Enhanced remodelable materials for occluding bodily vessels
View Patent ↗Described are methods, devices, and systems for occluding or ablating vascular vessels. Noninvasive procedures can be used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous valve insufficiency. Further described is the cooperative use of an angiogenic remodelable material with one or more sclerosing agents to cause closure of a targeted bodily vessel.
1. A medical product for occluding a venous vessel, comprising:
an occlusive construct comprising a remodelable material configured for deployment within a venous vessel to fill at least a luminal segment of the venous vessel so as to occlude the venous vessel, wherein the remodelable material is a dried collagenous extracellular matrix material harvested to retain and retaining bioactive components native to a source tissue for the dried collagenous extracellular matrix material and which is effective to induce angiogenesis when deployed within the vessel, wherein the dried collagenous extracellular matrix material is effective to promote the ingrowth of patient tissue into the lumen of the venous vessel and lead to angiogenesis and wherein the occlusive construct includes one or more dried sclerosants that are effective to injure the lining of the venous vessel so as to enhance the ingrowth of patient tissue into the occlusive construct and promote occlusion of the venous vessel, the dried collagenous extracellular matrix material comprising at least 80% by weight collagen on a dry weight basis, including uniaxial or multiaxial oriented fibers, and including at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.
2. The medical product of claim 1 , wherein the one or more dried sclerosants comprises sodium tetradecyl sulfate, morrhuate sodium, ethanolamine oleate, tetradecyl sulfate, tetracycline, glycerin, hypertonic glucose, talc, acetic acid, alcohol, bleomycin, picibanil, ethibloc, deoxycycline polidocanol, sotradecol, ethoxysclerol, or any suitable mixture thereof.
3. The medical product of claim 1 , wherein the one or more dried sclerosants comprises sodium tetradecyl sulfate, morrhuate sodium, ethanolamine oleate, tetradecyl sulfate, tetracycline, glycerin, hypertonic glucose, talc, acetic acid, alcohol, bleomycin, picibanil, ethibloc, deoxycycline polidocanol, sotradecol, ethoxysclerol, or any suitable mixture thereof.
4. The medical product of claim 1 , wherein the one or more dried sclerosants comprise polidocanol or sodium tetradecyl sulfate.
5. The medical product of claim 1 , wherein the collagenous extracellular matrix material comprises a sponge form material.
6. A medical product for occluding a bodily vessel, comprising:
an angiogenic remodelable collagenous extracellular matrix material constituted of at least 80% collagen, the extracellular matrix material harvested to retain and retaining non-collagen solids from a source tissue for the extracellular matrix material, wherein the non-collagen solids comprise native bioactive factors from the source tissue, wherein the angiogenic remodelable collagenous extracellular matrix material is dried and is configured for deployment in a bodily vessel of a patient; and
one or more dried sclerosing agents, wherein the dried sclerosing agents and the remodelable collagenous extracellular matrix material are configured for conjunctive or cooperative use to enhance closure of the bodily vessel.
7. The medical product of claim 6 , wherein the one or more dried sclerosing agents are located within the angiogenic remodelable collagenous extracellular matrix material.
8. The medical product of claim 7 , wherein the angiogenic remodelable collagenous extracellular matrix material comprises a sponge form or foam material.
9. The medical product of claim 8 , wherein the bioactive factors comprise growth factors.
10. The medical product of claim 8 , wherein the one or more dried sclerosing agents comprises sodium tetradecyl sulfate, morrhuate sodium, ethanolamine oleate, tetradecyl sulfate, tetracycline, glycerin, hypertonic glucose, talc, acetic acid, alcohol, bleomycin, picibanil, ethibloc, deoxycycline polidocanol, sotradecol, ethoxysclerol, or any suitable mixture thereof.
11. The medical product of claim 6 , wherein the angiogenic remodelable collagenous extracellular matrix material comprises an extracellular matrix sheet material.
12. The medical product of claim 11 , wherein the sheet material is folded.
13. The medical product of claim 12 , wherein the sheet material is fan folded.
14. The medical product of claim 11 , wherein the sheet material is rolled to form a cylindrical body of overlapping or layered sheet material.
15. The medical product of claim 14 , wherein the overlapping layers are dehydrothermally bonded.
16. A medical product, comprising:
a dry, implantable occlusive construct including a dried, bioactive remodelable extracellular matrix material with one or more dried sclerosants incorporated in the dried, bioactive remodelable extracellular matrix material, the occlusive construct configured for deployment within a venous vessel to fill at least a luminal segment of the venous vessel so as to occlude the venous vessel, wherein the dried, bioactive remodelable extracellular matrix material retains bioactive components native to a source tissue for the remodelable extracellular matrix material and is effective to induce cellular invasion and the ingrowth of patient tissue into the lumen of the venous vessel and to induce angiogenesis when deployed within the vessel, the one or more dried sclerosants being effective to injure the lining of the venous vessel so as to enhance the ingrowth of patient tissue into the occlusive construct and promote occlusion of the venous vessel.
17. The medical product of claim 16 , wherein the extracellular matrix material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.
18. The medical product of claim 17 , wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or basement membrane.
19. The medical product of claim 18 , wherein the submucosa comprises mammalian submucosa.
20. The medical product of claim 19 , wherein the mammalian submucosa comprises porcine, bovine, or ovine submucosa.
21. The medical product of claim 19 , wherein the mammalian submucosa comprises intestine submucosa, stomach submucosa, urinary bladder submucosa, or uterine submucosa.
22. The medical product of claim 21 , wherein the intestine submucosa comprises adult porcine small intestine submucosa.
23. The medical product of claim 17 , wherein the bioactive components comprises growth factors.
24. The medical product of claim 23 , wherein the one or more dried sclerosants comprise morrhuate sodium.
25. The medical product of claim 24 , wherein the one or more dried sclerosants comprise polidocanol or sodium tetradecyl sulfate.
26. The medical product of claim 25 , wherein the one or more dried sclerosants comprise polidocanol.
27. The medical product of claim 16 , wherein the remodelable extracellular matrix material comprises a sponge form material.