WO2000051660A1 - Catheter a ballonnet en polyurethane - Google Patents

Catheter a ballonnet en polyurethane Download PDF

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Publication number
WO2000051660A1
WO2000051660A1 PCT/US2000/005437 US0005437W WO0051660A1 WO 2000051660 A1 WO2000051660 A1 WO 2000051660A1 US 0005437 W US0005437 W US 0005437W WO 0051660 A1 WO0051660 A1 WO 0051660A1
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WO
WIPO (PCT)
Prior art keywords
balloon
approximately
medical catheter
diisocyanate
glycol
Prior art date
Application number
PCT/US2000/005437
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English (en)
Inventor
David J. Lentz
Show-Mean Wu
Ziyun Chen
Hans W. Kramer
Mark Wiltshire
Charles W. Mcgary
Original Assignee
Medtronic, 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 Medtronic, Inc. filed Critical Medtronic, Inc.
Publication of WO2000051660A1 publication Critical patent/WO2000051660A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • the present invention relates to an intravascular medical catheter and a method of manufacturing an intravascular medical catheter. More specifically, the present invention relates to a balloon catheter having excellent burst strength, flexibility, and compliance characteristics.
  • angioplasty Percutaneous transluminal coronary angioplasty
  • a medical catheter having an inflatable balloon attached to a catheter shaft is commonly used during the angioplasty procedure.
  • the catheter shaft and balloon are advanced over a guidewire which is positioned within the body vessel until the balloon is adjacent to the stenosis.
  • the balloon is inflated. This causes the site of the stenosis to compress into the arterial wall and the body vessel to dilate.
  • a stent can also be placed within the body vessel.
  • balloons for medical catheters are classified according to their "compliance" or expandability relative to other balloons.
  • a balloon is rated as being either “compliant,” “semi-compliant,” or “non- compliant.”
  • a comprehensive definition of these terms is provided in U.S. Patent No. 5,556,383, issued to Wang et al. and entitled “Block Copolymer Elastomer Catheter Balloons,” the contents of which are incorporated herein by reference.
  • non-compliant balloons are often relatively inflexible, are prone to develop pin holes, and the balloons do not rewrap well after inflation in the vessel. As a result thereof, these balloons can be difficult to move and remove from the vessel.
  • compliant balloons often have a relatively low tensile strength, do not expand in a predictable fashion, and are subject to rupture during high pressure applications.
  • the present invention is directed to a medical catheter which satisfies these objectives.
  • the material for the balloon is selected from a specific, relatively small group of polyurethane materials and the balloon is formed under relatively strict manufacturing procedures which maximizes the properties of the small group of polyurethane materials.
  • the resulting balloon is semi-compliant, flexible, and has excellent burst strength.
  • the balloon inflates in a predictable fashion, moves easily in the body vessel, commonly referred to as “improved tracking” and moves easily past a lesion in the vessel, commonly referred to as “improved lesion crossing characteristics.”
  • the balloon rewraps to have a relatively small profile to allow easy removal from the vessel.
  • the physical characteristics of the balloon are primarily influenced by the polyurethane material utilized in the balloon and how the balloon is formed.
  • the polyurethane material includes a hard segment derived from a diisocyanate and a short-chain diol and a soft segment derived from a polymeric glycol.
  • the polyurethane material preferably has a durometer hardness of between approximately 50D- 65D and more preferably between 55D and 60D prior to forming the balloon.
  • the use of a relatively soft polyurethane material enhances the flexibility of the resulting balloon. This improves tracking in the vessel and rewrapping of the balloon after inflation to minimize the retraction force necessary to remove the balloon after completion of the procedure.
  • the diisocyanate is preferably selected from a group consisting of 1 ,4- cyclohexane diisocyanate, dicyclohexylmethane-4,4'-diisocyanate, xylene diisocyanate, hexamethylene diisocyanate, methylcyclohexyl diisocyanate, 4,4'-biphenylene diisocyanate, m- and p-phenylene diisocyanates, diphenylmethane-4,4'-diisocyanate, diphenymethane-2,4'-diisocyanate, 1 ,5- napthalene diisocyanate, and isophorone diisocyanate.
