DILATATION BALLOONS CONTAINING POLYESTERETHERAMIDE COPOLYMER

Abstract: Disclosed is a dilatation balloon having a single layer containing polyesteretheramide copolymer. The dilatation balloon may also contain polyamide and/or additional polymers, and may contain substantially no polyetheramide having substantially no ester linkages.

Description: DILATATION BALLOONS CONTAINING POLYESTERETHERAMIDE COPOLYMER Background of the Invention The present invention is generally directed to dilatation balloons containing polyesteretheramide copolymer. The use of balloon catheters for coronary angioplasty is known in the art. In an angioplasty procedure, a partially occluded blood vessel, i.e., one containing a stenosis, is treated by the use of an expanding balloon member which presses the stenosis back against the vessel wall. Typically, the expander member or balloon is carried on the distal end of a dilatation catheter which is routed through the vascular system to a location within, for example, a coronary artery- containing a stenotic lesion. Following placement of the expander member across the lesion as desired, fluid is introduced into the proximal end of the catheter to inflate the expander member to a relatively high pressure, thereby restoring patency to the vessel. Coronary angioplasty procedures and angioplasty devices are described in detail in Vliestra et al., "Coronary Balloon Angioplasty, " Blackwell Scientific Publications (1994) . Medical balloons that are known in the art are disclosed in the following documents: U.S. Patent Nos. 4 964 853 and 4 994 032 to Sugiyama et al; U.S. Patents No. 4 906 244, 5 108 415, 5 156 612, 5 236 659, and 5 304 197, to Pinchuk et al; U.S. Patent Nos. 5 226 880 and 5 334 148 to Martin; U.S. Patent No. 5 250 069 to Nobuyoshi et al; U.S. Patent No. 5,328,468 to Kaneko et al.; European Patent Application No. 0 566 755; and Japanese laid-open patent application No. 58-188463. (All documents cited herein, including the foregoing, are incorporated herein in their entireties for all purposes.) It is an object of the present invention to provide a balloon for an angioplasty device which is made, at least in part, of polyesteretheramide copolymer. Other objects and advantages of the invention will become apparent to those skilled in the art through familiarization with the specification and claims herein. Summary of the Invention In sum, the present invention relates to a balloon for an angioplasty device having a single polymeric layer. The layer may have from about 20 to about 100 weight percent polyesteretheramide copolymer and from about 0 to about 80 weight percent polyamide. The layer contains substantially no polyetheramide having substantially no ester linkages. The polyesteretheramide copolymer may be a block or random copolymer. The polyesteretheramide copolymer may have a hardness of from about 45 Shore D to about 78 Shore D, preferably from about 55 Shore D to about 75 Shore D, and more preferably from about 63 to about 72 Shore D. Even more preferably, the polyesteretheramide copolymer may have a hardness selected from about 63 Shore D, about 70 Shore D, and about 72 Shore D. The single polymeric layer may contain at least about 2 weight percent polyamide such as nylon 12, nylon 11, nylon 6, nylon 6/6, nylon 4/6, and combinations thereof. The single polymeric layer may further contain at least about 2 weight percent polymer such as polyester copolymer, polyurethane copolymer, polyethylene, and combinations thereof. The polymeric layer may have at least about 40 weight percent polyesteretheramide copolymer and more preferably at least about 80 weight percent polyesteretheramide copolymer. The balloon may have from about 20 to about 80 weight percent nylon 12 and about 20 to about 80 weight percent polyesteretheramide copolymer, preferably about 60 weight percent nylon 12 and about 40 weight percent polyesteretheramide copolymer. Alternatively, the balloon may have about 25 to about 80 weight percent nylon 4/6 and about 20 to about 75 weight percent polyesteretheramide copolymer, preferably about 65 weight percent nylon 4/6 and about 35 weight percent polyesteretheramide copolymer. The present invention also relates to a balloon for an angioplasty device having a single polymeric layer consisting essentially of a polyesteretheramide copolymer. The polyesteretheramide copolymer may be a block or random copolymer. The polyesteretheramide copolymer may have a hardness of from about 45 Shore D to about 78 Shore D, preferably from about 55 Shore D to about 75 Shore D, and more preferably about 63 to about 72 Shore D. Even more preferably the polyesteretheramide copolymer may have a hardness selected from 63 Shore D, 70 Shore D, and 72 Shore D. The balloon may consist of polyesteretheramide. The present invention also relates to a balloon for an angioplasty device having a single polymeric layer having (a) at least 91 weight percent polyesteretheramide copolymer, (b) from 0 to 9 weight percent polyamide, and (c) from 0 to 9 weight percent of a polymer other than polyesteretheramide and polyamide. The balloon may have at least about 95 weight percent polyesteretheramide copolymer. Description of the Drawings FIG. 1 is a perspective view of an expander member of the present invention joined to the distal end of a catheter; FIG. 2 is a cross-sectional view of a balloon form used to make expander members of the present invention; FIG. 3 is a schematic view of a mold apparatus used to make expander members of the present invention; FIG. 4 shows a response surface that details the effects of processing variables and material selection on balloon wall thickness for PEBAX 6333 balloons; FIG. 5 shows a response surface that details the effects of processing variables and material selection on balloon burst pressure for PEBAX 6333 balloons; FIG. 6 shows a response surface that details the effects of processing variables and material selection on balloon K-stat for PEBAX 6333 balloons; FIG. 7 shows a response surface that details the effects of processing