Hydrophilic shape memory insertable medical articles
Insertable medical articles with a shape memory property having a body member formed of crosslinked hydrophilic polymers are described.
1 . An insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer having a molecular weight of 100,000 Da or less, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration upon insertion of the article at a target site in a subject.
2 . The insertable medical article of claim 1 wherein the hydrophilic polymer has a molecular weight of 50,000 Da or less.
3 . The insertable medical article of claim 2 wherein the hydrophilic polymer has a molecular weight of 25,000 Da or less.
4 . The insertable medical article of claim 3 wherein the hydrophilic polymer has a molecular weight in the range of 1000-10,000 Da.
5 . The insertable medical article of claim 1 wherein the matrix comprises hydrophilic polymer that is crosslinked via polymerized groups.
6 . The insertable medical article of claim 1 wherein the matrix comprises a hydrophilic polymer and a hydrophilic component crosslinked via first and second reacted groups, wherein the first and second reacted groups are pendent from the hydrophilic polymer and a hydrophilic component, respectively.
7 . The insertable medical article of claim 6 wherein the first reactive group is present on the polysaccharide in an amount to provide a degree of substitution of 1.0 or less.
8 . The insertable medical article of claim 7 wherein the first reactive group is present on the polysaccharide in an amount to provide a degree of substitution in the range of 0.2 to 0.3.
9 . The insertable medical article of claim 6 wherein the first or second reacted group is an amine group.
10 . The insertable medical article of claim 6 wherein the second component is non-biodegradable.
11 . The insertable medical article of claim 6 wherein the second component has a MW of 10,000 Da or less.
12 . The insertable medical article of claim 6 wherein the second component has a MW of 3,500 Da or less.
13 . The insertable medical article of claim 6 wherein the hydrophilic component comprises an alkoxyalkane.
14 . The insertable medical article of claim 8 wherein the alkoxyalkane is selected from the group consisting of tri(ethylene glycol), tetra(ethylene glycol), poly(ethylene oxide) (PEO), poly(ethylene glycol), and poly(propylene oxide) (PPO).
15 . The insertable medical article of claim 6 wherein the hydrophilic component is a liquid at 25° C.
16 . The insertable medical article of claim 1 wherein the hydrophilic polymer is a natural biodegradable polymer.
17 . The insertable medical article of claim 12 wherein the natural biodegradable polymer is selected from the group consisting of maltodextrin, amylose, polyalditol, and cyclodextrin.
18 . The insertable medical article of claim 1 wherein the body member comprises 15% or greater by weight hydrophilic polymer.
19 . The insertable medical article of claim 1 wherein the second configuration is linear.
20 . The insertable medical article of claim 1 wherein the first configuration comprises a coil configuration.
21 . The insertable medical article of claim 1 where the body member is in the form of a cylinder.
22 . The insertable medical article of claim 1 comprising a body member for use in the vasculature.
23 . The insertable medical article of claim 1 wherein the body member in the first configuration can exert pressure on tissue at the target site.
24 . The insertable medical article of claim 23 comprising a stent.
25 . The insertable medical article of claim 1 comprising a body member for use within the eye.
26 . The insertable medical article of claim 1 comprising a bioactive agent.
27 . The insertable medical article of claim 26 comprising a bioactive agent selected from the group consisting of polypeptides, polynucleotides, and polysaccharides.
28 . The insertable medical article of claim 26 comprises a bioactive agent having a molecular weight of 10,000 or greater.
29 . The insertable medical article of claim 1 wherein the body member is the second configuration has a second hydration state, and is capable of undergoing a shape memory transition to a first configuration upon insertion of the article at a target site in a subject which increases the hydration of the body member to a first hydration state.
30 . The insertable medical article of claim 29 wherein in the second hydration state, the body member comprises an amount of water of 35% or less.
31 . A method for preparing an insertable medical article comprising a body member having a shape memory property, the method comprising steps of:
providing a composition in a first configuration, the composition comprising:
a hydrophilic polymer having a molecular weight of 100,000 Da or less, and
a reactive group; and
causing reaction of the reactive group thereby forming a matrix of hydrophilic polymer and fabricating the body member in the first configuration,
wherein the body member is capable of reverting from a second configuration to the first configuration upon or following insertion at a target site in a subject.
32 . The method of claim 31 where, in the step of providing, the composition comprises a hydrophilic polymer at a concentration of 250 mg/mL or greater.
33 . The method of claim 31 where, in the step of providing, the composition comprises 50 wt % water or less.
34 . The method of claim 33 comprising a step of removing at least a portion of water from the body member to stabilize the body member in the second configuration.
35 . The method of claim 34 where, in the step of removing, at least 50% of the liquid present in the body member is removed.
36 . The method of claim 34 , wherein the step of providing a composition in a first configuration comprises a substep of mixing the hydrophilic polymer having a molecular weight of 100,000 Da or less comprising a first reactive group, and a second component that is hydrophilic and that comprises a second reactive group, wherein the first and second groups are specifically reactive and provide a crosslinked hydrophilic polymeric matrix upon mixing, thereby fabricating the body member in the first configuration.
37 . The method of claim 36 wherein the hydrophilic polymer and second component react to form a first polymeric network and the composition further comprises a second hydrophilic polymer comprising a pendent polymerizable group, and the method further comprises a step of treating to cause polymerization of the second hydrophilic polymer which forms a second polymeric network that penetrates the first polymeric network, which forms the body member.
38 . A method for treating a target site within a subject, comprising the steps of
obtaining an insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration;
delivering the article to a target site in the body in the second configuration;
allowing the body member to revert from the second configuration to the first configuration at the target site,
wherein the body member in the first configuration exerts force on a tissue at the target site.
39 . The method of claim 38 , wherein the step of allowing the body member becomes hydrated to promote change to the first configuration.
40 . A method for delivering a bioactive agent to a subject, comprising the steps of
obtaining an insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer having a molecular weight of 100,000 Da or less and a bioactive agent, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration;
delivering the article to a target site in the body in the second configuration;
allowing the body member to revert from the second configuration to the first configuration at the target site; and
allowing release of the bioactive agent from the body member at the target site.
41 . An insertable medical article comprising a body member formed of a hydrophilic matrix comprising a first polymeric network that penetrates a second polymeric network, wherein the body member is capable of undergoing a shape memory transition to the first configuration from a second configuration.
42 . A system for delivering to a portion of a body an insertable medical article comprising a body member having a shape memory property comprising (a) an insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration upon insertion of the article at a target site in a subject and (b) an insertion instrument capable of holding the article in the second configuration for delivery of the article to a portion of the body.