- the core wire 10 may optionally be surrounded by a helically wound spring coil 15 which provides pushability from within instead of the need to rely on an outer shaft for pushability.
- the core wire 10 also provides push to the distal tip 45.
- the spring coil 15 can be made of any biocompatible material, preferably of #304 stainless steel.
- the spring coil 15 extends from the manifold 110 to the distal end of the balloon 125.
- the balloon 25 is made of biocompatible material such as low density polyethylene.
- the catheter shaft is comprised of a helical spring coil 15, which is covered by a jacket 20 consisting of a biocompatible material such as a polymer or polyethylene.
- the jacket 20 is heat shrunk about the spring coil 15.
- the distal end of the balloon 125 is heat shrunk about the distal end of the spring coil 115.
- the proximal end of the balloon 120 is heat shrunk about the spring coil 15.
- the area of the spring coil 15 within the jacket 20 defines the balloon inflation lumen 30.
- An aperture 100 is cut through the spring coil 15 and jacket 20 to permit transmission of fluids from the balloon inflation lumen 30 to the balloon 25.
- the core wire 10 is affixed by bonding or welding the proximal end of the core wire 10 to the spring coil 15 at the proximal end of the manifold 110.
- the distal end of the core wire 10 could be welded to the spring coil distal end 115. If so, however, the device would not react symmetrically since such welding will stiffen only one side.
- the core wire 10 is free to float within the spring coil 15 and moves independently of the spring coil 15. Balloon inflation liquids are perfused through the balloon inflation lumen 30.
- a radiopaque marker band 40 is bonded to the core wire 10 preferably at the point which is the center of the balloon 25 although it could be located other places such as the proximal and/or distal ends of the balloon 25.
- the marker band 40 is used to provide a fluoroscopic indication of the location of the balloon 25 thereby allowing the operator to adjust the position of the balloon 25.
- Preferred materials for the marker band 40 include 100% gold, 100 % iridium, or alloys of these materials such as a Pt-Ir alloy consisting of 90% platinum and 10% iridium.
- the preferred density is of at least 19.3 to 21.0 gm/cm 3 .
- the entire spring coil 15, or just the distal portion of the spring coil 15 can be fabricated of a radiopaque materials as described above to make the spring coil 15 visible by fluoroscopy.
- a typical balloon 25 for any of applicant's embodiments has the following length, diameter and material characteristics. Balloon length ranges from 2 cm to 4 cm with the diameter size ranging from 1.5 mm to 5.0 mm.
- the balloon 25 is made of a biocompatible material such as low density polyethylene or similar materials which have a known diameter under a specific pressure.
- the distal end of the Balloon 25 is heat shrunk to the distal end of the core wire 10.
- Balloon 25 may also be heat shrunk over the distal tip 45 or portions thereof with the core wire 10 inserted therein and glued, bonded, brazed or fastened to the distal tip 45 with any other suitable method.
- Applicant's catheter material for all embodiments comprises any biocompatible polymer or metal. Polymers include polyimide and more preferably polyethylene which is clear. A clear radiolucent material is preferable because air bubbles visible during the purging process alert the operator to malfunction. In the preferred embodiment, only the spring coil 15 and radiopaque marker band 40 are not clear.
- the dual lumen invention can be better understood by referring to the drawing in FIGs. 1 through 4.
- the balloon catheter 5 dual lumen system consists of the following.
- a central core wire 10 provides stiffness which improves pushability and torquability.
- the core wire 10 may optionally be surrounded by a helically wound spring coil 15 to increase pushability instead of the need to rely on an outer shaft for pushability.
- the core wire 10 also provides push to the distal tip 45.
- the spring coil 15 would, however, increase the profile and the cost and it may be more desirable to use a polymer shaft 35 instead.
- a spring coil 15 When a spring coil 15 is used, it extends from the manifold 65 to the distal end of the balloon 125 and is covered by a plastic jacket 20 consisting of a biocompatible material such as polyethylene which is heat shrunk about the spring coil 15. The distal end of the balloon 125 is heat shrunk to the distal end of the spring coil 115. The proximal end of the balloon 120 is heat shrunk to the shaft 35. The area of the spring coil 15 within the jacket 20 defines the inner lumen 70. The core wire 10 is free to float within the spring coil 15 and moves independently of the spring coil 15. Liquids can flow through the inner lumen 70.
