Device for priming for improved adherence of gels to substrates

• US 5,749,968 A
• Filed: 06/07/1995
• Issued: 05/12/1998
• Est. Priority Date: 03/01/1993
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Levine, Marc Alan, Melanson, David A., Pichon, Dean M., Bromander, Thomas S., Spiridigliozzi, John C., Nedder, David J., Selecman, George
• Primary Examiner(s): Edwards, Laura
• Application Number:
  US08/472,745
• Time in Patent Office: 1,070 Days
• Field of Search: 118/300, 118/302, 604/59, 604/68, 604/181, 604/183, 604/184, 604/191, 606/214
• US Class Current: 118/300
• CPC Class Codes: A61K 38/42 Haemoglobins; Myoglobins
• CPC Class Codes: A61K 38/44 Oxidoreductases (1)
• CPC Class Codes: C08F 2/48 by ultraviolet or visible light
• CPC Class Codes: C08F 265/04 on to polymers of esters
• CPC Class Codes: C08F 271/00 Macromolecular compounds obtained by polymerising monomers on to polymers of nitrogen-containing monomers as defined in group C08F26/00
• CPC Class Codes: C08F 283/00 Macromolecular compounds obtained by polymerising monomers on to polymers provided for in subclass C08G
• CPC Class Codes: C08F 289/00 Macromolecular compounds obtained by polymerising monomers on to macromolecular compounds not provided for in groups C08F251/00 - C08F287/00
• CPC Class Codes: C08F 290/00 Macromolecular compounds obtained by polymerising monomers on to polymers modified by introduction of aliphatic unsaturated end or side groups
• CPC Class Codes: C08F 290/02 on to polymers modified by introduction of unsaturated end groups
• CPC Class Codes: C08F 290/06 Polymers provided for in subclass C08G
• CPC Class Codes: C08F 290/062 Polyethers
• CPC Class Codes: C08F 290/14 Polymers provided for in subclass C08G
• CPC Class Codes: C08F 291/00 Macromolecular compounds obtained by polymerising monomers on to macromolecular compounds according to more than one of the groups C08F251/00 - C08F289/00
• CPC Class Codes: C08L 2666/02 Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C09D 153/00 Coating compositions based on block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Coating compositions based on derivatives of such polymers
• CPC Class Codes: C09J 151/00 Adhesives based on graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds based on ABS polymers C09J155/02; Adhesives based on derivatives of such polymers
• CPC Class Codes: C12N 11/04 entrapped within the carrier, e.g. gel or hollow fibres
• CPC Class Codes: C12N 2533/30 Synthetic polymers
• CPC Class Codes: C12N 2533/32 Polylysine, polyornithine
• CPC Class Codes: C12N 2533/40 Polyhydroxyacids, e.g. polymers of glycolic or lactic acid (PGA, PLA, PLGA); Bioresorbable polymers
• CPC Class Codes: C12N 2533/74 : Alginate
• CPC Class Codes: C12N 5/0012 : Cell encapsulation

Abstract

An improved barrier or drug delivery system which is highly adherent to the surface to which it is applied is disclosed, along with methods for making the barrier. In the preferred embodiment, tissue is stained with a photoinitiator, then the polymer solution or gel having added thereto a defined amount of the same or a different photoinitator is applied to the tissue. On exposure to light, the resulting system polymerizes at the surface, giving excellent adherence, and also forms a gel in the rest of the applied volume. Thus a gel barrier of arbitrary thickness can be applied to a surface while maintaining high adherence at the interface. This process is referred to herein as "priming". The polymerizable barrier materials are highly useful for sealing tissue surfaces and junctions against leaks of fluids. In another embodiment, "priming" can be used to reliably adhere preformed barriers to tissue or other surfaces, or to adhere tissue surfaces to each other. A first surface and a barrier, or another surface, are prestained with initiator, and a thin layer of gellable monomer containing initiator is placed between them. Strong adhesion is obtained between the two surfaces on gelation of the monomer. In a similar fashion, tissue surfaces can be adhered to each other in repair of wounds and formation of anastomoses. Methods for use of non-photochemical systems and combined chemical/photochemical systems are described.

Claims

1. A combination device for conducting a primed photopolymerization treatment in a biological or medical setting comprising:

a shaft having a proximal end to be held by a person administering the treatment and a distal end from which one or more fluids are dispensed;

a first conduit fluidly connectable to a first reservoir containing a photoinitiator and fluidly connected to the distal end of the shaft;

a second conduit fluidly connectable to a second reservoir containing a monomer solution and fluidly connected to the distal end of the shaft; and

near the distal end of the shaft, a source of electromagnetic radiation of a wavelength that causes activation of the photoinitiator.

2. The device of claim 1 wherein the source of electromagnetic radiation is selected from the group consisting of a fiber optic, a light guide, a focused remote beam, and a light emitter.