variables and material selection on balloon hoop stress for PEBAX 6333 balloons; FIG. 8 shows a response surface that details the effects of processing variables and material selection on balloon wall thickness for PEBAX 7033 balloons; FIG. 9 shows a response surface that details the effects of processing variables and material selection on balloon burst pressure for PEBAX 7033 balloons; FIG. 10 shows a response surface that details the effects of processing variables and material selection on balloon K-stat 7033 for PEBAX 7033 balloons.; FIG. 11 shows a response surface that details the effects of processing variables and material selection on balloon hoop stress for PEBAX 7033 balloons; FIG. 12 shows a response surface that details the effects of processing variables and material selection on balloon wall thickness for PEBAX 7233 balloons; FIG. 13 shows a response surface that details the effects of processing variables and material selection on balloon burst pressure for PEBAX 7233 balloons; FIG. 14 shows a response surface that details the effects of processing variables and material selection on balloon K-stat for PEBAX 7233 balloons; and FIG. 15 shows a response surface that details the effects of processing variables and material selection on balloon hoop stress for PEBAX 7233 balloons. Description of the Preferred Embodiments With reference to FIG. 1, expander member 2 is attached to the distal end of a catheter shaft 4. The expander member 2, otherwise known as a balloon, has a single polymeric layer 6 which surrounds the catheter shaft . The expander member 2 shown is bonded at two bonding sites 8a,b by thermal bonding, by laser bonding, with adhesives, or by other methods known in the art. The expander members of the present invention contain polyesteretheramide copolymer. The structure of these polymers consists of regular and linear chains of rigid polyamide blocks and flexible polyether blocks. Such copolymers may be described by the following formula: 0 0 II if HO-tC-PA-C-O-PE-O-3- n -H where PA is a polyamide block; and where PE is a polyether block. Polyesteretheramide copolymer materials are sold under the trademark PEBAX by Atochem Inc. of Glen Rock, New Jersey. Properties of several grades of PEBAX are disclosed in Atochem's brochure entitled "PEBAX Polyether Block Amide" (December 1987) . The expander member of the present invention may contain polyamide. Polyamide materials include nylon 12, nylon 11, nylon 6, nylon 6/6, and nylon 4/6. Such materials are sold under the trademark ZYTEL by Dupont. The expander member of the present invention may further contain a polymer other than polyesteretheramide copolymer or polyamide, such as polyester copolymer, polyurethane copolymer, polyethylene, and combinations thereof. The single polymeric layer making up the expander member may be a blend of suitable materials. Such a blend may be created by mixing the desired resins and then extruding these resins to form a parison. The single layer can also be a graft copolymer. Such a graft copolymer can be formed, for example, by reacting polyamide (such as Nylon 12) with polyphenylether graft maleic anhydride (PPE-graft-MA) . So called polymer alloys, and the like, are also included within the purview of this application. The expander member of the present invention may be formed by first generating a parison in an extruder. The parison will typically have an inside diameter of from about .01 to .031 inches (0.025 to 0.079 cm), and a wall thickness of from about .0035 to .015 inches (.0089 to 0.038 cm) . Hot water treated molding devices may then be utilized to blow mold the expander members of the present invention. Tubing of the desired material and having a required size and thickness is inserted into a balloon processing mold and heated to a temperature of from about 200-212°F (93-100°C) . Weight may be added to the mold as desired. The tubing is subjected to longitudinal tension and high-pressure nitrogen 380-500 psi is introduced into the tubing in the mold. The mold remains in a hot water bath for a predetermined period of time of from about 10- 45 seconds, preferably 25 seconds. The mold is then removed and placed in a cooling pot for a predetermined period of time of from about 20-40 seconds, preferably 30 seconds, after which the mold may be opened and the balloon removed. In an alternative process, the balloons are formed in balloon blow molding machines. The tubing is inserted into the mold and the ends of the tubing secured into mold gaskets. The tubing is thereafter heated in the range of 190-220°F (87-104°C) for about 10 to 45 seconds, preferably 25-30 seconds, and the heated tubing is subjected to longitudinal tension and expanded 1-2 times its length in the axial direction. The stretched tubing is pressurized with nitrogen in the range of about 350- 500 psi and heat treated in the mold for about 10-20 seconds at about 250-280°F (121-138°C) , preferably about 260-270°F (127-132°C) . The mold is then cooled to room temperature and allowed to set at room temperature in the mold under pressure for approximately 10 to 15 seconds. Thereafter, the system can be depressurized and the balloon removed from the mold. Examples Balloons were made of polyesteretheramide block copolymer and then tested to determine certain characteristics. Examples 1-180 180 balloons were made according to the following process: Parisons of 100 weight percent polyesteretheramide block copolymer were extruded. The parisons had inside diameters of about .015 inches to about .023 inches, wall thicknesses of about .006 inches to about .010 inches, and lengths of about 18 inches. The parisons were placed in the mold apparatus illustrated in FIGS. 2 and 3. As shown in FIG. 2, the balloon form 8 had a void 10 corresponding to the final shape of the expander member. The void was made up by a proximal form 24, a body form 26, and a distal form 28. With reference to FIG. 3, the distal end of the parison was inserted into the proximal end 14 of the mold apparatus 12, and pushed through the proximal form 