Apparatus and method for local application of polymeric material to tissue

• US 5,612,050 A
• Filed: 06/07/1995
• Issued: 03/18/1997
• Est. Priority Date: 03/23/1993
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Herman, Stephen J., Hubbell, Jeffrey A., Rowe, Stephen C., Ahari, Frederick F., Lang, Michael F., Selecman, George E., Sun, Vae
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/476,124
• Time in Patent Office: 650 Days
• Field of Search: 604/20, 424/423, 424/78.08
• US Class Current: 424/423
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61C 19/004 Hand-held apparatus, e.g. guns
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: B05C 17/01 with manually mechanically or electrically actuated piston or the like B05C17/00533 takes precedence

Abstract

An apparatus is provided for applying to a surface of mammalian tissue including soft, living tissue an initially fluent material and then activating the material by exposure to an energy source. The material may be a liquid capable of polymerization to a non-fluent state by exposure to actinic light. The device, and methods that may be practiced in association with the device, enable a wide range of medical conditions to be treated including, for example, the application of a barrier to, soft tissue to prevent post-surgical adhesions.

Claims

1. A method of applying polymeric, non-fluent material to mammalian tissue, comprising:

applying an initially entirely fluent, pre-polymeric material to the tissue by emitting the pre-polymeric material from an emission element located on an applicator; and

applying to the material actinic light from an emitter of actinic light located on the applicator for a period of time sufficient to convert the material to a polymeric, non-fluent condition.

2. A method as in claim 1, the applying step comprising applying a predetermined volume of fluent, pre-polymeric material to the tissue.

3. A method as in claim 1, wherein the step of applying fluent pre-polymeric material to the tissue involves forming a coating of fluent pre-polymeric material on the tissue, and the step of applying actinic light involves converting the coating of fluent pre-polymeric material to a coating of polymeric, non-fluent material on the tissue.

4. A method as in claim 1, wherein the step of applying pre-polymeric material to the tissue involves emitting the pre-polymeric material from an emission element located at a distal portion of an applicator having a proximal portion and a distal portion, and

the step of applying actinic light involves applying the actinic light from an emitter of actinic light located at the distal portion of the applicator.

5. A method as in claim 4 wherein the step of applying actinic light further involves activating a source of actinic light that is connected, via an optical connector, to the emitter of actinic light.

6. A method as in claim 4 wherein the step of applying pre-polymeric material further involves dispersing the pre-polymeric material from a nozzle that is a component of the emission element, in a predetermined pattern.

7. A method as in claim 4, wherein the actinic light is emitted from the distal portion of the applicator in the same direction in which the pre-polymeric material is applied from the distal portion of the applicator.

8. A method as in claim 4, wherein the step of applying actinic light involves applying actinic light to a tissue surface in a pattern at least as large as a dispersion pattern in which the pre-polymeric material is applied to the tissue surface.

9. A method as in claim 4, wherein, following the step of applying pre-polymeric material to the tissue surface in a first pattern, the method involves applying actinic light to the tissue surface in a pattern that is substantially the same shape as that of the first pattern.

10. A method as in claim 4, further comprising allowing a controller that automatically operates the emitter of actinic light to activate the actinic light following the step of applying the pre-polymeric material to the tissue.

11. A method as in claim 1, further comprising inserting the applicator, percutaneously, into the body of a mammal.

12. A method as in claim 1, further comprising inserting the applicator via an incision into a mammal.

13. A method as in claim 1, further comprising inserting the applicator via a natural orifice into a mammal.

14. A method as in claim 4 wherein the distal portion of the applicator is adapted for insertion into a patient and proximal portion remains outside of the patient, the method further comprising inserting the distal portion of the applicator, percutaneously, into the body of a mammal.

15. A method as in claim 4, wherein the distal portion of the applicator is adapted for insertion into a patient and proximal portion remains outside of the patient, the method further comprising inserting the applicator via an incision into a mammal.

16. A method as in claim 14, wherein the distal portion of the applicator is adapted for insertion into a patient and proximal portion remains outside of the patient, the method further comprising inserting the applicator via a natural orifice into a mammal.

17. A method as in claim 2, wherein the step of applying a predetermined volume of fluent, pre-polymeric material to the tissue defines a first cycle of a cyclical procedure, the method further comprising applying a second predetermined volume of fluent pre-polymeric material to the tissue in a second cycle.

18. A method as in claim 17, wherein the first and second predetermined volumes of fluent pre-polymeric material are essentially the same.

19. A method as in claim 17, wherein the step of applying actinic light to the material is effected between the first and second cycles.

20. A method as in claim 1, wherein the step of applying the fluent pre-polymeric material involves spraying the fluent pre-polymeric material onto the tissue.

21. A method of aiming a fluent delivery device and for irradiating fluent material delivered by the device, comprising:

providing a delivery and activating device having an applicator constructed and arranged to deliver fluent material in a predetermined pattern, the device having an emitter that emits electromagnetic radiation in a substantially corresponding pattern;

preliminary irradiating a tissue surface with light in the predetermined pattern using the light pattern as a guide to orient the device at a selected location with respect to the tissue;

thereafter delivering the fluent material onto the tissue at the location in the predetermined pattern; and

thereafter emitting electromagnetic radiation from the emitter onto the fluent material to activate the material to convert it to a non-fluent state.

22. A method as in claim 21, wherein the step of delivering the fluent material onto the tissue involves spraying the fluent material onto the tissue.

23. A method as in claim 22, wherein the step of spraying the fluent material onto the tissue involves delivering a bolus of pre-polymer fluid into a gas stream moving at a velocity sufficient to atomize the pre-polymer fluid to form a spray.

24. A method as in claim 22, wherein the spraying step involves spraying the fluent material onto the tissue in a generally conical spray pattern.

25. A method as in claim 21, wherein the step of emitting electromagnetic radiation onto the fluent material to activate the material involves emitting actinic light from the emitter onto the fluent material.

26. A method as in claim 21, wherein the step of delivering fluent material onto the tissue involves delivering a predetermined volume of the fluent material onto the tissue.

27. A method as in claim 21, wherein the steps of delivering the fluent material onto the tissue and thereafter emitting electromagnetic radiation onto the fluent material to convert it to a non-fluent state defines a first cycle of operation, the method further comprising a second cycle involving delivering fluent material onto the tissue and emitting electromagnetic radiation from the emitter onto the fluent material to convert it to a non-fluent state.

28. A method as in claim 27, wherein each of the first and second cycles involves delivering a predetermined volume of fluent material onto the tissue.

29. A method as in claim 28 wherein the predetermined volume of fluent material delivered in each of the first and second cycles is essentially the same.

30. A method as in claim 21, further comprising orienting the delivery and activating device with respect to the tissue with a gauge.

31. A method as in claim 21, further comprising allowing a microprocessor to activate the emitter automatically following the delivery of the fluent material onto the tissue.

32. A method of applying, to mammalian tissue, a polymeric, non-fluent material, comprising:

applying an initially entirely fluent, pre-polymeric material to the tissue by emitting the pre-polymeric material from an emission element located on an applicator; and

applying to the material actinic light from an emitter of actinic light located on the applicator for a period of time sufficient to convert the material to a polymeric, non-fluent condition.

33. A method of applying a polymeric, non-fluent material to a surface of tissue internally of a mammal, comprising:

applying percutaneously an initially entirely fluent, pre-polymeric material to a tissue surface internally of a mammal, the material being activatable to a non-fluent, polymeric condition by exposure to actinic light; and

thereafter applying to the material actinic light for a sufficient length of time to effect in situ conversion of the material from a pre-polymeric, fluent to a polymeric, non-fluent condition.