3. The device of claim 1 further comprising means for application of the one or more fluids, selected from the group consisting of dripping means, irrigating means, spraying means, applicator pad means, and rigid surfaces.

4. The device of claim 3 further comprising one or more means mounted at the distal end of the shaft for spreading or rubbing a fluid onto a surface in addition to the means for application of the one or more fluids.

5. The device of claim 1 comprising at least two reservoirs, at least one of which contains a priming solution comprising an initiator and a carrier therefor, and at least one of which contains a polymerizable coating solution comprising a polymerizable monomer, an initiator, and a suitable carrier.

11. A device as in claim 1, constructed and arranged to deliver to a tissue surface, separately, a first composition from a first reservoir without delivering a second composition from a second reservoir.

12. A device as in claim 1, including a grippable member near the proximal end of the shaft, wherein the shaft extends distally from the grippable member.

13. A device as in claim 1, wherein the shaft is rigid.

14. A device as in claim 1, wherein the source of electromagnetic radiation is a light source.

15. A device as in claim 14, further comprising an optical fiber connecting a remote light source to the light source.

16. A device as in claim 15, wherein the light source comprises the terminal portion of the optical fiber.

17. A device as in claim 1, further comprising a switch near the proximal end of the shaft, operable by a user of the device, and movable between a first position allowing projection of electromagnetic radiation from the electromagnetic radiation source, and a second position preventing projection of electromagnetic radiation from the electromagnetic radiation source.

18. A device as in claim 1, further comprising a spray nozzle at the distal end of the shaft fluidly connected to at least the first conduit.

19. A device as in claim 1, wherein at least one of the first conduit and the second conduit is opaque.

6. A device as in claim 1l further comprising a first dispenser associated with a first reservoir containing a photoinitiator and a second dispenser associated with a second reservoir containing a monomer solution and a lever near the proximal end of the shaft-coupled to an actuator switchable between a first position in which the lever is operably linkable to the first dispenser and a second position in which the lever is operably linkable to the second dispenser.

7. A device as in claim 6, wherein the lever has freedom of movement between a first position and a second position, and wherein movement of the lever from the first position to the second position, when a first reservoir is carried by the device and the actuator is positioned in its first position, causes a set amount of a composition contained in the reservoir to be dispensed through a conduit to an applicator outlet.

8. A device as in claim 7, further comprising a ratchet mechanism operably linking the lever to the actuator.

9. A device as in claim 6, wherein the lever, when the actuator is in its first position, is not operably linkable to the second dispenser.

10. A device as in claim 6, wherein each of the first and second dispensers is a syringe plunger, and the actuator is a syringe plunger driver.

20. A combination device for conducting a primed photopolymerization treatment in a biological or medical setting comprising:

a shaft having a proximal end to be held by a person administering the treatment and a distal end from which one or more fluids are dispensed;

a first composition reservoir, including a dispenser, connected to a first conduit and a second composition reservoirs, including a dispenser, connected to a second conduit, the composition reservoirs each containing a primer, a monomer solution, or a combination thereof, and the conduits each fluidly connected to the distal end of the shaft;

a lever at the proximal end of the shaft movable between a first position and a second position;

a composition dispensing mechanism having a first position operably linking the first composition reservoir dispenser with the lever and a second position operably linking the second composition reservoir dispenser with the lever;

means for selection among the first position of the dispensing mechanism and the second position of the dispensing mechanism, wherein the lever, when moved from its first position to its second position, dispenses contents of the composition reservoir with which it is operably linked via the dispensing mechanism, whereby the contents of the first and second composition reservoirs are dispensable independently from the distal end from the shaft; and

a source of electromagnetic radiation near the distal end of the shaft.

21. A device as in claim 20, further comprising a switch near the proximal end of the shaft, operable by a user of the device, and movable between a first position allowing projection of electromagnetic radiation from the electromagnetic radiation source, and a second position preventing projection of electromagnetic radiation from the electromagnetic radiation source.

22. A device as in claim 21, wherein the source of electromagnetic radiation is a light source.

23. A device as in claim 22, further comprising an optical fiber connecting a remote light source to the light source near the distal end of the shaft.

24. A device as in claim 23, wherein the light source comprises the terminal portion of the optical fiber.

25. A device as in claim 20, at least one conduit being fluidly connected to a spray nozzle at the distal end of the shaft.

26. A device as in claim 20, wherein at least one of the first and second fluid conduits is opaque.

27. A device as in claim 20, wherein the lever, when moved from its first position to its second position, dispenses a set amount of the contents of the composition reservoir with which it is operably linked via the dispensing mechanism.

28. A device as in claim 27, further comprising a ratchet mechanism operably linking the lever to the dispensing mechanism.

29. A device as in claim 20, wherein at least one of the first composition reservoir and the second composition reservoir is a syringe.