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US3634924A - Method of making multilumen balloon catheter - Google Patents

Method of making multilumen balloon catheter Download PDF

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Publication number
US3634924A
US3634924A US29889A US2988970A US3634924A US 3634924 A US3634924 A US 3634924A US 29889 A US29889 A US 29889A US 2988970 A US2988970 A US 2988970A US 3634924 A US3634924 A US 3634924A
Authority
US
United States
Prior art keywords
tube
balloon
ferrules
catheter
lumen
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.)
Expired - Lifetime
Application number
US29889A
Other languages
English (en)
Inventor
Lawrence W Blake
Bruce D Bett
Clement E Lieber
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.)
Baxter International Inc
Original Assignee
American Hospital Supply Corp
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 American Hospital Supply Corp filed Critical American Hospital Supply Corp
Priority to US29889A priority Critical patent/US3634924A/en
Priority to CA110,446A priority patent/CA983801A/en
Priority to FR7113712A priority patent/FR2089844A5/fr
Priority to JP46025619A priority patent/JPS5122756B1/ja
Priority to GB00256/71A priority patent/GB1284701A/en
Priority to DE2119172A priority patent/DE2119172C3/de
Priority to US00183104A priority patent/US3746003A/en
Application granted granted Critical
Publication of US3634924A publication Critical patent/US3634924A/en
Assigned to BAXTER TRAVENOL LABORATORIES, INC. A CORP. OF DE reassignment BAXTER TRAVENOL LABORATORIES, INC. A CORP. OF DE MERGER (SEE DOCUMENT FOR DETAILS). EFFECTIVE ON 11/25/1985 ILLINOIS Assignors: AMERICAN HOSPITAL SUPPLY CORPORATION INTO
Anticipated expiration legal-status Critical
Assigned to BAXTER INTERNATIONAL INC. reassignment BAXTER INTERNATIONAL INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). EFFECTIVE ON 10/17/1988 Assignors: BAXTER TRAVENOL LABORATORIES, INC., A CORP. OF DE
Expired - Lifetime legal-status Critical Current

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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
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and 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
    • A61M2025/1065—Balloon catheters with special features or adapted for special applications having a balloon which is inversely attached to the shaft at the distal or proximal end
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49863—Assembling or joining with prestressing of part
    • Y10T29/49865—Assembling or joining with prestressing of part by temperature differential [e.g., shrink fit]