24, the body form 26, and the distal form 28 until it exited the distal end 16 of the mold section. Cap 18 was then placed over the distal end 16 of the apparatus 12 thereby clamping and sealing the distal end of the parison. The mold was then placed in a handle 20 such that the proximal end of the parison freely extended from the handle 20. Weights 22 were then placed over the proximal end of the parison and onto the mold. The open proximal end of the parison was then connected to a pressurized nitrogen source by a Touhy Borst clamp. The nitrogen source was capable of achieving maximum pressures of 1,000 psi. The nitrogen source was then opened to varying degrees of between 350- 500 psi and the mold was placed in a bath of hot water (212°F) . The hot water bath warmed the parison. The freely extending proximal end of the parison was held by hand such that only about the distal form 28 was under water, until the mold dropped due to longitudinal stretching and the distal end of the parison expanded radially (about 15-30 seconds) . Still holding the mold by hand, the mold continued to drop until it was entirely under water and the proximal end of the balloon expanded radially (about an additional 1-10 seconds) . The mold was then removed from the hot water bath and placed in a cold water bath of about 60-75°F for about 30 seconds. The nitrogen was then shut off, and the balloon was removed from the mold. The balloons were tested by attaching the balloons to a pressurized nitrogen source in a 37°C water bath, expanding the balloons under several predetermined pressures of nitrogen (50 psi, 100 psi, 150 psi, and burst pressure) , and then measuring several dimensions and the burst pressure of the balloons. Dimensions were measured with a snap gauge. Tables 1-18 below list certain parameters of the process utilized to make the subject balloons (hot pot temperature, cold pot temperature, weight added to mold, and nitrogen pressure) . The tables also show results of the testing of the expander members. K stat was calculated as follows: (Burst pressure) -( (K Stat) (Burst Pressure Standard Deviation) ) . Hoop stress was calculated as follows: (Balloon Burst Pressure) (Balloon Diameter)/ (2) (Balloon Wall Thickness) . Table 1 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 212° F. COLD POT: ROOM TEMP. WEIGHT: 250 GRAMS NITROGEN 400 PSI Double Double — I — Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter . Diameter Burst Balloon Thickness Thickness Thickness ID/OD - 50 psi 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (osi) 1 0.001250 0.001300 0.001250 .017X.031 0.1120 0.1200 0.1260 255 2 0.001350 0.001300 0.001300 .017X.031 0.1120 0.1200 0.1250 266 3 0.001400 0.001300 0.001300 .017X.031 0.1125 0.1210 0.1250 269 4 0.001300 0.001400 0.001250 .017X.031 0.1120 0.1200 0.1250 270 5 0.001350 0.001400 0.001300 .017X.031 0.1130 0.1200 0.1260 270 6 0.001350 0.001400 0.001300 .017X.031 252 7 0.001350 0.001400 0.001300 .017X.031 268 8 0.001300 0.001400 0.001300 .017X.031 270 9 0.001300 0.001350 0.001300 .017X.031 268 10 0.001350 0.001450 0.001300 .017X.031 280 Averaαe 0.001330 0.001370 0.001290 .017X.031 0.11230 0.12020 0.12540 266 8 Standard 4.2164E-05 5.37484E-05 2.10819E-05 0.000447 0.000447 0.000548 7 9693859 Calculated K- stat (psi): 225.3353 Calculated He op Stress (psi) 24112 Table 2 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 212° F. COLD POT: ROOM TEMP. WEIGHT: 300 GRAMS NITROGEN 480 PSI Double Double Double Proximal Distal ' i Centerwall Wall Wall Measured Diameter Diameter Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) ( vpr-s*"i)/ 11 0.00190 0.00190 0.00190 .015X.035 0.1080 0.1180 0.1230 300 12 0.00180 0.00185 0.00180 .015X.035 0.1090 0.1180 0.1220 275 13 0.00170 0.00185 0.00165 .015X.035 0.1090 0.1180 0.1220 296 14 0.00180 0.00180 0.00180 .015X.035 0.1075 0.1170 0.1220 285 15 0.00190 0.00195 0.00170 .015X.035 0.1080 0.1180 0.1220 285 16 0.00180 0.00185 0.00160 .015X.035 300 17 0.00180 0.00180 0.00180 .015X.035 293 18 0.00190 0.00185 0.00170 .015X.035 315 19 0.00185 0.00180 0.00165 .015X.035 285 20 0.00170 0.00170 0.00170 .015X.035 285 Averaαe 0.001815 0.001835 0.00173 .015X.035 0.1083 0.1178 0.1222 291.9 Standard 7.47E-05 6.687E-05 9.18937E-05 0.000671 0.000447 0.000447 11.34754 Calculated K-stat (psi): 232.8587 Calculated Hoop Stress (psi): 28594 40 13 Table 4 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 210° F. COLD POT: ROOM TEMP. WEIGHT: 300 GRAMS NITROGEN 320 PSI Double Double I Double Proximal Distal Center all Wall Wall Measured Diameter Diameter Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 31 0.00140 0.00140 0.00140 .020X.032 0.117 0.123 0.128 251 32 0.00140 0.00140 0.00140 .020X.032 0.117 0.123 0.129 249 33 0.00125 0.00125 0.00120 .020X.032 0.117 0.123 0.129 253 34 0.00135 0.00130 0.00120 .020X.032 0.116 0.123 0.129 251 35 0.00140 0.00130 0.00130 .020X.032 0.116 0.123 0.128 253 36 0.00140 0.00140 0.00135 .020X.032 243 37 0.00140 0.00135 0.00135 .020X.032 223 38 0.00130 0.00130 0.00130 .020X.032 253 39 0.00135 0.00135 0.00135 .020X.032 223 40 0.00125 0.00135 0.00125 .020X.032 253 Averaαe 0.001360 0.00134 0.0013100 .020X.032 0.1166 0.123 0.1286 245.2 Standard 5 16Ξ-05 5.164E-05 7.37865E-05 0.000548 1.86E-09 0.000548 12.0904 Calculated K-stat (psi): 182.2936 Calculated Hoop Stress (psi): 22176 Table 5 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 210° F. COLD POT: ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 400 PSI Double Double Double Proximal Distal 1 ! Centerwall Wall Wall Measured Diameter Diameter Diameter Burst Balloon Thickness Thickness Thickness ID/OD < - 50 psi n 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 41 0.00160 0.00160 0.00160 .020X.035 0.115 0.125 0.130 253 42 0.00170 0.00170 0.00170 .020X.035 0.117 0.125 0.130 263 43 0.00160 0.00170 0.00170 .020X.035 0.117 0.125 -0.130 269 44 0.00140 0.00150 0.00150 .020X.035 0.118 0.126 0.131 253 45 0.00145 0.00155 0.00150 .020X.035 0.114 0.123 0.129 250 45 0.00160 0.00160 0.00160 -020X.035 269 47 0.00150 0.00150 0.00140 .020X.035 268 48 0.00140 0.00140 