US2013150943A1PendingUtilityA1
Biodegradable endoprostheses and methods for their fabrication
Est. expiryJan 19, 2027(~0.5 yrs left)· nominal 20-yr term from priority
A61F 2/915A61L 31/041A61L 31/06A61F 2/91A61F 2210/0004A61F 2/82B33Y 80/00A61L 2400/16A61L 27/58A61F 2250/0036A61L 31/14A61L 31/148
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Claims
Abstract
The disclosure provides biodegradable implantable devices such as a stent comprising a biodegradable polymeric wherein the polymeric material is treated to control crystallinity and/or Tg. The stent is capable to expand at body temperature from a crimped configuration to a deployed diameter and have sufficient strength to support a body lumen.
Claims
exact text as granted — not AI-modified1 . An expandable stent, comprising:
a biodegradable polymeric material having an initial configuration, said stent at body temperature being self expandable from a crimped configuration to a first configuration and further expandable to a second larger configuration.
2 . The expandable stent of claim 1 wherein the polymeric material is treated to control one or more of crystallinity, Tg, or molecular weight.
3 . The expandable stent of claim 1 or 2 wherein the Tg ranges from about 20° C. to about 50° C.
4 . The expandable stent of claim 1 wherein the second configuration is a deployed configuration.
5 . The expandable stent of claim 1 wherein the stent expands to the first and second configurations without fracture and has sufficient strength to support a body lumen.
6 . The expandable stent of claim 1 wherein the first expanded configuration has a transverse dimension at least 0.35 times the transverse dimension of the initial configuration.
7 . The expandable stent of claim 1 wherein the first expanded configuration has a transverse dimension at least 0.45 times the transverse dimension of the initial configuration.
8 . The expandable stent of claim 1 wherein the transverse dimension of the first expanded configuration is at least 0.55 times the transverse dimension of the initial configuration.
9 . The expandable stent of claim 1 wherein the transverse dimension of the first expanded configuration is at least 0.7 times the transverse dimension of the initial configuration.
10 . The expandable stent of claim 1 wherein the transverse dimension of the first expanded configuration is at least 0.8 times the transverse dimension of the initial configuration.
11 . The expandable stent of claim 1 wherein the transverse dimension of the first expanded configuration is at least 1 times the transverse dimension of the initial configuration.
12 . The expandable stent of claim 1 wherein the stent is constrained in the crimped configuration and self expands after removal of constraint.
13 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 24 hours.
14 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 12 hours.
15 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 4 hours.
16 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 2 hours.
17 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 1 hour.
18 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 30 min.
19 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 5 min.
20 . The expandable stent of claim 1 wherein the stent self expands to the first expanded configuration within a period of 30 seconds.
21 . The expandable stent of claim 1 wherein the stent is balloon expandable to the second expanded configuration without fracture and with sufficient strength to support a body lumen.
22 . The expandable stent of claim 21 wherein the stent recoil from the second expanded configuration is less than 10%.
23 . The expandable stent of claim 1 wherein the stent longitudinal shortening after expansion to the first and the second expanded configurations is less than 15%.
24 . The expandable stent of claim 1 or claim 132 wherein the transverse dimension of the initial configuration is 1 to 1.5 times the transverse dimension of the second expanded configuration.
25 . The expandable stent of claim 24 wherein the polymeric material comprises a tubular body.
26 . The expandable stent of claim 25 wherein the initial configuration of the tubular body is an as-formed configuration.
27 . The expandable stent of claim 24 wherein the transverse dimension of the initial configuration is the transverse dimension of the stent after patterning.
28 . The expandable stent of claim 24 wherein the transverse dimension of the initial configuration is the transverse dimension of the stent before patterning.
29 . The expandable stent of claim 24 wherein the transverse dimension of the initial configuration is the transverse dimension of the stent before crimping.
30 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and transverse dimension of the second expanded configuration is at least 1.0 times the nominal expanded transverse dimension.
31 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and the transverse dimension of the second expanded configuration is at least 1.1 times the transverse dimension of the nominal expanded transverse dimension.
