WO1995025560A1 - Catheters a ballonnets intra-aortiques - Google Patents

Catheters a ballonnets intra-aortiques Download PDF

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Publication number
WO1995025560A1
WO1995025560A1 PCT/US1995/003464 US9503464W WO9525560A1 WO 1995025560 A1 WO1995025560 A1 WO 1995025560A1 US 9503464 W US9503464 W US 9503464W WO 9525560 A1 WO9525560 A1 WO 9525560A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
lumen
catheter
section
mandrel
Prior art date
Application number
PCT/US1995/003464
Other languages
English (en)
Inventor
Robert R. Andrews
William Edelman
Joseph A. Levendusky
Robert L. O'brien
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 CA002185920A priority Critical patent/CA2185920A1/fr
Priority to EP95914123A priority patent/EP0748240A4/fr
Publication of WO1995025560A1 publication Critical patent/WO1995025560A1/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
    • A61M25/10—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
    • 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
    • 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
    • A61M60/20—Type thereof
    • A61M60/295—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
    • A61M60/40—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
    • 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
    • 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
    • B29C55/00—Shaping by stretching, e.g. drawing through a die; Apparatus therefor
    • B29C55/22—Shaping by stretching, e.g. drawing through a die; Apparatus therefor of 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • 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
    • 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
    • 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 intra-aortic balloon (IAB) which is readily inflatable under low pressure to substantial size and displacement.
  • the balloon is mounted on a catheter device used for insertion of the balloon into a remote artery, typically a femoral 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.
  • IABP intracranial pressure
  • 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.
  • 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.
  • the aforenoted parameters for intra-aortic balloon catheters have resulted in these catheters being of significant complexity of construction and attendant substantial size, i.e. substantial effective diameter of the catheter structure during insertion as well as during the periods of pumping operation within the patient's vasculature.
  • a significant potential complication during use is associated with limb ischemia due to size mismatch between the overall size (diameter) of the counter pulsation catheter and the effective lumen size of the patient's vasculature through which the catheter must pass and in which it must remain during the period of pumping assistance.
  • the full featured IAB catheter systems available on the market have been of nominal 9 French (Fr) size or larger.
  • the Fr size designation of an IABC refers to the approximate size of the outer lumen.
  • catheters designated as 9 Fr may have outer lumens which slightly exceed that dimension, e.g., up to about .122".
  • such catheters may include balloons which originally were furled to about .126" outer diameter and in which the furling has relaxed to about .144" outer diameter in their packaging sheaths.
  • reduction in size of intra-aortic balloon catheters and introducer systems would improve systemic flow to limbs at risk.
  • IAB catheters intrinsically involves pushing the device along a tortuous path through the patient's vasculature. This requires applying and transmitting compressive forces through the very slender "column" structure of the catheter, which requires a significant degree of stiffness in the catheter. The catheter also must flex or bend to follow the desired path through the patient's vasculature without undue lateral reactive force which could cause trauma to the vessels. Thus IAB catheters should have a high degree of stiffness over a wide range of bending angles, while providing flexibility to follow tortuous paths along which the IAB catheter is being pushed.
  • IAB catheters also must resist kinking, i.e., sharp bending collapse of either or both of the lumen tubes with attendant loss of smooth curvature and closing or drastic reduction of the respective internal passageway. Resistance to kinking is necessary to maintain pushability of the catheter assembly and to avoid binding on the guide wire. Avoiding kinking also minimizes risks of cracking of the lumens during insertion and attendant risks of later leakage during operation, as well as minimizing risks of kink-blockage of the gas shuttle capacity between the lumens or blockage of medication or sensing operations through the inner lumen during pumping operation.
  • IAB catheters which attain some or all of the aforegoing objects and which maintain high degrees of flexibility, torquability, pushability and trackability for safe and easy insertion, with minimal risk of trauma to the patient.