Definitions

  • Balloon inflation openings are formed communicating with one of the lumens.
  • References Cited A sleeve of balloon material is secured by bindings over the UNITED STATES PATENTS ferrules.
  • the tube is limp and the balloon is utilized as a sail to flow carry the catheter through a vein into g i and through the heart and into the pulmonary artery.
  • erman e a 2,994,933 8/1951 Wolfe ..29/447 UX 8 Claims, 9 Drawing Figures PAIENTEU JAN 1 8 I9 nowadays SHEET 1 [1F 2 INVENTORS LAWRENCE W. B
  • This invention relates to multilumen balloon catheters and is particularly concerned with a new and improved method for making such catheters and with an improved flow-directed catheter.
  • Objects of the invention are, therefore, to provide an improved multilumen balloon catheter, to provide an improved and economical method for making such a catheter, to provide improved flow capacity in small multilumen catheters, to provide an improved support for the balloon windings, and to provide an improved flow-directed catheter.
  • multilumen catheter tubes are economically produced by extrusion of a thermoplastic material having a memory characteristic.
  • the novel process steps comprise heating an end portion of the tube sufficiently to permit drawing out said portion of the tube to reduced diameter, applying a pair of metal ferrules over the reduced diameter portion of the tube, heating said end portion of the tube sufiiciently to reexpand the tube and lock the metal ferrules in place, applying an elastic sleeve-type of balloon and binding end portions of the balloon over the metal ferrules.
  • the plastic material under the ferrules is thus not subject to the binding pressure and does not yield or creep causing constriction of the lumens.
  • Catheters of very small size may be made in this manner and the method is of particular advantage in making flow-directed catheters having a soft and limp tube.
  • FIG. I is a schematic illustration of the first step in the method of the invention.
  • FIG. 2 illustrates a second step
  • FIG. 3 illustrates a third step
  • FIG. 4 illustrates a fourth step
  • FIG. 5 illustrates the final step
  • FIG. 6 is a longitudinal sectional view of the completed catheter tip
  • FIG. 7 is a view on the line 77 in FIG. 6;
  • FIG. 8 is a view on the line 8-8 in FIG. 6;
  • FIG. 9 is a longitudinal sectional view of a flow-directed catheter embodying the invention.
  • Tube 10 is formed as an extrusion of a suitable thermoplastic material having a memory characteristic such as polyvinyl chloride.
  • This extrusion contains a large through LII lumen 11 of approximately semicircular shape in cross section as shown in FIG. 7 and a small circular balloon inflation lumen 12.
  • the extrusion is cut off to the desired length and the end portion which is to receive the balloon is heated with hot water 13 as shown in FIG. I.
  • the heated and softened portion of the tube is then drawn by pulling in opposite direction with the fingers as indicated by arrows 14, causing the softened portion 15 to neck down to reduced diameter. This drawing step does not impair the integrity of the lumens 11 and 12.
  • end portion 16 is cut oi? as shown in FIG. 2 and a pair of rigid ferrules 20 and 21 of suitable material such as stainless steel is placed on necked portion 15. These ferrules are placed in appropriate positions for the balloon windings and the necked portion of the tube is reexpanded by heating with heat lamp 22 as shown in FIG. 3.
  • necked portion l5 utilizing the memory characteristic of the plastic, necked portion l5 returns to its original diameter forming shoulders 25 which securely lock the ferrules 20 and 21 in place in indentations in the tube.
  • the ferrules preferably have an outside diameter slightly less than the original diameter of the extrusion.
  • the memory characteristic referred to is the result of crystalline structures set up within some of the polymer chains. When such material is heated under tension, these chains tend to untangle and straighten out. As long as the yield point is not exceeded, i.e., the chains are not broken, the material will return to its original form if reheated and not constrained.
  • One of the advantages of polyvinyl chloride for the present purpose is that it will undergo a great deal of elongation before reaching its yield point.
  • the reexpansion step in FIG. 3 also restores the lumens l1 and 12 to approximately original size.
  • a cylindrical plug 26 of suitable material such as polyvinyl chloride is secured in lumen 12 by a solvent bonding material. This plug is of sufficient length to extend from the cut end 27 of the tube to a point a short distance on the proximal side of ferrule 21.
  • a round wire 30 is inserted temporarily in lumen l l as indicated in FIG. 4 and a tapered tip 31 is formed on the end of the tube by a heated die.
  • the heat of the die causes the outer end portion of plug 26 to lose its identity and merge into the material of the tube as indicated by broken lines at 32 in FIG. 6.
  • wire 30 is removed leaving a round opening at the end of lumen 11.
  • wire 30 is held in concentric axial position within the tube so that opening 11a will be in the center of the tube.
  • a plurality of balloon inflation openings 33 are formed intersecting the lumen 12 and an elastic balloon sleeve 35 is pulled over the tube.
  • the ends of the balloon sleeve are secured by windings 40 of suitable material such as Dacron thread overlying the ferrules 20 and 21 as shown in FIG. 5.
  • These ferrules provide a solid backing for the windings whereby the lumens 11 and 12 are not constricted regardless of the tightness of the windings.
  • windings 40 may be substantially contained within the indentations in the tube created by the ferrules whereby the balloon portion of the catheter has approximately the same diameter as the rest of tube 10.
  • the catheter In use, the catheter is passed through a vein or artery or other body lumen until the tip reaches the area under investigation.
  • the proximal end of the catheter tube not shown, is equipped with the usual fittings providing fluid connections with the lumens 11 and 12.