  • the short-chain diol is selected from a group consisting of ethylene glycol, 1 ,2- and 1 ,3- propanediol, 1 ,4-butanediol, 1,4-cyclohexanediol, neopentyl glycol and 1 ,6- hexanediol.
  • the soft segment is derived from a polymeric glycol having an average molecular weight of between approximately 500-5000 and more preferably an average molecular weight of between approximately 1000-2000.
  • the polymeric glycol can be selected from a group which consists of a polyether diol and a polyester diol.
  • the polymeric glycol is selected from a group which consists of polyoxyethylene glycols, polyoxypropylene glycols, and poly(tetramethylene ether) glycol.
  • the polymeric glycol can be derived from a dibasic acid and a glycol.
  • the dibasic acid is selected from a group which includes succinic acid, maleic acid, glutaric acid, adipic acid, and sebacic acid.
  • the glycol is selected from a group which consists of ethylene glycol, 1 ,3-propanediol, 1 ,4-butanediol, neopentyl glycol, and 1 ,6-hexanediol.
  • the balloon is formed from a tube which is heated to above its glass transition temperature and radially expanded in a mold.
  • the tube is also subjected to an axial stretch so that the resulting balloon is highly bi-axially oriented.
  • the balloon is formed with a blow up ratio of between approximately 5-9 and more preferably 6-8.
  • blow-up ratio or "BUR” as utilized herein shall mean the ratio of the inner diameter of the balloon mold versus the inner diameter of the tube prior to forming the balloon. Because of the relatively high blow-up ratio utilized, the polyurethane material is stretched to near its limits to approach maximum alignment of the molecules in the material. Thus, a relatively soft polyurethane material can be used to achieve a high burst strength in combination with the desired flexibility and compliance characteristics.
  • the resulting balloon can achieve (i) a burst strength of at least approximately 250 psi, and more preferably between approximately 275 psi to 300 psi, and (ii) a compliance of less than approximately twenty-five percent (25%), and more preferably, a compliance between approximately ten percent to fifteen percent (10%-15%) between the nominal pressure and the rated burst pressure.
  • Figure 1 is a perspective view, in partial cutaway, of a medical catheter having features of the present invention
  • Figure 2 is a perspective view of the medical catheter positioned within a patient
  • Figure 3 is a cross-sectional view taken on line 3-3 of Figure 1;
  • Figure 4 is cross-sectional view of a tube positioned within a blow mold
  • Figure 5 is a first chart which outlines the compliance curves for a number of balloons made in accordance with the present invention
  • Figure 6 is a second chart which outlines the compliance curves for a number of balloons made in accordance with the present invention
  • Figure 7 is a chart which illustrate the compliance curve of a balloon made in accordance with the present invention and the compliance curves of alternate balloons
  • Figure 8 is a chart which illustrates retraction force for a balloon made in accordance with the present invention and the retraction forces for alternate balloons;
  • Figure 9 is a chart which illustrates the compliance curves for three balloons made in accordance with the present invention.
  • a medical catheter 10 having features of the present invention includes a catheter shaft 12, a guidewire shaft 14, and an inflatable balloon 16.
  • the material for the inflatable balloon 16 is selected from a specific, small group polyurethane materials and the balloon 16 is formed under relatively strict manufacturing parameters.
  • the balloon 16 has superior physical characteristics including a relatively high burst strength, a soft texture, good flexibility, and a relatively flat compliance curve.
  • Preferred embodiments of the balloon 16 are semi-compliant, flexible, and expand in a predictable manner.
  • a portion of the medical catheter 10 and a guidewire 18 can be positioned in a body vessel 20 of a patient 22 during an angioplasty procedure.
  • the location of entry into the patient 22 and the location of the balloon 16 illustrated in Figure 2 is merely exemplary.
  • the medical catheter 10 can be utilized for other procedures, such as deploying a stent (not shown) within the body vessel 20.
  • the catheter shaft 12 is used by the physician to position the inflatable balloon 16 within the body vessel 20 and transfer an inflation fluid (not shown) to the inflatable balloon 16.
  • the catheter shaft 12 includes a catheter shaft proximal end 24, a catheter shaft distal end 26, and an inflation lumen 28 in fluid communication with the balloon 16.
  • a manifold 30 having an inflation/deflation port 32 and a guidewire port 34 is secured to the catheter shaft proximal end 24.