  • IAB catheters using very small metal lumen tubes having high degrees of elasticity and particularly shape restorative elasticity will satisfy the aforementioned parameters. This will allow flexibility with stiffness over a wide range of bending angles of IAB catheters, down to quite severe bends and other temporary deformations which may occur in the course of insertion or operation.
  • the inner lumen can have a very thin wall with an inside diameter (ID) sufficient for a guidewire and a small outside diameter (OD) which allows reduction of the outer lumen and related components by at least one size Fr while providing gas shuttle capacity between the lumens for conventional IAB pump operation.
  • ID inside diameter
  • OD outside diameter
  • This design also attains excellent flexibility and stiffness of the catheters for ease of insertion and assurance of functionality while reducing the outside diameter to significantly reduce the risks of vascular and ischemia complications.
  • the terms “superelastic alloy” or “superelastic alloys” and “superelasticity” refer to those materials, specifically those metal alloys, which return to their original shape upon unloading after a substantial deformation. In most if not all instances superelasticity is related to shape memory. It is understood that a shape memory alloy is one which displays a thermoelastic martensitic transformation and is able to absorb several percent shear strain by preferential orientation of martensite variants, and then can reverse that shear strain upon being heated, as the martensite transforms back to the parent (austenite) phase.
  • a superelastic alloy is the same as a shape memory alloy except that it absorbs strain above the transformation temperature by the creation of stress-induced martensite variants of preferential orientation, and then reverts to the parent phase at the same temperature as reduced stress reverses the strain.
  • Superelastic alloys can be strained up to ten times more than ordinary spring materials without substantial permanent deformation, i.e., less than 0.5%. They provide nearly constant stress forces over a wide range of elastic deformation, as represented by typically "flag shaped" stress-strain curves, without significant change of temperature.
  • Nitinol nickel-titanium alloys
  • Nitinol nickel-titanium alloys
  • tranformational superelasticity is about ten times higher than elasticity in ordinary materials.
  • various nitinol alloys are known which are superelastic within the temperature ranges of the living human body.
  • Superelasticity characteristic and of nitenol alloys which provide this characteristic at human body temperatures appears in a publication of Raychem Corporation entitled "Superelasticity - Superelastic Tinel® Alloys". which is incorporated herein by this reference and a copy of which is being filed with this application.
  • outer lumen may be provided of co-extruded plastics to complement and enhance the size reduction and capacity goals noted above.
  • this includes a relatively thin major inner nylon portion for strength and a polyurethane outer portion for biocompatability, flexibility and compatibility for bonding to the balloon.
  • Improved techniques for production of appropriate balloons and for joining the respective components also are provided, particularly for joining of each balloon to the distal end of the outer lumen and to the distal end of the inner lumen while avoiding or minimizing buildup of diametral dimensions.
  • intra-aortic balloons may be made with thinner walls than heretofore to further complement the aforenoted results without compromising the integrity of the system.
  • a radiopaque metal marker ring also has been provided which is compatible with the size reduction goal while providing improved imaging capabilities.
  • 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. 3 is an enlarged cross-sectional view taken along line 3-3 of Fig. 1, on a lesser scale than Fig. 2.
  • Fig. 4 is an enlarged side elevation view of the balloon portion of the catheter with the balloon furled, such as for insertion.
  • Fig. 5 is an enlarged sectional view of a portion of the catheter assembly at the distal end of the balloon, taken along an axial diametral plane.
  • Fig. 6 is an enlarged side view of the outer lumen and adjacent proximal end portion of the balloon of the catheter of Fig. 1.
  • Fig. 7 is an end view of a radiopaque tracer ring included in the catheter of Fig. 1.
  • Figs. 7A and 7B illustrate alternative configurations of the tracer ring.
  • Fig. 8 is a side view of a stylet used in forming the guidewire of the catheter of Fig. 1.
  • Fig. 9 is an enlarged side view of the outer end of the guidewire used in the catheter of Fig. 1.
  • Figs 10A and 10B schematically illustrate the stripping of intra-aortic balloons from mandrels on which they have been formed by dip casting.
