US 12,357,800 B2
Combined osmotic and hydrogel cervical dilators and method of making same
Vladimír Stoy, Tuchomerice (CZ); Tomas Drunecký, Kysice (CZ); Miroslav Dudic, Praha 4 Krc (CZ); Petr Stehlicek, Kladno (CZ); and Zdenka Vokounova, Rudna (CZ)
Assigned to MEDICEM TECHNOLOGY S.R.O., Kamenne Zehrovice (CZ)
Filed by MEDICEM TECHNOLOGY S.R.O., Kamenne Zehrovice (CZ)
Filed on May 25, 2023, as Appl. No. 18/323,934.
Application 18/323,934 is a continuation of application No. 16/339,977, granted, now 11,660,431, issued on May 30, 2023, previously published as PCT/IB2017/056187, filed on Oct. 6, 2017.
Claims priority of provisional application 62/404,997, filed on Oct. 6, 2016.
Prior Publication US 2023/0293865 A1, Sep. 21, 2023
Int. Cl. A61M 29/02 (2006.01); A61B 17/00 (2006.01); A61L 31/14 (2006.01); A61B 17/42 (2006.01)
CPC A61M 29/02 (2013.01) [A61B 17/00 (2013.01); A61L 31/145 (2013.01); A61B 2017/00893 (2013.01); A61B 2017/00898 (2013.01); A61B 2017/00942 (2013.01); A61B 2017/4225 (2013.01)] 17 Claims
OG exemplary drawing
 
1. A cervical dilator comprising:
a stem comprising a partly or fully dehydrated hydrogel comprising a water-insoluble osmotically active synthetic hydrophilic polymer capable of radial expansion due to absorption of water from a bodily fluid, causing a first osmotic dehydration; and
at least one second osmotically active compound, dispersed within the hydrogel, causing a second osmotic dehydration;
wherein:
the at least one second osmotically active compound is a polymeric electrolyte entrapped in the hydrogel network, wherein at least 50%-wt of the polymeric electrolyte remains entrapped within the hydrogel during a cervical expansion procedure;
the polymeric electrolyte forms an interpenetrating network with the water-insoluble osmotically active synthetic hydrophilic polymer forming the hydrogel, or the polymeric electrolyte is present in the form of discrete domains dispersed within the hydrogel;
the cervical dilator is configured to cause osmotic withdrawal of water from tissue using the first and second osmotic dehydrations;
the water-insoluble synthetic osmotically active hydrophilic polymer is selected from the group consisting of polyvinyl alcohol, polyurethane, polyurea, and acrylic copolymer comprising pendant nitrile and carboxylate groups; and
the at least one second osmotically active compound is selected from:
a water-soluble polymeric electrolyte, which is a polymer with pendant substituents selected from the group consisting of a carboxylate group, a salt of the carboxylate group, a sulfate group, a salt of the sulfate group, a phosphate group, a salt of the phosphate group, a sulfonic acid group, and a salt of the sulfonic acid group; or
a non-toxic water-soluble salt comprising a monovalent cation selected from the group consisting of sodium, potassium, lithium, an ammonium and an organic amine cation, and an anion selected from the group consisting of chloride, bromide, a sulfate, a phosphate, a thiocyanate and an acetate anion, or a mixture of non-toxic water-soluble salts.