0.00140 .020X.035 239 49 0.00150 0.00150 0.00150 .020X.035 257 50 0.00150 0.00150 0.00150 .020X.035 257 Averaαe 0.001525 0.001555 0.001540 .020X.035 0.1162 0.1248 0.13 257 8 Standard 9.79E-05 9.56E-05 0.000107497 0.001643 0.001095 0.000707 9.681598 Calculated K-stat (psi): 207.4266 Calculated Hoop Stress (psi): 21097 Table 6 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 200° F. COLD POT: ROOM TEMP. WEIGHT: 250 GRAMS NITROGEN 400 PSI Calculated K-stat (psi): 185.8414 Calculated Hoop Stress (psi): 21922 Table 7 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 210° F. COLD POT: ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 420 PSI Calculated K-stat (psi): 228.7694 Calculated Hoop Stress (psi): 20810 Table 8 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 212° F. COLD POT: ROOM TEMP. WEIGHT: 250 GRAMS NITROGEN 460 PSI Calculated K-stat (psi): 246.0057 Calculated Hoop Stress (psi): 24776 Table 9 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 205° F. COLD POT: ROOM TEMP. WEIGHT: 250 GRAMS NITROGEN 380 PSI ■ > Calculated K-stat (psi): 235.0021 Calculated Hoop Stress (psi): 26844 Table 10 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 212° F. COLD POT: ROOM TEMP. WEIGHT: 250 GRAMS NITROGEN 400 PSI Calculated K-stat (psi): 265.829 Calculated Hoop Stress (psi): 26962 Table 11 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 210° F. COLD POT: ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 400 PSI Double Double Double Proximal Distal i .i Centerwall Wall Wall Measured Diameter Diameter Diameter Burst Balloon Thickness Thickness Thickness ID/OD - 50 psi 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 101 0.0014 0.0014 0.00140 .023X035 0.115 0.121 0.127 298 102 0.0013 0.0013 0.00125 .023X.035 0.117 0.126 0.134 253 103 0.0013 0.0013 0.00120 .023X.035 0.117 0.126 0.131 275 104 0.0013 0.0013 0.00130 .023X035 0.118 0.126 0.132 238 105 0.0013 0.0013 0.00140 .023X.035 0.116 0.127 0.133 281 106 0.0013 0.0013 0.00140 .023X035 280 107 0.0013 0.0013 0.00140 .023X.035 269 108 0.0012 0.0012 0.00130 .023X.035 280 109 0.0012 0.0012 0.00125 .023X035 . — 2B3 110 0.0012 0.0012 0.00125 .023X035 283 Averaαe 0.00128 0.00128 0.001315 .023X035 1 0.1166 0.1252 0.1314 274 Standard 6.32E-05 6.325E-05 7.83511Ξ-05 0.00114 0.002387 I 0.002702 I 17.06849 Calculated K-stat (psi): 185.1926 Calculated Hoop Stress (psi): 26800 Table 12 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 210" F. COLD POT: ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 420 PSI Double Double I Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi 150 psi Pressure r-o No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 111 0.00150 0.0015 0.0014 .023X.038 0.119 0.125 0.130 310 112 0.00160 0.0016 0.0016 .023X.038 0.118 0.125 0.130 300 113 0.00160 0.0016 0.0016 .023X.038 0.118 0.125 0.130 293 . 114 0.00150 0.0015 0.0015 .023X.038 0.118 0.126 0.131 283 115 0.00150 0.0015 0.0015 .023X.038 0.119 0.125 0.130 280 116 0.00150 0.0016 0.0015 .023X.038 300 117 0.00145 0.0015 0.0015 .023X.038 310 118 0.00160 0.0016 0.0016 .023X.038 298 119 0.00150 0.0015 0.0015 .023X.038 298 120 0.00145 0.0015 0.0015 .023X.038 313 Averaαe 0.00152 0.00154 0.00152 .023X.038 0.1184 0.1252 0.1302 298.5 Standard 5.87E-05 5.164E-05 6.32456E-05 0.000548 0.000447 0.000447 11.01766 Calculated K-stat (psi): 241.1751 Calculated Hoop Stress (psi). 24586 Table 13 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 212° F. COLD POT: ROOM TEMP. WEIGHT: 300 GRAMS NITROGEN 460 PSI Double Double Double Proximal Distal H Centerwall Wall Wall Measured Diameter Diameter Diameter Burst Balioon Thickness Thickness Thickness ID/OD . 50 psi 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 121 0.00110 0.00120 0.00110 .017x.031 0.108 0.116 0.120 330 122 0.00120 0.00135 0.00120 017x031 0.106 0.115 0.119 345 123 0.00130 0.00140 0.00135 017x031 0.106 0.116 0.120 300 124 0.00130 0.00130 0.00120 017x031 0.106 0.116 0.120 345 125 0.00130 0.00130 0.00125 017x031 0.108 0.116 0.120 360 126 0.00135 0.00130 0.00120 017x031 345 127 0.00145 0.00130 0.00130 017x031 375 128 0.00130 0.00130 0.00130 017x031 330 129 0.00145 0.00130 0.00140 017x031 300 130 0.00140 0.00140 0.00135 017x031 345 Averaαe 0.001315 0.001315 0.001265 .017x.031 0.10680 0.11580 0.11980 337.5 Standard 0.000108 5.798E-05 9.14391E-05 0.001095 0.000447 0.000447 I 23.71708 Calculated K-stat (psi): 214.1 Calculated Hoop Stress (psi): 29720 Table 14 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 212° F. COLD POT: ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 500 PSI Calculated K-stat (psi): 194.627 Calculated Hoop Stress (psi): 24117 Table 15 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS HOT POT. 210" F COLD POT ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 400 PSI Calculated K-stat (psi) 254 7526 Calculated Hoop Stress (psi) 27018 Table 16 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 >: 20 mm PARAMETERS: HOT POT: 205° F. COLD POT: ROOM TEMP. WEIGHT: 320 GRAMS NITROGEN 400 PSI Calculated K-stat (psi): 272.2306 Calculated Hoop Stress (psi): 33342 Table 17 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: 210° F. COLD POT: ROOM TEMP. WEIGHT: 380 GRAMS NITROGEN 400 PSI Calculated K-stat (psi): 207.4875 Calculated Hoop Stress (psi): 28274 Table 18 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: HOT POT: COLD POT: ROOM TEMP. WEIGHT: 350 GRAMS NITROGEN 420 PSI Calculated K-stat (psi): 194.9117 Calculated Hoop Stress (psi): 25898 Examples IS1-206 26 balloons were made according to the process described for Examples 1-180, except that the mold apparatus did not utilize weights 22 separately, but rather incorporated a preselected weight into handle 20. The balloons were tested to measure distension and balloon burst strength. Distension is defined as the ratio of two balloon diameters. In this test, a balloon was inflated to a series of pressures. The diameter was measured at each pressure. The distension is the ratio of the diameter at the lowest pressure to the diameter at the highest pressure. Inflation was performed at 1 bar increments