32 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and the transverse dimension of the second expanded configuration is at least 1.2 times the transverse dimension of the nominal expanded transverse dimension.
33 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and the transverse dimension of the second expanded configuration is at least 1.3 times the transverse dimension of the nominal expanded configuration.
34 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and the transverse dimension of the second expanded configuration is at least 1.4 times the transverse dimension of the nominal expanded configuration.
35 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and the transverse dimension of the second expanded configuration is at least 1.5 times the transverse dimension of the nominal expanded configuration.
36 . The expandable stent of claim 21 wherein the stent has a nominal expanded transverse dimension and the transverse dimension of the second expanded configuration is at least 1.6 times the transverse dimension of the nominal configuration
37 . The expandable stent of claims 30 through 36 wherein the stent is expanded to the second expanded configuration by balloon expansion.
38 . The expandable stent of claim 25 wherein the tubular body is formed into the initial configuration before patterning.
39 . The expandable stent of claim 25 wherein the tubular body is formed into the initial configuration after patterning.
40 . The expandable stent of claim 25 wherein the tubular body is substantially continuous.
41 . The expandable stent of claim 25 wherein the tubular body has foraminous wall.
42 . The expandable stent of claim 1 or 132 wherein the polymeric material in the initial configuration has a transverse dimension of about 3 mm to 25 mm.
43 . The expandable stent of claim 1 or 132 wherein the polymeric material in the initial configuration has a transverse dimension of about 3 mm to about 10 mm.
44 . The expandable stent of claim 1 or 132 wherein the second expanded configuration has a transverse dimension of about 3 mm to about 10 mm.
45 . The expandable stent of claim 1 wherein the stent self expands after expansion to the second expanded configuration to a third configuration having a larger transverse dimension.
46 . The expandable stent of claim 45 wherein the transverse dimension of the third expanded configuration is 0.01 mm to 0.5 mm larger than the transverse dimension of the second expanded configuration.
47 . The expandable stent of claim 45 or claim 46 wherein the stent self expands to the third configuration within 24 hours after expansion to the second configuration.
48 . The expandable stent of claim 2 or 133 wherein the crystallinity is controlled at a level between 0 and 45%.
49 . The expandable stent of claim 2 or 133 wherein the crystallinity is controlled at a level between 5 and 35%.
50 . The expandable stent of claim 2 or 133 wherein the crystallinity is controlled at a level between 0 and 20%.
51 . The expandable stent of claim 2 or 133 wherein the polymeric material has an elastic modulus ranging from 0.35 GPa to 1.5 GPa.
52 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg of less than 50° C.
53 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg of less than 45° C.
54 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg of less than 40° C.
55 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg between 37° C. and 50° C.
56 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg between 37° C. and 45° C.
57 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg between 37° C. and 40° C.
58 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg between 20° C. and 45° C.
59 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg between 20° C. and 40° C.
60 . The expandable stent of claim 2 or 133 wherein the polymeric material has a Tg between 20° C. and 37° C.
61 . The expandable stent of claim 2 or 133 , wherein the polymeric material has a Tg between 37° C. and 50° C.
62 . The expandable stent of claim 2 or 133 , wherein the polymeric material has a Tg between 37° C. and 45° C.
63 . The expandable stent of claim 2 or 133 , wherein the polymeric material has a Tg between 37° C. and 40° C.
64 . The expandable stent of claim 2 or 132 wherein the stent is expandable at body temperature in a physiologic environment.
65 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises at least one co-polymer.
66 . The expandable stent of claim 65 wherein the polymeric material further comprises less than 10% (by weight) of monomer or polymer.
67 . The expandable stent of claim 65 wherein the polymeric material further comprises less than 5% (by weight) of monomer or polymer.
68 . The expandable stent of claim 65 wherein the polymeric material further comprises less than 2.5% (by weight) of monomer or polymer.
69 . The expandable stent of claim 65 wherein the polymeric material further comprises less than 1% (by weight) of monomer or polymer.
