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WO1995017219A1 - Pompe a ballonnet intra-aortique - Google Patents

Pompe a ballonnet intra-aortique Download PDF

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Publication number
WO1995017219A1
WO1995017219A1 PCT/US1994/014721 US9414721W WO9517219A1 WO 1995017219 A1 WO1995017219 A1 WO 1995017219A1 US 9414721 W US9414721 W US 9414721W WO 9517219 A1 WO9517219 A1 WO 9517219A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
patient
catheter
intra
furled
Prior art date
Application number
PCT/US1994/014721
Other languages
English (en)
Inventor
William Edelman
Mark Thomas Kieras
Peter T. Majeski
Original Assignee
St. Jude Medical, 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 St. Jude Medical, Inc. filed Critical St. Jude Medical, Inc.
Priority to JP7517569A priority Critical patent/JPH09511155A/ja
Priority to EP95906051A priority patent/EP0735903A4/fr
Publication of WO1995017219A1 publication Critical patent/WO1995017219A1/fr

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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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/1038—Wrapping or folding devices for use with balloon 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
    • A61M60/843—Balloon aspects, e.g. shapes or materials
    • 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
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/295—Balloon pumps for circulatory assistance
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/14—Dipping a core
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters

Definitions

  • This invention relates to intra-aortic balloon pumps and particularly to improved intra-aortic balloon pump catheters.
  • Intra-aortic balloon pumps are used to provide counter pulsation within the aorta of ailing hearts over substantial periods of time, e.g. to provide ventricular assistance during cardiogenic shock, low cardiac output in post-operative care, weaning from cardiopulmonary bypass, treatment for refractory unstable angina, and other circumstances of sub-normal cardiac function.
  • Such pumps of the type involved in this invention include a flexible thin-walled balloon which is readily inflatable under low pressure to substantial size and displacement, mounted on a catheter device used for insertion of the balloon into a remote artery and through the intervening vascular system of the patient to the aortic pumping site while the balloon is deflated and furled.
  • the furled large capacity balloon through a small insertion passage, e.g., a small puncture opening or through an introducer cannula into the selected artery, and then sliding-threading of the catheter and furled balloon through tortuous lumen passageways of the patient's vascular system over a guidewire to the pumping site, e.g. from insertion into an artery in the groin area to the patient's descending aorta.
  • the balloon is unfurled and then successively and rapidly inflated and deflated in synchronism with the patient's cardiac pulsation rates over extended periods of time in a known counterpulsation technique to enhance cardiac output.
  • an IABP requires forceful sliding insertion of a relatively large balloon through a small insertion opening and tortuous arterial lumens, which may be randomly narrowed by arteriosclerotic deposits of plaque, and subsequent unfurling and reliable pulsation operation at heart-beat rates over substantial periods of time, e.g. for several days.
  • the balloon may be subject to abrasion by plaque deposits or the like during the pulsation operation at the pumping site.
  • the furled balloon, as well as the related catheter mechanism should be slippery during insertion for ease of sliding movement through the insertion site, through small lumens and along changes of direction in tortuous pathways during its passage along the patient's vascular system from the point of entry to the aorta, with minimum risk of inducing morbidity during such insertion and passage and during use in the pumping phase.
  • the balloon should be dry and non-slippery during handling, furling, packaging, unpackaging and handling by the health care personnel up to the time of actual insertion into the patient's vascular system.
  • the related catheter equipment typically includes dual concentric lumens, including a center lumen passageway to serve functions such as engaging over a guidewire, sensing values in the aorta, e.g. arterial pressure, and/or administration of medicaments.
  • a surrounding annular passageway between the inner and outer lumens must be of a size adequate to shuttle an operating gas such as helium at rates to obtain the rapid repetitious expansion and collapse of the balloon necessary for the pumping function in counterpulsation to the patient's heart.
  • polyvinylpyrrolidone is a commercially available poly (N- vinyl lactam) hydrophilic polymer which has several characteristics making it useful and desirable in forming hydrophilic lubricous coatings on catheters and other invasive devices.