  • the introduction of balloon inflation fluid under pressure into lumen 12 expands the balloon 35 sufficiently to occlude the body lumen.
  • Lumen 11 may be utilized for injection of therapeutic or diagnostic agents, sampling of a body fluid or pressure monitoring.
  • the extrusion may contain more than two lumens and a second balloon may be applied to the tube in the same manner on the proximal side of balloon 35 if desired.
  • FIG. 9 shows a highly flexible catheter embodying the invention for introduction percutaneously into a peripheral vein for flow guide catheterization of systemic veins, the right heart and pulmonary vessels.
  • Tube 50 is extruded from a suitable thermoplastic material having a memory characteristic, such as soft polyvinyl chloride.
  • the method steps essentially as shown in FIGS. 1 to 5 are utilized for application of the two rigid ferrules 51 and 52 of a suitable material such as stainless steel.
  • the catheter tube has a balloon inflation lumen 53 and a through flow lumen 54, the tube being flexible to the extent of being completely limp.
  • the distal end portion of the tube is heated and drawn out to shrink its diameter as shown in FIG. 1 and the ferrules applied as shown in FIG. 2.
  • the heating step in FIG. 3 utilizes the memory characteristic of the plastic to reexpand the tube, forming shoulders 55 which lock the ferrules in place in indentations in the tube.
  • a longitudinal balloon inflation slit S6 intersecting the lumen 53 is formed by a rotary cutter.
  • the end of lumen 53 is closed by a plug 57 and a contoured tip 58 is die formed on the end of the tube as described in connection with FIG. 4.
  • Ferrule 52 is positioned very close to the end of the tube for a reason which will presently appear.
  • balloon 60 The distal end of balloon 60 is everted under Dacron winding 61 overlying ferrule 52 and winding 62 overlying ferrule 51 is applied to the proximal end of the balloon as shown.
  • the balloon When the balloon is inflated it assumes the shape as shown in broken lines at 60a having a fold forming an annular bulge at 65 which preferably projects beyond and, in any event, forms a guard around the tip end 58 of the catheter tube.
  • Tip 58 is contained in a dimple in the end of the balloon.
  • a second balloon may also be provided, if desired, spaced a short distance in a proximal direction from the balloon 60 and inflated from lumen 53 or from a second balloon inflation lumen. In such case, four ferrules would be applied as shown in FIG. 2 instead of two ferrules.
  • the tube 50 may also include additional lumens 54. When there are two balloons, there may be an additional lumen having an external port opening between the two balloons. There may also be a still further lumen having an external port opening on the proximal side of the second balloon, if desired.
  • Balloon 60 acts as a sail to transport appropriate sensor devices in the catheter into the central circulation.
  • the balloon forms a blunt body which is subjected to the drag force of the blood flowing past it, causing the balloon to pull the catheter along with it.
  • the catheter may be inserted into an ante-cubital or other peripheral vein.
  • the balloon When the balloon is inflated, it will flow carry the catheter through the right heart chambers and into the smaller radicals of the pulmonary artery so that pulmonary capillary wedge pressure may be measured. If the balloon is deflated at this point, pulmonary arterial pressures are measured; when the balloon is inflated, wedge pressure is again seen.
  • the catheter is allowed to advance to the desired destination.
  • the catheter in FIG. 9 may be used for pressure monitoring, blood sampling or infusion without fluoroscopy and with a minimal hazard to the patient.
  • the field of use is in no way limited, however, to the particular example described.
  • the annular bulge 65 prevents point contact of the tip of the catheter tube with the heart or artery wall.
  • the presence of the balloon around the tip of the catheter alters the catheter system from one with a point force to one with forces dispersed over a surface. This markedly reduces the incidence and significance of ventricular extra-systoles which are occasioned by the pressure of a catheter tip on the endocardial and the subendocardial tissues. This is of critical importance in the management of seriously ill patients in whom an arrhythmia, even of transient duration, may prove to be fatal.
  • the method of making a balloon catheter comprising providing a catheter tube of a thermoplastic material having a memory characteristic and containing a balloon inflation lumen, appl ing heat to an end portion of said tube sufficient to soften sai material, drawing out and elongating said softened portion to shrink its diameter, applying a pair of rigid ferrules over said shrunken portion, applying heat to said shrunken portion to reexpand its diameter and lock said ferrules on said tube, forming a balloon inflation opening in said material communicating with said lumen, applying a sleeve of elastic balloon material over said reexpanded portion, and binding said balloon material to said ferrules.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
US29889A 1970-04-20 1970-04-20 Method of making multilumen balloon catheter Expired - Lifetime US3634924A (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
US29889A US3634924A (en) 1970-04-20 1970-04-20 Method of making multilumen balloon catheter
CA110,446A CA983801A (en) 1970-04-20 1971-04-15 Multi-lumen balloon catheter
FR7113712A FR2089844A5 (de) 1970-04-20 1971-04-19
GB00256/71A GB1284701A (en) 1970-04-20 1971-04-20 Improvements in or relating to multi-lumen balloon catheters and method for making the same
JP46025619A JPS5122756B1 (de) 1970-04-20 1971-04-20
DE2119172A DE2119172C3 (de) 1970-04-20 1971-04-20 Ballon Katheter und Verfahren zu seiner Herstellung
US00183104A US3746003A (en) 1970-04-20 1971-09-23 Multi-lumen balloon catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US29889A US3634924A (en) 1970-04-20 1970-04-20 Method of making multilumen balloon catheter