  • Figs. 11A-E are schematic illustrations of steps for reforming the proximal end sleeve portions of such balloons.
  • Fig. 12 is a schematic side view of one preferred apparatus used in the process illustrated by Figs. 11A-E.
  • Fig. 13 is a left-end view of the balloon clamp of Fig. 12.
  • Fig. 14 is a right-end view of the apparatus of Fig. 12.
  • Fig. 15 illustrates the shape of the cavity defined by the balloon clamp, as seen generally along line 15-15 of Fig. 13. While the invention will be further described in connection with certain preferred embodiments, it is not intended to limit the invention to those embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention.
  • an intra-aortic balloon pump catheter device 10 includes a flexible outer lumen tube 12 and a co-axial flexible inner lumen tube 14 which are attached to a wye connector 16.
  • the inner lumen tube 14 extends through the outer lumen 16 and through a single chamber intra-aortic balloon 18 to the distal tip end of the catheter.
  • the proximal end of the balloon 18 is attached to the distal end of the outer lumen tube 12.
  • the distal end of the balloon 18 is attached to a compatible tip element 20 on the distal end of the inner lumen tube 14.
  • Each of these balloon-lumen attachments is a gas-tight solvent bond connection between an end sleeve section 21,22 of the balloon and the outer surfaces of the outer lumen 12 and the tip 20, respectively.
  • 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. As indicated above, this is sometimes referred to as "shuttling" the inflation gas to and from the balloon.
  • the controller responds to signals corresponding 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 18 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 preferably covers the balloon and 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.
  • aqueous fluid such as blood
  • the balloon 18 is furled, as illustrated schematically at 18f in Fig. 4. 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.
  • the silicone avoids surface-to-surface sticking of the furled layers.
  • a thin tubular packaging sheath typically is placed over each furled balloon to maintain its furled compaction to a minimum effective outside diameter during shipping and handling, up to the place and time of insertion into the patient.
  • the furled balloons typically are heated, e.g., to a temperature on the order of about 135°F for about 12-16 hours, to assist in setting and thereby sustaining the furling during insertion following removal from the packaging sheath by the user. Balloons with the noted hydrophilic coatings also become very slippery promptly upon being wetted, with attendant benefits of ease of insertion and placement as well as reduction of trauma.
  • the wye connector 16 and related components and equipment may be of any suitable structure and size.
  • the inner lumen 14 is a very thin-walled tube formed of a tough and superelastic metal, namely nitinol.
  • a tough and superelastic metal namely nitinol.
  • an inner lumen tube 14 of such materials having a wall thickness of only about
  • the inner lumen tube 14 minimizes the outside diameter of the inner lumen while maintaining the necessary functional inside diameter as well as providing desirable characteristics of flexibility and strength throughout the length of the catheter.
  • An exemplary such inner lumen tube 14 has about .0276" ID and .0345" OD.
  • the inner lumen currently used in the 9 Fr IAB catheters being marketed by the Cardiac Assist Division of St. Jude Medical, Inc., under the trademark RediGuardTM consist of a polyurethane tube of about .008" wall thickness surrounded by a coiled stainless steel wire of .003" diameter generally as in the arrangement disclosed in US Patent No. 4,646,717, resulting in an effective overall thickness of the inner lumen wall of .011" and an attendant OD of .054" to provide an inner lumen ID of .032".
  • the outer lumen tube 12 is formed by coextrusion of a thin outer polyurethane layer around a thicker nylon inner layer 12b.
  • the nylon layer provides high compressive strength relative to the thickness, and it is believed that the polyurethane layer provides flexibility as well biocompatability and compatibility for ready bonding of the polyurethane balloon.
  • One advantageous combination has been found to be a .002" outer layer of polyurethane coextruded with a .006" inner layer of nylon, with the total wall thickness being about .008".
  • the outer lumen 12 also is a relatively thin-walled tube, as compared to current commercial polyurethane outer lumens which are on the order of 0.010" thick.