- one or more exit ports 60 are created in the jacket 20 and balloon distal end 125 to permit the liquid to move from the inner lumen 70 into the blood stream.
- a manifold 65 suitable for the introduction of additional fluids as required.
- a balloon inflation lumen 30 surrounds the jacket 20. The inflation lumen's 30 distal end is connected with the manifold 65 and receives liquids therethrough for purposes of inflating the balloon 25 thereby reducing the stenosis.
- the radiopaque marker band 40 is affixed to the spring coil 15 and can be used to fluoroscopically view the position of the balloon 25 to allow the user to adjust the position of the balloon 25.
- Surrounding the inflation lumen 30 is the shaft 35 which is constructed of any biocompatible material such as a polymer.
- the balloon 25 is affixed to the shaft 35 by heat shrinking.
- the molded distal tip 45 has a rearwardly extending guidewire lumen 50 through which the guidewire 55 is threaded.
- the guidewire 55 can be any useful size, preferably a standard size such as .010 mm, .014 mm, or .018 mm.
- the guidewire lumen 50 can be nearly parallel with the core wire
- the distal tip 45 guidewire lumen 50 can be implemented with a variety of attachment variations and tip shapes. Attachment variations include bonding the distal tip 45 to the shaft 35 or a one piece molded tip as in Fig. 9a.
- the distal tip 45 could also be molded with a staked pin 80 and welded to the core wire 10 as in Fig. 9b.
- the staked pin 80 could also be threaded, knurled or ribbed for improved grip.
- the distal tip 45 could be bored 85 as with a laser and the distal tip 45 then fit and bonded over the distal end of the catheter shaft.
- Tip shape embodiments include a recess 90 for ease of loading as in Fig. 9d.
- the distal tip 45 could be fluted, streamlined or bullet shaped. In Fig.
- Fig. 10 shows a balloon formed from a unitary tubular member 135 having a core wire 10 running therethrough.
- the tubular member 135 decreases in diameter distally to form a section of reduced diameter 130 such that the tubular member 135 makes contact with the core wire 10.
- the tubular member 135 has a section of expanded diameter distal to the section of reduced diameter 130, the distal end of the section of reduced diameter 130 is contiguous with the proximal end of the section of expanded diameter.
- the section of expanded diameter defines a guidewire lumen 50.
- a skive is cut in the proximal end of the section of expanded diameter to form a proximal port 105 for the guidewire lumen 50.
- Fig. 10 represents an embodiment of the invention with the polyimide annulus 95 in the distal tip 45.
- the polyimide annulus 95 acts as a reinforcement member and as a guidewire lumen 50.
- Polyimide is advantageous because it is stiff, absorbs force, is smooth, reduces friction, and it is strong.
- other biocompatible materials having these properties could be used.
- Other embodiments may include a spring coil with a polyethylene sheath. In such embodiments, the spring coil 15 does not stop at the proximal balloon bond as it does in the Fig. 10 embodiment but continues through the balloon 25.
- the polyimide annulus 95 should not be longer than about .75 cm due to the stiffness of polyimide.
- One example of a method of creating the polyimide annulus 95 includes the following. Cut the balloon 25 distal neck to 1 cm in length. Skive the proximal guidewire exit port 105. Insert a mandrel into a .25 cm to 1 cm length polyimide tube. Insert the polyimide tube into the catheter distal tip. Shrink the distal end of balloon 25 to capture the polyimide annulus 95. Remove the mandrel.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Vascular Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
L'invention concerne des cathéters à ballonnet et à fil mobile (5) s'utilisant en angioplastie coronaire transluminale percutanée et, plus particulièrement, un cathéter pouvant se remplacer rapidement, dont la pointe distale comporte la lumière du fil de guidage (50). Il s'agit d'un cathéter médical pouvant se remplacer rapidement et possédant un moyen de guidage du fil placé à l'extérieur de la tige (35), de manière à effectuer un montage coulissant au-dessus du fil de guidage (55), ce moyen de guidage de fil étant un élément tubulaire court possédant une extrémité proximale et une extrémité distale s'étendant de façon proximale selon un angle supérieur à 0 degrés depuis l'extrémité distale de la tige (35) et se terminant avant l'extrémité distale du ballonnet thérapeutique.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU37624/95A AU3762495A (en) | 1994-10-04 | 1995-10-03 | Rapid exchange catheter |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US32418794A | 1994-10-04 | 1994-10-04 | |