70 . The expandable stent of claim 65 wherein the polymeric material further comprises less than 0.5% (by weight) of monomer or polymer.
71 . The expandable stent of claim 65 wherein the polymeric material further comprises less than 0.25% (by weight) of monomer or polymer.
72 . The expandable stent of claim 65 wherein the polymeric material further comprises between 0-10% (by weight) of monomer or polymer.
73 . The expandable stent of claim 65 wherein the polymeric material further comprises between 0-5% (by weight) of monomer or polymer.
74 . The expandable stent of claim 65 wherein the polymeric material further comprises between 0-2.5% (by weight) of monomer or polymer.
75 . The expandable stent of claim 65 wherein the polymeric material further comprises between 0-1% (by weight) of monomer or polymer.
76 . The expandable stent of claim 65 , wherein the further monomer or polymer is blended with the at least one co-polymer of the polymeric material.
77 . The expandable stent of claim 65 , wherein the further monomer or polymer is at least one of: lactide, glycolide, polylactide-co-glycolide, caprolactone, or polylactide-co-caprolactone.
78 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises 1 to 50 micrograms of monomer or polymer per milligram of stent.
79 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises 1 to 25 micrograms of monomer or polymer per milligram of stent.
80 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises 1 to 15 micrograms of monomer or polymer per gram of stent.
81 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises 30 to 100 micrograms of monomer or polymer per milligram of stent.
82 . The expandable stent of claim 2 or 133 wherein the treatment comprises at least one of heating, heating and cooling, cooling, solvent removal, solvent incorporation, pressurization with gas, exposure to radiation, or expansion of the tubular body to about 1 to 1.5 times a stent deployed diameter.
83 . The expandable stent of claim 2 , 5 , or 133 wherein the polymeric material further comprises between 0.5% and 10% (by weight) of at least one solvent.
84 . The expandable stent of claim 65 wherein the polymeric material further comprises between 2% and 5% (by weight) of at least one solvent.
85 . The expandable stent of claim 2 , 5 , or 133 wherein the polymeric material further comprises between 3% and 5% (by weight) of at least one solvent.
86 . The expandable stent of claim 2 , 5 , or 133 wherein the polymeric material further comprises at least one solvent in amounts that does not substantially dissolve the polymeric material.
87 . The expandable stent of claim 2 , 5 , or 133 wherein the polymeric material further comprises at least one solvent that does not dissolve the polymeric material.
88 . The expandable stent of claim 2 , 5 , or 133 wherein the polymeric material further comprises at least one solvent in amounts that substantially dissolve at least portion of the polymeric material.
89 . The expandable stent of claim 82 wherein the treatment comprises heating and cooling at least once at a configuration smaller than the initial configuration and larger than the crimped configuration.
90 . The expandable stent of claim 89 wherein the heating temperature is at about Tg or below Tg.
91 . The expandable stent of claim 89 wherein the heating temperature is at or below 55° C.
92 . The expandable stent of claim 89 wherein the heating temperature is at or below 50° C.
93 . The expandable stent of claim 89 wherein the treatment is for a period of a fraction of a second to seven days.
94 . The expandable stent of claim 93 wherein the treatment is for a period of up to one day.
95 . The expandable stent of claim 93 wherein the treatment is for a period of up to one hour.
96 . The expandable stent of claim 82 wherein the treatment comprises heating and cooling at least once at a configuration having a transverse dimension at or above the transverse dimension of the second configuration at a temperature at or above Tg.
97 . The expandable stent of claim 96 wherein the transverse dimension of the second configuration is 3 mm or larger.
98 . The expandable stent of claim 96 wherein the transverse dimension of the second configuration is 3.5 mm or larger.
99 . The expandable stent of claim 96 wherein the treatment is for a period of a fraction of a second to seven days.
100 . The expandable stent of claim 99 wherein the treatment is for a period of up to one day.
101 . The expandable stent of claim 99 wherein the treatment is for a period of up to one hour.
102 . The expandable stent of claim 1 or 132 having a linear shrinkage ranging from about −20% to 20%.