  • the inflation/deflation port 32 is in fluid communication with the inflation lumen 28, while the guidewire port 34 is connected to the guidewire shaft 14.
  • the catheter shaft 12 encircles and is substantially coaxial with the guidewire shaft 14.
  • the guidewire shaft 14 includes a guidewire shaft proximal end (not shown), a guidewire shaft distal end 36, and a guidewire lumen 38.
  • the guidewire shaft proximal end is connected to the guidewire port 34, while the guidewire shaft distal end 36 is attached to the balloon 16.
  • the guidewire lumen 38 is sized and shaped to receive the guidewire 18.
  • a guidewire shaft 14 having a 0.017 inch inner diameter and a 0.023 inch outer diameter is suitable for a standard 0.14 inch guidewire 18.
  • a pair of spaced apart, tubular, radiopaque markers 40 can be bonded to the guidewire shaft 14 to facilitate proper positioning of the inflatable balloon 16 in the body vessel 24.
  • the inflatable balloon 16 is secured to the catheter shaft distal end 26 and the guidewire shaft 14.
  • the catheter shaft 12 and guidewire shaft 14 are made of a material which can be thermally bonded or adhered to the balloon 16 with a suitable adhesive.
  • a suitable catheter shaft 12 and guidewire shaft 14 can be manufactured by extruding a polymer such as PEBA, PET, High Density Polyethylene (“HDPE”), Low Density Polyethylene (“LDPE”), Polyurethane, or Nylon.
  • the balloon 16 includes a body section 42 which separates a distal cone section 44 from a proximal cone section 46. As illustrated in Figure 3, the balloon 16 has a balloon outer diameter 48, a balloon inner diameter 50, a balloon wall thickness 52, and a balloon length
  • the balloon 16 has superior physical characteristics, including a relatively high burst strength, a good tracking and lesion characteristics, good flexibility, and a relatively flat compliance curve.
  • Preferred embodiments of the balloon 16 provided herein are semi-compliant, flexible, and expand in a predictable manner.
  • the balloon 16 is formed from a polyurethane material which includes: (i) a hard segment derived from a diisocyanate and a short-chain diol and (ii) a soft segment derived from a polymeric glycol.
  • the proportion by weight of the soft segment in the polyurethane material is between approximately thirty- five percent to seventy percent (35%-70%)
  • the polyurethane material preferably has a hardness of between approximately 50D-65D and more preferably between approximately 55D-60D prior to forming the balloon. This hardness range results in a relatively flexible balloon which good tracking and lesion crossing characteristics.
  • the amount of hard segment controls the hardness of the polyurethane material.
  • approximately forty percent to sixty percent (40%-60%) of the balloon material would consist of the hard segment (the total of diisocyanate and short-chain diol).
  • a range of 55D-60D corresponds to approximately forty-five percent to fifty-five percent (45%-55%) of the hard segment. The exact amount depends on the diisocyanate, the short-chain diol, and the soft- segment diol molecular weight and selection.
  • the hard segment is derived from a diisocyanate and a short-chain diol.
  • Diisocyanates useful in introducing the urethane linkage into the polymer chain may be selected from a wide range of aliphatic, cycloaliphatic, and aromatic diisocyanates.
  • Useable diisocyanates can contain non- interfering groups, e.g., aliphatic hydrocarbon radicals such as lower alkyl or other groups, having substantially non-reactive hydrogens.
  • the diisocyanate often has at least six (6) carbon atoms and usually not more than about forty (40) carbon atoms. Diisocyanates having about eight to twenty (8-20) atoms in the hydrocarbon group are preferred.
  • Suitable diisocyanates include 2,4-toluene diisocyanate; 2,6-toluene diisocyanate; 1 ,4-cyclohexane diisocyanate; dicyclohexylmethane-4,4'- diisocyanate; xylene diisocyanate; hexamethylene diisocyanate; methylcyclohexyl diisocyanate; 4,4'-biphenylene diisocyanate; m- and p- phenylene diisocyanates; hexahydrotolylene diisocyanates; diphenylmethane-4,4' diisocyanate; diphenymethane-2,4'-diisocyanate; 1,5- napthalene diisocyanate; 1-methoxyphenyl-2, 4-diisocyanate; isophorone diisocyanate; and chlorophenylene diisocyanates.