  • the annular space therebetween is of adequate cross-section to accommodate the gas shuttle capacity required for normal IABP operations using a conventional controller while minimizing the outside diameter of the catheter, e.g., reduction of the catheter by one full size Fr, and meeting the other desirable parameters for IAB catheters.
  • IAB catheters using this construction and of the same nominal size as prior constructions would be capable of higher gas shuttle rates than those prior devices and thus capable of tracking higher heart pulsation rates.
  • the outer lumen also could be formed of a thin walled metal tube having superelasticity, for example also being formed of nitinol.
  • the guidewire 28 is of a stylet-type with a "floppy J" tip, similar to some guidewires utilized heretofore in other applications, e.g. in cholangiography (catheterization of bile ducts) .
  • the stylet 40 is a slim rod or wire which includes a main body portion 42 normally of uniform circular cross-section and a distal end portion 44 of modified configuration for forming the "J" tip.
  • the distal end portion is significantly reduced in diameter along the second portion 44, with an annular shoulder 46 between portions 42 and 44.
  • a third portion 48 which is tapered to a lesser diameter, and an end portion 50 which is flattened in cross-section.
  • the proximal end of a fine wire 52 is brazed or welded to the stylet shaft adjacent the shoulder 46.
  • the wire extends in closely wound coil fashion about the distal portion 44, with the distal end being brazed or welded to the distal tip of the stylet body 42.
  • the distal end portion 50a is bent approximately 180°, preferably being bent normal to the flattening planes, to form the bight of the "J" tip, generally as illustrated.
  • one guidewire 28 for use in one specific embodiment of this invention as described herein included a stylet 40 formed of 302/304 stainless steel, about 150cm in length and with the shoulder 46 being about 30cm from the distal end.
  • the main body portion 42 was about .025" in diameter.
  • Second portion 44 was about .013" in diameter and extended for about 23cm from the shoulder 46.
  • Portion 48 was tapered from the .013" diameter to about .0055" diameter over a length of about 6cm, and the distal end 3cm portion was flattened to about .0035" thickness.
  • the wire 52 was about .005" diameter, also being of 302/304 stainless steel.
  • the distal 3cm was bent to form the bight and remote leg of the "J" tip.
  • the entire assembly was coated with Teflon, providing a guidewire with a diameter not exceeding .025" for use through the inner lumen described above.
  • the balloon 18 may be of the same material, configuration and size as balloons currently in use in intra-aortic balloon pumps.
  • An example of a preferred embodiment includes a thin-walled polyether based polyurethane balloon of about 0.003"-0.004" wall thickness formed by dip molding on an appropriately shaped mandrel, with a hydrophilic coating as referred to above. This is a reduction of about .001 thickness from balloons currently in commercial use.
  • 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 58810".
  • an end tip 20 is affixed over the outer end of the inner lumen tube 14, as by being molded thereonto.
  • the outer surface of the end portion of the tube may be sandblasted as a preparatory step.
  • the tip 20 preferably is of a plastic which is compatible with the material of the balloon, e.g., polyurethane.
  • the outer end surface 62 of the tip is rounded in a bullet-nose shape to facilitate passage through the patient's vasculature.
  • the outer end portion has a central axial passage 64 which provides a smooth continuation of the central axial passage of the lumen tube 14 and preferably tapers or flares toward the distal end of the tip, as illustrated in Fig. 5.
  • This passage section 64 may be formed by a core pin being positioned in the outer end of the lumen tube 12 prior to the molding of the tip 20.
  • the cylindrical proximal sleeve portion 21 of the balloon 18 is bonded to the outer surface of the distal portion of the outer lumen 12 and the cylindrical distal sleeve portion 22 of the balloon is bonded to the outer surface of the tip 20.
  • These bonds must be airtight and effected in a manner to minimize the diametral dimension build-up of the catheter assembly.
  • Such bonding is facilitated by forming the tip 20 and at least the outer surface of the outer lumen 12 and the balloon 18 of the same types of materials, namely polyurethane in the illustrated preferred embodiment.
