The present invention provides a valve material having synergistic anti-coagulation and anti-calcification functions and a preparation method therefor. The preparation method comprises the following steps: performing glutaraldehyde cross-linking treatment on an animal-derived biological valve material; immersing the treated valve material in a blocking solution containing an amine compound for 0.5-6 h, thereby blocking the remaining aldehyde groups after glutaraldehyde cross-linking; then placing the valve material into a reaction solution containing an anticoagulant and a cross-linking agent, and performing cross-linking treatment for 6-24 h at 4° C.-37° C.; and finally washing and obtaining the valve material, and storing the valve material in a mixed solvent of glutaraldehyde or isopropyl alcohol/glycerol. The method can effectively solve the problem of calcification and thrombosis caused by residual aldehyde groups in a valve material prepared by the existing method. The valve material prepared by the present method can be used as a valve material required for aortic valve, pulmonary valve, venous valve, mitral valve and tricuspid valve replacement.

The present invention provides a valve material having synergistic anti-coagulation and anti-calcification functions and a preparation method therefor. The preparation method comprises the following steps: performing glutaraldehyde cross-linking treatment on an animal-derived biological valve material; immersing the treated valve material in a blocking solution containing an amine compound for 0.5-6 h, thereby blocking the remaining aldehyde groups after glutaraldehyde cross-linking; then placing the valve material into a reaction solution containing an anticoagulant and a cross-linking agent, and performing cross-linking treatment for 6-24 h at 4° C.-37° C.; and finally washing and obtaining the valve material, and storing the valve material in a mixed solvent of glutaraldehyde or isopropyl alcohol/glycerol. The method can effectively solve the problem of calcification and thrombosis caused by residual aldehyde groups in a valve material prepared by the existing method. The valve material prepared by the present method can be used as a valve material required for aortic valve, pulmonary valve, venous valve, mitral valve and tricuspid valve replacement.

A surgical device for assisting in the placement of a prosthetic implant. One or more sheets of polymer are in the form of a conical frustum such that a proximal end is sealed and a distal end is open, with an elongated slit extending from the distal end toward the proximal end. A single opening is formed by the distal opening and the elongated slit with a set of inter-lockable fastener elements disposed along opposing sides and configured to seal the elongated slit such that the distal end remains open to allow for egress of the prosthetic implant for placement into a surgical pocket. A lubricious coating is applied to the interior cavity of the frustum in addition to one or more surface active coatings. Movement of the prosthetic implant across the one or more surface active coatings causes the coatings to provide one or more offered benefits.

A surgical device for assisting in the placement of a prosthetic implant. One or more sheets of polymer are in the form of a conical frustum such that a proximal end is sealed and a distal end is open, with an elongated slit extending from the distal end toward the proximal end. A single opening is formed by the distal opening and the elongated slit with a set of inter-lockable fastener elements disposed along opposing sides and configured to seal the elongated slit such that the distal end remains open to allow for egress of the prosthetic implant for placement into a surgical pocket. A lubricious coating is applied to the interior cavity of the frustum in addition to one or more surface active coatings. Movement of the prosthetic implant across the one or more surface active coatings causes the coatings to provide one or more offered benefits.

According to the invention there is provided inter alia a process for the manufacture of a solid object having a surface comprising a layered coating of cationic and anionic polymer wherein the outer coating layer comprises an anticoagulant entity, comprising the steps of: i) treating a surface of the solid object with a cationic polymer; ii) treating the surface with an anionic polymer; iii) optionally repeating steps i) and ii) one or more times; iv) treating the surface with a cationic polymer; and v) treating the outermost layer of cationic polymer with an anticoagulant entity, thereby to covalently attach the anticoagulant entity to the outermost layer of cationic polymer; wherein, the anionic polymer is characterized by having (a) a total molecular weight of 650 kDa-10,000 kDa; and (b) a solution charge density of >4 μeq/g; and wherein, step ii) is carried out at a salt concentration of 0.25 M-5.0 M.

According to the invention there is provided inter alia a process for the manufacture of a solid object having a surface comprising a layered coating of cationic and anionic polymer wherein the outer coating layer comprises an anticoagulant entity, comprising the steps of: i) treating a surface of the solid object with a cationic polymer; ii) treating the surface with an anionic polymer; iii) optionally repeating steps i) and ii) one or more times; iv) treating the surface with a cationic polymer; and v) treating the outermost layer of cationic polymer with an anticoagulant entity, thereby to covalently attach the anticoagulant entity to the outermost layer of cationic polymer; wherein, the anionic polymer is characterized by having (a) a total molecular weight of 650 kDa-10,000 kDa; and (b) a solution charge density of >4 μeq/g; and wherein, step ii) is carried out at a salt concentration of 0.25 M-5.0 M.

There is described inter alia a device having a surface comprising a layered coating wherein the outer coating layer comprises a plurality of cationic hyperbranched polymer molecules characterized by having (i) a core moiety of molecular weight 14-1,000 Da (ii) a total molecular weight of 1,500 to 1,000,000 Da (iii) a ratio of total molecular weight to core moiety molecular weight of at least 80:1 and (iv) functional end groups, whereby one or more of said functional end groups have an anti-coagulant entity covalently attached thereto.

There is described inter alia a device having a surface comprising a layered coating wherein the outer coating layer comprises a plurality of cationic hyperbranched polymer molecules characterized by having (i) a core moiety of molecular weight 14-1,000 Da (ii) a total molecular weight of 1,500 to 1,000,000 Da (iii) a ratio of total molecular weight to core moiety molecular weight of at least 80:1 and (iv) functional end groups, whereby one or more of said functional end groups have an anti-coagulant entity covalently attached thereto.

Provided herein are bioactivated polymer/extracellular matrix (ECM) composites and methods of preparation and use thereof. In particular, heparinized cysteine-polymer/ECM composites, and methods of preparation and use thereof, are provided. In some embodiments, provided herein are compositions comprising a composite of: (a) extracellular matrix (ECM), and (b) a polyester covalently linked to a bioactive agent. In some embodiments, the composite is a homogeneous composite. In some embodiments, the ECM is decellularized ECM. In some embodiments, the ECM is not substantially crosslinked.

Provided herein are bioactivated polymer/extracellular matrix (ECM) composites and methods of preparation and use thereof. In particular, heparinized cysteine-polymer/ECM composites, and methods of preparation and use thereof, are provided. In some embodiments, provided herein are compositions comprising a composite of: (a) extracellular matrix (ECM), and (b) a polyester covalently linked to a bioactive agent. In some embodiments, the composite is a homogeneous composite. In some embodiments, the ECM is decellularized ECM. In some embodiments, the ECM is not substantially crosslinked.