  • diisocyanates can be utilized if desired.
  • the most preferred diisocyanates are diphenylmethane-4,4'-diisocyanate and dicyclohexylmethane-4,4'-diisocyanate.
  • Low molecular glycols which react with diisocyanate to form the hard segment typically contain two to ten (2-10) carbon atoms.
  • Suitable short chain diols include ethylene glycol; diethylene glycol; triethylene glycol; 1 ,2- and 1,3-propanediol; 1,4-butanediol; 2,3-butanediol; 1 ,4-cyclohexanediol; dipropylene glycol; neopentyl glycol; and 1,6-hexanediol; and mixtures thereof.
  • the soft segment is a long chain, polymeric glycol having a molecular weight of between approximately five hundred to five thousand (500-5000) and preferably between approximately one thousand to two thousand (1 ,000-
  • the polymeric glycol is co-polymerized with the diisocyanate and short-chain diol.
  • the ratios are normally such that after copolymerization occurs, the reacted diisocyanate-short-chain glycol blocks and the reacted diisocyanate-long-chain blocks are somewhat compatible and relatively homogeneous at temperatures above the melting point and are incompatible
  • thermoplastic polyurethanes can be fabricated at elevated temperatures and have the properties of thermoset polymers at lower temperatures.
  • the - polymers can be oriented at intermediate temperatures to provide a strong and stable balloon.
  • Suitable polymeric glycols are divided into the following categories: 2.1 Polvether Diols
  • Cyclic ethers such as ethylene oxide, proplyene oxide, butylene oxide, styrene oxide, and tetrahydrofuran react with active hydrogen initiators, such as water and glycols in the presence of catalysts, such as boron triflouride, to produce long chain polymeric ether diols.
  • active hydrogen initiators such as water and glycols in the presence of catalysts, such as boron triflouride
  • the ratio of cyclic ether to initiator determines the molecular weight.
  • Illustrative polyethers are polyoxyethylene glycols; polyoxypropylene glycols; polytetramethylene glycol; and admixtures.
  • the cyclic ethers can be co-reacted with an initiator as indicated above to give a copolymer polyether. The most preferred is the poly(tetramethylene ether) glycol.
  • Polyester diols are made from condensation of dibasic acids and glycols in various ratios to control the molecular weight and to give hydroxyl end groups.
  • the same diols can be used that were outlined under the above section on “short chain diols.”
  • the dicarboxylic acids are aliphatic, cycloaliphatic, aromatic, and/or heterocyclic and may be substituted, for example, by halogen atoms and/or unsaturated groups.
  • carboxylic acids of this kind include succinic acid, adipic acid, suberic acid, azelaic acid, sebacic acid, maleic acid, maleic acid anhydride, phthalic acid anhydride, glutaric acid anhydride, fumaric acid and terephthalic acid.
  • the aliphatic type is preferred to provide the desired soft segment.
  • the glycol include ethylene glycol; 1- 3, propanediol; 1 ,4-burtanediol; neopentyl glycol; and 1-6-hexanediol.
  • diols examples are poly(ethylene adipate) glycol; poly(tetramethylene adipate) glycol; and poly(hexamethylene adipate) glycol. O 00/5166 ° PCTtUSOO/05437
  • polyester diols This is a second class of polyester diols. They are made by reacting a lactone, such as epsilon-caprolactone, with an active bifunctional hydrogen initiator, such as an aliphatic glycol (e.g., 1,4-butanediol). Hydroxycarboxylic acids, for example, beta-hydroxybutyric acid and omega-hydroxycaproic acid, also can be used.
  • the preferred diol is polycaprolactone diol.
  • Polycarbonate diols can be made from phosgene and diols or by ester interchange with a dialkyl carbonate and a short chain diol as already described.
  • the repeat unit is HO-(CH 2 ) 4 -[O-CO-O(CH 2 ) -]nOH using 1 ,4- butanediol. Hydroxy-terminated polybutadiene copolymers have been made by Arco Chemical Company.