up to burst pressure. To test the balloons, the balloons were first placed in temperature controlled water bath, and warmed for a minimum of 1 minute in water. The balloons were then attached to a pneumatic inflation/deflation device. A vacuum was created. Starting with a 4 bar pressure for 20 seconds, the balloon diameter and length were measured. The balloons were deflated, and the measurements were recorded. Increasing the pressure by 1 bar, the balloon diameters and lengths were measured. This procedure was repeated until the balloons bursted. The burst pressure and the type of burst profile were recorded. Tables 19-21 below show the results of the testing of the expander members. Table 19 PEBAX GRADE 7233 Tubing Dimensions (ID x OD): 0.48 x 0.81 mm Balloon Dimensions (OD x length): 3.0 x 20 mm Diameter Form: 3.00 mm DIAMETER (mm) Balloon Num ber atm 181 182 183 184 185 186 187 188 189 190 Average 4 2.57 2.60 3 2.60 2.57 2.55 2.54 2.54 2.61 2.57 2.58 00 6 2.79 2.81 3 2.81 2.79 2.79 2.70 2.75 2.78 2.80 2.78 o 8 2.91 2.94 3 2.93 2.93 2.95 2.89 2.88 2.93 2.93 2.92 10 3.01 3.01 3 3.02 3.02 3.01 2.99 3.00 3.00 3.02 3.01 12 3.06 3.07 3 3.08 3.09 3.08 3.03 3.05 3.06 3.07 3.07 14 3.12 3.14 3 3.13 3.12 3.12 3.09 3.11 3.12 3.12 3.12 16 3.17 3.17 3 3.17 3.18 3.17 3.14 3.16 3.16 3.18 3.17 18 3.23 3.24 3 3.25 3.24 3.23 3.21 3.22 3.23 3.23 3.23 Average burst pressure 21.1 atm Minimum burst pressure 20.0 atm Maximum burst pressure 22.0 atm Table 20 PEBAX GRADE 7233 Tubing Dimensions (ID x OD): 0.48 x 0.82 mm Balloon Dimensions (OD x length): 3.0 x 20 mm Diameter Form: 3.25 mm DIAMETER (mm) Balloon Number atm 191 192 193 194 195 196 197 198 Average 4 2.73 2.74 2.66 2.71 2.69 2.71 2.70 2.77 2.71 6 2.97 2.93 2.89 2.92 2.92 2.94 2.97 3.01 2.94 8 3.12 3.06 3.03 3.08 3.06 3.07 3.08 3.12 3.08 10 3.18 3.12 3.15 3.16 3.12 3.17 3.18 3.19 3.16 12 3.23 3.20 3.22 3.23 3.19 3.23 3.23 3.26 3.22 oo 14 3.30 3.27 3.27 3.27 3.25 3.28 3.28 3.33 3.28 16 3.33 3.31 3.31 3.30 3.29 3.32 3.32 3.36 3.32 18 3.39 3.33 3.37 3.37 3.36 3.40 3.39 3.43 3.38 Average burst pressure 21.4 atm Minimum burst pressure 20.0 atm Maximum burse pressure 22.0 atm Table 21 PEBAX GRADE 7233 Tubing Dimensions (ID x OD): 0.65 x 0.90 mm Balloon Dimensions (OD x length): 3.0 x 20 mm Diameter Form: 3.25 mm DIAMETER (mm) Balloon Number atm 199 200 201 202 203 204 205 206 Average 4 2.91 2.92 2.94 2.91 2.87 2.85 2.93 2.99 2.92 6 3.17 3.15 3.16 3.13 3.14 3.10 3.17 3.19 3.15 8 3.28 3.32 3.29 3.29 3.28 3.25 3.31 3.33 3.29 10 3.40 3.44 3.41 3.39 3.40 3.36 3.42 3.44 3.41 12 3.52 3.52 3.49 3.52 3.51 3.48 3.52 3.53 3.51 14 3.66 3.65 3.64 3.65 3.65 3.62 3:66 3.66 3.65 16 3.79 3.79 3.82 3.83 3.80 3.78 3.82 3.85 3.81 18 4.05 - - - 4.06 4.08 4.05 4.17 4.08 Average burst pressure 19.3 atm Minimum burst pressure 18.0 atm Maximum burse pressure 20.0 atm Examples 207-236 30 balloons were made according to the procedure described above for Examples 1-180, except that parisons had inside diameters of about .025 inches and wall thicknesses of about .0065 inches. The balloons were tested according to the procedure described above for Examples 1-180, except that outside diameters were measured at 1 atm increments from 4-16 atms, and then the balloons were burst. Tables 22-28 below list certain parameters (PEBAX grade, dimensions, cone angle, rated burst, and hold time representing the total amount of time that the mold was held in the water) . The tables also show results of the testing of the expander members. Table 22 BALLOON COMPLIANCE PEBAX Grade: 7233 Dimensions (dia. x Igt.): 3.0 x 20 mm Cone Angle: 10 degrees Rated Burst: 176 psi Hold (Sees.) 15 DIAMETER (inches) Pressure Balloon Number atm psi 207 208 209 210 211 4 58.8 111 111 .112 112 112 , 5 73.5 113 114 .115 114 115 ' 6 88.2 116 116 .117 116 117 7 102.5 118 117 .118 117 118 oo 8 117.6 119 119 .119 118 119 9 132.3 120 120 .120 119 120 10 147.0 122 121 .121 120 121 11 161.7 122 122 .122 121 122 12 176.4 123 123 .123 122 123 13 191.1 124 124 .124 123 124 • 14 205.8 125 125 .125 124 125 15 220.5 126 126 .125 125 126 16 235.2 127 127 .126 125 127 Burst Pressure (psi) 278 249 278 307 291 Direction of Burst Axial Axial | Axial Axial Axial 36 Table 27 BALLOON COMPLIANCE PEBAX Grade: 7233 Dimensions (dia. x Igt.): 3.0 x 20 mm Cone Angle: 10 degrees Rated Burst: 176 psi Hold (Sees.) 15 DIAMETER (inches) Pressure Balloon Number atm psi 232 233 234 235 236 4 58.8 .111 .111 .110 .111 .112 5 73.5 .114 .114 .113 .114 .115 6 88.2 .116 .116 .116 .116 .1165 7 102.5 .117 .117 - .117 .117 .118 8 117.6 .119 .190 .118 .1185 .119 9 132.3 .120 .120 .119 .120 .120 10 147.0 .121 .121 .1205 .121 .121 11 161.7 .122 .122 .122 .122 .122 12 176.4 .1225 .123 .123 .123 .123 13 191.1 .124 .124 .124 .124 .124 14 205.8 .124 .125 .125 .125 .125 15 220.5 .125 .126 .125 .126 .126 16 235.2 .126 .127 .126 .127 .127 Burst Pressure (psi) 265 280 305 278 260 Direction of Burst Axial Axial Axial Axial Axial Table 28 BALLOON COMPLIANCE MEASUREMENTS BEFORE TESTING Double Wall Thickness Measurements Proximal Side-Body Center Distal Side-Body 207 .00175 .00120 .00135 208 .00145 .00140 .00120 209 .00130 .00140 .00140 210 .00140 .00150 .00140 21 1 .00165 .00175 .00185 212 .00135 .00120 .00125 213 .00150 .00140 .00120 214 .00135 .00120 .00115 215 .00155 .00130 .00120 216 .00135 .00120 .00125 217 .00140 .00135 .00145 218 .00165 .00130 .00125 219 .00145 .00135 .00130 220 .00155 .00120 .00140 221 .00135 .00120 .00120 222 .00155 .00135 .00140 223 .00140 .00130 .00135 224 .00145 .00135 .00120 225 .00160 .00135 .00125 226 .00150 .00135 .00130 227 .00155 .00135 .00135 228 .00155 .00150 .00135 229 .00150 .00135 .00130 230 .00135 .00135 .00120 231 .00160 .00135 .00130 232 .00160 .00135 .00130 233 .00140 .00120 .00120 234 .00145 .00135 .00125 235 .00150 .00145 .00120 236 .00145 .00135 .00125 Examples 237-266 30 balloons were made according to the procedure described above for Examples 1-180. The balloons were tested according to the procedure described above for Examples 1-180, except that balloons were tested at 1 atm increments from 4-16 atm and then burst. Tables 