Method for local application of polymeric material to tissue

• US 5,698,189 A
• Filed: 11/27/1995
• Issued: 12/16/1997
• Est. Priority Date: 03/23/1993
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Lang, Michael F., Herman, Stephen J., Hubbell, Jeffrey A., Rowe, Stephen C., Ahari, Frederick F., Selecman, George E., Sun, Vae
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/448,573
• Time in Patent Office: 750 Days
• Field of Search: 424/426, 424/78.08, 604/20
• US Class Current: 424/78.08
• 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

This invention relates to devices and techniques for applying therapeutic polymeric material to living tissue.

Claims

1. An apparatus for applying, to a surface of mammalian tissue, a pre-polymeric material that is entirely fluent and activatable to a polymeric non-fluent condition by exposure to actinic light, comprising:

an applicator having a proximal end and a distal end;

the distal end of the applicator having an emission element constructed to emit the pre-polymeric fluent material onto the tissue surface; and

an emitter of actinic light at the distal end of the applicator for applying said actinic light to the pre-polymeric fluent material in situ to initiate conversion of the applied material from pre-polymeric fluent to polymeric non-fluent form.

2. An apparatus as in claim 1, further comprising a source of actinic light, and an optical connector connecting the source to the emitter of actinic light.

3. An apparatus as in claim 1 wherein the emission element comprises a nozzle adapted to emit the entirely fluent pre-polymeric material and disperse it in a predetermined pattern.

4. An apparatus as in claim 3 wherein the nozzle and the emitter of actinic light are each constructed to direct the pre-polymeric fluent material and actinic light, respectively, in the same direction.

5. An apparatus as in claim 3 wherein the emitter of actinic light is adapted to apply the actinic light to the tissue in a pattern at least as large as the dispersion pattern of the nozzle, thereby to assure full exposure of the applied material to the actinic light.

6. An apparatus as in claim 3 wherein the emitter of actinic light is constructed to emit the actinic light in a pattern that is substantially the same shape as that in which the material is applied.

7. An apparatus as in claim 1 further comprising a controller that automatically operates the emitter of actinic light after the emission element has emitted the fluent pre-polymeric material.

8. An apparatus as in claim 5 wherein the direction of propagation of pre-polymeric fluent material and the direction of actinic light emission are substantially the same.

9. An apparatus as in claim 1 wherein the applicator has a grippable member at its proximal end and a shaft extending distally from the grippable member and further comprising:

the shaft having conduits for transmission of gas, actinic light, and the fluent pre-polymeric material.

10. An apparatus as in claim 9 wherein the grippable member comprises a handle, the apparatus further comprising:

a reservoir of fluent pre-polymeric material contained in the handle and a pump mechanism for pumping the fluent pre-polymeric material from the reservoir to and out of the emission element; and

a controller for operating the pump and the emitter of actinic light, exposed externally of the handle.

11. An apparatus as in claim 1 wherein the applicator includes a shaft extending to the distal end, the shaft being rigid.

12. An apparatus as in claim 1 wherein the applicator includes a shaft extending to the distal end of the device, at least part of the shaft being non-rigid.

13. An apparatus as in claim 1 wherein the apparatus emits a predetermined volume of fluent pre-polymeric material from the emission element for each cycle of operation of the apparatus.

14. An apparatus as in claim 4 wherein the nozzle is adapted to emit the fluent pre-polymeric material in a spray.

15. An apparatus as in claim 1 wherein the emission element is constructed to apply the material in the form of a coating on the tissue.

16. An apparatus as in claim 1 further comprising:

the distal end of the applicator being constructed and arranged to be inserted into the body of a mammal.

17. An apparatus as in claim 1 further comprising:

a pump mechanism carried by the applicator for effecting ejection of a predetermined volume of fluent material from the emission outlet, the pump mechanism including a self-contained power source for operating the pump mechanism to cause emission of fluent material.

18. An apparatus as in claim 17 further comprising:

a variable volume reservoir carried by the applicator;

the pump mechanism being connectable to the reservoir to reduce the volume of the reservoir in incremental steps.

