Methods and devices for forming biomedical coatings using variable mixing ratios of multi-part compositions

Patent metadata

Field	Value
Publication number	US-10085729-B2
Application number	US-201414199173-A
Country	US
Kind code	B2
Filing date	Mar 6, 2014
Priority date	Mar 6, 2014
Publication date	Oct 2, 2018
Grant date	Oct 2, 2018

Abstract

The present invention relates devices capable of continuous and simultaneous expression of components of a multi-part biomedical composition with variable mixing ratios. The device has at least two syringes that contain the inter-reactive components of the multi-part biomedical composition. At least the barrel of the first syringe has a first retention compartment having a cross-sectional area dimension that is larger than the cross-sectional area of a second retention compartment. The first piston has a cross-sectional dimension that matches the inside cross-sectional dimension of the small dimensioned retention compartment, while a ring-shaped gasket is located within the large dimensioned retention compartment and has an outside cross-sectional dimension that matches an interior dimension of the large dimension retention compartment.

First claim

The invention claimed is:

1. A device for uninterruptible simultaneous expression of components of a multi-part biomedical composition in varying mixing ratios, comprising
at least two syringes each containing a different component of the multi-part biomedical composition, each of said syringes positioned side by side and interconnected side-by-side by connecting linkages in a fixed position relative to each other, each of said syringes further comprising plungers connected to each other at a distal end and having pistons attached to said plungers at a proximal end;
wherein the first syringe comprises a first retention compartment and a second retention compartment that are spaced axially from each other along a linear axis,
wherein the first retention compartment has at least in part a larger cross-sectional dimension relative to the second retention compartment;
wherein the first piston located within a barrel of the first syringe has a first piston cross-sectional dimension that corresponds to an inside cross-sectional dimension of the second retention compartment; and
wherein a ring-shaped gasket is located within the first retention compartment and has an outside dimension that corresponds to an interior dimension of the first retention compartment.

2. The device of claim 1 wherein the second syringe comprises a second syringe first retention compartment and a second syringe second retention compartment that are spaced axially from each other along a linear axis, wherein the second syringe first retention compartment has at least in part a larger cross-sectional dimension relative to the second syringe second retention compartment.

3. The device of claim 1 , wherein the device further comprises a mixing manifold, an expression port and nozzles affixed to the at least first and second syringes, said nozzles connected to the mixing manifold and said manifold terminating at the expression port.

4. The device of claim 1 , wherein the retention compartments are cylindrical and the first retention compartments have inside diameters of their cross-sectional that is at least 20% larger than the inside diameter of the second retention compartment, and wherein the mixing ratios are changed step-wise.

5. The device of claim 1 , wherein the gasket engages with the first piston.

6. The device of claim 1 , wherein diameter of the first piston is equal to or larger than diameter of an opening of the gasket.

7. The device of claim 1 , wherein the components of the multi-part biomedical composition are: fibrinogen and thrombin or a polymer-based multi-arm macromer with ester functionality and multi-arm crosslinker with amine functionality.

8. The device of claim 1 , wherein the multi-part biomedical composition forms a coating on a tissue, wherein said coating has physiologically observable properties which are different on a side facing the tissue and on an opposing side thereof, wherein the physiologically observable properties are selected from the group consisting of sealant, hemostatic, adhesive, anti-adhesion and combinations thereof.

9. The device of claim 1 comprising three syringes wherein the first syringe contains a polymerizable or crosslinkable material, the second syringe contains a crosslinking or polymerization initiating agent, and the third syringe contains a material selected from the group consisting of a diluent, a colorant or dye, additional or different crosslinking agent or polymerization initiator and combinations thereof.

10. The device of claim 1 , wherein the first retention compartment has a large diameter and is positioned closer to the distal end; and wherein the second retention compartment has a small diameter and is positioned closer to the proximal end.

11. The device of claim 1 , wherein the first retention compartment has a large diameter and is positioned closer to the proximal end; and wherein the second retention compartment has a small diameter and is positioned closer to the distal end.

12. A device for uninterruptible simultaneous expression of a multi-part biomedical composition in a step-wise changing ratios, comprising
at least three chambers fixedly arranged together within an optional holder, each chamber having a spray pump and each chamber separately containing flowable components of the multi-part biomedical composition;
wherein each spray pump has an actuator positioned in proximity to said spray pump, with all actuators fixedly arranged together in an actuator assembly;
wherein said device further comprises a lever releasably restraining a first actuator from actuating a first spray pump;
wherein said device further comprises a spring between the actuator assembly and the first actuator releasably restrained by the lever,
said spring configured to push the first actuator to the same level as all the actuators;
said lever configured to restrain, release, reengage, and lock the first actuator.

13. The device of claim 12 , wherein the multi-part biomedical composition forms a coating in a final form on a tissue, wherein said coating in its final form has physiologically observable properties which are different on a side facing the tissue and on an opposing side, wherein the physiologically observable properties are selected from the group consisting of sealant, hemostatic, adhesive, anti-adhesion and mixtures thereof.

14. The device of claim 12 wherein the first chamber contains a polymerizable or crosslinkable material, the second chamber contains a polymerization initiator or crosslinking agent, and
the third chamber contains a material selected from the group consisting of a diluent, a colorant or dye, a polymerizable or crosslinkable material, a polymerization initiator, crosslinking agent and combinations thereof.

15. A device for uninterruptible simultaneous expression of a multi-part biomedical composition in varying mixing ratios comprising a first syringe, a second syringe and a third syringe,
each syringe having a proximal end and an opposing distal end, each syringe containing a component of the multi-part biomedical composition,
said syringes comprising a barrel and elongated rods, the rods having a front end and an opposing rear end and a piston attached to each of said rods at the front end;
wherein the pistons of the first and the second syringes are positioned at the distal end and the piston of the third syringe is located between the distal end and the proximal end;
wherein the rods of the first and the second syringes are attached at the rear end to a bar for simultaneous movement and the rod of the third syringe is not attached to said bar, forming a gap between the rear end of the rod of the third syringe and the bar; and
wherein the bar projects over said rod of the third syringe,
wherein the bar is configured to touch and engage the rod of the third syringe as the bar advances towards the proximal end.

16. The device of claim 15 , wherein the multi-part biomedical composition forms a coating on a tissue, wherein said coating has physiologically observable properties which are different on a side facing the tissue and on an opposing side thereof, wherein the physiologically observable properties are selected from the group consisting of sealant, hemostatic, adhesive, anti-adhesion and combinations thereof,
and wherein the first syringe contains a polymerizable or crosslinkable material, the second syringe contains a crosslinking or polymerization initiating agent, and the third syringe contains a material selected from the group consisting of a diluent, a colorant or dye, additional or different crosslinking agent or polymer

Assignees

• Ethicon Inc

Inventors

• Jamiolkowski Dennis D
• Sung An-Min Jason
• Kriksunov Leo B

Classifications

• B05B11/1083

  in adjustable proportion · CPC title

• B05B11/1059

  Means for locking a pump or its actuation means in a fixed position (B05B11/1091 takes precedence) · CPC title

• B05B11/1084

  each liquid or other fluent material being pumped by a separate pump · CPC title

• B05B11/3059

  Operations & Transport · mapped topic

• B05B11/3084

  Operations & Transport · mapped topic