29-35 below list certain parameters (PEBAX grade, dimensions, cone angle, rated burst, and hold time representing the total amount of time that the mold was held in the water) . The tables also show results of the testing of the expander members. Table 30 BALLOON COMPLIANCE PEBAX Grade: 6333 Dimensions (dia. x Igt.): 3.0 x 20 mm Cone Angle: 10 degrees Rated Burst: 176 psi Hold (Sees.) 15 DIAMETER (inches) Pressure Balloon Number atm psi 242 243 244 245 246 4 58.8 .116 .115 .115 .114 .115 5 73.5 .119 .118 .117 .117 .117 6 88.2 .121 .120 .119 .119 .119 7 102.5 .122 .122 .121 .121 .121 8 117.6 .124 .124 . .122 .1220 .122 9 132.3 .125 .125 .124 .124 .123 o 10 147.0 .127 .126 .125 .125 .125 11 161.7 .128 .128 .126 .126 .126 12 176.4 .129 .129 .128 .127 .128 13 191.1 .131 .131 .129 .129 .129 14 205.8 .133 .132 .131 .131 .130 " 15 220.5 .135 .134 .132 .132 .132 16 235.2 .136 .135 .134 .134 .133 Burst Pressure (psi) 250 250 250 250 260 Direction of Burst Axial Axial Axial Axial Axial Table 35 BALLOON COMPLIANCE MEASUREMENTS BEFORE TESTING Double WallThickness Measurements Proximal Side-Body Center Distal Side-Body 237 .00155 .00130 .00120 238 .00135 .00120 .00120 239 .00125 .00120 .00110 240 .00125 .00120 .00120 241 .00130 .00120 .00120 242 .00135 .00120 .00110 243 .00130 .00115 .00120 244 .00130 .00120 .00110 245 .00135 .00125 .00110 246 .00135 .00120 .00120 247 .00135 .00120 .00115 248 .00125 .00120 .00115 249 .00120 .00120 .00110 250 .00130 .00125 .00110 251 .00130 .00120 .00115 252 .00135 .00120 .00105 253 .00130 .00120 .00110 254 .00120 .00110 .00110 255 .00120 .00115 .00105 256 .00125 .00120 .00110 257 .00125 .00120 .00110 258 .00135 .00120 .00110 259 .00135 .00120 .00115 260 .00120 .00110 .00110 261 .00130 .00125 .00120 262 00130 .00120 .00110 263 .00125 .00120 .00115 264 .00130 .00115 .00115 265 .00135 .00120 .00110 266 .00120 .00110 .00105 Examples 267-276 10 balloons were made according to the procedure described above for Examples 1-180, except that parisons had inside diameters of about .025 inches and wall thicknesses of about .0065 inches. The balloons were tested according to the procedure described above for Examples 1-180, except that outside diameters were measured at 1 atm increments from 4-16 atms, and then the balloons were burst. Tables 36-38 below list certain parameters (PEBAX grade, dimensions, cone angle, rated burst, and hold time representing the total amount of time that the mold was held in the water) . The tables also show results of the testing of the expander members. Table 38 BALLOON COMPLIANCE MEASUREMENTS BEFORE TESTING Double Wall Thickness Measurements Proximal Side-Body Center Distal Side-Body 267 .00110 .00110 .00105 268 .00105 .00105 .00105 269 .00105 .00100 .00100 270 .00110 .00110 .00110 271 .00115 .00110 .00100 272 .00115 .00100 .00100 273 .00115 .00110 .00100 274 .00115 .00100 .00105 275 .00110 .00110 .00100 276 .00110 .00100 .00100 cn ro — Examples 277-306 30 balloons were made according to the procedure described above for Examples 1-180, except that cone angles were 267 and the parison inside diameter was .025 inches with a wall thickness of .0065. The balloons were tested according to the procedure described above for Examples 1-180, except that outside diameters were measured at 1 atm increments from 4-16 atms, and then the balloons were burst. Tables 39-41 below list certain parameters (PEBAX grade, dimensions, cone angle, rated burst, and hold time representing the total amount of time that the mold was held in the water) . The tables also show results of the testing of the expander members. Table 39 BALLOON COMPLIANCE PEBAX Grade: 7033 Dimensions (dia. x Igt.): 3.0 x 20 mm Cone Angle: 26° Rated Burst: 176 Hold (Sees.) 15 DIAMETER (cm) Pressure Balloon N umbers ' I atm 277 278 279 280 281 282 283 284 285 286 4 2.9972 3.0226 2.9718 2.9210 2.9210 2.9210 2.8448 2.8194 2.8956 2.9210 3.0988 3.1242 3.0988 3.0226 2.9972 2.9972 -P * > 5 2.9972 2.9972 3.0226 3.0480 6 3.1496 3.1750 3.1496 3.1242 30.7340 3.1496 30.9880 3.0988 3.1750 3.1496 7 3.2004 3.2258 3.2004 3.1750 3.1750 3.2258 3.2004 3.2004 3.2258 3.2004 8 3.2766 3.2512 3.2258 3.2258 3.2258 3.2766 3.2512 3.2512 3.2766 3.3020 9 3.3020 3.3020 3.2766 3.2766 3.2766 3.3528 3.3020 3.3020 3.3274 3.3528 10 3.3528 3.3528 3.3274 3.3030 3.3274 3.4036 3.3528 3.3528 3.4036 3.4036 11 3.3782 3.4036 3.3782 3.3528 3.3782 3.4544 3.4036 3.4036 3.4544 3.4544 12 3.4544 3.4544 3.4290 3.4036 3.4036 3.5052 3.4544 3.4544 3.5306 3.5306 13 3.5052 3.4798 3.5052 3.4290 3.4544 3.5814 3.5052 3.5052 3.5814 3.6068 14 3.5560 3.5560 3.5814 3.5052 3.5052 3.6576 3.5560 3.5560 3.6576 3.6576 15 3.5814 3.6068 3.6068 3.5306 3.5306 3.7338 3.6068 3.6322 3.8100 3.7592 16 3.6576 3.6830 3.6322 3.6068 3.6068 3.8608 3.6576 3.6576 3.8100 3.8100 Burst psi 290 265 265 295 260 265 265 260 250 265 atm 19.70 18.02 18.02 20.06 17.68 18.02 18.02 17.68 17.00 18.02 Table 41 BALLOON COMPLIANCE PEBAX Grade: 7033 Dimensions (dia. x Igt.): 3.0 x 20 mm Cone Angle: 26° Rated Burst: 176 Hold (Sees.) 15 DIAMETER (cm) j Pressure Balloon Numbers J atm 297 298 299 300 301 302 303 304 305 306 4 2.8702 2.8956 2.8194 2.8194 2.8702 2.7940 2.8448 2.8702 2.8956 2.8448 c 5 2.9972 2.9972 2.9972 2.9210 2.9972 2.9972 2.9972 2.9718 2.9972 2.9972 6 3.1242 3.1242 3.0988 3.0480 3.0988 3.1242 3.0988 3.0734 3.0988 3.0988 7 3.1750 3.1750 3.2004 3.1496 . 