103 . The expandable stent of claim 1 or 132 having a linear shrinkage ranging from about −10% to 10%.
104 . The expandable stent of claim 1 or 132 having a linear shrinkage ranging from about −5% to 5%.
105 . The expandable stent of claim 1 or 132 having a linear shrinkage between 0 to 20%.
106 . The expandable stent of claim 1 or 132 having a linear shrinkage between 0 to 10%.
107 . The expandable stent of claim 1 or 132 having a linear shrinkage between 0 to 5%.
108 . The expandable stent of claim 1 or 132 having a linear shrinkage between 0 to 2.5%.
109 . The expandable stent of claim 1 or 132 wherein the polymeric material does not exhibit substantial phase separation after treatment.
110 . The expandable stent of claim 1 or 132 wherein the polymeric material does not exhibit phase separation after treatment.
111 . The expandable stent of claim 1 or 132 wherein the polymeric material is selected from the group consisting of a polymer of lactic acid, a polymer of polyglycolic acid, a polymer of polylactic glycolic acid, a copolymer of a lactide and a glycolide, a copolymer of lactide and caprolactone, a copolymer of a lactide, a glycolide and caprolactone, a blend of a lactide and a glycolide, a blend of lactide and caprolactone, a blend of a lactide, a glycolide and caprolactone, a copolymer of glycolide and caprolactone, and a blend of glycolide and caprolactone.
112 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises 80-99% by weight of a lactide.
113 . The expandable stent of claim 1 or 132 wherein the polymeric material further comprises 1-20% by weight of a caprolactone.
114 . The expandable stent of claim 1 132 wherein the polymeric material further comprises 1-20% by weight of a glycolide.
115 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises a sheet that is joined at opposite edges.
116 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises a plurality of fibers woven into the initial configuration.
117 . The expandable stent of claim 116 wherein the polymeric material is treated after the fibers are woven into the initial configuration.
118 . The expandable stent of claim 1 or 132 wherein the polymeric material comprises a printed pattern.
119 . The expandable stent of claim 1 , 2 , or 132 wherein the polymeric material has a molecular weight between 30 kDa and 700 kDa.
120 . The expandable stent of claim 1 , 2 , or 132 wherein the polymeric material has a molecular weight between 30 kDa and 300 kDa.
121 . The expandable stent of claim 1 , 2 , or 132 wherein the polymeric material has a molecular weight between 30 kDa and 200 kDa.
122 . The expandable stent of claim 1 , 61 through 63 , or 132 wherein the polymeric material has a molecular weight between 30 kDa and 700 kDa.
123 . The expandable stent of claim 1 or 132 wherein the stent comprises an additional coating.
124 . The expandable stent of claim 123 wherein the coating contains a drug
125 . The expandable stent of claim 1 or 132 wherein the stent further comprises a drug.
126 . The expandable stent of claim 125 wherein the drug is an m-tor inhibitor
127 . The expandable stent of claim 1 or claim 132 wherein the stent has a recoil from the first or second expanded configuration of less than 15%.
128 . The expandable stent of claim 1 or 132 wherein the stent has a recoil from the first or second configuration of less than 10%.
129 . The expandable stent of claim 1 or 132 wherein the stent has a recoil from the first or second configuration of less than 7%.
130 . The expandable stent of claim 1 or 132 wherein the stent has a radial strength in the first or second expanded configuration of 1 psi or more.
131 . The expandable stent of claim 1 or 132 wherein the stent has a radial strength in the first or second expanded configuration of 3 psi or more.
132 . An expandable stent, comprising:
a biodegradable polymeric material having an initial configuration, said expandable stent at body temperature being expandable from a crimped configuration to a first expanded configuration and self expandable to a second larger configuration.
133 . The expandable stent of claim 132 wherein the polymeric material is treated to control one or more of crystallinity, Tg, or molecular weight.
134 . The expandable stent of claim 131 wherein the stent comprises a substantially continuous tubular body.
135 . The expandable stent as in claim 132 wherein the stent expands to the first configuration without fracture and has sufficient strength to support a body lumen.