  • Three (3) polyurethanes were prepared by mixing a poly(tetramethylene ether) glycol (Teracol 1000, sold by DuPont), and 1-4 butanediol, heating the mixture and degassing under vacuum. Teracol is a trademark of DuPont. A molten diphenylethene -4,4'-diisocyanate and 0.03 percent of dibutyltin dilaurate are added to the mixture. Subsequently, the mixture was stirred rapidly for thirty (30) seconds and then poured into an aluminum tray. After one (1) hour, the polyurethane was cured in an oven at approximately 100°C for one hour. After conditioning for seven (7) days at room temperature, the polyurethanes were tested for durometer D hardness. Each of the three (3) polyurethanes were then chipped, extruded into thin- wall tubing and subsequently formed into balloons. The approximate composition and test properties of the materials are provided below in Table 1:
  • polyurethane materials which are believed to be suitable, when formed in accordance with the present invention include Pellethane® Series 2102 and Pellethane® 2363 sold by Dow Chemical Company , located in Midland, Michigan.
  • Pellethane® is a registered trademark of Dow Chemical Company. Somewhat similar products are sold by Bayer Corporation, located in Pittsburgh, Pennsylvania, B.F. Goodrich, located in Cleveland, Ohio, BASF Corporation, located in Mt Olive, New Jersey, Thermedics located in Waburn, Massachusetts and Morton Chemical Inc., located in Chicago, Illinois.
  • the balloon 16 is manufactured utilizing a process which maximizes the physical characteristics of the specific polyurethane material disclosed herein. More specifically, the present invention utilizes a relatively high blowup ratio during the balloon forming process to approach maximum alignment of the molecules in the polyurethane material in the hoop/transverse direction. As provided herein, the physical characteristics, such as the compliance of the balloon 16, can be specifically tailored based upon the blow-up ratio utilized. Initially, the polyurethane material is extruded to form a tube 56 having a tube inner diameter 58, a tube outer diameter 60, and a tube wall thickness 62. Subsequently, the tube 56 is placed inside a mold 64 to form the balloon 16.
  • Figure 4 illustrates a mold 64 utilized for radially expanding and axially stretching the piece of tube 56.
  • a first clamp 66 and a second clamp 68 can be used to grasp the tube 56 on each side of the mold 64.
  • the first clamp 66 and/or the second clamp 68 can be moved apart by a stepper motor (not shown).
  • the tube 56 can be radially expanded by releasing pressurized fluid from a container 70 into the tube 56.
  • the pressurized fluid can be nitrogen gas, air, or some other suitable fluid which is under pressure.
  • the design of the mold 64 is varied according to the desired design and size of the balloon 16.
  • the mold 64 has a mold inner diameter 72 which is approximately between 5-9 and more preferably between 6-8 times larger than the tube inner diameter 58 to obtain the BUR of between 5-9 and more preferably 6-8.
  • the mold 64 is heated. This can be accomplished with a heating element (not shown) in the blow mold 64 or by directing a hot fluid through the mold 64.
  • the axial stretching and the radial expansion typically occur when the material is at or above the glass transition temperature.
  • a tube 56 is extruded from Pellethane® 2102-55D.
  • the tube 56 has a tube inner diameter 58 of between approximately 0.5mm and a tube outer diameter of between approximately 1mm and 1.5mm.
  • the tube 56 is then placed in a mold 64 having a mold inner diameter of approximately three millimeters (3.0 mm).
  • the first and second clamps 68 are locked on the tube 56.
  • the pressurized fluid is supplied to the tube 56 and the pressure is raised to approximately 250 psi, i.e., the pre-set "Pre-inflate" pressure.
  • the blow mold 64 is heated up to approximately 210°F, i.e., the "No.
  • the tube 56 is under a preset tension of 5.0 psi, which is called “P re-stretch” to molecuiarly orient the material.
  • the balloon 16 is formed as soon as the mold temperature reaches the "No. 1 Temperature.”
  • the balloon 16 is retained in the blow mold 64 at a temperature of 210°F, under 250 psi pressure and 5 psi tension for 1 second (Heat Soak Time 1).
  • the formed balloon 16 is immediately stretched by a higher tension of 10 psi (called Final stretch) and under a higher pressure of 300 psi (called Final inflate).
  • the mold temperature is immediately heated up to 215°F (called Temperature No. 2) for 15 seconds (called Heat Soak Time 2).