  • the cited U.S. Pat. Nos. 4,100,309 and 4,119,094 describe coating of such devices by a two step procedure. First a solution of an isocyanate containing prepolymer and polyurethane is applied to the substrate of the device to be coated followed by a coating solution of polyvinylpyrrolidone. Polyurethane may be omitted from the isocyanate containing prepolymer when the substrate is polyurethane.
  • U.S. Pat. No. 4,646,719 describes one beneficial structure and form of intra-aortic balloon pumps and includes a description of the manner of insertion and use of such pumps.
  • an outer surface coating of a blend of an organic solvent soluble thermoplastic polyurethane having no reactive isocyanate functionality and a poly (N-vinyl lactam) , specifically polyvinylpyrrolidone, in a suitable solvent, such as suggested in the U.S. Pat. No. 4,642,267, on an intra-aortic balloon provides a stable, highly lubricous surface while apparently preserving the functional physical characteristics of the balloon as a part of an intra-aortic balloon pump catheter device. This includes, for example, maintaining flexibility, bonding capacity, inflatability, aneurysm pressure, tensile strength and abrasion resistance to assure reliable pulsing operation over extended periods of intra-aortic pumping operation.
  • the coating may be readily applied to the balloon, which typically is of polyurethane, as by a casting or dip coating procedure to readily form a uniform film, and then dried to provide a dry non-slippery product for conventional handling, furling of the balloon, packaging and operation preparation purposes.
  • the coating is self- activated upon contact with an aqueous solution, including blood, whereby the coating hydrates substantially instantaneously and thereby acquires a coefficient of friction much lower than that of an uncoated balloon catheter.
  • the result is a very slippery external surface which provides ease of insertion of the intra-aortic balloon catheter through tissue or through an introducer cannula and through the patient's vasculature to facilitate placement in the aorta for counterpulsation therapy.
  • the highly lubricous surface of the balloon facilitates insertion and positioning of the pump balloon with minimal forces and is believed to reduce morbidity in terms of thromboembolism and/or dissection of the arterial walls.
  • the coating also may be pre-wetted just prior to insertion if preferred by the user, with the same beneficial effect. It is believed that the coating also reduces the impact of atherosclerotic lesions upon the balloon material, and thus aides in preserving the integrity of the balloon both during insertion and during use to enhance the necessary durability of the intra-aortic balloon pumping device.
  • An object of the invention is to provide intra-aortic balloon pump catheters which provide ease of insertion with minimum trauma while obtaining and maintaining good reliability and useful life of the balloon pump.
  • BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a simplified top view of an intra-aortic balloon catheter employing this invention.
  • Fig. 2 is an enlarged cross-sectional view taken along line 2-2 of Fig. 1.
  • Fig. 2A is a further enlarged schematic illustration of a cross-sectional segment of the balloon as in Fig. 2.
  • Fig. 3 is an enlarged side elevation view illustrating the balloon section of the pump device of Fig. 1 with the balloon furled and unsheathed, such as during insertion through a patient's vasculature.
  • Fig. 4 is a schematic side elevation of a tubular sheath for the furled balloon of Fig. 3.
  • Figs. 5A-5E schematically illustrate steps in one mode of applying the coating of the balloons of Figs. 1-3.
  • an intra-aortic balloon pump device 10 includes a flexible tubular outer lumen 12 and a co-axial flexible tubular inner lumen 14 attached to a wye connector 16.
  • a single chamber intra-aortic balloon 20 is attached at its proximal end to the distal end of the outer lumen 12.
  • the distal end of the balloon 20 is attached to the distal portion of the inner lumen 14.
  • Each of these balloon-lumen attachments is a gas-tight adhesive bond connection between an end sleeve section 21,22 of the balloon and the outer surface of the respective lumen 12,14.
  • these end attachment sleeves are of substantially lesser diameter than the main displacement body section 23 of the balloon and are joined thereto by short tapered sections 24,25.
  • the wye connector 16 provides access through the lateral branch 26 to an appropriate gas supply pump and control device (not shown) for inflating and deflating the balloon 20 by successively injecting and withdrawing a gas such as helium through the annular space between the lumens 12 and 14.
  • the controller responds to the pulsing of the heart and effects inflation and deflation of the balloon in timed counterpulsation to the pumping action of the heart in a known manner.