136 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
137 . The expandable stent of claim 132 or 133 wherein the first expanded configuration is a deployed configuration.
138 . The expandable stent of claim 132 or 133 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is 1 to 1.5 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
139 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.1 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
140 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.2 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
141 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.3 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
142 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.35 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
143 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.4 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
144 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.45 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
145 . The expandable stent of claim 132 or 133 or 135 wherein the stent has a nominal expanded configuration with a transverse dimension and the first expanded configuration has a transverse dimension that is at least 1.5 times the transverse dimension of the transverse dimension of the nominal expanded configuration.
146 . The expandable stent of claim 132 or 133 wherein the transverse dimension of the initial configuration is 1 to 1.5 times a transverse dimension of the first expanded configuration.
147 . The expandable stent of claim 132 or 133 wherein the initial configuration is before patterning.
148 . The expandable stent of claim 132 or 133 wherein the initial configuration is after patterning.
149 . The expandable stent of claim 132 or 133 wherein the transverse dimension of the initial configuration ranges from 3 to 25 mm.
150 . The expandable stent of claim 132 or 133 wherein the transverse dimension of the initial configuration ranges from 3 to 10 mm.
151 . The expandable stent of claim 149 wherein the transverse dimension of the initial configuration is at least 3.5 mm.
152 . The expandable stent of claim 134 wherein the tubular body has a foraminous wall.
153 . The expandable stent of claim 132 wherein the stent is expanded to the first expanded configuration by balloon expansion.
154 . The expandable stent as in claim 132 or 133 or 153 wherein the second expanded configuration has a transverse dimension of at least 0.01 mm greater than the transverse dimension of the first expanded configuration.
155 . The expandable stent as in claim 132 or 133 or 153 wherein the second expanded configuration has a transverse dimension of at least 0.05 mm greater than the transverse dimension of the first expanded configuration.
156 . The expandable stent as in claim 132 , 133 or 153 wherein the second expanded configuration has a transverse dimension of at least 0.1 mm greater than the transverse dimension of the first expanded configuration.
157 . The expandable stent as in claim 132 or 133 or 153 wherein the second expanded configuration has a transverse dimension of at least 0.15 mm greater than the transverse dimension of the first expanded configuration.
158 . The expandable stent as in claim 132 or 133 or 153 wherein the second expanded configuration has a transverse dimension of at least 0.2 mm greater than the transverse dimension of the first expanded configuration.
159 . The expandable stent as in claim 132 or 133 or 153 wherein the second expanded configuration has a transverse dimension of at least 0.3 mm greater than the transverse dimension of the first expanded configuration.
160 . The expandable stent as in claim 132 or 133 wherein said stent self expands to the second configuration within 24 hours.
161 . The expandable stent of claim 132 or 133 wherein said stent self expands to the second configuration within 12 hours
162 . The expandable stent of claim 132 or 133 wherein said stent self expands to the second configuration within 6 hours.
163 . The expandable stent of claim 132 or 133 wherein said stent self expands to the second configuration within 2 hours.
164 . The expandable stent of claim 132 or 133 wherein said stent self expands to the second configuration within 1 hour.
165 . The expandable stent of claim 132 or 133 wherein said stent self expands to the second configuration within 30 minutes.
166 . The expandable stent of claim 132 or 133 wherein said stent recoils after expansion to the first expanded configuration and then self expands after recoil to the second expanded configuration.
167 . The expandable stent of claim 132 or 133 wherein said stent recoils by less than 15% after expansion to the first expanded configuration and then self expands after recoil to the second expanded configuration
168 . The expandable stent of claim 132 or 133 wherein the stent self expands prior to expansion to the first configuration.
169 . The expandable stent of claim 168 wherein the stent self expands by 0.5 mm or less.
170 . The expandable stent of claim 168 wherein the stent self expands by 0.3 mm or less.
171 . The expandable stent of claim 168 wherein the stent self expands by 0.1 mm or less.Join the waitlist — get patent alerts
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