  • Heat Soak Time 2 After it reaches the end of the Heat Soak Time 2, the mold 64 is cooled down to 90°F (a preset cooling temperature). The cycle ends and the formed balloon 16 is removed.
  • Figure 5 illustrates the compliance curve for three alternate, three millimeter (3.0 mm) balloons made of Pellethane® 2102-55D. Each of the three millimeter (3.0 mm) balloons were formed with a different BUR.
  • the curve designated as reference number 74 illustrates the compliance curve for a balloon 16 formed with a blow-up ratio of 4.8.
  • curve designated as reference number 76 illustrates the compliance curve for a balloon formed with a blow-up ratio of 5.5
  • curve designated as reference number 78 illustrates the compliance curve for a balloon formed with a blow-up ratio of 6.4.
  • Figure 6 illustrates the compliance curve for three alternate, three millimeter (3.0 mm) balloons made of Pellethane® 2102-65D. Each of the three millimeter (3.0 mm) balloons were formed with a different BUR.
  • the curve designated as reference number 80 illustrates the compliance curve for a balloon formed with a blow-up ratio of 4.8
  • curve designated as reference number 82 illustrates the compliance curve for a balloon formed with a blow-up ratio of 5.5
  • the curve designated as reference number 84 illustrates the compliance curve for a balloon formed with a blow-up ratio of 6.4.
  • the unique material utilized herein could be tailored to be a compliant, semi-compliant or non-compliant simply by modifying the heat set rate used during manufacturing.
  • a balloon 16 is subjected to a heat set to bond the balloon 16 to the catheter shaft 14 and to provide memory for the balloon 16 at a wrapped state.
  • Table 3 below outlines the compliance measurements for three separate balloons made of Pellethane® 2102-55D. The three balloons were formed with the same blow-up ratios. However, the balloons were subjected to three alternate heat set rates.
  • Figure 7 illustrates (i) a compliance curve, designated 86, for a balloon made in accordance with the present invention of Pellethane® 2102-55D; (ii) a compliance curve, designated 88, for a balloon made by Scimed from Pebax and sold under the trademark "VIVA”; and (iii) a compliance curve, designated 90, for a balloon made by Cordis from nylon 12 and sold under the trademark "DURALYN". From Figure 7, it is evident that the balloon 16 made in accordance with the present invention, has a much smaller initial diameter. This facilitates movement of the balloon 16 through the vessel.
  • the balloon 16 made in accordance with the present invention is bi-compliant. Stated another way, the balloon 16 has two relatively distinct sections to the compliance curve 86 and the compliance curve 86 is nonlinear. More specifically, a first section 92 of compliance curve 86 extends from approximately 3.5 atms to approximately 6 atms while a second section 94 of compliance curve 86 extends from approximately 6 atms to approximately 18 atmospheres. In the first section 92, the balloon has a compliance greater than fifteen percent and preferably between approximately twenty to thirty-five percent. In contrast, in the second section 94, the balloon has a compliance of between approximately five to fifteen percent. This feature allows the balloon 16 to initially be relatively small to facilitate movement in the vessel. Subsequently, with the balloon 16 positioned in the vessel, the balloon 16 quickly expands to its nominal diameter. Subsequently, the balloon 16 is semi compliant over the desired inflation range.
  • Figure 8 is a bar graph which illustrates the retraction force required to pull a number of different balloons through a guiding catheter (not shown).
  • the guiding catheter was mounted to a peg board which was submerged in a water bath.
  • the guiding catheter had a 1.64 millimeter diameter lumen and the distal end of the guiding catheter included a one inch radius bend to simulate a tortous vessel.
  • a force gage (not shown) was used to measure the force required retract the balloon through the guiding catheter.
  • the designation "A” represents the retraction force required without inflating the balloon;
  • the designation "B” represents the retraction force required to retract a deflated balloon after inflation to a nominal diameter; and
  • the designation "C” represents the retraction force required to retract a deflated balloon after inflation to the rated burst pressure.
  • the balloon 16 made in accordance with the present invention easily outperforms all of the other balloons in the retraction force necessary to retract the balloon 16.