3.1750 3.2004 3.1750 3.1496 3.1750 3.2004 8 3.2512 3.2512 -3.2512 3.2004 3.2258 3.2512 3.2512 3.2004 3.2258 3.2766 9 3.3274 3.3020 3.2766 3.2512 3.3020 3.3274 3.3020 3.2512 3.2766 3.3274 10 3.3782 3.3528 3.3274 3.3274 3.3528 3.4036 3.3274 3.3020 3.3274 3.4036 11 3.4544 3.4036 3.3782 3.3782 3.4036 3.4544 3.3782 3.3782 3.3782 3.4544 12 3.5052 3.4798 3.4555 3.4036 3.4544 3.5052 3.4544 3.4290 3.4290 3.5052 13 3.5560 3.5052 3.5306 3.4544 3.5052 3.6068 3.5052 3.4544 3.4798 3.5814 14 3.6322 3.5306 3.5814 3.5052 3.5560 3.6576 3.5560 3.5052 3.5306 3.6322 15 3.6830 3.5814 3.6322 3.5560 3.6322 3.7592 3.6068 3.5560 3.5814 3.7084 16 3.7846 3.6322 3.7084 3.6322 3.6830 3.8100 3.6830 3.6322 3.6322 3.7846 Burst psi 265 260 265 265 265 265 265 265 265 265 atm 18.02 17.68 18.02 18.02 18.02 18.02 18.02 18.02 18.02 18.02 Examples 307-366 60 balloons were made according to the following procedure: Tubing was placed into a mold and preheated for 15-30 seconds to a preselected balloon blowing temperature. The tubing was stretched and inflated to make a balloon. The balloon was allowed to remain at the balloon blowing temperature for 15-30 seconds, and then elevated to at least the crystallization temperature for 10-20 seconds. The balloon was then cooled to room temperature and removed from the mold. The balloons were tested according to the procedure described above for Examples 1-180. Tables 42-47 below list certain parameters (PEBAX grade, dimensions, crystallization temperature, mold temperature, left and right stretch dimensions, nitrogen pressure, and air flow) . The tables also show results of the testing of the expander members. Table 42 PEBAX GRADE: 6333 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: TEMP: CRYSTALIZATION: 200° F MOLD: 190° F STRETCH: LEFT: 2.60 INCHES RIGHT: 2.60 INCHES PSI: 350 AIRFLOW: 200 Double Double Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter I Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 307 0.00120 0.00120 0.00130 .020X.035 0.119 0.128 0.135 238 o 308 0.00120 0.00130 0.00120 .020X.035 0.118 0.127 0.137 241 309 0.00135 0.00135 0.00145 .020X.035 0.118 0.128 0.136 245 310 0.00130 0.00140 ' 0.00120 .020X.035 0.117 0.127 0.137 238 311 0.00125 0.00135 0.00145 .020X.035 0.117 0.127 0.134 240 312 0.00135 0.00125 0.00125 .020X.035 249 313 0.00125 0.00125 0.00125 .020X.035 239 314 0.00135 0.00130 0.00130 .020X.035 230 315 0.00130 0.00130 0.00130 .020X.035 240 316 0.00130 0.00130 0.00135 .020X.035 240 Averaαe 0.001285 0.0013 0.001305 .020X.035 0.1178 0.1274 0.1358 240 Standard 5.79751 E-05 5.7735E-05 8.95979E-05 0.000837 0.000548 0.001304 4.898979 Calculated K-stat (psi): 214.5106 Calculated Hoop Stress (psi): 23794.55 Table 43 PEBAX GRADE: 6333 BALLOON DIME iNSIONS (diameter x leng th): 3 x 20 mm PARAMETERS: TEMP: CRYSTALIZATION: 260° F MOLD: 190° F STRETCH: LEFT: 2.75 INCHES RIGHT 2.75 INCHES PSI: 350 AIRFLOW: 200 Double Double Double Proximal Distal Centerwall Wall Wall Measured Diameter. Diameter j Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi .50 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) u 317 0.00130 0.00135 0.00130 .020X.035 0.116 0.127 0.135 240 318 0.00135 0.00140 0.00140 .020X.035 0.114 0.127 0.135 248 319 0.00135 0.00145 0.00135 .020X.035 0.116 0.127 0.134 240 320 0.00135 0.00135 0.00145 .020X.035 0.115 0.127 0.134 251 321 0.00130 0.00145 0.00130 .020X.035 0.115 0.127 0.135 240 322 0.00145 0.00135 0.00135 .020X.035 240 323 0.00140 0.00140 0.00140 .020X.035 248 324 0.00135 0.00135 0.00140 .020X.035 240 325 0.00135 0.00135 0.00135 .020X.035 240 326 0.00135 0.00135 0.00135 .020X.035 240 Average 0.001355 0.00138 0.00137 .020X.035 0.1152 0.127 0.1346 242.7 Standard 4.38E-05 4.216E-05 4.74342E-05 0.000837 1.86E-09 0.000548 | 4.423423 | Calculated K-stat (psi): 219.6849 Calculated Hoop Stress (psi): 22747.53 Table 44 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): x 30 mm PARAMETERS: TEMP: CRYSTALIZATION: 200° F MOLD: 190" F STRETCH: LEFT: 2.75 INCHES RIGHT 2.75 INCHES PSI: 380 AIRFLOW: 200 Double Double Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter jDiameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi .50 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) . 327 0.00130 0.001350 0.00130 .020X.035 0.115 0.125 0.129 270 σi o 328 0.00125 0.001300 0.00130 .020X.035 0.116 0.125 0.129 270 329 0.00130 0.001350 0.00130 .020X.035 0.116 0.125 0.132 270 330 0.00130 0.001300 0.00125 .020X.035 0.115 0.127 0.132 263 331 0.00125 0.001300 0.00130 .020X.035 0.116 0.126 0.132 270 332 0.00135 0.001350 0.00130 .020X.035 280 333 0.00135 0.001300 0.00130 .020X.035 280 334 0.00130 0.001300 0.00130 .020X.035 270 335 0.00125 0.001250 0.00120 .020X.035 283 336 0.00130 0.001200 0.00130 .020X.035 240 Averaαe 0.001295 0.0013 1.285E-03 .020X.035 0.1156 0.1256 0.1308 269.6 Standard 3.69E-05 4.714E-05 3.37474E-05 0.000548 0.000894 0.001643 12.09408 Calculated K-stat (psi): 206.6745 Calculated Hoop Stress (psi): 26148.08 Table 45 PEBAX GRADE: 7033 BALLOON DIMENSIONS (diameter x length): 3 x 30 mm PARAMETERS: TEMP: CRYSTALIZATION: 260° F MOLD: 210° F STRETCH: LEFT: 2.25 INCHES RIGHT: 2.25 INCHES PSI: 320 AIRFLOW: 200 Double Double Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter j Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi .50 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 337 0.00100 0.00100 0.00100 .020X.035 0.121 0.13 0.138 238 338 0.00115 0.00120 0.00100 .020X.035 0.121 0.129 0.136 230 339 0.00100 0.00105 0.00115 .020X.035 0.121 0.13 0.138 220 340 0.00110 0.00115 0.00100 .020X.035 0.121 - .0.129 0.136 219 341 0.00105 0.00110 0.00100 .020X.035 0.121 0.129 0.137 238 342 0.00105 0.00100 0.00100 .020X.035 239. 343 0.00120 0.00120 0.00105 .020X.035 238 344 0.00100 0.00110 0.00105 .020X.035 238 345 0.00100 0.00105 0.00105 .020X.035 220 346 0.00105 0.00110 0.00100 .020X.035 239 Average 0.00106 0.001095 0.00103 .020X.035 0.121 0.1294 0.137 231.9 Standard 6.99E-05 7.246E-05 4.83046E-05 0 0.000548 0.001 8.83742 Calculated K-stat (psi): 185.9189 Calculated Hoop Stress (psi): 28309.3 Table 46 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: TEMP: CRYSTALIZATION: 400° F MOLD: 190° F STRETCH: LEFT: 2 INCHES RIGHT: 2 INCHES PSI: 400 AIRFLOW: 200 Double Double Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter j Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi .50 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 347 0.00140 0.00140 0.00140 .020X.035 0.113 0.119 0.124 305 348 .0.00145 0.00150 0.00145 .020X.035 0.111 0.119 0.124 330 349 0.00145 0.00150 0.00150 .020X.035 0.113 0.122 0.124 315 350 0.00140 0.00140 0.00140 .020X.035 0.115 0.122 0.125 313 351 0.00150 0.00145 0.00140 .020X.035 0.113 0.120 0.124 343 352 0.00145 0.00145 0.00135 .020X.035 343 353 0.00150 0.00150 0.00140 .020X.035 329 354 0.00140 0.00150 0.00140 .020X.035 