  • the sleeve portions 21 and 22 are bonded to the respective elements by a solvent and pressure- bonding technique.
  • the balloons 18 are made by dip casting on a mandrel 66 having a shape corresponding to the inflated unstretched shape of the balloon 18, including the end sleeve sections 21,22, generally as seen in profile in Fig. 1 and 10A.
  • the dipping speed and time are adjusted to produce thin- walled balloons as referred to above.
  • Each of the balloon blanks as thus formed also includes an end section S which extends from the sleeve 21 over the mandrel hanger generally as illustrated, and which subsequently is trimmed from the blank.
  • the formed balloons are stripped from the respective mandrels by axial movement toward the distal end, whereby the proximal sleeve 21 and adjacent tapered portion 24, as well as section S, are stretched in diameter as they slide over the much larger central portion of the mandrel on which the main balloon body portion 23 was formed, as illustrated schematically in Fig. 10B.
  • This stretching of the proximal ends results in proximal end sleeves that are not reliably of a sufficiently small inner diameter to provide the desired snug fit of the balloon on the small outer lumen tubes 12 for facile formation of the necessary air-tight joint at this interface.
  • the production of the balloons preferably includes reduction of the size of the proximal end sleeves after removal of the balloons from the casting mandrels.
  • each balloon blank is mounted over an internal mandrel 70 and secured in place by a collet 72.
  • the balloon is stretched to a predetermined length of the proximal sleeve section 21, as indicated by the arrow A in Fig. 11A.
  • the balloon then is held in the stretched state to maintain the desired sleeve length, as by a hinged clamp 74 which engages the cone section 24 of the balloon, as in Fig. 11B.
  • the stretching causes the intervening sleeve to neck down to the desired reduced diameter, as indicated in Figs. HA and 11B. At this point the neck is in a stressed state.
  • At least the sleeve section of the balloon is heated, as by an internal heater 76, 78 which is positioned with the mandrel 70 (see Fig. 11C) , to an appropriate temperature over an appropriate dwell time thereby relaxing the necked-down balloon material in its reduced size configuration. That is, the stress induced by the stretching is relieved.
  • the balloon then is permitted to cool to a normalizing temperature while in the reduced, non-stressed configuration, as by turning off the power to the heater; see Fig. 11D. This precludes subsequent elastic return of the sleeve portion 21 to its previous oversize diametral dimension.
  • the balloon with the reduced diameter proximal end sleeve 21 then is removed from the clamp and mandrel, and the end section S is trimmed off as in Fig. HE.
  • a mandrel 70 is mounted in a support block 82 which is pivotally mounted to a fixed support 84 as by an appropriate pivot pin 86 located adjacent one end of the block 82, with the pivot pin offset from the mandrel 70.
  • the heating cable 78 extends through the mandrel 70 to a pin shaped heating element 76.
  • An intervening portion of the mandrel 70 has a bulbous section 88, with an annular outer surface 89 which tapers to smaller diameters toward the support block 82.
  • the collet 72 is of an annular or "washer" shape, having an internal surface which conforms to the tapered surface of the mandrel.
  • the clamp 74 comprises two hinged mating halves defining therebetween a truncated conical open section 90 communicating with a short small cylindrical section 92, which correspond generally to the configuration of the transitional section 24 and desired sleeve section 21 of the balloons being processed.
  • the clamp 74 is opened in preparation for receiving a balloon to be processed.
  • the collet 72 is retracted toward the heater cable base block 82.
  • the block 82 is pivoted to an upper position (about 90° counterclockwise) in Fig. 14, to raise the mandrel/heater further from a support surface on which the components are mounted and thereby providing greater space for the following described manipulations.
  • the distal end portion of a balloon then is slid onto the mandrel unit 70, from the left end in Fig. 12, with the distal end portion of the sleeve section S over the enlarged section 88 and onto the tapered section 89.