  • the axial section 27 of the wye provides axial access to the inner lumen for reception of a guide wire 28 as well as for sensing of arterial pressure and/or the injection of medicaments through the inner lumen.
  • Tie downs 32 are included for affixation to the skin of the patient by suturing and/or taping for securing the catheter in its inserted operative pumping position.
  • the balloon 20 is a large flexible thin-film balloon of conventional appropriate size, i.e., on the order of about 0.5" to about 1.0" in diameter when in an inflated but unstretched condition and about 8" to 12" in length. Typical sizes are of 30cc, 40cc and 50cc displacement.
  • the balloon may be formed of any suitable material, with polyurethane presently being preferred.
  • a hydrophilic coating 36 covers the balloon. The coating forms a lubricous outer surface which is very slippery when wetted by an aqueous fluid, such as blood, while permitting processing and furling of the balloon and handling of the balloon and related pump mechanism in a normal manner when dry.
  • Coatings which are available from Hydromer Inc., Whitehouse, New Jersey, and comprise polyvinylpyrrolidone have been found efficacious. These coatings comprise poly ⁇ vinylpyrrolidone and one or more polyurethane or isocyanate-containing prepolymers. It is reported that these polymers react with one another forming interpenetrating polymer networks which swell to varying degrees in the presence of water, depending on the concentration of the components, and that they have anti- thrombogenic properties. They swell immediately upon contact with water-based fluids but do not dissolve, becoming extremely lubricous and highly durable coatings e.g. typically of 0.2 - 0.5 mils thickness after drying.
  • hydrophilic coatings can be applied to intra-aortic balloons 20 to gain the desirable slipperiness when wet without significantly impairing the normal physical properties and handlability of the balloons and assembled devices.
  • the coated balloon 20 is furled, as illustrated schematically at 20f in Fig. 3. This minimizes its effective outer diameter during insertion into a patient's arterial system.
  • the furling may be accomplished in a conventional manner. This includes applying a solution of silicone and freon on the outer surface such as by spraying to deposit silicone thereon, then evacuating the air from the balloon thereby causing the balloon to collapse into flat generally radially extending "wings", then rolling those wings tightly about the inner lumen 14 in mutually interleaved relation with one another.
  • a thin tubular sheath 40 typically is placed over the furled balloon to maintain its radial compaction to a minimum effective outside diameter, e.g., 9 Fr. (about 0.117") during shipping and handling, up to the point and time of insertion into the patient.
  • the wye and tubular lumena and related components and equipment may be of any suitable structure and size.
  • the inner lumen may be a very thin-walled tube formed of Nitenol (a nickel- titanium alloy) to minimize the outside diameter of the inner lumen while maintaining the necessary functional inside diameter and strength characteristics
  • the outer lumen may be a thin-walled tube formed by coextrusion of polyurethane around nylon, to provide space between the lumena of adequate cross-section for the pulsation gas flow while minimizing the outside diameter of the outer lumen. That improved lumen design will reduce the obstruction of the patient's access arteries by the catheter during operation of the intra-aortic pump, relative to current commercial catheter devices which also may employ coated balloons as in this invention.
  • such an improved inner lumen may be a nickel-titanium alloy tube 0.0283 " ID and 0.0347" OD, and the outer lumen may be 0.090 ⁇ 0.001" ID and 0.105" to 0.111" OD (8 Fr.) .
  • the basic balloon 20, prior to coating, may be of the same material, configuration and size as uncoated balloons currently in use in intra-aortic balloon pumps.
  • An example of a preferred embodiment includes a polyether based polyurethane balloon of about 0.003"-0.005" wall thickness formed by dip molding on an appropriately shaped mandrel. Such balloons have satisfactory flexibility and strength, with high elasticity, e.g., about 525% stretchability without rupture.
  • One specific commercially available polyurethane which has proven satisfactory in such balloons, including those used in practicing this invention, is sold by B.F. Goodrich under the designation "Estane 58110".
  • the furled balloon typically represents the largest diameter portion of the catheter of an intra-aortic balloon pump. Therefore, maximizing the slipperiness as well as minimizing the effective outside diameter of the furled balloon are important considerations.
  • the coated balloon 20 provides the desirable slipperiness without significantly compromising strength, reliability or durability and without requiring other modifications from current conventional modes of manufacture, packaging and use. Also, there may be a benefit of an increase in thrombo- resistance of the coated surface as compared to a polyurethane film surface.