19. An apparatus as in claim 18 further comprising:

the self-contained power source including an energy storage element for providing the motive power for operating the pump mechanism in an ejection stroke, the spring being constructed to develop sufficient pressure in the reservoir to effect emission of the fluent material from the emission outlet.

20. An apparatus as defined in claim 19 further comprising:

a cocking and release mechanism for first activating the spring and then for releasing the mechanism to enable the energy stored in the storage element to effect the ejection stroke of the pump mechanism.

21. An apparatus as in claim 18 further constructed and arranged so that each of the incremental steps is adapted to cause an abrupt brief pulse of liquid emitted in a predetermined pattern from the emission outlet.

22. An apparatus as in claim 17 wherein the applicator includes a housing and wherein the pump mechanism further comprises:

the reservoir being mounted to the housing and having a movable element by which the volume of the reservoir may be varied;

the reservoir having an outlet;

a conduit connecting the outlet of the reservoir to the emission outlet;

a driver movably mounted to the housing and having a portion thereof engageable with the movable elements of the reservoir;

the self-contained power source being carried by the housing and being operatively connected to the driver to move the driver in a direction that will effect an ejection stroke;

the pump mechanism being constructed and arranged to limit the movement of the driver in the ejection stroke to said incremental movements.

23. An apparatus as in claim 22 wherein the power source comprises a spring.

24. An apparatus as in claim 23 wherein the spring is manually energized and releasable.

25. An apparatus as in claim 23 wherein the limiting mechanism comprises:

a stop mounted to the housing to limit the movement of the driver in an ejection stroke;

the driver being movable in a direction opposite to the ejection stroke and in opposition to the force of the spring, in readiness for an ejection stroke.

26. An apparatus as in claim 25 further comprising means for holding the driver in a cocked position.

27. An apparatus as in claim 26 further comprising:

means for releasing the driver from the cocked position to enable the driver to advance in an ejection stroke under the influence of the spring.

28. An apparatus as in claim 27 further comprising:

means responsive to operation of the means for releasing the driver from its cocked position for actuating the light source.

29. An apparatus as in claim 26 wherein the holding means further comprises a linear ratchet mechanism.

30. An apparatus as in claim 29 wherein the linear ratchet mechanism comprises:

the driver having a plurality of teeth formed thereon;

a pawl movable in an ejection direction and a retraction direction, the pawl having teeth engageable with the teeth on the driver;

the teeth on the driver and the driver pawl being constructed to enable the pawl to be retracted while maintaining the driver in a fixed position and to enable the pawl to drive the driver in an ejection direction;

a locking pawl having teeth cooperatively engageable with the teeth on the driver, the locking pawl being fixed securely to the housing, the teeth on the locking pawl being constructed to enable the driver to be advanced in an ejection direction but to preclude retraction of the driver.

31. An apparatus as in claim 30 further comprising:

means for disengaging the teeth of the driver and locking pawls with the teeth on the driver to enable the manual retraction of the driver.

32. An apparatus as in claim 1 further comprising:

at least one suction port disposed at the tip of the applicator adjacent the emission outlet, the suction port being adapted to be in fluid communication with the source of suction.

33. An apparatus as in claim 1 further comprising:

a gauge attached to and extending distally from the distal end of the applicator to facilitate orientation of the distal end of the applicator with respect to the target tissue.

34. An apparatus as in claim 33, wherein the gauge can flex relative to the applicator tip so that movement of the gauge can be observed and thereby provide an indication of the location of the tip of the applicator with respect to the target tissue.

35. An apparatus as in claim 34 wherein the gauge further comprises:

at least one elongate flexible gauge element disposed at an angle to the shaft axis.

36. An apparatus as in claim 35, wherein the angle defined between the gauge element and the shaft axis is greater than the half angle defined by the spray cone of the liquid emitted from the emission outlet.

37. An apparatus as in claim 35 further comprising:

a sheath slidably mounted on the distal end of the applicator for movement beyond the tip of the applicator to draw the gauge element toward alignment with the shaft axis and to permit insertion of the distal end of the applicator through a trocar cannula, the sheath being retractable to permit the gauge element to spread away from the axis after the applicator tip has been inserted into and beyond the distal end of the trocar cannula.