  • the collet 72 is then moved towards the enlarged section 88, to provide friction clamping of the balloon end S between the inner surface of the collet and the outer tapered surface of the mandrel.
  • the balloon is then stretched, e.g. manually by the operator, to the point where the tapered end section 24 will match up with the cavity defined by the sections 90 of the clamp halves, thereby suitably reducing the diameter of the neck or sleeve section 21.
  • the heater cable base block 82 is closed, and the balloon is positioned with the tapered end section 24 mating into the cavity defined by the sections 90 of the clamp halves, with the sleeve section stretched over the intervening internal mandrel and heater 76.
  • the clamp 74 then also is closed to retain the sleeve section of the balloon in the resulting stretched state.
  • the heater coil 76 Internal to the balloon at this point is the heater coil 76, which extends the entire length of the sleeve area and slightly into the balloon body area, as seen in Fig. 12. Subsequently, the heater is activated to thereby relax the necked down balloon material as described above. Following heating and subsequent cooling, the clamp 74 is opened and the collet 72 released, and the balloon is removed. The section S then is cut off.
  • a distal end portion of the stretched sleeve also may be trimmed to attain the desired length of sleeve 21 which now has the desired reduced inner diameter.
  • the internal mandrel/heater may be utilized as the form for setting the size of the reformed sleeve section 21.
  • the sleeve portion 21 has been stretched to about 150% of its original length in this process, e.g., stretched from 0.5" to 0.75," to effect the desired reduction of the diameter of the neck in polyurethene balloons as described hereinabove.
  • one and/or the other of the clamping mechanisms 74 and 72,88 may be movable toward and away from the other whereby the balloon blank may be clamped therein prior to stretching and then may be stretched by lateral movement of one or both of the clamping mechanisms relative to the other.
  • radiopaque marker material is applied to the outer lumen 12 in a position to be adjacent the proximal end of the balloon in the final assembly.
  • this marker is a thin short ring 94 of highly elastic metal such as nitinol, being the same material as the inner lumen.
  • nitinol highly elastic metal
  • Use of the same metal for the marker and the lumen avoids any problems of incompatibility of dissimilar metals, such as electrokinetic corrosion of either element, while providing a highly radiopaque and therefore highly visible marker for the positioning of the IAB during use.
  • the marker may be press-fit in place in the outer lumen 12 and the compression of the lumen will hold the ring in place.
  • the balloon is bonded over the outer lumen 12, preferably with the sleeve 21 of the balloon over the marker ring 94, and is furled tightly over the inner lumen tube 14 as noted above.
  • the high degree of elasticity of the ring permits the marker to deform in the process of packaging and insertion while assuring return to its nominal desired shape and size in use.
  • a nominal 8 Fr IAB catheter 10 was fabricated with an inner lumen tube 14 formed of a nitinol alloy tubing of Raychem Corporation designated Tinel Alloy BB formed of only nickel and titanium and only those trace elements naturally occurring in commercially available grades of those constituents.
  • the tube 14 had a nominal inner diameter of .0276", a nominal outer diameter of .0345", and a length of 32.775".
  • the outer tube 12 was a coextrusion of 2363-55D Pellethane polyurethane (Dow Chemical Company, Midland, MI) .002" thick over Nylon 11 Besno (Elf Atochem, Philadelphia, PA) .006" thick, as described above, with a nominal inner diameter of .090" and a nominal outer diameter of .108".
  • the tip and guide wire used in the catheter were as described above, and the balloon was of .003" nominal thickness.
  • the balloon was furled to a diameter of .118" and could relax to about .124" diameter in its packaging sheath.
  • kink tests and stiffness tests were conducted on inner and outer lumens and the combination of the two as described above, with only slightly different dimensions.
  • the nitinol inner lumens tested had an inner diameter of .0283" ⁇ .0003" and an outer diameter of .0347" + .0003.
  • the coextruded outer lumens had a nominal inside diameter of .090" and a nominal outside diameter of .106".
  • Crush tests also were conducted on various outer lumens.