  • Coated Balloons Polyurethane balloons as described above with a coating 36 comprising polyvinylpyrrolidone as the hydrophilic agent have provided beneficial results.
  • the polyvinylpyrrolidone has been applied to the polyurethane balloon substrate in two forms. One was in a prepolymer solution containing isocyanate in an organic solvent. Evaporating the solvent is believed to form a polyvinylpyr- rolidone/polyurethane interpolymer coating on the substrate.
  • This coating herein designated as "Coating A”
  • Coating A was of the following formulation:
  • the second coating was a blend of thermoplastic polyurethane with polyvinylpyrrolidone in another organic solvent, with the following formulation, herein designated as "Coating B":
  • Coating B (Hydromer. Inc. Designation 11B or 503) 3.0% by weight Polyvinylpyrrolidone 0.1% by weight Polyurethane 13 ppm Surfactant
  • N-Methyl Pyrrolidone 2.2% by weight
  • Other manners of coating with polyvinylpyrrolidone and related hydrophilic materials also are deemed to be operable.
  • the coating with an interpolymer blend as with Coating B presently is preferred. It is simple and easy to apply. It has no free isocyanates and therefore avoids the need to insure that reactive isocyanates are removed from the final product. It is believed that such isocyanates may introduce chemical instability and/or inactivate desirable additives such as pharmaceuticals surfactants and dyes.
  • the balloons coated with Coating B seem to have better lubricity and flexibility.
  • Figs. 5A-5E illustrate schematically a dipping process of coating balloons 20 in a one step coating process using the interpolymer blend of Coating B.
  • the balloons are mounted on long slender mandrels 48 of racks 50, as in Fig 5A, by sliding them on from the lower end of the mandrel and gripping the proximal (upper) ends, such as by engaging the balloon necks 21 on barbs on the upper portions of the mandrels.
  • the lower ends of the balloons remain sealed, from the mode of their manufacture.
  • the balloons then are dipped into the coating solution 52 in an appropriate container 54 as illustrated in Fig. 5B, to a depth to insure that the proximal necks 21 are immersed at least to the length to which they will be trimmed later.
  • the open upper ends are maintained above the coating liquid to avoid entry of coating into the balloons.
  • the balloons then are withdrawn as in Fig. 5C and allowed to drip and dry for a minimum of 15 minutes.
  • the viscosity of the coating solution, the insertion and withdrawal rates and the dwell time of immersion are adjusted to control the thickness of the coating.
  • An immersion cycle of 10 seconds, with a dwell time of 1 second and withdrawal cycle of 10 seconds has been found to provide a satisfactory coating when using a Coating B at a viscosity of 19-24 sec.
  • the coated balloons then are heated to evaporate the solvent, as by being placed in an oven 56 (Fig. 5D) at about 150°F. for 60 minutes. Upon removal from the oven the racks of balloons are allowed to cool under ambient room temperature conditions for a minimum of ten minutes.
  • the balloons then are removed from the mandrels and each balloon is placed in a polyethylene sleeve 60, inspected and stored for curing at ambient room temperatures, e.g., about 70°F, for at least 7 days before use, as illustrated in Fig. 5E.
  • the latter "curing" period appears to facilitate restoration of the strength of the balloon material following coating, perhaps by permitting further dissipation of any remaining solvent and/or completion of the interbonding of the substrate and the coating at the bonding interface therebetween.
  • the coated balloons are biocompatible and appear to retain substantially their original strength, flexibility and wearability after coating and curing as outlined above, while attaining a highly lubricous surface when ultimately wetted. Moreover, while dry they can be handled, furled, packaged in tubes 40, unpacked and prepared for insertion in the same manner as uncoated balloons. This includes tolerance to the heating step often employed following furling, wherein the furled balloons are heated to a temperature on the order of 135°F for about 12-16 hours to assist in setting and thereby sustaining the furling during insertion following removal from the tube 40.
  • the coated balloons become very slippery promptly upon being wetted, with attendant benefits of ease of insertion and placement as well as reduction of trauma, and the coating does not appear to either prompt undesired unfurling prior to insertion or to hinder normal intentional unfurling when in place at the pumping site in the patient's aorta.
  • the noted coatings are stable and apparently are of uniform characteristics throughout their thickness to maintain the same lubricity and inert characteristics despite reasonable wear during extended periods of use normally encountered with IABP devices. Also, the coating does not present a hazard to effective assembly of the complete balloon pump catheter devices.
