Removal of tubular tissue supports
View Patent ↗The invention provides a process by which tubular tissue supports (stents) can be removed from hollow organs of humans or of animals after heating to a temperature below the transition temperature Ttrans until softening occurs.
1. A process for removal of a tubular tissue support from a hollow organ of a human or of an animal,
wherein the tubular tissue support comprises at least one shape-memory polymer having physical or covalent crosslinking points determining a permanent shape of the tissue support and at least one switching segment, the at least one switching segment having a transition temperature T trans at which the shape memory effect can be triggered wherein the transition temperature T trans of the at least one switching segment is higher than a body temperature of the human or of the animal, and the polymer further has a softening point at which the elastic modulus is less than 200 MPa, wherein the softening point is below the transition temperature T trans ,
said process comprising the steps of heating a previously implanted and expanded tissue support to a temperature corresponding to the softening point and below the transition temperature T trans of the at least one switching segment until softening occurs while substantially retaining the expanded size and shape of the softened tissue support; and withdrawing the softened implanted tissue support in a minimally invasive way from the hollow organ while substantially retaining its expanded size and shape.
2. The process according to claim 1 , wherein the tissue support comprises at least one of a thermoplastic, a polymer network, a blend, an interpenetrating network or a mixed interpenetrating network.
3. The process according to claim 1 , wherein the tissue support comprises at least one of a urethane, a polyether, a polyester, a polycarbonate or a polyamide series.
4. The process according to claim 1 , wherein the transition temperature of the polymer is up to approximately 60° C.
5. The process according to claim 1 , wherein the tissue support is heated to a temperature that is below the transition temperature by approximately 0.5° C. to approximately 10° C.
6. The process according to claim 1 , wherein the tissue support is heated to a temperature that is at least approximately 0.5° C. above blood temperature.
7. The process according to claim 1 , wherein a diameter of the tubular tissue support is retained.
8. The process according to claim 1 , wherein the tissue support is a stent.
9. The process according to claim 1 , wherein the transition temperature T trans is higher than body temperature and up to 50° C.
10. The process according to claim 1 , wherein the softening point is below the transition temperature T trans by 1 to 5° C.
11. The process according to claim 1 , wherein at the softening point of the polymer, the elastic modulus is less than 120 MPa.
12. The process according to claim 1 , wherein at the softening point of the polymer, the elastic modulus is at least 10 MPa below the value at blood temperature.
13. The process according to claim 1 , wherein the shape-memory polymer is a thermoplastic elastomer comprising a multiblock copolymer.
14. The process according to claim 13 , wherein the multiblock copolymer is composed of α,ω-diol polymers of poly(ε-caprolactone), poly(ethylene glycol), poly(pentadecalactone), poly(ethylene oxide), poly(propylene oxide), poly(propylene glycol), poly(tetrahydrofuran), poly(dioxanone), poly(dilactide), poly(glycolide) and poly(lactide-ran-glycolide) or of α,ω-diol copolymers of the monomers on which these polymers are based.
15. The process according to claim 1 , wherein the shape memory polymer is an interpenetrating network capable of memorizing two shapes.
16. The process according to claim 15 , wherein the interpenetrating network comprises a covalent network based on poly(caprolactone)dimethacrylate as macromonomer and an interpenetrating component which is a multiblock copolymer composed of macrodiols based on pentadecalactone and ε-caprolactone and on a diisocyanate.
17. A process for insertion of a tubular tissue support into a hollow organ of a human or of an animal and removal of the tubular tissue support therefrom, wherein the tubular tissue support comprises at least one shape-memory polymer having physical or covalent crosslinking points determining a permanent shape of the tissue support and at least one switching segment, the at least one switching segment having a transition temperature T trans at which the shape memory effect can be triggered wherein the transition temperature T trans of the at least one switching segment is higher than a body temperature of the human or of the animal, the polymer further has a softening point at which the elastic modulus is less than 200 MPa, wherein the softening point is below the transition temperature T trans :
said process comprising the steps of:
inserting the tubular tissue support in its permanent shape into the hollow organ of the human or the animal, and after insertion of the tissue support,
converting the permanent shape of the tubular tissue support to its temporary expanded shape via heating above a transition temperature T trans of the shape-memory polymer,
heating the implanted tissue support to a temperature corresponding to the softening point and below the transition temperature T trans of the at least one switching segment until softening occurs while substantially retaining the expanded size and shape of the softened tissue support;
and withdrawing the softened implanted tissue support in a minimally invasive way from the hollow organ while substantially retaining its expanded size and shape.
18. The process according to claim 17 , wherein control of the temperature in the tissue support takes place via a heating wire in contact with the polymer.