  • the kink tests utilized a template having multiple circles imprinted thereon, all with a common tangent point. The circles were 2", 1 ", 1 ", 1 ", l", %" and %" in diameter.
  • each tubing being tested was formed into a larger loop and held against the template with the ends crossing and tangent to the circles at the aforenoted common tangent point. While maintaining this relationship to the template, one end of the looped tube was pulled to gradually reduce the loop diameter until the sample kinked. The diameter, also in inches, at which kinking occurred was recorded. When the tubing kinked between two circles, the average of those two circles was used as the kink diameter for calculations. In the case of outer lumen tubes, notes also were made of whether the kinking occurred quickly, moderately or slowly.
  • the 9 Fr outer lumen tubes were of the aforedescribed current commercial design, being polyurethane tubes with an inner diameter of about .101" and an outer diameter of about .122".
  • the average first kinking diameter for the 9 Fr outer lumen tubes was 1", and they kinked "slowly”.
  • the nitinol tubes tested included both extruded tubes and drawn and machined tubes, with the results being substantially the same.
  • Thin-walled balloons as alluded to above also were tested for operational strength, using thirty sample uncoated balloons with an average measured thickness of
  • Aneurysm tests also were conducted using such sample balloons which were adhered to outer lumens and leak tested prior to being subjected to aneurysm pressures. Pressure was increased in each balloon until a dramatic reduction of pressure was noted, indicating rapid expansion of the balloon membrane. The average aneuryzation pressures so measured were 13.6 psi for the uncoated balloons and 10.58 psi for the coated balloons. Thus, all were far above the normal usage pressure of about 150mmHG or 2.9 psi for such balloons, by a factor of more than three.

Abstract

Un cathéter à contre-pulsion et ballonnet intra-aortique comporte une lumière (14) interne formée d'un tube d'un alliage métallique super-élastique à paroi mince, le nitinol, dont le diamètre interne suffit pour le passage d'un fil-guide (28) et le diamètre extérieur est réduit, ce qui permet de diminuer les dimensions d'une lumière externe et des composants connexes d'au moins une taille Fr, tout en permettant le va-et-vient d'un gaz entre les lumières en cas de fonctionnement conventionnel à contre-pulsion par ballonnet intra-aortique. La lumière (12) externe est un tube, formé de plastiques co-extrudés, tenant compte de la réduction de taille et des objectifs en matière de capacité et doté d'une partie (12b) interne de nylon assurant la robustesse et d'une partie (12a) externe relativement mince en polyuréthane assurant la biocompatibilité, la souplesse et la compatibilité de soudure à un fin ballonnet (18) de polyuréthane. Le manchon d'extrémité proximale du ballonnet est étiré puis stabilisé par chauffage par un dispositif de chauffage interne placé sur un mandrin (70) de fabrication, ce qui donne le diamètre réduit désiré. Un anneau (94) repère de métal radio-opaque, le nitinol, améliore les possibilités d'imagerie tout en étant compatible avec des matériaux des lumières.