  • Figure 9 illustrates (i) a compliance curve, designated 106, for a balloon made in accordance with the present invention of Pellethane® 2102- 55D having a blow up ratio of 5.5, a double wall thickness of 2.05 mil and a rated burst pressure of 351 psi; (ii) a compliance curve, designated 108, for a balloon made in accordance with the present invention of Pellethane® 2102- 55D with a blow up ratio of 6.4, a double wall thickness of 2.25 mils and a rated burst pressure of 321 psi; and (iii) a compliance curve, designated 1 10, for a balloon made in accordance with the present invention of Pellethane® 2102-55D, with a blow up ratio of 6.04, a double wall thickness of 3.3 mils and a rated burst pressure of 323 psi.
  • a compliance curve, designated 106 for a balloon made in accordance with the present invention of Pellethane® 2102-
  • a compliant balloon, a semi-compliant balloon or a non-compliant balloon can be made by altering the blow up ratio and/or the double wall thickness.
  • the balloon having curve designated 106 is considered a compliant balloon and has a compliance of greater than approximately 16 percent between nominal diameter and rated burst pressure.
  • the balloon having curve designated 108 is considered a semi- compliant balloon and has a compliance of between approximately ten to fifteen percent between nominal diameter and rated burst pressure.
  • the balloon having curve designated 110 is considered a non-compliant balloon and has a compliance of less than approximately 10 percent and preferably between eight to nine percent between nominal diameter and rated burst pressure.
  • COMPONENT LIST medical catheter 64 mold catheter shaft 66 first clamp guidewire shaft 68 second clamp inflatable balloon 70 container guidewire 72 mold inner diameter body vessel 74 curve 4.8 BUR patient 76 curve 5.5 BUR catheter shaft proximal end 78 curve 6.4 BUR catheter shaft distal end 80 curve 4.8 BUR inflation lumen 82 curve 5.5 BUR manifold 84 curve 6.4 BUR inflation deflation port 86 curve for our Balloon guidwire port 88 curve for Pebax Balloon guidewire shaft distal end 90 curve for DURALYN guidewire lumen Balloon markers 92 first section of curve body section 94 second section of curve distal cone section 96A-C our Balloon proximal cone section 98A-C VIVA Balloon balloon outer diameter 100A-C MAXXUM Balloon balloon inner diameter 102A-C CALYPSO Balloon balloon wall thickness 104A-C ROCKET Balloon balloon length 106 our Balloon 5.5 BUR tube 108 our Balloon 6.4 BUR

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Abstract

La présente invention concerne un cathéter médical intravasculaire. Ce cathéter médical comprend un ballonnet fabriqué à partir d'un petit groupe spécifique de matériaux polyuréthane. Le ballonnet est formé selon des paramètres strictes de fabrication en vue d'obtenir les caractéristiques voulues de compliance ou de contrainte/déformation, de résistance à l'éclatement, et de flexibilité. De préférence, avant la formation du ballonnet, le matériau polyuréthane présente une dureté comprise entre environ 50D à 65D. Ce matériau polyuréthane comprend: (1) un segment dur obtenu à partir d'un diisocyanate et d'un diol à chaîne courte, et (2) un segment mou obtenu à partir d'un glycol polymère présentant un poids moléculaire moyen compris entre environ 500 et 5000. Lorsque le matériau polyuréthane est fabriqué selon les paramètres précités, le ballonnet obtenu présente alors des caractéristiques supérieures, notamment une résistance relativement élevée à l'éclatement, une compliance relativement basse, et une bonne flexibilité.