  • the aforedescribed specific embodiment with Coating B included polyether urethanes for the balloon substrate and in the coatings, and a compatible solvent, with beneficial results. However it is believed that acceptable results also would be obtained with balloons and coatings using other polyurethanes and appropriate compatible solvents.
  • Ten of the 30cc balloons were coated both externally and internally by immersion into and withdrawal from the coating solution at 1/6 in/sec with a bottom dwell time of 3 seconds.
  • the other eighteen of the 30cc balloons and the thirty 40cc balloons were coated only externally by dip coating with immersion and withdrawal at 1/4 in/sec and 3 seconds bottom dwell time. All then were permitted to drip and dry in ambient room air for 20 ⁇ 5 minutes, followed by oven drying for 30 ⁇ 1 minutes at 65 ⁇ 2°C. At least seven days thereafter these balloons were subjected to numerous tests including those referred to below.
  • test and control catheters were manufactured by the normal steps for manufacturing a current commercial IABP by the Cardiac Assist Division of St. Jude Medical, Inc. Post-furl pressure decay leak tests were performed upon return of the catheters from the sterilizer. Those which did not pass this test were not tested further.
  • control catheters experienced balloon aneurysm at an average of 13.6 psi (range of 13.5-14 psi) while those with coated balloons aneurized at an average of 12.9 psi (range of 12.75-13 psi), all with no leakage of the balloons or the bonds.
  • IABP catheters similarly manufactured, namely thirty control catheters consisting of ten each with 30cc, 40cc and 50cc balloons and twenty-nine catheters having balloons coated with Coating B as follows: ten 30cc, ten 40cc and nine 50cc. All of these fifty-nine samples were aged for 45 days in a 65°C oven, simulating 2 years of shelf life. The average and range of aneurysm pressures observed were as follows, stated in psi:
  • the differences of the aneurysm pressures are not deemed to be clinically significant as the observed aneurysm pressures all were far above the normal usage pressure of about l ⁇ OmmHG or 2.9 psi, i.e. by a factor of more than four.
  • the calculated hoop stress on the balloon material during a usage pressure of 3 psi is about 190 to 220 psi for balloons of the above size range and about 0.0048 inches coated thickness whereas the noted aneurizing pressures calculate to a range of about 895 to 922 psi.
  • the ten 30cc balloons coated internally as well as externally and built into catheters were not furled and were not subjected to the in-sheath leak test. However, they were immersed in water for 7 days at room temperature and then subjected to the aneurysm test, with an average aneurysm pressure of 12.8 psi (range of 12.5-13 psi), with no leakage of the balloons or the bonds. This indicates that presence of the coating on the inner surface of the connection sleeves 21,22 would not impair the functionality of the catheter.
  • the catheters used for the foregoing inflation testing also were subjected to performance testing. After the inflation test, each was run through the autopurge cycle with the Model 700 controller and then cycled under several different operating parameters using the "neutral" timing setting, i.e. no lead or lag time bias relative to the cardiac cycle. These catheters were tested at 80 beats per minute (bpm) with 75mmHg back-pressure, with data taken at initiation and after one hour of operation. The same catheters were tested at 125 bpm with 75mmHg back-pressure and 80 bpm with lOOmmHg back-pressure.
  • the following table reports the average time in milliseconds to inflate to 90% of the full volume, the average time to deflate from the peak volume to 90% deflated state, and the sum of the latter two as the average total cycle time for these balloons, with notes as to the range of the latter.
  • the control samples had an average elongation at break of 17.5", with a standard deviation of 0.9", and a computed average tensile strength of 7420 psi, with a standard deviation of 545 psi.
  • the coated samples had an average elongation at break of 16.4", with a standard deviation of 1.0", and a computed tensile strength of 6705 psi, with a standard deviation of 620 psi.
  • Coated balloons which had been sterilized in a normal manner also passed bacterial endotoxin and MEM Cytotoxicity assay tests.
  • a pin-on-disk tribo eter was used for further tests under an aqueous 25°C environment using an alumina pin and an aluminum disk with a five gram load at speeds of 5.08- 5.13 cm/sec for 35 minutes. These tests showed coefficients of friction ( ⁇ ) substantially all well below 0.10 for coated balloons and from about 0.15 to over 0.40 for control balloons.
  • Subjective observations and tactile examinations also have confirmed that the coated intra- aortic catheter balloons have a high degree of slipperiness when wetted, substantially exceeding that of wet balloons of uncoated polyurethane or similar materials.