PCT/US1995/003464 1994-03-18 1995-03-20 Catheters a ballonnets intra-aortiques WO1995025560A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA002185920A CA2185920A1 (fr) 1994-03-18 1995-03-20 Catheters a ballonnets intra-aortiques
EP95914123A EP0748240A4 (fr) 1994-03-18 1995-03-20 Catheters a ballonnets intra-aortiques

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21061194A 1994-03-18 1994-03-18
US08/210,611 1994-03-18

Publications (1)

Publication Number Publication Date
WO1995025560A1 true WO1995025560A1 (fr) 1995-09-28

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EP (1) EP0748240A4 (fr)
CA (1) CA2185920A1 (fr)
WO (1) WO1995025560A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0951311A1 (fr) * 1996-11-15 1999-10-27 Bristol-Myers Squibb Company Dispositifs et procedes utilises pour appliquer un melange de deux composants liquides ou davantage pour former un biomateriau
EP1184041A1 (fr) * 1999-05-16 2002-03-06 YS, Medical Co., Ltd. Catheter a ballonnet, procede de fabrication associe et procede de fixation d'un ballonnet a une tubulure de catheter
US7654264B2 (en) 2006-07-18 2010-02-02 Nellcor Puritan Bennett Llc Medical tube including an inflatable cuff having a notched collar

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US4646719A (en) * 1984-06-11 1987-03-03 Aries Medical Incorporated Intra-aortic balloon catheter having flexible torque transmitting tube
US4994018A (en) * 1989-05-31 1991-02-19 Datascope Corporation Intra-aortic balloon assembly
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US5042985A (en) * 1989-05-11 1991-08-27 Advanced Cardiovascular Systems, Inc. Dilatation catheter suitable for peripheral arteries
US5087394A (en) * 1989-11-09 1992-02-11 Scimed Life Systems, Inc. Method for forming an inflatable balloon for use in a catheter
US5120308A (en) * 1989-05-03 1992-06-09 Progressive Angioplasty Systems, Inc. Catheter with high tactile guide wire
US5156612A (en) * 1988-10-04 1992-10-20 Cordis Corporation Balloons for medical devices and fabrication thereof
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US4531512A (en) * 1981-06-15 1985-07-30 Datascope Corporation Wrapping system for intra-aortic balloon utilizing a wrapping envelope
US4646719A (en) * 1984-06-11 1987-03-03 Aries Medical Incorporated Intra-aortic balloon catheter having flexible torque transmitting tube
US4994047A (en) * 1988-05-06 1991-02-19 Menlo Care, Inc. Multi-layer cannula structure
US4998917A (en) * 1988-05-26 1991-03-12 Advanced Cardiovascular Systems, Inc. High torque steerable dilatation catheter
US5156612A (en) * 1988-10-04 1992-10-20 Cordis Corporation Balloons for medical devices and fabrication thereof
US5120308A (en) * 1989-05-03 1992-06-09 Progressive Angioplasty Systems, Inc. Catheter with high tactile guide wire
US5042985A (en) * 1989-05-11 1991-08-27 Advanced Cardiovascular Systems, Inc. Dilatation catheter suitable for peripheral arteries
US4994018A (en) * 1989-05-31 1991-02-19 Datascope Corporation Intra-aortic balloon assembly
US5087394A (en) * 1989-11-09 1992-02-11 Scimed Life Systems, Inc. Method for forming an inflatable balloon for use in a catheter
US5304340A (en) * 1991-09-06 1994-04-19 C. R. Bard, Inc. Method of increasing the tensile strength of a dilatation balloon

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0951311A1 (fr) * 1996-11-15 1999-10-27 Bristol-Myers Squibb Company Dispositifs et procedes utilises pour appliquer un melange de deux composants liquides ou davantage pour former un biomateriau
EP0951311A4 (fr) * 1996-11-15 2000-11-08 Bristol Myers Squibb Co Dispositifs et procedes utilises pour appliquer un melange de deux composants liquides ou davantage pour former un biomateriau
EP1184041A1 (fr) * 1999-05-16 2002-03-06 YS, Medical Co., Ltd. Catheter a ballonnet, procede de fabrication associe et procede de fixation d'un ballonnet a une tubulure de catheter
EP1184041A4 (fr) * 1999-05-16 2004-10-20 Ys Medical Co Ltd Catheter a ballonnet, procede de fabrication associe et procede de fixation d'un ballonnet a une tubulure de catheter
US7654264B2 (en) 2006-07-18 2010-02-02 Nellcor Puritan Bennett Llc Medical tube including an inflatable cuff having a notched collar
US8096299B2 (en) 2006-07-18 2012-01-17 Nellcor Puritan Bennett Llc Medical tube including an inflatable cuff having a notched collar

Also Published As

Publication number Publication date
CA2185920A1 (fr) 1995-09-28
EP0748240A4 (fr) 1998-04-29
EP0748240A1 (fr) 1996-12-18

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