US08/324,187 | 1994-10-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1996010434A1 true WO1996010434A1 (fr) | 1996-04-11 |
Family
ID=23262480
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1995/012715 WO1996010434A1 (fr) | 1994-10-04 | 1995-10-03 | Catheter pouvant se remplacer rapidement |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU3762495A (fr) |
WO (1) | WO1996010434A1 (fr) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7077841B2 (en) * | 2001-03-26 | 2006-07-18 | Curon Medical, Inc. | Systems and methods employing a guidewire for positioning and stabilizing external instruments deployed within the body |
WO2011034491A1 (fr) * | 2009-09-15 | 2011-03-24 | St Jude Medical Systems Ab | Unité de guidage à échange rapide |
WO2016158475A1 (fr) * | 2015-03-30 | 2016-10-06 | 株式会社グッドマン | Cathéther |
EP3950036A1 (fr) * | 2020-08-06 | 2022-02-09 | Canon U.S.A. Inc. | Gaine de cathéter optimisée pour cathéter rx |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0344530A1 (fr) * | 1988-05-27 | 1989-12-06 | Advanced Cardiovascular Systems, Inc. | Ensemble de cathéter vasculaire avec cheville guide |
US5098376A (en) * | 1989-12-22 | 1992-03-24 | Cardiopulmonics, Inc. | Apparatus and methods for furling and introducing an extrapulmonary blood gas exchange device |
US5221258A (en) * | 1991-01-22 | 1993-06-22 | Shturman Technologies, Inc. | Introduction balloon catheter |
WO1994011048A1 (fr) * | 1992-11-12 | 1994-05-26 | Medtronic Inc | Catheter a echange rapide |
EP0611582A2 (fr) * | 1993-01-19 | 1994-08-24 | Datascope Investment Corp. | Cathéter intra-aortique à ballonet, sur le guide, à un seul lumen |
-
1995
- 1995-10-03 AU AU37624/95A patent/AU3762495A/en not_active Abandoned
- 1995-10-03 WO PCT/US1995/012715 patent/WO1996010434A1/fr active Application Filing
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0344530A1 (fr) * | 1988-05-27 | 1989-12-06 | Advanced Cardiovascular Systems, Inc. | Ensemble de cathéter vasculaire avec cheville guide |
US5098376A (en) * | 1989-12-22 | 1992-03-24 | Cardiopulmonics, Inc. | Apparatus and methods for furling and introducing an extrapulmonary blood gas exchange device |
US5221258A (en) * | 1991-01-22 | 1993-06-22 | Shturman Technologies, Inc. | Introduction balloon catheter |
WO1994011048A1 (fr) * | 1992-11-12 | 1994-05-26 | Medtronic Inc | Catheter a echange rapide |
US5383853A (en) * | 1992-11-12 | 1995-01-24 | Medtronic, Inc. | Rapid exchange catheter |
EP0611582A2 (fr) * | 1993-01-19 | 1994-08-24 | Datascope Investment Corp. | Cathéter intra-aortique à ballonet, sur le guide, à un seul lumen |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7077841B2 (en) * | 2001-03-26 | 2006-07-18 | Curon Medical, Inc. | Systems and methods employing a guidewire for positioning and stabilizing external instruments deployed within the body |
US7731684B2 (en) | 2001-03-26 | 2010-06-08 | Mederi Therapeutics Inc. | Systems and methods employing a guidewire for positioning and stabilizing external instruments deployed within the body |
US8439866B2 (en) | 2001-03-26 | 2013-05-14 | Mederi Therapeutics, Inc. | Systems and methods employing a guidewire for positioning and stabilizing external instruments deployed within the body |
US9107674B2 (en) | 2001-03-26 | 2015-08-18 | Mederi Therapeutics, Inc. | Systems and methods employing a guidewire for positioning and stabilizing external instruments deployed within the body |
WO2011034491A1 (fr) * | 2009-09-15 | 2011-03-24 | St Jude Medical Systems Ab | Unité de guidage à échange rapide |
WO2016158475A1 (fr) * | 2015-03-30 | 2016-10-06 | 株式会社グッドマン | Cathéther |
EP3950036A1 (fr) * | 2020-08-06 | 2022-02-09 | Canon U.S.A. Inc. | Gaine de cathéter optimisée pour cathéter rx |
Also Published As
Publication number | Publication date |
---|---|
AU3762495A (en) | 1996-04-26 |
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