303 355 0.00140 0.00140 0.00140 .020X.035 313 356 0.00140 0.00150 0.00140 .020X.035 330 Averaαe 0.001433 0.00146 0.00141 .020x.035 0.113 0.1204 0.1242 322.4 Standard 4.33E-05 4.595E-05 3.94405E-05 0.001414 0.001517 0.000447 14.59985 Calculated K-stat (psi): 246.437 Calculated Hoop Stress (psi): 27081.6 Table 47 PEBAX GRADE: 7233 BALLOON DIMENSIONS (diameter x length): 3 x 20 mm PARAMETERS: TEMP: CRYSTAUZATION: 260° F MOLD: 210° F STRETCH: LEFT: 2.25 INCHES RIGHT 2.25 INCHES PSI: 330 AIRFLOW: 200 Double Double Double Proximal Distal Centerwall Wall Wall Measured Diameter Diameter Diameter Burst Balloon Thickness Thickness Thickness ID/OD 50 psi 100 psi ' 150 psi Pressure No. (inches) (inches) (inches) (inches) (inches) (inches) (inches) (psi) 357 0.00110 0.00100 0.00125 .020X.035 0.118 0.125 0.128 240 o 358 0.00100 0.00105 0.00115 .020X.035 0.119 0.125 0.13 260 359 0.00100 0.00105 0.00120 .020x.035 0.118 0.123 0.128 242 360 0.00110 0.00120 0.00100 .020X.035 0.119 0.126 0.131 245 361 0.00110 0.00120 0.00120 .020X.035 0.119 0.125 0.13 260 362 0.00100 0.00100 0.00120 .020X.035 260 363 0.00120 0.00120 0.00130 .020X.035 242 364 0.00115 0.00105 0.00120 .020X.035 262 365 0.00100 0.00105 0.00120 .020X.035 260 366 0.00110 0.00100 0.00115 .020X.035 231 Average 0.001075 0.00108 0.001185 .020X.035 0.1186 0.1248 0.1294 250.2 Standard 7.17E-05 8.5635E-05 7.83511 E-05 0.000548 0.001095 0.001342 11.34117 Calculated K-stat (psi): 191.192 Calculated Hoop Stress (psi): 29046.47 64 Figures 4-15 were prepared by collecting data according to material type, and reducing the data to a series of quadratic equations that include stretch, crystallization temperature, and balloon blowing temperature as dependant variables. The equations were then plotted using a statistical design of experiments _ program called ECHIP . Response variables of interest were then plotted. With regard to Figures 4-15, the balloons were expanded to two times their original length in the axial direction. The foregoing specification and figures are presented for the purpose of illustrating, and not limiting, the present invention.

Claims: __ __I1__£ 1. A balloon for an angioplasty device having a single polymeric layer comprising (a) from about 20 to about 100 weight percent polyesteretheramide copolymer, and (b) from about 0 to about 80 weight percent polyamide; wherein the polymeric layer contains substantially no polyetheramide having substantially no ester linkages. 2. The balloon of claim 1 wherein the polyesteretheramide copolymer comprises a block copolymer. 3. The balloon of claim 1 wherein the polyesteretheramide copolymer comprises a random copolymer. 4. The balloon of claim 1 wherein the polyesteretheramide copolymer has a hardness of from about 45 Shore D to about 78 Shore D. 5. The balloon of claim 4 wherein the polyesteretheramide copolymer has a hardness of from about 55 Shore D to about 75 Shore D. 6. The balloon of claim 5 wherein the polyesteretheramide copolymer has a hardness of from about 63 to about 72 Shore D. 7. The balloon of claim 6 wherein the polyesteretheramide copolymer has a hardness selected from about 63 Shore D, about 70 Shore D, and about 72 Shore D. 8. The balloon of claim 1 wherein the single polymeric layer comprises at least about 2 weight percent polyamide. 9. The balloon of claim 8 wherein the polyamide is selected from the group consisting of nylon 12, nylon 11, nylon 6, nylon 6/6, nylon 4/6, and combinations thereof. 10. The balloon of claim 9 comprising from about 20 to about 80 weight percent nylon 12 and about 20 to about 80 weight percent polyesteretheramide copolymer. 11. The balloon of claim 10 comprising about 60 weight percent nylon 12 and about 40 weight percent polyesteretheramide copolymer. 12. The balloon of claim 9 comprising from about 25 to about 80 weight percent nylon 4/6 and about 20 to about 75 weight percent polyesteretheramide copolymer. 13. The balloon of claim 12 comprising about 65 weight percent nylon 4/6 and about 35 weight percent polyesteretheramide copolymer. 14. The balloon of claim 1 wherein the single polymeric layer further comprises at least about 2 weight percent of a polymer selected from polyester copolymer, polyurethane copolymer, polyethylene, and combinations thereof. 15. The balloon of claim 1 wherein the polymeric layer comprises at least about 40 weight percent polyesteretheramide copolymer. 16. The balloon of claim 15 wherein the polymeric layer comprises at least about 80 weight percent polyesteretheramide copolymer. 17. A balloon for an angioplasty device having a single polymeric layer consisting essentially of a polyesteretheramide copolymer. 18. The balloon of claim 17 wherein the polyesteretheramide copolymer comprises a block copolymer. 19. The balloon of claim 17 wherein the polyesteretheramide copolymer has a hardness of from about 45 Shore D to about 78 Shore D. 20. The balloon of claim 19 wherein the polyesteretheramide copolymer has a hardness of from about 55 Shore D to about 75 Shore D. 21. The balloon of claim 20 wherein the polyesteretheramide copolymer has a hardness of from about 63 to about 72 Shore D. 22. The balloon of claim 21 wherein the polyesteretheramide copolymer has a hardness selected from about 63 Shore D, about 70 Shore D, and about 72 Shore D. 23. The balloon of claim 17 consisting of a polyesteretheramide copolymer. 24. A balloon for an angioplasty device having a single polymeric layer comprising (a) at least 91 weight percent polyesteretheramide copolymer, (b) from 0 to 9 weight percent polyamide, and (c) from 0 to 9 weight percent of a polymer other than polyesteretheramide and polyamide. 25. The balloon of claim 24 comprising at least about 95 weight percent polyesteretheramide copolymer.

Inventors: BURGMEIER ROBERT E, FORMAN MICHAEL R, HELMUS MICHAEL N, NIEDERHAUSER WERNER, STOWELL LORI L, BURGMEIER, ROBERT, E., FORMAN, MICHAEL, R., HELMUS, MICHAEL, N., NIEDERHAUSER, WERNER, STOWELL, LORI, L.
Applicants: SCHNEIDER USA INC, SCHNEIDER (USA) INC.
Application year: 1996
Main classification: A61L29
IPC codes: A61L29