Publications (1)

Publication Number Publication Date
US3634924A true US3634924A (en) 1972-01-18

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Application Number Title Priority Date Filing Date
US29889A Expired - Lifetime US3634924A (en) 1970-04-20 1970-04-20 Method of making multilumen balloon catheter
US00183104A Expired - Lifetime US3746003A (en) 1970-04-20 1971-09-23 Multi-lumen balloon catheter

Family Applications After (1)

Application Number Title Priority Date Filing Date
US00183104A Expired - Lifetime US3746003A (en) 1970-04-20 1971-09-23 Multi-lumen balloon catheter

Country Status (6)

Country Link
US (2) US3634924A (de)
JP (1) JPS5122756B1 (de)
CA (1) CA983801A (de)
DE (1) DE2119172C3 (de)
FR (1) FR2089844A5 (de)
GB (1) GB1284701A (de)

Cited By (76)

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Publication number Priority date Publication date Assignee Title
US3746003A (en) * 1970-04-20 1973-07-17 American Hospital Supply Corp Multi-lumen balloon catheter
US3791560A (en) * 1968-09-26 1974-02-12 Precision Sampling Corp Seals (psc-14)
US3833004A (en) * 1973-10-26 1974-09-03 American Hospital Supply Corp Balloon catheter having single ferrule support for balloon bindings
US3889676A (en) * 1973-03-30 1975-06-17 Ezem Co Enemata administering device
US3933379A (en) * 1972-12-22 1976-01-20 Jacques Pontigny Separable coupling between two tubes and its production process
US4100246A (en) * 1976-06-21 1978-07-11 Dow Corning Corporation Method of forming a gastrointestinal tube
US4143112A (en) * 1974-05-30 1979-03-06 Johnson & Johnson Method for making probe covers for electronic thermometers
US4143651A (en) * 1977-11-03 1979-03-13 The Kendall Company Catheter
US4306246A (en) * 1976-09-29 1981-12-15 Motorola, Inc. Method for trimming active semiconductor devices
US4543963A (en) * 1983-11-22 1985-10-01 Gessman Lawrence J Method and apparatus for differentiating antegrade from retrograde P-waves and for preventing pacemaker generated tachycardia
US4566183A (en) * 1981-06-12 1986-01-28 Raychem Corporation Method for making bi-polar electrocautery needle
US4577634A (en) * 1983-11-22 1986-03-25 Gessman Lawrence J Method and apparatus for alleviating paroxysmal atrail tachycardia
US4645490A (en) * 1984-12-18 1987-02-24 The Kendall Company Nephrostomy catheter with formed tip
US4661095A (en) * 1985-02-12 1987-04-28 Becton, Dickinson And Company Method for bonding polyurethane balloons to multilumen catheters
US4666164A (en) * 1984-08-22 1987-05-19 Raychem Gmbh Method and means for sealing with heat-recoverable foam layer
US4692141A (en) * 1982-03-08 1987-09-08 Mahurkar Sakharam D Double lumen catheter
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US4808155A (en) * 1986-02-27 1989-02-28 Mahurkar Sakharam D Simple double lumen catheter
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CN119113351A (zh) * 2024-11-14 2024-12-13 科塞尔医疗科技（苏州）有限公司 一种颅内球囊扩张导管

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GB1284701A (en) 1972-08-09
CA983801A (en) 1976-02-17
DE2119172B2 (de) 1973-04-05
JPS5122756B1 (de) 1976-07-12
US3746003A (en) 1973-07-17
DE2119172C3 (de) 1973-11-15
FR2089844A5 (de) 1972-01-07
DE2119172A1 (de) 1971-11-04

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