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  • Health & Medical Sciences (AREA)
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Abstract

Un gros ballonnet (20) en polyuréthane à parois minces pour un cathéter (10) à pompe à ballonnet intra-aortique est enduit d'un revêtement (36) lubrifiant hydrophile qui comprend une polyvinylpyrrolidone hydrosoluble, de préférence mélangée à un polyuréthane thermoplastique, et un solvant organique approprié, et il est ensuite séché et amené à durcir pendant une période suffisante. Le ballonnet (20) séché et durci est assemblé dans un cathéter (10) et enroulé. Le ballonnet enroulé (20f) s'avère très glissant lorsqu'il est hydraté en vue de son insertion dans l'appareil vasculaire d'un patient, se déroule facilement et fait preuve de souplesse, de solidité et de résistance pour une utilisation en pulsations intra-aortique.
PCT/US1994/014721 1993-12-20 1994-12-19 Pompe a ballonnet intra-aortique WO1995017219A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP7517569A JPH09511155A (ja) 1993-12-20 1994-12-19 大動脈内バルーンポンプ装置
EP95906051A EP0735903A4 (fr) 1993-12-20 1994-12-19 Pompe a ballonnet intra-aortique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17051393A 1993-12-20 1993-12-20
US170,513 1993-12-20

Publications (1)

Publication Number Publication Date
WO1995017219A1 true WO1995017219A1 (fr) 1995-06-29

Family

ID=22620156

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/014721 WO1995017219A1 (fr) 1993-12-20 1994-12-19 Pompe a ballonnet intra-aortique

Country Status (4)

Country Link
EP (1) EP0735903A4 (fr)
JP (1) JPH09511155A (fr)
CA (1) CA2179510A1 (fr)
WO (1) WO1995017219A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999021604A3 (fr) * 1997-10-27 1999-08-12 Datascope Investment Corp Catheter a ballonnet intra-aortique ameliore
US6024693A (en) * 1998-10-16 2000-02-15 Datascope Investment Corp. Intra-aortic balloon catheter

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7789846B2 (en) 2005-01-25 2010-09-07 Thermopeutix, Inc. System and methods for selective thermal treatment
US8721592B2 (en) 2006-01-25 2014-05-13 Thermopeutix, Inc. Variable length catheter for drug delivery
JP5912685B2 (ja) * 2012-03-08 2016-04-27 株式会社東海メディカルプロダクツ Ｉａｂｐ用バルーンカテーテルのバルーン
CN111467660A (zh) * 2020-05-28 2020-07-31 浙江海圣医疗器械有限公司 球囊自动浸制设备

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5160790A (en) * 1990-11-01 1992-11-03 C. R. Bard, Inc. Lubricious hydrogel coatings
US5221258A (en) * 1991-01-22 1993-06-22 Shturman Technologies, Inc. Introduction balloon catheter
US5230692A (en) * 1990-09-30 1993-07-27 Aisin Seiki Kabushiki Kaisha Intra-aortic balloon pump
US5295978A (en) * 1990-12-28 1994-03-22 Union Carbide Chemicals & Plastics Technology Corporation Biocompatible hydrophilic complexes and process for preparation and use
US5331027A (en) * 1987-09-02 1994-07-19 Sterilization Technical Services, Inc. Lubricious hydrophilic coating, resistant to wet abrasion

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5331027A (en) * 1987-09-02 1994-07-19 Sterilization Technical Services, Inc. Lubricious hydrophilic coating, resistant to wet abrasion
US5230692A (en) * 1990-09-30 1993-07-27 Aisin Seiki Kabushiki Kaisha Intra-aortic balloon pump
US5160790A (en) * 1990-11-01 1992-11-03 C. R. Bard, Inc. Lubricious hydrogel coatings
US5295978A (en) * 1990-12-28 1994-03-22 Union Carbide Chemicals & Plastics Technology Corporation Biocompatible hydrophilic complexes and process for preparation and use
US5221258A (en) * 1991-01-22 1993-06-22 Shturman Technologies, Inc. Introduction balloon catheter

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0735903A4 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999021604A3 (fr) * 1997-10-27 1999-08-12 Datascope Investment Corp Catheter a ballonnet intra-aortique ameliore
US6024693A (en) * 1998-10-16 2000-02-15 Datascope Investment Corp. Intra-aortic balloon catheter

Also Published As

Publication number Publication date
EP0735903A4 (fr) 1998-03-25
EP0735903A1 (fr) 1996-10-09
CA2179510A1 (fr) 1995-06-29
JPH09511155A (ja) 1997-11-11

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