PCT/US2000/005437 1999-03-05 2000-03-03 Catheter a ballonnet en polyurethane WO2000051660A1 (fr)

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US09/263,364 1999-03-05

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002041934A2 (fr) * 2000-10-20 2002-05-30 Advanced Cardiovascular Systems, Inc. Procede de gonflement de ballonnet par gonflement volumetrique calibre
EP2035072A1 (fr) * 2006-06-22 2009-03-18 Nellcor Puritan Bennett LLC Coussinet mince pour utilisation avec une tubulure médicale et méthode et appareil pour le fabriquer
WO2010031792A1 (fr) 2008-09-18 2010-03-25 Basf Se Polyuréthanes à base de polyesterdiols présentant des caractéristiques de cristallisation améliorées
WO2011039418A1 (fr) * 2009-10-01 2011-04-07 Bayer Schering Pharma Oy Stérilet
WO2011157691A1 (fr) 2010-06-15 2011-12-22 Basf Se Procédé de préparation de mélanges de polylactides (pla) et de polyuréthanes thermoplastiques (tpu)
US8177742B1 (en) 2010-12-23 2012-05-15 Kimberly-Clark Wordwide, Inc. Inflatable retention system for an enteral feeding device
US8633283B2 (en) 2010-06-15 2014-01-21 Basf Se Process for producing blends made of polylactides (PLAS) and of thermoplastic polyurethanes (TPUS)
WO2015000722A1 (fr) 2013-07-02 2015-01-08 Basf Se Polyuréthane à base de matières premières renouvelables
US20170233520A1 (en) * 2014-03-25 2017-08-17 Basf Se Tpu pneumatic hose
WO2019002263A1 (fr) 2017-06-26 2019-01-03 Basf Se Polyuréthane thermoplastique
WO2022043428A1 (fr) 2020-08-28 2022-03-03 Basf Se Granulés expansés faits de polyuréthane thermoplastique

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US5439443A (en) * 1991-09-30 1995-08-08 Nippon Zeon Co., Ltd. Balloon catheter
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Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002041934A2 (fr) * 2000-10-20 2002-05-30 Advanced Cardiovascular Systems, Inc. Procede de gonflement de ballonnet par gonflement volumetrique calibre
WO2002041934A3 (fr) * 2000-10-20 2003-03-13 Advanced Cardiovascular System Procede de gonflement de ballonnet par gonflement volumetrique calibre
US6620128B1 (en) 2000-10-20 2003-09-16 Advanced Cardiovascular Systems, Inc. Balloon blowing process with metered volumetric inflation
EP2035072A1 (fr) * 2006-06-22 2009-03-18 Nellcor Puritan Bennett LLC Coussinet mince pour utilisation avec une tubulure médicale et méthode et appareil pour le fabriquer
WO2010031792A1 (fr) 2008-09-18 2010-03-25 Basf Se Polyuréthanes à base de polyesterdiols présentant des caractéristiques de cristallisation améliorées
EA019061B1 (ru) * 2009-10-01 2013-12-30 Байер Ой Внутриматочная система
CN102573715B (zh) * 2009-10-01 2014-03-19 拜耳股份有限公司 子宫内系统
US9949869B2 (en) 2009-10-01 2018-04-24 Bayer Oy Intrauterine system
CN102573715A (zh) * 2009-10-01 2012-07-11 拜耳股份有限公司 子宫内系统
WO2011039418A1 (fr) * 2009-10-01 2011-04-07 Bayer Schering Pharma Oy Stérilet
WO2011157691A1 (fr) 2010-06-15 2011-12-22 Basf Se Procédé de préparation de mélanges de polylactides (pla) et de polyuréthanes thermoplastiques (tpu)
US8633283B2 (en) 2010-06-15 2014-01-21 Basf Se Process for producing blends made of polylactides (PLAS) and of thermoplastic polyurethanes (TPUS)
US9149415B2 (en) 2010-12-23 2015-10-06 Avent, Inc. Inflatable retention system for an enteral feeding device
US8475406B2 (en) 2010-12-23 2013-07-02 Kimberly-Clark Worldwide, Inc. Inflatable retention system for enteral feeding device
US9155684B2 (en) 2010-12-23 2015-10-13 Avent, Inc. Inflatable retention system for an enteral feeding device
US8177742B1 (en) 2010-12-23 2012-05-15 Kimberly-Clark Wordwide, Inc. Inflatable retention system for an enteral feeding device
WO2015000722A1 (fr) 2013-07-02 2015-01-08 Basf Se Polyuréthane à base de matières premières renouvelables
US11124594B2 (en) 2013-07-02 2021-09-21 Basf Se Polyurethane based on renewable raw materials
US20170233520A1 (en) * 2014-03-25 2017-08-17 Basf Se Tpu pneumatic hose
WO2019002263A1 (fr) 2017-06-26 2019-01-03 Basf Se Polyuréthane thermoplastique
US11542361B2 (en) 2017-06-26 2023-01-03 Basf Se Thermoplastic polyurethane
WO2022043428A1 (fr) 2020-08-28 2022-03-03 Basf Se Granulés expansés faits de polyuréthane thermoplastique

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